What science can do
AstraZeneca Annual Report and Form 20-F Information 2016
Welcome to the AstraZeneca
Annual Report and Form 20-F Information 2016.
We are a global, science-led
biopharmaceutical business and
in this Annual Report we report on
the progress we made in 2016 in
pushing the boundaries of science
to deliver life-changing medicines.
AstraZeneca.
What science can do.
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(cid:89)(cid:76)(cid:72)(cid:90)
(cid:15) (cid:89)(cid:76)(cid:72)
(cid:89)(cid:72)
(cid:81)(cid:70)(cid:72)
(cid:72)
(cid:82)
(cid:89)(cid:72)
(cid:87)(cid:72)(cid:74)(cid:74)(cid:92)(cid:92)(cid:92)
(cid:92)(cid:3)(cid:82)(cid:73)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:86)(cid:87)(cid:85)(cid:68)(cid:87)(cid:72)(cid:74)(cid:92)(cid:17)
(cid:92)(cid:17)
(cid:81)
(cid:75)
(cid:75)
Important information for readers
of this Annual Report
For more information in relation to the inclusion of reported
(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:15)(cid:3)(cid:38)(cid:82)(cid:85)(cid:72)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:80)(cid:72)(cid:68)(cid:86)(cid:88)(cid:85)(cid:72)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:70)(cid:82)(cid:81)(cid:86)(cid:87)(cid:68)(cid:81)(cid:87)(cid:3)
exchange rate (CER) growth rates as used in this Annual
Report, please see the Financial Review on page 64.
> (cid:38)(cid:75)(cid:76)(cid:72)(cid:73)(cid:3)(cid:40)(cid:91)(cid:72)(cid:70)(cid:88)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:50)(cid:433)(cid:70)(cid:72)(cid:85)(cid:350)(cid:86)(cid:3)(cid:53)(cid:72)(cid:89)(cid:76)(cid:72)(cid:90)
> Therapy Area Review
> Business Review
> Resources Review: including Employees
> Financial Review: Financial risk management
> Corporate Governance: including the Audit Committee
(cid:39)(cid:72)(cid:430)(cid:81)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)
(cid:55)(cid:75)(cid:72)(cid:3)(cid:42)(cid:79)(cid:82)(cid:86)(cid:86)(cid:68)(cid:85)(cid:92)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:48)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:3)(cid:71)(cid:72)(cid:430)(cid:81)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:87)(cid:68)(cid:69)(cid:79)(cid:72)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:83)(cid:68)(cid:74)(cid:72)(cid:3)
239 are intended to provide a useful guide to terms and
(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:350)(cid:86)(cid:3)(cid:71)(cid:72)(cid:430)(cid:81)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:86)(cid:15)(cid:3)(cid:68)(cid:86)(cid:3)(cid:90)(cid:72)(cid:79)(cid:79)(cid:3)(cid:68)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)
acronyms and abbreviations, used in this Annual Report.
Use of terms
In this Annual Report, unless the context otherwise
requires, ‘AstraZeneca’, ‘the Group’, ‘we’, ‘us’ and ‘our’ refer
to AstraZeneca PLC and its consolidated entities.
Cautionary statement regarding
forward-looking statements
A cautionary statement regarding forward-looking
statements and other essential information relating to this
Annual Report can be found on page 243.
Directors’ Report
The following sections make up the Directors’ Report,
(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:75)(cid:68)(cid:86)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:83)(cid:85)(cid:72)(cid:83)(cid:68)(cid:85)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:85)(cid:71)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:98)(cid:87)(cid:75)(cid:72)(cid:3)
requirements of the Companies Act 2006:
Report and Corporate Governance Report
> Directors’ Responsibility Statement
> Development Pipeline
> Sustainability: supplementary information
> Shareholder Information
> Corporate Information
Strategic Report
The following sections make up the Strategic Report, which
has been prepared in accordance with the requirements of
the Companies Act 2006:
> AstraZeneca at a glance
> (cid:38)(cid:75)(cid:76)(cid:72)(cid:73)(cid:3)(cid:40)(cid:91)(cid:72)(cid:70)(cid:88)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:50)(cid:433)(cid:70)(cid:72)(cid:85)(cid:350)(cid:86)(cid:3)(cid:53)(cid:72)(cid:89)(cid:76)(cid:72)(cid:90)
> Strategy: including Risk overview
> Therapy Area Review
> Business Review
> Resources Review
> Financial Review
Learn about our main therapy areas:
Oncology
Our ambition is to eliminate cancer as a
(cid:70)(cid:68)(cid:88)(cid:86)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:71)(cid:72)(cid:68)(cid:87)(cid:75)(cid:3)(cid:87)(cid:75)(cid:85)(cid:82)(cid:88)(cid:74)(cid:75)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:71)(cid:76)(cid:86)(cid:70)(cid:82)(cid:89)(cid:72)(cid:85)(cid:92)(cid:3)
and collaborations.
See page 25
Cardiovascular & Metabolic Disease
We address multiple risk factors to reduce
cardiovascular morbidity, mortality and
organ damage.
See page 30
Respiratory
We aim to transform the treatment of
respiratory disease with our growing
portfolio of medicines.
See page 35
Front cover
Treatment for hyperkalaemia
Current treatments for hyperkalaemia, a potentially
life-threatening condition associated with chronic kidney
disease and chronic heart failure, are poorly tolerated by
patients. AstraZeneca is developing a treatment which traps
potassium in the gut and removes it from the body.
Financial highlights
Total Revenue*
down 7% to $23,002 million at actual rate
of exchange (down 5% at CER)
(cid:49)(cid:72)(cid:87)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:82)(cid:83)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:68)(cid:70)(cid:87)(cid:76)(cid:89)(cid:76)(cid:87)(cid:76)(cid:72)(cid:86)
up 25% at actual rate of exchange
to $4,145 million
2016
2015
2014
$23bn
$23,002m
$24,708m
$26,547m
2016
2015
2014
$4.1bn
(cid:53)(cid:72)(cid:83)(cid:82)(cid:85)(cid:87)(cid:72)(cid:71)(cid:3)(cid:82)(cid:83)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:83)(cid:85)(cid:82)(cid:430)(cid:87)(cid:3)
up 19% at actual rate of exchange
to $4,902 million (up 9% at CER)
(cid:38)(cid:82)(cid:85)(cid:72)(cid:3)(cid:82)(cid:83)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:83)(cid:85)(cid:82)(cid:430)(cid:87)
down 3% at actual rate of exchange
to $6,721 million (down 7% at CER)
2016
2015
2014
$4.9bn
$4,902m
$4,114m
$2,137m
2016
2015
2014
$6.7bn
Reported EPS
for the full year up 24% at actual rate of
exchange to $2.77 (up 9% at CER)
Core EPS
for the full year up 1% at actual rate of
exchange to $4.31 (down 5% at CER)
2016
2015
2014
$2.77
$2.77
$2.23
$0.98
2016
2015
2014
$4.31
$4,145m
$3,324m
$7,058m
$6,721m
$6,902m
$6,937m
$4.31
$4.26
$4.28
Financial Review from page 62
* As detailed on page 142, Total Revenue consists
of Product Sales and Externalisation Revenue.
For more information within
this Annual Report
For more information see
www.astrazeneca.com
Contents
Strategic Report
AstraZeneca at a glance
(cid:38)(cid:75)(cid:76)(cid:72)(cid:73)(cid:3)(cid:40)(cid:91)(cid:72)(cid:70)(cid:88)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:50)(cid:433)(cid:70)(cid:72)(cid:85)(cid:350)(cid:86)(cid:3)(cid:53)(cid:72)(cid:89)(cid:76)(cid:72)(cid:90)(cid:3)
Strategy
Therapy Area Review
Oncology
Cardiovascular & Metabolic Disease
Respiratory
Other Disease Areas
Business Review
Resources Review
Financial Review
Corporate Governance
Chairman’s Statement
Corporate Governance Overview
Board of Directors
Senior Executive Team
Corporate Governance Report
Audit Committee Report
Directors’ Remuneration Report
Financial Statements
Auditor’s Reports (Group)
Consolidated Statements
Group Accounting Policies
Notes to the Group Financial
Statements
Group Subsidiaries and Holdings
Auditor’s Report (Company)
Company Statements
Company Accounting Policies
Notes to the Company Financial
Statements
Group Financial Record
Additional Information
Development Pipeline
Patent Expiries of Key Marketed
Products
Risk
Geographical Review
Sustainability:
supplementary information
Shareholder Information
Corporate Information
Trade Marks
Glossary
Index
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This Annual Report is also available on our website,
www.astrazeneca.com/annualreport2016
AstraZeneca Annual Report and Form 20-F Information 2016
1
Strategic Report
AstraZeneca at a glance
A global biopharmaceutical business delivering medicines to patients through
innovative science and excellence in development and commercialisation.
(cid:50)(cid:88)(cid:85)(cid:3)(cid:86)(cid:87)(cid:85)(cid:68)(cid:87)(cid:72)(cid:74)(cid:76)(cid:70)(cid:3)(cid:83)(cid:85)(cid:76)(cid:82)(cid:85)(cid:76)(cid:87)(cid:76)(cid:72)(cid:86)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:3)(cid:75)(cid:82)(cid:90)(cid:3)(cid:90)(cid:72)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:90)(cid:82)(cid:85)(cid:78)(cid:76)(cid:81)(cid:74)(cid:3)(cid:87)(cid:82)(cid:3)(cid:68)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:51)(cid:88)(cid:85)(cid:83)(cid:82)(cid:86)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:83)(cid:88)(cid:86)(cid:75)(cid:76)(cid:81)(cid:74)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:69)(cid:82)(cid:88)(cid:81)(cid:71)(cid:68)(cid:85)(cid:76)(cid:72)(cid:86)(cid:3)
of science to deliver life-changing medicines:
(cid:20)(cid:3) (cid:36)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:79)(cid:72)(cid:68)(cid:71)(cid:72)(cid:85)(cid:86)(cid:75)(cid:76)(cid:83)(cid:3)
2 Return to growth
3 Be a great place to work
A science-led, innovation strategy
Distinctive R&D capabilities: small molecule
and biologic medicine, including immunotherapies
and protein engineering, as well as devices,
biomarkers and translational science
Strategy and key performance indicators from page 16
Broad R&D platform in three main therapy areas
12 new molecular entities (NMEs) in Phase III/pivotal
Phase II or under regulatory review
2016
2015
2014
2013
12
12
15
13
11
Oncology
Cardiovascular
& Metabolic Disease
Respiratory
> Our ambition is to eliminate cancer
(cid:68)(cid:86)(cid:3)(cid:68)(cid:3)(cid:70)(cid:68)(cid:88)(cid:86)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:71)(cid:72)(cid:68)(cid:87)(cid:75)(cid:3)(cid:87)(cid:75)(cid:85)(cid:82)(cid:88)(cid:74)(cid:75)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)
discovery and collaborations. We seek to
achieve this by means of our combination-
focused pipeline that exploits the power
(cid:82)(cid:73)(cid:3)(cid:73)(cid:82)(cid:88)(cid:85)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:83)(cid:79)(cid:68)(cid:87)(cid:73)(cid:82)(cid:85)(cid:80)(cid:86)
> We push the boundaries of science to
create life-changing medicines for
patients that reduce morbidity, mortality
and organ damage by addressing
multiple risk factors
> We aim to transform the treatment of
respiratory disease with our growing
portfolio of inhaled and biologic
(cid:80)(cid:72)(cid:71)(cid:76)(cid:70)(cid:76)(cid:81)(cid:72)(cid:86)(cid:3)(cid:68)(cid:79)(cid:82)(cid:81)(cid:74)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:85)(cid:72)(cid:86)(cid:72)(cid:68)(cid:85)(cid:70)(cid:75)(cid:3)
(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:71)(cid:76)(cid:86)(cid:72)(cid:68)(cid:86)(cid:72)(cid:3)(cid:80)(cid:82)(cid:71)(cid:76)(cid:430)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)
Portfolio of specialty and primary care products
Oncology
Cardiovascular &
Metabolic Disease
Respiratory
Other Disease
Areas
$3,383m
$8,116m
$4,753m
$5,067m
Product Sales
2015: $2,825m
2014: $3,027m
Product Sales
2015: $9,489m
2014: $9,802m
Product Sales
2015: $4,987m
2014: $5,063m
Product Sales
2015: $6,340m
2014: $8,203m
> Oncology sales represented 16%
> CVMD sales represented 38%
> Respiratory sales represented 22%
> Other sales represented 24%
of Total Product Sales
of Total Product Sales
of Total Product Sales
of Total Product Sales
> Lynparza (sales of $218 million)
> Sales of Onglyza in the US
> Pulmicort sales of $1,061 million,
available in 31 countries by end 2016
> Iressa sales of $513 million,
down 6% (5% at CER), as we
prioritised Tagrisso
declined 10% to $376 million,
as we prioritised Farxiga
> In the US, Crestor sales declined
(cid:24)(cid:26)(cid:8)(cid:3)(cid:87)(cid:82)(cid:3)(cid:7)(cid:20)(cid:15)(cid:21)(cid:21)(cid:22)(cid:3)(cid:80)(cid:76)(cid:79)(cid:79)(cid:76)(cid:82)(cid:81)(cid:15)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)
entry of generic Crestor
up 5% (8% at CER)
> Bevespi Aerosphere inhalation
aerosol launched in the US in
January 2017
> Nexium sales of $2,032 million,
down 19% (18% at CER) and
Seroquel XR sales of $735 million,
down 28% (27% at CER) following
loss of exclusivity
(cid:3) (cid:55)(cid:75)(cid:72)(cid:85)(cid:68)(cid:83)(cid:92)(cid:3)(cid:36)(cid:85)(cid:72)(cid:68)(cid:3)(cid:53)(cid:72)(cid:89)(cid:76)(cid:72)(cid:90)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:83)(cid:68)(cid:74)(cid:72)(cid:3)(cid:21)(cid:22)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:36)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:79)(cid:72)(cid:68)(cid:71)(cid:72)(cid:85)(cid:86)(cid:75)(cid:76)(cid:83)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:83)(cid:68)(cid:74)(cid:72)(cid:3)(cid:23)(cid:24)
2
AstraZeneca Annual Report and Form 20-F Information 2016
Global commercial presence, with strength in Emerging Markets
US
Europe
Established Rest of World
Emerging Markets
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$7,365m
$5,064m
$3,096m
$5,794m
Product Sales
2015: $9,474m
2014: $10,120m
Product Sales
2015: $5,323m
2014: $6,638m
Product Sales
2015: $3,022m
2014: $3,510m
Product Sales
2015: $5,822m
2014: $5,827m
Commercial Highlights: Growth Platforms grew by 4% (5% at CER) in 2016
> Emerging Markets: Stable (growth of 6% at CER), supported by China,
> Brilinta/Brilique sales grew by 36% (39% at CER)
up 4% (10% at CER) to $2,636 million
> (cid:53)(cid:72)(cid:86)(cid:83)(cid:76)(cid:85)(cid:68)(cid:87)(cid:82)(cid:85)(cid:92)(cid:29)(cid:3)(cid:36)(cid:3)(cid:71)(cid:72)(cid:70)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:24)(cid:8)(cid:3)(cid:11)(cid:22)(cid:8)(cid:3)(cid:68)(cid:87)(cid:3)(cid:38)(cid:40)(cid:53)(cid:12)(cid:15)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:56)(cid:54)(cid:3)(cid:83)(cid:85)(cid:76)(cid:70)(cid:76)(cid:81)(cid:74)(cid:3)(cid:83)(cid:85)(cid:72)(cid:86)(cid:86)(cid:88)(cid:85)(cid:72)(cid:3)
> Diabetes: Growth of 9% (11% at CER), as Farxiga/Forxiga became
for Symbicort
our largest-selling Diabetes medicine
> New Oncology: Strong sales with Tagrisso delivering sales of $423 million
> (cid:45)(cid:68)(cid:83)(cid:68)(cid:81)(cid:29)(cid:3)(cid:54)(cid:68)(cid:79)(cid:72)(cid:86)(cid:3)(cid:88)(cid:83)(cid:3)(cid:27)(cid:8)(cid:3)(cid:11)(cid:71)(cid:72)(cid:70)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:22)(cid:8)(cid:3)(cid:68)(cid:87)(cid:3)(cid:38)(cid:40)(cid:53)(cid:12)(cid:15)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:72)(cid:91)(cid:70)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:3)(cid:85)(cid:68)(cid:87)(cid:72)(cid:3)
(cid:76)(cid:81)(cid:3)(cid:76)(cid:87)(cid:86)(cid:3)(cid:430)(cid:85)(cid:86)(cid:87)(cid:3)(cid:73)(cid:88)(cid:79)(cid:79)(cid:3)(cid:92)(cid:72)(cid:68)(cid:85)
impact and a biennial price reduction
Return to growth from page 48
Our talented employees are committed to achieving our Purpose in a sustainable way and our
Values foster a strong AstraZeneca culture
59,700
Gothenburg, Sweden
Cambridge, UK (HQ)
Employees
California, US
92%
of employees feel able
to bring our Values to
life in their daily work
Cambridge,
UK (HQ)
Boston, MA, US
Gaithersburg, MD, US
Be a great
place to
work from
page 52 and
Employees
from page 54
Gothenburg, Sweden
Osaka,
Japan
Shanghai,
China
Gaithersburg, Maryland US
Research centres
Our capital-allocation
priorities strike a balance
between the interests of
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creditors and shareholders,
and support our progressive
dividend policy
Financial Review from page 62
Distributions to shareholders $m
Dividends
Proceeds from issue of shares
Total
Dividend per Ordinary Share $
Dividend per Ordinary Share
Dividend per Ordinary Share for 2016
First interim dividend
Second interim dividend
Total
$
0.90
1.90
2.80
2016
3,561
(47)
3,514
2016
2.80
Pence
68.7
150.2
218.9
2015
3,486
(43)
3,443
2015
2.80
2014
3,521
(279)
3,242
2014
2.80
SEK
Payment date
7.81 12 September 2016
16.57
24.38
20 March 2017
AstraZeneca Annual Report and Form 20-F Information 2016
3
Strategic Report
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2017 should be
a turning point in our
journey as we bring new
medicines to patients
across the globe.”
year with $423 million in Product Sales in
its first full year. In diabetes, Farxiga/Forxiga
is a global leader in the SGLT2 class of
diabetes treatments with a 35% volume
share. Product Sales of Brilinta/Brilique
reached $839 million and in many countries
it is the leading medicine for patients
discharged with acute coronary syndrome.
While AstraZeneca benefits from realising
the potential of the new medicines emerging
from our pipeline, we never forget that the
main beneficiaries of our life-changing
medicines are patients. For instance, since
its launch at the end of 2014, we have
treated nearly 5,000 cancer patients with
Lynparza and launched it in 31 countries
with seven ongoing reviews.
Investing for the future
As we look ahead to 2017 and beyond,
continued investment in our pipeline keeps
us on track to return to sustainable growth
in line with our targets. Examples of how
we are investing for the future for the benefit
of patients appear throughout this Annual
Report. However, none is more significant
than our investment in Cambridge, UK, as
illustrated on page 7. Cambridge, along with
Gaithersburg, MD, US and Gothenburg in
Sweden, is one of our three strategic R&D
centres and it also became our global
corporate headquarters in May 2016.
Our activities there demonstrate our focus
on science, collaborative way of working
and commitment to sustainability.
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The panel to the right provides an overview
of how we performed against each of our
three strategic priorities in 2016. At the heart
of our plans to achieve scientific leadership
is our focus on three therapy areas.
While challeennges sttiill lie aheaadd, aa new AAstraZeneca is
eemmergiing andd iitts shaappe iss the result of tthhe strategy we
announncced in MMaarch 222013. It is an AstraaZeneca built
on a pippelliine-driveenn trannnsformation aanndd a focus on
three mmaainn ttherapy aarreass.
A transitional phase
The first phase in our journey ended in 2015
and was focused on rebuilding our pipeline.
2016 was a crucial year in the second stage
of our journey, as we manage a transitional
period of patent expiries, drive our Growth
Platforms and roll out our new medicines.
While now largely behind us, the impact of
the loss of exclusivity on some of our most
important medicines has been significant
and will continue in 2017. Between 2011 and
2016, Product Sales in Established Markets
of brands that have lost exclusivity, including
Crestor, a statin, Nexium, a proton pump
inhibitor and Seroquel, an anti-psychotic,
have reduced from $20 billion to $6 billion.
Unfavourable currency movements account
for $2 billion of this $14 billion reduction. This
decline represents a significant ‘headwind’,
but we have made significant progress
rebuilding our Company for the future and
preparing for a new period of growth driven
by our pipeline delivery.
In parallel to managing our legacy brands
decline, we have launched a significant
number of new medicines and increased
revenues from our recently launched
medicines. For example, Tagrisso was only
launched in November 2015 and became
our biggest lung cancer medicine during the
4
AstraZeneca Annual Report and Form 20-F Information 2016
2016 Strategic priorities overview
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> 11 approvals of NMEs or major LCM projects in major markets
– Oncology: Tagrisso – lung cancer (EU, JP) and ctDNA blood test (US, JP)
– CVMD: Brilinta/Brilique – post myocardial infarction (EU) and acute coronary
syndromes and post myocardial infarction (JP); Qtern – Type 2 diabetes (EU)
– Respiratory: Bevespi Aerosphere (PT003) – COPD (US)
– Other: Zurampic – gout (EU); Zavicefta – serious infections (EU); Pandemic
(cid:47)(cid:76)(cid:89)(cid:72)(cid:3)(cid:36)(cid:87)(cid:87)(cid:72)(cid:81)(cid:88)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:44)(cid:81)(cid:432)(cid:88)(cid:72)(cid:81)(cid:93)(cid:68)(cid:3)(cid:57)(cid:68)(cid:70)(cid:70)(cid:76)(cid:81)(cid:72)(cid:3)(cid:347)(cid:3)(cid:83)(cid:68)(cid:81)(cid:71)(cid:72)(cid:80)(cid:76)(cid:70)(cid:3)(cid:76)(cid:81)(cid:432)(cid:88)(cid:72)(cid:81)(cid:93)(cid:68)(cid:3)(cid:11)(cid:40)(cid:56)(cid:12)
> 7 Phase III NME investment decisions
> 14 NME or major LCM regulatory submissions in major markets: Faslodex –
breast cancer (US, EU, JP); Tagrisso – lung cancer (CN); Tagrisso – lung cancer
(AURA3 study for full approval) (US, EU); durvalumab – bladder cancer (US);
(cid:39)(cid:56)(cid:53)(cid:36)(cid:55)(cid:44)(cid:50)(cid:49)(cid:16)(cid:27)(cid:3)(cid:11)(cid:72)(cid:91)(cid:72)(cid:81)(cid:68)(cid:87)(cid:76)(cid:71)(cid:72)(cid:14)(cid:71)(cid:68)(cid:83)(cid:68)(cid:74)(cid:79)(cid:76)(cid:432)(cid:82)(cid:93)(cid:76)(cid:81)(cid:12)(cid:3)(cid:11)(cid:40)(cid:56)(cid:12)(cid:30)(cid:3)(cid:69)(cid:72)(cid:81)(cid:85)(cid:68)(cid:79)(cid:76)(cid:93)(cid:88)(cid:80)(cid:68)(cid:69)(cid:3)(cid:347)(cid:3)(cid:86)(cid:72)(cid:89)(cid:72)(cid:85)(cid:72)(cid:3)(cid:68)(cid:86)(cid:87)(cid:75)(cid:80)(cid:68)(cid:3)
(US, EU); lesinurad+allopurinol FDC – gout (US); three further submissions
made await regulatory acceptance
> 10 accelerated reviews included
– Breakthrough Therapy Designation: durvalumab – bladder cancer (US)
– Orphan Drug Designation: acalabrutinib – blood cancers (EU); selumetinib –
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– Fast Track Designation: Lynparza – ovarian cancer (2nd line) (US), prostate
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(cid:36)(cid:79)(cid:93)(cid:75)(cid:72)(cid:76)(cid:80)(cid:72)(cid:85)(cid:350)(cid:86)(cid:3)(cid:71)(cid:76)(cid:86)(cid:72)(cid:68)(cid:86)(cid:72)(cid:3)(cid:11)(cid:56)(cid:54)(cid:12)
– Priority Review Designation: Tagrisso (CN); durvalumab – bladder cancer (US)
> 22 projects discontinued
Return to growth
> 7% decrease in Total Revenue to $23,002 million at actual rate of exchange;
comprising Product Sales of $21,319 million (down 10%) and Externalisation
Revenue of $1,683 million (up 58%)
– At CER, Total Revenue declined by 5%
> 4% increase in Growth Platforms revenue (5% at CER) contributing 63%
of Total Revenue
– Emerging Markets: Stable (growth of 6% at CER) to $5,794 million,
supported by China, up 4% (10% at CER) to $2,636 million
– Diabetes: Growth of 9% (11% at CER), as Farxiga/Forxiga became our
largest-selling Diabetes medicine
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rate impact and a biennial price reduction
– Brilinta/Brilique sales grew by 36% (39% at CER) to $839 million
– (cid:53)(cid:72)(cid:86)(cid:83)(cid:76)(cid:85)(cid:68)(cid:87)(cid:82)(cid:85)(cid:92)(cid:29)(cid:3)(cid:36)(cid:3)(cid:71)(cid:72)(cid:70)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:24)(cid:8)(cid:3)(cid:11)(cid:22)(cid:8)(cid:3)(cid:68)(cid:87)(cid:3)(cid:38)(cid:40)(cid:53)(cid:12)(cid:3)(cid:87)(cid:82)(cid:3)(cid:7)(cid:23)(cid:15)(cid:26)(cid:24)(cid:22)(cid:3)(cid:80)(cid:76)(cid:79)(cid:79)(cid:76)(cid:82)(cid:81)(cid:15)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:56)(cid:54)(cid:3)
pricing pressure for Symbicort
– New Oncology: Strong sales of $664 million, with Tagrisso delivering sales
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> US revenue was down 22% to $7,365 million; Europe down 5% to $5,064 million;
and Established ROW rose by 2% to $3,096 million (all at actual rate of exchange)
Be a great place to work
> (cid:39)(cid:72)(cid:70)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:76)(cid:81)(cid:3)(cid:86)(cid:70)(cid:82)(cid:85)(cid:72)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:72)(cid:80)(cid:83)(cid:79)(cid:82)(cid:92)(cid:72)(cid:72)(cid:3)(cid:86)(cid:88)(cid:85)(cid:89)(cid:72)(cid:92)(cid:3)(cid:11)(cid:51)(cid:88)(cid:79)(cid:86)(cid:72)(cid:12)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:86)(cid:3)(cid:76)(cid:80)(cid:83)(cid:68)(cid:70)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:85)(cid:72)(cid:86)(cid:75)(cid:68)(cid:83)(cid:76)(cid:81)(cid:74)(cid:3)
the business
> Second in Pharmaceuticals, Biotechnology and Life Sciences industry group
of Dow Jones Sustainability Index
> Biggest riser in the Access to Medicine Index since the last survey, moving
to 7th place in 2016 from 15th in 2014
S
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Some of the most exciting science being
undertaken at the moment is in Oncology as
we explore the potential for novel therapies.
As you can see, 2016 was a significant year
for our Oncology team: we had four regional
approvals, seven expedited reviews and
seven regulatory submissions for our
medicines. Looking ahead, we have the
potential to deliver our third Oncology
medicine in 2017 – halfway to our 2020
target in just four years.
Of course, pushing the boundaries of
science means we sometimes encounter
setbacks. Thus, in 2016, for example,
we voluntarily withdrew the marketing
authorisation application submitted to the
EMA for cediranib in advanced ovarian
cancer. However, there remain ongoing
studies to investigate cediranib as a
combination partner with Lynparza and
other compounds. In addition, three of our
Oncology trials failed to meet their primary
endpoints. Another development showed
our Values in action. In pushing the
boundaries of science with clinical trials of
durvalumab for head and neck squamous
cell carcinoma, we observed bleeding
events. Following the precautionary
principle, we put patients first and placed
a voluntary hold on the enrolment of new
patients. This was followed by a partial
clinical hold from the FDA. However, by
following the science, we provided a
comprehensive analysis about the events
that had been observed and the FDA’s
hold was subsequently lifted.
In 2016, our Cardiovascular & Metabolic
Disease team saw three approvals, four
regulatory submissions and two Brilinta trials
which failed to meet their primary endpoints.
We received a complete response letter
from the FDA for ZS-9 for the treatment of
hyperkalaemia and subsequently made a
resubmission. In diabetes, positive results
from our DURATION-8 trials demonstrated
the efficacy of Farxiga and Bydureon in
combination for the treatment of Type 2
diabetes and should help us maximise
the value of our Diabetes portfolio.
During the year, Bevespi Aerosphere was
approved in the US and launched in early
2017. Our Respiratory team also made
three regulatory submissions, including
two in respect of benralizumab for treating
severe, uncontrolled asthma. We believe
benralizumab, which would be our first
Respiratory biologic, will become an
AstraZeneca Annual Report and Form 20-F Information 2016
5
Strategic Report
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important medicine for patients with severe
asthma and potentially COPD, as well as an
important growth driver for our Company,
broadening and deepening our offering in
the Respiratory market.
Business development and collaboration
are at the heart of the way AstraZeneca
operates. It is particularly evident in our work
in Other Disease Areas. For example, we
enter into collaborations to maximise the
potential of key products that fall outside
our main therapy areas and bring them to
patients quicker. Examples in 2016 include
our development and commercialisation
agreements with LEO Pharma for
brodalumab for psoriasis and tralokinumab
for dermatitis, and with Allergan for
MEDI2070 for inflammatory diseases.
In Alzheimer’s disease, together with our
partner Lilly, we obtained a Fast Track
Designation for the BACE inhibitor and have
entered a second collaboration with them
to co-develop MEDI1814. We are also
partnering some of our in-line products
that we believe still have growth potential
but which cannot receive promotional
support as we focus our resources on
our main therapy areas. An example is the
agreement we reached with China Medical
System Holdings for the promotion of
Plendil in China: our partner will manage
the commercialisation and both companies
will share the benefits. Finally, we have been
divesting smaller non-core products that will
be better managed by companies that can
focus on them. The value unlocked through
these deals is reinvested in our pipeline,
creating more long-term value through
our main therapy areas.
Prioritised and accelerated pipeline
Since we announced our science-led
strategy in 2013, we set ourselves some
ambitious pipeline targets for the end of
2016. For example, we aimed for nine to 10
new molecular entities (NMEs) in Phase III
or registration: by the end of 2016, there
were 12 such projects. We also set
ourselves the target of eight to 10 new
medicines and major line extension
regulatory approvals in 2015 to 2016 and
achieved a total of eight. This is a significant
improvement compared to our historical
pipeline performance.
We also made substantial progress in
reshaping our research and early
development efforts to help us to produce
a steady stream of new products that will
support our long-term growth: we believed
we had the potential for 12 to 16 Phase II
starts in 2015 to 2016. In fact, we achieved
25. Looking ahead, we believe we have the
potential for an unprecedented number of
submissions in the next 24 months, with
around half in our Oncology therapy area.
To ensure we can deliver this potential,
in April we announced plans to sharpen
further the prioritisation of investments
in our main therapy areas, particularly
Oncology. We also want to increase
partnering in relation to projects in our
inflammation, infection and neuroscience
disease areas. The 10 strategic transactions
we undertook in 2016 bear witness to the
progress we have made in that regard.
We also took action to align costs to our
changing business shape and streamline
our operations.
Return to growth
Our Return to growth is underpinned by
our Growth Platforms, shown in the panel.
As our strategy has progressed, so our
Growth Platforms have evolved – New
Oncology (new products) was added and,
from January 2017, New CVMD combined
our Diabetes and Brilinta/Brilique Platforms.
As the treatment of diabetes becomes more
focused on cardiovascular risk reduction
based on recent data, we believe there are
clear synergies managing diabetes and
Brilinta/Brilique together.
The panel shows how our Growth
Platforms performed in 2016. Despite
increasing competition, pricing pressures
and geopolitical instability, they grew by
4% at actual exchange rates (5% at CER)
and now represent 63% of all revenues.
Emerging Markets are particularly important
in achieving our goals. This importance
was recognised towards the end of the year
with the appointment of Leon Wang, our
Country President in China, as Executive
Vice-President of Asia Pacific and a
member of the Senior Executive Team.
Be a great place to work
None of the progress we are making in
achieving our strategic objectives would
be possible without our people; we want to
ensure AstraZeneca is a great place to work
and I am very grateful to each and every
employee for all their efforts throughout
the year.
6
AstraZeneca Annual Report and Form 20-F Information 2016
Employee opinion surveys help us measure
satisfaction and engagement and how
we are doing in our aim to be a great place
to work. Our most recent survey, carried
out in December 2016, showed a decline
compared to our very high 2015 score,
although results are in line with the ‘global
pharma norm’. This decline might not be
unexpected given the challenges of the
strategic journey on which we are embarked
and the restructuring we undertook in
2016 as we continued losing sales to
patent expiries. Nevertheless, we are
focused on improving performance in
those areas employees tell us are important
drivers of employee engagement. These
include people development and line
manager communication.
One area in which we made significant
progress during 2016, and which the
Chairman reports on in more detail in
his Statement on page 82, was external
recognition for our commitment to
sustainability – whether that be in the
Dow Jones Sustainability Index or Access
to Medicine Index, or in the recognition
of our science-based environmental
targets. During the year, the Executive
team also reviewed and refreshed our
sustainability strategy.
Looking ahead
Our financial results for 2016 were in
line with expectations and reflected our
ongoing transition. We brought a sharper
strategic focus to our three main therapy
areas, boosting pipeline productivity
further. Our underlying business is growing
as the new AstraZeneca emerges,
driven by competitive franchises and
Emerging Markets.
2017 should be a turning point in our journey
as we bring new medicines to patients
across the globe. It is an exciting time as
we approach the inflection point for our
anticipated return to long-term growth, built
on the foundations of a science-led pipeline.
Pascal Soriot
Chief Executive Officer
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Being committed to protecting
the environment, we are:
> working towards a Building Research
Establishment ‘excellent’ rating for
sustainability performance for our R&D
centre in addition to delivering a low
carbon emission facility
> building the largest ground source heat
pump system in Europe and a combined
heat and power station to meet on-site
energy needs.
To inspire the next generation
of scientists, we:
> have three schemes to support more
than 80 PhD scholarships and eight
clinical lectureships
> partner with the Cambridge Science
Centre to ensure life science education
activities reach underserved communities
in the wider Cambridgeshire area
> have an active community support
scheme, involving more than 160
staff volunteers, focused around
science-based educational events
for young people.
Investing for the future:
Led by science in Cambridge
As we navigate the transitional phase in our strategy, locating
our new R&D centre and corporate headquarters in Cambridge
demonstrates our strategy in practice – a Company led by science
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from our collaborative approach.
We announced our move to Cambridge
in 2013. In doing so, we join MedImmune
who have been in the city for 25 years. We
begin the staged occupation of our new
state-of-the-art building (illustrated above
and right) in 2018 and already have some
2,000 staff actively engaged in Cambridge’s
scientific, academic, clinical and business
life. They are realising the value of being
located at a world-leading academic and
life science hub.
> shaped the laboratory spaces at our
R&D centre collaboratively, involving
our scientists in the design and
commissioning process, including an
on-site teaching lab for science outreach.
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> initiated over 130 collaborations with
Cambridge organisations, including
over 100 with the University of Cambridge
> collaborated with Microsoft to develop
a new cancer treatment modelling system
Key facts
As a global science-led business,
we have:
> provided new life science businesses
with access to more than 60 mentors
from across AstraZeneca, including
support for the University of Cambridge
Judge Business School’s ‘Accelerate’
programme
> established the CRUK MedImmune
Alliance Laboratory to provide capabilities
to discover novel biologics and diagnostics
> established a world-class mass
spectroscopy capability with the
Laboratory of Molecular Biology
and the University of Cambridge
> developed the AstraZeneca Medical
Research Council UK Centre for
Lead Discovery.
130
Over 130 collaborations
in Cambridge
2,000
Around 2,000 employees
in Cambridge
Watch the video at
www.astrazeneca.com
AstraZeneca Annual Report and Form 20-F Information 2016
7
Strategic Report Strategy
Business model and life-cycle of a medicine
AstraZeneca at a glance summarises our business. In this section, we review our
business model – how we make money, the resources we need and how we add
value across the entire life-cycle of a medicine.
Why AstraZeneca?
We are an integrated, science-led biopharmaceutical Company with a strategic focus on three main therapy
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> pipeline
> skills and capabilities
> quality of science
> commercial expertise
> intellectual property
What do we do?
Our business activities span the entire life-cycle
of a medicine.
How do we make money?
Investment
We invest in the discovery, development,
manufacturing and commercialisation of our
pipeline of innovative small molecule and biologic
prescription medicines, including targeted business
development through collaboration, in-licensing
and acquisitions.
Revenue generation
We generate revenue from sales of our mature
products and Growth Platform launches, as well as
from our externalisation activities and divestments.
Our focus is on creating products that facilitate
future revenue generation.
Reinvestment
We reinvest in developing the next generation of
innovative medicines and in our Growth Platforms
that provide the platform for future sustainable
revenues in the face of potential losses of revenue
from the loss of key product patents.
Investment in disc
Research and dev
o
v
er
y, d
1
Find potential
medicine
Reinvest m e n t o f r e t u
s
n
r
Inputs
> Applying our resources to
meet unmet medical need
Outputs
> Returns to shareholders
> Improved health
y
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+
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9
Post-
exclusivity
Our
Purpose
n
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8
Post-launch
research and
development
s
r
a
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y
0
1
–
5
7
Launch new
medicine
e
s
a
h
h p
nc
Lau
5
Phase III
studies
6
Regulatory
submission
and pricing
e
v
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n
t
,
elo
p
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t
p
2
Pre-clinical
studies
h
a
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s
1
0
–
1
5
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r
s
m
a
n
u
f
a
c
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u
r
i
n
g
a
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o
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m
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atio
n of patent-protected m
3
Phase I
studies
4
Phase II
studies
edicin
e
s
Our Purpose
We push the boundaries of science to deliver life-changing medicines.
Our Purpose underpins everything we do. It gives us a reason to come to work
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to patients and create value for shareholders.
Our Values
We follow the science.
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We play to win.
We do the right thing.
We are entrepreneurial.
8
AstraZeneca Annual Report and Form 20-F Information 2016
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
Life-cycle of a medicine
Research and development phases 10–15 years
1 Find potential medicine
> Identify unmet medical need aligned with our
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research to identify potential new medicines
> Initiate process of seeking patent protection
2 Pre-clinical studies
> Conduct laboratory and animal studies to
understand if the potential medicine is safe to
introduce into humans and in what quantities
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and maximum dose estimates
3 Phase I studies
> Begin clinical studies with small groups of
healthy human volunteers (small molecules)
or patients (biologics) to understand how the
potential medicine is absorbed into the body,
distributed around it and excreted
> Determine approximate dosage and identify
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4 Phase II studies
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tolerability of the medicine and determine
optimal dose
> Design Phase III studies to generate data needed
for regulatory approvals and pricing/
reimbursement globally
5 Phase III studies
> Engage in studies in a larger group of patients
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safety of the medicine and evaluate the overall
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> Initiate branding for the new medicine in
preparation for its launch
6 Regulatory submission and pricing
> Seek regulatory approvals for
manufacturing, marketing and selling
the medicine
> Submit clinical data to regulatory authorities
(and, if requested, generate further data
increasingly in real-world settings) to
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medicine to enable them to decide on
whether to grant regulatory approvals
Launch phase 5–10 years
Post-exclusivity 20+ years
7 Launch new medicine
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8 Post-launch research and development
> Conduct studies to further understand the
appropriate use, market and sell medicine
> Clinicians begin to prescribe medicines and
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and/or additional patient populations
9 Post-exclusivity
> Patent expiry and generic entry
> Reinvestment of returns
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> Continuously monitor, record and analyse
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(cid:87)(cid:75)(cid:72)(cid:3)(cid:86)(cid:76)(cid:71)(cid:72)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:3)(cid:90)(cid:68)(cid:85)(cid:81)(cid:76)(cid:81)(cid:74)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)(cid:72)(cid:81)(cid:86)(cid:88)(cid:85)(cid:72)(cid:3)(cid:87)(cid:75)(cid:68)(cid:87)(cid:3)
patients’ wellbeing is maintained
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opportunities to support patients and
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from the medicine
> Life-cycle management activities to broaden
understanding of a medicine’s full potential
> Consider additional diseases or aspects
of disease to be treated by or better ways
of administering the medicine
> Submit data packages with requests for
life-cycle management to regulatory authorities
for review and approval
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medicine discovered and/or developed by AstraZeneca, or the probability of success or approval of any AstraZeneca medicine.
Sustainability
Our Values determine how we work
together and the behaviours that drive
our success. Our Values guide our
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foster a strong AstraZeneca culture.
We want to be valued and trusted by our stakeholders as a source of great
medicines over the long term. Our sustainability commitments, which are
driven by our Purpose and Values, underpin our business model and support
the delivery of our business strategy.
Business Review from page 42
AstraZeneca Annual Report and Form 20-F Information 2016
9
Strategic Report Strategy
Business model and life-cycle of a medicine continued
What does our business model require to be successful?
A talented and diverse workforce
We need to acquire, retain and develop a
talented and diverse workforce united in
pursuit of our Purpose and Values and
fostering a strong AstraZeneca culture.
59,700 employees
See Employees from page 54
A leadership position in science
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if we are to deliver life-changing medicines.
To that end, we need to focus on innovative
science, prioritise and accelerate our
pipeline and transform our innovation
and culture model.
Commercialisation skills
We need a strong global commercial
presence and skilled people to ensure that
we can successfully launch our medicines,
that they are available when needed and
that patients have access to them.
$5.9bn invested
in our science
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leadership from page 45 and
R&D resources on page 59
>100 countries
in which we are active
See Return to growth from
page 48
Intellectual property
We need to create and protect our IP rights.
Developing a new medicine requires
(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:76)(cid:81)(cid:89)(cid:72)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:82)(cid:89)(cid:72)(cid:85)(cid:3)(cid:80)(cid:68)(cid:81)(cid:92)(cid:3)(cid:92)(cid:72)(cid:68)(cid:85)(cid:86)(cid:15)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)
no guarantee of success. For our investments
to be viable, we seek to protect new medicines
from being copied for a reasonable period of
time through patent protection.
>100 countries where
we obtain patent protection
See Intellectual Property from
page 57
A robust supply chain
We need a supply of high-quality medicines,
whether from one of the 31 Operations sites
(cid:76)(cid:81)(cid:98)(cid:20)(cid:27)(cid:3)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:85)(cid:76)(cid:72)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:90)(cid:72)(cid:3)(cid:80)(cid:68)(cid:81)(cid:88)(cid:73)(cid:68)(cid:70)(cid:87)(cid:88)(cid:85)(cid:72)(cid:3)(cid:82)(cid:85)(cid:3)
the $13 billion we spend on the purchase of
goods, services and active pharmaceutical
ingredients (API).
$13bn spent
with suppliers
See Manufacturing from page
58 and Working with suppliers
from page 52
(cid:40)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:83)(cid:68)(cid:85)(cid:87)(cid:81)(cid:72)(cid:85)(cid:86)(cid:75)(cid:76)(cid:83)(cid:86)
(cid:58)(cid:72)(cid:3)(cid:81)(cid:72)(cid:72)(cid:71)(cid:3)(cid:69)(cid:88)(cid:86)(cid:76)(cid:81)(cid:72)(cid:86)(cid:86)(cid:3)(cid:71)(cid:72)(cid:89)(cid:72)(cid:79)(cid:82)(cid:83)(cid:80)(cid:72)(cid:81)(cid:87)(cid:15)(cid:3)(cid:86)(cid:83)(cid:72)(cid:70)(cid:76)(cid:430)(cid:70)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)
partnering, which is an important element
(cid:82)(cid:73)(cid:98)(cid:82)(cid:88)(cid:85)(cid:3)(cid:69)(cid:88)(cid:86)(cid:76)(cid:81)(cid:72)(cid:86)(cid:86)(cid:3)(cid:80)(cid:82)(cid:71)(cid:72)(cid:79)(cid:17)(cid:3)(cid:44)(cid:87)(cid:3)(cid:86)(cid:88)(cid:83)(cid:83)(cid:79)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)
(cid:86)(cid:87)(cid:85)(cid:72)(cid:81)(cid:74)(cid:87)(cid:75)(cid:72)(cid:81)(cid:86)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:83)(cid:76)(cid:83)(cid:72)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:72)(cid:428)(cid:82)(cid:85)(cid:87)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)
(cid:68)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:79)(cid:72)(cid:68)(cid:71)(cid:72)(cid:85)(cid:86)(cid:75)(cid:76)(cid:83)(cid:17)
600 collaborations
worldwide
See Partnering from page 23
Financial strength
(cid:58)(cid:72)(cid:3)(cid:81)(cid:72)(cid:72)(cid:71)(cid:3)(cid:86)(cid:87)(cid:85)(cid:82)(cid:81)(cid:74)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:86)(cid:15)(cid:3)(cid:76)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:76)(cid:81)(cid:74)(cid:3)
(cid:68)(cid:70)(cid:70)(cid:72)(cid:86)(cid:86)(cid:98)(cid:87)(cid:82)(cid:3)(cid:72)(cid:84)(cid:88)(cid:76)(cid:87)(cid:92)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:71)(cid:72)(cid:69)(cid:87)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:72)(cid:15)(cid:3)(cid:87)(cid:82)(cid:3)(cid:69)(cid:72)(cid:68)(cid:85)(cid:3)
(cid:87)(cid:75)(cid:72)(cid:98)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:85)(cid:76)(cid:86)(cid:78)(cid:3)(cid:82)(cid:73)(cid:3)(cid:76)(cid:81)(cid:89)(cid:72)(cid:86)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:72)(cid:81)(cid:87)(cid:76)(cid:85)(cid:72)(cid:3)
life-cycle of a medicine.
$4.1bn net cash
(cid:432)(cid:82)(cid:90)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:82)(cid:83)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)
activities
See Financial Review from page 62
10
AstraZeneca Annual Report and Form 20-F Information 2016
How do we add value?
Financial value
Revenue from the sale of our medicines
(cid:74)(cid:72)(cid:81)(cid:72)(cid:85)(cid:68)(cid:87)(cid:72)(cid:86)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:15)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:75)(cid:72)(cid:79)(cid:83)(cid:86)(cid:3)(cid:88)(cid:86)(cid:29)
> fund our investment in science and Growth
Platforms to drive long-term value
> meet our debt service obligations
> follow our progressive dividend policy.
This involves balancing the interests
(cid:82)(cid:73)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:69)(cid:88)(cid:86)(cid:76)(cid:81)(cid:72)(cid:86)(cid:86)(cid:15)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:70)(cid:85)(cid:72)(cid:71)(cid:76)(cid:87)(cid:82)(cid:85)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)
shareholders.
See Financial Review from page 62
Improved health
(cid:38)(cid:82)(cid:81)(cid:87)(cid:76)(cid:81)(cid:88)(cid:82)(cid:88)(cid:86)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:76)(cid:81)(cid:81)(cid:82)(cid:89)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:76)(cid:86)(cid:3)(cid:89)(cid:76)(cid:87)(cid:68)(cid:79)(cid:3)
to achieving sustainable healthcare which
creates value by:
> improving health outcomes and
transforming patients’ lives
> enabling healthcare systems to reduce
(cid:70)(cid:82)(cid:86)(cid:87)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:76)(cid:81)(cid:70)(cid:85)(cid:72)(cid:68)(cid:86)(cid:72)(cid:3)(cid:72)(cid:433)(cid:70)(cid:76)(cid:72)(cid:81)(cid:70)(cid:92)
> improving access to healthcare and
healthcare infrastructure
> helping develop the communities in
which we operate through local
employment and partnering.
Marketplace
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Despite global economic, political and ssoccial
challenges, the pharmaceutical industry is
expected to enjoy long-term growth. This is
due to favourable demographic trenddss aanndd
(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:88)(cid:81)(cid:80)(cid:72)(cid:87)(cid:3)(cid:80)(cid:72)(cid:71)(cid:76)(cid:70)(cid:68)(cid:79)(cid:3)(cid:81)(cid:72)(cid:72)(cid:72)(cid:72)(cid:71)(cid:71)(cid:17)
Overview
> Global pharmaceutical sales grew by 6.9% in 2016
> The sector remains highly competitive
> Patient populations are expanding and ageing
> Non-communicable diseases (NCDs) kill 39 million people each year
> The costs of developing a new medicine continue to rise
> Priority Reviews and Breakthrough Therapies are becoming more prevalent
> (cid:36)(cid:3)(cid:75)(cid:76)(cid:74)(cid:75)(cid:79)(cid:92)(cid:3)(cid:85)(cid:72)(cid:74)(cid:88)(cid:79)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:86)(cid:72)(cid:70)(cid:87)(cid:82)(cid:85)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:86)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:71)(cid:72)(cid:80)(cid:68)(cid:81)(cid:71)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:86)(cid:68)(cid:73)(cid:72)(cid:15)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:75)(cid:76)(cid:74)(cid:75)(cid:3)
quality medicines
> Pricing and reimbursement continue to be challenging
> Patents are expiring on some of the biggest-selling drugs ever produced
> The sector faces challenges in building and maintaining trust
> (cid:38)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:83)(cid:82)(cid:79)(cid:76)(cid:87)(cid:76)(cid:70)(cid:68)(cid:79)(cid:3)(cid:79)(cid:68)(cid:81)(cid:71)(cid:86)(cid:70)(cid:68)(cid:83)(cid:72)(cid:15)(cid:3)(cid:86)(cid:88)(cid:70)(cid:75)(cid:3)(cid:68)(cid:86)(cid:3)(cid:37)(cid:85)(cid:72)(cid:91)(cid:76)(cid:87)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:3)(cid:72)(cid:79)(cid:72)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:88)(cid:79)(cid:87)(cid:86)
2bn
By 2050, the world’s population
aged 60 years and older is expected
to total some 2 billion.
$154bn
Global investment in pharmaceutical
R&D expected to reach an estimated
$154 billion in 2016, an 11% increase
from $139 billion in 2012.
The global context
The October 2016 World Economic Outlook
of the International Monetary Fund (IMF)
highlighted the precarious nature of the
recovery eight years after the global financial
crisis. It raised the spectre that persistent
stagnation, particularly in advanced
economies, could further fuel populist calls
for restrictions on trade and immigration. The
IMF went on to observe that such restrictions
would hamper productivity, growth and
innovation. In China, a shift from investment
and industry towards consumption and
services was expected to slow growth in
the short term while building the foundations
for a more sustainable long-term expansion.
Japan’s economy would be hampered by
a shrinking population.
More generally, both political and economic
uncertainty followed the Brexit vote in the
UK and the election of Donald Trump to
president of the US. Instability in a number
of other European countries has been
exacerbated by refugees fleeing civil war
and unrest in the Middle East and from
further afield.
Against this uncertain background, however,
the demand for healthcare continues to
increase. While this is a favourable trend
for long-term industry growth, challenges
remain. These include expiring patents,
competition from and growing use of
generic medicines, obtaining regulatory
approval, securing reimbursement for new
medicines, improving R&D productivity
and attaining pricing and sales sufficient
to generate revenue and sustain the cycle
of innovation.
AstraZeneca Annual Report and Form 20-F Information 2016
11
Strategic Report Strategy
Marketplace continued
Global pharmaceutical sales
World $bn
2016
2015
2014
$967bn (6.9%)
US $bn
2016
2015
2014
$446bn (7.1%)
Europe $bn
2016
2015
2014
$201bn (5.6%)
Established ROW $bn
2016
2015
2014
$120bn (5.1%)
Emerging Markets $bn
2016
2015
2014
$200bn (9.1%)
967
905
826
446
416
369
201
190
179
120
115
110
200
184
168
Data based on world market sales using AstraZeneca market
(cid:71)(cid:72)(cid:430)(cid:81)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:68)(cid:86)(cid:3)(cid:86)(cid:72)(cid:87)(cid:3)(cid:82)(cid:88)(cid:87)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:48)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:3)(cid:71)(cid:72)(cid:430)(cid:81)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:82)(cid:81)(cid:3)(cid:83)(cid:68)(cid:74)(cid:72)(cid:3)(cid:21)(cid:22)(cid:28)(cid:17)(cid:3)
Source: IMS Health, IMS Midas Quantum Q3 2016 (including
US data). Reported values and growth are based at CER. Value
(cid:430)(cid:74)(cid:88)(cid:85)(cid:72)(cid:86)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:85)(cid:82)(cid:88)(cid:81)(cid:71)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:81)(cid:72)(cid:68)(cid:85)(cid:72)(cid:86)(cid:87)(cid:3)(cid:69)(cid:76)(cid:79)(cid:79)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:74)(cid:85)(cid:82)(cid:90)(cid:87)(cid:75)(cid:3)
percentages are rounded to the nearest tenth.
Expanding patient populations
The number of people accessing healthcare
is increasing, as is healthcare spending,
particularly by the elderly. For example,
WHO estimates that, by 2050, the world’s
population aged 60 years and older is
expected to total some two billion, up
from 900 million in 2015 and that, by then,
80% of all older people will live in low-
and middle-income countries. As the
diagram on page 14 shows, we expect
developing markets to continue to fuel
pharmaceutical growth.
Unmet medical need
The prevalence of NCDs, such as
cancer and cardiovascular, metabolic
and respiratory diseases, is increasing
worldwide. NCDs are often associated
with ageing populations and lifestyle
choices, including smoking, diet and lack
of exercise. Many NCDs require long-term
management. WHO estimates that
NCDs kill 39 million people each year
and disproportionately affect low- and
middle-income countries where nearly
three-quarters of these deaths occur. For
example, more than 60% of the world’s total
new annual cancer cases occur in Africa,
Asia, and Central and South America.
These regions account for 70% of the
world’s cancer deaths.
The pharmaceutical sector:
opportunities and challenges
As shown in the table on the left, global
pharmaceutical sales grew by 6.9% in 2016.
Established Markets saw average revenue
growth of 6.4% and Emerging Markets
revenue grew at 9.1%. The US, Japan,
China, Germany and France are the world’s
top five pharmaceutical markets. In 2016,
the US had 44.7% of global sales (2015:
46.0%; 2014: 44.7%).
Science and technology
Innovation is critical to addressing
unmet medical need. The delivery of new
medicines will rely on a more advanced
understanding of disease and the use of
new technology and approaches, including
personalised healthcare (PHC) and
predictive science.
Technological breakthroughs in the
design and testing of novel compounds
present fresh opportunities for using small
molecules as the basis for new medicines.
The use of large molecules, or biologics,
has also become an important source of
innovation. Biologics are among the most
commercially successful new products.
By 2020, biologics, excluding vaccines, are
expected to account for 27% of the global
pharmaceutical market, having risen from
14% in 2006. As such, most pharmaceutical
companies now pursue R&D in both small
molecules and biologics.
Priority Reviews and Breakthrough
Therapies are becoming more prevalent.
Between the inception of the Breakthrough
Therapy Designation programme in
October 2012 and the end of 2016, the
FDA granted more than 150 such requests
(out of more than 450 applications), and
one-third of these have already resulted
in product approvals.
The cost of developing new medicines
continues to rise. Global R&D investment is
expected to reach $154 billion in 2016. While
the growth rate of R&D spend has slowed
in recent years, pharmaceutical companies
continue to deliver new medicines. In
2016, the FDA approved 22 novel drugs
compared with 45 in 2015 and 41 in 2014.
To ensure sustainable returns on R&D
investment, the industry is working to
increase its success rate in developing
commercially viable new drugs while
achieving a lower, more flexible cost base.
Regulators and payers, however, are
demanding greater evidence of comparative
effectiveness of medicines. This increases
development times and costs.
Fortunately, innovative technology is helping
accelerate product approvals. A greater
emphasis on Proof of Concept is also
helping to improve productivity and reduce
costs by showing the potential efficacy of
drugs earlier in the development process.
12
AstraZeneca Annual Report and Form 20-F Information 2016
the in-progress review of China’s Drug
Administration Law and Drug Registration
Regulation are likely to help address this
issue over the next few years.
Greater transparency and public access
to regulatory submissions that support
approval of new medicines continue to
be an area of interest. A recent example
involves the EMA policy 0070 on publication
of clinical data for medicinal products for
human use, which provides guidance for the
publication of clinical reports that underpin
the EMA’s decision making. Paediatric
development continues to present
challenges to the industry as differences
between study requirements and
timeframes may vary significantly among
health authorities. However, there have been
efforts to provide incentives to stimulate
paediatric research. An example is the
EMA’s initiative offering free-of-charge
meetings focused on paediatric studies
early in drug development. In addition, the
industry has appreciated the opportunity
afforded by the US paediatric rare disease
voucher programme to encourage
paediatric drug development. International
harmonisation is being advanced in this
area through the revision of the ICH E11
paediatric guideline, which has facilitated
discussion between regulators and the
industry on topics of mutual interest.
Regulatory requirements for the registration
of biosimilar products continue to develop
and become better defined, as exemplified
by the publication of a new pathway for
China and the approvals of more biosimilar
products in the US. However, significant
areas of regulatory policy are still evolving.
Among these are transparency of data
regarding level of evidence to support
approval of claims for biosimilarity in
labelling, standards for interchangeability
and pharmaceutical substitution, and
traceability of pharmacovigilance reports
through naming conventions that permit
differentiation of products.
For more information about biosimilars,
please see Patent expiries and genericisation
on page 15
Regulatory requirements
A highly regulated biopharmaceutical
industry reflects the public’s expectation of
safe, effective and high-quality medicines.
Meeting this expectation requires responsible
testing, manufacturing and marketing. It
also relies on maintaining effective working
relationships with health authorities
worldwide, including the FDA in the US, the
EMA in the EU, the PMDA in Japan, and the
CFDA in China. Increasingly, regulation and
governmental policy are being introduced
to stimulate innovation in drug development.
In the US, for example, the 21st Century
Cures Act, signed into law on 13 December
2016, focuses on accelerating the discovery,
development and delivery of promising
new treatments for patients. Similarly,
the Prescription Drug User Fee Act
reauthorisation legislation that is required to
be considered by the US Congress in 2017
is anticipated to contain proposals aimed at
accelerating innovation and modernising
the US regulatory environment. Additionally,
the growing complexity and globalisation
of clinical studies have led to an increase
in public-private consortia. Such consortia,
which include industry, academia and
government bodies, aim to drive innovation,
streamline regulatory processes, and define
and clarify approval requirements for
innovative drug and biologic products.
Regulatory health authorities continue
to implement programmes intended to
address unmet medical need and to
speed up patient access to transformative
medicines. This is demonstrated by the
Breakthrough Therapy programme
employed by the FDA and the EMA’s
initiative to implement ‘adaptive pathways’
to improve timely patient access to new
medicines. In Japan, the SAKIGAKE
Designation System has been introduced
to designate innovative medicines that
hold the promise for a significant advance
over currently available therapy. Once
designated, the PMDA collaborates with
sponsors to accelerate the development
and approval of these promising
unapproved medicines for serious and
life-threatening diseases. The lengthy review
process in China extends new medicine
approval periods to as long as five years.
This challenges the ability of pharmaceutical
companies to deliver innovative medicines
and treat unmet medical need in China.
However, recent developments, including
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Pricing of medicines
Pricing and reimbursement remain
challenging in many markets. We continue
to see examples where healthcare services
(including pharmaceuticals) are highly
regulated by governments, insurers and
other private payers through various
controls on pricing and reimbursement.
Implementation of cost containment reforms
and shifting market dynamics are further
constraining healthcare providers, while
difficult economic conditions burden patients
who have out-of-pocket expenses relating to
their medicines. Pharmaceutical companies
are now expending significant resources to
demonstrate the economic as well as the
therapeutic value of their medicines.
In the US, the Affordable Care Act (ACA)
has directly affected the healthcare system
by reshaping the market through various
policies and approaches designed to expand
insurance coverage, reduce costs, transform
the delivery system, and improve healthcare
and patient coverage. We, along with other
pharmaceutical companies, have continued
to work with policymakers and regulators to
increase access, improve outcomes and to
support an environment that fosters medical
and scientific innovation and value.
The new political leadership in the US has
proposed to repeal and replace the ACA
and has taken initial steps to that end.
While it is unclear if some or all of the ACA
might be repealed or what the scope of
replacement might entail if implemented,
it is possible that proposals could require
the healthcare industry to offset the cost
of replacement. This may include changes
to the pharmaceutical industry excise tax,
Medicaid reform by, for example, granting
the states greater flexibility in designing
and funding their Medicaid programmes,
including the choice of a block grant
or per capita allotment of federal funds,
and/or repeal the marketplace exchanges
that were established under the ACA.
These changes, whether directly or
indirectly targeted at drugs or the
pharmaceutical industry, could impact
pharmaceutical coverage and patient
access to healthcare under insurance plans
and government programmes and could,
accordingly, significantly affect the
pharmaceutical industry.
Further details on the impact of the ACA
on our business are contained in Return
to growth on page 48
AstraZeneca Annual Report and Form 20-F Information 2016
13
Strategic Report Strategy
Marketplace continued
We expect developing
markets to continue to boost
pharmaceutical growth.”
84.7%
Generics constituted 84.7%
of prescriptions dispensed
in the US.
Political leadership in the US has also
continued to focus on drug pricing.
Various drug pricing proposals have
included measures relating to the repeal of
the Medicare Part D non-interference clause
that currently prohibits the government
from negotiating directly with manufacturers
on drug prices and US drug importation
policies. In addition, lawmakers and
policymakers at both the federal and
state level have developed drug pricing
transparency proposals that include
measures relating to the submission
of proprietary manufacturer data,
establishment of price parameters that
are indexed to certain federal programmes,
and reporting of changes in pricing beyond
certain thresholds. While the implementation
timeline and details of such proposals are
not clear, significant changes to laws and
regulations regarding drug pricing could
have a significant impact on the
pharmaceutical industry.
In Europe, governments continue to
implement and expand price control
measures for medicines, including
mandatory discounts, clawbacks and
price referencing rules. These measures
are decreasing drug prices, particularly
in the challenged economies of Greece,
Romania and Italy. In France, price
negotiations are particularly challenging
due to budgetary pressures. In Germany,
Europe’s largest pharmaceutical market,
manufacturers must now prove the added
benefit of their drug over existing alternatives
if they are to avoid relegation to an
unfavourable price reference or face
non-pricing barriers to market access.
In China, pricing practices remain a priority
for regulators. New national regulations
and provincial and hospital tenders continue
to put increasing pricing pressures on
pharmaceutical companies. In Russia and
selected Middle East markets, governments
are encouraging local manufacturing by
offering more favourable pricing legislation.
In Japan, mandated biennial cuts are likely
to continue as are experimental decisions
by regulators based on cost effectiveness
assessments. In Latin America, pricing is
increasingly controlled by governments as,
for example, in Colombia and Brazil with
price referencing regulations.
For more information about price controls,
reductions and US healthcare reform, and price
regulation, please see the Business Review,
Return to growth from page 48 and Risk from
page 214
Estimated pharmaceutical sales and market growth – 2020
North America
EU
Other Europe (Non-EU countries)
Japan
$640bn
7.0%
$240bn
3.2%
$23bn
8.7%
$92bn
0.6%
Oceania
$15bn
4.8%
South East and East Asia
Latin America
$202bn
6.5%
$78bn
2.3%
Africa
$28bn
8.1%
CIS
$23bn
Middle East
Indian subcontinent
6.7%
$25bn
6.6%
$38bn
12.1%
Estimated pharmaceutical sales – 2020.
Ex-manufacturer prices at CER. Source:
IMS Health.
Estimated pharmaceutical market growth
– 2015 to 2020. Compound annual growth
rate. Source: IMS Health.
14
AstraZeneca Annual Report and Form 20-F Information 2016
Patent expiries and genericisation
Patent protection for pharmaceutical
products is finite. Patents are expiring on
some of the biggest-selling drugs ever
produced and this means that payers,
physicians and patients are gaining greater
access to generic alternatives (both
substitutable and analogue) in many
important drug classes. These generic
alternatives are primarily lower priced
because generic manufacturers are largely
spared the costs of R&D and market
development. As a result, demand for
generics is high. For prescriptions dispensed
in the US in 2016, generics constituted 84.7%
of the market by volume (2015: 84.0%).
Generic competition can also result from
patent disputes or challenges before patent
expiry. Increasingly, generics companies
are launching products ‘at risk’, for example,
before resolution of the relevant patent
litigation. This trend, which is likely to
continue, creates significant market
presence for the generic version while the
litigation remains unresolved. Given the
unpredictable nature of patent litigation,
some companies have settled such
challenges on terms acceptable to the
innovator and generic manufacturer. While
competition authorities generally accept
such agreements as a legitimate way to
settle these disputes, they have questioned
some settlements as being anti-competitive.
Biologics typically retain exclusivity for
longer than traditional small molecule
pharmaceuticals, with less generic
competition. With limited experience to date,
the substitution of biosimilars for the original
branded product has not followed the same
pattern as generic substitution in small
molecule products and, as a result, erosion
of the original biologic’s branded market
share has not been as rapid. This is due to
biologics’ complex manufacturing processes
and the inherent difficulties in producing a
biosimilar, which could require additional
clinical trials. However, with regulatory
authorities in Europe and the US continuing
to implement abbreviated approval pathways
for biosimilar versions, innovative biologics
are likely to face increased competition.
Similar to biologics, some small molecule
pharmaceutical products are in complex
formulations and/or require technically
challenging manufacturing and thus may
not follow the pattern of generic market
erosion seen with traditional, tableted
pharmaceuticals. For those products, the
introduction of generic alternatives (both
substitutable and analogue) can be slower.
Building trust
The pharmaceutical industry faces
challenges in building and maintaining
trust, particularly with governments and
regulators. This reflects the past decade’s
legal disputes between pharmaceutical
companies and governmental and
regulatory authorities. To address this
challenge, companies are strengthening
a culture of ethics and integrity, adopting
higher governance standards and improving
relationships with employees, shareholders
and other stakeholders.
During 2016, there were also
pharmaceutical industry investigations
and Congressional hearings in the US
related to pricing while, in the UK, the
Competition and Markets Authority
has been investigating allegations of
excessive charging and fining companies
for unfair prices.
Numerous companies, including those
in the pharmaceutical industry, have been
investigated by the China Public Security
Bureau following allegations of bribery,
and criminal and financial penalties have
been imposed. Investigations by the DOJ
and SEC under the Foreign Corrupt
Practices Act are continuing as are
investigations by the UK Serious Fraud
Office under the UK Bribery Act. Information
about material legal proceedings can be
found in Note 28 to the Financial Statements
from page 185.
Strategic responses
Our industry remains highly competitive.
It includes large, research-based
pharmaceutical companies (such as
AstraZeneca) that discover, develop
and sell innovative, patent-protected
prescription medicines and vaccines,
smaller biotechnology and vaccine
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businesses, and companies that produce
generic medicines. However, the
pharmaceutical market is highly competitive.
For example, our Diabetes franchise
continues to see pricing pressure. In
immuno-oncology, the large number of
clinical trials that are being carried out
highlight the competitive nature of this
area and renders speed to market critical.
While many of our peers face similar
challenges, they tackle them in different
ways. Some companies have pursued a
strategy focused on branded prescription
pharmaceuticals. Others have diversified
by acquiring or building branded generics
businesses or consumer portfolios.
A number of companies are focused on
improving R&D productivity and operational
efficiency. Other companies have looked
to geographic expansion, especially in
Emerging Markets and Japan.
Across the industry, business development
deals (including licensing and collaborations),
and competition for business development
opportunities, while down over 2015,
continued in 2016. For example, one report
estimates that the value of mergers and
acquisitions announced in the healthcare
sector during the year amounted to more
than $270 million, compared with almost
$400 million in 2015.
As outlined in AstraZeneca at a glance
from page 2 and our Business model
from page 8, our strategic response to
the pharmaceutical marketplace is to
be a ‘pure-play’, global, science-led
biopharmaceutical company that focuses
on the discovery, development and
commercialisation of prescription medicines,
primarily for the treatment of diseases in
three main therapy areas. The strategic
priorities that follow on from this response
are outlined in the next section.
AstraZeneca Annual Report and Form 20-F Information 2016
15
Strategic Report Strategy
Strategy and key performance indicators
We are focused on returning to growth through a science-led innovation strategy.
(cid:50)(cid:88)(cid:85)(cid:98)(cid:86)(cid:87)(cid:85)(cid:68)(cid:87)(cid:72)(cid:74)(cid:76)(cid:70)(cid:3)(cid:83)(cid:85)(cid:76)(cid:82)(cid:85)(cid:76)(cid:87)(cid:76)(cid:72)(cid:86)(cid:15)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:76)(cid:81)(cid:71)(cid:76)(cid:70)(cid:68)(cid:87)(cid:82)(cid:85)(cid:86)(cid:3)(cid:68)(cid:74)(cid:68)(cid:76)(cid:81)(cid:86)(cid:87)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:90)(cid:72)(cid:3)(cid:80)(cid:72)(cid:68)(cid:86)(cid:88)(cid:85)(cid:72)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:86)(cid:88)(cid:70)(cid:70)(cid:72)(cid:86)(cid:86)(cid:15)(cid:3)
are based on investing in three therapy areas, building a strong and balanced
portfolio of primary care and specialty care medicines, and accelerating key R&D
(cid:83)(cid:85)(cid:82)(cid:74)(cid:85)(cid:68)(cid:80)(cid:80)(cid:72)(cid:86)(cid:17)(cid:3)(cid:55)(cid:75)(cid:72)(cid:92)(cid:98)(cid:68)(cid:79)(cid:86)(cid:82)(cid:3)(cid:76)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:72)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:72)(cid:71)(cid:3)(cid:69)(cid:88)(cid:86)(cid:76)(cid:81)(cid:72)(cid:86)(cid:86)(cid:3)(cid:71)(cid:72)(cid:89)(cid:72)(cid:79)(cid:82)(cid:83)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:79)(cid:72)(cid:89)(cid:72)(cid:85)(cid:68)(cid:74)(cid:76)(cid:81)(cid:74)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)
global commercial presence.
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Strategic priorities
Key performance indicators
Focus on innovative science
in three therapy areas
Focus on Oncology, Cardiovascular
& Metabolic Disease, and Respiratory.
We are also selectively active in
Autoimmunity, Infection
and Neuroscience.
Work across small molecules and
biologics, including immunotherapies
and protein engineering, as well
as devices, biomarkers and
translational science.
Prioritise and accelerate
our pipeline
Accelerate and invest in key R&D
programmes. At the end of 2016,
12 NMEs were in Phase III or under
regulatory review compared with our
March 2013 target of nine to 10.
Against the targets we had set
ourselves since 2013, by the end of
2016, we had made 25 Phase II starts
(2015 to 2016 target: 12 to 16); 14
NME and major line extension
regulatory submissions (2015 to 2016
target: 14 to 16); and eight NME and
major line extension regulatory
approvals (2015 to 2016 target:
eight to 10).
Strengthen our early-stage pipeline
through novel science and technology.
Transform our innovation
and culture model
Focus on novel science, such as
immune-mediated therapy
combinations and PHC.
Co-location near bioscience clusters at
three strategic centres in Cambridge,
UK; Gaithersburg, Maryland US;
and Gothenburg, Sweden helps to
leverage our capabilities and foster
collaboration with leading scientists
and research organisations.
Accelerate through business
development
Work to reinforce our therapy areas
and strengthen our portfolio and
pipeline through targeted business
development, including collaborations,
in-licensing and acquisitions.
Collaborate strategically to broaden
and accelerate the development of key
pipeline assets (externalisation) and
divest non-core assets to realise value.
Phase III investment decisions
NME or LCM project regulatory
submissions in major markets
Clinical-stage strategic
transactions
7
2016
2015
2014
14
7
6
9
2016
2015
2014
10
141
12
6
2016
2015
2014
10
10
3
savolitinib (papillary renal cell
carcinoma); durvalumab+
tremelimumab (hepatocellular
carcinoma); Forxiga (heart failure);
Forxiga (chronic kidney disease);
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two further decisions made through
strategic partnering.
Faslodex – breast cancer (US, EU, JP);
Tagrisso – lung cancer (CN); Tagrisso
– lung cancer (AURA3 study for full
approval) (US, EU); durvalumab –
bladder cancer (US); DURATION-8
(cid:11)(cid:72)(cid:91)(cid:72)(cid:81)(cid:68)(cid:87)(cid:76)(cid:71)(cid:72)(cid:14)(cid:71)(cid:68)(cid:83)(cid:68)(cid:74)(cid:79)(cid:76)(cid:432)(cid:82)(cid:93)(cid:76)(cid:81)(cid:12)(cid:3)(cid:11)(cid:40)(cid:56)(cid:12)(cid:30)(cid:3)
(cid:69)(cid:72)(cid:81)(cid:85)(cid:68)(cid:79)(cid:76)(cid:93)(cid:88)(cid:80)(cid:68)(cid:69)(cid:3)(cid:347)(cid:3)(cid:86)(cid:72)(cid:89)(cid:72)(cid:85)(cid:72)(cid:3)(cid:68)(cid:86)(cid:87)(cid:75)(cid:80)(cid:68)(cid:3)(cid:11)(cid:56)(cid:54)(cid:15)(cid:3)
EU); lesinurad+allopurinol FDC – gout
(US); three further submissions made
await regulatory acceptance.
Includes alliances, collaborations and
acquisitions to enhance our portfolio
and pipeline in our main therapy areas;
externalisation activity to maximise the
value of our assets; and divestments of
non-priority medicines.
1 13 for determining Annual Bonus.
See page 108
NME Phase II starts/progressions
NME and major LCM regional
approvals
16
2016
2015
2014
11
161
11
13
2016
2015
2014
11
6
12
Tagrisso – lung cancer (EU, JP) and
ctDNA blood test (US, JP); Brilinta/
Brilique – post myocardial infarction
(EU) and acute coronary syndromes
and post myocardial infarction (JP);
Qtern – Type 2 diabetes (EU); Bevespi
Aerosphere (PT003) – COPD (US);
Zurampic – gout (EU); Zavicefta –
serious infections (EU); Pandemic Live
(cid:36)(cid:87)(cid:87)(cid:72)(cid:81)(cid:88)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:44)(cid:81)(cid:432)(cid:88)(cid:72)(cid:81)(cid:93)(cid:68)(cid:3)(cid:57)(cid:68)(cid:70)(cid:70)(cid:76)(cid:81)(cid:72)(cid:3)(cid:347)(cid:3)
(cid:83)(cid:68)(cid:81)(cid:71)(cid:72)(cid:80)(cid:76)(cid:70)(cid:3)(cid:76)(cid:81)(cid:432)(cid:88)(cid:72)(cid:81)(cid:93)(cid:68)(cid:3)(cid:11)(cid:40)(cid:56)(cid:12)(cid:17)
Vidaza and durvalumab for the
treatment of acute myeloid leukaemia
and CC486+durvalumab for
myelodysplastic syndromes (with
Celgene); MEDI0680+durvalumab for
solid tumours; MEDI0562 (humanised
OX40); AZD6738+Lynparza for gastric
cancer; AZD1775 (Wee1);
daratumumab+durvalumab for
multiple myeloma; in collaboration
with Incyte, epacadostat (IDO)+
durvalumab for solid tumours;
MEDI4166 (PCSK9/GLP-1); MEDI0382;
AZD4076; abediterol (AZD0548)
(LABA); AZD1419 (Inhaled TLR9);
MEDI2070 (IL-23); MEDI3902
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MEDI8897 (RSV).
1 15 for determining Annual Bonus.
See page 108
Therapy Area Review from page 23
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Development Pipeline from page 204
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Return to growth
Strategic priorities
Key performance indicators
Focus on Growth Platforms
Brilinta/Brilique – Work to deliver
Brilinta/Brilique’s potential to reduce
cardiovascular deaths through
ongoing clinical studies.
Diabetes – Work to maximise the
potential of our broad and innovative
non-insulin, anti-diabetic portfolio
to transform patient care.
From January 2017, New CVMD
Growth Platform combines our
Diabetes franchise, Brilinta/Brilique
and any new launches.
Respiratory – Work to maximise
pipeline value, devices and medicines
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improve patient outcomes in asthma
and COPD.
New Oncology – Aim to deliver
six new cancer medicines to
patients by 2020. It became our sixth
Growth Platform in January 2015
and includes Lynparza, Iressa (US)
and Tagrisso.
Japan – Strengthen our Oncology
franchise and work to maximise the
success of our Diabetes medicines
and established brands: Symbicort,
Nexium and Crestor.
Emerging Markets – Focus on
delivering innovative medicines
by investing in Emerging Markets
capabilities, with a focus on China
and other leading markets, such
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transformation of our capabilities
is supporting new products and
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Transform through specialty care,
devices and biologics
Biologics now account for about
half of our NMEs in development,
potentially enhancing asset longevity.
A greater focus on innovative and
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ensuring product durability.
Our new specialty care portfolio is
expected to balance our strength
in primary care medicines.
Brilinta/Brilique
Diabetes
Respiratory
$839m
Product Sales
$2,427m
Product Sales
$4,753m
Product Sales
2016
2015
2014
$839m
$619m
$476m
2016
2015
2014
$2,427m
$2,224m
$1,870m
2016
2015
2014
$4,753m
$4,987m
$5,063m
Actual growth
2016 +36%
2015 +30%
2014 +68%
CER growth
2016 +39%
2015 +44%
2014 +70%
Actual growth
2016 +9%
2015 +19%
2014 +138%
CER growth
2016 +11%
2015 +26%
2014 +139%
Actual growth
2016 -5%
2015 -2%
2014 +8%
CER growth
2016 -3%
2015 +7%
2014 +10%
Brilinta delivered Product Sales of
$839 million. Continued progress was
seen across the US and Europe with
45% and 12% growth (15% at CER)
in the year respectively.
Diabetes Product Sales grew by
9% (11% at CER) despite intense
competition in this space with a
positive contribution from all Regions.
Our focus in diabetes remains on
the fastest-growing SGLT2 and
GLP-1 classes.
2016 was a challenging year.
Respiratory Product Sales declined by
5% (3% at CER), the main driver of this
being Symbicort, which continued to
grow volume share, however, Product
Sales were down by 12% (10% at CER),
(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:71)(cid:72)(cid:89)(cid:72)(cid:79)(cid:82)(cid:83)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)
(cid:40)(cid:88)(cid:85)(cid:82)(cid:83)(cid:72)(cid:15)(cid:3)(cid:82)(cid:428)(cid:86)(cid:72)(cid:87)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:82)(cid:86)(cid:76)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:40)(cid:80)(cid:72)(cid:85)(cid:74)(cid:76)(cid:81)(cid:74)(cid:3)
Markets and Established ROW growth.
New Oncology
Japan
Emerging Markets
$664m
Product Sales
$2,184m
Product Sales
$5,794m
Product Sales
2016
2015
2014
$664m
$119m
N/A
2016
2015
2014
$2,184m
$2,020m
$2,227m
2016
2015
2014
$5,794m
$5,822m
$5,827m
Actual growth
2016 n/m
2015 N/A
2014 N/A
CER growth
2016 n/m
2015 N/A
2014 N/A
Actual growth
2016 +8%
2015 -9%
2014 -10%
CER growth
2016 -3%
2015 +4%
2014 -3%
Actual growth
2016 0%
2015 0%
2014 +8%
CER growth
2016 +6%
2015 +12%
2014 +12%
New Oncology Product Sales of
Lynparza, Iressa (US) and Tagrisso
were $664 million. Tagrisso continued
to demonstrate strong uptake in the
US, Europe and Japan with global
Product Sales of $423 million and 46
regulatory approvals. Lynparza Product
Sales were $218 million.
In Japan, Product Sales were up
(cid:69)(cid:92)(cid:3)(cid:27)(cid:8)(cid:3)(cid:11)(cid:71)(cid:82)(cid:90)(cid:81)(cid:3)(cid:22)(cid:8)(cid:3)(cid:68)(cid:87)(cid:3)(cid:38)(cid:40)(cid:53)(cid:12)(cid:15)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)
exchange rate impact and the
mandated biennial price cuts. We had
volume growth of about 2%. Our three
biggest medicines, Crestor, Nexium
and Symbicort, continued to perform
well, but Crestor Product Sales were
impacted by inventory reductions at
our local marketing partner.
Emerging Markets growth mainly
driven by Brilinta, Forxiga and our
Respiratory franchise. China
represented just under half of the
total Emerging Markets Product
Sales in 2016.
Return to growth from page 48
Therapy Area Review from page 23
Geographical Review from page 226
AstraZeneca Annual Report and Form 20-F Information 2016
17
Strategic Report Strategy
Strategy and key performance indicators continued
Be a great place to work
Strategic priorities
Key performance indicators
Evolve our culture
Work to improve our employees’
(cid:76)(cid:71)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:51)(cid:88)(cid:85)(cid:83)(cid:82)(cid:86)(cid:72)(cid:3)
and Values and promote greater
understanding of and belief in
our strategy.
Invest in and implement tailored
leadership development programmes.
Simplify our business
(cid:39)(cid:72)(cid:89)(cid:72)(cid:79)(cid:82)(cid:83)(cid:3)(cid:86)(cid:76)(cid:80)(cid:83)(cid:79)(cid:72)(cid:85)(cid:15)(cid:3)(cid:80)(cid:82)(cid:85)(cid:72)(cid:3)(cid:72)(cid:433)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:3)
(cid:83)(cid:85)(cid:82)(cid:70)(cid:72)(cid:86)(cid:86)(cid:72)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:432)(cid:68)(cid:87)(cid:87)(cid:72)(cid:81)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)
organisational structure to encourage
accountability and improve decision
making and communication.
Attract and retain the best talent
(cid:36)(cid:70)(cid:70)(cid:72)(cid:79)(cid:72)(cid:85)(cid:68)(cid:87)(cid:72)(cid:3)(cid:72)(cid:428)(cid:82)(cid:85)(cid:87)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)(cid:68)(cid:87)(cid:87)(cid:85)(cid:68)(cid:70)(cid:87)(cid:3)(cid:71)(cid:76)(cid:89)(cid:72)(cid:85)(cid:86)(cid:72)(cid:15)(cid:3)
top talent with new capabilities.
Employee belief in our strategy
Organisational structure –
percentage of employees within six
management steps of the CEO
Employees who would recommend
AstraZeneca as a great place to work
80%
2016
2015
2014
82%
74%
80%1
89%2
86%3
2016
2015
2014
82%
71%
75%
2016
2015
2014
74%1
83%2
82%3
This is a key indicator of employee
(cid:72)(cid:81)(cid:74)(cid:68)(cid:74)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:17)(cid:3)(cid:39)(cid:72)(cid:70)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:86)(cid:3)(cid:76)(cid:80)(cid:83)(cid:68)(cid:70)(cid:87)(cid:3)
of reshaping the business.
1 Source: December 2016 Pulse survey
across a sample of the organisation.
2 Source: January 2016 Pulse survey
across a sample of the organisation.
3 Source: Global FOCUS all-employee
survey.
This is a key indicator of our progress
(cid:76)(cid:81)(cid:3)(cid:82)(cid:85)(cid:74)(cid:68)(cid:81)(cid:76)(cid:86)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:79)(cid:3)(cid:72)(cid:433)(cid:70)(cid:76)(cid:72)(cid:81)(cid:70)(cid:92)(cid:15)(cid:3)(cid:87)(cid:75)(cid:85)(cid:82)(cid:88)(cid:74)(cid:75)(cid:3)
improved decision making, driving
accountability to the right level and
(cid:76)(cid:80)(cid:83)(cid:85)(cid:82)(cid:89)(cid:76)(cid:81)(cid:74)(cid:3)(cid:70)(cid:82)(cid:80)(cid:80)(cid:88)(cid:81)(cid:76)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:432)(cid:82)(cid:90)(cid:17)
This is a key indicator of whether
employees believe AstraZeneca is a
(cid:74)(cid:85)(cid:72)(cid:68)(cid:87)(cid:3)(cid:83)(cid:79)(cid:68)(cid:70)(cid:72)(cid:3)(cid:87)(cid:82)(cid:3)(cid:90)(cid:82)(cid:85)(cid:78)(cid:17)(cid:3)(cid:39)(cid:72)(cid:70)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:86)(cid:3)
impact of reshaping the business.
1 Source: December 2016 Pulse survey
across a sample of the organisation.
2 Source: January 2016 Pulse survey
across a sample of the organisation.
3 Source: Global FOCUS all-employee
survey.
Be a great place to work from page 52
Employees from page 54
Do business sustainably
Strategic priorities
Key performance indicators
Deliver business success
over the long term
Deliver our business strategy in a way
(cid:87)(cid:75)(cid:68)(cid:87)(cid:3)(cid:71)(cid:72)(cid:79)(cid:76)(cid:89)(cid:72)(cid:85)(cid:86)(cid:3)(cid:90)(cid:76)(cid:71)(cid:72)(cid:85)(cid:3)(cid:69)(cid:72)(cid:81)(cid:72)(cid:430)(cid:87)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)(cid:86)(cid:82)(cid:70)(cid:76)(cid:72)(cid:87)(cid:92)(cid:3)
and the planet.
Focus on:
> maintaining ethics and
transparency in everything we do
> increasing access to healthcare for
more people
> minimising the environmental
impact of our products and
processes.
Align our work with the UN
Sustainable Development Goals and
work to integrate our commitments
into day-to-day business activities.
Dow Jones Sustainability
Index ranking
86%
2016
2015
2014
Screening, diagnosis and treatment
of hypertension as part of Healthy
Heart Africa programme
2 million
patients
Operational carbon footprint1
1,657 kt CO2e
86%
84%
79%
2016
2015
2014
2m
1m
N/A
2016
2015
2014
1,657 kt CO2e
1,743 kt CO2e
N/A
Met the target of maintaining position
in the Dow Jones Sustainability World
and Europe Indexes comprising the top
10% of the largest 2,500 companies
with a score of 86%.
Healthy Heart Africa was launched
in October 2014. By the end of 2016,
we had conducted over two million
hypertension screenings in the
community and healthcare facilities.
Our 2016 operational carbon footprint
met our target emission of 1,708 kt
CO2e and represents a 5% reduction
from our 2015 baseline.
Sustainability from page 43
(cid:49)(cid:82)(cid:87)(cid:72)(cid:29)(cid:3)(cid:38)(cid:82)(cid:81)(cid:430)(cid:85)(cid:80)(cid:72)(cid:71)(cid:3)(cid:69)(cid:85)(cid:72)(cid:68)(cid:70)(cid:75)(cid:72)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:72)(cid:91)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:79)(cid:3)(cid:86)(cid:68)(cid:79)(cid:72)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:70)(cid:82)(cid:71)(cid:72)(cid:86)(cid:3)(cid:82)(cid:85)(cid:3)(cid:85)(cid:72)(cid:74)(cid:88)(cid:79)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:74)(cid:79)(cid:82)(cid:69)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)(cid:76)(cid:86)(cid:3)(cid:81)(cid:82)(cid:3)(cid:79)(cid:82)(cid:81)(cid:74)(cid:72)(cid:85)(cid:3)(cid:85)(cid:72)(cid:74)(cid:68)(cid:85)(cid:71)(cid:72)(cid:71)(cid:3)(cid:68)(cid:86)(cid:3)(cid:68)(cid:3)(cid:46)(cid:51)(cid:44)(cid:17)(cid:3)(cid:43)(cid:82)(cid:90)(cid:72)(cid:89)(cid:72)(cid:85)(cid:15)(cid:3)(cid:87)(cid:75)(cid:76)(cid:86)(cid:3)(cid:76)(cid:81)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:76)(cid:86)(cid:3)
reported on page 52 of the Annual Report.
¹ Operational carbon footprint is emissions
from all Scope 1, 2, and selected Scope 3
sources. See page 231.
18
AstraZeneca Annual Report and Form 20-F Information 2016
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
(cid:36)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:42)(cid:85)(cid:82)(cid:88)(cid:83)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:86)(cid:3)
Strategic priorities
Key performance indicators
Drive on-market value
Invest in R&D and on-market
Growth Platforms to return to
growth. Our aim is to deliver
industry-leading productivity by
restructuring to create scope for
(cid:76)(cid:81)(cid:89)(cid:72)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:68)(cid:3)(cid:432)(cid:72)(cid:91)(cid:76)(cid:69)(cid:79)(cid:72)(cid:3)(cid:70)(cid:82)(cid:86)(cid:87)(cid:3)(cid:69)(cid:68)(cid:86)(cid:72)(cid:17)
Maintain a progressive dividend
Policy is to maintain or grow
dividend per share.
Maintain a strong balance sheet
Target a strong, investment-grade
credit rating, operational cash
balance and periodic share
repurchases.
Total Revenue1
(cid:49)(cid:72)(cid:87)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:82)(cid:83)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)
activities
Dividend per share1
$23,002m $4,145m
$2.80
2016
2015
2014
$23,002m
$24,708m
$26,547m
2016
2015
2014
Actual growth
2016 -7%
2015 -7%
2014 +3%
CER growth
2016 -5%
2015 +1%
2014 +5%
Actual growth
2016 +25%
2015 -53%
2014 -5%
$4,145m
$3,324m
$7,058m
2016
2015
2014
$2.80
$2.80
$2.80
Cash generated from operating
activities improved cash management
(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:82)(cid:81)(cid:72)(cid:16)(cid:82)(cid:428)(cid:3)(cid:87)(cid:68)(cid:91)(cid:3)(cid:85)(cid:72)(cid:73)(cid:88)(cid:81)(cid:71)(cid:86)(cid:17)
Dividend is consistent with the
progressive dividend policy pursuant
to which the Board intends to maintain
or grow the dividend each year.
Total Revenue comprised Product
Sales of $21,319 million (down by 10%
at actual rate of exchange and 8% at
CER) and Externalisation Revenue of
$1,683 million (up by 57% at actual
rate of exchange and 59% at CER).
Decline in Total Revenue at actual
(cid:72)(cid:91)(cid:70)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:3)(cid:85)(cid:68)(cid:87)(cid:72)(cid:86)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:68)(cid:85)(cid:87)(cid:76)(cid:70)(cid:88)(cid:79)(cid:68)(cid:85)(cid:3)
weakness of key trading currencies
against the US dollar.
1 First and second interim dividend
for the year.
1 As detailed on page 142, Total Revenue
consists of Product Sales and
Externalisation Revenue.
Reported EPS
Core EPS
$2.77
$4.31
2016
2015
2014
$2.77
$2.23
$0.98
2016
2015
2014
$4.31
$4.26
$4.28
Actual growth
2016 +24%
2015 +128%
2014 -52%
CER growth
2016 +9%
2015 +137%
2014 -34%
Actual growth
2016 +1%
2015 0%
2014 -15%
CER growth
2016 -5%
2015 +7%
2014 -8%
Reported EPS of $2.77 represented
growth of 24% (9% at CER). This
included a gain of $0.76 on the
revaluation of acquisition-related
liabilities.
Core EPS increased by 1% (decreased
5% at CER), driven by the same rate of
decline in Total Revenue at CER.
Financial Review from page 62
AstraZeneca Annual Report and Form 20-F Information 2016
19
Strategic Report Strategy
Risk overview
Principal Risks
We face a diverse range of risks and uncertainties and this table provides insight into the Principal Risks that could have a materially
adverse effect on the business or results of operations. We outline why effective management of these risks is important and relevant
to the business, how we are managing them and which risks are rising, falling or have remained static during the past 12 months.
Our approach to risk management is designed to encourage clear decision making on which risks we take and how we manage these
risks. Fundamental to this process is a sound understanding of every risk’s potential strategic, commercial, financial, compliance, legal
and reputational implications.
Risk category and Principal Risks
Context/potential impact
Product pipeline and intellectual property
Delivery of pipeline and new products
The development of any pharmaceutical product candidate is a complex, risky and lengthy process involving
(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:15)(cid:3)(cid:53)(cid:9)(cid:39)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:82)(cid:87)(cid:75)(cid:72)(cid:85)(cid:3)(cid:85)(cid:72)(cid:86)(cid:82)(cid:88)(cid:85)(cid:70)(cid:72)(cid:86)(cid:17)(cid:3)(cid:36)(cid:3)(cid:83)(cid:85)(cid:82)(cid:77)(cid:72)(cid:70)(cid:87)(cid:3)(cid:80)(cid:68)(cid:92)(cid:3)(cid:73)(cid:68)(cid:76)(cid:79)(cid:3)(cid:82)(cid:85)(cid:3)(cid:69)(cid:72)(cid:3)(cid:71)(cid:72)(cid:79)(cid:68)(cid:92)(cid:72)(cid:71)(cid:3)(cid:68)(cid:87)(cid:3)(cid:68)(cid:81)(cid:92)(cid:3)(cid:86)(cid:87)(cid:68)(cid:74)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:85)(cid:82)(cid:70)(cid:72)(cid:86)(cid:86)(cid:3)(cid:71)(cid:88)(cid:72)(cid:3)
(cid:87)(cid:82)(cid:3)(cid:68)(cid:3)(cid:81)(cid:88)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:82)(cid:73)(cid:3)(cid:73)(cid:68)(cid:70)(cid:87)(cid:82)(cid:85)(cid:86)(cid:15)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:70)(cid:82)(cid:88)(cid:79)(cid:71)(cid:3)(cid:85)(cid:72)(cid:71)(cid:88)(cid:70)(cid:72)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:79)(cid:82)(cid:81)(cid:74)(cid:16)(cid:87)(cid:72)(cid:85)(cid:80)(cid:3)(cid:74)(cid:85)(cid:82)(cid:90)(cid:87)(cid:75)(cid:15)(cid:3)(cid:85)(cid:72)(cid:89)(cid:72)(cid:81)(cid:88)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:83)(cid:85)(cid:82)(cid:430)(cid:87)
Meet quality, regulatory and ethical drug
approval and disclosure requirements
(cid:39)(cid:72)(cid:79)(cid:68)(cid:92)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:85)(cid:72)(cid:74)(cid:88)(cid:79)(cid:68)(cid:87)(cid:82)(cid:85)(cid:92)(cid:3)(cid:85)(cid:72)(cid:89)(cid:76)(cid:72)(cid:90)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:68)(cid:83)(cid:83)(cid:85)(cid:82)(cid:89)(cid:68)(cid:79)(cid:86)(cid:3)(cid:76)(cid:80)(cid:83)(cid:68)(cid:70)(cid:87)(cid:3)(cid:83)(cid:68)(cid:87)(cid:76)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:3)(cid:68)(cid:70)(cid:70)(cid:72)(cid:86)(cid:86)(cid:15)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:70)(cid:68)(cid:81)(cid:3)(cid:80)(cid:68)(cid:87)(cid:72)(cid:85)(cid:76)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)(cid:68)(cid:428)(cid:72)(cid:70)(cid:87)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)
(cid:69)(cid:88)(cid:86)(cid:76)(cid:81)(cid:72)(cid:86)(cid:86)(cid:3)(cid:82)(cid:85)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:85)(cid:72)(cid:86)(cid:88)(cid:79)(cid:87)(cid:86)
Secure and protect product IP
Commercialisation
Externally driven demand, pricing,
access and competitive pressures
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(cid:76)(cid:81)(cid:89)(cid:72)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:15)(cid:3)(cid:87)(cid:75)(cid:85)(cid:82)(cid:88)(cid:74)(cid:75)(cid:3)(cid:74)(cid:72)(cid:81)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:82)(cid:73)(cid:3)(cid:86)(cid:88)(cid:433)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:3)(cid:85)(cid:72)(cid:89)(cid:72)(cid:81)(cid:88)(cid:72)(cid:86)(cid:15)(cid:3)(cid:81)(cid:72)(cid:90)(cid:3)(cid:80)(cid:72)(cid:71)(cid:76)(cid:70)(cid:76)(cid:81)(cid:72)(cid:86)(cid:3)(cid:80)(cid:88)(cid:86)(cid:87)(cid:3)(cid:69)(cid:72)(cid:3)(cid:86)(cid:68)(cid:73)(cid:72)(cid:74)(cid:88)(cid:68)(cid:85)(cid:71)(cid:72)(cid:71)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:69)(cid:72)(cid:76)(cid:81)(cid:74)(cid:3)(cid:70)(cid:82)(cid:83)(cid:76)(cid:72)(cid:71)(cid:3)
with a reasonable amount of certainty for a reasonable amount of time
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and in individual countries. There can be additional pressure from governments and other healthcare payers
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Quality and execution of commercial
strategies
If commercialisation of a product does not succeed as anticipated, or its rate of sales growth is slower than
anticipated, there is a risk that we may not be able to fully recoup the costs in launching it
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Maintain supply of compliant,
quality product
Delays or interruptions in supply can lead to recalls, product shortages, regulatory action, reputational harm
and lost sales
Information technology and data
security and privacy
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operations. This could lead to regulatory penalties or non-compliance with laws and regulations
Delivery of gains from
productivity initiatives
Inappropriately managed initiatives could lead to low employee engagement and reduced productivity, increased
absence and attrition levels, or even industrial action. All could adversely impact the value of the initiative
Attract, develop, engage and retain
talented and capable employees
at all levels
Failure to attract and retain highly skilled personnel may weaken our succession plans for critical positions in the
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the achievement of our strategic objectives
Legal, regulatory and compliance
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Defence of product, pricing
and practices litigation
Meet regulatory and ethical expectations
on commercial practices, including
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exchanges
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Achieve strategic plans and meet
targets and expectations
20
AstraZeneca Annual Report and Form 20-F Information 2016
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medicines. Failure to do this could adversely impact our reputation, our business and the results of operations,
and could lead to product liability claims
Investigations or legal proceedings could be costly, divert management attention or damage our reputation
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Any failure to comply with applicable laws, rules and regulations, including bribery and corruption legislation,
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(cid:41)(cid:68)(cid:76)(cid:79)(cid:88)(cid:85)(cid:72)(cid:3)(cid:87)(cid:82)(cid:3)(cid:86)(cid:88)(cid:70)(cid:70)(cid:72)(cid:86)(cid:86)(cid:73)(cid:88)(cid:79)(cid:79)(cid:92)(cid:3)(cid:76)(cid:80)(cid:83)(cid:79)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:69)(cid:88)(cid:86)(cid:76)(cid:81)(cid:72)(cid:86)(cid:86)(cid:3)(cid:86)(cid:87)(cid:85)(cid:68)(cid:87)(cid:72)(cid:74)(cid:92)(cid:3)(cid:80)(cid:68)(cid:92)(cid:3)(cid:73)(cid:85)(cid:88)(cid:86)(cid:87)(cid:85)(cid:68)(cid:87)(cid:72)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:82)(cid:85)(cid:3)(cid:82)(cid:87)(cid:75)(cid:72)(cid:85)(cid:3)
(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:86)(cid:3)(cid:82)(cid:85)(cid:3)(cid:72)(cid:91)(cid:83)(cid:72)(cid:70)(cid:87)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:17)(cid:3)(cid:55)(cid:75)(cid:76)(cid:86)(cid:3)(cid:73)(cid:68)(cid:76)(cid:79)(cid:88)(cid:85)(cid:72)(cid:3)(cid:70)(cid:82)(cid:88)(cid:79)(cid:71)(cid:15)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:88)(cid:85)(cid:81)(cid:15)(cid:3)(cid:71)(cid:68)(cid:80)(cid:68)(cid:74)(cid:72)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:85)(cid:72)(cid:83)(cid:88)(cid:87)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:80)(cid:68)(cid:87)(cid:72)(cid:85)(cid:76)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)(cid:68)(cid:428)(cid:72)(cid:70)(cid:87)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:69)(cid:88)(cid:86)(cid:76)(cid:81)(cid:72)(cid:86)(cid:86)(cid:15)(cid:3)
(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:83)(cid:82)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:82)(cid:85)(cid:3)(cid:85)(cid:72)(cid:86)(cid:88)(cid:79)(cid:87)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:82)(cid:83)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)
Strategy key
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Be a great place to work
Return to growth
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(cid:36)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:42)(cid:85)(cid:82)(cid:88)(cid:83)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:86)
Trend key
Increasing risk
Decreasing risk
Unchanged
Further information on our key risk management
and assurance processes can be found in Risk
from pages 214 to 225 which also includes
a description of circumstances under which
principal and other risks and uncertainties
might arise in the course of our business and
their potential impact
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Management actions
Trend versus prior year
> Prioritise and accelerate our pipeline
> Strengthen pipeline through acquisitions, licensing and collaborations
> Focus on innovative science in three main therapy areas
> Quality management systems incorporating monitoring, training and assurance activities
> Collaborating with regulatory bodies and advocacy groups to monitor and respond to changes in the
regulatory environment, including revised process, timelines and guidance
> Active management of IP rights
Increasing importance of pipeline contribution given loss of
exclusivity on key brands
> Focus on Growth Platforms
> Demonstrating value of medicines/health economics
> Global footprint
> (cid:39)(cid:76)(cid:89)(cid:72)(cid:85)(cid:86)(cid:76)(cid:430)(cid:72)(cid:71)(cid:3)(cid:83)(cid:82)(cid:85)(cid:87)(cid:73)(cid:82)(cid:79)(cid:76)(cid:82)
Global economic and political conditions placing downwards
pressure on healthcare pricing and spending, and therefore
on revenue
> Focus on Growth Platforms
> Accelerate and risk share through business development and strategic collaborations and alliances
Loss of exclusivity on key brands increases challenge to achieve
our short- to medium-term targets
> Business continuity and resilience initiatives, disaster and data recovery and emergency response plans
> Establishment of new manufacturing facilities, creating capacity and technical capability to support new
Supply chain evolving to incorporate new supply chains and
to support product launches
product launches, particularly biologics
> Contingency plans including dual sourcing, multiple suppliers and stock levels
> Quality management systems
> Disaster and data recovery plans
> Strategies to secure critical systems and processes
Several key transformational programmes involving large
IT-related aspects
> Appropriate project governance structure and oversight
> Regular review of strategic initiatives by appropriate senior executive and Board level committees
Ongoing restructuring projects
> Evolve our culture
> (cid:41)(cid:82)(cid:70)(cid:88)(cid:86)(cid:3)(cid:82)(cid:81)(cid:3)(cid:86)(cid:76)(cid:80)(cid:83)(cid:79)(cid:76)(cid:430)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)
> Development of our employees
Ongoing restructuring projects
> (cid:53)(cid:82)(cid:69)(cid:88)(cid:86)(cid:87)(cid:3)(cid:83)(cid:85)(cid:82)(cid:70)(cid:72)(cid:86)(cid:86)(cid:72)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:86)(cid:92)(cid:86)(cid:87)(cid:72)(cid:80)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:83)(cid:79)(cid:68)(cid:70)(cid:72)(cid:3)(cid:87)(cid:82)(cid:3)(cid:80)(cid:68)(cid:81)(cid:68)(cid:74)(cid:72)(cid:3)(cid:83)(cid:68)(cid:87)(cid:76)(cid:72)(cid:81)(cid:87)(cid:3)(cid:86)(cid:68)(cid:73)(cid:72)(cid:87)(cid:92)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:72)(cid:433)(cid:70)(cid:68)(cid:70)(cid:92)(cid:3)(cid:87)(cid:85)(cid:72)(cid:81)(cid:71)(cid:86)(cid:3)(cid:68)(cid:86)(cid:3)(cid:90)(cid:72)(cid:79)(cid:79)(cid:3)(cid:68)(cid:86)(cid:3)(cid:72)(cid:91)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)
reported risks through regulatory agencies and other parties. This includes a comprehensive
pharmacovigilance programme supplemented by close monitoring and review of adverse events
The number of new products in our marketed portfolio is growing
and is anticipated to increase further as our pipeline develops. Our
(cid:68)(cid:69)(cid:76)(cid:79)(cid:76)(cid:87)(cid:92)(cid:3)(cid:87)(cid:82)(cid:3)(cid:68)(cid:70)(cid:70)(cid:88)(cid:85)(cid:68)(cid:87)(cid:72)(cid:79)(cid:92)(cid:3)(cid:68)(cid:86)(cid:86)(cid:72)(cid:86)(cid:86)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:86)(cid:68)(cid:73)(cid:72)(cid:87)(cid:92)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:72)(cid:433)(cid:70)(cid:68)(cid:70)(cid:92)(cid:3)(cid:82)(cid:73)(cid:3)(cid:81)(cid:72)(cid:90)(cid:3)(cid:83)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:86)(cid:3)
is inherently limited due to relatively short periods of product
testing and relatively small clinical study patient samples
> Combined internal and external counsel management
> Strong ethical and compliance culture
> Established compliance framework in place including annual Code of Conduct training for all employees
> Focus on due diligence and oversight of third party engagements
> Established new requirements on providing appropriate information about our products
> Established sustainability framework in place including a refreshed sustainability strategy for 2016
Increasing government and regulatory scrutiny and evolving
compliance challenges as complexity of business relationships
increases
> Focus on Growth Platforms and innovative science in three main therapy areas
> Strengthen pipeline through acquisitions, licensing and collaborations
> Appropriate capital structure and balance sheet
> Portfolio-driven decision making process governed by senior executive-led committees
Increasing challenge to balance long- and short-term investments
as we navigate a period of loss of exclusivity on key brands
AstraZeneca Annual Report and Form 20-F Information 2016
21
Strategic Report Strategy
Risk overview continued
Managing risk
We work to ensure that we have effective
risk management processes in place to
support the delivery of our strategic
priorities. This enables us to meet the
expectations of our stakeholders and
upholds our Values. We monitor our
business activities and external and internal
environments for new, emerging and
changing risks to ensure that these are
managed appropriately.
The Board believes that existing processes
provide it with adequate information on the
risks and uncertainties we face. Details of
these risks and the potential impacts on our
business are contained on pages 214 to
225. The Board defines those risks which
have a potential to have a material impact
on our business or results of operations as
our Principal Risks.
Risk management embedded in
business processes
We strive to embed sound risk management
in our strategy, planning, budgeting and
performance management processes.
The Board defines the Group’s risk appetite,
enabling the Group, in both quantitative and
qualitative terms, to judge the level of risk it
is prepared to take in achieving its overall
objectives. The Board expresses the
acceptable levels of risk for the Group using
three key dimensions. These are: (i) earnings
and cash flow; (ii) return on investment;
and (iii) ethics and reputation. Annually,
the Group develops a detailed three-year
bottom-up business plan and 10-year
long-range projection to support the delivery
of its strategy. The Board considers these
in the context of the Group’s risk appetite.
Adjustments are made to the plan or risk
appetite to ensure they remain aligned.
Our risk management approach is aligned
to our strategy and business planning
processes. We cross-check financial risks
and opportunities identified through the
business planning process and integrate
our findings into the overall risk management
reporting. Line managers are accountable
for identifying and managing risks and for
delivering business objectives in accordance
with the Group’s risk appetite.
The Senior Executive Team (SET) is required
by the Board to oversee and monitor the
effectiveness of the risk management
processes implemented by management.
Within each SET function, leadership teams
discuss the risks the business faces. Every
year, we map these risks to AstraZeneca’s
risk ‘taxonomy’. This process provides a
Group-wide assessment for the Board,
Audit Committee and SET. Quarterly,
each SET function assesses changes to
these risks, new and emerging risks, and
mitigation plans. These are assimilated into
a Group Risk Report for the Board, Audit
Committee and SET. Supporting tools are in
place to assist risk leaders and managers in
managing, monitoring and planning for risk
and we continue to work on developing our
risk management standards and guidelines.
Global Compliance, Finance and Internal
Audit Services support SET by advising on
policy and standard setting, monitoring and
auditing, communication and training, as
well as reporting on the adequacy of line
management processes as they apply to
risk management.
We have a business resilience framework
which governs our ability to prevent or
quickly adapt to situations while maintaining
continuous business operations and
safeguarding our people, processes and
reputation. Within this we have business
continuity plans to address situations in
which specific risks have the potential to
severely impact our business. These plans
include training and crisis simulation
activities for business managers.
More information about our Global Compliance
function and the Code of Conduct can be
found in the Corporate Governance Report
from page 90
Viability statement
In accordance with provision C.2.2 of the
2014 UK Corporate Governance Code,
the Board has determined that a three-year
period to 31 December 2019 constitutes an
appropriate period over which to provide its
viability statement.
The Board considers annually and on
a rolling basis, a three-year bottom-up
detailed business plan. The Board also
considers a 10-year long-range projection
but, given the inherent uncertainty involved,
believes that the three-year statement
presents readers of the Annual Report with
a reasonable degree of assurance while still
providing a longer-term perspective.
The three-year detailed business plan
recognises the significant political
uncertainty arising from Brexit, the US
presidential election result and elections
in other key markets. Risks to the sales
and cost forecasts are identified at a market
and SET function level. The plan is used
to perform central net debt and headroom
profile analysis. This analysis considers
a severe but plausible downside scenario
incorporating the Principal Risks such as
market pricing and access, delivery of
pipeline and loss of IP. The resilience of
the Group to absorb further Principal Risk
events such as regulatory/litigious fines and
the need to meet pension fund obligations
has also been analysed. The Group has
adequate resilience against these and the
other Principal Risks due to our diversified
product portfolio; our global footprint; our
robust supply infrastructure; our access
to external financing, which includes
committed facilities; and our ability to
manage our cost base.
Based on the results of this analysis, the
Directors have a reasonable expectation
that the Company will be able to continue
in operation and meet its liabilities as they
fall due over the three-year period of
their assessment.
Brexit
On 23 June 2016, the UK held a remain-or-
leave referendum on the UK’s membership
within the EU, the outcome of which was
a decision for the UK to exit from the EU
(Brexit). A process of negotiation will likely
determine the future terms of the UK’s
relationship with the EU, as well as whether
the UK will be able to continue to benefit
from the EU’s free trade and similar
arrangements. Until the Brexit negotiation
process is initiated and completed, it is
difficult to anticipate the potential impact
on AstraZeneca’s market share, sales,
profitability and results of operations. The
Group operates from a global footprint
and retains flexibility to adapt to changing
circumstances. The uncertainty before,
during and after the period of negotiation is
also expected to increase volatility and may
have an economic impact, particularly in the
UK and Eurozone. The Board reviews the
potential impact of Brexit as an integral part
of its Principal Risks (as outlined on page 20)
rather than as a stand-alone risk. As the
process of Brexit evolves, the Board will
continue to assess its impact.
22
AstraZeneca Annual Report and Form 20-F Information 2016
Therapy Area Overview and Pipeline
Our Therapy Area teams are focused on maximising the value of our pipeline for
patients and shareholders alike. We adopt a dynamic approach to portfolio management
(cid:68)(cid:81)(cid:71)(cid:3)(cid:88)(cid:86)(cid:72)(cid:3)(cid:69)(cid:88)(cid:86)(cid:76)(cid:81)(cid:72)(cid:86)(cid:86)(cid:3)(cid:71)(cid:72)(cid:89)(cid:72)(cid:79)(cid:82)(cid:83)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:87)(cid:82)(cid:3)(cid:86)(cid:88)(cid:83)(cid:83)(cid:79)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:83)(cid:76)(cid:83)(cid:72)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:82)(cid:90)(cid:81)(cid:3)(cid:72)(cid:428)(cid:82)(cid:85)(cid:87)(cid:86)(cid:17)
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Strategy
We have transformed our drugs portfolio
by focusing on three main therapy areas:
Oncology, Cardiovascular & Metabolic
Disease (CVMD) and Respiratory, while
selectively pursuing promising therapies in
Autoimmunity, Infection and Neuroscience.
Our sales in each of these areas in 2016 are
shown in the table below.
We are building value by strengthening
our in-line portfolios through commercial
excellence, life-cycle management and
expansion into new patient populations as
well as by translating our late-stage pipeline
into differentiated therapies for disease
areas with high unmet medical need. We
continue to pursue externalisation where
it provides an opportunity to focus and
enhance our portfolio as well as access
capabilities we do not have internally.
We are seeking to expand our
comprehensive Respiratory portfolio to
meet the needs of asthma and COPD
patients across the severity spectrum of
these diseases. Building on an ICS/LABA
foundation with Symbicort, we are evolving
our mono- and fixed-dose combination
therapies as well as optimising our delivery
device platforms.
In CVMD, we are expanding our portfolio
into the cardiovascular-renal area with late-
stage assets such as ZS-9 and roxadustat,
as well as investing to explore the potential
benefits of our SGLT2 and GLP-1 franchises
in chronic kidney disease (CKD) and heart
failure (HF).
We have completed the transformation
of our Oncology portfolio where we
are balancing our efforts across four
disease areas – lung, ovarian, breast and
haematology – and investing in immuno-
oncology (IO) which has the potential to
benefit patients in multiple tumour types
and different lines of therapy.
For more information on our potential
new products and product life-cycle
developments, please see the Therapy Area
pipeline tables on pages 26, 31, 36 and 38
and the Development Pipeline table from
page 204. For information on Patent Expiries
of our Key Marketed Products, please see
from page 211.
As we invest in our main therapy areas
we continue to build upon our strong
commercial and medical capabilities
to ensure that our medicines reach the
patients who need them most.
Indications for each product described in
this Therapy Area Review may vary among
countries. Please see local prescribing
information for country-specific indications
for any particular product.
Development pipeline
As shown in the table overleaf, our pipeline
includes 132 projects, of which 120 are in
the clinical phase of development, and
we are making significant progress in
advancing our late-stage programmes
through regulatory approval with 14 NME
or major LCM regulatory submissions
during 2016, and 11 major approvals. At
the end of 2016, we had 12 NME projects
in pivotal studies or under regulatory review
compared with 15 at the end of 2015. 15
NMEs progressed to their next phase of
development, 22 projects were discontinued
in 2016, 17 for poorer than anticipated
safety and efficacy results, four as a result of
strategic shift in the environment or portfolio
prioritisation, and one because of a change
in regulatory requirements.
Our products
While this Therapy Area Review
concentrates on our key marketed
products, many of our other products are
crucial to our business in certain countries
in Emerging Markets.
For those of our products subject to
litigation, information about material legal
proceedings can be found in Note 28 to the
Financial Statements from page 185.
Details of relevant risks are set out in
Risk from page 214.
Partnering
As outlined in Strategy and key
performance indicators from page 16,
business development, specifically
partnering, is an important element of our
business. It supplements and strengthens
our pipeline and our efforts to achieve
scientific leadership. We partner with
others around the world, including
academia, governments, industry, scientific
organisations and patient groups to access
the best science to stimulate innovation and
accelerate the delivery of new medicines
to target unmet medical need. We currently
have more than 600 collaborations around
the world.
Global Product Sales by therapy area
Oncology
Cardiovascular & Metabolic Disease
Respiratory
Other Disease Areas
Total
Actual
growth
%
2016
CER
growth
%
20
(14)
(5)
(20)
(10)
20
(13)
(3)
(19)
(8)
Sales
$m
3,383
8,116
4,753
5,067
21,319
Sales
$m
2,825
9,489
4,987
6,340
23,641
Actual
growth
%
(7)
(3)
(2)
(23)
(9)
2015
CER
growth
%
7
4
17
(16)
(1)
Sales
$m
3,027
9,802
5,063
8,203
26,095
Actual
growth
%
2014
CER
growth
%
(5)
11
8
(9)
1
(2)
12
10
(7)
3
23
AstraZeneca Annual Report and Form 20-F Information 2016
Strategic Report Therapy Area Review
Therapy Area Overview and Pipeline continued
Development pipeline overview (as at 31 December 2016)
Phase I
Phase II
Late-stage development*
Life-cycle management
projects*
41
36
27
28
> 41 projects in Phase I, including:
> 36 projects in Phase II, including:
> 27 projects in late-stage
> 28 LCM projects
– 29 NMEs
– (cid:20)(cid:3)(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:68)(cid:71)(cid:71)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:79)(cid:3)(cid:76)(cid:81)(cid:71)(cid:76)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)
projects that have reached Phase III
– 11 oncology combination projects
– 25 NMEs
– (cid:23)(cid:3)(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:68)(cid:71)(cid:71)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:79)(cid:3)(cid:76)(cid:81)(cid:71)(cid:76)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)
for projects that have reached
Phase III
– 7 oncology combination projects
development, either in Phase
III/pivotal Phase II studies or
under regulatory review:
– 12 NMEs not yet approved
in any market
– 9 projects exploring
additional indications for
these NMEs, of which 5 are
oncology combinations
– 5 NMEs already approved or
launched in the EU, China,
Japan and/or the US
– (cid:20)(cid:3)(cid:70)(cid:82)(cid:81)(cid:430)(cid:85)(cid:80)(cid:68)(cid:87)(cid:82)(cid:85)(cid:92)(cid:3)(cid:86)(cid:87)(cid:88)(cid:71)(cid:92)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:73)(cid:88)(cid:79)(cid:79)(cid:3)
approval of a launched NME
(cid:13)(cid:3) (cid:3)(cid:49)(cid:48)(cid:40)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:68)(cid:71)(cid:71)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:79)(cid:3)
indications.
* Only includes material projects
(cid:90)(cid:75)(cid:72)(cid:85)(cid:72)(cid:3)(cid:430)(cid:85)(cid:86)(cid:87)(cid:3)(cid:76)(cid:81)(cid:71)(cid:76)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:76)(cid:86)(cid:3)(cid:79)(cid:68)(cid:88)(cid:81)(cid:70)(cid:75)(cid:72)(cid:71)(cid:3)
in all markets.
More generally, our business development
activity takes many forms and can be
broadly grouped into:
> alliances, collaborations and acquisitions
to enhance our portfolio and pipeline in
our main therapy areas
> externalisation activity to maximise
the value of our assets
> divestments of non-priority medicines.
This activity creates additional value from
our existing medicines as well as recurring
Externalisation Revenue and falls broadly
into two categories: (a) collaborations that
help us access therapy area expertise and
(b) collaborations that help us increase
the number of patients and the reach of
medicines in which we maintain an ongoing
interest, but which sit outside our main
therapy areas.
We continue to assess opportunities to
make strategic, value-enhancing additions
to our portfolio and pipeline in our main
therapy areas, including through in-licensing
and acquisitions. Acquisitions completed
during 2016 included the acquisition of
Takeda’s respiratory portfolio, in May,
and the acquisition of a controlling equity
position in Acerta Pharma, in February,
both of which were signed in 2015.
Over the past three years, we have
completed more than 270 major or
strategically important business development
transactions, including some 80 in 2016.
Of these transactions, 55 were related to
pre-clinical assets or programmes and 11 to
PHC and biomarkers. 17 transactions helped
expand our biologics capabilities.
Externalisation is a core component of our
strategy and has an important role to play in
the delivery of our ambition as we continue
to sharpen our focus on developing key
assets within our main therapy areas.
Examples of collaborations that help us
access therapy area expertise include:
> in Alzheimer’s disease through our
partnership with Lilly for the BACE
inhibitor
> in dermatology through our agreements
with Valeant and LEO Pharma for
brodalumab and LEO Pharma for
tralokinumab
> in haematology through our collaboration
with Celgene for durvalumab.
In each case we are optimising the
long-term value of each medicine through
the collaboration.
Examples of collaborations that help us
increase our reach to a greater number
of patients include Plendil, an established
cardiovascular medicine, and the
anaesthetics portfolio. We partnered
with Aspen on our anaesthetics portfolio,
as a company with established expertise
who can dedicate the right resources to
24
AstraZeneca Annual Report and Form 20-F Information 2016
grow the business, while we retain a
significant proportion of the value, which
we also book as Externalisation Revenue.
Alongside these externalisation
opportunities, we also divest medicines
that sit outside our main therapy areas and
that can be deployed better by a partner,
in order to redirect investment and resource
in our main areas of focus while ensuring
continued or expanded patient access.
For example, in 2016, we sold to Pfizer the
commercialisation and development rights
to our late-stage small molecule antibiotics
business in most markets outside the US.
The agreement reinforces our focus on
developing transformational medicines
in our three main therapy areas, while
realising value through Pfizer’s dedicated
commercialisation and development
capabilities in anti-infectives.
The resulting revenue from these activities
supports our R&D investments in our
main therapy areas. Ten transactions that
contribute to Externalisation Revenue and
a further nine divestments or out-licences
were completed in 2016.
More information on our partnering activity in
2016 can be found in subsequent sections of
this Therapy Area Review, Business Review
from page 42, Financial Review from page 62
and Note 25 to the Financial Statements from
page 173
Tumour drivers and
resistance: AstraZeneca
is investigating a number
of proteins and signalling
molecules designed to
impact tumour growth and
resistance mechanisms.
Oncology
Our ambition is to eliminate cancer as a
(cid:70)(cid:68)(cid:88)(cid:86)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:71)(cid:72)(cid:68)(cid:87)(cid:75)(cid:3)(cid:87)(cid:75)(cid:85)(cid:82)(cid:88)(cid:74)(cid:75)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:71)(cid:76)(cid:86)(cid:70)(cid:82)(cid:89)(cid:72)(cid:85)(cid:92)(cid:3)
and collaborations. We seek to achieve
this by means of our combination-focused
pipeline that exploits the power of four
(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:83)(cid:79)(cid:68)(cid:87)(cid:73)(cid:82)(cid:85)(cid:80)(cid:86)(cid:17)
AstraZeneca Annual Report and Form 20-F Information 2016
25
Strategic Report Therapy Area Review
Oncology continued
Following the science
of oncology
More than eight million lives are lost
every year to cancer. Even as R&D
continues to push boundaries in how
we understand and fight cancer, there
is still more to do. At AstraZeneca, we
are committed to advancing the science
of oncology to deliver life-changing
medicines to people most in need.
Our strategic priorities
In Oncology, our vision is to respond to
unmet medical need by redefining the
cancer treatment paradigm. We are
doing this through scientific innovation,
accelerated clinical programmes and
collaboration. We have a strong heritage –
more than 40 years – in developing
cancer drugs. By the end of 2016, several
submissions were underway and we aim
to deliver at least four new cancer therapies,
in addition to Lynparza and Tagrisso, and
12 new line extensions by 2020. In 2015,
we decided to consider all new Oncology
launches, including Lynparza, Iressa (US)
and Tagrisso, as our sixth Growth Platform,
under the designation of New Oncology.
Our broad pipeline of next-generation
medicines is focused on four main
disease areas: breast, ovarian, lung
and haematological cancers, using
four key scientific approaches:
immunotherapy, tumour drivers and
resistance mechanisms, DNA damage
response, and antibody-drug conjugates.
Oncology – pipeline progressions
Regional approvals
Tagrisso – lung cancer (EU, JP) and ctDNA blood test (US, JP)*
Expedited review
Breakthrough Therapy Designation: durvalumab – bladder cancer (US)
Orphan Drug Designation: acalabrutinib – blood cancers (EU); selumetinib – thyroid cancer
(US)
Fast Track Designation: Lynparza – ovarian cancer (2nd line) (US), prostate cancer (2nd line)
(US)
Priority Review Designation: Tagrisso (CN); durvalumab – bladder cancer (US)
Regulatory submissions
Faslodex – breast cancer (1st line) (US, EU, JP)
Tagrisso – lung cancer (CN)
Tagrisso – lung cancer (AURA3 study for full approval) (US, EU)
Durvalumab – bladder cancer (US)
Savolitinib – papillary renal cell carcinoma
Durvalumab+tremelimumab – hepatocellular carcinoma
In collaboration with Celgene, the combination of Vidaza and durvalumab for the treatment
of acute myeloid leukaemia and CC486+durvalumab for myelodysplastic syndromes;
MEDI0680+durvalumab for solid tumours; MEDI0562 (humanised OX40) for solid tumours;
AZD6738+Lynparza for gastric cancer; AZD1775 (Wee1) for solid tumours;
daratumumab+durvalumab for multiple myeloma; in collaboration with Incyte, epacadostat
(IDO)+durvalumab for solid tumours
Acquisition of majority stake in Acerta Pharma providing access to acalabrutinib
Phase III investment
decisions
Phase II starts/progressions
Strategic transactions
completed
Setbacks and terminated
projects
FDA placed and subsequently lifted a partial clinical hold on the enrolment of new patients
with head and neck squamous cell carcinoma (HNSCC) for clinical trials of durvalumab
Tremelimumab DETERMINE, Lynparza GOLD, selumetinib SELECT-1 trials failed to meet
primary endpoint; voluntarily withdrew the marketing authorisation application submitted
to the EMA for cediranib in advanced ovarian cancer
(cid:55)(cid:75)(cid:72)(cid:3)(cid:73)(cid:82)(cid:79)(cid:79)(cid:82)(cid:90)(cid:76)(cid:81)(cid:74)(cid:3)(cid:70)(cid:79)(cid:76)(cid:81)(cid:76)(cid:70)(cid:68)(cid:79)(cid:3)(cid:83)(cid:85)(cid:82)(cid:74)(cid:85)(cid:68)(cid:80)(cid:80)(cid:72)(cid:86)(cid:3)(cid:90)(cid:72)(cid:85)(cid:72)(cid:3)(cid:71)(cid:76)(cid:86)(cid:70)(cid:82)(cid:81)(cid:87)(cid:76)(cid:81)(cid:88)(cid:72)(cid:71)(cid:29)(cid:3)(cid:76)(cid:81)(cid:72)(cid:69)(cid:76)(cid:79)(cid:76)(cid:93)(cid:88)(cid:80)(cid:68)(cid:69)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:71)(cid:76)(cid:428)(cid:88)(cid:86)(cid:72)(cid:3)(cid:79)(cid:68)(cid:85)(cid:74)(cid:72)(cid:3)(cid:37)(cid:16)(cid:70)(cid:72)(cid:79)(cid:79)(cid:3)
(cid:79)(cid:92)(cid:80)(cid:83)(cid:75)(cid:82)(cid:80)(cid:68)(cid:30)(cid:3)(cid:48)(cid:40)(cid:39)(cid:44)(cid:22)(cid:25)(cid:20)(cid:26)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:86)(cid:82)(cid:79)(cid:76)(cid:71)(cid:3)(cid:87)(cid:88)(cid:80)(cid:82)(cid:88)(cid:85)(cid:86)(cid:30)(cid:3)(cid:76)(cid:81)(cid:72)(cid:69)(cid:76)(cid:79)(cid:76)(cid:93)(cid:88)(cid:80)(cid:68)(cid:69)(cid:3)(cid:11)(cid:48)(cid:40)(cid:39)(cid:44)(cid:16)(cid:24)(cid:24)(cid:20)(cid:12)(cid:14)(cid:85)(cid:76)(cid:87)(cid:88)(cid:91)(cid:76)(cid:80)(cid:68)(cid:69)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)
haematological malignancies; AZD5312 for solid tumours; AZD8835 for solid tumours;
Tagrisso(cid:14)(cid:71)(cid:88)(cid:85)(cid:89)(cid:68)(cid:79)(cid:88)(cid:80)(cid:68)(cid:69)(cid:3)(cid:11)(cid:38)(cid:36)(cid:56)(cid:53)(cid:36)(cid:47)(cid:12)(cid:3)(cid:426)(cid:21)(cid:81)(cid:71)(cid:3)(cid:79)(cid:76)(cid:81)(cid:72)(cid:3)(cid:68)(cid:71)(cid:89)(cid:68)(cid:81)(cid:70)(cid:72)(cid:71)(cid:3)(cid:40)(cid:42)(cid:41)(cid:53)(cid:80)(cid:3)(cid:55)(cid:26)(cid:28)(cid:19)(cid:48)(cid:3)(cid:49)(cid:54)(cid:38)(cid:47)(cid:38)(cid:30)(cid:3)(cid:48)(cid:40)(cid:39)(cid:44)(cid:25)(cid:22)(cid:27)(cid:22)(cid:3)
for solid tumours; durvalumab+MEDI6383 for solid tumours; MEDI0639 for solid tumours
(cid:13)(cid:3) (cid:53)(cid:82)(cid:70)(cid:75)(cid:72)(cid:3)(cid:75)(cid:82)(cid:79)(cid:71)(cid:86)(cid:3)(cid:79)(cid:76)(cid:70)(cid:72)(cid:81)(cid:70)(cid:72)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:70)(cid:87)(cid:39)(cid:49)(cid:36)(cid:3)(cid:69)(cid:79)(cid:82)(cid:82)(cid:71)(cid:3)(cid:87)(cid:72)(cid:86)(cid:87)(cid:30)(cid:3)(cid:70)(cid:82)(cid:79)(cid:79)(cid:68)(cid:69)(cid:82)(cid:85)(cid:68)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:72)(cid:428)(cid:82)(cid:85)(cid:87)(cid:3)(cid:69)(cid:72)(cid:87)(cid:90)(cid:72)(cid:72)(cid:81)(cid:3)(cid:53)(cid:82)(cid:70)(cid:75)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:87)(cid:82)(cid:3)(cid:86)(cid:72)(cid:70)(cid:88)(cid:85)(cid:72)(cid:3)(cid:68)(cid:83)(cid:83)(cid:85)(cid:82)(cid:89)(cid:68)(cid:79)(cid:17)
26
AstraZeneca Annual Report and Form 20-F Information 2016
Therapy area world market
(MAT/Q3/16)
$84.2bn
Annual worldwide market value
Chemotherapy $19.7bn
Hormonal therapies
$11.0bn
Monoclonal antibodies
(MAbs) $25.0bn
Small molecule tyrosine
kinase inhibitors (TKIs)
$22.6bn
Immune checkpoint
inhibitors $5.9bn
Four key scientific platforms are driving our
efforts to discover new cancer treatments:
> Immunotherapy: Our ambition is to
be a scientific leader in immunotherapy,
a promising therapeutic approach that
harnesses the patient’s own immune
system to help fight cancer. We are
working to understand how cancer
evades the immune system and to identify
approaches that enhance the immune
system’s ability to fight cancer.
> Tumour drivers and resistance
mechanisms: Potent inhibition of genetic
disease drivers is a clinically validated
approach to shrink tumours and improve
progression-free survival. Tumours,
however, eventually develop resistance
to these therapies. Our programmes seek
to develop therapies that target resistance
mechanisms and the mutations that
cause cancer cells to proliferate.
> DNA damage response: Exploiting
mechanisms that selectively damage
tumour cell DNA is another clinically
validated approach to shrink tumours
and improve progression-free survival.
Our programmes focus on identifying
and exploiting vulnerabilities unique to
tumour cells to kill the tumour cells while
minimising toxicity to the patient.
> Antibody-drug conjugates: The use
of antibody-drug conjugates (ADC) is a
clinically validated, highly potent approach
that selectively targets cancer cells.
We seek to combine innovative antibody
engineering capabilities with cytotoxic
drug molecules to attack and kill the
tumour while minimising toxicity to
the patient.
Our marketed products
> Arimidex (anastrozole)
> Casodex/Cosudex (bicalutamide)
> Faslodex (fulvestrant)
> Iressa (gefitinib)
> Lynparza (olaparib)
> Nolvadex (tamoxifen citrate)
> Tagrisso (osimertinib)
> Zoladex (goserelin acetate implant)
Full product information on page 211
We are also focused on identifying and
developing combination therapies. Our
immuno-oncology portfolio, which we
believe is one of the most comprehensive
in our industry, enables us to explore and
exploit scientific and biological synergies
to pursue combinations that improve
outcomes and maximise patient benefit.
Our 2016 focus
In total, our marketed Oncology products
generated sales of $3.4 billion worldwide in
2016. Sales from our New Oncology Growth
Platform, totalled $0.7 billion in 2016, an
increase of 458% at actual rate of exchange
(450% at CER) over 2015 ($0.1 billion). We
continue to explore ways to maximise the
benefit of our medicines for patients.
Tagrisso is the first approved epidermal
growth factor receptor tyrosine kinase
inhibitor (EGFR-TKI) indicated for patients
with metastatic EGFR T790M mutation-
positive non-small cell lung cancer (NSCLC).
This indication was approved in November
2015 under the FDA’s Accelerated Approval
Programme based on tumour response rate
and duration of response. Full approval for
this indication is dependent on verification
and description of clinical benefit in the
confirmatory trial, AURA3, for which positive
results were presented in December.
The EMA and FDA accepted the AURA3
submission in October and November
respectively, and the FDA has granted
it a Priority Review.
In February 2016, Tagrisso was approved
by the EMA for the treatment of adult
patients with locally advanced or metastatic
EGFR T790M mutation-positive NSCLC.
In March 2016, it was approved in Japan
and, by the end of 2016, Tagrisso had
received regulatory approval in more than
40 countries. In September 2016, the
FDA approved a blood-based companion
diagnostic test for use with Tagrisso. This
clinically-validated companion diagnostic
test uses either tissue or a blood sample to
confirm the presence of a T790M mutation
in patients. Japan approved the same test
in December 2016.
Iressa was the first EGFR-TKI to be
approved in advanced NSCLC and, as of
31 December 2016, had been approved in
90 countries. Indicated for the treatment of
advanced EGFR mutation NSCLC, it is the
leading EGFR-TKI outside the US. Iressa
received approval in the US in July 2015.
Lynparza is an oral poly ADP ribose
polymerase (PARP) inhibitor available to
patients in 31 countries for the treatment
of adult patients with BRCA-mutated
high-grade serous epithelial ovarian,
fallopian tube or primary peritoneal cancer.
In October 2016, AstraZeneca announced
positive high level results of SOLO-2,
a Phase III randomised, double-blind,
placebo-controlled, multicentre study
of Lynparza maintenance monotherapy
in platinum sensitive relapsed BRCA
gene-mutated ovarian cancer patients
who are in complete or partial response
following platinum-based chemotherapy.
Data from SOLO-2 could form the core
Phase III component for an FDA NDA
submission, a Japan NDA submission
and an EU variation to the MAA in 2017.
Faslodex 500mg is approved in more than
80 countries, including the EU, the US and
Japan. In March 2016, the FDA approved
a new indication expanding the use of
Faslodex, in combination with palbociclib
(Pfizer), for the treatment of women with
hormone receptor-positive (HR+), human
epidermal growth factor receptor 2 negative
(HER2-) advanced or metastatic breast
cancer whose cancer has progressed after
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endocrine therapy. In October 2016, at
the European Society of Medical Oncology
Congress, we presented positive results of
the Phase III FALCON clinical trial comparing
the efficacy and safety of Faslodex 500mg
with Arimidex in the 1st line advanced breast
cancer setting (hormone-naïve patients).
These positive outcomes will form the basis
of a continuous expansion of Faslodex in
metastatic breast cancer.
Details of litigation relating to Faslodex
are included in Note 28 to the Financial
Statements from page 185.
Zoladex continues to be a significant
asset in our on-market portfolio and a
driver of our prostate cancer and breast
cancer portfolios.
14m
Annual cancer cases are expected to rise
from 14 million in 2012 to an estimated
22 million within the next two decades.
Source: WHO Factsheet February 2014 (data from 2012).
AstraZeneca Annual Report and Form 20-F Information 2016
27
Strategic Report Therapy Area Review
Oncology continued
In the pipeline
Our Oncology pipeline continued to
progress in 2016. It now includes 32 NMEs
in development. We also expanded several
of our projects to incorporate novel
combinations and various types of cancer.
Some of our projects from each of our
platforms are outlined below.
Immuno-oncology franchise
> Durvalumab (MEDI4736) is an anti-PD-L1
antibody in Phase III development for
NSCLC as a monotherapy and in
combination with tremelimumab, an
anti-Cytotoxic T-Lymphocyte-Associated
protein 4 antibody. The lung cancer
programme includes studies in the
1st line, 2nd line and 3rd line setting.
Additional registration studies are
progressing in head and neck squamous
cell carcinoma (1st and 2nd line), and
bladder cancer (1st line). The development
programme also includes additional
Phase I and Phase II studies in a broad
range of solid tumours and an extensive
range of combination programmes. In
February 2016, durvalumab was granted
Breakthrough Therapy Designation by
the FDA for the treatment of patients with
PD-L1 positive inoperable or metastatic
urothelial bladder cancer and, in
December 2016, it was additionally
granted Priority Review status with
a Prescription Drug User Fee Act set
for the second quarter of 2017.
> MEDI0680 is an antiprogrammed cell
death protein 1 (PD-1) MAb that may help
promote an effective anti-tumour immune
response by blocking the interactions
between PD-1 and its ligands. It could
also improve the intrinsic functionality of
T-cells by triggering internalisation of PD-1,
a mechanism that may be unique to
MEDI0680. MEDI0680 is in Phase I
development for solid tumours as a
monotherapy and in combination with
durvalumab.
> Other immuno-oncology agents in early
development include: MEDI6383, a
human tumour necrosis factor receptor
superfamily, member 4 (OX40) agonist;
MEDI9447 targeting ecto-5’-nucleotidase
(CD73); and MEDI1873 targeting
glucocorticoid-induced tumour necrosis
factor receptor-ligand (GITRL). These
agents are in Phase I development for
a range of solid tumours and have the
potential for combination with other
molecules in the portfolio.
Tumour drivers and resistance
mechanisms franchise
> Tagrisso is a highly selective, irreversible
inhibitor of the activating sensitising EGFR
mutation and the resistance mutation
T790M. The product is being investigated
in Phase III studies in the adjuvant setting
for the treatment of patients with EGFRm
NSCLC and in the advanced setting as a
1st line treatment of EGFRm NSCLC and
as a ≥2nd line treatment of EGFRm
T790M NSCLC. Additionally, studies in
combination with small molecules are
under investigation.
> Selumetinib is a mitogen-activated protein
kinase inhibitor in Phase III development
for adjuvant differentiated thyroid cancer.
In May 2016, selumetinib was granted
Orphan Drug Designation by the FDA for
differentiated thyroid cancer. In August
2016, the selumetinib Phase III study
SELECT-1 in 2nd line KRAS mutant
NSCLC failed to meet its primary
endpoint of progression-free survival.
> Cediranib is an orally administered
multi-Vascular Endothelial Growth Factor
receptor (VEGFR) inhibitor which is
currently being tested in combination
with Lynparza in patients with platinum-
sensitive relapsed (PSR) ovarian cancer
and platinum-resistant/refractory (PRR)
ovarian cancer. In September 2016,
AstraZeneca made the decision to
withdraw the MAA for cediranib in
combination with platinum-based
chemotherapy followed by maintenance
monotherapy for the treatment of adult
patients with platinum-sensitive relapsed
ovarian cancer (ICON6).
> AZD5363 is a protein kinase B (AKT)
inhibitor in Phase II development for
breast and prostate cancer.
> Savolitinib (AZD6094) is a hepatocyte
growth factor receptor (c-MET) inhibitor.
It is in Phase II development for lung and
renal cancer.
> Vistusertib (AZD2014) is an inhibitor of the
mammalian target of rapamycin serine/
threonine kinase (TORC1, TORC2) and is
in Phase II development for the treatment
of solid and haematological tumours.
> AZD9496 is a selective oestrogen
receptor down-regulator (SERD) in
Phase I development for the treatment
of breast cancer.
> Acalabrutinib is a Bruton’s tyrosine kinase
(BTK) inhibitor in Phase III development in
B-cell malignancies and solid tumours. In
April 2016, acalabrutinib was designated
as an orphan medicinal product by the
28
AstraZeneca Annual Report and Form 20-F Information 2016
EMA for the treatment of chronic
lymphocytic leukaemia (CLL)/small
lymphocytic lymphoma (SLL), mantle cell
lymphoma (MCL) and lymphoplasmacytic
lymphoma (Waldenström’s
macroglobulinaemia, WM).
DNA damage response franchise
> Lynparza is being evaluated in a broad
range of Phase III trials, including BRCAm
adjuvant and metastatic breast cancer,
gBRCAm pancreatic cancer, gBRCAm
ovarian cancer and prostate cancer.
Lynparza was granted Breakthrough
Therapy Designation by the FDA for
treatment of BRCA1/2 or ATM gene-
mutated metastatic castration resistant
prostate cancer. In May 2016, the
Lynparza GOLD study in 2nd line gastric
cancer failed to meet its primary endpoint
of overall survival. In October 2016, results
from the Phase III SOLO-2 trial
demonstrated a clinically meaningful and
statistically significant improvement of
progression-free survival (PFS) among
patients treated with Lynparza tablets
(300mg twice daily) compared to placebo
and provided additional evidence to
support the potential use of Lynparza
as a monotherapy for the maintenance
treatment of platinum-sensitive relapsed,
BRCA-mutated ovarian cancer.
> AZD1775 is a Wee1 inhibitor in Phase II
development for ovarian and other solid
tumours in combination with Lynparza.
> Phase I clinical studies are progressing
for the ATR inhibitor AZD6738 (2nd line
gastric cancer with Lynparza and also in
combination with ionising radiation in solid
tumours), the ATM inhibitor AZD0156 (for
the treatment of gastric and colorectal
cancers) and the aurora b kinase
AZD2811 (in solid tumours).
8.2m
Cancer is a leading cause of death
worldwide and accounted for 8.2 million
deaths in 2012.
Source: WHO Factsheet February 2014 (data from 2012).
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combination with Incyte’s oral indoleamine
dioxygenase-1 (IDO1) inhibitor, epacadostat
(INCB24360).
We also extended our collaboration with
Moderna to discover, co-develop and
co-commercialise messenger RNA (mRNA)
therapeutic candidates for the treatment
of a range of cancers.
In February 2016, we completed a
transaction for a majority equity stake
investment in Acerta Pharma. The
transaction provides AstraZeneca with a
potential best-in-class irreversible oral BTK
inhibitor, acalabrutinib (ACP-196), currently
in Phase III development for B-cell blood
cancers and in Phase I/II clinical trials in
multiple solid tumours.
In June 2016, we signed a definitive
agreement with Foundation Medicine, Inc.
to develop a novel companion diagnostic
assay for Lynparza to support its global
development programme. The companion
diagnostic seeks to enable physicians
to identify those patients most likely to
benefit from AstraZeneca’s first-in-class
PARP inhibitor.
In November 2016, CancerLinQ, a non-profit
subsidiary of the American Society of
Clinical Oncology, announced a new
non-exclusive partnership with AstraZeneca,
which will use CancerLinQ Discovery, a
groundbreaking offering that aims to provide
insights through the analysis of real-world
cancer care data. As a ‘Founding Enterprise
Partner’, AstraZeneca will be able to gather
insights on specific cancer care questions
and provide critical input to maximise
CancerLinQ Discovery’s utility and usability.
60%
More than 60% of the world’s total new
annual cancer cases occur in Africa,
Asia and Central and South America.
These regions account for 70% of the
world’s cancer deaths.
Source: WHO Factsheet February 2014 (data from 2012).
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AstraZeneca has been at the forefront
of PHC since its inception, with 80% of
current investigative molecules using a
PHC approach. This research includes
investment in understanding the science
of PD-L1 protein expression, which plays
a role in suppressing the immune system.
Testing for expression levels of PD-L1
may help to identify patients most likely
(cid:87)(cid:82)(cid:3)(cid:69)(cid:72)(cid:81)(cid:72)(cid:430)(cid:87)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:44)(cid:50)(cid:16)(cid:69)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)(cid:70)(cid:68)(cid:81)(cid:70)(cid:72)(cid:85)(cid:3)(cid:87)(cid:75)(cid:72)(cid:85)(cid:68)(cid:83)(cid:76)(cid:72)(cid:86)(cid:17)
However, choosing between the many
PD-L1 diagnostic tests available can be
challenging. We embarked on a series of
studies to compare the currently available
PD-L1 tests across various tumour types,
and demonstrated a strong association –
concordance – between most of them.
This research suggests that the tests
might one day be used interchangeably
(cid:87)(cid:82)(cid:3)(cid:72)(cid:81)(cid:68)(cid:69)(cid:79)(cid:72)(cid:3)(cid:76)(cid:71)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:82)(cid:73)(cid:3)(cid:68)(cid:83)(cid:83)(cid:85)(cid:82)(cid:83)(cid:85)(cid:76)(cid:68)(cid:87)(cid:72)(cid:3)
patients for IO therapies, thereby driving
(cid:72)(cid:433)(cid:70)(cid:76)(cid:72)(cid:81)(cid:70)(cid:76)(cid:72)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:70)(cid:68)(cid:81)(cid:70)(cid:72)(cid:85)(cid:3)(cid:70)(cid:68)(cid:85)(cid:72)(cid:17)
Antibody-drug conjugates franchise
> Moxetumomab pasudotox, an anti-CD22
recombinant immunotoxin, is being
investigated in a Phase III study for adult
patients with hairy cell leukaemia who
have relapsed after, or not responded to,
standard therapy.
> MEDI4276 is a HER2 bispecific ADC,
which entered clinical development for
a range of solid tumours.
Key Oncology collaborations
and transactions
Collaboration is key to accessing the best
science and technology, achieving scientific
leadership and delivering innovative,
life-changing medicines. In 2016, we
continued to strengthen our portfolio and
accelerate clinical programmes through
acquisitions and collaborations.
In January 2016, we announced a new
collaboration with Incyte to evaluate the
efficacy and safety of Incyte’s Janus-
associated kinase (JAK) 1 inhibitor,
INCB39110, in combination with Tagrisso.
This builds on an existing collaboration
between the two companies to explore
AstraZeneca’s anti-PD-L1 immune
checkpoint inhibitor, durvalumab, in
AstraZeneca Annual Report and Form 20-F Information 2016
29
Strategic Report Therapy Area Review
Current treatments for
hyperkalaemia, a potentially
life-threatening condition
associated with chronic
kidney disease and chronic
heart failure, are poorly
tolerated by patients.
AstraZeneca is developing
a treatment which traps
potassium in the gut and
removes it from the body.
Cardiovascular &
Metabolic Disease
We push the boundaries of science
to create life-changing medicines for
patients that reduce morbidity, mortality
and organ damage by addressing
multiple risk factors.
Following the science
of cardiovascular and
metabolic disease
AstraZeneca is following the science to
transform how cardiovascular disease
(CVD), chronic kidney disease (CKD) and
diabetes are understood, interact and
impact one another – ensuring the focus
of treatment is across cardiovascular and
metabolic disease (CVMD) to slow
progression and save more lives.
Our strategic priorities
Our strategic focus is on transformative
medicines that address the high unmet
medical need in CVMD, including
thrombosis (blood clotting), atherosclerosis
(hardening of the arteries), dyslipidaemia
(abnormal levels of blood lipids), chronic
heart failure (CHF), diabetes and CKD.
Currently an estimated 17.5 million people
die annually from CVD, representing 31%
of all global deaths, and CVD is the leading
cause of death in people with CKD and
people with diabetes. Despite improvements
in the diagnosis and treatment of CVMD,
unmet medical need, as well as access and
affordability challenges, remain high, while
co-morbidity is common in patients living
with CVMD.
We are seeking to unlock the scientific
potential of our CVMD therapy area by
investigating disease causes and
progression, supporting our larger objective
of innovating to develop novel therapeutic
approaches. Our efforts aim to reduce
long-term morbidity and mortality, and
to ultimately reduce the burden, as well
as the human, social and economic costs,
of these diseases.
Our commitment is demonstrated in both
our clinical development and life-cycle
management programmes. More than
60,000 patients are participating in our
R&D-led cardiovascular trials at more
than 6,000 sites worldwide. Our focus
on diabetes research includes almost
50 clinical trials worldwide with an
enrolment target of 56,000 patients.
Our scientific leadership is strengthened by
developing cutting edge technologies with
our strategic partners:
> Participation in the RPC2 consortium
(renal precompetitive consortium) formed
with the University of Michigan and Lilly
to identify new therapeutic targets for the
treatment of CKD.
> Alliance with Moderna and Professor Ken
Chien at the Integrated Cardio Metabolic
Centre (ICMC), Karolinska Institutet in
Stockholm, Sweden, to identify targets
and pathways involved in repairing
damaged cardiac muscle.
Cardiovascular & Metabolic Disease – pipeline progressions
Regional approvals
Brilinta/Brilique – post myocardial infarction (EU) and acute coronary syndromes and post
myocardial infarction (JP)
Qtern(cid:3)(cid:11)(cid:86)(cid:68)(cid:91)(cid:68)(cid:74)(cid:79)(cid:76)(cid:83)(cid:87)(cid:76)(cid:81)(cid:18)(cid:71)(cid:68)(cid:83)(cid:68)(cid:74)(cid:79)(cid:76)(cid:432)(cid:82)(cid:93)(cid:76)(cid:81)(cid:12)(cid:3)(cid:347)(cid:3)(cid:55)(cid:92)(cid:83)(cid:72)(cid:3)(cid:21)(cid:3)(cid:71)(cid:76)(cid:68)(cid:69)(cid:72)(cid:87)(cid:72)(cid:86)(cid:3)(cid:11)(cid:40)(cid:56)(cid:12)
Expedited review
None
Regulatory submissions
ZS-9 – hyperkalaemia in response to a CRL (US)
(cid:39)(cid:56)(cid:53)(cid:36)(cid:55)(cid:44)(cid:50)(cid:49)(cid:16)(cid:27)(cid:3)(cid:11)(cid:72)(cid:91)(cid:72)(cid:81)(cid:68)(cid:87)(cid:76)(cid:71)(cid:72)(cid:14)(cid:71)(cid:68)(cid:83)(cid:68)(cid:74)(cid:79)(cid:76)(cid:432)(cid:82)(cid:93)(cid:76)(cid:81)(cid:12)(cid:3)(cid:11)(cid:40)(cid:56)(cid:12)
Two further submissions await regulatory acceptance
Forxiga – heart failure; Forxiga – chronic kidney disease
Phase III investment
decisions
Phase II starts/progressions MEDI4166 – diabetes/cardiovascular disease; MEDI0382 – diabetes/obesity; AZD4076 –
non-alcoholic steatohepatitis
Strategic transactions
completed
Setbacks and terminated
projects
Partnering with 3SBio Inc. for commercialisation of Bydureon and Byetta in China
Brilinta SOCRATES and EUCLID trials failed to meet primary endpoint; CRL received from
FDA for ZS-9 for treatment of hyperkalaemia; Epanova/Farxiga combination discontinued
for non-alcoholic steatohepatitis (NASH)
Therapy area world market
(MAT/Q3/16)
$186.8bn
Annual worldwide market value
S
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t
High blood pressure
$37.9bn
Abnormal levels of
blood cholesterol
$26.7bn
Diabetes $70.9bn
Thrombosis $8.6bn
Other $42.7bn
> Collaboration with the Harvard Stem Cell
Institute to adapt a technique that creates
human beta cells from stem cells in the
search for new, transformative treatment
options for diabetes.
Cardiovascular disease
Our 2016 focus
Acute coronary syndromes (ACS) is an
umbrella term for sudden chest pain
and other symptoms due to ischaemia
(insufficient blood supply) to the heart.
ACS is associated with considerable
mortality and morbidity. There is a
significant need to improve patient
outcomes and reduce treatment costs.
Brilinta/Brilique is an oral antiplatelet
treatment for ACS. It is approved in over
100 countries, including the US, Canada
and Brazil under the trade name Brilinta,
and in the EU, Iceland and Norway under
the trade name Brilique. Since it was first
launched in Europe in December 2010,
it has been included in 12 major ACS
treatment guidelines globally.
In February 2016, the European Commission
granted marketing authorisation for Brilique
for long-term prevention of cardiovascular
death, heart attack and stroke for patients
with a history of heart attack. The EU
approval was based on the results from
the PEGASUS TIMI-54 trial, a large-scale
outcomes trial involving more than
21,000 patients.
AstraZeneca Annual Report and Form 20-F Information 2016
31
Strategic Report Therapy Area Review
Cardiovascular & Metabolic Disease continued
Our marketed products
Cardiovascular disease
> Atacand1/Atacand HCT/Atacand Plus
(candesartan cilexetil)
> Brilinta/Brilique (ticagrelor)
> Crestor 2 (rosuvastatin calcium)
> Imdur 3 (isosorbide mononitrate)
> Plendil 4 (felodipine)
> Seloken/Toprol-XL5 (metoprolol succinate)
> Tenormin6 (atenolol)
> Zestril 7 (lisinopril dihydrate)
Metabolic disease
> Bydureon (exenatide XR injectable suspension)
> Byetta (exenatide injection)
> Farxiga/Forxiga (dapagliflozin)
> Kombiglyze XR (saxagliptin and metformin HCl)
> Komboglyze (saxagliptin and metformin HCl)
> Onglyza (saxagliptin)
> Qtern (saxagliptin/dapagliflozin)
> Symlin (pramlintide acetate)
> Xigduo (dapagliflozin and metformin HCI)
> Xigduo XR (dapagliflozin and metformin HCI)
Full product information on page 211
1 Licensed from Takeda Chemicals Industries Ltd.
2 Licensed from Shionogi. The extension of the global
licence agreement with Shionogi for Crestor and the
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(cid:20)(cid:98)(cid:45)(cid:68)(cid:81)(cid:88)(cid:68)(cid:85)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:23)(cid:17)
3 Divested China rights to China Medical Systems
(cid:43)(cid:82)(cid:79)(cid:71)(cid:76)(cid:81)(cid:74)(cid:86)(cid:3)(cid:47)(cid:87)(cid:71)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:20)(cid:19)(cid:98)(cid:50)(cid:70)(cid:87)(cid:82)(cid:69)(cid:72)(cid:85)(cid:98)(cid:21)(cid:19)(cid:20)(cid:25)(cid:17)
4 Divested China rights to China Medical Systems
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5(cid:3) (cid:3)(cid:39)(cid:76)(cid:89)(cid:72)(cid:86)(cid:87)(cid:72)(cid:71)(cid:3)(cid:56)(cid:54)(cid:3)(cid:85)(cid:76)(cid:74)(cid:75)(cid:87)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)(cid:36)(cid:85)(cid:68)(cid:79)(cid:72)(cid:93)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:70)(cid:72)(cid:88)(cid:87)(cid:76)(cid:70)(cid:68)(cid:79)(cid:86)(cid:3)(cid:55)(cid:85)(cid:68)(cid:71)(cid:76)(cid:81)(cid:74)(cid:3)
(cid:39)(cid:36)(cid:38)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:23)(cid:3)(cid:50)(cid:70)(cid:87)(cid:82)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:17)
6 Divested US rights to Tenormin to Alvogen Pharma US
(cid:44)(cid:81)(cid:70)(cid:17)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:28)(cid:3)(cid:45)(cid:68)(cid:81)(cid:88)(cid:68)(cid:85)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:24)(cid:17)
7 Licensed from Merck. Divested US rights to Zestril to
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In October 2016, the EUCLID Phase III
trial in peripheral artery disease (PAD)
results were announced. Brilinta did not
demonstrate benefit over clopidogrel in a
symptomatic PAD patient population and
did not meet the primary endpoint of the
trial. However, the safety profile observed in
both this trial and the SOCRATES trial was
consistent with the known safety profile of
Brilinta. Based on the current expectations,
it is unlikely that we will seek regulatory
submission of an indication in PAD.
Crestor is approved in 109 countries
for the treatment of dyslipidaemia and
hypercholesterolaemia (elevated
cholesterol). The medicine has been shown
to effectively lower low-density lipoprotein
cholesterol (LDL-C) and achieve LDL-C
goals and to increase high-density
lipoprotein cholesterol (HDL-C) and reduce
atherosclerotic plaque. Crestor faces
competition from atorvastatin (Lipitor) and
other generic products. The substance
patent protecting Crestor in the US expired
on 8 January 2016 and the paediatric
exclusivity period expired on 8 July 2016.
Watson Laboratories, Inc. and Actavis, Inc.
began selling generic rosuvastatin in the
US in May 2016 as the result of a litigation
settlement with AstraZeneca. Details of
these matters are included in Note 28
to the Financial Statements, from page 185.
Additional manufacturers have made
generic rosuvastatin available in the
US in 2016, in line with AstraZeneca’s
business assumptions.
Epanova (omega-3-carboxylic acids)
is the first FDA approved prescription
omega-3 fatty acid in free fatty acid form.
It has the potential to help patients with
severe hypertriglyceridaemia by reducing
high triglycerides (TG) levels. Epanova is
approved in the US as an adjunct to diet
to reduce TG levels in adult patients with
severe hypertriglyceridaemia (TG levels
≥500mg/dL). We remain committed to
the launch of Epanova in the US and other
key markets.
In March 2016, the SOCRATES trial top-line
results were announced. The trial assessed
the efficacy of Brilinta 90mg tablets twice
daily when compared to aspirin 100mg
once daily in patients with acute ischaemic
stroke or transient ischaemic attack. Fewer
events were observed on Brilinta versus the
comparator in the overall trial population;
the trend, however, did not reach statistical
significance and the primary efficacy
endpoint of time to first occurrence of
any event from the composite of stroke
(ischaemic or haemorrhagic), myocardial
infarction (MI) and death was not met.
In March 2016, the American College of
Cardiology (ACC) and American Heart
Association (AHA) updated their treatment
guidelines for ACS and the duration of dual
antiplatelet therapy. Brilinta is now preferred
over clopidogrel for the management of
patients with ACS who have received a
coronary stent and in non-ST Elevation ACS
patients treated with medical therapy alone.
This update was the first time that the
ACC and AHA have recommended Brilinta
over clopidogrel for patients who have
experienced an ST-elevation myocardial
infarction (STEMI).
The update was also the first US guideline
to provide the medical community with
insights drawn from the PEGASUS TIMI-54
trial. The guideline supported continuation
of P2Y12 platelet inhibitor therapy beyond
12 months in prior MI patients who are not
at high bleeding risk.
There were three new treatment guidelines
updated in China in the first half of 2016.
The ACS Emergency Room Rapid
Guideline, Chinese PCI Guideline and the
Coronary Artery Bypass Graft Consensus
(2016) Guideline. These recommended
Brilinta as ‘first-choice treatment’ over any
other platelet inhibitor.
The Japanese Ministry of Health, Labour
and Welfare approved Brilinta 90mg for
patients with ACS for whom the use of other
antiplatelet medicines in combination with
aspirin is difficult. Brilinta 60mg was also
approved for patients who have suffered
a heart attack at least one year prior and
are at high risk of developing a further
atherothrombotic event.
32
AstraZeneca Annual Report and Form 20-F Information 2016
S
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Our 2016 focus
We are focused on redefining the Type 2
diabetes treatment approach and harnessing
complementary mechanisms of action, as
well as evaluating potential CV outcomes
benefit. Our current portfolio is intended to
enable combination treatment, and data
from our Phase III programmes are expected
to further support the outcomes benefit of
this new class approach.
In 2016, we saw ongoing approvals
and launches for Farxiga/Forxiga for the
treatment of Type 2 diabetes. Starting with
the EU in 2012, it is now approved in over
85 countries. It is under regulatory review
in 12 additional countries.
Xigduo is approved in 55 countries,
including the US with Xigduo XR with
ongoing approvals in 2017 expected. In
2016, we continued to receive approvals
and launch the Bydureon Pen in new
markets, which is now either approved
or launched in 30 countries, including the
US, Japan and key European countries.
The Bydureon Pen is a pre-filled, single-use
pen injector. In the US, we are engaged in
patent litigation against multiple generic
companies challenging patents listed in
the FDA Orange Book with reference to
Onglyza, and are awaiting the outcome of
a trial that took place in September 2016.
17.5m
An estimated 17.5 million people die
annually from CV disease, representing
31% of all global deaths. More than
three-quarters of these deaths occur
in low- to middle-income countries.
Source: WHO Factsheet 2016 (data from 2012).
Inveeeessststini g for the future:
Patients with chronic kidney ddddissiseeaasesesese
(C(CCKDKDKD)) ) ananandd d hehearart failure (HF)
is an SGLT2 inhibitor
Farxiga/Forxiga
a
//
indicated for the treatment of Type 2
diabetes. It is also being investigated
in two Phase IIIb outcome trials for the
management of CKD and HF in people
with and without Type 2 diabetes. This
(cid:80)(cid:68)(cid:85)(cid:78)(cid:86)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:430)(cid:85)(cid:86)(cid:87)(cid:3)(cid:87)(cid:76)(cid:80)(cid:72)(cid:3)(cid:68)(cid:3)(cid:80)(cid:68)(cid:77)(cid:82)(cid:85)(cid:3)(cid:82)(cid:88)(cid:87)(cid:70)(cid:82)(cid:80)(cid:72)(cid:3)(cid:87)(cid:85)(cid:76)(cid:68)(cid:79)
(cid:90)(cid:76)(cid:79)(cid:79)(cid:3)(cid:69)(cid:72)(cid:3)(cid:70)(cid:82)(cid:81)(cid:71)(cid:88)(cid:70)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:72)(cid:89)(cid:68)(cid:79)(cid:88)(cid:68)(cid:87)(cid:72)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)
an SGLT2 inhibitor in CKD, for which
there are currently few treatment options
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Clinical studies
PARTHENON is AstraZeneca’s largest ever
cardiovascular (CV) outcomes programme
involving nearly 80,000 patients. It includes
five key studies covering broad patient
populations across varying timescales and
aims to support four new indications for
Brilinta/Brilique over the next four years.
Following the SOCRATES and EUCLID
trials, which failed to meet primary endpoint,
THEMIS is the next major trial, studying
the benefit of ticagrelor for the prevention
of CV events among Type 2 diabetic
patients. The whole programme continues
to progress.
To better understand the interplay between
CKD, CVD and diabetes, AstraZeneca
recently announced two Phase IIIb
outcomes trials designed to evaluate the
potential role of an SGLT2 inhibitor, which
is currently indicated for the treatment of
Type 2 diabetes, in the management of both
CHD and CKD in people with and without
Type 2 diabetes. This marks the first time
a major outcome trial will evaluate the effect
of an SGLT2 inhibitor on CKD.
We are also committed to further evaluating
the clinical profile of Epanova and identifying
other patient groups it may benefit.
AstraZeneca continues to advance its
large-scale CV outcomes trial (STRENGTH),
STatin Residual risk reduction with EpaNova
in hiGh cardiovascular risk paTients with
Hypertriglyceridaemia, to evaluate the safety
and efficacy of Epanova on CV outcomes
in combination with statin therapy for
the treatment of patients with mixed
dyslipidaemia who are at increased risk
of CV disease.
Metabolic and renal
diseases
Type 2 diabetes is a chronic progressive
disease that accounts for more than 90%
of diabetes cases worldwide. Disease
prevalence continues to grow, particularly
among those at a younger age, and many
patients require multiple medications.
Various oral generic and branded
treatments exist and newer classes of
treatments continue to enter the market.
There are more than 200 million people
worldwide living with CKD and AstraZeneca
is working to create an innovative standard
of care to prevent, treat and manage CKD
with a long-term ambition of modifying
the disease itself. Complications of CKD,
such as hyperkalaemia and anaemia, are
associated with significant CV risk plus
morbidity and mortality.
AstraZeneca Annual Report and Form 20-F Information 2016
33
Strategic Report Therapy Area Review
Cardiovascular & Metabolic Disease continued
422m
The number of people with diabetes
has risen from 108 million in 1980 to
422 million in 2014. Diabetes prevalence
has been rising more rapidly in middle-
and low-income countries.
Source: WHO Factsheet November 2016.
200m
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people worldwide.
Source: Ojo A. ‘Addressing the Global Burden of Chronic
Kidney Disease Through Clinical and Translational Research.’
Transactions of the American Clinical and Climatological
Association 2015; 125: 229-246.
In July 2016, we also saw the approval
of Qtern (a fixed-dose combination of
saxagliptin and dapagliflozin) by the
European Commission for the treatment
of Type 2 diabetes in European markets –
the first DPP-4i/SGLT2i combination
product to be approved in Europe. The
resubmission for Qtern in the US was
completed and accepted by the FDA,
and we anticipate a Prescription Drug
User Fee Act date in early 2017.
submitted data which it had yet to review.
In October 2016, the FDA confirmed
acceptance of the NDA resubmission.
The resubmission did not require the
generation of new data and a regulatory
decision is expected in the first half of 2017.
Interactions are ongoing with other health
authorities in the EU and Australia, where
ZS-9 is currently under separate regulatory
review. Additional regulatory submissions
in other markets are planned for 2017.
In September, we saw positive results
from the Phase III DURATION-8 trial,
demonstrating that Bydureon (exenatide
extended-release formulation) 2mg once-
weekly in combination with Forxiga
(dapagliflozin) 10mg once-daily, significantly
reduced blood sugar as measured by
HbA1c, versus the individual medicines
alone in patients with Type 2 diabetes
inadequately controlled on metformin.
In the pipeline
The Phase III programme for a once-weekly
suspension of Bydureon continues to
progress and the Bydureon auto-injector
is due for submission to the FDA in 2017.
Through our strategic collaboration with
FibroGen and Astellas, we continue to
develop roxadustat, a potential first-in-class
oral hypoxia-inducible factor prolyl
hydroxylase inhibitor (HIF-PHI) in Phase III
development for the treatment of anaemia
in patients with CKD, including those who
are dialysis dependent and non-dialysis
dependent. Roxadustat is in Phase III in the
US, Europe, Japan and China. The Phase III
programme consists of 15 studies enrolling
more than 7,000 patients worldwide.
To date, roxadustat has been studied in
over 1,100 subjects in completed Phase I
and II studies.
We continue to progress ZS-9 (sodium
zirconium cyclosilicate), a treatment for
hyperkalaemia being developed by ZS
Pharma, a wholly-owned subsidiary of
AstraZeneca which was acquired in
December 2015.
In May 2016, the FDA issued a complete
response letter (CRL) regarding the NDA
for ZS-9. The CRL referred to observations
arising from a pre-approval inspection at
the manufacturing facility and the FDA
acknowledged the receipt of recently-
Verinurad (RDEA3170) is a potent selective
uric acid reabsorption inhibitor that has been
in Phase II development as a urate-lowering
therapy. We will now progress development
of verinurad for CKD in a Phase II trial, which
is planned to start during 2017.
For more information please see Financial
Review from page 62
Clinical studies
The Dapagliflozin Effect on CardiovascuLAR
Events (DECLARE) study, a large CV
outcomes trial to assess the impact of
Farxiga/Forxiga on CV risk/benefit, when
added to a patient’s current diabetes
therapy, continued in 2016. The trial was
fully enrolled in 2015 with approximately
17,000 adult patients with Type 2 diabetes
and is expected to be completed in 2019.
The Exenatide Study of Cardiovascular
Event Lowering (EXSCEL) study also
continued during 2016. This study, which
began in 2010 and is expected to end in
2018, is evaluating the impact of Bydureon,
in addition to standard of care, on CV
outcomes in patients with Type 2 diabetes.
AstraZeneca and FibroGen continue to
investigate roxadustat for the treatment
of anaemia in patients with CKD. The
OLYMPUS and ROCKIES pivotal studies
evaluate roxadustat for the treatment of
anaemia in patients with CKD not on dialysis
and on dialysis, respectively. The initial data
read-out for our sponsored trials is expected
to align with the availability of pooled safety
data in coordination with our partners,
expected in early 2018, and we anticipate
a 2018 regulatory filing in the US.
34
AstraZeneca Annual Report and Form 20-F Information 2016
One of our key focus areas in
Respiratory is lung immunity,
where we are aiming to reset
immunological dysfunctions
that may be underlying
causes of disease.
Respiratory
We aim to transform the treatment of
respiratory disease with our growing
portfolio of inhaled and biologic medicines
(cid:68)(cid:79)(cid:82)(cid:81)(cid:74)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:85)(cid:72)(cid:86)(cid:72)(cid:68)(cid:85)(cid:70)(cid:75)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)
(cid:71)(cid:76)(cid:86)(cid:72)(cid:68)(cid:86)(cid:72)(cid:3)(cid:80)(cid:82)(cid:71)(cid:76)(cid:430)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:17)
AstraZeneca Annual Report and Form 20-F Information 2016
35
Strategic Report Therapy Area Review
Respiratory continued
Following the science
of respiratory disease
Our 40-year heritage in respiratory
medicines is just the beginning
of our story. The age of targeted
biologics to address the unmet
needs of specific patient populations
has now arrived in asthma, and
AstraZeneca has three biologics in
mid- or late-stage development with
each one targeting different biologic
pathways that play important roles
in this heterogeneous disease.
Our strategic priorities
Respiratory is one of AstraZeneca’s main
therapy areas, and our medicines reached
more than 18 million patients in 2016. We
have a strong pipeline with about 22,000
patients involved in clinical trials, and we
expect up to four launches of new
medicines between 2016 and 2020.
Our work focuses on transforming the
treatment of asthma and COPD in three
areas: (i) inhaled combinations at the core
of care, (ii) biologic medicines for the unmet
needs of specific patient populations, and
(iii) scientific advancements where our
ambition is to achieve disease modification
and durable remission. We have
considerable capabilities in inhalation
technologies, which span both pressurised
metered-dose inhalers (pMDIs) and dry
powder inhalers (DPIs), as well as our
innovative particle Co-Suspension Delivery
Technology. In our early development
pipeline, we focus our research on three key
areas: lung immunity, lung epithelium and
lung regeneration.
Asthma is one of the most common and
chronic lung diseases worldwide and a
serious global health problem, affecting the
lungs’ airways. Inflammation and narrowing
of the airways may cause wheezing,
breathlessness, chest tightness and
coughing. Fixed-dose combinations (FDCs)
of an inhaled corticosteroid (ICS) with a
long-acting beta2-agonist (LABA) such as
Symbicort are the cornerstone of treatment,
helping to treat moderate-to-severe asthma.
For patients with mild asthma, we are
investigating the use of Symbicort dosed
‘as needed’, recognising the variability and
inflammatory nature of disease in these
patients. For the approximately 10%
of asthma patients who have severe,
uncontrolled asthma despite standard-of-
care medications, we are working to
develop targeted biologics that address
the underlying causes of disease. The
FDA and EMA have accepted regulatory
submissions for benralizumab, our first
respiratory biologic, which is being
developed for severe asthma.
COPD is a progressive and chronic disease.
There are unmet needs in the treatment of
COPD, such as exacerbation and symptom
control, improving health status and slowing
the decline of lung function and disease
progression. We foresee physicians
increasingly treating earlier and more
actively with different strategies for
inflammatory and non-inflammatory
patients, and both our portfolio and
development pipeline address these
different needs in mild and severe disease.
Respiratory – pipeline progressions
Regional approvals
Bevespi Aerosphere (PT003) – COPD (US)
Expedited review
None
Regulatory submissions
(cid:37)(cid:72)(cid:81)(cid:85)(cid:68)(cid:79)(cid:76)(cid:93)(cid:88)(cid:80)(cid:68)(cid:69)(cid:3)(cid:347)(cid:3)(cid:86)(cid:72)(cid:89)(cid:72)(cid:85)(cid:72)(cid:3)(cid:68)(cid:86)(cid:87)(cid:75)(cid:80)(cid:68)(cid:3)(cid:11)(cid:56)(cid:54)(cid:15)(cid:3)(cid:40)(cid:56)(cid:12)(cid:3)
One further submission awaits regulatory acceptance
Phase III investment
decisions
None
Phase II starts/progressions
Abediterol (AZD0548) – for asthma/COPD; AZD1419 (inhaled TLR9) – asthma
Strategic transactions
completed
Setbacks and terminated
projects
Acquisition of Takeda’s core respiratory business
AZD8999 for COPD; MEDI7836 for asthma; AZD7624 for COPD
36
AstraZeneca Annual Report and Form 20-F Information 2016
Therapy area world market
(MAT/Q3/16)
$64.8bn
Annual worldwide market value
Asthma $19.4bn
COPD $15.4bn
Other $30.0bn
Our 2016 focus
We continue to invest in Symbicort,
which was the number one ICS/LABA
combination globally in volume terms
in 2016. In the US, the FDA approved
Symbicort Inhalation Aerosol 80/4.5
micrograms for the treatment of asthma
in paediatric patients aged six to 12 years.
The FDA approval is based on the CHASE
(ChildHood Asthma Safety and Efficacy)
clinical trial programme, which included the
CHASE 3 Phase III trial. In addition, on 25
January 2017, the FDA granted six months
of paediatric exclusivity for Symbicort
Inhalation Aerosol. Budesonide/formoterol
was already approved in the US to treat
asthma in patients 12 years and older and
for the maintenance treatment of airflow
obstruction in COPD in adults.
In the EU, two new indications were
approved during 2016 – Symbicort pMDI
for the treatment of COPD and Symbicort
SMART for adolescents with asthma.
Also, Pulmicort continues to be a leading
ICS therapy, with significant sales growth
in 2016 driven by China and other
Emerging Markets.
In April 2016, the FDA approved Bevespi
Aerosphere inhalation for the long-term
maintenance treatment of airflow
obstruction in patients with COPD, including
chronic bronchitis and/or emphysema.
Bevespi Aerosphere is the first combination
long-acting muscarinic antagonist (LAMA)
and LABA medicine to be delivered in
a pMDI and the first medicine using
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
Our marketed products
> Accolate (zafirlukast)
> Bevespi Aerosphere (glycopyrrolate
and formoterol fumarate)
> Bricanyl Respules (terbutaline)1
> Bricanyl Turbuhaler (terbutaline)2
> Daliresp/Daxas (roflumilast)
> Duaklir Genuair (aclidinium/formoterol)2
> Eklira Genuair/Tudorza Pressair (aclidinium)2
> Oxis Turbuhaler (formoterol)2
> Pulmicort Turbuhaler/Pulmicort Flexhaler
(budesonide)
> Pulmicort Respules (budesonide)1
> Symbicort pMDI (budesonide/formoterol)
> Symbicort Turbuhaler (budesonide/formoterol)2
Full product information on page 211
1 Inhalation suspension.
2 In a dry powder inhaler.
AstraZeneca’s unique Co-Suspension
Delivery Technology. The technology is
designed to enable medicine crystals to
be evenly distributed in the aerosol allowing
for more consistent delivery of one or more
different medicines from a single pMDI.
The technology is also being applied to a
range of AstraZeneca respiratory inhaled
combination therapies currently in clinical
development, such as the fixed-dose triple
combination of LAMA/LABA/ICS (PT010).
We have launched the LAMA/LABA
combination Duaklir for the maintenance
treatment of COPD symptoms in 25
countries across Europe, Asia and
Latin America. Phase III development
in the US and China is underway with
anticipated regulatory filings in 2018
and 2019 respectively.
In May 2016, we completed our acquisition
of Takeda’s core respiratory business.
The deal included the acquisition of non-US
rights to Daliresp, which is known as Daxas
in certain countries. In December 2016,
we completed the divestment of the non-US
rights to Rhinocort Aqua, a nasal spray
indicated for rhinitis nasal polyps, to
Cilag GmbH International, an affiliate of
Johnson & Johnson.
315m
It is estimated that approximately
315 million people worldwide
(cid:86)(cid:88)(cid:428)(cid:72)(cid:85)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:68)(cid:86)(cid:87)(cid:75)(cid:80)(cid:68)(cid:17)(cid:3)
Source: To T, Stanojevic S, Moores G et al. Global asthma
(cid:83)(cid:85)(cid:72)(cid:89)(cid:68)(cid:79)(cid:72)(cid:81)(cid:70)(cid:72)(cid:3)(cid:76)(cid:81)(cid:3)(cid:68)(cid:71)(cid:88)(cid:79)(cid:87)(cid:86)(cid:29)(cid:3)(cid:430)(cid:81)(cid:71)(cid:76)(cid:81)(cid:74)(cid:86)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:70)(cid:85)(cid:82)(cid:86)(cid:86)(cid:16)(cid:86)(cid:72)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:79)(cid:3)(cid:90)(cid:82)(cid:85)(cid:79)(cid:71)(cid:3)
health survey. BioMed Central Public Health. 2012: 12(204)
In the pipeline
In COPD, PT010 is a twice-daily triple
inhaled medicine combination LAMA/
LABA/ICS composed of glycopyrrolate,
formoterol and budesonide (key
components of Symbicort and Bevespi
Aerosphere) in late-stage development.
PT010 is delivered in a pMDI using the
Aerosphere Technology. Topline data from
the KRONOS study will be available in 2017.
Benralizumab is an anti-eosinophil MAb
that directly induces cellular apoptosis,
which results in rapid and near-complete
depletion of eosinophils. Eosinophils
are the biological effector cells that
drive inflammation and airway hyper-
responsiveness in approximately 50%
of asthma patients. The FDA and EMA
have accepted regulatory submissions
for benralizumab, based on our Phase III
clinical trial programme. The SIROCCO and
CALIMA studies demonstrated that adding
benralizumab to standard-of-care medicine
significantly reduced exacerbations and
improved lung function and asthma
symptoms in severe asthma patients with
an eosinophilic phenotype compared to
patients taking a placebo. These outcomes
were demonstrated for the eight week
dosing regimen, which may support less-
frequent dosing than available medicines.
An additional Phase III study showed
benralizumab also reduced dependence on
oral corticosteroid use in this same
patient population. Benralizumab is also
in development for COPD. Phase III results
and regulatory filings for COPD studies are
expected in 2018.
Tralokinumab is an investigational MAb
that binds to IL-13. Blocking IL-13 is a
potentially important target in the treatment
of certain types of severe asthma,
estimated to affect around half the total
severe asthma population. Analysis of
the tralokinumab Phase II data suggests
that IL-13 neutralisation may improve lung
function and reduce asthma exacerbation
rate in a subpopulation of moderate-
to-severe asthma patients who are
uncontrolled with standard-of-care therapy.
In August 2014, we initiated a Phase III
programme to evaluate the safety and
efficacy of tralokinumab in reducing asthma
exacerbations in adults and adolescents
with severe, inadequately controlled asthma.
The Phase III asthma programme is on track
to deliver results in the second half of 2017.
329m
The global prevalence of COPD is estimated
to be 329 million people(cid:446) and WHO predicts
that COPD will become the third leading
cause of death worldwide by 2030(cid:447).
1(cid:3)(cid:3)(cid:54)(cid:82)(cid:88)(cid:85)(cid:70)(cid:72)(cid:29)(cid:3)(cid:37)(cid:72)(cid:85)(cid:72)(cid:93)(cid:68)(cid:3)(cid:37)(cid:42)(cid:15)(cid:3)(cid:49)(cid:76)(cid:72)(cid:79)(cid:86)(cid:72)(cid:81)(cid:3)(cid:36)(cid:55)(cid:15)(cid:3)(cid:57)(cid:68)(cid:79)(cid:74)(cid:68)(cid:85)(cid:71)(cid:86)(cid:86)(cid:82)(cid:81)(cid:3)(cid:54)(cid:3)(cid:72)(cid:87)(cid:3)(cid:68)(cid:79)(cid:17)(cid:3)(cid:51)(cid:68)(cid:87)(cid:76)(cid:72)(cid:81)(cid:87)(cid:3)
preferences in severe COPD and asthma: a comprehensive
literature review. International Journal of COPD. 2015: 10:
739-744.
2 Source: WHO. Burden of COPD. http://www.who.int/
respiratory/copd/burden/en/. Accessed December 2016.
AstraZeneca Annual Report and Form 20-F Information 2016
37
Strategic Report Therapy Area Review
Other Disease Areas
In addition to our focus on the treatment of diseases
in our three main therapy areas, we are also selectively
active in the areas of Autoimmunity, Infection and
Neuroscience, as well as Gastroenterology, where
we aim to develop best-in-class therapies and follow
an opportunity-driven approach.
Our approach in our other disease areas
looks to maximise revenue through
externalisation and on-market products;
advance the novel product pipeline with
partnerships where appropriate; and
preserve a company stake in the most
promising assets.
Autoimmunity
Systemic lupus erythematosus (SLE),
or lupus, is an autoimmune disease
that occurs when the immune system
produces antibodies that attack healthy
tissue, including skin, joints, kidney, the
brain and blood vessels. SLE can cause
a wide range of symptoms. Among these
are pain, rashes, fatigue, swelling in joints,
and fevers. SLE is associated with a
greater risk of death from causes such
as infection, nephritis and cardiovascular
disease. Inflammation of the kidneys caused
by SLE – known as lupus nephritis – can
lead to significant morbidity and even
death. Current treatment of SLE focuses
on suppressing symptoms and controlling
disease flares and, in the case of lupus
nephritis, preventing renal failure.
Neuromyelitis optica (NMO) is a rare, life-
threatening autoimmune disease of the
central nervous system in which the body’s
immune system attacks healthy cells, most
commonly in the optic nerves and spinal
cord, resulting in severe damage. NMO
causes severe muscle weakness and
paralysis, loss of vision, respiratory failure,
problems with bowel and bladder function
and neuropathic pain.
Other Disease Areas – pipeline progressions
Regional approvals
Zurampic – gout (EU)
Zavicefta (previously CAZ AVI) – serious infections (EU)
(cid:51)(cid:68)(cid:81)(cid:71)(cid:72)(cid:80)(cid:76)(cid:70)(cid:3)(cid:47)(cid:76)(cid:89)(cid:72)(cid:3)(cid:36)(cid:87)(cid:87)(cid:72)(cid:81)(cid:88)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:44)(cid:81)(cid:432)(cid:88)(cid:72)(cid:81)(cid:93)(cid:68)(cid:3)(cid:57)(cid:68)(cid:70)(cid:70)(cid:76)(cid:81)(cid:72)(cid:3)(cid:347)(cid:3)(cid:83)(cid:68)(cid:81)(cid:71)(cid:72)(cid:80)(cid:76)(cid:70)(cid:3)(cid:76)(cid:81)(cid:432)(cid:88)(cid:72)(cid:81)(cid:93)(cid:68)(cid:3)(cid:11)(cid:40)(cid:56)(cid:12)
Expedited review
(cid:50)(cid:85)(cid:83)(cid:75)(cid:68)(cid:81)(cid:3)(cid:39)(cid:85)(cid:88)(cid:74)(cid:3)(cid:39)(cid:72)(cid:86)(cid:76)(cid:74)(cid:81)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:29)(cid:3)(cid:76)(cid:81)(cid:72)(cid:69)(cid:76)(cid:79)(cid:76)(cid:93)(cid:88)(cid:80)(cid:68)(cid:69)(cid:3)(cid:11)(cid:48)(cid:40)(cid:39)(cid:44)(cid:16)(cid:24)(cid:24)(cid:20)(cid:12)(cid:3)(cid:347)(cid:3)(cid:81)(cid:72)(cid:88)(cid:85)(cid:82)(cid:80)(cid:92)(cid:72)(cid:79)(cid:76)(cid:87)(cid:76)(cid:86)(cid:3)(cid:82)(cid:83)(cid:87)(cid:76)(cid:70)(cid:68)(cid:3)(cid:11)(cid:56)(cid:54)(cid:12)
(cid:41)(cid:68)(cid:86)(cid:87)(cid:3)(cid:55)(cid:85)(cid:68)(cid:70)(cid:78)(cid:3)(cid:39)(cid:72)(cid:86)(cid:76)(cid:74)(cid:81)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:29)(cid:3)(cid:48)(cid:40)(cid:39)(cid:44)(cid:27)(cid:27)(cid:24)(cid:21)(cid:3)(cid:347)(cid:3)(cid:75)(cid:82)(cid:86)(cid:83)(cid:76)(cid:87)(cid:68)(cid:79)(cid:76)(cid:86)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:432)(cid:88)(cid:72)(cid:81)(cid:93)(cid:68)(cid:3)(cid:11)(cid:56)(cid:54)(cid:12)(cid:30)(cid:3)(cid:36)(cid:61)(cid:39)(cid:22)(cid:21)(cid:28)(cid:22)(cid:3)(cid:347)(cid:3)(cid:36)(cid:79)(cid:93)(cid:75)(cid:72)(cid:76)(cid:80)(cid:72)(cid:85)(cid:350)(cid:86)(cid:3)
disease (US)
Regulatory submissions
Lesinurad+allopurinol FDC – gout (US)
Phase III investment
decisions
(cid:36)(cid:61)(cid:39)(cid:22)(cid:21)(cid:28)(cid:22)(cid:3)(cid:347)(cid:3)(cid:36)(cid:79)(cid:93)(cid:75)(cid:72)(cid:76)(cid:80)(cid:72)(cid:85)(cid:350)(cid:86)(cid:3)(cid:71)(cid:76)(cid:86)(cid:72)(cid:68)(cid:86)(cid:72)(cid:30)(cid:3)(cid:36)(cid:55)(cid:48)(cid:16)(cid:36)(cid:57)(cid:44)(cid:13)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:86)(cid:72)(cid:85)(cid:76)(cid:82)(cid:88)(cid:86)(cid:3)(cid:69)(cid:68)(cid:70)(cid:87)(cid:72)(cid:85)(cid:76)(cid:68)(cid:79)(cid:3)(cid:76)(cid:81)(cid:73)(cid:72)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:30)(cid:3)(cid:87)(cid:85)(cid:68)(cid:79)(cid:82)(cid:78)(cid:76)(cid:81)(cid:88)(cid:80)(cid:68)(cid:69)(cid:13)(cid:3)
for atopic dermatitis
Phase II starts/progressions MEDI2070 for Crohn’s disease; MEDI3902 for the prevention of nosocomial pseudomonas
pneumonia; MEDI8897 for RSV
Strategic transactions
completed
Licensing agreements with Ironwood for the US rights to Zurampic and with Gru¨ nenthal
GmbH for rights in the EU and Latin America; two licensing agreements with LEO Pharma
on our dermatology portfolio (brodalumab for EU, and tralokinumab for atopic dermatitis);
(cid:86)(cid:68)(cid:79)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:86)(cid:80)(cid:68)(cid:79)(cid:79)(cid:3)(cid:80)(cid:82)(cid:79)(cid:72)(cid:70)(cid:88)(cid:79)(cid:72)(cid:3)(cid:68)(cid:81)(cid:87)(cid:76)(cid:69)(cid:76)(cid:82)(cid:87)(cid:76)(cid:70)(cid:86)(cid:3)(cid:83)(cid:82)(cid:85)(cid:87)(cid:73)(cid:82)(cid:79)(cid:76)(cid:82)(cid:3)(cid:87)(cid:82)(cid:3)(cid:51)(cid:430)(cid:93)(cid:72)(cid:85)(cid:30)(cid:3)(cid:79)(cid:76)(cid:70)(cid:72)(cid:81)(cid:86)(cid:76)(cid:81)(cid:74)(cid:3)(cid:48)(cid:40)(cid:39)(cid:44)(cid:21)(cid:19)(cid:26)(cid:19)(cid:3)(cid:87)(cid:82)(cid:3)(cid:36)(cid:79)(cid:79)(cid:72)(cid:85)(cid:74)(cid:68)(cid:81)(cid:30)(cid:3)
agreement with ProStrakan Group (now Kyowa Kirin International plc) for the rights to
Moventig(cid:3)(cid:11)(cid:81)(cid:68)(cid:79)(cid:82)(cid:91)(cid:72)(cid:74)(cid:82)(cid:79)(cid:12)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:40)(cid:56)(cid:15)(cid:3)(cid:44)(cid:70)(cid:72)(cid:79)(cid:68)(cid:81)(cid:71)(cid:15)(cid:3)(cid:49)(cid:82)(cid:85)(cid:90)(cid:68)(cid:92)(cid:15)(cid:3)(cid:54)(cid:90)(cid:76)(cid:87)(cid:93)(cid:72)(cid:85)(cid:79)(cid:68)(cid:81)(cid:71)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:47)(cid:76)(cid:72)(cid:70)(cid:75)(cid:87)(cid:72)(cid:81)(cid:86)(cid:87)(cid:72)(cid:76)(cid:81)
Setbacks and terminated
projects
Abrilumab for Crohn’s disease/ulcerative colitis; MEDI7510 for prevention of RSV disease
in older patients
* Achieved as a result of partnering; will not be progressed by AstraZeneca.
38
AstraZeneca Annual Report and Form 20-F Information 2016
Psoriasis is a chronic disease in which the
immune system causes skin cells to grow
rapidly. Instead of being shed, the skin cells
pile up, causing painful and itchy, red, scaly
patches that can bleed. Approximately
100 million people worldwide suffer from
psoriasis. Despite available treatment
options for moderate-to-severe plaque
psoriasis, many patients do not experience
a resolution of underlying inflammation,
clearing of symptoms or an improved
quality of life.
Gout is a serious, chronic, progressive
and debilitating form of inflammatory arthritis
that affects more than 15.8 million people
in major markets. The underlying cause
of gout is hyperuricemia (elevated serum
uric acid), which leads to the deposition
of crystals primarily in the joints and in
other tissues. This can result in recurrent
attacks of inflammatory arthritis and, if
left uncontrolled, can lead to chronic,
progressive arthritis and tophus (visible soft
tissue deposits of urate crystals) formation.
Rheumatoid arthritis is an autoimmune
disease that affects about 1% of the
population and causes inflammation in
the joints, with joint pain and swelling
symptoms. There is a need for novel
treatments, since only about a third of
patients treated with biologics achieve
their treatment goals.
In the pipeline
We are strengthening our pipeline and
improving treatment options and clinical
outcomes for patients with inflammatory
and autoimmune diseases. Common
molecular pathways are often shared
across multiple autoimmune diseases,
which provides opportunities to identify
and work with approaches that could
become treatments for more than
one disease.
Anifrolumab is a developmental MAb that
inhibits the activity of all type I interferon (IFN)
receptors, which play a central role in lupus.
A majority of patients with SLE show a high
interferon gene signature, and increased
levels of type I IFN have been shown to
correlate with SLE disease activity and
severity. Phase II trial results presented
in November 2015 demonstrated that
anifrolumab significantly reduced disease
activity in moderate-to-severe SLE patients
as measured by several SLE composite
Investing for the future:
Breaking the lupus code
Recognition of the importance of the role
played by the interferon pathway in lupus
led to the development of anifrolumab, an
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MAb that inhibits the activity of all type 1
interferons (IFN). Anifrolumab is being
developed with an IFN gene signature
diagnostic test designed to identify
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from treatment. The role of the interferon
pathway may go beyond lupus; elevated
type 1 IFN signature has been found in
several other autoimmune diseases.
agreement entered into in July 2016. Valeant
and LEO Pharma assume decision making
on future development and all development
costs associated with brodalumab.
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Zurampic inhibits the urate transporter,
URAT1, which is responsible for the
majority of the renal reabsorption of uric
acid. By inhibiting URAT1, Zurampic
increases uric acid excretion and thereby
lowers serum uric acid levels. In combination
with the current standard-of-care, xanthine
oxidase inhibitors (XOIs) allopurinol or
febuxostat, Zurampic provides a dual
mechanism of action to increase
excretion and decrease production of
uric acid, enabling more patients with
inadequately controlled gout to achieve
target treatment goals.
In April 2016, AstraZeneca entered into a
licensing agreement with Ironwood for the
exclusive US rights to Zurampic. Zurampic
was approved by the FDA in December
2015, in combination with an XOI, for the
treatment of hyperuricemia associated with
gout in patients who have not achieved
target serum uric acid levels with an XOI
alone. Ironwood launched Zurampic in the
US in October 2016. In addition, Ironwood
has exclusive US rights to the fixed-dose
combination of lesinurad and allopurinol.
In February 2016, the European Commission
granted marketing authorisation for Zurampic
200mg in combination with an XOI for the
adjunctive treatment of hyperuricemia in
gout patients (with or without tophi) who
have not achieved target serum uric acid
levels with an adequate dose of an XOI alone.
In June 2016, we licensed out the exclusive
rights to Zurampic in the EU, Switzerland,
Iceland, Norway and Liechtenstein, and in
all Latin American countries to Grünenthal
GmbH. The agreement includes rights to
the fixed-dose combination of lesinurad
and allopurinol in gout.
Verinurad (RDEA3170) is a potent selective
uric acid reabsorption inhibitor, also
intended for use as a combination urate-
lowering therapy with XOIs. Verinurad is in
Phase II development. We have recently
initiated plans to study verinurad for CKD
in a Phase II study.
endpoints. It also improved symptoms of
lupus such as rash and arthritis. Anifrolumab
is currently in Phase III development for SLE
and Phase II for lupus nephritis. A Phase I
subcutaneous administration study was
completed in 2016 with plans for further
studies ongoing.
In March 2016, the FDA granted Orphan
Drug Designation for inebilizumab (MEDI-
551) for the treatment of patients with NMO
as well as neuromyelitis optica spectrum
disorders (NMOSD). Inebilizumab is an
anti-CD19 MAb currently in Phase IIb clinical
development. The FDA’s Orphan Drug
Designation programme provides orphan
status to potential medicines intended for
the safe and effective treatment, diagnosis
or prevention of rare diseases or disorders
that affect fewer than 200,000 people
in the US.
Brodalumab is a human MAb that
targets the interleukin-17 (IL-17) receptor.
Brodalumab is currently under regulatory
review in the US and Europe for adult
patients with moderate-to-severe plaque
psoriasis, with decisions anticipated in
early 2017.
Through a collaboration agreement,
Valeant, an expert in dermatology, has
an exclusive licence to develop and
commercialise brodalumab globally, except
in Japan and certain other Asian countries
where rights are held by Kyowa Hakko
Kirin, and in Europe, where LEO Pharma
holds exclusive rights to develop and
commercialise brodalumab based on an
AstraZeneca Annual Report and Form 20-F Information 2016
39
Strategic Report
Strategic Report Therapy Area Review
Other Disease Areas continued
Our marketed products
Infection
> Fluenz Tetra/FluMist Quadrivalent1,2 (influenza
vaccine live)
> Synagis3 (palivizumab)
Full product information on page 211
1 Intra-nasal.
2 Daiichi Sankyo holds rights to Fluenz Tetra/FluMist
Quadrivalent in Japan.
3 US rights only. AbbVie holds rights to Synagis outside
the US.
Neuroscience
> Movantik/Moventig (naloxegol)
> Seroquel IR (quetiapine fumarate)
> Seroquel XR (quetiapine fumarate)
> Vimovo1 (naproxen and esomeprazole
magnesium)
> Zomig (zolmitriptan)
Full product information on page 211
1(cid:3) (cid:3)(cid:47)(cid:76)(cid:70)(cid:72)(cid:81)(cid:86)(cid:72)(cid:71)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:51)(cid:82)(cid:93)(cid:72)(cid:81)(cid:17)(cid:3)(cid:39)(cid:76)(cid:89)(cid:72)(cid:86)(cid:87)(cid:72)(cid:71)(cid:3)(cid:56)(cid:54)(cid:3)(cid:85)(cid:76)(cid:74)(cid:75)(cid:87)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)(cid:43)(cid:82)(cid:85)(cid:76)(cid:93)(cid:82)(cid:81)(cid:3)
(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:56)(cid:54)(cid:36)(cid:15)(cid:3)(cid:44)(cid:81)(cid:70)(cid:17)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:21)(cid:21)(cid:3)(cid:49)(cid:82)(cid:89)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:22)(cid:17)
Gastrointestinal
> Losec/Prilosec (omeprazole)
> Nexium (esomeprazole magnesium)
Full product information on page 211
3-5m
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estimated to result in about three
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and about 250,000 to 500,000 deaths.
Source: WHO Factsheet November 2016.
Mavrilimumab, an investigational MAb that
inhibits a key pathway in the development
of rheumatoid arthritis, achieved its primary
and secondary endpoints in recently
completed Phase IIb trials. Results showed
that mavrilimumab improved signs and
symptoms of rheumatoid arthritis, measures
of disability and patient-reported outcomes.
Infection
Seasonal influenza is a serious public
health problem that causes severe illness
and death in high-risk populations. In
2016, the US Centers for Disease Control
and Prevention (CDC) issued an interim
recommendation that FluMist Quadrivalent/
Fluenz Tetra should not be used in the US
for the 2016 to 2017 influenza season based
on concerns regarding low effectiveness
of the vaccine in the US during the last
three influenza seasons (2013 to 2016).
The vaccine remains licensed in the US
and AstraZeneca/MedImmune remain
committed to FluMist Quadrivalent and
supporting it in the US and in the rest of the
world. The FDA continues to find that the
benefits of FluMist Quadrivalent outweigh
any potential risks. We are conducting
non-clinical and clinical studies in order to
provide data to help support a renewed
recommendation for use in the US in future
seasons. The vaccine continues to be
recommended for use in many countries
outside the US based on their respective
public health authorities’ review of existing
and recent vaccine effectiveness data. We
also recently reached an agreement with
the WHO to donate and supply at reduced
prices a portion of vaccine production in
the event of an influenza pandemic.
MEDI8852, an investigational human
MAb for the treatment of patients
hospitalised with Type A strain influenza,
received Fast Track Designation from the
FDA in March 2016.
Since its approval in 1998, Synagis has
helped protect at risk babies globally against
respiratory syncytial virus (RSV). RSV is
a common seasonal virus and the most
prevalent cause of lower respiratory tract
infections among infants and young
children, affecting approximately two-thirds
of all infants in their first year of life (68%
by 12 months of age and 97% by 24 months
of age). It is the leading cause of
hospitalisations and admissions to
paediatric intensive care units and leads to
nearly 200,000 deaths globally in children
under five years of age, with the majority
of deaths occurring in developing countries.
Synagis is approved in more than 80
countries and is the global standard of care
for RSV prevention. We continue to work
with our worldwide partner, AbbVie, to
protect vulnerable infants.
MEDI8897 is a novel extended half-life MAb
for the prevention of serious respiratory
disease caused by RSV in infants. It requires
dosing only once per RSV season – a
potential breakthrough in RSV prophylaxis.
In November 2016, the first patient was
dosed in a Phase IIb trial. The FDA granted
Fast Track status to MEDI8897 in April 2015.
Through a broad collaboration and
significant funding, AstraZeneca joined in
a public-private partnership with Vaccines
Europe, the European Commission, the
European Federation of Pharmaceutical
Industries and Associations (EFPIA) and the
Innovative Medicines Initiative (IMI) to further
define the substantial unmet needs of RSV
in paediatrics and older adults. Funding
for the partnership, called RESCEU, will
support the existing MEDI8897 programme
and further strengthens our relationship
with IMI.
In June 2016, the European Commission
granted marketing authorisation for
Zavicefta (ceftazidime-avibactam, previously
known as CAZ AVI), a new combination
antibiotic for the treatment of patients with
serious Gram-negative bacterial infections
requiring hospitalisation.
Zavicefta has been developed in response
to the urgent need for new antibiotics to
treat serious infections that are becoming
increasingly resistant, such as multi-drug
resistant P. aeruginosa, carbapenem-
resistant Gram-negative pathogens, and
ESBL-producing Enterobacteriaceae.
In December 2016, we confirmed the
completion of an agreement to sell the
development and commercialisation rights
of our late-stage, small molecule antibiotics
business to Pfizer. The portfolio comprised
Zinforo, Zavicefta, Merrem, ATM-AVI and
CXL in all markets where we held the rights.
40
AstraZeneca Annual Report and Form 20-F Information 2016
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We are committed to ensuring that pain
patients who need to manage the side
effect of opioid induced constipation
continue to get access to Movantik/
Moventig. In March 2016, AstraZeneca
announced an agreement with ProStrakan
Group, now Kyowa Kirin International
plc, for the rights to Moventig (naloxegol)
in the EU, Iceland, Norway, Switzerland
and Liechtenstein. In December 2016,
we completed a sub-licence to Knight
Therapeutics Inc. to commercialise
Movantik/Moventig in Canada and Israel.
This follows the 2015 co-commercialisation
agreement with Daiichi Sankyo for Movantik
in the US. These agreements are in line
with delivering on our externalisation
strategy to create value by partnering on
pipeline assets that are outside our three
main therapy areas.
Gastrointestinal
In 2016, use of Nexium continued to grow
in markets including China and Japan.
Demand for Nexium in China is expected
to continue to grow over the next several
years, based on broader geographic
expansion as well as anticipated label
expansions, and has the potential to
become a top-selling medicine in its class,
as in Japan. Patent protection for Nexium
remains in Japan. For the rest of the world,
Nexium is subject to generic competition.
Investing for the future:
Searching for a treatment for
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(cid:36)(cid:79)(cid:93)(cid:75)(cid:72)(cid:76)(cid:80)(cid:72)(cid:85)(cid:350)(cid:86)(cid:3)(cid:71)(cid:76)(cid:86)(cid:72)(cid:68)(cid:86)(cid:72)(cid:3)(cid:85)(cid:72)(cid:80)(cid:68)(cid:76)(cid:81)(cid:86)(cid:3)(cid:82)(cid:81)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)
largest areas of unmet medical need and
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BACE inhibitor in collaboration with Lilly
received Fast Track Designation by the
FDA in August 2016.
Neuroscience
Current commercialised AstraZeneca
neuroscience molecules include
Zomig (triptan) and Seroquel (atypical
antipsychotics), which have lost exclusivity
in all major markets. In November 2016,
two licensed generics of Seroquel XR
were launched in the US. In June 2016,
AstraZeneca announced an agreement
with Aspen Global Incorporated, part
of Aspen Group, for the rights to the
global anaesthetics portfolio outside
the US. The agreement covered seven
established medicines – Diprivan (general
anaesthesia), EMLA (topical anaesthetic)
and five local anaesthetics (Xylocaine/
Xylocard/Xyloproct, Marcaine, Naropin,
Carbocaine and Citanest).
AZD3293 is our BACE inhibitor which
we are progressing in collaboration with
Lilly for the potential treatment of Alzheimer’s
disease. It experienced several critical
milestones throughout 2016, including
continuation of the Phase II/III trial
AMARANTH into Phase III and the initiation
of DAYBREAK-ALZ, a new Phase III trial
to evaluate the safety and efficacy of
AZD3293 in people with mild Alzheimer’s
dementia. The investigational treatment
also received Fast Track Designation by
the FDA in August 2016.
Further underpinning AstraZeneca’s
commitment to Alzheimer’s disease,
in December 2016, we announced
that MEDI1814, an investigational MAb
selective for toxic proteins associated with
Alzheimer’s disease, will be developed
beyond Phase I, also in collaboration
with Lilly.
AstraZeneca Annual Report and Form 20-F Information 2016
41
Strategic Report Business Review
Business Review
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(cid:87)(cid:82)(cid:3)(cid:71)(cid:72)(cid:79)(cid:76)(cid:89)(cid:72)(cid:85)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:86)(cid:87)(cid:85)(cid:68)(cid:87)(cid:72)(cid:74)(cid:76)(cid:70)(cid:3)(cid:83)(cid:85)(cid:76)(cid:82)(cid:85)(cid:76)(cid:87)(cid:76)(cid:72)(cid:86)(cid:86)(cid:3)(cid:76)(cid:76)(cid:81)(cid:81)(cid:3)(cid:68)(cid:68)(cid:3)(cid:86)(cid:88)(cid:86)(cid:87)(cid:68)(cid:76)(cid:81)(cid:68)(cid:69)(cid:79)(cid:72)(cid:3)(cid:90)(cid:68)(cid:92)(cid:92)(cid:17)
Overview
> Focused investment in accelerating late-stage programmes to ensure
new treatments get to patients safely and as quickly as possible
> (cid:51)(cid:79)(cid:68)(cid:81)(cid:86)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:68)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:76)(cid:81)(cid:74)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:79)(cid:72)(cid:68)(cid:71)(cid:72)(cid:85)(cid:86)(cid:75)(cid:76)(cid:83)(cid:3)(cid:76)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:72)(cid:3)(cid:85)(cid:72)(cid:86)(cid:72)(cid:68)(cid:85)(cid:70)(cid:75)(cid:76)(cid:81)(cid:74)(cid:3)(cid:81)(cid:72)(cid:90)
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personalised healthcare
> Six Growth Platforms represented 63% of revenues in 2016, up 4%
at actual exchange rates (5% at CER) over 2015
> In April, announced further focus on our main therapy areas to drive
greater productivity across the organisation, sharpen the prioritisation
of investments, increase partnering and streamline our operations
> Began to refresh our sustainability programme and embed it into our
business practices, with focus on three areas: ethics and transparency;
broadening access to healthcare; and environmental protection
b oade
g access to ea t ca e; a d e v o
e ta p otect o
> Committed to delivering value in pricing our medicines with policy based
on four principles
> Continued to promote a safe and healthy work environment, coupled
with our commitment to working only with those who share our
ethical standards
Throughout this Annual Report this symbol
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42
AstraZeneca Annual Report and Form 20-F Information 2016
Organisation
Our science is led by our two biotech
units which conduct innovative discovery
research and early-stage development
from initial target selection to Phase II trial
completion. The Innovative Medicines and
Early Development (IMED) Biotech Unit
focuses on scientific advances in small
molecules, nucleotides and other emerging
technologies and drug discovery platforms,
while MedImmune is responsible for global
biologics R&D. Both units are responsible
for delivering projects to our Global
Medicines Development (GMD) unit for
late-stage development.
We have three strategic R&D centres:
Gaithersburg, Maryland US; Gothenburg,
Sweden; and Cambridge, UK. For more
information on our move to Cambridge,
announced in 2013, see page 7.
Our Global Product and Portfolio Strategy
group (GPPS) leads our therapy area
activities. GPPS also serves as the bridge
between our R&D and Commercial
functions and works to provide strategic
direction from early-stage research to
commercialisation. GPPS also works
closely with healthcare providers,
regulatory authorities and those who pay
for our medicines, seeking to ensure those
medicines help to fulfil unmet medical
need and provide economic as well as
therapeutic benefits.
We group our Commercial functions into
Regions: North America (US and Canada);
Europe; International East (China, Hong
Kong, Asia Area, Australia & New Zealand);
and International West (Russia & Eurasia,
Middle East & Africa, Latin America and
Brazil). Japan is categorised separately
and is one of our Growth Platforms.
Our Operations function plays a key
role in the development, manufacturing,
testing and delivery of our medicines
to our customers.
Restructuring
Since 2007, we have made significant efforts
to restructure and reshape our business
to improve long-term competitiveness. Full
details are provided in the Financial Review
from page 62. We have created a leaner
and simpler organisation, focused on driving
distinctive science in our main therapy
areas. To advance our strategy, in April
2016, we announced plans to:
> sharpen prioritisation of investments
and focus in our main therapy areas,
particularly Oncology
> increase partnering in relation to projects
in our inflammation, infection and
neuroscience disease areas, and to
products in markets where there is
a clear rationale
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> align costs to our changing business
shape and to streamline our operations
at a global, regional and country level;
reshaping manufacturing as we build
our biologics capacity; to drive
simplification; and to implement
small footprint changes.
Restructuring charges of $1,107 million
were incurred in the year and we remain
on track to realise the benefits and incur
the costs we announced.
Sustainability
We want to be valued and trusted by our
stakeholders as a source of great medicines
over the long term. That is why we are
committed to operating in a way that
recognises the interconnection between
business growth, the needs of society and
the limitations of our planet. This means
delivering our business strategy in a way
that broadens access to our medicines,
minimises the environmental footprint of
our products and processes, and ensures
that ethics and transparency underpin
everything we do. Our commitment to
growing our business in a sustainable way
also helps us protect our licence to operate,
attract and retain talent, manage risk and,
most importantly, deliver life-changing
medicines to patients. The SET and Board
regularly review our sustainability work as
part of their risk management and business
review activities.
Refreshed sustainability strategy
In 2016, we embarked on a process to
refresh and focus our sustainability
programme and further embed it into our
business practices and strategic priorities.
We worked with an independent think-tank
to complete a sustainability materiality
assessment to help identify priorities.
Sustainability framework
A sustainability framework is embedded in the way we operate:
Sustainability
Advisory Board
Established in 2015
and meets twice annually
to provide external
insight, feedback and
advice to help sharpen
our understanding of,
and responses to,
established and
emerging sustainability
issues. The Advisory
Board also helps identify
opportunities for further
innovation and
collaboration.
Board
Non-Executive Director, Geneviève Berger, oversees implementation
of the sustainability framework and reporting to the Board.
SET
SET is responsible for the framework.
Senior managers throughout the Group are accountable for operating
in line with the sustainability commitments within their areas, taking
into account national, functional, and site issues and priorities.
Line managers are accountable for ensuring that their teams understand
the requirements and improvement targets, and that people are clear about
what is expected of them as they work to achieve our business goals.
Sustainability Council
The Council is chaired by a SET member, currently Katarina Ageborg.
Members comprise senior leaders from each relevant SET function. Its
agenda focuses on driving long-term value creation by, among other things:
> agreeing sustainability priorities for the Group in line with strategic
business objectives
> managing and monitoring the annual process of setting sustainability
objectives and targets, as well as reviewing performance against KPIs
> agreeing appropriate policy positions to support our objectives and
reputation management.
Sustainability Working Group
A network of SET function representatives and subject matter experts
supports the Council. The network reviews issues with the potential to
impact AstraZeneca’s sustainability agenda and helps deliver the
substantive elements of our programme.
Stakeholders
Regular engagement
with external
stakeholders, which
takes place with a range
of socially responsible
investors and other
interest groups, provides
the opportunity for
sustainable issues or
concerns to be raised
and discussed.
AstraZeneca Annual Report and Form 20-F Information 2016
43
Strategic Report Business Review
Business Review continued
The assessment process identified
27 sustainability issues relevant to us.
These became the basis for benchmarking
analysis, engagement with external and
internal stakeholders, and an internal
review that examined our areas of
strength, weakness and opportunity,
and our alignment with the UN
Sustainable Development Goals.
Through this process, we have identified
three priority areas that, given their
alignment with our Purpose and business
strategy, will allow us to have the most
impact in benefiting our patients, our
Company, broader society and the planet.
We remain committed to managing and
building our performance in the other
areas within the scope of AstraZeneca’s
sustainability programmes, such as human
rights, diversity, and workplace health and
safety. We will continue to work across our
business to integrate these commitments
into the way we work, engage with
stakeholders and evaluate our performance.
The three priority areas are as follows.
1. Broadening access to healthcare.
Through collaboration and innovation we
strive to expand access to our medicines by:
> Applying sound bioethics to all our work
and maintaining a strong focus on patient
safety (see pages 47 and 48).
> Exploring innovative ways of increasing
access to healthcare for more people,
tailored to meet differing patient needs
and circumstances (see page 51 and
Healthy Heart Africa on page 49).
> Making a positive contribution to our local
communities around the world, through
community support programmes
consistent with improving health and
promoting science (see page 53).
3. Environmental protection.
We follow the science to protect the
planet by:
> Managing our impact on the environment,
across all our activities, with a particular
focus on carbon emissions, waste and
water use.
> Minimising the environmental impact of
our products (see pages 60 and 61).
2. Ethics and transparency.
We will maintain integrity in everything
we do by:
Our focus on these three areas does not
diminish our commitment to other areas
of our sustainability agenda. For example:
> Working to consistent global standards of
ethical sales and marketing practices in all
our markets (see page 52).
> Working only with suppliers who have
standards consistent with our own as we
increase our outsourcing to drive
business efficiency (see page 52).
> Working on continued transparency with
our data in clinical trials, enhancing the
understanding of how our medicines
work and benefit patients (see page 47).
> Ensuring that diversity in its broadest
sense is reflected in our leadership and
people strategies (see page 55).
> Continuing to develop and embed
a consistent approach to human
rights across our worldwide activities
(see page 56).
> Promoting the safety, health and
wellbeing of all our people worldwide
(see page 53).
Benchmarking and assurance
Our work in sustainability has been recognised by a number of organisations in 2016:
DJSI
> Second in Pharmaceuticals,
Biotechnology and Life Sciences
industry group.
> Sector best scores attained for:
Occupational Health and Safety,
Code of Conduct, Marketing
Practices, Climate Strategy and
Health Outcomes Contribution.
Access to Medicine Index
> Biggest riser in the Index since the
last survey, moving to 7th place in
2016 from 15th in 2014.
> Recognition for industry best
practice in a number of areas,
including transparent approach to
intellectual property in relation to
Index Countries: disclosing where
we will not enforce patents, where
we would consider granting a
licence, and disclosing the status
of our patents for products used
to treat Index Diseases.
CDP
> Climate A List – Among the top 9%
of companies participating in CDP’s
climate change programme in
recognition of our actions to reduce
emissions and mitigate climate
change.
> Water A List – Among the leading
25 companies for our commitment to
transparency around environmental
risks and demonstration of pursuing
best practice.
> Supplier Climate A List – Among
the 3% of companies awarded an
(cid:36)(cid:3)(cid:74)(cid:85)(cid:68)(cid:71)(cid:72)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:72)(cid:428)(cid:82)(cid:85)(cid:87)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:68)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)
to combat climate change by
implementing programmes to
reduce emissions in both direct
operations and supply chain.
Bureau Veritas has provided
independent external assurance to
a limited level on the sustainability
information contained within this
Annual Report.
For more information
on Bureau Veritas’ work and
benchmarking, please see
Sustainability: supplementary
information on page 231 and the
Sustainability pages on our
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44
AstraZeneca Annual Report and Form 20-F Information 2016
Safety, Health and Environment strategy
Throughout 2016, we worked to embed
our 2016 to 2025 Safety, Health and
Environment (SHE) strategy and deliver the
targets we have set ourselves as regards:
> eliminating workplace accidents and
illnesses (see page 53)
> protecting natural resources (see pages
60 and 61)
> ensuring the environmental safety of our
products (see page 61).
We have made good progress to date,
attaining independent verification that our
climate change targets are science-based,
setting out our RE100 strategy to source
100% renewable power globally, and
disclosing our climate information in public
reports. We have also made a commitment
to responsible water stewardship as part
of The Business Alliance for Water and
Climate partnership. We are working closely
with our operating sites to agree on specific
contributions to our 2025 strategy targets.
More information on our performance in
2016 can be found in Safety, health and
wellbeing on page 53 and Environment
from page 60.
We are proud of the external recognition
we are receiving for our work. As shown to
the left, the Dow Jones Sustainability Index
(DJSI) has scored our climate change
strategy and occupational health and safety
performance as best in our industry. Our
submissions to investor benchmarking
organisation, CDP achieved an A-list
ranking for both climate change and water
stewardship. During 2016, we committed
approximately $25 million to natural
resource projects at our sites. These
projects are expected to accelerate our
resource efficiency performance and
include: solvent recovery to reduce
hazardous waste; a novel heat pump
system to reduce reliance on natural gas;
and a number of resource efficiency minor
works programmes. Site water stress
assessments and natural resource audits
continue to identify further opportunities for
management and investment. We continue
to hold third party suppliers accountable
for protecting the environment across our
supply chains and we are active members
of the Pharmaceutical Supply Chain Initiative
to promote a collaborative approach across
our industry.
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leadership
We are using our distinctive
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molecules and biologics, including
immunotherapies and protein
engineering, as well as investing in
key programmes and focused
business development, to deliver
life-changing medicines.
Overview
> Launched six diagnostic tests linked to
our products in line with our personalised
healthcare (PHC) strategy
> Delivered clinical trial data and
submissions that resulted in 11 approvals
for brand new medicines in the US, EU,
China or Japan
> (cid:54)(cid:76)(cid:80)(cid:83)(cid:79)(cid:76)(cid:430)(cid:72)(cid:71)(cid:3)(cid:83)(cid:85)(cid:82)(cid:74)(cid:85)(cid:68)(cid:80)(cid:80)(cid:72)(cid:86)(cid:15)(cid:3)(cid:83)(cid:85)(cid:82)(cid:70)(cid:72)(cid:86)(cid:86)(cid:72)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)
systems, and prioritised resources
towards late-stage drug development
> Published 75 manuscripts in ‘high-impact’
publications compared to seven in 2010
> Continued to strengthen early-stage
portfolio with new drug modalities,
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areas while maintaining a clear focus on
disease mechanisms
> Strive to access the best science, both
internal and external, in our biotech units,
and we are open to exploring new and
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> Committed to working responsibly and in
accordance with our global bioethics policy
Early science
We continued to strengthen our early-stage
portfolio with new drug modalities such as
modified RNA, anti-micro RNA, antisense
oligonucleotides, bi-specific monoclonal
antibodies (MAbs) and antibody-drug
conjugates (ADC). This is allowing us to
expand into novel scientific areas while
maintaining a clear focus on disease
mechanisms. In 2016, in partnership
with Regulus Therapeutics Inc., we saw
AZD4076, an anti-micro RNA targeting
the miR103/107 gene, being dosed into
patients. These patients had non-alcoholic
steatohepatitis or ‘silent-liver disease’, for
which there are no approved medicines.
Also in 2016, in partnership with Moderna,
we filed the clinical trials application for
AZD8601, a modified RNA for VEGF-A for
cardiac regeneration. We also extended
our partnership with Moderna to include
immuno-oncology programmes, combining
MedImmune’s protein engineering and
cancer biology expertise with Moderna’s
technology.
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See Oncology from page 25 for more
information
Working collaboratively and fostering
open innovation
Our biotech-style operating model gives
us access to the best science, both internal
and external, and we are open to exploring
new and different kinds of collaborations.
Our partnership models include in-licensing
of new chemical modalities and platforms,
disease understanding, technology
advances, uncovering novel target
opportunities, and clinical partnerships.
For example, two key pieces of scientific
research were published in high-impact
journals by scientists at our joint centre for
cardiometabolic diseases at the Karolinska
Institutet. We also identify collaborations
that allow us to out-license our technology
platforms. For instance, we have expanded
the utilisation of our ADC technology
platform through an agreement with
Regeneron Pharmaceuticals Inc., giving them
access to MedImmune’s ADC technology.
In 2016, IMED continued to pioneer new
approaches to open innovation, enabling
our scientists more freely to share their ideas
and collaborate on projects with external
scientists. The IMED Open Innovation portal
allows external researchers to access the
full range of open innovation programmes.
By the end of 2016, our teams had reviewed
more than 500 proposals for new drug
projects. Of these, 26 have progressed
as far as clinical trials, while more than 150
are at pre-clinical trial stage.
During 2016, MedImmune continued
to forge collaborations, including
a research collaboration with the
University of California, San Francisco
US, with an emphasis on basic research
and translational sciences. We also
announced an innovative programme
with Johns Hopkins University, providing
a first-of-its-kind industry-academic PhD
programme in the US. Furthermore, in
late 2016, MedImmune and a consortium
of UK universities – Cambridge, Leeds,
Manchester and Sheffield – announced
that they will be afforded a Collaborative
AstraZeneca Annual Report and Form 20-F Information 2016
45
Strategic Report Business Review
Business Review continued
linked to molecular mechanisms of disease
across our main therapy areas. The initiative
includes new collaborations with Human
Longevity, Inc., US, the Wellcome Trust
Sanger Institute, UK, and The Institute
for Molecular Medicine, Finland. We are
also establishing an in-house Centre for
Genomics Research led by Professor
David Goldstein, a leader in genomics.
This Centre aims to apply genomic
insight across our entire R&D pipeline by
developing a bespoke database comprising
genome sequences from samples donated
by patients in clinical trials together with
associated clinical and drug response data.
Late-stage development
GMD designs and delivers clinical trials
and makes regulatory submissions to
seek approval for new drugs and line
extensions. During 2016, we delivered
clinical trial data and submissions that
resulted in 11 approvals for brand new
medicines in the US, EU, China or Japan.
We also had some setbacks during the
year, with some disappointing Phase III data
results – for example, Brilinta for peripheral
arterial disease, selumetinib for non-small
cell lung cancer, and tremelimumab for
mesothelioma – see Cardiovascular &
Metabolic Disease and Oncology from
pages 30 and 25 respectively for more
information. However, this is to be expected
when we are investigating treatments for
diseases that are hard to treat.
In order to maintain a focus on our main
therapy areas and enable us to maximise
time and resources in accelerating certain
programmes, we identified opportunities
to collaborate on developing assets within
our late-stage pipeline. For example, we
made an agreement for the development
of tralokinumab for patients with atopic
dermatitis (allowing us to focus on its
development for asthma) and an agreement
for an accelerated global development
programme for savolitinib for patients
with papillary renal cell carcinoma.
Accelerating the pipeline
In 2016, we presented scientific rationale
that resulted in 10 regulatory designations
for Priority or Fast Track review for new
medicines which offer the potential to
address unmet medical need in certain
diseases, and we also worked to secure
Orphan Drug status for the development
of medicines to treat very rare diseases.
For example, in the US, we were granted
Breakthrough Therapy Designation for our
Investstinininng g for the fuututure:
Listening to patieents
Since 2015, we have introduced over
60,000 patients from the PatientsLikeMe
network to our research teams to inform
our R&D programmes. After simulating
a clinical study visit with lupus patients,
their feedback resulted in 16 changes
to the way the study was conducted.
That study is now delivering ahead
of time, demonstrating the value of
working with patients to deliver more
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will improve our ability to bring more
life-changing medicines, more quickly
to more patients.
6
In 2016, launched six diagnostic
tests linked to our products.
Training Partnership (CTP), structured
as 12 PhD studentships, from the
Biotechnology and Biological Sciences
Research Council (BBSRC). These CTP
studentships are designed to invest in the
training of the next generation of scientists,
providing access to facilities and expertise
unavailable in an academic setting alone.
Our personalised healthcare strategy
Personalised healthcare (PHC) allows us
to tailor both new and existing treatments
to the needs of individual patients by means
of diagnostic tests. It is an integral part of
our plans to achieve scientific leadership
and we are committed to bringing PHC to
patients in all main disease areas. Three
of our products (Iressa, Lynparza and
Tagrisso) are coupled with companion
diagnostic tests that select patients based
on their molecular profiles. In addition,
80% of our clinical pipeline is following our
PHC approach and over 50 planned drug
launches by 2023 require a diagnostic test.
In 2016, we worked with our partners to
launch six diagnostic tests linked to our
products increasing our total number of
diagnostics launched since 2014 to 15.
Our commitment to bring PHC to patients
in all main disease areas has resulted in
our first diagnostic test outside oncology:
the Nova Biomedical Pro Uric Acid Test.
It is a hand-held serum uric acid point of
care test, aligned to Zurampic, which can
be used to measure a patient’s response
to gout treatment. We are also developing
diagnostic tests with Abbott for treating
asthma and with Qiagen for treating lupus.
Also in 2016, we announced our integrated
genomics initiative which focuses on the
discovery of new targets and biomarkers
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immunotherapy treatment – durvalumab for
bladder cancer. We also received Fast Track
Designation for Lynparza for 2nd line ovarian
cancer and for MEDI8852 for patients
hospitalised with Type A strain influenza.
Orphan Drug Designations were granted
for acalabrutinib for three haematological
indications, for selumetinib for differentiated
thyroid cancer, and for MEDI-551 for treating
neuromyelitis optica. We are also working
alongside regulatory authorities to drive
change within the regulatory environment
by ensuring that the clinical benefits of
our medicines for patients are clearly
understood. For example, using Patient
Reported Outcomes data can help define
how oncology medicines are used to
treat patients with cancer.
With 132 drug projects in the pipeline,
GMD is prioritising by focusing investment
to accelerate specific programmes, so
that new treatments get to patients more
quickly but still safely. As a result, several
immuno-oncology clinical trials, including
some for lung cancer, head and neck
cancer and bladder cancer, completed
recruitment in 2016, with read-outs expected
in 2017. Teams have also been quick to
turn positive clinical trial data into regulatory
submissions. In 2016, we made submissions
in the US and EU for our first respiratory
biologic treatment, benralizumab, for severe
asthma and for our lung cancer treatment,
Tagrisso, in China. We secured a priority
review for Tagrisso following its accelerated
development programme and previous
approvals in the US, EU, Japan and 13
other countries.
We also work in partnership to advance our
clinical research – from strategic alliances
with contract research organisations
(CROs) for the delivery of clinical trials, to
academic collaborations. These include
new partnerships with the Department of
Medical Statistics at the London School of
Hygiene & Tropical Medicine and with the
University of Manchester’s Health eResearch
Centre. These partnerships aim to deploy
statistical techniques in examining clinical
and healthcare data to make medicines more
personalised and effective for patients, and
to drive smarter clinical trials.
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Demonstrating the quality of the research
conducted in our laboratories, through
publication in high-quality and ‘high-impact’
journals, is an essential element in building
our scientific reputation and achieving
scientific leadership. It is also critical for
recruiting and retaining the best scientists
from around the world. Scientists from IMED,
MedImmune and GMD have published 75
manuscripts (a record number) in ‘high-
impact’ peer-reviewed journals, each with
an impact factor exceeding 15 (Thomson
Reuters 5yr IF score) and a score exceeding
1,050 in total. This represents an eleven-fold
improvement since our drive to publish in
‘high-impact’ journals began in 2010.
Responsible research
Our commitment to working in a
transparent and ethical manner is essential
to achieving scientific leadership and
delivering life-changing medicines. Our
global standards of bioethics apply to all our
research activity, whether conducted by us
or third parties on our behalf. The following
sections summarise our activities in this area
– for more information, see our website,
www.astrazeneca.com/sustainability.html
Patient safety
Patient safety is very important and we
strive to minimise the risks and maximise
the benefits of our medicines. Through
a pharmacovigilance programme, we
monitor our medicines once they are in the
marketplace to learn of any side effects not
identified during the development process
and provide information concerning the
safety profile of our medicines to regulators,
healthcare professionals and, where
appropriate, patients.
We have a dedicated patient safety team
to help us fulfil our commitment to patient
safety. Each developing and marketed
medicine is allocated a Global Safety
Physician and a patient safety scientist.
In addition, each market is supported by
a dedicated patient safety manager. Our
Chief Medical Officer is accountable for
the benefit/risk profiles of our products
in development and on the market. He
provides medical oversight and enforces
risk assessment processes to help us make
efficient and informed decisions about
patient safety.
Clinical trials and transparency
In 2016, we conducted a range of clinical
trials at many sites as shown in the chart
to the right. This broad span helps ensure
that study participants reflect the diversity
of patients for whom our medicines are
intended and identifies the patients for
whom the medicine may be most beneficial.
Our global governance process provides
the framework for ensuring a consistent,
high-quality approach worldwide. Protecting
participants throughout the trial process is
a priority and we have strict procedures to
help ensure participants are not exposed
to unnecessary risks.
All our clinical studies are designed and
finally interpreted in-house but some are
conducted by CROs on our behalf. In 2016,
approximately 48% of patients in our small
molecule studies and 44% of patients in our
biologics studies were monitored by CROs.
We require these organisations to comply
with our global standards and we conduct
risk-based audits to monitor compliance.
We believe that transparency enhances
the understanding of how our medicines
work and benefit patients. We publish
information about our clinical research,
as well as the registration and results of
our clinical trials – regardless of whether
they are favourable – for all products and
all phases, including marketed medicines,
drugs in development and drugs where
development has been discontinued.
In 2016, we implemented new global
standards which give patients and
researchers more information about
our research. Specifically:
> Every patient who participates in
a study sponsored by us receives
a note recognising their contribution
as well as a copy of the study’s Trial
Results Summary.
> In 2016, we launched a portal (https://
astrazenecagroup-dt.pharmacm.com)
for external researchers to allow them
to request our clinical data and reports
to support additional research. We have
responded to over 50 requests so far.
For more information, please see our website,
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Clinical trials by region
Region
Europe
US/Canada
Asia Pacific
Central/Eastern Europe
Japan
Latin America
Middle East and Africa
Small
molecule
Biologics
15%
27%
15%
28%
2%
10%
3%
23%
26%
11%
24%
5%
10%
1%
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Research use of human biological
samples
The use of human biological samples,
such as solid tissue, biofluids and their
derivatives, plays a vital role in developing
a deeper understanding of human diseases
and their underlying mechanisms, which
helps us develop effective, new and
personalised medicines.
When we conduct this important research,
we maintain policies and processes to
ensure that we comply with the law and
meet regulatory concerns. We place an
emphasis on informed consent that protects
the rights and expectations of donors and
families throughout the process of our
acquisition, use, storage and disposal of the
samples. Protecting the confidentiality of a
donor’s identity is of the utmost importance,
and a key part of our process includes the
coding of biological samples and associated
data (including genetic data).
In rare circumstances, we may use human
fetal tissue (hFT) or human embryonic stem
cells (hESC). In these circumstances, an
internal review of the scientific validity of the
research proposal will be conducted and
permission to use the tissue will be granted
only when no other scientifically reasonable
alternative is available. We also insist our
third party vendors adopt the highest ethical
standards and we rigorously assess the
ability of tissue suppliers to meet our quality
and ethical expectations. We are committed
to minimising the use of fetal tissue by
exploring technological alternatives.
To date, seven research proposals that
include use of cells derived from hFT have
been received for consideration, but none
of these has progressed so far, either for
scientific or other reasons. We continue
to review our processes for the supply
of hFT but, at the end of 2016, had yet
to approve a single source. Currently, four
projects using three different hESC lines
have been approved.
Animal research
We are committed to helping the public
understand our use of animals in research
and our methods for reducing, refining, or
replacing this use (3R approach).
We share our transparency goals externally
through presentations at conferences and
workshops throughout the US and EU, and
we also highlighted our latest refinement
techniques and approach to implementing
the 3Rs in a recent blog for the UK National
Council for the 3Rs. Internally we are
working to refine our study designs by
improving access to a refreshed training
programme on the principles of good
statistical practice. The objective of this
training is to ensure that scientists are better
able to appropriately power their studies,
account for variability and control bias
wherever possible.
Animal research use varies depending on
numerous factors, including our amount of
pre-clinical research, the complexity of the
diseases under investigation and regulatory
requirements. We believe that without our
active commitment to reducing, refining, or
replacing animals in research, our animal
use would be much greater. In 2016, we
used 193,451 animals in-house (2015:
182,055). In addition, 25,651 animals were
used by CROs on our behalf (2015: 33,220).
2. Return to growth
We seek to return to growth by
focusing on our Growth Platforms
and leveraging our strong global
commercial presence, particularly
in Emerging Markets, to ensure the
right medicines are available and
that patients have access to them.
Overview
> Ongoing scrutiny of pharmaceutical
pricing in US and Europe
> Despite biennial price cuts, Japan
remained an attractive market
> Third fastest growing top 10 multinational
pharmaceutical company in Emerging
Markets
> Growth rate in China expected to
moderate due to increased price pressure
and hospital cost containment
> Pricing policy based on principles of value,
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> Sought to make our medicines more
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on ability to pay
> Expanded Healthy Heart Africa
programme from Kenya to Ethiopia
and partnered with The US President’s
Emergency Plan for AIDS Relief
Our plans for growth
Our Commercial teams, which comprised
around 34,100 employees at the end of
2016, are active in more than 100 countries.
In most countries, we sell our medicines
through wholly-owned local marketing
companies. We also sell through distributors
and local representative offices and market
our products largely to primary care and
specialty care physicians.
Even as we continue to be impacted by
the loss of exclusivity on some of our
leading medicines, such as Crestor,
Nexium and Seroquel, we have witnessed
increasing revenues from our growth
brands and launches. This return to growth
is underpinned by our internal Growth
Platforms which are our growth levers.
As our strategy has progressed, so our
Growth Platforms have evolved, as shown
in Strategy and key performance indicators
from page 16. Respiratory was joined by
New Oncology from January 2015 and,
from January 2017, New CVMD replaced
Diabetes and Brilinta/Brilique. Our two
remaining Growth Platforms, Emerging
Markets and Japan, reflect the importance
of these markets to growing future revenues.
Overall, our Growth Platforms grew by 4%
at actual exchange rates (5% at CER) in
2016 and now represent 63% of all revenues.
However, the pharmaceutical market
is highly competitive. For example, our
Diabetes franchise continues to see pricing
pressure. In immuno-oncology, the large
number of clinical trials that are being
carried out highlight the competitive
nature of this area and renders speed
to market critical.
More information on our performance
around the world in 2016 can be found in
the Geographical Review from page 226
US
As the eleventh largest prescription-
based pharmaceutical company in the
US, we have a 3.9% market share of US
pharmaceuticals by sales value.
In 2016, sales in the US decreased by
22% to $7,365 million (2015: $9,474
million). Declines in revenue from Nexium,
Crestor and Synagis were partially offset
by the strong performance of our Growth
Platforms, including Farxiga, Bydureon
and Brilinta, the launches of Lynparza and
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Tagrisso, and the impact of completing the
acquisition of Actavis’ rights to Tudorza and
Daliresp in the US.
The US healthcare system is complex with
multiple payers and intermediaries exerting
pressure on patient access to branded
medicines through regulatory and voluntary
rebates. Regulatory rebates are statutorily
mandated chargebacks and discounts
paid on government-funded programmes
such as Medicaid, Department of Defense
(including TRICARE) and Department
of Veteran’s Affairs. Voluntary rebates
are paid to managed care organisations
and pharmacy benefit managers for
commercially insured patients, including
Medicare Part D patients. In the Medicare
Part D programme, in addition to voluntary
negotiated rebates, branded pharmaceutical
manufacturers are statutorily required to pay
50% of the patient’s out-of-pocket costs
during the ‘coverage gap’ portion of their
benefit design. As part of the ACA, we also
pay a portion of an overall industry Patient
Protection and Affordable Care Act Branded
Prescription Drug Fee.
In 2016, the overall measurable reduction
in our profit before tax for the year due to
discounts on branded pharmaceuticals and
an industry-wide excise fee was $471 million
(2015: $786 million; 2014: $714 million).
In the US, there is significant pricing
pressure driven by payer consolidation,
restrictive reimbursement policies and
cost control tools, such as exclusionary
formularies and price protection clauses.
Many formularies employ ‘generic first’
strategies and/or require physicians
to obtain prior approval for the use of
a branded medicine where a generic
alternative exists. These mechanisms can
be used by intermediaries to limit the use
of branded products and put pressure on
manufacturers to reduce net prices. In 2016,
84.7% of prescriptions dispensed in the
US were generic, compared with 84.0%
in 2015. In addition, patients are seeing
changes in the design of their health plan
benefits and may experience variation,
including increases, in both premiums and
out-of-pocket payments for their branded
medications. The patient out-of-pocket
spend is generally in the form of a co-
payment or co-insurance, but there is
a growing trend towards high deductible
health plans which require patients to pay
the full list price until they meet certain
InInvevestss ining gg fofofor r ththee fufuututututurerereerere:
HHealallththhthhy yyyy HeH art AAfrica
Healthy Heart Africa (HHA) was launched
in Kenya in October 2014 in collaboration
with the Ministry of Health in support of its
commitment to combat NCDs.
HHA aims to reach 10 million hypertensive
patients across Sub-Saharan Africa by
2025 and, after two years, it has already:
> conducted over two million hypertension
screenings in the community and in
health facilities
> trained over 3,000 healthcare workers,
including doctors, nurses, community
health volunteers and pharmacists
to provide education and awareness,
screening and treatment services for
hypertension across 31 counties
> activated 403 health facilities to provide
hypertension services, including
the establishment of secure supply
chains for low-cost, high-quality
antihypertensive medicines.
Following the success of HHA in Kenya,
we developed a partnership with the
Federal Ministry of Health in Ethiopia to
integrate HHA programming into the
Ethiopian healthcare system in support of
the Government National Strategic Action
Plan for NCDs.
In September, we announced a $10 million,
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with The US President’s Emergency Plan
for AIDS Relief (PEPFAR) that will expand
access to HIV/AIDS and hypertension
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manner at existing PEPFAR-supported
HIV/AIDS sites, beginning in Kenya. For
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population to engage for HIV care, and
HHA’s innovative way of working presents
an opportunity for the partnership with
PEPFAR to improve HIV care in this
hard-to-reach population.
3,000
Trained over 3,000 healthcare workers
as part of Healthy Heart Africa.
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out-of-pocket thresholds. We understand
that our medicines will not benefit patients
if they are unable to afford them, and that
is why we offer a number of resources
and programmes that can help patients
afford their medications by reducing their
out-of-pocket costs. We focus our formulary
access on affordability for patients through
rebate payments as well as savings cards
for eligible patients when the out-of-pocket
costs are not affordable.
Ongoing scrutiny of the US pharmaceutical
industry, focused largely on pricing,
is placing increased emphasis on the
value of medicines. This scrutiny is likely
to continue from many stakeholders,
including policymakers and legislators.
Proposed policy and legislative changes
which are being considered, include
different approaches to price controls on
medicines (including price transparency),
potential changes to government regulated
programmes (such as Medicare Part
B, Medicare Part D, Medicaid or other
provisions under the ACA), and changes
affecting the commercial importation of
medicines into the US.
While widespread adoption of a broad
national price-control scheme in the near
future is unlikely, we expect the increased
focus on pharmaceutical prices and their
impact on healthcare costs to continue for
the foreseeable future.
For more information on pricing pressure and
the ACA, please see Marketplace from page 11
Europe
The total European pharmaceutical market
was worth $201 billion in 2016. We are
the twelfth largest prescription-based
pharmaceutical company in Europe (see
Market definitions on page 239) with a
2.4% market share of pharmaceutical
sales by value.
In 2016, our sales in Europe decreased by
5% at actual rate of exchange (3% at CER)
to $5,064 million (2015: $5,323 million).
Key drivers of the decline, leaving aside
the impact of divestments, such as the
anaesthetics portfolio, were continued
competition from Symbicort analogues,
ongoing volume erosion of Pulmicort,
Seroquel XR and Nexium following loss of
exclusivity, and pricing and volume pressure
for Crestor. The continued macroeconomic
environment, increased government
interventions (for example, on price and
volume) and parallel trade across markets
also affected sales. Despite these
conditions, we continue to launch innovative
medicines across Europe and saw
significant progress within our Growth
Platforms, in particular with Forxiga, Xigduo,
Brilinta, Lynparza and Tagrisso.
moderated while the sales growth from
new products such as Brilinta and the
Diabetes portfolio has started to pick up.
Brilinta and the Diabetes portfolio grew by
18% (actual and CER) and 57% (actual
and CER) respectively.
* Established ROW comprises Australia, Canada,
New Zealand and Japan.
Established Rest of World (ROW)*
In 2016, sales in Japan increased by 8% at
actual rate of exchange (decreased 3% at
CER) to $2,184 million (2015: $2,020 million),
as a result of the biennial National Health
Insurance (NHI) price cuts effective from
1 April 2016. We experienced price cuts
of approximately 5% on our 2016 revenue.
Despite the NHI price cuts, across our
Growth Platforms we saw strong volume
growth. Particularly strong performance
from Nexium and Crestor, and the Diabetes
franchise helped to drive this volume
growth, offsetting generic competition.
In addition, in May 2016, we launched
Tagrisso in Japan which generated
$82 million of sales and we expect will
continue to be a major driver of growth.
We now hold ninth position in the ranking
of pharmaceutical companies by sales of
medicines in Japan. Despite the biennial
government price cuts and increased
intervention from the government to rapidly
increase the volume share of generic
products, Japan remains an attractive
market for innovative pharmaceuticals.
Canada has a mixed public/private payer
system for medicines that is funded by the
provinces, insurers and individual patients.
It has also now become common for public
payers to negotiate lower non-transparent
prices after they have gone through a review
by the Canadian Agency for Drugs and
Technology in Health, a health technology
assessment body. Most private insurers
pay full price although there is increasing
pressure to achieve lower pricing. Overall,
the split for AstraZeneca’s portfolio is 65%
funded by private payers and 35% with
public plans.
Our sales in Australia and New Zealand
declined by 12% at actual rate of exchange
(10% at CER) in 2016. This was primarily
due to the continued erosion of Crestor,
Atacand and Nexium by generic medicines.
Sales declined less in 2016 than in 2015
as the pace of generic erosion has been
Emerging Markets: expansion
and collaboration
Emerging Markets, as defined in Market
definitions on page 239, comprise
various countries with dynamic, growing
economies. As outlined in Marketplace from
page 11, these countries represent a major
growth opportunity for the pharmaceutical
industry due to strong demand and sound
economic fundamentals. Emerging Markets
are not immune, however, to economic
downturn. Market volatility is higher than in
Established Markets and various political and
economic challenges exist. These include
regulatory and government interventions.
With revenues of $5,794 million,
AstraZeneca was the fifth largest
multinational pharmaceutical company,
as measured by prescription sales, and the
third fastest-growing top 10 multinational
pharmaceutical company in Emerging
Markets in 2016.
In China, AstraZeneca is the second largest
pharmaceutical company in the hospital
sector, as measured by sales. Sales in
China in 2016 increased by 4% at actual rate
of exchange (10% at CER) to $2,636 million
(2015: $2,530 million). We delivered sales
growth above the growth rate of the hospital
market sector through strategic brands
investment, systematic organisational
capability improvements and long-term
market expansion programmes in core
therapy areas. The industry growth rate
is expected to be moderated to high
single digits, impacted by increased price
pressure and hospital cost containment.
Nevertheless, the healthcare environment
in China remains dynamic. Opportunities
are arising from incremental healthcare
investment, strong underlying demand and
the emergence of innovative medicines.
Growth drivers for Emerging Markets
include our new medicines, notably Brilinta
and Forxiga, and our Diabetes, Respiratory,
Oncology and CV portfolios. To educate
50
AstraZeneca Annual Report and Form 20-F Information 2016
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understand their priorities and
requirements, and play a leading role in
projects to align better the requirements
of regulatory and health technology
assessment (HTA) agencies or other
organisations that provide value
assessment of medicines. For example,
we have a leading role in the European
IMI ADAPT-SMART programme for
exploring adaptive licensing.
> We pursue a flexible pricing approach
that reflects the wide variation in global
healthcare systems. We have developed
patient access programmes that are
aligned with the ability to pay of patients
and healthcare systems. We are
committed to the appropriate use
of managed entry schemes and the
development of real world evidence
and we are investigating innovative
approaches to the pricing of medicines,
such as payment for outcomes received
by the patient and healthcare system.
Pricing and access to healthcare
We continue to make our medicines
affordable to more people on a
commercially and socially sustainable
basis. As, on average, almost half of
medicine funding in emerging countries
is paid for by the user or their families,
we base our approach in these markets
on an understanding of their economic
circumstances and the burden placed
on them by health costs. Our new pricing
strategy addressing out-of-pocket funding,
developed in 2016, focuses on two of our
therapy areas, Respiratory and CVMD,
and uses socio-economic evaluation on
a country-by-country basis to determine
affordable price points for self-pay patients
based on ability to pay.
Our efforts to price medicines affordably
were seen by the Access to Medicine
Foundation as an important step and,
together with our approach to IP and our
capacity building strategy in markets such
as Brazil and China, contributed to our rise
from 15th place in 2014 to 7th place in 2016
in the Foundation’s biennial Access to
Medicine Index. For more information on
our initiatives, see Healthy Heart Africa
on page 49, affordability programme in
Brazil on this page, and our Young Health
Programme on page 53. We will continue
to work with partners and patients to
develop sustainable access initiatives for
as many patients as possible.
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(cid:76)(cid:81)(cid:71)(cid:76)(cid:89)(cid:76)(cid:71)(cid:88)(cid:68)(cid:79)(cid:350)(cid:86)(cid:3)(cid:68)(cid:69)(cid:76)(cid:79)(cid:76)(cid:87)(cid:92)(cid:3)(cid:87)(cid:82)(cid:3)(cid:83)(cid:68)(cid:92)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:85)(cid:76)(cid:70)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)
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(cid:21)(cid:17)(cid:24)(cid:3)(cid:80)(cid:76)(cid:79)(cid:79)(cid:76)(cid:82)(cid:81)(cid:3)(cid:83)(cid:68)(cid:87)(cid:76)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:86)(cid:76)(cid:81)(cid:70)(cid:72)(cid:3)(cid:76)(cid:87)(cid:3)(cid:90)(cid:68)(cid:86)(cid:3)(cid:79)(cid:68)(cid:88)(cid:81)(cid:70)(cid:75)(cid:72)(cid:71)
(cid:76)(cid:81)(cid:3)(cid:21)(cid:19)(cid:19)(cid:27)(cid:17)
2.5m
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helped some 2.5 million patients.
physicians about our broad portfolio, we
are selectively investing in sales capabilities
where opportunities from unmet medical
need exist. We are also expanding our
reach through multi-channel marketing
and external partnerships.
Pricing and delivering value
Our medicines help treat unmet medical
need, improve health and create economic
benefits. Effective treatments can lower
healthcare costs by reducing the need for
more expensive care, preventing more
serious and costly diseases and increasing
productivity. Nevertheless, and as outlined
in Marketplace from page 11, we are acutely
aware of the economic challenges faced by
payers and remain committed to delivering
value. We are committed to a pricing policy
for our medicines based on four principles:
> We determine the price of our medicines
while considering their full value for
patients, payers and society. The
agreement on price involves many
national, regional and local stakeholders,
reflecting factors such as clinical benefit,
cost effectiveness, improvement to life
expectancy and quality of life.
> We aim to ensure the sustainability
of both the healthcare system and
our research-led business model. We
believe we share a collective responsibility
with healthcare providers and other
stakeholders to work together to enable
an efficient healthcare system for patients
today and support a pipeline of new
medicines for patients tomorrow.
> We seek to ensure appropriate patient
access to our medicines. We work
closely with payers and providers to
AstraZeneca Annual Report and Form 20-F Information 2016
51
Strategic Report Business Review
Business Review continued
3. Be a great place
to work
Great people (see Employees from
page 54) are central to our success
and being a great place to work is
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the talents of our people. We promote
a culture, both for employees and
those third parties with whom we
work, that delivers sustainable
good performance and long-term
business success.
Overview
> We continued to train employees on
the ethical standards that govern the
way we operate
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external sales and marketing regulations
or codes
> We carried out 8,977 risk assessments
on third parties as part of our risk
management process
> We are developing a health and wellbeing
framework based on the WHO Healthy
Workplace Model
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continents were provided with skills and
information to improve their health
Sales and marketing ethics
We are committed to employing high ethical
standards of sales and marketing practice
worldwide, which are detailed in our Code
of Conduct and supporting Global Policies
on Ethical Interactions. Approximately
34,100 employees are engaged in our
Commercial activities. We report publicly
on the number of:
> confirmed breaches of external sales
and marketing codes
> breaches of our Code of Conduct, Global
Policies or supporting requirements by
employees and third parties in our
Commercial Regions, and associated
corrective actions.
Code of Conduct; one is for new starters
to introduce the Code, while the other is
the annual training for all employees, which
serves as an important reminder of our key
commitments and principles.
During 2016, we continued to train
employees on the ethical standards that
govern the way we operate. We maintain
a robust compliance programme in our
efforts to ensure that there is compliance
with all applicable laws, regulations and
adopted industry codes, and that our
business is operating with high ethical
standards. Our compliance programme
is delivered by dedicated compliance
professionals who advise on and monitor
adherence to our Code of Conduct, Global
Policies and supporting requirements.
These professionals also support our line
managers locally, seeking to ensure that
their staff meet our high ethical standards.
A network of nominated signatories
reviews our promotional materials and
activities against applicable requirements.
In 2016, audit professionals in Internal
Audit Services also conducted compliance
audits on selected marketing companies.
When engaging third parties for sales and
marketing activities or other services, we
are committed to working with only those
third parties who embrace high standards of
ethical behaviour consistent with our own.
We identified six confirmed breaches of
external sales and marketing regulations
or codes in 2016 (2015: 11).
There were 1,729 instances, most of them
minor, of non-compliance with our Code
of Conduct, Global Policies or supporting
requirements in our Commercial Regions,
including instances by employees and third
parties (2015: 1,749).
We removed a total of 222 employees and
third parties from their roles as a result of
these breaches (a single breach may involve
more than one person). We also formally
warned 429 others and provided further
guidance or coaching on our policies to
1,283 more. The most serious breaches
were raised with the Audit Committee.
Alongside our Company Values, our Code
of Conduct guides us on how we can make
the best day-to-day choices on behalf
of AstraZeneca and act in a consistent,
responsible way, worldwide. There are two
mandatory training courses dedicated to the
The US Foreign Corrupt Practices Act
investigation involving AstraZeneca was
resolved in 2016 following a civil settlement
agreed with the SEC; the DOJ closed its
investigation without taking action against
the Company. More information about
material legal proceedings can be found
in Note 28 to the Financial Statements
from page 185.
Transparency reporting
AstraZeneca is committed to the highest
standards of conduct in all of our operations,
including transparency in how we partner
with physicians and medical institutions.
In the US, our external transparency
reporting meets the requirements of the
Physician Payments Sunshine Act (Open
Payments), as well as relevant state
transparency laws. In Europe, AstraZeneca’s
reporting meets the requirements of the
European Federation of Pharmaceutical
Industries and Associations (EFPIA)
Disclosure Code, as well as applicable
local transparency requirements.
Working with suppliers
With most of our API manufacturing
outsourced, we need an uninterrupted
supply of high-quality raw materials. We
therefore place great importance on our
global procurement policies and integrated
risk management processes. We purchase
materials from a wide range of suppliers
and work to mitigate supply risks, such as
natural or man-made disasters that disrupt
supply chains or the unavailability of raw
materials. Contingency plans include using
dual or multiple suppliers where appropriate,
maintaining adequate stock levels and
working to mitigate the effect of pricing
fluctuations in raw materials.
We also seek to manage reputational
risk. Our ethical standards are integral to
our procurement and partnering activities
and we continuously monitor compliance
through assessments and improvement
programmes. We work only with those
suppliers whose standards of ethical
behaviour are consistent with our own.
We will not use suppliers who are unable
to meet our standards.
To achieve this, we have an established
process for third party risk management.
This process assesses risk based upon
defined criteria. These include risks related
to bribery and corruption, data privacy,
the environment and wages. Each step
of the process provides an additional level
of assessment, and we conduct more
detailed assessments on those relationships
identified as higher risk. Through this
52
AstraZeneca Annual Report and Form 20-F Information 2016
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Program. Additionally, we donated over
$20 million in products across multiple
therapeutic areas to our NGO partners
AmeriCares and Direct Relief International
in support of public health needs and
disaster relief.
Young Health Programme
We continued to develop the three strands
of our Young Health Programme (YHP):
on-the-ground programmes; advocacy;
and research and evidence generation.
Our on-the-ground programmes focus
on the primary prevention of NCDs and
associated adolescent risk behaviours.
From 2010 to 2016, the programme has
provided over 1.6 million young people in
communities across five continents with
the skills and information they need to
improve their health. Over 47,000 of these
young people have been trained to share
this health information with their peers and
the community. The programmes have also
trained more than 12,600 frontline health
workers in adolescent health. 2016 saw
the launch of a programme in Kenya, the
extension of the India programme to 2020
and a new programme in Canada. Further
programmes are in development for 2017.
Further information on YHP can be found on its
website, www.younghealthprogrammeyhp.com
Disaster relief
The British Red Cross continues to act as
our global disaster relief partner, channelling
the bulk of our disaster relief donations.
In addition to the charitable donations
referenced in Community investment above,
in July 2016 we donated $200,000 via the
British Red Cross to the Kuala Lumpur
Emergency Response Unit, and $25,000 to
replenish stocks of hygiene kits at the British
Red Cross/Crescent Panama Warehouse
following Hurricane Matthew.
risk-mitigation process, we seek to better
understand the partner’s risk approach and
seek to ensure the partner understands and
can meet our standards. We conducted a
total of 8,977 assessments in 2016, taking
our total number of assessments to 21,622
since May 2014. Of these, 6,622 were in
the Asia Pacific region, 6,488 in Europe and
5,712 in the Americas. The remaining 2,800
assessments relate to global suppliers and
those based in the Middle East and Africa.
In 2016, we conducted 66 audits on
high-risk suppliers, seeking to ensure
that they employ appropriate practices
and controls. Thirty two percent of
suppliers met our expectations, with a
further 42% implementing improvement
plans to address minor instances of
non-compliance. Through our due diligence
process, we rejected 40 suppliers because
of reputational concerns.
Safety, health and wellbeing
We work to promote a safe, healthy and
energising work environment for employees
and partners. As outlined in our Safety,
Health and Environment (SHE) strategy
on page 45, we have established a set of
safety, health and wellbeing targets aimed
at supporting our people and keeping
AstraZeneca among the sector leaders
in SHE performance.
We made good progress against our
new strategic targets in 2016, achieving a
16% reduction in the reportable injury rate
and a 12% reduction in vehicle collision
rate from 2015 baseline. Building on our
previous success in establishing a culture
of health and wellbeing, we are developing
a health and wellbeing framework, based
21,000
Carried out more than 21,000
supplier assessments since May 2014.
on the World Health Organization’s Healthy
Workplace Model, which will give sites
and marketing companies a blueprint for
continuous improvement in this area.
In 2016, we carried out a number of
activities and initiatives focused on delivery
of improvements in key areas of concern,
including driver safety, fall prevention,
behavioural SHE, risk management,
industrial hygiene and stress management.
We also continued to focus on learning from
incidents, using a dedicated website where
all employees can access the learning to
help ensure incidents are not repeated.
Vehicle collisions
Year
2016
2015
Reportable injuries
Year
2016
2015
Collisions
per million km
3.62
4.13
Reportable
injury rate
per million
hours worked
1.45
1.73
Target
4.00
5.60
Target
1.64
N/A
Community investment
Our global community investment strategy
focuses on healthcare in the community
and science. For example, 2016 was the
sixth year of our partnership with the UK
educational charity Career Ready to support
increased participation by 16- to 19-year-
olds in science, technology, engineering
and maths subjects.
In 2016, we spent a total of approximately
$501 million (2015: approximately
$680 million) on community investment
sponsorships, partnerships and charitable
donations worldwide, including our
product donation and patient assistance
programmes which make our medicines
available free of charge or at reduced prices.
In 2016, we provided more than $466 million
(2015: over $617 million) in savings to almost
200,000 patients in the US and Puerto Rico
through our AZ&Me Prescription Savings
AstraZeneca Annual Report and Form 20-F Information 2016
53
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Iff wwee are to acchhieve our straatteegic priorriitties, we need
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aarree oour grreeatest asset but we alsso reelly on oour
intellectuaall property and our R&&D iinnvestmmenntt, our
manufaaccttuuring resources aanndd oour iinformmaattiioonn serviccees
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Overview
> 59,700 employees in more than 100 countries
> People strategy built around four key pillars: build and develop
organisations and capabilities; develop a strong and diverse pipeline
of leaders; drive a vibrant, high-performing culture; and generate a passion
for people development
> (cid:38)(cid:82)(cid:80)(cid:80)(cid:76)(cid:87)(cid:3)(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:85)(cid:72)(cid:86)(cid:82)(cid:88)(cid:85)(cid:70)(cid:72)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)(cid:72)(cid:86)(cid:87)(cid:68)(cid:69)(cid:79)(cid:76)(cid:86)(cid:75)(cid:76)(cid:81)(cid:74)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:71)(cid:72)(cid:73)(cid:72)(cid:81)(cid:71)(cid:76)(cid:81)(cid:74)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:83)(cid:68)(cid:87)(cid:72)(cid:81)(cid:87)(cid:3)
and related IP protections for inventions
> 31 sites in 18 countries where we are working on the development,
manufacture and supply of our products
> Launched our Operations 2020 strategy to enhance supply capabilities
in order to respond better to patient and market needs
g,
hree strategic R&D centres: in the US (Gaithersburg, MD); UK
g
);
(
> T
(Cambridge); and Sweden (Gothenburg). A total of nine R&D sites in
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> Our vision for IT focuses on areas that will enable competitive advantage
for us
> Embedding our 2025 Safety, Health and Environment strategy into
our business
54
AstraZeneca Annual Report and Form 20-F Information 2016
Employees
To achieve our strategic priorities,
we continue to acquire, retain and
develop a talented and diverse
workforce united in the pursuit
of our Purpose and Values.
Overview
> Hired 9,200 permanent employees
to help us achieve our strategic priorities
> Piloted an online Leading People
development experience
> Established a global target for all
employees to have a development
conversation with their manager
and associated development plan
> Increased the gender diversity
of our leadership
> Piloted a global Women as Leaders
programme
We value the talents and skills of our
employees and our people strategy
supports our strategic priority of being
a great place to work.
Build and develop organisations
and capabilities
During 2016, we hired 9,200 permanent
employees. An additional 200 employees
joined us through acquisitions, most
notably Takeda and Acerta Pharma.
We are committed to hiring and promoting
talent ethically and in compliance
with applicable laws. Our policies and
procedures are designed to help protect
against discrimination on any grounds
(including disability) and cover recruitment
and selection, performance management,
career development and promotion,
transfer, training, retraining (including
retraining, if needed, for people who have
become disabled), and reward. To help
deliver our strategic priorities, we are
identifying and recruiting emerging talent, as
well as investing in internships and
recruitment opportunities globally. For
example, we conduct a global programme
to hire recent graduates for our
procurement, quality, engineering, IT and
supply chain functions. We also have a
graduate programme for IMED, which
complements our established IMED Post
Doctorate Programme for researcher
recruitment. Additionally, we offer a 12-week
internship opportunity for business school
students to contribute to key initiatives in our
Oncology therapeutic area.
Hiring over recent years means that
employees with less than two years’
service now represent 30% of our global
workforce (up from 20% in 2012). This
provides a greater balance in terms of
refreshing talent and retaining organisational
experience. The composition of our
international workforce has also changed
with our business focus. This can be seen
in the Sales and Marketing figures to the
right, which shows a greater concentration
in Emerging Markets.
Voluntary employee turnover increased
marginally to 9.6% in 2016 from 8.6% in
2015 (restated 2015 number). The voluntary
employee turnover rate among our high
performers also increased in 2016 to 6.1%.
We seek to reduce regretted turnover
through more effective hiring and induction,
high-level reviews of resignations, risk
assessments and retention plans.
Develop a strong and
diverse pipeline of leaders
To foster innovation, we seek to harness
different perspectives, talents and ideas as
well as ensuring that our employees reflect
the diversity of the communities in which
we operate.
During 2016, we implemented new talent
management and succession planning
processes. This focused on the deliberate
identification, sourcing and accelerated
development of our highest potential talent,
seeking to ensure that we have credible
successors with the capabilities and
experiences necessary for our business
critical roles.
Sales and Marketing
workforce
composition (%)
Emerging Markets 57%
Established Markets
43%
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
We continue to focus on diversity and
inclusion with a goal to increase the
presence of women on our leadership
teams. In 2016, we piloted a European
Women as Leaders experience to
support the accelerated development
of high potential women in AstraZeneca.
In 2017, this programme will be offered
globally. As shown in the gender diversity
figure on the next page, women comprise
49.9% of our global workforce. There are
currently three women on our Board (30%).
Below Board level, the representation of
women in senior roles (ie roles at Career
Level F or above which constitute the six
highest bands of our employee population)
increased to 43.2% in 2016, which
exceeded our Scorecard target of 42.5%
for this measure and compares favourably
to external benchmarks.
A global business
59,700
employees by geographical area
13,000
employees
in US
(21.8%)
700
employees
in Canada
(1.2%)
6,500
employees
in UK
(10.9%)
5,700
employees
in Sweden
(9.6%)
1,300
employees
in Russia
(2.1%)
Co-locating around three strategic
R&D centres
> Cambridge, UK (2,000 employees)
> Gaithersburg, Maryland US (2,900 employees)
> Gothenburg, Sweden (2,200 employees)
7,400
employees in
Other Europe
(12.4%)
10,800
employees
in China
(18.1%)
2,900
employees
in Japan
(4.9%)
Employees by
reporting region (%)
US 21.8%
Europe 32.9%
Established
Rest of World 7.7%
Emerging
Markets 37.6%
All numbers as at 31 December 2016
3,000
employees in
Central and
South America
(5.1%)
1,700
employees in
Middle East
and Africa
(2.7%)
5,700
employees in
(cid:50)(cid:87)(cid:75)(cid:72)(cid:85)(cid:3)(cid:36)(cid:86)(cid:76)(cid:68)(cid:3)(cid:51)(cid:68)(cid:70)(cid:76)(cid:430)(cid:70)(cid:3)
(9.6%)
1,000
employees
in Australia
and New Zealand
(1.6%)
AstraZeneca Annual Report and Form 20-F Information 2016
55
Strategic Report Resources Review
Resources Review continued
We continue to develop high-quality leaders.
In 2016, 15% of the approximately 130
leadership roles that report to our senior
leadership team were either promoted into
the leadership population, or moved roles
within the leadership population. To ensure
our senior leadership reflects our diverse
geographic footprint, we track the country
of origin of senior leaders and reflect this
in our diversity targets. In 2016, 14.5% of
leadership roles that report to our senior
leadership team have a country of origin
that is an Emerging Market or Japan (an
increase from 5% in 2012).
Drive a vibrant, high-performing
culture
Continuing our emphasis on high
performance, in 2016, we extended our
single global performance management
framework and approach to cover 94%
of the workforce. We also implemented
a global annual salary and incentive
review process which covers 60% of the
workforce. We require every employee
to have high quality objectives, aligned to
our strategy, which we monitor closely.
Managers are accountable for working with
their employees to develop individual and
team performance targets, and for ensuring
employees understand how they contribute
to our overall business objectives.
Equally important are our performance-
related bonus and incentive plans. We
encourage participation in various employee
share plans, some of which are described
in the Directors’ Remuneration Report
from page 103, and also in Note 27 to the
Financial Statements, from page 182.
Employee opinion surveys help us measure
employee satisfaction and engagement
and how we are doing in our aim of being
a great place to work. Our most recent
survey, carried out in December 2016,
showed a decline compared to the survey
at the start of the year in scores for all
10 items common to both surveys.
Although this might not be unexpected
given the action we are taking to reshape
our business to improve long-term
competitiveness, we are continuing to focus
on improving areas identified in our surveys
as being important drivers of employee
engagement. For example, we are driving
our agenda around people development,
encouraging improved dialogue between
colleagues and their line managers on
development. We have also continued our
efforts to simplify the work environment
for colleagues, whether this be through
simplifying business processes or improving
the IT tools we use in the workplace.
Gender diversity
Board of Directors
of the Company 10
Male 70%
Female 30%
SET* 12
Male 67%
Female 33%
Directors of the
Company’s
subsidiaries* 435
Male 71.7%
Female 28.3%
AstraZeneca
employees 59,700
Male 50.1%
Female 49.9%
* For the purposes of section 414C(8)(c)(ii) of the Companies Act 2006, ‘Senior Managers’ are the SET, the directors of all
of the subsidiaries of the Company and other individuals holding named positions within those subsidiaries.
56
AstraZeneca Annual Report and Form 20-F Information 2016
Generate a passion for
people development
We encourage employees to take
ownership of their own development
and encourage leaders to spend time
supporting their employees’ development.
To support this, in 2016 we implemented
a global platform to increase the visibility
and accessibility of job opportunities.
We strive to attract talent by offering
rewarding careers that connect the potential
of our people with the capabilities required
by our business. We are focusing on
ensuring development opportunities are
available to all employees, alongside our
investment in our highest potential talent.
In 2016, we piloted a new best-practice
technology-enabled leadership experience,
rooted in social learning, with 180 supply
and manufacturing leaders based in West
Chester and Mount Vernon in the US, and
Vorsino in Russia. This experience can be
accessed on any device at any time, with
the goal of implementing global technology
enabled development programmes in 2017.
Human rights
We are committed to respecting and
promoting international human rights – not
only in our own operations, but also in our
wider spheres of influence (such as our
third party providers). To that end, we
integrate human rights considerations into
our policies, processes and practices.
We are also committed to ensuring that
there is no modern slavery or human
trafficking in our supply chains or any part
of our business. Our full statement required
under section 54 of the UK Modern Slavery
Act will be published on our website,
www.astrazeneca.com, later in 2017.
We support the principles set out in the
United Nations Universal Declaration of
Human Rights and the International Labour
Organization’s (ILO) standards on child
labour and minimum wages. We are also
members of the United Nations Global
Compact on Human Rights.
In 2016, we began conducting our third
biennial Human Rights labour review in
all countries where we have a presence.
The review focuses on ILO core themes,
including freedom of association and
collective bargaining, child labour,
discrimination, working hours and wages,
including questions on the Living Wage.
Where a gap to ILO minimum standards
is identified, we will put in place local plans
to close those gaps. In 2016, AstraZeneca
became accredited with the Living Wage
Foundation in the UK and will treat this as
an experience to be evaluated alongside
all other associated evidence in respect
of seeking a global solution, for example,
monitoring impact on our cost base.
Managing change
In 2013, we announced plans to invest in
three strategic R&D centres as outlined
in Organisation on page 42. This affected
employees in the US and the UK. We
encouraged and supported employees to
relocate and have made good progress. For
example, as at 31 December 2016, 2,000
employees were working in Cambridge and,
of these employees, 500 have relocated
from other sites in the UK. In addition to the
750 employees hired in 2015 and 2016, we
expect to hire a further approximately 350
employees in Cambridge in 2017. We are
using interim infrastructure in and around
Cambridge to house these employees
until our new site is ready. For employees
who do not accept offers to relocate to
Cambridge, we provide career support,
outplacement support and competitive
severance packages.
For more information on Cambridge, see page
7; on our restructuring programme, please see
Restructuring from page 69 and Financial
Review from page 62
Employee relations
We seek to follow a global approach
to employee relations guided by global
employment principles and standards,
local laws and good practice. We work to
develop and maintain good relations with
local workforces and work closely with
our recognised national trade unions.
We also regularly consult with employee
representatives or, where applicable, trade
unions, who share our aim of retaining key
skills and mitigating job losses.
S
t
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Intellectual Property
Discovering and developing
(cid:80)(cid:72)(cid:71)(cid:76)(cid:70)(cid:76)(cid:81)(cid:72)(cid:86)(cid:3)(cid:85)(cid:72)(cid:84)(cid:88)(cid:76)(cid:85)(cid:72)(cid:86)(cid:3)(cid:68)(cid:3)(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)
investment of resources by research-
based pharmaceutical companies.
The process can take a decade or
more. For this to be a viable
investment, new medicines must be
safeguarded from being copied with
a reasonable amount of certainty for
a reasonable period of time.
Our industry’s principal economic safeguard
is a well-functioning patent system that
recognises our efforts and rewards
innovation with appropriate protection –
and allows time to generate the revenue
we need to reinvest in pharmaceutical
innovation. Patent rights are limited by
territory and duration. A significant portion
of a patent’s duration can be spent during
R&D, before it is possible to launch the
protected product. Therefore, we commit
significant resources to establishing and
defending our patent and related IP
protections for inventions.
Patent process
We file patent protection applications
for our inventions to safeguard the large
investment required to obtain marketing
approvals for potential new drugs. As we
further develop a product and its uses,
these new developments may necessitate
new patent filings. We apply for patents
through government patent offices around
the world. These assess whether our
inventions meet the strict legal requirements
for a patent to be granted. Our competitors
can challenge our patents in patent offices
and/or courts. We may face challenges early
in the patent application process and
throughout a patent’s life. The grounds for
these challenges could be the validity of a
patent and/or its effective scope and are
based on ever-evolving legal precedents.
We are experiencing increased challenges
in the US and elsewhere in the world (such
as in Australia, Brazil, Canada, China,
Europe and Japan) and there can be no
guarantee of success for either party in
patent proceedings. For information about
third party challenges to patents protecting
our products, see Note 28 to the Financial
Statements from page 185. For more
information on the risks relating to patent
litigation and early loss and expiry of
patents, please see Risk from page 214.
The basic term of a patent is typically
20 years from the filing of the patent
application with the relevant patent
office. However, a product protected by
a pharmaceutical patent may not be
marketed for several years after filing,
due to the duration of clinical trials and
regulatory approval processes. Patent Term
Extensions (PTE) are available in certain
major markets, including the EU and the
US, to compensate for these delays.
The term of the PTE can vary from zero
to five years, depending on the time taken
to obtain any marketing approval. The
maximum patent term, when including PTE,
cannot exceed 15 years (EU) or 14 years
(US) from the first marketing authorisation.
Patent expiries
The tables on pages 211 to 213 set out
certain patent expiry dates and sales for
our key marketed products.
Other exclusivities
In addition to patent protection, regulatory
data protection (RDP or ‘data exclusivity’) is
an important IP right, which arises in respect
of data which is required to be submitted
to regulatory authorities to obtain marketing
approvals for our medicines. Significant
investment is required to generate such
data (for example, through conducting
global clinical trials) and this proprietary data
is protected from use by third parties (such
as generic manufacturers) for a number of
years in a limited number of countries. The
period of such protection, and the extent
to which it is respected, differs significantly
among countries. RDP is an important
protection for our products, and we strive to
enforce our rights to it, particularly as patent
rights are increasingly being challenged.
The RDP period starts from the date of the
first marketing approval from the relevant
regulatory authority and runs parallel to any
patent protection. RDP generally expires
prior to patent expiry in all major markets.
AstraZeneca Annual Report and Form 20-F Information 2016
57
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If a product takes an unusually long time
to secure marketing approval, or if patent
protection has not been secured, has
expired or has been lost, then RDP may be
the sole IP right protecting a product from
copying. Generic manufacturers should not
be allowed to rely on AstraZeneca’s data to
support the generic product’s approval or
marketing until the RDP right has expired.
In the EU, the RDP period is eight years
followed by two years’ marketing exclusivity.
In the US, new chemical entities (NCEs) are
entitled to a period of five years’ exclusivity
under the Federal Food, Drug and Cosmetic
Act. This period of exclusivity runs parallel
to any pending or granted patent protection
and starts at the approval of the new
application. As with RDP, there are
circumstances where this protection could
be the sole IP right protecting a product
from being copied. Further, under the
Biologics License Application process, the
FDA will grant 12 years’ data exclusivity for a
new biologic to an innovator manufacturer.
Under Orphan Drug laws in the EU and US,
exclusivity is granted to an innovator who
gains approval for a pharmaceutical product
developed to treat a rare disease. What
qualifies as a rare condition differs between
the EU and US. Qualifying Orphan Drugs
are granted 10 years’ market exclusivity in
the EU and seven years’ market exclusivity
in the US.
Manufacturing
Our 2020 strategy provides a focus
for our investments to help ensure
we are able to respond to patient and
market needs for our medicines.
Overview
> Operations 2020 strategy started with
a number of global initiatives in 2016
> Biologics manufacturing footprint
increased in preparation for new product
launches
> The Pharmaceutical Technology &
Development teams have been integrated
into Operations to enhance the way we
design, develop, manufacture and launch
new products
Strategy
Operations 2020 strategy was launched in
2015 to enhance supply capabilities in order
to respond better to patient and market
needs. Our strategy focuses on supporting
the delivery of our new product launches,
strengthening our science and technology
capabilities across the globe, creating a
more agile and flexible supply chain, and
embedding Lean principles throughout our
network. Our objective is to be recognised
as a leader in biopharmaceutical supply
chain by the end of 2020.
Compulsory licensing
Compulsory licensing (where a Patent
Authority imposes a licence on the Patentee)
is on the increase in certain markets in
which we operate. We recognise the right of
developing countries to use the flexibilities in
the World Trade Organization’s Agreement
on Trade-Related Aspects of Intellectual
Property Rights (including the Doha
amendment) in certain circumstances, such
as a public health emergency. We believe
this should apply only when all other ways
of meeting the emergency needs have
been considered and where healthcare
frameworks and safeguards exist to ensure
the medicines reach those who need them.
Quality, regulation and compliance
We are committed to high product
quality, which underpins the safety and
efficacy of our medicines. We maintain
a comprehensive quality management
system to assure compliance and quality.
Similarly, we set strict standards for safety,
health and environment at each of our sites.
Manufacturing facilities and processes
are subject to rigorous and continuously
evolving regulatory standards. They
are subject to inspections by regulatory
authorities, who are authorised to mandate
improvements to facilities and processes,
halt production and impose conditions for
production to resume.
In 2016, we hosted 33 independent
inspections from 18 regulatory authorities.
We reviewed observations from these
inspections together with the outcomes
of internal audits and, where necessary,
implemented improvement actions.
We are committed to maintaining the
highest ethical standards and compliance
with internal policies, laws and regulations.
We review and comment upon evolving
national and international compliance
regulations through our membership of
industry associations including IFPMA,
EFPIA and PhRMA.
Pharmaceutical Technology &
Development (PT&D)
In January 2016, the integration of PT&D into
Global Operations commenced to support
further and accelerate successive new
product launches, new device platforms
and manage an increase in the overall
product portfolio complexity. The integration
is also expected to enhance collaboration
and alignment and our focus on late-stage
development, adding substantial scientific
expertise and leadership to Operations.
We are actively working on over 150 drug
projects across our R&D and Commercial
portfolios, supporting more than 300
AstraZeneca clinical studies worldwide
and an additional 400 External Sponsored
Research studies. We also support over 100
in-line brands and small molecule products.
Our continued science and technology
innovation allows us to enable and
differentiate products including Lynparza,
Tagrisso, acalabrutinib, Brilinta and new
respiratory products such as PT010 as they
are introduced into the marketplace and
ultimately into the hands of patients globally.
Manufacturing capabilities
Our principal tablet and capsule formulation
sites are in the UK, Sweden, China,
Puerto Rico and the US, with local/regional
supply sites in Russia, Japan, Indonesia,
Egypt, India, Germany, Mexico, Brazil,
Argentina and Algeria. We also have major
formulation sites for the global supply of
parenteral and/or inhalation products in the
US, Sweden, France, Australia and the UK.
Most of the manufacture of API is delivered
through the efficient use of external sourcing
that is complemented by internal capability
in Sweden.
58
AstraZeneca Annual Report and Form 20-F Information 2016
At the end of 2016, approximately 12,200
R&D resources
people were employed at 31 Operations
sites in 18 countries.
We have approximately 8,400
employees in our R&D organisation,
working in various sites around
the world.
S
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Our small molecule sites are located in
the UK (Alderley Park, Cambridge and
Macclesfield), Sweden (Gothenburg), the
US (Gaithersburg, Maryland, Waltham,
Massachusetts and California), Japan
(Osaka) and China (Shanghai). Our biologics
sites are located in the UK (Cambridge)
and in the US (Gaithersburg, Maryland
and California). Our Gaithersburg, Maryland
US; Cambridge, UK; and Warsaw, Poland
sites focus on late-stage development for
small molecules and biologics across our
entire portfolio.
In 2016, R&D expenditure was $5,890
million in our R&D organisation (2015:
$5,997 million; 2014: $5,579 million),
including core R&D costs of $5,631 million
(2015: $5,603 million; 2014: $4,941 million).
In addition, we spent $821 million on
acquiring product rights (such as
in-licensing) (2015: $1,341 million;
2014: $907 million). We also invested
$178 million on the implementation of
our R&D restructuring strategy (2015:
$258 million; 2014: $497 million). The
allocations of spend by early-stage and
late-stage development are presented
in the R&D spend analysis table below.
R&D spend analysis
Discovery and
early-stage
development
Late-stage
development
2016
2015
2014
36%
39%
47%
64%
61%
53%
InInveveeststs ininng g fofor rr thththe ee fufuuututut rere: : ::
MaManuufactctctururining bib olologgogicics
We are investing in our supply network,
with a focus on increasing production
capacity to support the growing demand
for biologics. The addition of three new
high-tech biologics manufacturing
facilities (Gärtuna in Sweden (above), and
Boulder and Longmont, both in Colorado
in the US) to our supply network will
leave us well-positioned for the future.
For biologics, our principal commercial
manufacturing facilities are in the US
(Frederick, Maryland; Greater Philadelphia,
Pennsylvania; Boulder and Longmont,
Colorado), the UK (Speke), and the
Netherlands (Nijmegen) with capabilities in
process development, manufacturing and
distribution of biologics, including global
supply of MAbs and influenza vaccines.
We are developing our manufacturing
capability in biologics and expect our bulk
manufacturing facility in Boulder, Colorado
US to be licensed for commercial
production by the end of 2017. In Sweden,
we expect our new $285 million biologics
manufacturing facility to be available for
clinical trial programmes by the end of
2018 and fully operational by 2019. These
projects, in addition to an expansion plan
at Frederick, Maryland US, will increase
production capacity to support the growing
demand for biologics, which represents
about half of our development pipeline. We
acquired our facility in Longmont, Colorado
US, in 2016 which will both support our
operations in Boulder and provide space for
additional biologics expansion as required.
For small molecules we are constructing a
new small scale development and launch
facility alongside our existing manufacturing
facility in Wuxi, China. In addition, regulatory
validation work continues at Vorsino, Russia,
which opened in 2015. First commercial
production commenced in early 2016,
improving our ability to supply local markets.
At the end of 2016, approximately 12,200
people were employed at 31 Operations
sites in 18 countries.
8,400
Around 8,400 employees
in our R&D organisation.
AstraZeneca Annual Report and Form 20-F Information 2016
59
Strategic Report Resources Review
Resources Review continued
Environment
We follow the science to protect
the planet by managing our impact
on the environment across all
our operations.
Overview
> (cid:44)(cid:81)(cid:71)(cid:72)(cid:83)(cid:72)(cid:81)(cid:71)(cid:72)(cid:81)(cid:87)(cid:3)(cid:89)(cid:72)(cid:85)(cid:76)(cid:430)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:82)(cid:73)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:70)(cid:72)(cid:16)(cid:69)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)
climate change targets and commitment
to responsible water stewardship
> 2016 greenhouse gas footprint reduced
by 5%
> 2016 waste management generation
increased by 1%
> 2016 water consumption performance
reduced by 5%
We are working to reduce our greenhouse
gas emissions by, among other things,
investment in improving energy and fuel
efficiency and pursuing lower-carbon
alternatives to fossil fuels, utilising a
hierarchy approach of Avoid-Reduce-
Substitute. During 2016, site energy use
improved to reduce consumption by 0.2%
and procurement of electricity from certified
renewable sources increased to represent
58% of total electricity imports. Our travel
and freight transport emissions decreased
due to reduced business air travel,
increased fuel efficiency of our commercial
sales fleet and continued achievement in
switching freighting of goods from air to sea.
Operational greenhouse gas footprint
emissions (tonnes CO2e)
1,656,917
1,743,199
N/A
37,923
37,510
35,797
3.99
4.21
3.79
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As outlined in Safety, Health and
Environment strategy on page 45, we have
begun work on delivering our 2016 to 2025
Safety, Health and Environment (SHE)
targets. Our 2016 natural resource targets
included reducing:
> operational greenhouse gas footprint by
2% to 1,708,335 tonnes CO2e
> waste generation by 2% to 36,760 tonnes
> water use by 2% to 4.13 million m3.
2016
2015
2014
Waste production (tonnes)
2016
2015
2014
Water use (million m3)
The table to the right provides data on our
global greenhouse gas emissions, waste
production and water consumption for
2016. The data coverage includes 100%
of our owned and controlled sites globally.
2015 data was recalculated to include
acquired sites that form part of the 2016
to 2025 strategy baseline.
2016
2015
2014
We continue to integrate environmental
considerations across a medicine’s entire
life-cycle, from discovery, R&D to
manufacturing, commercialisation and
disposal. This considers the natural
resources used to manufacture our
products and the environmental impact of
our active pharmaceutical ingredients (APIs).
Information technology
and information services
resources
Our continuing vision for IT is to
focus on areas that may provide a
competitive advantage for
AstraZeneca.
At the end of 2016, we successfully
completed our three-year IT Transformation
Programme. The wide-ranging programme
has delivered improved productivity,
efficiency, responsiveness and innovation
allowing us to better support our business
priorities while at the same time significantly
reducing cost.
First, to implement our vision for IT, we seek
to identify, prioritise and drive adoption of
new technologies to support the business
and enable our science. Second, we aim
to make significant investments in data and
analytics to allow the business to manage
information more effectively in order to
drive faster, more effective decision making.
Finally, we seek to drive operational
excellence and improvements in the
performance, stability, security and cost
of the underlying application landscape
and infrastructure of our IT.
Protecting our IT systems, IP and
confidential information against cyberattacks
is a key concern. Our IT organisation
seeks continuous improvement of our IT
protection by developing and implementing
robust, effective and agile risk-based
approaches to protect our resources
and keep pace with the rapidly evolving
cybersecurity risk landscape. To help guard
against cybercrime, we have adopted a
comprehensive cybersecurity process
and policy, which we regularly review and
update. We monitor our systems and data
with sophisticated technology to identify
and address potential weaknesses in the
management of cybersecurity risk.
At the end of 2016, our IT organisation
comprised approximately 3,500 people
across our sites in the UK, Sweden, the US,
and our new technology centres in India
(Chennai) and Mexico (Guadalajara).
60
AstraZeneca Annual Report and Form 20-F Information 2016
Innveeveeststtstinininining gg g g fofofofofor thhee e ee future:
FoFolllll owowwwinininininggggg thththththe e scscieeienncnnnce to protect
thhht e e enennvivirorooor nmnmnn enentt
We were one of only four FTSE 350
companies to have had our climate
change targets approved by the Science
Based Targets initiative which is a
partnership with CDP, the UN Global
Compact, World Resources Institute,
and World Wide Fund for Nature. The
initiative seeks to create a systematic
change in how targets are set, so that
companies contribute their fair share of
the challenging emissions reduction
needed to limit global temperature
increase to under two degrees centigrade.
c ease to u de two deg ees ce t g ade.
S
t
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a
t
e
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R
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o
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We recognise the need to use water
responsibly and, where possible, to
minimise water use in our facilities.
In 2016, we targeted a 2% reduction from
our 2015 water use. In 2016, our water
footprint was 3.99 million m3, a 5%
reduction. This was achieved in part by
investing in water efficiency projects such
as the reclamation and reuse of water
at a number of our manufacturing sites
in Australia and the US. During 2016, our
major sites completed Water Conservation
Plans and we standardised the assessment
of water stress across our network, enabling
prioritisation of water efficiency in areas
where water scarcity is of greatest concern.
We are also working on measuring and
reporting the environmental impact of our
external manufacturing activity and work
to set appropriate environmental targets
with our suppliers. We capture data for
more than 90% (based on spend) of the
globally managed outsourced manufacture
of key intermediates and APIs, formulation
and packaging for our established brands.
Understanding and management of
our external supplier footprint will be a
continued focus of our SHE commitment
going forward.
With regard to pharmaceuticals in the
environment (PIE), we manage the
manufacturing emissions of our APIs
in a responsible manner to ensure that
we do not exceed the safe discharge
standards set for our own manufacturing
sites and those of key suppliers. We review
compliance with these safe discharge
standards annually. Using a concept
called ‘ecopharmacovigilance’, we review
emerging science and literature for new
information that might change the way we
assess and manage any environmental risks
associated with our products. Our proactive
SHE research also addresses some of the
key risks posed by PIE. In 2016, we signed
an industry declaration presented to the
United Nations General Assembly ensuring
the responsible use, patient access and
production of antibiotics to help combat
the threat of antimicrobial resistance.
Further information, including environmental
risk assessment data for our medicines, is
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com/sustainability/environmental-
sustainability.html
Our pMDI inhaler therapy relies on
hydrofluoroalkane (HFA) propellants which
affects our greenhouse gas footprint. While
HFAs have no ozone depletion potential
and a third or less of the global warming
potential than the chlorofluorocarbons they
replace, they are still potent greenhouse
gases. During 2016, we continued to
explore practical opportunities to reduce
the climate impact of these devices while
continuing to fulfil patient needs. Including
emissions from patient use of our inhaler
therapies, our aim by 2016 was to reduce
our operational greenhouse gas footprint
by 2% from our 2015 level. We achieved
this, with our operational greenhouse gas
footprint totalling 1,656,917 metric tonnes
in 2016, a reduction of 5% from our
2015 baseline.
For more information on carbon reporting,
please see Sustainability: supplementary
information from page 231
Waste management is another key
aspect of our commitment to minimise
environmental impact. In 2016, we targeted
a 2% reduction in waste generation from our
2015 baseline. In 2016, our total waste was
37,923 metric tonnes, a 1% increase on
2015. Although we initiated waste reduction
projects, such as major investment to
enable solvent reuse at a Swedish
manufacturing site, these were insufficient
to offset the increase in activity across
our network. While waste prevention
is an essential goal, we seek to maximise
treatment by material recycling and
avoiding landfill disposal when prevention
is impractical.
AstraZeneca Annual Report and Form 20-F Information 2016
61
Strategic Report Financial Review
Financial Review
Product Sales were supplemented by
$1.7 billion of Externalisation Revenue
arising from partnerships including the
global agreement with Aspen for the
commercial rights to the anaesthetics
portfolio and local agreements in China for
Plendil and in the US for Toprol-XL. The level
of sustainable and ongoing income from
such partnerships and collaborations has
continued to increase during 2016.
Excluding the impact of Externalisation
Revenue, the Reported Gross Profit margin
was broadly stable in the year, with lower
restructuring and amortisation charges
offset by the adverse impact from the mix
of sales and a write-down of FluMist
inventory in the US. Excluding the lower
restructuring and amortisation charges,
Core Gross Profit margin declined by
one percentage point to 82%.
Reported Other Operating Income was
$1.7 billion in the year and included receipts
from the divestments of the small molecule
antibiotics business to Pfizer and Rhinocort
Aqua to Cilag.
Reported Operating Profit increased by 19%
(CER: increased by 9%) to $4.9 billion and
Core Operating Profit declined by 3% (CER:
declined by 7%) to $6.7 billion. Reported
earnings per share increased by 24%
(CER: increased by 9%) to $2.77 and Core
earnings per share increased by 1% (CER:
declined by 5%) to $4.31. Both Reported
and Core EPS included a non-recurring
benefit of $0.36, following agreements
between the Canadian tax authority and the
UK and Swedish tax authorities in respect of
transfer pricing arrangements for the period
from 2004 to 2016.
We generated a net cash inflow from
operating activities of $4.1 billion in the year
with a continued improvement in working
capital investment. We maintain a strong,
investment-grade credit rating and, in May,
issued a total of $2.5 billion of loans for
general corporate purposes. We ended
the year with net debt of $10.7 billion.
Marc Dunoyer
Chief Financial Officer
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rr
In 2016, continued growth in Emerging
Markets and Diabetes, coupled with strong
sales of our New Oncology medicines and
further progress for Brilinta, resulted in a 4%
increase (CER: 5% increase) in our Growth
Platform Sales.
However, the continued effect of patent
expiries, in particular the US entry of Crestor
generic medicines, resulted in a decline in
Total Revenue of 7% (CER: decline of 5%) in
the year. Our continued focus on cost
discipline delivered a decrease of 2% (CER:
increase restricted to 2%) in Reported R&D
costs and stable (CER: increase restricted to
5%) Core R&D costs, despite the absorption
of Acerta Pharma and ZS Pharma costs.
The decline of 15% (CER: decline of 12%) in
Reported SG&A costs, which also benefited
from fair value adjustments to long-term
liabilities, and the decline of 12% (CER:
decline of 9%) in Core SG&A costs,
reflected the evolving shape of the business
and efficiency savings. This, combined with
a non-recurring benefit resulting from
agreements on transfer pricing between
various tax authorities, delivered Reported
EPS of $2.77 and Core EPS of $4.31.
Product Sales in Emerging Markets were
stable compared to 2015 (CER: grew
by 6%) in the year at $5.8 billion, against a
background of challenging macro-economic
conditions in Latin America. We have
reduced our activities in Venezuela and
there were also cuts in healthcare spending
in Saudi Arabia. However, China maintained
growth of 4% (CER: growth of 10%), ahead
of the overall market, and Russia grew at 1%
(CER: growth of 13%).
Our Diabetes franchise grew by 9% (CER:
grew by 11%) to $2.4 billion and Farxiga
became our largest-selling diabetes
medicine, consolidating its position as global
leader in the SGLT2 class. Brilinta sales
increased by 36% (CER: increased by 39%)
to $839 million, reflecting updated preferred
guidelines from the American College of
Cardiology and the American Heart
Association. In addition, sales of our New
Oncology medicines reached $664 million
in the year, with Tagrisso and Lynparza
growing strongly. Respiratory declined
by 5% (CER: declined by 3%) in the year,
impacted by US pricing pressure on
Symbicort. Japan Product Sales increased
by 8% (CER: declined by 3%).
Patent expiries continued to impact
negatively in our Established Markets and
more than offset the performance of the
Growth Platforms. US sales fell by 22% to
$7.4 billion and reflected the competition
from generic Crestor medicines that entered
the US market from July and the continued
decline of Nexium sales following the loss of
US exclusivity in 2015. Sales in Europe were
down by 5% (CER: down 3%) and sales in
other Established Markets grew by 2%
(CER: fell by 4%).
62
AstraZeneca Annual Report and Form 20-F Information 2016
Contents
62
63
64
Introduction
Business background and results
overview
Measuring performance
Results of operations – summary
analysis of year ended 31 December 2016 65
70
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72
Financial position
76
Capitalisation and shareholder return
76
Future prospects
76
Financial risk management
Critical accounting policies and estimates 77
81
Sarbanes-Oxley Act Section 404
The purpose of this Financial Review is
to provide a balanced and comprehensive
analysis of the financial performance of the
business during 2016, the cash flow and
liquidity position of the business, the
financial position as at the end of the year,
and the main business factors and trends
which could affect the future financial
performance of the business.
Business background and results
overview
The business background is covered in
the Marketplace section from page 11, the
Therapy Area Review from page 23 and the
Geographical Review from page 226, and
describes in detail the developments in both
our products and the geographical regions
in which we operate.
As described earlier in this Annual Report,
sales of our products are directly influenced
by medical need and are generally paid for
by health insurance schemes or national
healthcare budgets. Our operating results
can be affected by a number of factors
other than the delivery of operating plans
and normal competition, such as:
> The risk of competition from generics
following loss of patent protection or
patent expiry of one of our products or
an ‘at risk’ launch by a competitor or
the launch of a generic competitor in the
same class as one of our products, with
the potential adverse effects on sales
volumes and prices. Details of patent
expiries for our key marketed products
are included in Patent Expiries of Key
Marketed Products from page 211.
> The adverse impact on pharmaceutical
prices as a result of the macroeconomic
and regulatory environment. For instance,
although there is no direct governmental
control on prices in the US, action from
federal and individual state programmes
and health insurance bodies is leading to
downward pressures on realised prices.
In other parts of the world, there is a
variety of price and volume control
mechanisms and retrospective rebates
based on sales levels that are imposed
by governments.
> The timings of new product launches,
which can be influenced by national
regulators, and the risk that such new
products do not succeed as anticipated,
together with the rate of sales growth and
costs following new product launches.
> Currency fluctuations. Our functional
and reporting currency is the US dollar,
but we have substantial exposures
to other currencies, in particular the
euro, Japanese yen, pounds sterling,
Chinese renminbi and Swedish krona.
> Macro factors such as greater demand
from an ageing population and increasing
requirements of Emerging Markets.
Over the longer term, the success of our
R&D is crucial and we devote substantial
resources to this area. The benefits of this
investment are expected to emerge over the
long term and there is considerable inherent
uncertainty as to whether and when it will
generate future products.
The most significant features of our financial
results in 2016 are:
> Total Revenue down 7% to $23,002
million (CER: down 5%). Product Sales
were down 10% (CER: down 8%)
reflecting the entry in the US of multiple
Crestor generic medicines, as well as
the reducing impact of Nexium generic
medicines in the US and the impact of
pricing pressure in the US on Symbicort.
Product Sales of Crestor, Nexium
and Symbicort in the US declined
by 57%, 39% and 18% respectively.
> Revenues of our Growth Platforms
increased 4% (CER: increased 5%) and
constituted 63% of our Total Revenue, with
S
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– Emerging Markets flat at actual
exchange rates (CER: 6% growth)
supported by China, up by 4%
(CER: up by 10%)
– Diabetes up 9% (CER: up 11%), which
included growth of 70% (CER: growth
of 72%) on Farxiga which became
our largest-selling diabetes medicine
– Japan up 8% (CER: down 3%) to
$2,184 million
– Brilinta Product Sales up 36% (CER:
up 39%) to $839 million
– Respiratory down 5% (CER: down 3%)
reflecting an 18% fall in US Product
Sales of Symbicort
– New Oncology Product Sales of
$664 million.
> Reported operating profit was up 19%
(CER: up 9%) to $4,902 million (2015:
$4,114 million). The increase reflected
the reduction in SG&A costs, largely
due to fair value gains on contingent
consideration and lower legal charges.
This reduction in SG&A costs more than
offset the decline in Product Sales, while
we continued to invest in our pipeline and
Growth Platforms.
> Revaluations of contingent consideration
resulted in a reduction of $1,158 million in
SG&A costs in the year, and included a
decrease of $999 million relating to the
acquisition of BMS’s share of the Global
Diabetes Alliance, based on revised
milestone probabilities, and revenue and
royalty forecasts. Total restructuring costs
associated with the global programme
to reshape the cost base of our business
were $1,107 million in 2016.
> Core operating profit was down 3%
(CER: down 7%) to $6,721 million (2015:
$6,902 million).
> Reported operating margin of 21.3% of
Total Revenue was up 4.6 percentage
points (CER: 2.6 percentage points).
Core operating margin was 29.2% of
Total Revenue (2015: 27.9%).
> Reported EPS was up 24% (CER: up 9%)
to $2.77. Core EPS for the full year was
$4.31, up 1% (CER: down 5%).
> Dividends paid amounted to $3,561
million (2015: $3,486 million).
AstraZeneca Annual Report and Form 20-F Information 2016
63
Strategic Report Financial Review
Financial Review continued
Measuring performance
The following measures are referred to in
this Financial Review when reporting on our
performance both in absolute terms, but
more often in comparison to earlier years:
> Reported performance. Reported
performance takes into account all the
factors (including those which we cannot
influence, such as currency exchange
rates) that have affected the results of
our business, as reflected in our Group
Financial Statements prepared in
accordance with IFRSs as adopted by
the EU and as issued by the IASB (IFRS).
> Core financial measures. These are
non-GAAP measures because, unlike
Reported performance, they cannot be
derived directly from the information in
the Group Financial Statements. These
measures are adjusted to exclude certain
significant items, such as
– amortisation and impairment of
intangibles, including impairment
reversals but excluding any charges
relating to IT assets
– charges and provisions related to our
global restructuring programmes (this
includes such charges that relate
to the impact of our global restructuring
programmes on our capitalised
IT assets)
– other specified items, principally
comprising legal settlements and
acquisition-related costs which include
fair value adjustments and the imputed
finance charge relating to contingent
consideration.
In determining the adjustments to arrive
at the Core result, we use a set of
established principles relating to the
nature and materiality of individual
items or groups of items, excluding, for
example, events which (i) are outside the
normal course of business, (ii) are incurred
in a pattern that is unrelated to the trends
in the underlying financial performance of
our ongoing business, or (iii) are related
to major acquisitions, to ensure that
investors’ ability to evaluate and analyse
the underlying financial performance
of our ongoing business is enhanced.
See the 2016 Reconciliation of Reported
results to Core results table on the
opposite page for a reconciliation
of Reported to Core performance.
> Constant exchange rate (CER) growth
rates. These are also non-GAAP
measures. These measures remove
the effects of currency movements
(by retranslating the current year’s
performance at previous year’s
exchange rates and adjusting for other
exchange effects, including hedging).
A reconciliation of the Reported results
adjusted for the impact of currency
movements is provided in the 2016
Reported operating profit table on
the page opposite.
> Gross and operating margin percentages.
These measures set out the progression
of key performance margins and illustrate
the overall quality of the business.
> Prescription volumes and trends for key
products. These measures can represent
the real business growth and the
progress of individual products better and
more immediately than invoiced sales.
> Net funds/debt. This represents our cash
and cash equivalents, current investments
and derivative financial instruments less
interest-bearing loans and borrowings.
We strongly encourage readers of the
Annual Report not to rely on any single
financial measure but to review our financial
statements, including the notes thereto,
and our other publicly filed reports, carefully
and in their entirety.
CER measures allow us to focus on the
changes in revenues and expenses driven
by volume, prices and cost levels relative to
the prior period. Revenues and cost growth
expressed in CER allows management to
understand the true local movement in
revenues and costs, in order to compare
recent trends and relative return on
investment. CER growth rates can be used
to analyse revenues in a number of ways
but, most often, we consider CER growth
by products and groups of products, and by
countries and regions. CER revenues growth
can be further analysed into the impact of
revenues volumes and selling price. Similarly,
CER cost growth helps us to focus on the
real local change in costs so that we can
manage the cost base effectively.
We believe that disclosing Core financial
and growth measures, in addition to our
Reported financial information, enhances
investors’ ability to evaluate and analyse
the underlying financial performance of
our ongoing business and the related key
business drivers. As detailed in our 2012
Annual Report, we revised our definition
of Core financial measures in 2013, with
consistent application thereafter. The
adjustments are made to our Reported
financial information in order to show Core
financial measures that illustrate clearly,
on a year-on-year or period-by-period basis,
the impact on our performance caused by
factors such as changes in revenues and
expenses driven by volume, prices and cost
levels relative to such prior years or periods.
Readers of the Annual Report should
note that Core results cannot be achieved
without incurring the costs that the Core
measures exclude such as:
> Amortisation of intangible assets which
generally arise from business combinations
and individual licence acquisitions.
We adjust for these charges because
their pattern of recognition is largely
uncorrelated with the underlying
performance of the business. However,
a significant part of our revenues could
not be generated without owning the
associated acquired intangible assets.
> Charges and provisions related to our
global restructuring programmes which
can take place over a significant period
of time, given the long life-cycle of our
business. We adjust for these charges
and provisions because they primarily
reflect the financial impact of change
to legacy arrangements, rather than
the underlying performance of our
ongoing business. However, our Core
results do reflect the benefits of such
restructuring initiatives.
It should also be noted that other costs
excluded from our Core results, such
as finance charges related to contingent
consideration will recur in future years
and other excluded items such as
impairments and legal settlement costs,
along with other acquisition-related costs,
may recur in the future.
As shown in the 2016 Reconciliation of
Reported results to Core results table
on the page opposite, our reconciliation
of Reported financial information to Core
financial measures includes a breakdown
of the items for which our Reported financial
information is adjusted and a further
breakdown by specific line item as such
items are reflected in our Reported income
statement. This illustrates the significant
items that are excluded from Core financial
measures and their impact on our Reported
financial information, both as a whole and
in respect of specific line items.
Management presents these results
externally to meet investors’ requirements
64
AstraZeneca Annual Report and Form 20-F Information 2016
for transparency and clarity. Core financial
measures are also used internally in the
management of our business performance,
in our budgeting process and when
determining compensation.
Core financial measures are non-GAAP
measures. All items for which Core financial
measures are adjusted are included in
our Reported financial information as they
represent actual costs of our business in
the periods presented. As a result, Core
financial measures merely allow investors
to differentiate between different kinds
of costs and they should not be used
in isolation. You should also refer to our
Reported financial information in the 2016
Reported operating profit table below and
our reconciliation of Core financial measures
to Reported financial information in the
Reconciliation of Reported results to Core
results table below for our discussion of
comparative Actual growth measures that
reflect all factors that affect our business.
Our determination of non-GAAP measures,
and our presentation of them within this
financial information, may differ from
similarly titled non-GAAP measures
of other companies.
The SET retains strategic management
of the costs excluded from Reported
financial information in arriving at Core
financial measures, tracking their impact
on Reported operating profit and EPS, with
operational management being delegated
on a case-by-case basis to ensure clear
accountability and consistency for each
cost category.
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
Results of operations – summary analysis of year ended 31 December 2016
2016 Reported operating profit
2016
2015 Percentage of Total Revenue
2016 compared with 2015
Growth
due to
exchange
effects
$m
(332)
(18)
(350)
188
(162)
17
257
326
(23)
415
CER
growth
$m
(1,990)
634
(1,356)
332
(1,024)
(4)
(150)
1,373
178
373
Product Sales
Externalisation Revenue
Total Revenue
Cost of sales
Gross profit
Distribution costs
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Operating profit
Net finance expense
Share of after tax losses of joint ventures and associates
Profit before tax
Taxation
Profit for the period
Basic earnings per share ($)
Reported
$m
21,319
1,683
23,002
(4,126)
18,876
(326)
(5,890)
(9,413)
1,655
4,902
(1,317)
(33)
3,552
(146)
3,406
2.77
Reported
$m
Reported
2016
%
Reported
2015
%
Actual
growth
%
CER
growth1
%
(10)
58
(7)
(11)
(6)
(4)
(2)
(15)
10
19
(8)
59
(5)
(7)
(5)
1
2
(12)
12
9
(17.9)
82.1
(1.5)
(25.6)
(40.9)
7.2
21.3
(18.8)
81.2
(1.4)
(24.3)
(44.9)
6.1
16.7
23,641
1,067
24,708
(4,646)
20,062
(339)
(5,997)
(11,112)
1,500
4,114
(1,029)
(16)
3,069
(243)
2,826
2.23
1(cid:3) (cid:36)(cid:86)(cid:3)(cid:71)(cid:72)(cid:87)(cid:68)(cid:76)(cid:79)(cid:72)(cid:71)(cid:3)(cid:82)(cid:81)(cid:3)(cid:83)(cid:68)(cid:74)(cid:72)(cid:3)(cid:25)(cid:23)(cid:15)(cid:3)(cid:38)(cid:40)(cid:53)(cid:3)(cid:74)(cid:85)(cid:82)(cid:90)(cid:87)(cid:75)(cid:3)(cid:76)(cid:86)(cid:3)(cid:70)(cid:68)(cid:79)(cid:70)(cid:88)(cid:79)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:88)(cid:86)(cid:76)(cid:81)(cid:74)(cid:3)(cid:83)(cid:85)(cid:76)(cid:82)(cid:85)(cid:3)(cid:92)(cid:72)(cid:68)(cid:85)(cid:3)(cid:68)(cid:70)(cid:87)(cid:88)(cid:68)(cid:79)(cid:3)(cid:85)(cid:72)(cid:86)(cid:88)(cid:79)(cid:87)(cid:86)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:72)(cid:71)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:70)(cid:72)(cid:85)(cid:87)(cid:68)(cid:76)(cid:81)(cid:3)(cid:72)(cid:91)(cid:70)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:86)(cid:3)(cid:76)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:76)(cid:81)(cid:74)(cid:3)(cid:75)(cid:72)(cid:71)(cid:74)(cid:76)(cid:81)(cid:74)(cid:17)
2016 Reconciliation of Reported results to Core results
Gross profit
Product Sales gross margin %2
Total Revenue gross margin %
Distribution costs
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Operating profit
Operating margin as a % of Total Revenue
Net finance expense
Taxation
Basic earnings per share ($)
2016
Reported
$m
Restructuring
costs
$m
Intangible
amortisation
and
impairments
$m
BMS’s share
of diabetes
alliance
$m
Legal
provisions
and other
$m
18,876
80.8%
82.1%
(326)
(5,890)
(9,413)
1,655
4,902
21.3%
(1,317)
(146)
2.77
130
124
–
178
823
(24)
1,107
–
(232)
0.69
–
81
1,000
86
1,291
–
(307)
0.78
–
–
–
(627)
–
(627)
389
23
(0.17)
–
–
–
48
–
48
267
4
0.24
2016
Core1
$m
19,130
82.0%
83.2%
(326)
(5,631)
(8,169)
1,717
6,721
29.2%
(661)
(658)
4.31
Actual
growth
%
(7)
Core1 2016
CER
growth
%
(6)
(4)
–
(12)
13
(3)
1
5
(9)
14
(7)
1 Each of the measures in the Core column in the above table are non-GAAP measures.
2(cid:3) (cid:42)(cid:85)(cid:82)(cid:86)(cid:86)(cid:3)(cid:80)(cid:68)(cid:85)(cid:74)(cid:76)(cid:81)(cid:3)(cid:68)(cid:86)(cid:3)(cid:68)(cid:3)(cid:8)(cid:3)(cid:82)(cid:73)(cid:3)(cid:51)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:3)(cid:54)(cid:68)(cid:79)(cid:72)(cid:86)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:86)(cid:3)(cid:74)(cid:85)(cid:82)(cid:86)(cid:86)(cid:3)(cid:83)(cid:85)(cid:82)(cid:430)(cid:87)(cid:3)(cid:71)(cid:72)(cid:85)(cid:76)(cid:89)(cid:72)(cid:71)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:51)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:3)(cid:54)(cid:68)(cid:79)(cid:72)(cid:86)(cid:15)(cid:3)(cid:71)(cid:76)(cid:89)(cid:76)(cid:71)(cid:72)(cid:71)(cid:3)(cid:69)(cid:92)(cid:3)(cid:51)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:3)(cid:54)(cid:68)(cid:79)(cid:72)(cid:86)(cid:17)
AstraZeneca Annual Report and Form 20-F Information 2016
65
Strategic Report Financial Review
Financial Review continued
Total Revenue
Total Revenue for the year was down 7% to
$23,002 million, comprising Product Sales
of $21,319 million (down 10%) and
Externalisation Revenue of $1,683 million
(up 58%). At CER, Total Revenue declined
by 5% in the year.
Product Sales
The decline in Product Sales primarily
reflected the entry in the US of multiple
Crestor generic medicines.
By Geography
US Product Sales were down 22% to
$7,365 million, reflecting the competition
from multiple generic Crestor medicines
that entered the US market from July 2016
as well as lower Product Sales of Nexium
and Symbicort. In Europe, strong growth in
Product Sales of Forxiga and Brilique were
more than offset by a decline in Symbicort,
leading to a decrease of 5% (CER: decrease
of 3%) in the region in total to $5,064 million.
Established Markets were up 2% (CER:
down 4%) at $3,096 million including an
increase of 8% in Japan (CER: decrease
of 3%) to $2,184 million, with Crestor
Product Sales in Japan stable at $521
million. Product Sales in Emerging Markets
were flat (CER: up 6%) at $5,794 million in
2016 despite growth in China of 4% (CER:
growth of 10%) to $2,636 million, as we
encountered challenging macro-economic
conditions in Latin America, where full-year
Product Sales declined by 20% (CER:
declined by 7%) to $516 million.
By Product
Our largest selling products in 2016 were
Crestor ($3,401 million), Symbicort ($2,989
million), Nexium ($2,032 million) and Pulmicort
($1,061 million). Global Product Sales of
Crestor declined in the year by 32% (CER:
declined by 32%), which primarily reflected
the market entry of multiple Crestor generic
medicines. Symbicort global Product Sales
declined by 12% (CER: down 10%) including
a reduction of 18% in the US due to the
impact of a competitive environment on net
pricing. Nexium Product Sales were down
19% (CER: down 18%), including a 39%
decrease in the US, reflecting lower demand
and inventory de-stocking as a result of the
loss of exclusivity in 2015. Strong underlying
volume growth in Emerging Markets drove a
5% Global Product Sales increase (CER: 8%
increase) in Pulmicort, with 66% of Product
Sales of the medicine coming from that
region in the year.
Growth Platforms
In the periods under review, our Growth
Platforms included products in our three
main therapy areas, and a focus on
the Emerging Markets and Japan. Our
Growth Platforms grew by 4% (CER: 5%),
representing 63% of Total Revenue after
removing the effect of certain Product
Sales which are included in more than
one Growth Platform.
Growth Platforms
Respiratory
Brilinta
Diabetes
Emerging Markets
Japan
New Oncology1
Total Growth Platform Product Sales2
2016
Product Sales
$m
2015
Product Sales
$m
Actual
growth
%
CER
growth
%
4,753
839
2,427
5,794
2,184
664
4,987
619
2,224
5,822
2,020
119
14,491
14,003
(5)
36
9
–
8
n/m
4
2016
$m
520
298
175
115
100
–
–
–
–
356
1,564
119
1,683
(3)
39
11
6
(3)
n/m
5
2015
$m
–
–
–
–
50
450
200
100
123
57
980
87
1,067
1 New Oncology comprises Lynparza, Iressa (US) and Tagrisso.
2 Certain Product Sales are included in more than one Growth Platform. Total Growth Platform sales represents the net total sales for all Growth Platforms.
Externalisation Revenue
Milestones
Global non-US anaesthetics portfolio (Aspen) – upfront
Plendil (China Medical System Holdings) – upfront
Toprol-XL (Aralez) – upfront
tralokinumab (LEO Pharma) – upfront
AZD3293 (Lilly) – milestone
durvalumab (Celgene) – upfront
Movantik (Daiichi Sankyo) – upfront
brodalumab (Valeant) – upfront
Nexium (Daiichi Sankyo) – milestone
Others
Total upfront/milestones
Royalties
Total Externalisation Revenue
66
AstraZeneca Annual Report and Form 20-F Information 2016
Product Sales of our Respiratory
medicines declined by 5% (CER: declined
by 3%) reflecting pricing pressure in the
US for Symbicort.
Sales of Brilinta in the year were $839
million, an increase of 36% (CER: increase of
39%). Brilinta sales in the US were up 45%
to $348 million, as it remained the branded
oral anti-platelet market leader in the US.
Our Diabetes Product Sales were 9%
higher than in 2015 (CER: 11% higher),
driven primarily by growth of 70% (CER:
growth of 72%) on Farxiga with global sales
of $835 million as it became our largest-
selling Diabetes medicine.
Product Sales in Emerging Markets were
flat compared to 2015 (CER: increase of
6%). Product Sales in China increased
by 4% in 2016 (CER: increased by 10%)
representing 45% of Emerging Markets
Product Sales in the year.
Japan Product Sales increased by 8%
(CER: declined by 3%).
Product Sales of New Oncology medicines
were up to $664 million in 2016 (2015: $119
million), $423 million of which came from
Tagrisso (2015: $19 million) which became
our leading medicine for the treatment
of lung cancer in the year.
Externalisation Revenue
Externalisation Revenue, alongside
Product Sales, is included in Total
Revenue. Externalisation Revenue includes
development, commercialisation and
collaboration revenue, such as royalties and
milestone receipts. Income is recorded as
Externalisation Revenue when we have a
significant ongoing interest in the product
and/or it is repeatable business and there
is no derecognition of an intangible asset.
Disposals of assets and businesses, where
we do not retain an interest, are recorded in
other operating income.
Details of our significant business
development transactions which give rise
to Externalisation Revenue are given below:
> In October 2016, we announced an
agreement with Aralez for the rights
to the branded and authorised generic
(marketed by Par Pharmaceuticals) for
Toprol-XL (metoprolol succinate) in the
US. Aralez paid us $175 million upon
completion of the transaction. Aralez will
also pay us up to $48 million in milestone
and sales-related payments, as well as
mid-teen percentage royalties on sales.
We will continue to manufacture and
supply Toprol-XL and the authorised
generic medicine to Aralez. We will retain
a significant ongoing interest in Toprol-XL
in the rest of the world, and significant
interest in the US through the ongoing
manufacture and supply of the product.
> In June 2016, we entered into a licence
agreement with LEO Pharma for the
global development and commercialisation
of tralokinumab in dermatology
indications. We will continue to develop
tralokinumab in asthma, and will
manufacture and supply tralokinumab
to LEO Pharma at a mark-up of 10%
on cost. LEO Pharma have been granted
an exclusive licence to the global
dermatology rights to tralokinumab,
which has completed Phase IIb for
atopic dermatitis. LEO Pharma paid an
upfront payment to us of $115 million
for the exclusive licence. LEO Pharma
will also pay us up to $1 billion in
commercially-related milestones
and up to mid-teen tiered percentage
royalties on Product Sales.
> In June 2016, we announced that we
had entered into a commercialisation
agreement with Aspen for rights to its
global anaesthetics portfolio outside
the US. The agreement covers seven
established medicines – Diprivan, EMLA
and five local anaesthetics (Xylocaine,
Marcaine, Naropin, Carbocaine and
Citanest). Under the terms of the
agreement, Aspen acquired the
commercialisation rights for an upfront
consideration of $520 million ($410 million
paid on completion and $110 million
to be paid in 2017). Additionally, Aspen
will pay us up to $250 million on a Product
Sales-related payment, as well as double
digit percentage trade mark royalties on
Product Sales. For an initial period of 10
years, we will manufacture and supply
the products to Aspen at cost plus 20%.
Aspen have assumed responsibility for all
activities relating to the sale of the portfolio
in all relevant markets.
> In February 2016, we entered into a
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
licensing agreement with China Medical
System Holdings Ltd (CMS) for the
commercialisation rights in China to
our calcium channel blocker, Plendil
(felodipine). Plendil achieved Product
Sales in China of $189 million in 2015.
Under the terms of the agreement, CMS
paid us $155 million in 2016 for the licence
to sell Plendil in China, and committed to
pay us a further $155 million in 2017
(recognised as Externalisation Revenue
in 2016 after applying a discount factor
of 8%). We will manufacture and supply
the medicine to CMS and retain the
global rights to Plendil outside China. The
transaction did not include the transfer of
any of our employees or facilities. Over the
term of the licence, we will supply finished
product to CMS for a supply value
equivalent to approximately 40% of the
net sales value booked by CMS for Plendil
in each given year and will sit on the
Joint Steering Committee governing the
commercialisation of the product in China.
> In September 2015, we announced
that we had entered into a collaboration
agreement with Valeant under which
we will grant an exclusive licence for
Valeant to develop and commercialise
brodalumab. Under the agreement,
Valeant will hold the exclusive rights to
develop and commercialise brodalumab
globally, except in Japan and certain
other Asian countries where rights are
held by Kyowa Hakko Kirin under a prior
arrangement with Amgen. Valeant
will assume all development costs
associated with the regulatory approval
for brodalumab. Under the terms of
the agreement, Valeant made an upfront
payment to us of $100 million and
may also pay pre-launch milestones
of up to $170 million and further sales
related milestone payments of up to
$175 million. If approved, we will share
profits with Valeant.
AstraZeneca Annual Report and Form 20-F Information 2016
67
Strategic Report Financial Review
Financial Review continued
> In April 2015, we signed a Collaboration
and License Agreement with Celgene,
a global leader in haematological
cancers, to develop and commercialise
durvalumab across a range of blood
cancers including non-Hodgkin
lymphoma, myelodysplastic syndromes
and multiple myeloma. Under the terms of
the agreement, Celgene made an upfront
payment of $450 million to us in relation to
durvalumab, which is recorded within
Externalisation Revenue. Celgene will lead
on development across all clinical trials
within the collaboration and took on all
R&D costs until the end of 2015, after
which they now take on 75% of these
costs. Celgene will also be responsible
for global commercialisation of approved
treatments. We will manufacture and
record all sales of durvalumab and will
pay a royalty to Celgene on worldwide
sales in haematological indications. The
royalty rate will start at 70% and will
decrease to approximately half of the
sales of durvalumab in haematological
indications over a period of four years.
> In March 2015, we announced a
co-commercialisation agreement with
Daiichi Sankyo, for Movantik in the US.
The drug was launched on 31 March
2015. Under the terms of the agreement,
Daiichi Sankyo paid a $200 million upfront
fee and will pay subsequent sales-related
payments of up to $625 million. $200
million was recorded in Externalisation
Revenue in 2015. We will be responsible
for manufacturing, will record all sales
and will make sales-related commission
payments to Daiichi Sankyo. Both
companies will be jointly responsible
for commercial activities.
> In September 2014, we entered into an
agreement with Lilly to jointly develop
and commercialise AZD3293, an oral
beta secretase cleaving enzyme (BACE)
inhibitor currently in development as
a potential treatment for Alzheimer’s
disease. Under the terms of the
agreement, Lilly will pay us up to $500
million in development and regulatory
milestone payments. We received the
first milestone payment of $50 million in
2015, and a further $100 million in 2016.
The companies will equally share all
future costs for the development and
commercialisation of AZD3293, as well
as net global revenues post-launch. Lilly
lead the clinical development, working
with researchers from our Innovative
Medicines Unit for neuroscience, while
we will be responsible for manufacturing.
The companies are jointly responsible for
the commercialisation of AZD3293.
As detailed in Risk from page 214, the
development of any pharmaceutical product
candidate is a complex and risky process
that may fail at any stage in the development
process due to a number of factors
(including items such as failure to obtain
regulatory approval, unfavourable data from
key studies, adverse reaction to the product
candidate or indications of other safety
concerns). The potential future milestones
quoted above are subject to these risks.
Gross margin, operating margin
and earnings per share
Reported gross margin as a percentage of
Product Sales was 80.8% in the year, 0.5
percentage points higher than last year.
Excluding the impact of Externalisation
Revenue, the Reported gross margin was
broadly flat compared to 2015 at CER,
with lower restructuring and amortisation
charges offset by an adverse impact from
the mix of sales, the market entry of multiple
Crestor generic medicines in the US and a
write-down of FluMist inventory in the US.
Reported R&D expense in the year was
down 2% (CER: up 2%) to $5,890 million,
as we continued our focused investment
in the pipeline. Adjusting for exchange
rate movements, the full-year increase
at CER reflected the number of potential
medicines in pivotal trials as well as the
inclusion of the R&D costs of ZS Pharma
and Acerta Pharma. These costs were
partially offset by lower restructuring
costs and impairment charges.
Reported SG&A costs declined by 15%
(CER: declined by 12%) to $9,413 million
reflecting the fair value adjustment to
acquisition-related liabilities based on
revised milestone probabilities and
revenue and royalty forecasts relating
to the acquisition of BMS’s share of
the Global Diabetes Alliance and the
acquisition of Almirall. The decline was
also driven by the movement to a more
even split between the sale of primary and
specialty care medicines and efficiency
savings in sales and marketing operations
and further reductions in IT costs. These
actions included a material reduction in the
sales and head-office structure in the US
marketing business.
68
AstraZeneca Annual Report and Form 20-F Information 2016
Reported other operating income in
the year was up 10% (CER: up 12%) at
$1,655 million which, in addition to royalty
income of $165 million for Crestor and
$134 million for Human Papillomavirus (HPV)
vaccine, includes $368 million on the sale
of our small-molecule antibiotics business
to Pfizer, $321 million on the sale of our
non-US rights to Rhinocort Aqua to Cilag,
$183 million on the sale of our non-US rights
to Imdur and $148 million (after deduction
of $83 million payable to Amgen) on the
disposal of global rights to MEDI2070 to
Allergan. As these elements of our income
arose from product divestments, where
we no longer retain a significant element of
continued interest, in accordance with our
Externalisation Revenue definition and the
requirements of IFRS, proceeds from these
divestments continue to be recorded as
other operating income.
In 2015, Reported other operating income
included $380 million for the divestment
of rights to the Entocort business in the
US to Elan Pharma International Limited,
part of the Perrigo Group, $215 million
for the divestment of the rights to sell and
develop Entocort capsules and enema
formulations outside the US to Tillotts
Pharma AG, $193 million gain on the
divestment of the global rights to develop,
manufacture and commercialise Myalept
subject to an existing distributor licence with
Shionogi covering Japan, South Korea, and
Taiwan with Aegerion and $165 million for the
divestment of Caprelsa in an agreement with
Genzyme Corporation, part of Sanofi S.A.
Reported operating profit increased
by 19% (CER: increased by 9%) to
$4,902 million in the year. The Reported
operating margin increased by 4.6
percentage points (CER: 2.6 percentage
points) to 21.3% of Total Revenue. The
increase reflected the reduction in SG&A
costs which more than offset the decline
in Product Sales and Externalisation
Revenue, while we continued to invest in
our pipeline and Growth Platforms.
Core operating profit declined by 3%
(CER: declined by 7%) in the year to
$6,721 million. Fair value adjustments
to acquisition-related liabilities reduced
SG&A costs and increased Reported
operating profit by $1,158 million in the
current year (2015: $432 million). These fair
value movements reflected estimates for
future liabilities that can change materially
over time.
Reported net finance expense was
$1,317 million (2015: $1,029 million). The
increase of $288 million was largely due
to an increase in Net Debt that was driven
by the acquisition of ZS Pharma and the
majority investment in Acerta Pharma.
Excluding the discount unwind on
acquisition-related liabilities and other
adjustments, Core Net Finance Expense
increased by 31% (CER: increased by
46%) in the year to $661 million.
Profit before tax amounted to $3,552 million
in 2016 (2015: $3,069 million). Pre-tax
adjustments to arrive at Core profit before
tax amounted to $2,475 million in 2016
(2015: $3,312 million), comprising $1,819
million adjustments to operating profits
(2015: $2,788 million) and $656 million to
net finance expenses (2015: $524 million).
Excluded from Core results were:
> Restructuring costs totalling $1,107 million
(2015: $1,034 million), incurred as we
continued to enhance productivity
through the implementation of our
restructuring initiatives. To continue the
focus on cost discipline, in 2016 we
announced plans to advance our strategy
through sharper focus by streamlining
operations, primarily in Commercial and
Manufacturing, to redeploy investment to
key therapy areas, particularly Oncology.
We incurred restructuring costs totalling
$555 million relating to this programme in
2016. We also disposed of our R&D
facility in Bangalore, India in the period
and announced plans to bring together
five of our San Francisco Bay Area, US
sites into one location.
> Amortisation totalling $1,247 million
value decrease of $999 million reflecting
lower expected Diabetes portfolio
revenues in line with latest forecasts
was partially offset by $372 million of
amortisation charges and $389 million
of interest charges relating to a discount
unwind on contingent consideration
arising on the acquisition.
> Net legal provisions and other charges of
$315 million (2015: $211 million), including
$267 million discount unwind charges,
offset by $199 million of net fair value
adjustments relating to contingent
consideration arising on our other
business combinations as detailed in
Note 18 to the Financial Statements from
page 164. The net charge of $315 million
also included legal charges relating to the
unsuccessful defence of the validity of
Crestor-related patents in Australia,
damages claims in Europe relating to
Seroquel XR and other matters. Further
details of legal proceedings we are
currently involved in are contained within
Note 28 to the Financial Statements from
page 185.
Reported EPS of $2.77 in the year
represented growth of 24% (CER: growth
of 9%), partly reflecting the revaluation
of acquisition-related liabilities described
above. Core EPS in the year increased
by 1% (CER: declined by 5%) to $4.31.
The CER decline of 5% mirrored the
rate of decline in Total Revenue. Both
Reported and Core EPS in the year
included a non-recurring benefit of
$0.36, following agreements between
the Canadian tax authority and the UK
and Swedish tax authorities.
(2015: $1,460 million) relating to intangible
assets, except those related to IT and
to our acquisition of BMS’s share of
our Global Diabetes Alliance (which
are separately detailed below). Further
information on our intangible assets is
contained in Note 9 to the Financial
Statements from page 157.
The Reported taxation charge for the year
of $146 million (2015: $243 million) consisted
of a current tax charge of $370 million
(2015: $633 million) and a credit arising from
movements on deferred tax of $224 million
(2015: $390 million). The current tax charge
included a prior period current tax credit of
$14 million (2015: $404 million).
> Intangible impairment charges of $44
million (2015: $143 million) excluding those
related to IT. Further details relating to
intangible asset impairments are included
in Note 9 to the Financial Statements from
page 157.
> Net credit associated with our acquisition
of BMS’s share of our Global Diabetes
Alliance in February 2015 amounting
to $238 million (2015: net cost of $463
million). A contingent consideration fair
The Reported tax rate for the year was 4%
(2015: 8%). The Reported tax rate of 4%
benefited from a $453 million adjustment
following agreements between the
Canadian tax authority and the UK and
Swedish tax authorities. Excluding these
effects, the Reported tax rate for the year
was 17%. The Core tax rate for the year
was 11%. Excluding the benefit following
agreements between the Canadian tax
authority and the UK and Swedish tax
authorities in respect of transfer pricing
arrangements for the 13-year period from
2004-2016, the Core tax rate was 18%.
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
The tax paid for the year was $412 million
(12% of Reported profit and 7% of Core
profit). The cash tax paid for the year was
$266 million higher than the tax charge
for the year as a result of certain items
with no cash impact including a $453
million adjustment following the agreement
between the Canadian tax authority and the
UK and Swedish tax authorities referred to
above, other net reductions in provisions for
tax contingencies of $52 million, $244 million
of deferred tax credits, net cash refunds
received following agreement of prior period
tax liabilities and audit settlements of $274
million and other cash tax timing differences.
Reported post-tax profit for the year was
$3,406 million, an increase of 21% (CER:
increase of 6%). Reported earnings per
share was up 24% (CER: up 9%) to $2.77.
Total comprehensive income decreased by
$860 million from the prior year, resulting
in a net income of $1,628 million for 2016.
This was driven by the increase in profit
for the year of $580 million being more
than offset by a reduction of $1,440 million
in other comprehensive income. The
decrease in other comprehensive income
arose principally from losses recorded on
the remeasurement of our defined benefit
pension liability of $575 million (2015:
gains of $652 million) due to a decrease
in the discount rate applied to our pension
liabilities reflecting an increase in corporate
bond yields and other reference interest
rate instruments, and foreign exchange
losses arising on consolidation of the Group
numbers of $1,050 million (2015: losses
of $528 million) as a result of the strong
performance of the US dollar against
other major currencies in 2016.
Restructuring
Since 2007, we have undertaken
significant efforts to restructure and
reshape our business to improve long-term
competitiveness, the first two phases of
which were completed in 2011.
In 2013, we announced our Phase 4
restructuring programme, which was
subsequently expanded in 2014. This
consisted of centralisation of our global R&D
footprint into three strategic centres,
AstraZeneca Annual Report and Form 20-F Information 2016
69
Strategic Report Financial Review
Financial Review continued
transformation of the IT organisation,
closure of a number of manufacturing
facilities and other activities to simplify
and streamline the organisation. At the
time of the announcement, the Phase 4
programme was estimated to incur $3.2
billion of costs and deliver $1.1 billion of
annualised benefits by 2016. By the end of
2016, the Phase 4 programme had incurred
costs of $3.3 billion and realised annual
benefits of $0.9 billion, creating headroom
for investment in our pipeline and launch
capability. The Phase 4 programme is now
expected to complete in 2018 with total
programme costs estimated to be
$3.6 billion and annualised benefits
$1.2 billion. During the latter part of 2015,
we implemented further targeted
restructuring of our Commercial business.
This resulted in $102 million of restructuring
costs in 2015, with a further $47 million
incurred in 2016. Furthermore, as part
of our ongoing commitment to improve
productivity, we initiated multi-year
transformation programmes within our
G&A functions (principally Finance and
HR) with anticipated costs by the end of
2018 of $258 million. Once complete, we
expect these transformation programmes
to deliver annualised benefits of $100 million
by the end of 2018. By the end of 2016,
these programmes had incurred costs
of $124 million.
In 2016, we announced plans to advance
our strategy through sharper focus by
streamlining operations, primarily in
Commercial and Manufacturing, to
redeploy investment to key therapy areas,
particularly Oncology. Restructuring costs
associated with this programme are
expected to be $1.5 billion by the end of
2017 and generate net annualised benefits
of $1.1 billion by 2018. We incurred
restructuring costs totalling $555 million
relating to this programme in 2016.
The aggregate restructuring charge incurred
in 2016 across all our restructuring
programmes was $1,107 million. Final
estimates for programme costs, benefits
and headcount impact in all functions are
subject to completion of the requisite
consultation in the various areas. Our priority
as we undertake these restructuring initiatives
is to work with our affected employees on
the proposed changes, acting in accordance
with relevant local consultation requirements
and employment law.
(cid:38)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:79)(cid:76)(cid:84)(cid:88)(cid:76)(cid:71)(cid:76)(cid:87)(cid:92)(cid:3)(cid:347)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)
Summary cash flows
Net (debt)/funds brought forward at 1 January
Profit before tax
Sum of changes in interest, tax, depreciation, amortisation, impairment, and share of after tax losses
on joint ventures and associates
Movement in working capital and short-term provisions
Tax paid
Interest paid
Gains on disposal of intangible assets
Fair value movements on contingent consideration arising from business combinations
Non-cash and other movements
Net cash available from operating activities
Disposal/(purchase) of intangibles (net)
Upfront payments on business acquisition
Payment of contingent consideration from business combinations
Other capital expenditure (net)
Investments
Dividends
Share proceeds
Distributions
Other movements
Net debt carried forward at 31 December
Net debt/funds reconciliation
Cash and cash equivalents
Other investments1
Net derivative financial instruments
Cash, short-term investments and derivatives
Overdraft and short-term borrowings
Finance leases
Current instalments of loans
Loans due after one year
Loans and borrowings
Net debt
1 Other investments in 2016 includes $14 million of non-current investments which is not separately disclosed on the Statement of Financial Position.
70
AstraZeneca Annual Report and Form 20-F Information 2016
2016
$m
(7,762)
3,552
3,707
926
(412)
(677)
(1,301)
(1,158)
(492)
4,145
559
(2,564)
(293)
(1,405)
(3,703)
(3,561)
47
(3,514)
177
(10,657)
2016
$m
5,018
898
235
6,151
(451)
(93)
(1,769)
(14,495)
(16,808)
(10,657)
2015
$m
(3,223)
3,069
3,897
(49)
(1,354)
(496)
(961)
(432)
(350)
3,324
(330)
(2,446)
(579)
(1,326)
(4,681)
(3,486)
43
(3,443)
261
(7,762)
2015
$m
6,240
613
438
7,291
(849)
(95)
–
(14,109)
(15,053)
(7,762)
2014
$m
39
1,246
4,173
2,508
(1,201)
(533)
–
512
353
7,058
(1,740)
(3,804)
(657)
(924)
(7,125)
(3,521)
279
(3,242)
47
(3,223)
2014
$m
6,360
795
465
7,620
(1,486)
(108)
(912)
(8,337)
(10,843)
(3,223)
Bonds issued in 2016 and 2015
Bonds issued in 2016:
0.25% Euro bond
0.75% Euro bond
1.25% Euro bond
Total 2016
Bonds issued in 2015:
Floating rate notes
1.750% Callable bond
2.375% Callable bond
3.375% Callable bond
4.375% Callable bond
Total 2015
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
Repayment
dates
Face value
of bond
$m
Net book
value of
bond at
31 December
2016
$m
2021
2024
2028
2018
2018
2020
2025
2045
566
1,016
897
2,479
400
1,000
1,600
2,000
1,000
6,000
522
937
827
2,286
399
998
1,589
1,976
979
5,941
Net cash generated from operating activities
was $4,145 million in the year ended 31
December 2016, compared with $3,324
million in 2015. The increase of $821 million
reflected improved cash management
performance and one-off tax refunds in
2016 compared to an increase of $49 million
in working capital and short-term provisions
in the prior year.
Gains on disposal of intangible assets of
$1,301 million included $368 million on
the disposal of our late-stage antibiotics
business, $321 million on the sale of our
rights to Rhinocort Aqua outside of the US,
$231 million on the out-licence agreement
for MEDI-2070, and $183 million for the
divestment of the global rights to Imdur
outside the US. 2015 included $380 million
on the disposal of US rights to Entocort,
$215 million on the disposal of Rest of
World rights to Entocort, $193 million on
the disposal of global rights to Myalept and
$165 million on the disposal of global rights
to Caprelsa. Fair value adjustments on
acquisition-related liabilities were a credit
of $1,158 million in 2016 (2015: a credit of
$432 million) including $999 million on our
acquisition of BMS’s share of our Global
Diabetes Alliance in February 2015. Other
non-cash movements amounted to $492
million in 2016 (2015: $350 million).
Investment cash outflows of $3,703 million
(2015: $4,681 million) included $2,383 million
relating to the majority investment in Acerta
Pharma. This compared to cash payments
relating to business acquisitions in 2015
of $2,446 million, primarily related to the
ZS Pharma acquisition. Further details of
business combination acquisitions and
their impact on our cash flows and balance
sheet are given in the table on page 73.
Investment cash outflows also include $293
million (2015: $579 million) of payments
against contingent consideration arising on
business combinations and $868 million
(2015: $1,460 million) for the purchase of
other intangible assets, which included
$561 million on the purchase of the
core respiratory assets of Takeda. The
comparative period of 2015 included $684
million on the acquisition of the rights to
Actavis’ branded respiratory portfolio in the
US and Canada.
Investment cash inflows include $1,427
million (2015: $1,130 million) from the sale of
intangible assets, including $552 million for
the disposal of our late-stage antibiotics
business, $330 million for the sale of our
rights to Rhinocort Aqua outside of the US
and $250 million on the out-licence
agreement for MEDI-2070. The comparative
period in 2015 included the divestments of
Entocort in the US for $380 million, and in
the Rest of World for $215 million and of
Myalept for $325 million.
Net cash distributions to shareholders
were $3,514 million (2015: $3,443 million)
including dividends of $3,561 million (2015:
$3,486 million). Proceeds from the issue of
shares on the exercise of share options
amounted to $47 million (2015: $43 million).
In May 2016, we issued €2.2 billion of
bonds in the euro debt capital markets
with maturities of 5, 8 and 12 years.
In November 2015, we issued bonds
worth $6 billion to fund the acquisition of ZS
Pharma, to repay certain of our outstanding
commercial paper obligations and for
general corporate purposes. The bonds
are listed in the table above.
In 2015, we repaid a 5.125% non-callable
euro bond which had a 31 December 2015
carrying value of $912 million.
At 31 December 2016, outstanding
gross debt (interest-bearing loans and
borrowings) was $16,808 million (2015:
$15,053 million). Of the gross debt
outstanding at 31 December 2016, $2,307
million is due within one year (2015: $916
million). Net debt at 31 December 2016 was
$10,657 million, compared to $7,762 million
at the beginning of the year, as a result of
the net cash outflow as described above.
Off-balance sheet transactions and
commitments
We have no off-balance sheet arrangements
and our derivative activities are non-
speculative. The following table on page
72 sets out our minimum contractual
obligations at the year end.
AstraZeneca Annual Report and Form 20-F Information 2016
71
Strategic Report Financial Review
Financial Review continued
Payments due by period
Bank loans and other borrowings1
Finance leases
Operating leases
Contracted capital expenditure
Total
Less than
1 year
$m
1-3 years
$m
3-5 years
$m
2,829
3,421
3,843
42
98
629
3,598
40
145
–
13
102
–
Over
5 years
$m
14,796
–
96
–
2016
Total
$m
2015
Total
$m
24,889
23,263
95
441
629
141
409
518
3,606
3,958
14,892
26,054
24,331
1 Bank loans and other borrowings include interest charges payable in the period, as detailed in Note 26 to the Financial Statements on page 178.
In 2016, net assets decreased by $1,840
million to $16,669 million. The decrease in
net assets is broadly as a result of dividends
of $3,540 million and adverse movements
on exchange taken to reserves of $1,641
million, partially offset by the Group profit
of $3,406 million.
Business combinations
In 2016, we acquired a majority equity stake
in Acerta Pharma. In 2015, we completed
the acquisition of ZS Pharma. During 2016
we revised our assessment of the fair values
of the assets and liabilities acquired with
ZS Pharma, as a result of new information
obtained about facts and circumstances
that existed at the date of acquisition that
impact the value of deferred tax. This has
resulted in a reduction to both deferred tax
liabilities and goodwill of $68 million. Further
details of our business combinations are
contained in Note 25 to the Financial
Statements from page 173.
Fair values of assets and liabilities acquired,
and consideration for the acquisitions in
2016 and 2015, as at the acquisition date,
are summarised on the opposite page.
Contingent consideration
The majority of our acquisitions in
recent years have included elements of
consideration that are contingent on future
development and/or sales milestones,
with both the diabetes and respiratory
acquisitions in 2014 also including royalty
payments linked to future revenues. The
acquisitions of ZS Pharma in 2015 and
Acerta Pharma in 2016 had no contingent
consideration element.
Our agreement with BMS provides for
potential further payments of up to $0.7
billion for future regulatory, launch and
sales-related milestones, and various
sales-related royalty payments up until 2025.
Our transaction with Almirall includes further
payments of up to $1.0 billion for future
development, launch, and sales-related
milestones and various other sales-related
payments as detailed in Note 18 to the
Financial Statements on page 164. All these
future payments are treated as contingent
consideration on our balance sheet, and
are fair valued using decision-tree analyses,
with key assumptions, including the
probability of success, the potential for
delays and the expected levels of future
revenues. The fair value is updated at each
balance sheet reporting date to reflect our
latest estimate of the probabilities of these
key assumptions. Given the long-term
nature of our contingent consideration
payments, the fair value calculation includes
the discounting of future potential payments
to their present value using discount rates
appropriate to the period over which
payments are likely to be made. Over time,
as the target date of a consideration
payment approaches, the discount in
absolute terms of such future potential
payment to its present value decreases.
Therefore, in each period we take a
corresponding charge reflecting the
passage of time. We refer to this charge
as ‘discount unwind’.
Financial position – 31 December 2016
All data in this section is on a Reported basis.
Summary statement of financial position
Property, plant and equipment
Goodwill and intangible assets
Inventories
Trade and other receivables
Trade and other payables
Provisions
Net income tax payable
Net deferred tax liabilities
Retirement benefit obligations
Non-current other investments (excluding Treasury investments of $14 million in 2016)
Investment in associates and joint ventures
Net debt
Net assets
1(cid:3) (cid:21)(cid:19)(cid:20)(cid:24)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:68)(cid:85)(cid:68)(cid:87)(cid:76)(cid:89)(cid:72)(cid:86)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:87)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:3)(cid:68)(cid:81)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:84)(cid:88)(cid:76)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:61)(cid:54)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:17)
72
AstraZeneca Annual Report and Form 20-F Information 2016
2016
$m
Movement
$m
2015
As restated1
$m
6,848
39,244
2,334
5,474
(19,974)
(1,418)
(954)
(2,854)
(2,186)
713
99
(10,657)
16,669
435
4,798
191
(2,055)
(854)
(176)
142
(1,483)
(212)
255
14
(2,895)
(1,840)
6,413
34,446
2,143
7,529
(19,120)
(1,242)
(1,096)
(1,371)
(1,974)
458
85
(7,762)
18,509
Movement
$m
403
1,915
183
(815)
757
(135)
929
(794)
977
(44)
26
(4,539)
(1,137)
2014
$m
6,010
32,531
1,960
8,344
(19,877)
(1,107)
(2,025)
(577)
(2,951)
502
59
(3,223)
19,646
Business combinations
Assets acquired:
Non-current assets
Property, plant and equipment
Goodwill
Intangible assets
Current assets
Current liabilities
Non-current liabilities
Non-controlling interests
Total assets
Consideration:
Upfront consideration
Deferred consideration
Total consideration
Contingent consideration arising on business combinations
At 1 January
Settlements
Fair value adjustments
Discount unwind
Foreign exchange
At 31 December
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
2016
Acerta
Pharma
$m
2015
ZS Pharma
As Restated
$m
–
19
7,307
253
(90)
(1,777)
(1,903)
3,809
2,477
1,332
3,809
Acquisition of
BMS’s share
of Diabetes
Alliance
$m
Other
business
combinations
$m
5,092
1,319
(242)
(999)
389
–
(51)
(159)
108
–
2016
Total
2016
$m
6,411
(293)
(1,158)
497
–
Acquisition of
BMS’s share of
Diabetes
Alliance
$m
Other
business
combinations
$m
5,386
(325)
(378)
409
–
1,513
(254)
(54)
115
(1)
21
388
3,162
169
(50)
(990)
–
2,700
2,700
–
2,700
2015
Total
2015
$m
6,899
(579)
(432)
524
(1)
4,240
1,217
5,457
5,092
1,319
6,411
Both the discount unwind and any
movements of the fair value of the
underlying future payments can result in
significant income statement movements.
As detailed in the Results of operations
section above, these movements are treated
as non-Core items in our income statement
analysis. In 2016, we recorded an interest
charge of $497 million on the discount
unwind on contingent consideration arising
on our business combinations, and a net fair
value decrease on contingent consideration
of $1,158 million (which resulted in a credit to
our income statement for the same amount)
driven, principally, by revised forecasts
for revenues for our Diabetes franchise
reflecting the competitive marketplace.
At 31 December 2016, our contingent
consideration balance held on the balance
sheet amounted to $5,457 million (2015:
$6,411 million) with the movements of the
balance detailed in the table above.
Further details of our business combinations
in the past three years are contained in
Note 25 to the Financial Statements from
page 173. Further information on our
business combinations can also be found
in the Investments, divestments and capital
expenditure section of the Financial Review
from page 75.
Property, plant and equipment
Property, plant and equipment increased
by $435 million to $6,848 million. Additions
of $1,449 million (2015: $1,422 million) were
offset by depreciation of $609 million (2015:
$677 million), impairments of $2 million
(2015: $28 million) and disposals of $74
million (2015: $70 million).
Goodwill and intangible assets
Our goodwill of $11,658 million (2015:
$11,800 million) principally arose on the
acquisition of MedImmune in 2007, the
restructuring of our US joint venture
with Merck in 1998 and the acquisition
of BMS’s share of the Global Diabetes
Alliance. Goodwill of $19 million arising
on the acquisition of Acerta Pharma was
capitalised in 2016.
Intangible assets amounted to $27,586
million at 31 December 2016 (2015: $22,646
million). Intangible asset additions were
$8,205 million in 2016 (2015: $4,640 million),
including product rights acquired in the
acquisition of Acerta Pharma of $7,307
million ($3,162 million on the acquisition of
ZS Pharma in 2015). Amortisation in the year
was $1,701 million (2015: $1,999 million).
Impairment charges in the year amounted
to $45 million (2015: $148 million), including
$15 million for RDEA119. Disposals of
intangible assets totalled $331 million
in the year (2015: $169 million).
AstraZeneca Annual Report and Form 20-F Information 2016
73
Strategic Report Financial Review
Financial Review continued
Further details of our additions to intangible
assets, and impairments recorded,
are included in Note 9 to the Financial
Statements from page 157.
Receivables, payables and provisions
Trade and other receivables decreased
by $2,055 million with trade receivables
reduced by $2,050 million to $2,583 million
as a result of more factored invoices during
the year and lower gross invoiced sales
in the US. Non-current other receivables
decreased by $6 million to $901 million, the
majority of which is the Shionogi Crestor
royalty prepayment as detailed in Note 13
to the Financial Statements on page 161.
Trade and other payables increased by
$854 million in 2016 to $19,974 million,
including a $1,901 million put option, and
$1,332 million deferred consideration on
the majority investment in Acerta Pharma,
partially offset by reductions in contingent
consideration of $954 million, a decrease
in trade payables of $479 million, and a
decrease of $495 million on rebates and
chargebacks driven by reduced Product
Sales in the US. Further details on the
put option are included in Note 25 to the
Financial Statements from page 173.
The increase in provisions of $176 million
in 2016 included $988 million of additional
charges recorded in the year, partially
offset by $686 million of cash payments.
Included within the $988 million of charges
for the year were $578 million for our global
restructuring initiatives and $223 million in
respect of legal charges. Cash payments
included $433 million for our global
restructuring programmes. Further details
of the charges made against provisions
are contained in Notes 19 and 28 to the
Financial Statements on page 165, and
185 to 191, respectively.
Tax payable and receivable
Net income tax payable has decreased
by $142 million to $954 million, principally
due to a $453 million adjustment following
agreements between the Canadian tax
authority and the UK and Swedish tax
authorities in respect of transfer pricing
arrangements for the 13-year period from
2004-2016, partially offset by net cash
refunds received following agreement
of prior period tax liabilities and audit
settlements of $274 million. The tax
receivable balance of $426 million (2015:
$387 million) comprises tax owing to us
from certain governments expected to be
received on settlements of transfer pricing
audits and disputes of $161 million (see
Note 28 to the Financial Statements from
page 185) and cash tax timing differences
of $265 million.
Net deferred tax liabilities increased by
$1,483 million in the year mainly due to
deferred tax liabilities arising from the
acquisition of Acerta Pharma. Additional
information on the movement in deferred
tax balances is contained in Note 4 to the
Financial Statements from page 150.
Retirement benefit obligations
Net retirement benefit obligations increased
by $212 million in 2016 (2015: decrease
of $977 million) to $2,186 million. Net
remeasurement adjustments of $575
million in the UK, Sweden and Germany
arising from reductions in discount rate
assumptions were partially offset by a
$312 million impact of exchange rate
movements in the year as the US dollar
strengthened against pound sterling,
euro and Swedish krona and employer
contributions to the pension scheme of
$192 million. Benefits paid amounted to
$500 million (2015: $580 million).
Approximately 92% of our obligations
are concentrated in the UK, the US
and Sweden. In recent years, we have
undertaken several initiatives to reduce our
net pension obligation exposure. For the UK
defined benefit pension scheme, which is
our largest defined benefit scheme, these
initiatives have included agreeing funding
principles for cash contributions to be paid
into the UK pension scheme to target a
level of assets in excess of the current
expected cost of providing benefits, and,
in 2010, amendments to the scheme to
freeze pensionable pay at 30 June 2010
levels. During 2016, we realised a credit
of $74 million on our Pensions Increase
Exchange (‘PIE’) exercise which offered
certain pensioner members the option of
taking a higher amount of pension right
away, in exchange for giving up any potential
future inflation linked increases on all or part
of their pension.
From 2017, for our largest pension plans,
we will move to a multiple discount rate
approach. This will result in separate
discount rates for defined benefit
obligations, service cost and interest
cost. This change had no effect on the
2016 expense, and will not affect the
future measurement of the defined benefit
obligations, but will impact the service cost
and interest cost in future years.
Further details of our pension schemes
are included in Note 20 to the Financial
Statements from page 165.
Commitments and contingencies
We have commitments and contingencies
which are accounted for in accordance
with the accounting policies described
in the Financial Statements in the Group
Accounting Policies section from page 142.
We also have taxation contingencies. These
are described in the Taxation section in the
Critical accounting policies and estimates
section on page 81 and in Note 28 to the
Financial Statements from page 185.
Research and development
collaboration payments
Details of future potential R&D collaboration
payments are also included in Note 28 to
the Financial Statements on page 185.
As detailed in Note 28, payments to our
collaboration partners may not become
payable due to the inherent uncertainty in
achieving the development and revenue
milestones linked to the future payments.
As part of our overall externalisation
strategy, we may enter into further
collaboration projects in the future that
may include milestone payments and,
74
AstraZeneca Annual Report and Form 20-F Information 2016
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
therefore, as certain milestone payments
fail to crystallise due to, for example,
development not proceeding, they may
be replaced by potential payments under
new collaborations.
Investments, divestments and
capital expenditure
We have completed over 270 major
or strategically important business
development transactions over the past
three years, five of which were accounted
for as business acquisitions under IFRS 3
‘Business Combinations’, being the majority
investment in Acerta Pharma in 2016,
the acquisition of ZS Pharma in 2015, the
acquisition of BMS’s share of our Global
Diabetes Alliance, the rights to Almirall’s
respiratory franchise and the acquisition
of Definiens in 2015.
In addition to the business development
transactions detailed under Externalisation
Revenue from page 67 of this Financial
Review, the following significant collaborations
remain in the development phase:
> In April 2015, we entered into two
oncology agreements with Innate
Pharma, firstly, a licence which provides
us with exclusive global rights to
co-develop and commercialise IPH2201
in combination with durvalumab, and
secondly, an option to license exclusive
global rights to co-develop and
commercialise IPH2201 in monotherapy
and other combinations in certain
treatment areas. Under the terms of
the combination licence, we assumed
exclusive global rights to research,
develop, and commercialise IPH2201 in
combination with durvalumab. We jointly
fund Phase II studies with Innate Pharma
and we lead the execution of these studies.
Under the terms of the agreements, we
made an initial payment to Innate Pharma
of $250 million, which included the
consideration for exclusive global rights to
co-develop and commercialise IPH2201
in combination with durvalumab, as well
as access to IPH2201 in monotherapy
and other combinations in certain
treatment areas. The agreement includes
a Phase III initiation milestone of $100
million, as well as additional regulatory
and sales-related milestones. We record
all sales and will pay Innate Pharma
double digit royalties on net sales. The
arrangement includes the right for Innate
Pharma to co-promote in Europe for a
50% profit share in the territory.
> In July 2013, we entered into a strategic
collaboration with FibroGen to develop
and commercialise roxadustat (FG-4592),
a first-in-class oral compound in
late-stage development for the treatment
of anaemia associated with chronic
kidney disease (CKD) and end-stage renal
disease (ESRD). This broad collaboration
focuses on the US, China and all major
markets excluding Japan, Europe, the
CIS, the Middle East and South Africa,
which are covered by an existing
agreement between FibroGen and
Astellas. Under the arrangement, we
agreed to pay FibroGen upfront and
subsequent non-contingent payments
totalling $350 million, as well as potential
development-related milestone payments
of up to $465 million, and potential future
sales-related milestone payments, in
addition to tiered royalty payments on
future sales of roxadustat in the low
20% range. Additional development
milestones will be payable for any
subsequent indications which the
companies choose to pursue. We will be
responsible for the US commercialisation
of roxadustat, with FibroGen undertaking
specified promotional activities in the
ESRD segment in this market. The
companies will also co-commercialise
roxadustat in China where FibroGen will
be responsible for clinical trials, regulatory
matters, manufacturing and medical
affairs, and we will oversee promotional
activities and commercial distribution.
> In March 2013, we signed an exclusive
agreement with Moderna to discover,
develop and commercialise pioneering
medicines based on messenger RNA
Therapeutics for the treatment of serious
cardiovascular, metabolic and renal
diseases, as well as cancer. Under the
terms of the agreement, we made an
upfront payment of $240 million. We will
have exclusive access to select any target
of our choice in cardiometabolic and renal
diseases, as well as selected targets in
oncology, over a period of up to five years
for subsequent development of messenger
RNA Therapeutics. In addition, Moderna
is entitled to an additional $180 million
for the achievement of three technical
milestones. Through this agreement, we
have the option to select up to 40 drug
products for clinical development and
Moderna will be entitled to development
and commercial milestone payments as
well as royalties on drug sales. We will
lead the pre-clinical, clinical development
and commercialisation of therapeutics
resulting from the agreement and
Moderna will be responsible for designing
and manufacturing the messenger RNA
Therapeutics against selected targets.
We are currently progressing 19 projects
across CVMD and Oncology. Utilising
both companies’ expertise, significant
progress has also been made to the
technology platform, with the focus on
formulation, safety, and drug metabolism
and pharmacokinetics.
We determine the above business
development transactions to be significant
using a range of factors. We look at the
specific circumstances of the individual
externalisation arrangement and apply
several quantitative and qualitative
criteria. Because we consider business
development transactions to be an
extension of our R&D strategy, the expected
total value of development payments
under the transaction and its proportion
of our annual R&D spend, both of which
are proxies for overall R&D effort and cost,
are important elements of the significance
determination. Other quantitative criteria we
apply include, without limitation, expected
levels of future sales, the possible value of
milestone payments and the resources used
for commercialisation activities (for example,
the number of staff). Qualitative factors we
consider include, without limitation, new
market developments, new territories, new
areas of research and strategic implications.
AstraZeneca Annual Report and Form 20-F Information 2016
75
Strategic Report Financial Review
Financial Review continued
Capitalisation and shareholder return
Dividends for 2016
First interim dividend
Second interim dividend
Total
Capitalisation
The total number of shares in issue at
31 December 2016 was 1,265 million
(2015: 1,264 million). 1.1 million Ordinary
Shares were issued upon share option
exercises for a total of $47 million.
Shareholders’ equity decreased by
$3,636 million to $14,854 million at the
year end. Non-controlling interests were
$1,815 million (2015: $19 million), with
the increase in the year as a result of the
acquisition of a 55% equity stake in
Acerta Pharma.
Dividend and share repurchases
The Board has recommended a second
interim dividend of $1.90 (150.2 pence,
16.57 SEK) to be paid on 20 March
2017. This brings the full-year dividend to
$2.80 (218.9 pence, 24.38 SEK). Against
Core earnings per share the Group has
a dividend cover ratio of 1.5 in 2016
(2015: 1.5).
This dividend is consistent with the
progressive dividend policy, by which the
Board intends to maintain or grow the
dividend each year.
The Board regularly reviews its distribution
policy and its overall financial strategy to
continue to strike a balance between the
interests of the business, our financial
creditors and our shareholders. Having
regard for business investment, funding
the progressive dividend policy and
meeting our debt service obligations, the
Board currently believes it is appropriate
to continue the suspension of the share
repurchase programme which was
announced in October 2012.
Future prospects
As outlined earlier in this Annual Report, our
strategy is focused on innovation, returning
to growth and building a sustainable,
durable and more profitable business.
In support of this, we made certain choices
around our three strategic priorities.
$
0.90
1.90
2.80
Pence
68.7
150.2
218.9
SEK
Payment date
7.81
12 September 2016
16.57
24.38
20 March 2017
As we experience a period of patent
expiries:
> Our immediate priorities are to continue
to drive Product Sales of our on-market
medicines through investment in our
Growth Platforms and our portfolio of
legacy medicines outside of the Growth
Platforms. The Growth Platforms include
products in our three main therapy areas,
and a focus on the Emerging Markets and
Japan. We are also pursuing business
development and investment in R&D.
We have already accelerated a number
of projects and progressed them into
Phase III development.
> Our late-stage pipeline is progressing
ahead of plans. Our science-driven,
collaborative culture is driving increased
R&D productivity.
> Our long-term aspiration, in line with our
strategic ambition, is to achieve scientific
leadership and sustainable growth.
We expect 2017 Total Revenue to decline
by low to mid single-digit percent at CER
compared to 2016. Core R&D costs as a
percentage of Total Revenue are expected
to be broadly in line with 2016. We are also
anticipating a further reduction in Core
SG&A costs in 2017 versus 2016. Core
earnings per share is expected to decrease
in 2017 by low to mid teens percent at CER.
This guidance reflects a significantly higher
expected effective Core tax rate of 16 to
20% (2016: 11%).
Financial risk management
Financial risk management policies
Insurance
Our risk management processes are
described in Risk overview from page 20.
These processes enable us to identify
risks that can be partly or entirely mitigated
through the use of insurance. We negotiate
the best available premium rates with
insurance providers on the basis of our
extensive risk management procedures.
We focus our insurance resources on the
most critical areas, or where there is a
legal requirement, and where we can get
best value for money. Risks to which we
pay particular attention include business
interruption, directors’ and officers’ liability,
and property damage. Insurance for
product liability has not been available on
commercially acceptable terms for several
years and we have not purchased in the
market product liability insurance since
February 2006.
Taxation
Our approach to managing tax risk is
integrated with our broader business
risk management and compliance
framework. Our approach is to manage
tax risks and tax costs in a manner
consistent with applicable regulatory
requirements and with shareholders’ best
long-term interests, taking into account
operational, economic and reputational
factors. We manage tax risks in the context
of substantive business transactions.
Treasury
The principal financial risks to which we
are exposed are those arising from liquidity,
interest rate, foreign currency and credit.
We have a centralised treasury function to
manage these risks in accordance with
Board-approved policies. Specifically,
liquidity risk is managed through maintaining
access to a number of sources of funding
to meet anticipated funding requirements,
including committed bank facilities and cash
resources. Interest rate risk is managed
through maintaining a debt portfolio that
is weighted towards fixed rates of interest.
Accordingly, our net interest charge is not
significantly affected by movements in
floating rates of interest. We monitor the
impact of currency on a portfolio basis
(to recognise correlation effect), and may
hedge to protect against significant adverse
impacts on cash flow over the short- to
medium-term. We also hedge the currency
76
AstraZeneca Annual Report and Form 20-F Information 2016
exposure that arises between the booking
and settlement dates on non-local currency
purchases and sales by subsidiaries and
the external dividend.
Credit risk is managed through setting and
monitoring credit limits appropriate for the
assessed risk of the counterparty.
Our capital and risk management objectives
and policies are described in further detail
in Note 26 to the Financial Statements
from page 177 and in Risk overview from
page 20. Sensitivity analysis of the Group’s
exposure to exchange rate and interest rate
movements is also detailed in Note 26 to
the Financial Statements from page 177.
Critical accounting policies
and estimates
Our Financial Statements are prepared in
accordance with IFRSs as adopted by the
EU (adopted IFRS) and as issued by the
IASB, and the accounting policies employed
are set out in the Group Accounting Policies
section in the Financial Statements from
page 142. In applying these policies, we
make estimates and assumptions that
affect the Reported amounts of assets and
liabilities and disclosure of contingent assets
and liabilities. The actual outcome could
differ from those estimates. Some of these
policies require a high level of judgement
because the areas are especially subjective
or complex. We believe that the most critical
accounting policies and significant areas of
judgement and estimation are in:
> revenue recognition
> research and development
> business combinations and contingent
consideration
> impairment testing of goodwill and
intangible assets
> litigation
> post-retirement benefits
> taxation.
Revenue recognition
Product Sales are recorded at the invoiced
amount (excluding inter-company sales
and value-added taxes) less movements
in estimated accruals for rebates and
chargebacks given to managed-care and
other customers and product returns – a
particular feature in the US. It is the Group’s
policy to offer a credit note for all returns
and to destroy all returned stock in all
markets. Cash discounts for prompt
payment are also deducted from sales.
Revenue is recognised at the point of
delivery, which is usually when title passes
to the customer, either on shipment or
on receipt of goods by the customer
depending on local trading terms.
Rebates, chargebacks and returns
in the US
When invoicing Product Sales in the US, we
estimate the rebates and chargebacks that
we expect to pay. These rebates typically
arise from sales contracts with third party
managed-care organisations, hospitals,
long-term care facilities, group purchasing
organisations and various federal or
state programmes (Medicaid contracts,
supplemental rebates etc). They can be
classified as follows:
> Chargebacks, where we enter into
arrangements under which certain
parties, typically hospitals, long-term care
facilities, group purchasing organisations,
the Department of Veterans Affairs, Public
Health Service Covered Entities and the
Department of Defense, are able to buy
products from wholesalers at the lower
prices we have contracted with them.
The chargeback is the difference between
the price we invoice to the wholesaler
and the contracted price charged by
the wholesaler to the other party.
Chargebacks are credited directly to
the wholesalers.
> Regulatory, including Medicaid and other
federal and state programmes, where we
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
pay rebates based on the specific terms
of agreements with the US Department
of Health and Human Services and with
individual states, which include product
usage and information on best prices
and average market prices benchmarks.
> Contractual, under which entities such as
third party managed-care organisations
are entitled to rebates depending on
specified performance provisions,
which vary from contract to contract.
The effects of these deductions on our
US pharmaceuticals revenue and the
movements on US pharmaceuticals revenue
provisions are set out overleaf.
Accrual assumptions are built up on a
product-by-product and customer-by-
customer basis, taking into account specific
contract provisions coupled with expected
performance, and are then aggregated
into a weighted average rebate accrual
rate for each of our products. Accrual rates
are reviewed and adjusted on a monthly
basis. There may be further adjustments
when actual rebates are invoiced based
on utilisation information submitted to us
(in the case of contractual rebates) and
claims/invoices are received (in the case
of regulatory rebates and chargebacks).
We believe that we have made reasonable
estimates for future rebates using a similar
methodology to that of previous years.
Inevitably, however, such estimates involve
judgements on aggregate future sales
levels, segment mix and the customers’
contractual performance.
Overall adjustments between gross and net
US Product Sales amounted to $12,275
million in 2016 (2015: $14,167 million) with
the decrease driven by an overall reduction
in our US Product Sales.
Cash discounts are offered to
customers to encourage prompt
payment. Accruals are calculated based
on historical experience and are adjusted
to reflect actual experience.
AstraZeneca Annual Report and Form 20-F Information 2016
77
Strategic Report Financial Review
Financial Review continued
Gross to net Product Sales – US pharmaceuticals
Gross Product Sales
Chargebacks
Regulatory – Medicaid and state programmes
Contractual – Managed-care and Medicare
Cash and other discounts
Customer returns
US Branded Pharmaceutical Fee
Other
Net Product Sales
Movement in provisions – US pharmaceuticals
Chargebacks
Regulatory – Medicaid and state programmes
Contractual – Managed-care and Medicare
Cash and other discounts
Customer returns
US Branded Pharmaceutical Fee
Other
Total
Chargebacks
Regulatory – Medicaid and state programmes
Contractual – Managed-care and Medicare
Cash and other discounts
Customer returns
US Branded Pharmaceutical Fee
Other
Total
Chargebacks
Regulatory – Medicaid and state programmes
Contractual – Managed-care and Medicare
Cash and other discounts
Customer returns
US Branded Pharmaceutical Fee
Other
Total
78
AstraZeneca Annual Report and Form 20-F Information 2016
2016
$m
19,640
(3,449)
(1,903)
(5,219)
(358)
(130)
(145)
(1,071)
7,365
2015
$m
23,641
(2,985)
(1,714)
(7,543)
(472)
(333)
(174)
(946)
2014
$m
23,414
(2,794)
(1,389)
(7,730)
(436)
(295)
(113)
(537)
9,474
10,120
Brought
forward at
1 January
2016
$m
Provision for
current year
$m
Adjustment in
respect of
prior years
$m
Returns and
payments
$m
Carried
forward at
31 December
2016
$m
324
777
2,206
44
467
264
186
4,268
Brought
forward at
1 January
2015
$m
457
707
2,366
33
318
245
163
3,470
1,976
5,517
358
130
195
1,071
12,717
(21)
(73)
(298)
–
–
(50)
–
(3,211)
(1,873)
(5,982)
(396)
(124)
(149)
(1,096)
562
807
1,443
6
473
260
161
(442)
(12,831)
3,712
Provision for
current year
$m
3,019
Adjustment in
respect of
prior years
$m
(34)
Returns and
payments
$m
(3,118)
Carried
forward at
31 December
2015
$m
324
1,809
7,666
464
349
206
947
(95)
(123)
8
(16)
(32)
(1)
(1,644)
(7,703)
(461)
(184)
(155)
(923)
777
2,206
44
467
264
186
4,289
14,460
(293)
(14,188)
4,268
Recognition of
US Branded
Pharmaceutical
Fee as a
revenue
deduction
$m
–
Brought
forward at
1 January
2014
$m
355
784
1,714
32
222
–
74
3,181
–
–
–
–
132
–
132
Provision for
current year
$m
2,838
Adjustment in
respect of
prior years
$m
(44)
Returns and
payments
$m
(2,692)
Carried
forward at
31 December
2014
$m
457
1,544
7,703
436
295
113
537
(155)
27
–
–
–
–
(1,466)
(7,078)
(435)
(199)
–
(448)
707
2,366
33
318
245
163
13,466
(172)
(12,318)
4,289
Industry practice in the US allows
wholesalers and pharmacies to return
unused stocks within six months of, and
up to 12 months after, shelf-life expiry.
The customer is credited for the returned
product by the issuance of a credit note.
Returned products are not exchanged for
products from inventory and once a return
claim has been determined to be valid and a
credit note has been issued to the customer,
the returned products are destroyed. At
the point of sale in the US, we estimate the
quantity and value of products which may
ultimately be returned. Our returns accruals
in the US are based on actual experience.
Our estimate is based on the preceding 12
months for established products together
with market-related information, such as
estimated stock levels at wholesalers and
competitor activity, which we receive via
third party information services. For newly
launched products, we use rates based on
our experience with similar products or a
pre-determined percentage.
For products facing generic competition,
we may lose the ability to estimate the
levels of returns from wholesalers with the
same degree of precision that we can for
products still subject to patent protection.
This is because we may have limited or no
insight into a number of areas: the actual
timing of the generic launch (for example, a
generic manufacturer may or may not have
produced adequate pre-launch inventory);
the pricing and marketing strategy of the
competitor; the take-up of the generic; and
(in cases where a generic manufacturer has
approval to launch only one dose size in
a market of several dose sizes) the likely
level of switching from one dose to another.
Under our accounting policy, revenue
is recognised only when the amount
of the revenue can be measured reliably.
Our approach in meeting this condition
for products facing generic competition
will vary from product to product depending
on the specific circumstances.
The adjustment in respect of prior years
increased 2016 net US pharmaceuticals
revenue by 6.0% (2015: 3.1%; 2014:
1.7%). However, taking into account the
adjustments affecting both the current and
the prior year, 2015 revenue would have
been increased by 1.6% and 2014 revenue
would have been increased by 1.2%, by
adjustments between years.
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We have distribution service agreements
with major wholesaler buyers which serve
to reduce the speculative purchasing
behaviour of the wholesalers and reduce
short-term fluctuations in the level of
inventory they hold. We do not offer
any incentives to encourage wholesaler
speculative buying and attempt, where
possible, to restrict shipments to underlying
demand when such speculation occurs.
Component revenue accounting
A consequence of charging all internal
R&D expenditure to the income statement
in the year in which it is incurred (which
is normal practice in the pharmaceutical
industry) is that we own valuable intangible
assets which are not recorded on the
balance sheet. We also own acquired
intangible assets which are included on the
balance sheet. As detailed on page 67, our
externalisation business model means that,
from time to time, we sell such assets and
generate income. Sales of product lines
are often accompanied by an agreement
on our part to continue manufacturing the
relevant product for a reasonable period
(often about two years) while the purchaser
constructs its own manufacturing facilities.
The contracts typically involve the receipt
of an upfront payment, which the contract
attributes to the sale of the intangible assets,
and ongoing receipts, which the contract
attributes to the sale of the product we
manufacture. In cases where the transaction
has two or more components, we account
for the delivered item (for example, the
transfer of title to the intangible asset) as
a separate unit of accounting and record
revenue on delivery of that component,
provided that we can make a reasonable
estimate of the fair value of the undelivered
component. Where the fair market value of
the undelivered component (for example,
a manufacturing agreement) exceeds the
contracted price for that component, we
defer an appropriate element of the upfront
consideration and amortise this over the
performance period. However, where
the fair market value of the undelivered
component is equal to or lower than the
contracted price for that component, we
treat the whole of the upfront amount
as being attributable to the delivered
intangible assets and recognise that part
of the revenue upon delivery. No element
of the contracted revenue related to the
undelivered component is allocated to the
sale of the intangible asset. This is because
the contracted revenue relating to the
undelivered component is contingent on
future events (such as sales) and so cannot
be anticipated.
Research and development
Our business model includes investment
in targeted business developments to
strengthen our portfolio, pipeline and
capabilities. These business development
transactions include collaborations, asset
in-licences and business acquisitions.
Each transaction is considered to
establish whether it qualifies as a business
combination by applying the criteria
assessment detailed in IFRS 3 ‘Business
Combinations’.
On the acquisition of a business, fair values
are attributed to the identifiable assets and
liabilities and contingent liabilities unless
the fair value cannot be measured reliably,
in which case the value is subsumed into
goodwill. Goodwill is the difference between
the fair value of the consideration and the fair
value of net assets acquired. Fair value is the
price that would be received to sell an asset
or pay for a liability in an orderly transaction
at the date of acquisition. The price may
be directly observable but in most cases is
estimated using valuation techniques which
normally involve predicting future cash flows
and applying a market participant discount
rate. Further details of our recent business
acquisitions are included in Note 25 to the
Financial Statements from page 173.
Future contingent elements of consideration,
which may include development and launch
milestones, revenue threshold milestones
and revenue-based royalties, are fair valued
at the date of acquisition using decision-tree
analysis with key inputs including probability
of success, consideration of potential
delays and revenue projections based on
the Group’s internal forecasts. Unsettled
amounts of consideration are held at fair
value within payables with changes in fair
value recognised immediately in profit.
Several of our recent business combinations
have included significant amounts of
contingent consideration. Details of
the movements in the fair value of the
contingent consideration in the year, and the
range of possible contingent consideration
amounts that may eventually become
payable are contained in Note 18
to the Financial Statements on page 164.
AstraZeneca Annual Report and Form 20-F Information 2016
79
Strategic Report Financial Review
Financial Review continued
Where not all of the equity of a subsidiary
is acquired, the non-controlling interest
is recognised either at fair value or at the
non-controlling interest’s proportionate
share of the net assets of the subsidiary,
on a case-by-case basis. Put options over
non-controlling interests are recognised as
a financial liability measured at amortised
cost, with a corresponding entry in either
retained earnings or against non-controlling
interest reserves on a case-by-case basis.
Impairment testing of goodwill
and intangible assets
As detailed above, we have significant
investments in goodwill and intangible
assets as a result of acquisitions of
businesses and purchases of assets,
such as product development and
marketing rights.
Details of the estimates and assumptions
we make in our annual impairment testing
of goodwill are included in Note 8 to the
Financial Statements on page 156. The
Group, including acquisitions, is considered
a single cash-generating unit for impairment
purposes. No impairment of goodwill
was identified.
Impairment reviews have been carried
out on all intangible assets that are in
development (and not being amortised),
all major intangible assets acquired during
the year and all intangible assets that have
had indications of impairment during the
year. Sales forecasts and specific allocated
costs (which have both been subject to
appropriate senior management sign-
off) are discounted using appropriate
rates based on our risk-adjusted, pre-tax
weighted average cost of capital. Our
weighted average cost of capital reflects
factors such as our capital structure
and our costs of debt and equity. In
building to the range of rates used in
our internal investment appraisal of future
projects and capital investment decisions,
we adjust our weighted average cost
of capital for other factors which reflect,
without limitation, local matters such
as risk on a case-by-case basis.
A significant portion of our investments
in intangible assets and goodwill arose
from the restructuring of the joint venture
with Merck in 1998, the acquisition of
MedImmune in 2007, and the payments
arising from the restructuring of the joint
venture with Merck in the US. In addition,
our recent business combinations,
as detailed in Note 25 to the Financial
Statements from page 173, have added
significant product, marketing and
distribution intangible rights to our intangible
asset portfolio. We are satisfied that the
carrying values of our intangible assets
as at 31 December 2016 are fully justified
by estimated future cash flows. The
accounting for our intangible assets is
fully explained in Note 9 to the Financial
Statements from page 157.
Further details of the estimates and
assumptions we make in impairment testing
of intangible assets are included in Note 9
to the Financial Statements.
Litigation
In the normal course of business, contingent
liabilities may arise from product-specific
and general legal proceedings, from
guarantees or from environmental liabilities
connected with our current or former
sites. Where we believe that potential
liabilities have a less than 50% probability
of crystallising, or where we are unable to
make a reasonable estimate of the liability,
we treat them as contingent liabilities. These
are not provided for but are disclosed in
Note 28 to the Financial Statements from
page 185.
In cases that have been settled or
adjudicated, or where quantifiable fines and
penalties have been assessed and which
are not subject to appeal (or other similar
forms of relief), or where a loss is probable
(more than 50% assessed probability) and
we are able to make a reasonable estimate
of the loss, we indicate the loss absorbed
or the amount of the provision accrued.
Where it is considered that the Group is
more likely than not to prevail, or in the
rare circumstances where the amount
of the legal liability cannot be estimated
reliably, legal costs involved in defending
the claim are charged to profit as they are
incurred. Where it is considered that we
have a valid contract which provides the
right to reimbursement (from insurance or
otherwise) of legal costs and/or all or part
of any loss incurred or for which a provision
has been established and we consider
recovery to be virtually certain, then the
best estimate of the amount expected
to be received is recognised as an asset.
Assessments as to whether or not to
recognise provisions or assets and of
the amounts concerned usually involve a
series of complex judgements about future
events and can rely heavily on estimates
and assumptions. We believe that the
provisions recorded are adequate based
on currently available information and that
the insurance recoveries recorded will
be received. However, given the inherent
uncertainties involved in assessing the
outcomes of these cases and in estimating
the amount of the potential losses and
the associated insurance recoveries, we
could in future periods incur judgments or
insurance settlements that could have a
material adverse effect on our results in any
particular period.
The position could change over time, and
there can, therefore, be no assurance that
any losses that result from the outcome of
any legal proceedings will not exceed the
amount of the provisions that have been
booked in the accounts.
Although there can be no assurance
regarding the outcome of legal proceedings,
we do not currently expect them to have
a material adverse effect on our financial
position, but they could significantly affect
our financial results in any particular period.
Post-retirement benefits
We offer post-retirement benefit plans
which cover many of our employees around
the world. In keeping with local terms and
conditions, most of these plans are defined
contribution in nature, where the resulting
income statement charge is fixed at a set
level or is a set percentage of employees’
pay. However, several plans, mainly in the
UK (which has by far the largest single
scheme), the US, Sweden and Germany
are defined benefit plans where benefits
are based on employees’ length of service
and final salary (typically averaged over
one, three or five years). The UK and US
defined benefit schemes were closed to
new entrants in 2000. All new employees
in these countries are offered defined
contribution schemes.
In applying IAS 19 ‘Employee Benefits’,
we recognise all actuarial gains and losses
immediately through Other Comprehensive
Income. Investment decisions in respect
of defined benefit schemes are based
on underlying actuarial and economic
circumstances with the intention of ensuring
80
AstraZeneca Annual Report and Form 20-F Information 2016
that the schemes have sufficient assets
to meet liabilities as they fall due, rather
than meeting accounting requirements.
The trustees follow a strategy of awarding
mandates to specialist, active investment
managers, which results in a broad
diversification of investment styles and
asset classes. The investment approach is
intended to produce less volatility in the plan
asset returns.
In assessing the discount rate applied
to the obligations, we have used rates
on AA corporate bonds with durations
corresponding to the maturities of those
obligations, except in Sweden where we
have used rates on mortgage bonds as the
market in high quality corporate bonds is
insufficiently deep.
In all cases, the pension costs recorded in
the Financial Statements are assessed in
accordance with the advice of independent
qualified actuaries, but require the exercise
of significant judgement in relation to
assumptions for long-term price inflation,
and future salary and pension increases.
Further details of our accounting for post-
retirement benefit plans are included in
Note 20 to the Financial Statements from
page 165.
Taxation
Accruals for tax contingencies require
management to make judgements and
estimates of exposures in relation to tax
audit issues. Tax benefits are not recognised
unless the tax positions will probably be
sustained based upon management’s
interpretation of applicable laws and
regulations and the likelihood of settlement.
Once considered to be probable,
management reviews each material tax
benefit to assess whether a provision
should be taken against full recognition
of the benefit on the basis of potential
settlement through negotiation and/or
litigation. Accruals for tax contingencies are
measured using the single best estimate
of likely outcome approach. Any liability to
interest on tax liabilities is provided for in the
tax charge.
We face a number of audits in jurisdictions
around the world and, in some cases, are in
dispute with the tax authorities. The issues
under discussion are often complex and
can require many years to resolve.
Further details of the estimates and
assumptions we make in determining
our recorded liability for transfer pricing
contingencies and other tax contingencies
are included in the Tax section of Note 28 to
the Financial Statements from page 185.
Strategic Report
The Strategic Report, which has been
prepared in accordance with the
requirements of the Companies Act
2006, comprises the following sections:
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> AstraZeneca at a glance
> Chief Executive Officer’s Review
> Strategy, including Risk overview
> Therapy Area Review
> Business Review
> Resources Review
> Financial Review
and has been approved and signed
on behalf of the Board.
A C N Kemp
Company Secretary
2 February 2017
Sarbanes-Oxley Act Section 404
As a consequence of our NYSE listing,
we are required to comply with those
provisions of the Sarbanes-Oxley Act
applicable to foreign issuers. Section
404 of the Sarbanes-Oxley Act requires
companies annually to assess and make
public statements about the quality and
effectiveness of their internal control over
financial reporting. As regards Sarbanes-
Oxley Act Section 404, our approach is
based on the Committee of Sponsoring
Organizations (COSO) 2013 framework.
Our approach to the assessment has
been to select key transaction and financial
reporting processes in our largest operating
units and a number of specialist areas,
(eg financial consolidation and reporting,
treasury operations and taxation etc),
so that, in aggregate, we have covered
a significant proportion of the key lines in
our Financial Statements. Each of these
operating units and specialist areas has
ensured that its relevant processes and
controls are documented to appropriate
standards, taking into account, in particular,
the guidance provided by the SEC. We
have also reviewed the structure and
operation of our ‘entity level’ control
environment. This refers to the overarching
control environment, including structure
of reviews, checks and balances that are
essential to the management of a well-
controlled business.
The Directors have concluded that our
internal control over financial reporting
is effective at 31 December 2016 and
the assessment is set out in the Directors’
Responsibilities for, and Report on,
Internal Control over Financial Reporting
on page 133. KPMG LLP has audited the
effectiveness of our internal control over
financial reporting at 31 December 2016
and, as noted in the Auditor’s Reports on
the Financial Statements and on Internal
Control over Financial Reporting (Sarbanes-
Oxley Act Section 404) on page 134, their
report is unqualified.
AstraZeneca Annual Report and Form 20-F Information 2016
81
Corporate Governance
Chairman’s Statement
AstraZeneca’s
Directors take
very seriously their
responsibility to have
a robust governance
structure in place.”
the cycle of innovation. We need to
work hard to continue to improve R&D
productivity by carefully selecting those
therapy areas and projects in which we
invest, as well as controlling costs.
Returns to shareholders and outlook
In 2016, Reported earnings per share
(EPS) of $2.77 for the year represented an
increase of 9%, including a gain of $0.76
on the revaluation of acquisition-related
liabilities. Core EPS in the year declined by
5% to $4.31, driven by the decline in Total
Revenue. Both Reported and Core EPS for
the year included a non-recurring benefit of
$0.36, following agreements between the
Canadian tax authority and the UK and
Swedish tax authorities.
Given this performance, the Board was able
to declare a second interim dividend of
$1.90 per share (150.2 pence, 16.57 SEK)
bringing the dividend per share for the full
year to $2.80 (218.9 pence, 24.38 SEK).
At the same time, the Board reaffirmed its
commitment to the Company’s progressive
dividend policy.
Sound governance
AstraZeneca’s Directors take very seriously
their responsibility to have a robust
governance structure in place to ensure
that we are able properly to discharge
our responsibilities in setting our strategy,
as well as monitoring and reviewing
progress as it is implemented, and ensuring
that we manage our risks and carry out
business responsibly.
We are also very conscious that, as
Directors, we are accountable to our
shareholders and must have regard to
In 2016, your Board of DDDiirreeccccttttoooorrrrss ccooontinued to focus
on imppllementing the sttttrraatteeggggyyyy uuuuppooon which we
embarrked in 2013, as wwwweellll aaaassss eeeennsssuring that our
progrreess was underpinnnnneeeedddd bbbbbyyyy gggood governance.
Strategic progress
As reported by Pascal Soriot, our Chief
Executive Officer, we made good progress
in delivering our strategic priorities in 2016.
During the year, we brought a sharper
focus to our three main therapy areas
and boosted pipeline productivity further.
As is to be expected, we encountered
some setbacks on the way but our
underlying business is growing and a new
AstraZeneca is emerging, driven by our
competitive franchises and our businesses
in Emerging Markets.
As Marc Dunoyer, our Chief Financial
Officer, outlines, our financial results for
2016 were in line with expectations and
reflected the ongoing transition of our
Company. The fall in Product Sales revenue
was primarily due to the entry of generic
competition to Crestor in the US. We now
look ahead to the impact of our recent
launches as well as the future launches that
are to come from our late-stage pipeline.
Each year the Board reviews our strategy.
Our review in 2016 confirmed our belief that
2017 has the potential to be a defining year
for AstraZeneca as we bring new medicines
to patients across the globe. We have the
opportunity to launch several life-changing
medicines for cancer, respiratory and
metabolic diseases.
An uncertain world
Our performance in 2016 and in the year
ahead takes place in an uncertain world.
The economic recovery following the global
financial crisis is still precarious and is
fuelling calls for restrictions on trade and
immigration. In the UK, following the vote
for ‘Brexit’, we expect increased uncertainty
both in the UK and the Eurozone. In
the US, we expect the increased focus
on pharmaceutical prices and their impact
on healthcare costs to continue, while
there remains uncertainty over the future
of the Affordable Care Act and what might
replace it.
On the other hand, and against this
uncertain background, we believe the
demand for healthcare will continue to
increase with a growing and ageing world
population. Access to our range of
innovative medicines also continues to
improve. Of course, challenges will always
remain in what is a very competitive
marketplace. These include the continuing,
and planned for, cycle of expiring patents
that lie at the heart of our business model,
as well as competition from and the
growing use of generic medicines. We
need to obtain regulatory approval for new
medicines, secure reimbursement for those
medicines, and achieve pricing and sales
sufficient to generate revenue and sustain
82
AstraZeneca Annual Report and Form 20-F Information 2016
Compliance with the UK Corporate Governance Code
We have prepared this Annual Report
with reference to the UK Corporate
Governance Code published by the
UK Financial Reporting Council (FRC)
in September 2014.
This Corporate Governance Report
(together with other sections of this
Annual Report) describes how we apply
the main principles of good governance
in the UK Corporate Governance Code.
We have complied throughout the
accounting period with the provisions
of the UK Corporate Governance Code,
which is available on the FRC’s website.
www.frc.org.uk
other stakeholders such as employees,
customers, suppliers, the communities in
which we do business and the environment.
We welcome the opportunity at our Annual
General Meeting to meet and answer
shareholders’ questions. We also maintain
an active dialogue with shareholders
throughout the year and listen to views of
representatives of investors and financial
institutions. The views of other stakeholders
are also important.
During the year we said farewell to two
members of the Board. Jean-Philippe
Courtois stood down from the Board
on 1 December. He was approaching
nine years’ tenure and had recently taken
on new responsibilities at Microsoft.
We will miss his business acumen,
extensive experience of the global
technology industry, common sense
and collegiality. We wish him all the best
for his future endeavours.
We maintain an active dialogue with
shareholders about executive remuneration.
Our pay structure is intended to be sufficient
to attract and retain high-calibre individuals
in order to deliver the Company’s strategy.
In setting individual pay levels, we consider
the individual’s skills and experience, internal
relativities and conditions in the local
external market. Over the course of 2016,
we have reviewed our Remuneration
Policy and in his introduction to this year’s
Directors’ Remuneration Report on page
103, Graham Chipchase, Chairman of the
Remuneration Committee, gives more
details about the changes we are proposing
and why. We are grateful to those who
contributed to the review and the Board
commends the revised Remuneration Policy
to shareholders for approval.
Board changes
I am grateful to Graham and all the
Directors for their contribution during 2016,
especially those of my other colleagues
who have the added responsibility of
chairing Board Committees: Rudy
Markham, our Senior independent
Non-Executive Director, who chairs the
Audit Committee and Bruce Burlington
who chairs the Science Committee.
Earlier in the year, Dr Cornelia (Cori)
Bargmann, also stood down from the
Board after accepting a new position as
President of Chan Zuckerberg Science,
part of the Chan Zuckerberg Initiative.
We congratulate Cori on her new
appointment and thank her for her
contribution to AstraZeneca.
Searches for new Non-Executive Directors
are continuing and succession plans will be
announced during 2017.
A sustainable business
As we look ahead and plan for the
sustainable growth of AstraZeneca, how
we operate is as important as what we do.
It is therefore particularly gratifying to see
increasing external recognition of our efforts
to operate in a sustainable way and in a
way that recognises the interconnection
between business growth, the needs of
society, and the limitations of our planet.
This means delivering our business
strategy so that access to our medicines is
broadened, the environmental footprint of
our products and processes is minimised,
and ethics and transparency underpin
everything we do.
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In the annual Dow Jones Sustainability
Index, we improved our score compared
with 2015 and came second in the
‘Pharmaceuticals, Biotechnology and Life
Sciences’ industry group. We also achieved
an A-list ranking for climate change, supplier
climate change and water stewardship by
investor benchmarking organisation CDP.
In the biennial Access to Medicine Index,
our efforts to improve access to our
innovative medicines and to healthcare
more generally was recognised in
AstraZeneca being the biggest riser in the
Index since the last survey. We moved to
7th place in 2016 from 15th in 2014 and
were recognised for multiple best practices
and innovations.
Life-changing medicines
In 2016, we made good progress pushing
the boundaries of science to deliver
medicines to patients. Your Board of
Directors remains focused on ensuring
that more patients are able to benefit
from our expanding portfolio of innovative
medicines that meet unmet medical
need and change lives.
Leif Johansson
Chairman
AstraZeneca Annual Report and Form 20-F Information 2016
83
Corporate Governance
Corporate Governance Overview
How our governance supports the delivery of our strategy.
Board
Audit Committee
Remuneration Committee
Chairman: Leif Johansson
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All Directors are collectively responsible for the success of the Group.
(cid:55)(cid:75)(cid:72)(cid:98)(cid:49)(cid:82)(cid:81)(cid:16)(cid:40)(cid:91)(cid:72)(cid:70)(cid:88)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:39)(cid:76)(cid:85)(cid:72)(cid:70)(cid:87)(cid:82)(cid:85)(cid:86)(cid:3)(cid:72)(cid:91)(cid:72)(cid:85)(cid:70)(cid:76)(cid:86)(cid:72)(cid:3)(cid:76)(cid:81)(cid:71)(cid:72)(cid:83)(cid:72)(cid:81)(cid:71)(cid:72)(cid:81)(cid:87)(cid:15)(cid:3)(cid:82)(cid:69)(cid:77)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:77)(cid:88)(cid:71)(cid:74)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)
(cid:76)(cid:81)(cid:98)(cid:85)(cid:72)(cid:86)(cid:83)(cid:72)(cid:70)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:37)(cid:82)(cid:68)(cid:85)(cid:71)(cid:3)(cid:71)(cid:72)(cid:70)(cid:76)(cid:86)(cid:76)(cid:82)(cid:81)(cid:86)(cid:15)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:86)(cid:70)(cid:85)(cid:88)(cid:87)(cid:76)(cid:81)(cid:76)(cid:86)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:70)(cid:75)(cid:68)(cid:79)(cid:79)(cid:72)(cid:81)(cid:74)(cid:72)(cid:3)(cid:80)(cid:68)(cid:81)(cid:68)(cid:74)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:17)(cid:3)
They also have various responsibilities concerning the integrity of
(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:76)(cid:81)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:15)(cid:3)(cid:76)(cid:81)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:79)(cid:3)(cid:70)(cid:82)(cid:81)(cid:87)(cid:85)(cid:82)(cid:79)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:85)(cid:76)(cid:86)(cid:78)(cid:3)(cid:80)(cid:68)(cid:81)(cid:68)(cid:74)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:17)
The Board is responsible for setting our strategy and policies, overseeing
risk and corporate governance, and monitoring progress towards meeting
our objectives and annual plans. It is accountable to our shareholders for
the proper conduct of the business and our long-term success, and
represents the interests of all stakeholders.
The Board conducts an annual review of the Group’s overall strategy.
The CEO, CFO and Senior Executive Team (SET) take the lead in
developing our strategy, which is then reviewed, constructively challenged
and approved by the Board.
The Board has delegated some of its powers to the CEO and operates with
the assistance of four Committees.
Members of the Board and their biographies are shown on pages 86 and 87.
Chairman: Rudy Markham
Chairman: Graham Chipchase
The Remuneration Committee
considers and sets, on behalf
(cid:82)(cid:73)(cid:98)(cid:87)(cid:75)(cid:72)(cid:3)(cid:37)(cid:82)(cid:68)(cid:85)(cid:71)(cid:15)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:85)(cid:72)(cid:80)(cid:88)(cid:81)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)
(including pension rights and
compensation payments) of
Executive Directors and other
senior executives. No Director
(cid:76)(cid:86)(cid:98)(cid:76)(cid:81)(cid:89)(cid:82)(cid:79)(cid:89)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:71)(cid:72)(cid:70)(cid:76)(cid:71)(cid:76)(cid:81)(cid:74)(cid:3)(cid:75)(cid:76)(cid:86)(cid:3)(cid:82)(cid:85)(cid:3)(cid:75)(cid:72)(cid:85)(cid:3)
own remuneration.
The Audit Committee provides
assurance to the Board in the
following areas: the integrity
(cid:82)(cid:73)(cid:98)(cid:82)(cid:88)(cid:85)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:85)(cid:72)(cid:83)(cid:82)(cid:85)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)
(cid:76)(cid:81)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:79)(cid:3)(cid:70)(cid:82)(cid:81)(cid:87)(cid:85)(cid:82)(cid:79)(cid:86)(cid:3)(cid:82)(cid:89)(cid:72)(cid:85)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)
matters; our internal controls over
(cid:81)(cid:82)(cid:81)(cid:16)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:80)(cid:68)(cid:87)(cid:87)(cid:72)(cid:85)(cid:86)(cid:30)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:79)(cid:76)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)
with laws and our Code of
Conduct; the quality of the
Company’s relationship with
(cid:76)(cid:87)(cid:86)(cid:98)(cid:72)(cid:91)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:79)(cid:3)(cid:68)(cid:88)(cid:71)(cid:76)(cid:87)(cid:82)(cid:85)(cid:30)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:85)(cid:82)(cid:79)(cid:72)(cid:15)(cid:3)
(cid:85)(cid:72)(cid:86)(cid:82)(cid:88)(cid:85)(cid:70)(cid:72)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:81)(cid:72)(cid:86)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)
(cid:87)(cid:75)(cid:72)(cid:98)(cid:38)(cid:82)(cid:80)(cid:83)(cid:68)(cid:81)(cid:92)(cid:350)(cid:86)(cid:3)(cid:76)(cid:81)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:79)(cid:3)(cid:68)(cid:88)(cid:71)(cid:76)(cid:87)(cid:3)
(cid:73)(cid:88)(cid:81)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:30)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:81)(cid:72)(cid:86)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)
the Company’s risk management
framework, in each case with the
ultimate aim of protecting our
shareholders’ interests.
Corporate Governance Report from page 90
Audit Committee Report from
page 98
Directors’ Remuneration
Report from page 103
Board Committee membership and meeting attendance in 2016
Name
Cori Bargmann²
Geneviève Berger
Bruce Burlington
Ann Cairns
Graham Chipchase
Jean-Philippe Courtois³
Marc Dunoyer
Leif Johansson
Rudy Markham
Pascal Soriot
Shriti Vadera
Marcus Wallenberg
Board
(cid:22)(cid:3)8(9)
(cid:22)(cid:3)11(11)
(cid:22)(cid:3)10(11)
(cid:22)(cid:3)8(11)
(cid:22)(cid:3)11(11)
(cid:22)(cid:3)8(10)
(cid:22)(cid:3)11(11)
Chairman 11(11)
(cid:22) 11(11)
(cid:22)(cid:3)11(11)
(cid:22)(cid:3)11(11)
(cid:22)(cid:3)9(11)
Audit
Remuneration
(cid:22)(cid:3)5(5)
(cid:22)(cid:3)4(5)
(cid:22)(cid:3)4(4)
Chairman 5(5)
(cid:22)(cid:3)5(5)
Chairman 5(5)
(cid:22)(cid:3)4(5)
(cid:22)(cid:3)4(5)
(cid:22)(cid:3)5(5)
Nomination
and
Governance
(cid:22)(cid:3)4(4)
(cid:22)(cid:3)4(4)
Chairman 4(4)
(cid:22)(cid:3)4(4)
Science
(cid:22)(cid:3)3(3)
(cid:22)(cid:3)4(4)
Chairman 4(4)
(cid:22)(cid:3)4(4)
Independent1
(cid:22)
(cid:22)
(cid:22)
(cid:22)
(cid:22)
(cid:22)
N/A
N/A4
(cid:22)
N/A
(cid:22)
Note: number in brackets denotes number of meetings during the year that Board members were entitled to attend.
1 As determined by the Board for the purposes of the UK Corporate Governance Code.
2(cid:3) (cid:38)(cid:82)(cid:85)(cid:76)(cid:3)(cid:37)(cid:68)(cid:85)(cid:74)(cid:80)(cid:68)(cid:81)(cid:81)(cid:3)(cid:86)(cid:87)(cid:72)(cid:83)(cid:83)(cid:72)(cid:71)(cid:3)(cid:71)(cid:82)(cid:90)(cid:81)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:37)(cid:82)(cid:68)(cid:85)(cid:71)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:68)(cid:86)(cid:3)(cid:68)(cid:3)(cid:80)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:54)(cid:70)(cid:76)(cid:72)(cid:81)(cid:70)(cid:72)(cid:3)(cid:38)(cid:82)(cid:80)(cid:80)(cid:76)(cid:87)(cid:87)(cid:72)(cid:72)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:20)(cid:3)(cid:50)(cid:70)(cid:87)(cid:82)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:17)
3(cid:3) (cid:45)(cid:72)(cid:68)(cid:81)(cid:16)(cid:51)(cid:75)(cid:76)(cid:79)(cid:76)(cid:83)(cid:83)(cid:72)(cid:3)(cid:38)(cid:82)(cid:88)(cid:85)(cid:87)(cid:82)(cid:76)(cid:86)(cid:3)(cid:86)(cid:87)(cid:72)(cid:83)(cid:83)(cid:72)(cid:71)(cid:3)(cid:71)(cid:82)(cid:90)(cid:81)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:37)(cid:82)(cid:68)(cid:85)(cid:71)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:68)(cid:86)(cid:3)(cid:68)(cid:3)(cid:80)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:36)(cid:88)(cid:71)(cid:76)(cid:87)(cid:3)(cid:38)(cid:82)(cid:80)(cid:80)(cid:76)(cid:87)(cid:87)(cid:72)(cid:72)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:20)(cid:3)(cid:39)(cid:72)(cid:70)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:17)
4 Leif Johansson was considered by the Board to be independent upon his appointment as Chairman. In accordance with the UK Corporate Governance Code, the test of independence is not
appropriate in relation to the Chairman after his appointment.
84
AstraZeneca Annual Report and Form 20-F Information 2016
Nomination and
Governance Committee
Chairman: Leif Johansson
The Nomination and Governance
Committee recommends new
Board appointments for decision
by the Board and, more broadly,
considers succession planning for
senior executive management and
Board positions. The Nomination
and Governance Committee also
(cid:68)(cid:71)(cid:89)(cid:76)(cid:86)(cid:72)(cid:86)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:37)(cid:82)(cid:68)(cid:85)(cid:71)(cid:3)(cid:82)(cid:81)(cid:3)(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)
developments in corporate
governance.
Science Committee
Senior Executive Team
Key governance roles
Chairman: Bruce Burlington
The members of the SET are:
The Science Committee provides
assurance to the Board regarding
the Group’s R&D activities
by reviewing and assessing
our approaches in our chosen
(cid:87)(cid:75)(cid:72)(cid:85)(cid:68)(cid:83)(cid:92)(cid:3)(cid:68)(cid:85)(cid:72)(cid:68)(cid:86)(cid:30)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)
technology and R&D capabilities
we deploy; the quality and
(cid:71)(cid:72)(cid:89)(cid:72)(cid:79)(cid:82)(cid:83)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:82)(cid:88)(cid:85)(cid:98)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:86)(cid:87)(cid:86)(cid:30)(cid:3)
and our decision making.
>CEO
> CFO
(cid:33)(cid:3)(cid:3)(cid:49)(cid:76)(cid:81)(cid:72)(cid:3)(cid:40)(cid:91)(cid:72)(cid:70)(cid:88)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:57)(cid:76)(cid:70)(cid:72)(cid:16)
Presidents (EVPs) from across
the organisation, representing
the three science units, the
(cid:430)(cid:89)(cid:72)(cid:3)(cid:70)(cid:82)(cid:80)(cid:80)(cid:72)(cid:85)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:88)(cid:81)(cid:76)(cid:87)(cid:86)(cid:3)
(including GPPS), Operations
& IT and HR
> General Counsel
(cid:33)(cid:3)(cid:38)(cid:75)(cid:76)(cid:72)(cid:73)(cid:3)(cid:38)(cid:82)(cid:80)(cid:83)(cid:79)(cid:76)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:50)(cid:433)(cid:70)(cid:72)(cid:85)(cid:17)
The SET is the body through
which the CEO exercises the
authority delegated to him
by the Board. It usually meets
monthly and considers major
business issues and makes
recommendations to the CEO,
and typically reviews matters that
are to be submitted to the Board
for its consideration. The CEO
is responsible for establishing
and chairing the SET.
Chairman:
Leadership, operation and
governance of the Board, ensuring
(cid:37)(cid:82)(cid:68)(cid:85)(cid:71)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:81)(cid:72)(cid:86)(cid:86)
CEO:
Responsible to the Board for the
management, development and
performance of the business
Senior independent
(cid:49)(cid:82)(cid:81)(cid:16)(cid:40)(cid:91)(cid:72)(cid:70)(cid:88)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:39)(cid:76)(cid:85)(cid:72)(cid:70)(cid:87)(cid:82)(cid:85)(cid:29)(cid:3)
Acts as a sounding board for the
Chairman and an intermediary for
other Directors and shareholders
when necessary
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Nomination and Governance
Science Committee from
The biographies of SET
Committee from page 93
page 93
members are shown on pages
88 and 89
Gender split of
Directors as at
31 December 2016
Male 7
Female 3
Directors’
nationalities as at
31 December 2016
American 1
British 4
French 3
Swedish 2
Length of tenure of
Non-Executive Directors
Under 3 years 1
Ann Cairns
3–6 years 4
Leif Johansson
Geneviève Berger
Graham Chipchase
Shriti Vadera
6–9 years 2
Bruce Burlington
Rudy Markham
9+ years 1
Marcus Wallenberg
AstraZeneca Annual Report and Form 20-F Information 2016
85
Corporate Governance
Board of Directors
as at 31 December 2016
1
3
5
7
9
2
4
6
8
10
86
AstraZeneca Annual Report and Form 20-F Information 2016
1 Leif Johansson (65)
Non-Executive Chairman of the Board
(April 2012*)
Committee membership Chairman of the
Nomination and Governance Committee and
member of the Remuneration Committee
Skills and experience From 1997 to 2011, Leif was
Chief Executive Officer of AB Volvo. Prior to that, he
served at AB Electrolux, latterly as Chief Executive
Officer from 1994 to 1997. He was a Non-Executive
Director of BMS from 1998 to September 2011,
serving on the Board’s Audit Committee, and
Compensation and Management Development
Committee. He holds an MSc in engineering from
Chalmers University of Technology, Gothenburg.
Other appointments Leif is Chairman of global
telecommunications company, LM Ericsson. He
holds board positions at Autoliv, Inc and Ecolean
AB. He has been a member of the Royal Swedish
Academy of Engineering Sciences since 1994,
serving as Chairman since 2012. Leif is also
a member of the European Round Table of
Industrialists and Chairman of the International
Advisory Board of the Nobel Foundation.
2 Pascal Soriot (57)
Executive Director and CEO (October 2012)
Skills and experience Pascal brings a passion
for science and medicine as well as significant
experience in established and emerging markets,
strength of strategic thinking, a successful track
record of managing change and executing strategy,
and the ability to lead a diverse organisation. He
served as Chief Operating Officer of Roche’s
pharmaceuticals division from 2010 to September
2012 and, prior to that, Chief Executive Officer of
Genentech, a biologics business, where he led its
successful merger with Roche. Pascal joined the
pharmaceutical industry in 1986 and has worked
in senior management roles in numerous major
companies around the world. He is a doctor of
veterinary medicine (École Nationale Vétérinaire
d’Alfort, Maisons-Alfort) and holds an MBA from
HEC, Paris.
3 Marc Dunoyer (64)
Executive Director and CFO (November 2013)
Skills and experience Marc’s career in
pharmaceuticals, which has included periods
with Roussel Uclaf, Hoechst Marion Roussel and
GlaxoSmithKline (GSK), has given him extensive
industry experience, including finance and
accounting; corporate strategy and planning;
research and development; sales and marketing;
business reorganisation; and business development.
Marc is a qualified accountant and joined AstraZeneca
in 2013, serving as Executive Vice-President, GPPS
from June to October 2013. Prior to that, he served
as Global Head of Rare Diseases at GSK and
(concurrently) Chairman, GSK Japan. He holds
an MBA from HEC, Paris and a Bachelor of Law
degree from Paris University.
7 Ann Cairns (59)
Non-Executive Director (April 2014)
9 Shriti Vadera (54)
Non-Executive Director (January 2011)
Committee membership Member of the
Audit Committee
Committee membership Member of the Audit
Committee and the Remuneration Committee
Skills and experience Shriti has significant
knowledge of global finance, emerging markets and
public policy. She has advised governments, banks
and investors on the Eurozone crisis, the banking
sector, debt restructuring and markets. She has
served as a G20 Adviser and a Minister in the UK
Cabinet Office and Business Department and
International Development Department. She has
also served on the Council of Economic Advisers,
HM Treasury, where she focused on business and
international economic issues. Prior to that, Shriti
spent 14 years in investment banking with SG
Warburg/UBS.
Other appointments Shriti is Chairman of
Santander UK plc and Senior Independent Director
of BHP Billiton.
10 Marcus Wallenberg (60)
Non-Executive Director (April 1999)
Committee membership Member of the Science
Committee
Skills and experience Marcus has international
business experience across various industry
sectors, including the pharmaceutical industry
from his directorship with Astra prior to 1999.
Other appointments Marcus is Chairman of
Skandinaviska Enskilda Banken AB, Saab AB and
FAM AB. He is a member of the boards of Investor
AB, Temasek Holdings Limited, and the Knut and
Alice Wallenberg Foundation.
* Date of appointment.
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Skills and experience Ann has more than 20
years’ experience as a senior leader, having held
management positions across Europe and the
US, and has previously run global retail, commercial
and investment banking operations. As president
of International Markets at MasterCard, Ann is
responsible for the management, growth and
expansion of all markets and customer-related
activities outside of North America. Prior to
MasterCard, in 2011, Ann oversaw the European
liquidation of Lehman Brothers Holdings
International and was the Chief Executive,
Transaction Banking at ABN AMRO. In 2017, Ann
will join the board of directors of Intercontinental
Exchange, Inc., a company listed on the New York
Stock Exchange. Ann holds a Pure Mathematics
degree from Sheffield University and an MSc
from Newcastle University. Among her many
accomplishments, Ann has been an award-winning
research engineer and was the first woman qualified
to go offshore in Britain. Ann is a champion of
inclusion – digital, financial and gender – and is also
a member of the World Food Programme
investment committee.
8 Graham Chipchase (53)
Non-Executive Director (April 2012)
Committee membership Chairman of the
Remuneration Committee and member of the
Nomination and Governance Committee
Skills and experience Graham served as Chief
Executive Officer of global consumer packaging
company, Rexam PLC from 2010 to 2016 after
serving at Rexam as Group Director, Plastic
Packaging and Group Finance Director. Previously,
he was Finance Director of Aerospace Services at
the global engineering group GKN PLC from 2001
to 2003. After starting his career with Coopers &
Lybrand Deloitte, he held various finance roles in
the industrial gases company The BOC Group PLC
(now part of The Linde Group). He is a Fellow of the
Institute of Chartered Accountants in England and
Wales and holds an MA (Hons) in chemistry from
Oriel College, Oxford.
Other appointments In January 2017, Graham
joined Brambles Limited, the Sydney-listed supply
chain logistics company, as CEO designate, and
will become CEO from 20 February 2017.
4 Rudy Markham (70)
Senior independent Non-Executive Director
(April 2015. Member of the Board since
September 2008)
Committee membership Chairman of the
Audit Committee and member of the
Remuneration Committee and Nomination
and Governance Committee
Skills and experience Rudy has significant
international business and financial experience,
having formerly held various senior commercial and
financial positions with Unilever, culminating in his
appointment as its Chief Financial Officer. He also
served as a Non-Executive Director of the UK
Financial Reporting Council from 2007 to 2012 and
formerly as Chairman and a Non-Executive Director
of Moorfields Eye Hospital NHS Foundation Trust.
Other appointments Rudy is a non-executive
member of the Boards of United Parcel Services Inc.
and Legal & General plc. He is also Vice Chairman
of the Supervisory Board of Corbion NV (formerly
CSM NV), a Fellow of the Chartered Institute of
Management Accountants and a Fellow of the
Association of Corporate Treasurers.
5 Geneviève Berger (61)
Non-Executive Director (April 2012)
Committee membership Member of the Science
Committee and oversees sustainability matters on
behalf of the Board
Skills and experience Geneviève was Chief
Science Officer at Unilever PLC and a member
of the Unilever Leadership Executive from 2008 to
April 2014. She holds three doctorates – in physics,
human biology and medicine – and was appointed
Professor of Medicine at l’Université Pierre et Marie
Curie, Paris in 2006. Her previous positions include
Professor and Hospital Practitioner at l’Hôpital de la
Pitié-Salpêtrière in Paris; Director of the Biotech and
Agri-Food Department; Head of the Technology
Directorate at the French Ministry of Research and
Technology; Director General, at the Centre National
de la Recherche Scientifique; and Chairman of the
Health Advisory Board of the EU Commission.
Other appointments In May 2015, Geneviève was
appointed as a Director of Air Liquide S.A. for a term
of four years. She is currently Chief Research Officer
at Firmenich SA, Geneva, Switzerland.
6 Bruce Burlington (68)
Non-Executive Director (August 2010)
Committee membership Chairman of the Science
Committee and member of the Audit Committee
and the Nomination and Governance Committee
Skills and experience Bruce is a pharmaceutical
product development and regulatory affairs
consultant and brings extensive experience in these
areas. He spent 17 years with the FDA, serving as
Director of its Center for Devices and Radiological
Health, as well as holding various senior roles in the
Center for Drug Evaluation and Research. After
leaving the FDA, he held various senior executive
positions at Wyeth (now part of Pfizer).
Other appointments Bruce is a Non-Executive
Director of the International Partnership for
Microbicides.
AstraZeneca Annual Report and Form 20-F Information 2016
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Corporate Governance
Senior Executive Team
as at 31 December 2016
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4
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1 Pascal Soriot
CEO
See page 86.
2 Marc Dunoyer
CFO
See page 86.
3 Katarina Ageborg
Chief Compliance Officer
Katarina was appointed Chief Compliance Officer
and a member of the SET on 1 July 2011. She has
overall responsibility for the delivery, design and
implementation of the Company’s compliance
programme and since her appointment has
driven increased efficiency and effectiveness in
compliance. She has also assumed responsibility
for Safety, Health & Environment, and most recently
in 2015 for the Company’s sustainability programme.
Katarina led the Global IP function from 2008 to
2011, during which time she streamlined the
organisation and launched a new patent filing
strategy. After joining AstraZeneca in 1998, she held
a series of senior legal roles supporting Commercial,
Regulatory and IP. Prior to AstraZeneca, Katarina
established her own law firm and worked as a
lawyer on both civil and criminal cases. Katarina
holds a Master of Law Degree from Uppsala
University School of Law in Sweden.
4 Dr Sean Bohen
Executive Vice-President,
Global Medicines Development and
Chief Medical Officer
Sean was appointed Executive Vice-President,
GMD in September 2015 and leads our global
late-stage development organisation for both small
molecules and biologics. He is also the Company’s
Chief Medical Officer and is responsible for
patient safety across the entire AstraZeneca and
MedImmune portfolio. He joined AstraZeneca
from Genentech, where he held a number of senior
leadership roles across various therapy areas and
was most recently Senior Vice President of Early
Development. Before joining Genentech, Sean
was a Clinical Instructor in Oncology at Stanford
University School of Medicine, a research associate
at the Howard Hughes Medical Institute and a
postdoctoral fellow at the National Cancer Institute.
He is a graduate of the University of Wisconsin and
later earned his doctorate in biochemistry and his
medical degree at the University of California, San
Francisco.
5 Pam Cheng
Executive Vice-President, Operations
and Information Technology
Pam joined AstraZeneca in June 2015 after having
spent 14 years in Global Manufacturing and Supply
Chain roles at Merck/MSD. Pam was the Head of
Global Supply Chain Management & Logistics for
Merck from 2006 to 2011 and led the transformation
of Merck supply chains across the global supply
network. More recently, Pam was President of MSD
China, responsible for MSD’s entire business in
China. Prior to joining Merck, Pam held various
engineering and project management positions at
Universal Oil Products, Union Carbide Corporation
and GAF Chemicals. Pam holds Bachelor’s and
Master’s degrees in chemical engineering from
Stevens Institute of Technology in New Jersey and
an MBA in marketing from Pace University in New
York. She has been a member of the Board of
Directors for Codexis Inc. (CDXS) since 2014.
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General Counsel
Jeff was appointed General Counsel in January
2009 and has overall responsibility for all aspects
of AstraZeneca’s Legal and IP function. He joined
AstraZeneca in 1995 and has worked in various
litigation roles, where he has had responsibility for IP,
anti-trust and product liability litigation. Before joining
AstraZeneca, he spent five years at the US legal firm
Drinker Biddle and Reath LLP, where he specialised
in pharmaceutical product liability litigation and
anti-trust advice and litigation. He received his
bachelor’s degree in political science from Wheaton
College and his Juris Doctor Degree from Villanova
University School of Law.
12 Leon Wang
Executive Vice-President, Asia Pacific
Leon was appointed Executive Vice-President,
Asia Pacific in January 2017. This is a region of
great importance for the future of the Group and
Leon is responsible for the overall strategy and
the promotion of the sustainable growth of our
activities in China and Hong Kong, Asia Area,
Australia and New Zealand. He joined AstraZeneca
China in 2013 as a Vice-President and became
President in 2014. Under his leadership China
became AstraZeneca’s second-largest market
worldwide. Leon has 20 years of experience in
the pharmaceutical industry, including a series of
positions of increasing responsibility in marketing
and business leadership at Roche where he
was a Business Unit Vice President before joining
AstraZeneca. He is Council Vice Chairman of the
Shanghai Association of Foreign Investment,
Executive Committee Member responsible for
Pricing of the R&D-based Pharmaceutical
Association Committee under the China Association
of Enterprises with Foreign Investment and
Corporate Advisory Board Member of China
Europe International Business School. He holds
a Bachelor of Arts from Shanghai International
Studies University and an EMBA from China
Europe International Business School.
Note: The position of Executive Vice-President, Europe is
vacant at the date of this report with recruitment activity
underway. From September 2016 until January 2017, the
position was held by Luke Miels (who prior to that led GPPS,
AstraZeneca’s global marketing, business development and
commercial portfolio strategy operations). It was announced
in January 2017 that Mr Miels would leave AstraZeneca to
take up a senior position with a main competitor. As a result,
Mr Miels was placed on garden leave pending agreement
of his start date.
6 Fiona Cicconi
Executive Vice-President, Human Resources
Fiona joined AstraZeneca in September 2014 as
Executive Vice-President, Human Resources. She
started her career at General Electric, where she
held various human resources roles within the
oil and gas business, which included experience
in major global acquisitions and driving change.
Subsequently, Fiona spent a number of years
at Cisco, overseeing human resources in seven
countries in Europe and latterly handling employee
relations in Europe, Middle East and Africa, before
joining Roche in 2006. There, she was most recently
responsible for global human resources for Pharma
Technical Operations, where her primary focus was
to identify and develop a sustainable supply of
leadership and talent from within the organisation.
7 Dr Ruud Dobber
Executive Vice-President, North America
Ruud was appointed Executive Vice-President,
North America in August 2016 and is responsible
for driving growth and maximising the contribution
of the commercial operations in North America
to AstraZeneca’s global business. Ruud joined
AstraZeneca in 1997 and has held various senior
commercial and leadership roles. Most recently,
Ruud was Executive Vice-President, Europe
and oversaw business functions in the 28 EU
member states. Ruud was also responsible for
the development of our late-stage, small
molecule antibiotic pipeline as well as its global
commercialisation. Prior to that, Ruud was Regional
Vice-President of AstraZeneca’s European, Middle
East and African division, Regional Vice-President
for the Asia Pacific region and Interim Executive
Vice-President, GPPS. Ruud was a member of the
Board and Executive Committee of the European
Federation of Pharmaceutical Industries and
Associations (EFPIA) and was previously Chairman
of the Asia division of Pharmaceutical Research and
Manufacturers of America. Holding a doctorate in
immunology from the University of Leiden in the
Netherlands, Ruud began his career as a scientist,
researching in the field of immunology and ageing.
8 Dr Bahija Jallal
Executive Vice-President, MedImmune
Bahija was appointed Executive Vice-President,
MedImmune in January 2013 and is responsible for
biologics research and development activities. Bahija
is tasked with advancing the biologics pipeline of
medicines. She joined MedImmune in 2006 as
Vice-President, Translational Sciences and has
held roles of increasing responsibility at AstraZeneca.
Prior to joining AstraZeneca, Bahija worked with
Chiron Corporation, where she served as Vice-
President, Drug Assessment and Development.
Bahija received a Master’s degree in biology from
l’Université de Paris VII and her doctorate in
physiology from l’Université Pierre et Marie Curie,
Paris VI. She conducted her postdoctoral research
at the Max-Planck Institute of Biochemistry in
Martinsried, Germany. She is the President of the
Board of Directors of the Association for Women
in Science and she is also on the Board of Trustees
of the Johns Hopkins University.
9 Mark Mallon
Executive Vice-President, Global Product and
Portfolio Strategy, Global Medical Affairs &
Corporate Affairs
Executive Vice-President, International West
Mark was appointed Executive Vice-President,
Global Product and Portfolio Strategy, Global
Medical Affairs & Corporate Affairs in August 2016,
leading AstraZeneca’s global marketing and
commercial portfolio strategy as well as the medical
affairs and corporate affairs functions. Prior to this,
Mark was EVP for the International region with
responsibility for the growth and performance of
AstraZeneca’s commercial businesses in various
parts of the world, including Asia Pacific, Russia,
Latin America, the Middle East and Africa. He retains
responsibility for these International businesses
excluding Asia Pacific for which a new SET position
was created in early 2017. Since joining AstraZeneca
in 1994, Mark has held a number of senior sales and
marketing roles, including Regional Vice-President
for Asia Pacific, President of AstraZeneca’s Chinese
and Italian subsidiaries, Chief Operating Officer
of AstraZeneca’s Japanese subsidiary and
Vice-President of AstraZeneca’s US gastrointestinal
and respiratory businesses. He has served as a
member of the Board of Directors for Christiana
Care, the largest hospital system in Delaware.
He has also been an Executive Committee Member
for R&D-based Pharmaceutical Association
Committee, the China industry association for
innovative pharmaceutical companies. Mark
began his career in the pharmaceutical industry
in management consulting. He holds a degree
in chemical engineering from the University of
Pennsylvania and an MBA in marketing and finance
from the Wharton School of Business.
10 Dr Menelas Pangalos
Executive Vice-President, IMED Biotech Unit
and Global Business Development
Menelas (Mene) was appointed Executive
Vice-President, IMED Biotech Unit in January 2013
and leads AstraZeneca’s small molecule research
and early development activities. In 2016, Mene was
also made Global Head of Business Development.
Mene joined AstraZeneca from Pfizer, where he was
Senior Vice-President and Chief Scientific Officer of
Neuroscience Research. Previously, he held senior
discovery and neuroscience roles at Wyeth and
GSK. He completed his undergraduate degree in
biochemistry at the Imperial College of Science
and Technology, London and earned a doctorate
in neurochemistry from the University of London.
He is a Visiting Professor of Neuroscience at King’s
College London and is a Fellow of Clare Hall at the
University of Cambridge. Mene is a Fellow of the
Academy of Medical Sciences and the Royal Society
of Biology. In the UK, Mene serves on the Medical
Research Council, is on the Board of the British
Pharmaceutical Group and a Non-Executive Director
of the UK Precision Medicine Catapult.
AstraZeneca Annual Report and Form 20-F Information 2016
89
Corporate Governance
Corporate Governance Report
Board composition
The membership of the Board at
31 December 2016 and information about
individual Directors is contained in the Board
of Directors section on pages 86 and 87.
Corporate governance
We have prepared this Annual Report with
reference to the UK Corporate Governance
Code published by the UK Financial
Reporting Council (FRC) in September 2014.
This Corporate Governance Report
(together with other sections of this Annual
Report) describes how we apply the main
principles of good governance in the UK
Corporate Governance Code. We have
complied throughout the accounting period
with the provisions of the UK Corporate
Governance Code, which is available
on the FRC’s website, www.frc.org.uk.
Leadership and responsibilities
The roles of Chairman and CEO are
split. Leif Johansson, our Non-Executive
Chairman, is responsible for leadership of
the Board. Our CEO, Pascal Soriot, leads
the SET and has executive responsibility for
running our business. The Board comprises
10 Non-Executive Directors, including the
Chairman, and two Executive Directors –
the CEO, Pascal Soriot, and the CFO, Marc
Dunoyer. Its responsibilities are set out in the
Corporate Governance Overview on pages
84 and 85. As at 31 December 2016, two
Non-Executive Director positions were
vacant and work is continuing to identify
and secure the services of new Board
members, as described in the Nomination
and Governance Committee section on
page 93.
Rudy Markham, who joined the Board
as a Non-Executive Director in 2008,
was appointed as our Senior independent
Non-Executive Director in April 2015.
The role of the Senior independent
Non-Executive Director is to serve as a
sounding board for the Chairman and as
an intermediary for the other Directors
when necessary. The Senior independent
Non-Executive Director is also available
to shareholders if they have concerns that
contact through the normal channels of
Chairman or Executive Directors has failed
to resolve, or for which such contact is
inappropriate.
As shown in the Corporate Governance
Overview, there are four principal Board
Committees. The membership and work
of these Committees is described on the
following pages. In addition, there may from
time to time be constituted ad hoc Board
Committees for specific projects or tasks.
In these cases, the scope and
responsibilities of the Committee are
documented. The Board provides adequate
resources to enable each Committee to
undertake its duties.
Reserved matters and delegation
of authority
The Board maintains and periodically
reviews a list of matters that are reserved to,
and can only be approved by, the Board.
These include: the appointment, termination
and remuneration of any Director; approval
of the annual budget; approval of any item of
fixed capital expenditure or any proposal for
the acquisition or disposal of an investment
or business which exceeds $150 million; the
raising of capital or loans by the Company
(subject to certain exceptions); the giving of
any guarantee in respect of any borrowing
of the Company; and allotting shares of the
Company. The matters that have not been
expressly reserved to the Board are
delegated by the Board to its Committees
or the CEO.
The CEO is responsible to the Board
for the management, development and
performance of our business for those
matters for which he has been delegated
authority from the Board. Although the CEO
retains full responsibility for the authority
delegated to him by the Board, he has
established, and chairs, the SET, which
is the vehicle through which he exercises
that authority in respect of our business.
The roles of the Board, Board Committees,
Chairman and CEO are documented, as
are the Board’s reserved powers and
delegated authorities.
Operation of the Board
The Board discharges its responsibilities
as set out in the Corporate Governance
Overview on pages 84 and 85 through
a programme of meetings that includes
regular reviews of financial performance
and critical business issues, and the formal
annual strategy review day. The Board also
aims to ensure that a good dialogue with
our shareholders is maintained and that
their issues and concerns are understood
and considered.
The Board held 11 meetings in 2016,
including its usual annual strategy review.
Five took place in London, UK; one in
Cambridge, UK; one at the offices of
AstraZeneca’s subsidiary in Japan; and four
by telephone conference call. The Board
is currently scheduled to meet six times in
2017 and will meet at such other times as
may be required to conduct business.
As part of the business of each Board
meeting, the CEO typically submits a
progress report, giving details of business
performance and progress against the
goals the Board has approved. To ensure
that the Board has good visibility of the
key operating decisions of the business,
members of the SET attend Board meetings
regularly and Board members meet other
senior executives throughout the year.
The Board also receives accounting and
other management information about our
resources, and presentations from internal
and external speakers on legal, governance
and regulatory developments. At the end
of Board meetings, the Non-Executive
Directors meet without the Executive
Directors present to review and discuss any
matters that have arisen during the meeting
and/or such other matters as may appear
to the Non-Executive Directors to be
relevant in properly discharging their duty
to act independently.
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Composition of the Board, succession
planning and diversity
The Nomination and Governance
Committee and, where appropriate, the full
Board, regularly review the composition of
the Board and the status of succession to
both senior executive management and
Board level positions. Directors have regular
contact with, and access to, succession
candidates for senior executive
management positions.
The Board aims to maintain a balance in
terms of the range of experience and skills
of individual Board members, which
includes relevant international business,
pharmaceutical industry and financial
experience, as well as appropriate scientific
and regulatory knowledge. The biographies
of Board members set out on pages 86 and
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AstraZeneca Annual Report and Form 20-F Information 2016
87 give more information about current
Directors in this respect. The Board views
gender, nationality and cultural diversity
among Board members as important
considerations when reviewing the
composition of the Board. The Board
recognises, in particular, the importance
of gender diversity. Currently, 37% of the
Company’s Non-Executive Directors are
women and women make up 30% of the
full Board. Although it has not set any
specific measurable objectives, the Board
intends to continue with its current approach
to diversity in all its aspects, while at the
same time seeking Board members of the
highest calibre, and with the necessary
experience and skills to meet the needs
of the Company and its shareholders.
Information about our approach to diversity
in the organisation below Board level can be
found in Employees from page 54.
The following changes to the composition
of the Board and its Committees have
occurred during the period covered by
this Annual Report:
> Cornelia (Cori) Bargmann stepped down
from the Board and as a member of the
Science Committee with effect from
1 October 2016 after she accepted a new
position as President of Chan Zuckerberg
Science, part of the Chan Zuckerberg
Initiative.
> Jean-Philippe Courtois stepped down
from the Board and as a member of
the Audit Committee with effect from
1 December 2016. Mr Courtois was
appointed as a Non-Executive Director
in 2008. The Nomination and Governance
Committee started succession planning
earlier in 2016 in anticipation of Mr
Courtois reaching nine years’ tenure
as a Board member in 2017.
Independence of the Non-Executive
Directors
During 2016, the Board considered the
independence of each Non-Executive
Director for the purposes of the UK
Corporate Governance Code and the
corporate governance listing standards
of the NYSE (Listing Standards). With the
exception of Marcus Wallenberg, the Board
considers that all of the Non-Executive
Directors are independent. Leif Johansson
was considered by the Board to be
independent upon his appointment as
Chairman. In accordance with the UK
Corporate Governance Code, the test of
independence is not appropriate in relation
to the Chairman after his appointment.
Marcus Wallenberg was appointed as
a Director of Astra in May 1989 and
subsequently became a Director of the
Company in 1999. He is a Non-Executive
Director of Investor AB, which has a 4.1%
interest in the issued share capital of
the Company as at 2 February 2017.
Mr Wallenberg, Investor AB and a number
of Wallenberg charitable foundations are
connected. For these reasons, the Board
does not believe that he can be determined
independent under the UK Corporate
Governance Code. However, the Board
believes that he has brought, and continues
to bring, considerable business experience
and makes a valuable contribution to the
work of the Board. In April 2010, he was
appointed as a member of the Science
Committee, reflecting his interest in
innovation and R&D, knowledge of the
history of the Company and its scientific
heritage and culture, and his broad
experience of other industries and
businesses in which innovation and R&D
are important determinants of success.
Conflicts of interest
The Articles enable the Directors to
authorise any situation in which a Director
has an interest that conflicts or has the
potential to conflict with the Company’s
interests and which would otherwise be a
breach of the Director’s duty, under Section
175 of the Companies Act 2006. The Board
has a formal system in place for Directors to
declare such situations to be considered for
authorisation by those Directors who have
no interest in the matter being considered.
In deciding whether to authorise a situation,
the non-conflicted Directors must act in the
way they consider, in good faith, would be
most likely to promote the success of the
Company, and they may impose limits or
conditions when giving the authorisation,
or subsequently, if they think this is
appropriate. Situations considered by
the Board and authorisations given are
recorded in the Board minutes and in
a register of conflicts maintained by the
Company Secretary, and are reviewed
annually by the Board. The Board believes
that this system operates effectively.
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Appointments to the Board
The Nomination and Governance
Committee section on page 93 provides
information about the appointment process
for new Directors.
Newly appointed Directors are provided
comprehensive information about the Group
and their role as Non-Executive Directors.
They also typically participate in tailored
induction programmes that take account
of their individual skills and experience.
Time commitment
Our expectation is that Non-Executive
Directors should be prepared to commit
15 days a year, as an absolute minimum,
to the Group’s business. In practice, Board
members’ time commitment exceeds this
minimum expectation when all the work that
they undertake for the Group is considered,
particularly in the case of the Chairman of
the Board and the Chairmen of the Board
Committees. As well as their work in relation
to formal Board and Board Committee
meetings, the Non-Executive Directors
also commit time throughout the year to
meetings and telephone calls with various
levels of executive management, visits to
AstraZeneca’s sites throughout the world
and, for new Non-Executive Directors,
induction sessions and site visits.
On occasions when a Director is
unavoidably absent from a Board or Board
Committee meeting, for example where
a meeting clashes with their existing
commitments, they still receive and review
the papers for the meeting and typically
provide verbal or written input ahead of the
meeting, usually through the Chairman of
the Board or the Chairman of the relevant
Board Committee, so that their views
are made known and considered at the
meeting. Given the nature of the business
to be conducted, some Board meetings are
convened at short notice, which can make
it difficult for some Directors to attend due
to prior commitments.
Information and support
The Company Secretary is responsible
to the Chairman for ensuring that all
Board and Board Committee meetings
are properly conducted, that the Directors
receive appropriate information prior
to meetings to enable them to make
an effective contribution, and that
governance requirements are considered
and implemented.
AstraZeneca Annual Report and Form 20-F Information 2016
91
Corporate Governance
Corporate Governance Report continued
The Company maintained Directors’ and
Officers’ Liability Insurance cover throughout
2016. The Directors are also able to obtain
independent legal advice at the expense
of the Company, as necessary, in their
capacity as Directors.
The Company has entered into a deed of
indemnity in favour of each Board member
since 2006. These deeds of indemnity are
still in force and provide that the Company
shall indemnify the Directors to the fullest
extent permitted by law and the Articles,
in respect of all losses arising out of, or
in connection with, the execution of their
powers, duties and responsibilities as
Directors of the Company or any of its
subsidiaries. This is in line with current
market practice and helps us attract and
retain high quality, skilled Directors.
Performance evaluation
During the year, the Board conducted the
annual evaluation of its own performance
and that of its Committees and individual
Directors. The 2016 evaluation involved
each Board member responding to a
web-based questionnaire covering a wide
range of topics prepared by Lintstock Ltd
(Lintstock), a London-based corporate
advisory firm that provides objective and
independent counsel to leading European
companies. Lintstock supplies software
and services to the Company Secretary’s
team for Board evaluation questionnaires
and for the management of insider lists but
has no other commercial relationship with
the Company.
Feedback from the questionnaire was
discussed by the Board at its meeting in
January 2017 and was also used by the
Chairman as the basis for individual
conversations with each Board member
prior to the full Board discussion. In respect
of the 2016 evaluation, overall it was
concluded that the Board continues to
operate effectively and in an open manner
and no significant problems were raised.
The questionnaire feedback and both the
individual and the full Board discussions
included suggestions about providing more
strategic, competitive and financial context
for Board members in respect of their
reviews of the Company’s very early-stage
science and development programmes;
maintaining and further improving the
diversity of the Board; maintaining and
further improving full Board oversight of
succession planning for Board-level roles;
providing more opportunities for Board
members to meet senior employees having
the potential to progress to the most senior
executive roles in the Company; and how
best to maintain the right balance of Board
time for R&D matters on the one hand,
and commercial and operations matters
on the other.
As part of each Director’s individual
discussion with the Chairman, his or her
contribution to the work of the Board
and personal development needs were
considered. Directors’ training needs
are met by a combination of internal
presentations and updates and external
speaker presentations as part of Board
and Board Committee meetings; specific
training sessions on particular topics, where
required; and the opportunity for Directors
to attend external courses at the Company’s
cost, should they wish to do so. In respect
of the 2016 annual performance evaluation it
was concluded that each Director continues
to perform effectively and to demonstrate
commitment to his or her role.
The 2016 evaluation also included a
review of the performance of the Chairman
by the other Directors, led by the Senior
independent Non-Executive Director and
absent the Chairman. The review covered
how Board meetings were managed and
chaired; the Chairman’s broader activities
for the Company (for example, his
interactions with employees in various
parts of the business); his relationship
with shareholders and other external
stakeholders in various parts of the world,
such as governments and senior regulatory
authority officials; his relationship with
executive management; and suggestions
as to areas that the Board might prioritise
for its work in 2017. It was concluded that
overall the Chairman continues to perform
very effectively, both in respect of Board
matters and in relation to other aspects
of his chairmanship role, and that he
continues to devote significant time to
promoting the interests of the Company
for the long-term benefit of shareholders
and other stakeholders.
The reviews of the Board’s Committees
did not raise any significant problems and
concluded that the Committees are
operating effectively.
The Board intends to continue to comply
with the UK Corporate Governance Code
guidance that the evaluation should be
externally facilitated at least every three
years and expects to commission the next
externally facilitated review in 2017.
Re-election of Directors
In accordance with Article 66 of the
Articles, all Directors retire at each AGM
and may offer themselves for re-election
by shareholders. Accordingly, all of the
Directors will retire at the AGM in April 2017.
The Notice of AGM will give details of those
Directors seeking re-election.
Accountability
Risk management and internal control
The Board has overall responsibility for
our system of internal controls and risk
management policies and has an
ongoing responsibility for reviewing their
effectiveness. During 2016, the Directors
continued to review the effectiveness of our
system of controls, risk management and
high level internal control processes. These
reviews included an assessment of internal
controls and, in particular, financial,
operational and compliance controls, and
risk management and their effectiveness,
supported by management assurance of
the maintenance of controls reports from IA,
as well as the external auditor on matters
identified in the course of its statutory audit
work. The system is designed to manage
rather than eliminate the risk of failure
to achieve business objectives and can
only provide reasonable (not necessarily
absolute) assurance of effective operation
and compliance with laws and regulations.
The internal control framework was in
operation throughout 2016 and continues
to operate up to the date of the approval of
this Annual Report. The Directors believe
that the Group maintains an effective,
embedded system of internal controls and
complies with the FRC’s guidance entitled
‘Guidance on Risk Management, Internal
Control and Related Financial and Business
Reporting’ and, in the view of the Directors,
no significant deficiencies have been
identified in the system.
More information about the ways in which
we manage our business risks and describe
our principal risks and uncertainties is set
out in the Risk overview from page 20 and
Risk from page 214.
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Remuneration
Information about our approach to
remuneration and the role and work of the
Remuneration Committee, including our
policy on executive remuneration, is set
out in the Directors’ Remuneration Report.
Policy on external appointments and
retention of fees
Subject to specific Board approval in
each case, Executive Directors and other
SET members may accept external
appointments as non-executive directors
of other companies, and retain any related
fees paid to them, provided that such
appointments are not considered by the
Board to prevent or reduce the ability of the
executive to perform his or her role within
the Group to the required standard.
Relations with shareholders
In our quarterly, half yearly and annual
financial and business reporting to
shareholders and other interested parties,
we aim to present a balanced and
understandable assessment of our strategy,
financial position and prospects.
We make information about the Group
available to shareholders through a range
of media, including our corporate website,
www.astrazeneca.com, which contains a
wide range of data of interest to institutional
and private investors. We consider our
website to be an important means of
communication with our shareholders.
The Company has been authorised by
shareholders to place shareholder
communications (such as the Notice of
AGM and this Annual Report) on the
corporate website in lieu of sending paper
copies to shareholders (unless specifically
requested). While recognising and
respecting that some shareholders may
have different preferences about how they
receive information from us, we will continue
to promote the benefits of electronic
communication given the advantages that
this has over traditional paper-based
communications, both in terms of the
configurability and accessibility of the
information provided and the consequent
cost savings and reduction in environmental
impact.
We have frequent discussions with
institutional shareholders on a range of
issues. In addition to holding discussions
with groups of shareholders, we also hold
individual meetings with some of our largest
institutional shareholders to seek their views.
Board members are kept informed of any
issues, and receive regular reports and
presentations from executive management
and our brokers to assist them to develop
an understanding of major shareholders’
views about the Group. From time to
time, we conduct an audit of institutional
shareholders to ensure that we are
communicating clearly with them and that
a high quality dialogue is being maintained.
The results of this audit are reported to,
and discussed by, the full Board. We also
respond to individual ad hoc requests for
discussions from institutional shareholders
and analysts. Our Investor Relations team
acts as the main point of contact for
investors throughout the year. As discussed
above, the Senior independent Non-
Executive Director, Rudy Markham, is
also available to shareholders if they have
concerns that contact through the normal
channels of Chairman, CEO and/or CFO
has failed to resolve, or in relation to
which such contact is inappropriate. All
shareholders, including private investors,
have an opportunity at the AGM to put
questions to members of the Board
about our operation and performance.
Formal notification of the AGM is sent to
shareholders at least one month in advance.
All Board members ordinarily attend the
AGM to answer questions raised by
shareholders. In line with the UK Corporate
Governance Code, details of proxy voting by
shareholders, including votes withheld, are
given at the AGM and are posted on our
website following the AGM.
Nomination and Governance
Committee
The Nomination and Governance
Committee’s role is to recommend to the
Board any new Board appointments and to
consider, more broadly, succession plans at
Board level. It reviews the composition of
the Board using a matrix that records the
skills and experience of current Board
members, comparing this with the skills and
experience it believes are appropriate to the
Company’s overall business and strategic
needs, both now and in the future. Any
decisions relating to the appointment of
Directors are made by the entire Board
based on the merits of the candidates and
the relevance of their background and
experience, measured against objective
criteria, with care taken to ensure that
appointees have enough time to devote
to our business.
The Nomination and Governance
Committee also advises the Board
periodically on significant developments in
corporate governance and the Company’s
compliance with the UK Corporate
Governance Code.
During 2016, the members of the
Nomination and Governance Committee
were Leif Johansson (Chairman of the
Committee), Rudy Markham, Bruce
Burlington and Graham Chipchase. Each
member is a Non-Executive Director and
considered independent by the Board. The
Company Secretary acts as secretary to the
Nomination and Governance Committee.
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The Nomination and Governance
Committee considers both planned and
unplanned (unanticipated) succession
scenarios and met four times in 2016,
spending the majority of its time on
succession planning for Non-Executive
Directors with the assistance of the search
firms MWM Consulting, Spencer Stuart
and Korn Ferry and continued routine
succession planning (internal and external)
for the roles of CEO and CFO, with the
assistance of Spencer Stuart. Korn
Ferry and Spencer Stuart periodically
undertake executive search assignments
for the Company.
The attendance record of the Nomination
and Governance Committee’s members
is set out on page 84.
The Nomination and Governance
Committee’s terms of reference are available
on our website, www.astrazeneca.com.
Science Committee
The Science Committee’s core role is to
provide assurance to the Board regarding
the quality, competitiveness and integrity
of the Group’s R&D activities by way of
meetings and dialogue with our R&D
leaders and other scientist employees;
visits to our R&D sites throughout the world;
and review and assessment of:
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Corporate Governance Report continued
> the approaches we adopt in respect
of our chosen therapy areas
> the scientific technology and R&D
capabilities we deploy
> the decision-making processes for R&D
projects and programmes
> the quality of our scientists and their
career opportunities and talent
development
> benchmarking against industry and
scientific best practice, where
appropriate.
The Science Committee periodically reviews
important bioethical issues that we face,
and assists in the formulation of, and agrees
on behalf of the Board, appropriate policies
in relation to such issues. It may also
consider, from time to time, future trends
in medical science and technology. The
Science Committee does not review
individual R&D projects but does review,
on behalf of the Board, the R&D aspects
of specific business development or
acquisition proposals and advises the
Board on its conclusions.
During 2016, the members of the Science
Committee, all of whom have a knowledge
of, or an interest in, life sciences, were Bruce
Burlington (Chairman of the Committee),
Cori Bargmann until she stepped down
from the Board with effect from 1 October
2016, Geneviève Berger and Marcus
Wallenberg. As usual, the EVP, GMD; the
EVP, IMED; and the EVP, MedImmune,
participated in meetings of the Science
Committee as co-opted members in 2016.
The Vice-President, IMED Operations acts
as secretary to the Science Committee.
The Science Committee met twice in
person in 2016, in Gothenburg, Sweden
and Gaithersburg, US and held two other
meetings, both of which were by telephone,
to review specific business development
or acquisition proposals and aspects of
the Group scorecard in relation to ‘Achieve
scientific leadership’ targets.
The Science Committee’s terms of
reference are available on our website,
www.astrazeneca.com.
US corporate governance requirements
Our ADSs are traded on the NYSE and,
accordingly, we are subject to the reporting
and other requirements of the SEC
applicable to foreign private issuers. Section
404 of the Sarbanes-Oxley Act requires
companies to include in their annual report
on Form 20-F filed with the SEC, a report
by management stating its responsibility for
establishing internal control over financial
reporting and to assess annually the
effectiveness of such internal control.
We have complied with those provisions
of the Sarbanes-Oxley Act applicable to
foreign private issuers. The Board continues
to believe that the Group has a sound
corporate governance framework, good
processes for the accurate and timely
reporting of its financial position and results
of operations, and an effective and robust
system of internal controls. We have
established a Disclosure Committee,
further details of which can be found in
the Disclosure Committee section below.
The Directors’ assessment of the
effectiveness of internal control over
financial reporting is set out in Directors’
Responsibilities for, and Report on, Internal
Control over Financial Reporting in the
Financial Statements on page 133.
We are required to disclose any significant
ways in which our corporate governance
practices differ from those followed by US
companies under the Listing Standards.
In addition, we must comply fully with the
provisions of the Listing Standards relating
to the composition, responsibilities and
operation of audit committees, applicable
to foreign private issuers. These provisions
incorporate the rules concerning audit
committees implemented by the SEC under
the Sarbanes-Oxley Act. We have reviewed
the corporate governance practices
required to be followed by US companies
under the Listing Standards and our
corporate governance practices are
generally consistent with those standards.
making that drives business performance
and accountability.
Specifically, the ESPCs have responsibility
for the following:
> approving early-stage investment decisions
> prioritising the respective portfolios
> licensing activity for products in Phase I
and earlier
> delivering internal and external
opportunities
> reviewing allocation of R&D resources.
Late Stage Product Committee (LSPC)
The LSPC is also a senior level governance
body, accountable for the quality of the
portfolio post-Phase III investment decision.
Jointly chaired by the EVPs of GMD and
GPPS, members include, as appropriate,
members of the SET, including the CEO and
CFO, and members of the GMD and GPPS
leadership teams.
The LSPC seeks to maximise the value
of our investments in the late-stage
portfolio, also ensuring well-informed
and robust decision making. Specific
accountabilities include:
> approval of the criteria supporting Proof
of Concept
> decision to invest in Phase III development
based on agreement of commercial
opportunity and our plans to develop
the medicine
> evaluation of the outcome of the
development programme and decision
to proceed to regulatory filing
> decision to invest in life-cycle
management activities for the late-stage
assets
> decision to invest in late-stage business
development opportunities.
Business organisation
Early Stage Product Committees (ESPCs)
The ESPCs are senior level, cross-functional
governance bodies with accountability for
oversight of our early-stage small molecule
and biologics portfolio to Proof of Concept
stage. The EVPs of our two science units,
IMED and MedImmune, chair our ESPCs.
The ESPCs seek to deliver a flow of
products to GMD for Phase III development
through to launch. The ESPCs also seek
to maximise the value of our internal and
external R&D investments through robust,
transparent and well-informed decision
Disclosure Committee
Our disclosure policy provides a framework
for the handling and disclosure of inside
information and other information of interest
to shareholders and the investment
community. It also defines the role of the
Disclosure Committee. The members of
the Disclosure Committee in 2016 were:
the CFO, who chaired the Disclosure
Committee; the EVP, GMD (who is also the
Company’s Chief Medical Officer); the EVP,
GPPS, Global Medical Affairs & Corporate
Affairs; the General Counsel; the Vice-
President, Corporate Affairs; the Vice-
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President, Investor Relations; and the
Vice-President Finance, Group Controller.
Other senior executives attend its meetings
on an agenda-driven basis. The Deputy
Company Secretary acted as secretary to
the Disclosure Committee. The Disclosure
Committee meets regularly to assist and
inform the decisions of the CEO concerning
inside information and its disclosure.
Periodically, it reviews our disclosure
controls and procedures and its own
operation as part of work carried out to
enable management and the Board to
assure themselves that appropriate
processes are operating for both our
planned disclosures, such as our quarterly
results announcements and scheduled
investor relations events, and our unplanned
disclosures in response to unforeseen
events or circumstances. During 2016, we
implemented the requirements of the EU
Market Abuse Regulation, which involved
making some changes to our disclosure
controls and procedures.
Disclosure of information to auditors
The Directors who held office at the date
of approval of this Annual Report confirm
that, so far as they are each aware, there
is no relevant audit information of which
the Company’s auditors are unaware; and
each Director has taken all the steps that
he or she ought to have taken as a Director
to make himself or herself aware of any
relevant audit information and to establish
that the Company’s auditors are aware of
that information.
Global Compliance and Internal Audit
Services (IA)
The role of the Global Compliance
function is to help the Group achieve
its strategic priorities by doing business
the right way, with integrity and high
ethical standards. Global Compliance
continues to focus on ensuring the delivery
of an aligned approach to compliance
that addresses key risk areas across
the business, including risks relating
to external parties and anti-bribery/
anti-corruption. Our priorities include
improving compliance behaviours through
effective training and communication;
monitoring compliance with our Code of
Conduct, Global Policies and supporting
requirements; conducting appropriate risk
assessments and due diligence on third
parties whom we engage for services;
and ensuring that employees and
external parties can raise any concerns.
Global Compliance and IA work with
various specialist compliance functions
throughout our organisation to coordinate
compliance activities.
We take all alleged compliance breaches
and concerns extremely seriously, and
investigate them and report the outcome of
such investigations to the Audit Committee,
as appropriate. Internal investigations are
undertaken by staff from our Global
Compliance, Human Resources and/or
Legal functions. When necessary, external
advisers are engaged to conduct and/or
advise on investigations. Serious breaches
are raised with the Audit Committee.
Where a significant breach has occurred,
management, in consultation with our Legal
function, will consider whether the Group
needs to disclose and/or report the findings
to a regulatory or governmental authority.
Risk from page 214
Global Compliance provides direct
assurance to the Audit Committee on
matters concerning compliance issues,
including an analysis of compliance
breaches. Complementing this, IA
carries out a range of audits that include
compliance-related audits and reviews
of the assurance activities of other Group
assurance functions. The results from
these activities are reported to the
Audit Committee.
IA is established by the Audit Committee
on behalf of the Board and acts as an
independent and objective assurance
function guided by a philosophy of adding
value to improve the operations of the
Group. The scope of IA’s responsibilities
encompasses, but is not limited to,
the examination and evaluation of the
adequacy and effectiveness of the Group’s
governance, risk management, and internal
control processes in relation to the Group’s
defined goals and objectives.
Internal control objectives considered by
IA include:
> compliance with significant policies,
plans, procedures, laws, and regulations
> reliability and integrity of management
and financial information processes,
including the means to identify, measure,
classify, and report such information
> safeguarding of assets.
Based on its activity, IA is responsible for
reporting significant risk exposures and
control issues identified to the Board and
to senior management, including fraud
risks, governance issues, and other
matters needed or requested by the Audit
Committee. It may also evaluate specific
operations at the request of the Audit
Committee or management, as appropriate.
Code of Conduct
Our Code of Conduct (the Code),
which is available on our website,
www.astrazeneca.com, applies to all
full-time and part-time Directors, officers,
employees and temporary staff, in all
companies within our Group worldwide.
A Finance Code complements the Code
and applies to the CEO, the CFO, the
Group’s principal accounting officers
(including key Finance staff in major
overseas subsidiaries) and all Finance
function employees. This reinforces the
importance of the integrity of the Group’s
Financial Statements, the reliability of the
accounting records on which they are
based and the robustness of the relevant
controls and processes.
The Code is at the core of our compliance
programme. It has been translated into
40 languages and provides clear direction
as to how our commitment to honesty and
integrity is to be realised through consistent
actions across all areas of the business.
Compliance with the Code is mandatory
and every employee receives annual training
on it which they are required to complete.
The Code is reviewed periodically and
updated to take account of changing legal
and regulatory obligations. Our Global
Policies, as well as local and functional
procedures, support the Code and provide
clear guidance in key risk areas.
> consistency of operations or programmes
with established objectives and goals and
effective performance
> effectiveness and efficiency of operations
and employment of resources
The Code contains information on how
to report possible violations through our
Helpline, which includes the AZethics
telephone lines, the AZethics website, and
the Global Compliance email and postal
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Corporate Governance Report continued
addresses described in the Code. The
externally-operated website is available in 38
languages, and the phone lines are operable
in 96 countries, to facilitate reporting. Our
reporting channels are available to both
employees and to external parties to report
any concerns. Reports can be made
anonymously where desired and where
permitted by local law. Anyone who raises
a potential breach in good faith is fully
supported by management.
> AstraZeneca UK Limited: Algeria (scientific
office), Angola, Belarus, Chile, Costa Rica,
Croatia, Cuba, Dubai (branch office),
Georgia, Ghana (scientific office), Jordan,
Kazakhstan, Romania, Russia, Saudi
Arabia (scientific office), Serbia, Slovenia
(branch office), Syria, Ukraine and Yemen
(scientific office)
> AstraZeneca AB: Egypt (scientific office)
and Slovakia (branch office)
> AstraZeneca Singapore Pte Limited:
In 2016, 320 reports of alleged compliance
breaches or other ethical concerns were
made through the Helpline, including reports
made by any anonymous route that could
be considered whistleblowing; in 2015 there
were 326 reports. The majority of cases
come to our attention through management
and self-reporting, which can be seen as an
indication that employees are comfortable
in raising their concerns with line managers,
local Human Resources, Legal or
Compliance, as recommended in the Code
and reinforced in the 2016 Code training.
Other matters
Corporate governance statement under
the UK Disclosure Guidance and
Transparency Rules (DTR)
The disclosures that fulfil the requirements
of a corporate governance statement under
the DTR can be found in this section and in
other parts of this Annual Report as listed
below, each of which is incorporated into
this section by reference:
> major shareholdings
> Articles.
Shareholder Information from page 232
and Corporate Information on page 237
Subsidiaries and principal activities
The Company is the holding company
for a group of subsidiaries whose principal
activities are described in this Annual
Report. The Group’s principal subsidiaries
and their locations are given in Group
Subsidiaries and Holdings in the Financial
Statements on page 193.
Branches and countries in which the
Group conducts business
In accordance with the Companies Act
2006, we disclose below our subsidiary
companies that have representative or
scientific branches/offices outside the UK:
Vietnam
> Astra Export & Trading AB: United
Arab Emirates (branch office).
Distributions to shareholders –
dividends for 2016
Details of our distribution policy are set out
in the Financial Review from page 76 and
Notes 22 and 23 to the Financial Statements
on page 172.
The Company’s dividend for 2016 of $2.80
(218.9 pence, SEK 24.38) per Ordinary
Share amount to, in aggregate, a total
dividend payment to shareholders of
$3,542 million. An employee share trust,
AstraZeneca Share Trust Limited, waived
its right to a dividend on the Ordinary
Shares that it holds and instead received
a nominal dividend.
A shareholders’ resolution was passed at
the 2016 AGM authorising the Company
to purchase its own shares. The Company
did not repurchase any of its own shares in
2016. On 31 December 2016, the Company
did not hold any shares in treasury.
Going concern accounting basis
Information on the business environment
in which AstraZeneca operates, including
the factors underpinning the industry’s
future growth prospects, is included in the
Strategic Report. Details of the product
portfolio of the Group are contained in
both the Strategic Report (in the Therapy
Area Review from page 23) and the
Directors’ Report. Information on patent
expiry dates for key marketed products is
included in Patent Expiries of Key Marketed
Products from page 211. Our approach to
product development and our development
pipeline are also covered in detail with
additional information by therapy area
in the Strategic Report.
The financial position of the Group, its
cash flows, liquidity position and borrowing
facilities are described in the Financial
Review from page 62. In addition, Note 26
to the Financial Statements from page 177
includes the Group’s objectives, policies and
processes for managing capital; financial
risk management objectives; details of its
financial instruments and hedging activities;
and its exposures to credit, market and
liquidity risk. Further details of the Group’s
cash balances and borrowings are included
in Notes 16 and 17 to the Financial
Statements from page 162.
The Group has considerable financial
resources available. As at 31 December
2016 the Group had $5.7 billion in financial
resources (cash balances of $5.0 billion
and undrawn committed bank facilities of
$3.0 billion which are available until April
2020, with only $2.3 billion of debt due
within one year). The Group’s revenues
are largely derived from sales of products
which are covered by patents which provide
a relatively high level of resilience and
predictability to cash inflows, although
our revenue is expected to continue to
be significantly impacted by the expiry of
patents over the medium term. In addition,
government price interventions in response
to budgetary constraints are expected
to continue to adversely affect revenues
in many of our mature markets. However,
we anticipate new revenue streams from
both recently launched medicines and
products in development, and the Group
has a wide diversity of customers and
suppliers across different geographic areas.
Consequently, the Directors believe that,
overall, the Group is well placed to manage
its business risks successfully.
After making enquiries, the Directors have
a reasonable expectation that the Company
and the Group have adequate resources
to continue in operational existence for
the foreseeable future. Accordingly, they
continue to adopt the going concern
basis in preparing the Annual Report
and Financial Statements.
Changes in share capital
Changes in the Company’s Ordinary
Share capital during 2016, including details
of the allotment of new shares under the
Company’s share plans, are given in Note
22 to the Financial Statements on page 172.
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Directors’ shareholdings
The Articles require each Director to be
the beneficial owner of Ordinary Shares
in the Company with an aggregate
nominal value of $125 (which currently
represents at least 500 shares because
each Ordinary Share has a nominal value
of $0.25). Such holding must be obtained
within two months of the date of the
Director’s appointment. At 31 December
2016, all of the Directors complied with
this requirement and full details of each
Director’s interests in shares of the Company
are set out in Directors’ interests in shares
on pages 114 and 115. Information about
the shareholding expectations of the
Remuneration Committee (in respect of
Executive Directors and SET members)
and the Board (in respect of Non-Executive
Directors) is also set out in Directors’
interests in shares on pages 114 and 115.
Political donations
Neither the Company nor its subsidiaries
made any EU political donations or incurred
any EU political expenditure in 2016 and they
do not intend to do so in the future in respect
of which shareholder authority is required, or
for which disclosure in this Annual Report is
required, under the Companies Act 2006.
However, to enable the Company and its
subsidiaries to continue to support interest
groups or lobbying organisations concerned
with the review of government policy or law
reform without inadvertently breaching the
Companies Act 2006, which defines political
donations and other political expenditure in
broad terms, a resolution will be put to
shareholders at the 2017 AGM, similar to
that passed at the 2016 AGM, to authorise
the Company and its subsidiaries to:
> make donations to political parties
or independent election candidates
> make donations to political organisations
other than political parties
> incur political expenditure, up to an
aggregate limit of $250,000.
Corporate political contributions in the US
are permitted in defined circumstances
under the First Amendment of the US
Constitution and are subject to both federal
and state laws and regulations. In 2016, the
Group’s US legal entities made contributions
amounting in aggregate to $1,568,250
(2015: $1,224,550) to national political
organisations, state-level political party
committees and to campaign committees
of various state candidates. No corporate
donations were made at the federal level
and all contributions were made only where
allowed by US federal and state law. We
publicly disclose details of our corporate US
political contributions, which can be found
on our website, www.astrazeneca-us.com/
sustainability/corporate-transparency.html.
The annual corporate contributions budget
is reviewed and approved by the US
Vice-President, Corporate Affairs and the
President of our US business to ensure
robust governance and oversight. US
citizens or individuals holding valid green
cards exercised decision making over
the contributions and the funds were not
provided or reimbursed by any non-US legal
entity. Such contributions do not constitute
political donations or political expenditure for
the purposes of the Companies Act 2006
and were made without any involvement
of persons or entities outside the US.
Significant agreements
There are no significant agreements to
which the Company is a party that take
effect, alter or terminate on a change
of control of the Company following a
takeover bid. There are no persons with
whom we have contractual or other
arrangements, who are deemed by the
Directors to be essential to our business.
Use of financial instruments
The Notes to the Financial Statements,
including Note 26 from page 177, include
further information on our use of financial
instruments.
Annual General Meeting
The Company’s AGM will be held on
27 April 2017. The meeting place will be
in London, UK. A Notice of AGM will be sent
to all registered holders of Ordinary Shares
and, where requested, to the beneficial
holders of shares.
External auditor
A resolution will be proposed at the AGM
on 27 April 2017 for the appointment of
PricewaterhouseCoopers LLP (PwC) as
auditor of the Company. The external
auditor during 2016 was KPMG LLP. The
proposed change of auditor follows a
recommendation by the Audit Committee to
the Board in 2015 based on a formal tender
in line with best practice. During 2016,
KPMG undertook various non-audit
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services. More information about this work
and the audit and non-audit fees that we
have paid are set out in Note 30 to the
Financial Statements on page 192. The
external auditor is not engaged by
AstraZeneca to carry out any non-audit
work in respect of which it might, in the
future, be required to express an audit
opinion. As explained more fully in the Audit
Committee Report from page 98, the Audit
Committee has established pre-approval
policies and procedures for audit and
non-audit work permitted to be carried out
by the external auditor and has carefully
monitored the objectivity and independence
of the external auditor throughout 2016.
Directors’ Report
The Directors’ Report, which has been
prepared in accordance with the
requirements of the Companies Act 2006,
comprises the following sections:
> Chief Executive Officer’s Review
> Therapy Area Review
> Business Review
> Resources Review, including Employees
> Financial Review: Financial risk
management
> Corporate Governance: including the
Audit Committee Report and Corporate
Governance Report
> Directors’ Responsibility Statement
> Development Pipeline
> Sustainability: supplementary information
> Shareholder Information
> Corporate Information
and has been approved by the Board
and signed on its behalf.
The Board considers this Annual Report,
taken as a whole, to be fair, balanced
and understandable, and provides the
necessary information for shareholders
to assess AstraZeneca’s position and
performance, business model and strategy.
A C N Kemp
Company Secretary
2 February 2017
AstraZeneca Annual Report and Form 20-F Information 2016
97
Corporate Governance
Audit Committee Report
The quality of
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reporting is underpinned
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controls, appropriate
accounting practices and
policies, and the exercise
of good judgement.”
Risk management
During the year, the Committee regularly
reviewed the Company’s approach to risk
management, its risk reporting framework
and risk mitigation. These discussions also
provided the context for the Committee’s
consideration of the Directors’ viability
statement and the analysis that underpins
the assurance provided by that statement.
For more details on the viability statement,
please refer to the Risk overview from
page 20. The Committee’s consideration
of risk management was supported by
‘deep dive’ reviews of key activities such
as: supply chain responsiveness;
improvements to IS/IT infrastructure and
the adequacy of cybersecurity; commercial
operations in China and the US; and pricing,
reimbursement and market access. Further
information on the Company’s Principal
Risks are on pages 20 to 21. The Committee
visited the Company’s US Commercial head
office in Wilmington and the MedImmune
leadership team in Gaithersburg to gain
further insight into emerging risks as the
Company’s strategy develops in a dynamic
external environment.
Compliance with the Code of Conduct
The Committee’s priorities continue to
include: maintaining compliance with the
Company’s Code of Conduct; high ethical
standards; and operating within the law
in all countries where we conduct business
or have interactions. In 2015, the Company
had met all of its obligations under its
five-year Corporate Integrity Agreement
in the US, which terminated in April 2015.
During a visit to the Company’s US
Commercial head office in Wilmington,
the Committee heard about how the US
Compliance Programme has evolved,
after completion of the Corporate Integrity
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Financial reporting
The quality of AstraZeneca’s financial
reporting is underpinned by effective internal
controls, appropriate accounting practices
and policies, and the exercise of good
judgement. The Committee reviewed, at
least quarterly, the Company’s significant
accounting matters and, where appropriate,
challenged management’s decisions before
approving the accounting policies applied.
During 2016, the Committee reviewed
aspects of the Group’s significant
restructuring programmes initiated from
2013 onwards, including accounting for
restructuring charges, control over capital
expenditure and arrangements for
monitoring the effective implementation
of these programmes. The Committee
continued to monitor the inclusion of
Externalisation Revenue in AstraZeneca’s
Statement of Comprehensive Income.
For more information on Externalisation
Revenue, please refer to the Financial
Review from page 62.
The Committee looked closely at intangible
asset impairment reviews, including reviews
of our FluMist and Ardea intangible assets;
legal provisions and other related charges,
to ensure that items are appropriately
accounted for in ‘Reported’ and
‘Core’ results.
Following the competitive tender of the
Company’s external audit services in 2015
and the Board’s decision to recommend the
appointment of PwC to shareholders at the
Company’s 2017 AGM, the Committee has
monitored the transition planning to ensure
the Company is well prepared for a change
of external auditors should this be approved
by shareholders.
In December 2015, the FRC announced
that it would conduct a thematic review of
companies’ tax reporting to encourage more
transparent recording of the relationship
between the tax charges and accounting
profit. The FRC Corporate Reporting Review
Team subsequently conducted a review of
the tax disclosures in the Company’s
financial statements for the year ended 31
December 2015 and in 2016 confirmed that
they had no substantive issues to raise. The
Committee took note of and was satisfied
with relevant reports from the regulators that
exercise routine oversight over the Company’s
external auditors, the FRC and the Public
Company Accounting Oversight Board.
98
AstraZeneca Annual Report and Form 20-F Information 2016
Agreement, to maintain strong focus and
remain relevant, proactively addressing
key compliance risks. Throughout 2016,
the Committee monitored and reviewed
compliance with our Code of Conduct,
including the effectiveness of our
anti-bribery and anti-corruption controls,
across the Group. The Committee
prioritised its focus on countries where we
have significant operations and countries
in which doing business is generally
considered to pose a higher corruption or
general compliance risk such as the US,
the UK, China, Japan, Nigeria and India.
Engagement with senior leaders
The Committee considers it important to
interact with members of management
below the SET. In July, members of the
Committee visited the Company’s US
Commercial and MedImmune leadership
teams in Wilmington and Gaithersburg
respectively. We talked to senior leaders
about the opportunities and challenges
the Company faces, and the current and
emerging risks arising from the development
and successful delivery to patients of
medicines from our rapidly evolving pipeline.
The Committee also met informally with
senior leaders from the Operations IS/IT,
Finance, Legal and Global Payer Evidence
& Pricing teams. In June 2016, I participated
in a discussion at the Company’s Internal
Audit Services (IA) team conference on
the role of the Board and Audit Committee
generally and at AstraZeneca, and I shared
my perspective on the importance of the
work of IA in providing assurance on
AstraZeneca’s risk management, controls
and governance generally.
Finally, I would like to offer thanks from the
Committee to Jean-Philippe Courtois, who
retired from the Committee on 1 December
2016, for his valued contribution to the
Committee and its work.
We value dialogue with our shareholders
and welcome your feedback on this report.
Yours sincerely
Rudy Markham
Chairman of the Audit Committee
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Audit Committee membership
and attendance
All Committee members are Non-Executive
Directors and considered by the Board to
be independent under the UK Corporate
Governance Code. The Committee’s
members are Rudy Markham (Committee
Chairman), Bruce Burlington, Ann Cairns
and Shriti Vadera. Jean-Philippe Courtois
was a member of the Committee until
he stepped down from the Board on
1 December 2016.
In December 2016, the Board determined
that, for the purposes of the UK Corporate
Governance Code, at least one Audit
Committee member has recent and
relevant financial experience and that
Rudy Markham and Ann Cairns are financial
experts for the purposes of the Sarbanes-
Oxley Act. The Board of Directors’
biographies on pages 86 and 87 contain
details of each Audit Committee member’s
skills and experience.
The Audit Committee held five meetings in
2016 and Committee members’ attendance
is set out in the table on page 84.
Role and operation of the
Audit Committee
The Audit Committee’s terms of
reference are available on our website,
www.astrazeneca.com.
The Committee regularly reports to the
Board on how it discharges its main
responsibilities, which include:
> monitoring the integrity of the Company’s
financial reporting and formal
announcements relating to its financial
performance, and reviewing significant
financial reporting judgements contained
within them
> ensuring the Company’s Annual Report
and Accounts present a fair, balanced
and understandable assessment of the
Company’s position and prospects
> reviewing the effectiveness of the
Company’s internal financial controls,
internal non-financial controls, risk
management systems (including
whistleblowing procedures) and
compliance with laws and the
AstraZeneca Code of Conduct
> monitoring and reviewing the role,
resources and effectiveness of the
Company’s Internal Audit function, its
Compliance function, the external audit
process and the Company’s relationship
with its external auditor
> monitoring and reviewing the external
auditor’s independence and objectivity
> ensuring the provision of non-audit
services by the external auditor are
appropriate and in accordance with policy
approved by the Committee
> making recommendations to the Board
for shareholder approval relating to the
appointment, reappointment and removal
of the external auditor, and to approve the
remuneration and terms of engagement
of the external auditor
> monitoring the Company’s response to
any external enquiries and investigations
regarding matters within the Committee’s
area of responsibility.
Audit Committee meeting minutes are
circulated to the Board. Following each
Committee meeting, the Committee
Chairman informs the Board of the principal
matters the Committee considered and of
any significant concerns it has or that have
been reported by the external auditor, the
Vice-President, IA or the Chief Compliance
Officer. The Committee identifies matters
that require action or improvement and
makes recommendations on the steps
to be taken.
The Committee’s work is supported by
valuable insight gained from its interactions
with other Board Committees, senior
executives, managers and external experts.
Committee meetings are routinely attended
by the CFO; the General Counsel; the Chief
Compliance Officer; the Vice-President,
IA; the Vice-President Finance, Group
Controller; and the Company’s external
auditor. The CEO attends on an agenda-
driven basis.
In addition, the Committee and separately
the Committee Chairman, meet privately
with the CFO; Chief Compliance Officer;
General Counsel; Vice-President, IA; and
the Company’s external auditor on an
individual basis to ensure the effective
flow of material information between
the Committee and management.
AstraZeneca Annual Report and Form 20-F Information 2016
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Corporate Governance
Audit Committee Report continued
Activities of the Audit Committee
in 2016
During 2016 and in January 2017, the Audit
Committee considered and discussed the
following standing items:
> key elements of the Financial Statements
and the estimates and judgements
contained in the Company’s financial
disclosures. Accounting matters
considered included the areas described
in the Financial Review under ‘Critical
accounting policies and estimates’ (with
a focus on accounting issues relevant to
revenue recognition, litigation and taxation
matters, goodwill and intangible asset
impairment) from page 77 and other
important matters such as monitoring
the accounting for Externalisation
Revenue in the Group’s Consolidated
Statement of Comprehensive Income.
The Committee reviewed the Company’s
definition of Externalisation Revenue
against market practice, and individual
judgements on items falling within that
definition. Discussion of these matters
was supported by papers prepared by
management and the external auditor,
and input from the Science Committee
(as appropriate)
> the external auditor’s reports on its audit
of the Group Financial Statements, and
reports from management, IA, Global
Compliance and the external auditor on
the effectiveness of our system of internal
controls and, in particular, our internal
control over financial reporting
> quarterly reports of work carried out by
IA, Global Compliance and Finance
including the status of follow-up actions
with management
> the Company’s principal, enduring and
emerging risks, including the Company’s
risk management approach, risk reporting
framework and risk mitigation. More
information about the principal risks faced
by the Company is set out in the Risk
overview section from page 20
> compliance with applicable provisions of
the Sarbanes-Oxley Act. In particular, the
status of compliance with the programme
of internal controls over financial reporting
implemented pursuant to Section 404 of
the Sarbanes-Oxley Act. The Committee
continued its focus on IT controls in the
context of the changes to the Group’s IT
environment. More information about this
is set out in the Sarbanes-Oxley Act
Section 404 section of the Financial
Review on page 81
> data from reports made by employees via
the AZethics helpline, online facilities and
other routes regarding potential breaches
of the Code of Conduct, together with the
results of enquiries into those matters
> reports from the Group Treasury function,
in particular, concerning the Company’s
liquidity and cash position and the
appropriateness of its investment
management policy in the context of
the current economic situation
> the going concern assessment and
adoption of the going concern basis
in preparing this Annual Report and the
Financial Statements. More information
on the basis of preparation of Financial
Statements on a going concern basis
is set out in the Financial Statements
on page 142
> the preparation of the Directors’ viability
statement and the adequacy of the
analysis supporting the assurance
provided by that statement
> quarterly reports from the General
Counsel on the status of significant
litigation matters and governmental
investigations
> audit and non-audit fees of the external
auditor during 2016, including the
objectivity and independence of the
external auditor through the application
of the Non-Audit Services Policy as
described further below. Further
information about the audit and non-audit
fees for 2016 is disclosed in Note 30 to
the Financial Statements on page 192
> the Audit Committee conducted the
annual evaluation of its own performance
with each Committee member
responding to a web-based questionnaire
prepared by an external third party.
The effectiveness review of the Audit
Committee was assessed as high
performing with a good balance struck
between the necessary rigour and a
holistic understanding of issues under
consideration, quality engagement with
the business outside formal meetings,
and appropriate attention given to the
external auditor transition
> effectiveness review of Internal Audit,
which noted an external assessment
of IA observed that the function is well
respected and trusted, providing
assurance that is aligned to the
Company’s risk profile and well-
coordinated with the other risk and
assurance functions. IA continues to build
its capabilities seeking opportunities for
continuous improvement.
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AstraZeneca Annual Report and Form 20-F Information 2016
Matters considered and discussed by the
Audit Committee in addition to its usual
business as described above included:
> significant capital expenditure and the
execution of restructuring programmes,
including the construction of the new
strategic bioscience site and corporate
head office in Cambridge, UK and review
of historic restructuring programmes
> the level of assurance regarding the
effective integration of recently acquired
entities and their compliance with Group
policies and governance arrangements
> regular updates from the IT team with
particular attention to cybersecurity
and the progress of the Group’s IT
infrastructure transformation, including
the set-up of the global technology centre
in Chennai, India and related business
continuity arrangements, noting a new
global technology centre in Guadalajara,
Mexico has become operational
> supply chain responsiveness for launches
of new products, in particular biologics,
including critical capabilities and robust
processes that will support delivery of the
evolving pipeline
> opportunities, challenges, compliance
and risk management discussed with the
US commercial business leadership team
and MedImmune leadership team during
the Committee’s visit to the Company’s
Wilmington and Gaithersburg sites
> key compliance risks arising from our
activities in China, including the
effectiveness of controls, noting senior
leadership’s continued focus on a strong
compliance and ethics culture as the
China business grows
> consideration of major trends regarding
pricing, reimbursement and market
access for biopharmaceuticals, and
the key external and internal risks the
Company faces
> monitoring the external audit transition
process to ensure an effective transition
of the Group’s external auditors in 2017,
subject to shareholders’ approval to
appoint the new external auditor at the
Company’s AGM in April 2017
> the Group’s approach to taxation noting
that AstraZeneca aims to comply with
tax laws in the countries in which it does
business and is committed to transparent
and constructive relationships with all
relevant tax authorities
> relevance to the Company of new
Compliance and Disclosure Interpretations
issued by the SEC on the use of
non-GAAP measures, in particular the
disclosure of and prominence given
to non-GAAP measures and the
appropriateness of items removed from
GAAP numbers in arriving at non-GAAP
measures
> proposals for the Directors’ Slavery
and Human Trafficking Statement
and the adequacy of the arrangements
supporting the assurance provided by
that statement, and preparation for
compliance with the Market Abuse
Regulation before it came into force
on 3 July 2016
> monitoring the resource requirements
of key control functions (Finance, IA,
Compliance) with particular reference
to succession planning and the potential
impact of ongoing restructuring on the
effectiveness of risk and control processes.
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considered by the Audit Committee
in 2016
Revenue recognition
The US is our largest single market and
sales accounted for 35% of our Product
Sales in 2016. Revenue recognition,
particularly in the US, is impacted by
rebates, chargebacks, cash discounts
and returns (for more information, please
see the Financial Review from page 62).
The Audit Committee pays particular
attention to management’s estimates of
these items, its analysis of any unusual
movements and their impact on revenue
recognition informed by commentary
from the external auditor.
Valuation and possible impairment
of intangible assets
The Group carries significant intangible
assets on its Balance Sheet arising from
the acquisition of businesses and IP rights
to medicines in development and on the
market. Each quarter, the CFO outlines
the carrying value of the Group’s intangible
assets and, in respect of those intangible
assets that are identified as at risk of
impairment, the difference between the
carrying value and management’s current
estimate of discounted future cash flows for
‘at risk’ products (the headroom). Products
will be identified as ‘at risk’ because the
headroom is small or, for example, in the
case of a medicine in development, there is
a significant development milestone such
as the publication of clinical trial results
which could significantly alter management’s
forecasts for the product.
In 2016, the Audit Committee considered
specific impairment review papers and
supporting information on the Group’s
FluMist and Ardea intangible assets.
The FluMist impairment review included
detailed consideration of the impact
of the announcement in June 2016 by
the Advisory Committee on Immunization
Practices of the Center for Disease
Control and Prevention of an interim
recommendation on the use of FluMist
Quadrivalent in the US during the 2016/2017
influenza season. The Ardea intangible
asset impairment review included
considerations in both the gout indication
as well as indications in the CVMD
therapy area. The Audit Committee
obtained valuable input from the Science
Committee for this review. The Audit
Committee agreed with the conclusion
that no impairment was required.
In 2016, there were no significant
impairments of intangible assets.
Litigation and contingent liabilities
The Audit Committee was regularly
informed by the General Counsel
and external auditor about IP litigation,
product liability actions and governmental
investigations that might result in fines or
damages against the Company, to assess
whether provisions should be taken and,
if so, when and in what amount. Of the
matters the Committee considered in
2016, the most significant included: FCPA
investigation (US); Nexium anti-trust litigation
(US); Pulmicort Respules patent litigation
(US); Faslodex patent litigation (US and
Europe); and Crestor damages claims
(Australia). The US FCPA investigation was
resolved in 2016 following a civil settlement
agreed with the SEC; the DOJ closed its
investigation without taking action against
the Company. Notwithstanding the
Company’s success defending the claims
in the Nexium anti-trust case, the plaintiffs
continue to seek opportunities to assert
their claims. Faslodex patent litigation
continues in the US and Europe.
Settlements have been reached with lead
litigants in the US. Further information about
the Company’s litigation and contingent
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liabilities is set out in Note 28 to the Financial
Statements from page 185.
Tax accounting
The Audit Committee reviewed the
Company’s approach to tax including
governance, risk management and
compliance, tax planning, dealings
with tax authorities and the level of tax
risk the Company is prepared to accept.
The full statement, which was published
in November 2016, can be found at
www.astrazeneca.com. In 2016, following
a review by the FRC designed to encourage
more transparent recording of the relationship
between the tax charges and accounting
profit, the FRC confirmed that they had
no substantive issues to raise in respect
of the tax disclosures in the Company’s
2015 accounts. The FRC has noted that
their review does not provide assurance
that our report and accounts are correct
in all material respects and that the
FRC’s role is not to verify the information
provided but to consider compliance
with reporting requirements.
Retirement benefits
Pension accounting continues to be a
significant area of focus recognising the
level of pension fund deficit and its sensitivity
to small changes in interest rates, which
the Committee continues to monitor
carefully. The Audit Committee reviewed
the Company’s defined benefit pension
global funding objective and principles,
focusing in particular on the Company’s
main defined benefit pensions obligations
in the UK, Sweden and the US, and the
defined benefit plans in Germany.
Internal controls
The Audit Committee receives a report of
the matters considered by the Disclosure
Committee during each quarter. At the
January 2017 meeting, the CFO presented
to the Committee the conclusions of the
CEO and the CFO following the evaluation
of the effectiveness of our disclosure
controls and procedures required by Item
15(a) of Form 20-F at 31 December 2016.
Based on their evaluation, the CEO and the
CFO concluded that, as at that date, we
maintained an effective system of disclosure
controls and procedures.
AstraZeneca Annual Report and Form 20-F Information 2016
101
Fees paid to the auditor for audit,
audit-related and other services are
analysed in Note 30 to the Financial
Statements on page 192. Fees for non-audit
services amounted to 29% of the fees paid
to KPMG for audit, audit-related and other
services in 2016.
(cid:36)(cid:86)(cid:86)(cid:72)(cid:86)(cid:86)(cid:76)(cid:81)(cid:74)(cid:3)(cid:72)(cid:91)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:79)(cid:3)(cid:68)(cid:88)(cid:71)(cid:76)(cid:87)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:81)(cid:72)(cid:86)(cid:86)
In accordance with its normal practice,
the Audit Committee considered the
performance of KPMG and its compliance
with the independence criteria under the
relevant statutory, regulatory and ethical
standards applicable to auditors. Having
considered all these factors (Judgement,
Mind-set & Culture, Skills, Character &
Knowledge and Quality Control) and
changes in audit approach in response to
finding and comments in the Audit Quality
Review report performed by the FRC
issued in May 2016. The Audit Committee
concluded that the KPMG audit was
effective for the financial year commencing
1 January 2016.
Corporate Governance
Audit Committee Report continued
There was no change in our internal control
over financial reporting that occurred during
the period covered by this Annual Report
that has materially affected, or is reasonably
likely to materially affect, our internal control
over financial reporting.
Appointing the auditor
As we reported in 2012, the Audit
Committee determined that the audit would
be put out to tender by 2018 in accordance
with the UK Corporate Governance Code
and guidance issued by the FRC. KPMG
was first appointed as sole external auditor
to Zeneca Group PLC in 1993 and to
AstraZeneca PLC in 2001 following a
competitive tender. Anthony Cates is the
current lead audit partner at KPMG
following lead partner rotation in 2013.
Having concluded the competitive tender
process in December 2015, the Audit
Committee recommended to the Board that
PwC be appointed as the Group’s statutory
auditor for the 2017 financial year. The Audit
Committee confirmed in September 2016
that PwC is independent under SEC and
UK independence regulations. A resolution
to approve the appointment of PwC will be
put to shareholders at the Company’s
AGM in 2017.
The Audit Committee considers that
the Company has complied with the
Competition and Markets Authority’s
Statutory Audit Services for Large
Companies Market Investigation (Mandatory
Use of Competitive Tender Processes and
Audit Committee Responsibilities) Order
2014 in respect of its financial year
commencing 1 January 2016.
Non-audit services and safeguards
The Audit Committee maintains a policy (the
Audit and Non-Audit Services Pre Approval
Policy) for the pre-approval of all audit
services and permitted non-audit services
undertaken by the external auditor, the
principal purpose of which is to ensure that
the independence of the external auditor
is not impaired. The policy covers three
categories of work: audit services;
audit-related services; and tax services.
The policies define the type of work that
falls within each of these categories and
the non-audit services that the external
auditor is prohibited from performing
under the rules of the SEC and other
relevant UK and US professional and
regulatory requirements. The pre-approval
procedures permit certain audit, audit-
related and tax services to be performed
by the external auditor during the year,
subject to fee limits agreed with the
Audit Committee in advance. The Audit
Committee is mindful of the 70% non-audit
services fee cap under EU regulation,
together with the overall proportion
of fees for audit and non-audit services
in determining whether to pre-approve
such services.
The CFO (supported by the Vice-President
Finance, Group Controller), monitors the
status of all services being provided by
the external auditor. Authority to approve
work in excess of the pre-agreed fee limits
is delegated to the Chairman of the Audit
Committee together with one other
Audit Committee member in the first
instance. A standing agenda item at
Audit Committee meetings covers the
operation of the pre-approval procedures
and regular reports are provided to the
full Audit Committee.
In 2016, non-audit services provided to the
Company by KPMG included the audit of a
product line required as part of the disposal
of this asset, audit services in relation to
employee benefit funds such as the audit
of subsidiary company pension funds
and, tax compliance services. KPMG was
considered better placed to provide these
services, in terms of skills, capability and
efficiency, than any alternative audit firm.
All such services were either within the
scope of the pre-approved services set
out in the Non-Audit Services Policy or
were presented to Audit Committee
members for pre-approval.
102
AstraZeneca Annual Report and Form 20-F Information 2016
Directors’ Remuneration Report
We remain
committed to ensuring
that our remuneration
arrangements support
our strategy and deliver
sustainable value to
our shareholders.”
C
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As AstraZeneca’s pipeline-driven
transformation continues, the Committee
has taken care to ensure that the
Company’s remuneration arrangements
remain aligned to its strategy with strong
links between long-term performance
and our shareholders’ experience.
As our 2014 Policy comes to the end of
its three-year life-cycle, we are required
to put a new Remuneration Policy forward
to a shareholder vote at the 2017 AGM.
During 2016, we consulted our major
shareholders and their representatives
extensively on executive remuneration
and we would like to thank those who
took part in this process. The feedback
we received has informed the Committee’s
approach to executive remuneration in 2017.
The Committee’s intention is to give
shareholders assurance that:
> the CEO’s remuneration opportunity
overall will not increase as a percentage
of base salary
> LTI arrangements will be simplified
> our incentives will continue to reward
good long-term decisions aligned with
the Company’s strategy
> the transparency of performance
measures and targets will be increased
further
> if discretion is used, it will be well
balanced and justified.
Taking into account shareholder
feedback, two substantive changes to our
Remuneration Policy are proposed, namely:
(i) a reduction in the level of LTI vesting at
threshold performance under the PSP
from 25% to 20% of maximum; and (ii) that
no new awards will be made under the
AZIP. From 2017, LTI awards for Executive
103
106
107
107
110
112
112
112
114
115
117
119
122
123
128
128
129
130
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AstraZeneca Annual Report and Form 20-F Information 2016
103
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Contents
Annual Statement from the Chairman of the Committee
At a glance summary
Annual Report on Remuneration
> What did we pay our Directors?
> Share interests awarded in 2016
> Payments to former Directors
> (cid:51)(cid:68)(cid:92)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:79)(cid:82)(cid:86)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:82)(cid:433)(cid:70)(cid:72)
> Remuneration context and our past performance
> Directors’ interests in shares
> Governance
Implementation of Remuneration Policy in 2017
Additional information: Executive Directors’ share plans
Remuneration Policy
> Remuneration Policy for Executive Directors
> Remuneration scenarios for Executive Directors
> Approach to recruitment remuneration for Executive Directors
> Service contracts for Executive Directors
> (cid:51)(cid:85)(cid:76)(cid:81)(cid:70)(cid:76)(cid:83)(cid:79)(cid:72)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:83)(cid:68)(cid:92)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:79)(cid:82)(cid:86)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:82)(cid:433)(cid:70)(cid:72)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:40)(cid:91)(cid:72)(cid:70)(cid:88)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:39)(cid:76)(cid:85)(cid:72)(cid:70)(cid:87)(cid:82)(cid:85)(cid:86)
> Remuneration Policy for Non-Executive Directors
Corporate Governance
Directors’ Remuneration Report continued
Directors will only be made under the PSP.
We have also taken the opportunity to
simplify the proposed Remuneration Policy
which we hope shareholders will find helpful.
R&D cost control despite the absorption of
Acerta Pharma and ZS Pharma R&D costs.
Core SG&A expenses declined by 12%
(9% at CER).
2016 performance
We delivered a strong pipeline performance
in 2016 as AstraZeneca’s transformation
continues and we implement our strategy
to achieve scientific leadership, return to
growth and achieve our Group financial
targets. The majority of the elements of our
performance-related pay are directly aligned
to the business plan based on these three
strategic pillars with the intention of driving
performance that promotes the long-term
success of the Company.
We continued to make strong progress
towards achieving scientific leadership and
our ability to deliver innovation to the market.
A number of significant opportunities, not
expected to be achieved in 2016, have been
successfully accelerated. For example,
the FDA’s acceptance of the Company’s
first Biologics License Application for
durvalumab in urothelial bladder cancer
is an important milestone demonstrating
the advance of our immuno-oncology
medicines. The US and European regulatory
submission acceptances for Tagrisso in lung
cancer and fast track review in China further
demonstrate AstraZeneca’s commitment
to prioritise the progression of our new
oncology pipeline.
Overall, our 2016 financial performance was
in line with expectations as AstraZeneca’s
pipeline-driven transformation continues.
While 2016 Product Sales declined by 10%
(8% at CER), driven by the entry of multiple
Crestor generic medicines in the US, our six
Growth Platforms grew by 4% (5% at CER)
representing 63% of our Total Revenue.
We have completed a number of strategic
business development transactions this
year, such as the sale of the Company’s
small molecule antibiotics business to Pfizer
and the agreement with Aspen Pharma
for the commercialisation rights to the
Company’s global anaesthetics portfolio
outside the US. The 7% decline (5% at CER)
in Total Revenue reflects the loss of Crestor
exclusivity. Core EPS increased by 1% (5%
decline at CER). Our leadership team has
taken care to manage costs and continue
investment in the long-term success of the
Company. Good progress was made on
2016 remuneration outcomes
The performance measures used in our
incentives are closely aligned with Company
strategy, ensuring our Executive Directors
are only rewarded for delivery of stretching
and appropriately balanced financial, non-
financial and individual performance. The
Committee’s evaluation has ensured that
executive reward reflects the performance
of the business and shareholder experience.
Valuable insight was provided by the
Science Committee for the assessment
of science related matters and by the
two Committee members who are also
members of the Audit Committee.
When considering business performance
together with the Executive Directors’
individual performance, annual bonus
awards of 98% and 88.2% of base salary
were awarded to Mr Soriot and Mr Dunoyer,
respectively, reflecting the Group scorecard
outcome. Following the end of 2016,
performance was tested for the three-year
performance period for the 2014 PSP
awards. As a result of our performance
over the past three years, the 2014 PSP
award will vest at 92% of maximum.
The two performance tests (progressive
dividend and 1.5 times dividend cover) for
the AZIP granted in 2013 were met in each
year of the four-year performance period
ending 31 December 2016, meaning that
the award vests in full. Awards are subject
to a further four-year holding period and they
will be released on 31 December 2020.
We have reported Mr Soriot’s single total
figure remuneration for 2016 on page 107.
In addition to the regular 2013 AZIP award,
this figure includes the previously reported
one-off AZIP award granted to buyout LTIs
from Mr Soriot’s previous employment,
which he forfeited in order to join AstraZeneca.
To enable a like-for-like comparison to be
made between Mr Soriot’s 2015 and 2016
remuneration we have included columns with
and without the one-off buyout award in the
single figure table. The one-off AZIP award is
subject to a further four-year holding period
before the award pays out.
Shareholder engagement
We received approximately 90%
shareholder support for our 2015 Directors’
Remuneration Report. We have consulted
with our major shareholders in developing
our proposals for executive remuneration
for 2017.
Overall our major shareholders responded
positively to the proposals we discussed
and they encouraged further simplification
of the Company’s executive remuneration
arrangements in the future where possible.
In light of the positive feedback received,
the Committee decided to proceed with
the changes it proposed, which I have
summarised below.
Remuneration in 2017
Overall executive pay opportunity
Executive Directors will receive salary
increases of 2.5%, effective from
1 January 2017, in line with those for the
wider UK employee population. There will
be no increase in the CEO’s maximum
pay opportunity as a percentage of base
salary, and LTI awards in excess of 500%
base salary (at face value) will cease to be
available under the proposed Directors’
Remuneration Policy as only a single LTI
plan will be operated. Mr Soriot’s and
Mr Dunoyer’s target LTI awards are
unchanged at 250% and 200% of base
salary respectively. The level of LTI vesting at
threshold performance under the PSP will
be reduced from 25% to 20% of maximum.
From 2017 onwards no awards will be made
under the AZIP. LTI awards for Executive
Directors will be made under the PSP only.
Since the AZIP was first introduced in 2010,
AstraZeneca has undergone significant
change and the AZIP is no longer closely
aligned to the delivery of the Company’s
strategy. The Company’s pipeline of
potential innovative medicines has been
transformed and the Company’s efforts
need to be sharply focused on delivering
value from the late-stage pipeline through
the successful approval and launch of its
new medicines.
In addition, shareholder concern that the
AZIP has the potential to incentivise short-
termism in decision making rather than
delivering sustainable value for shareholders
is addressed through ceasing awards under
104
AstraZeneca Annual Report and Form 20-F Information 2016
this plan. Awards under the PSP have
an expected value of 50%, whereas the
expected value that has been used when
making AZIP awards has been 100%.
A consequence of awarding shares entirely
under the PSP is that the value that could
potentially be delivered to the CFO for
maximum performance under the LTI plan
has increased from 350% of base salary
to 400% (face value). There is no increase
in Mr Soriot’s maximum remuneration
opportunity under the LTI plan, which
remains at 500%.
2017 PSP simplification, transparency
and alignment to strategy
Building on the simplification of the PSP
last year, in 2017 we will reduce the five
Achieve scientific leadership measures
to three: NME approvals, major life-cycle
management approvals, and Phase III
registration/NME approvals. These three
measures focus on the successful delivery
of the late-stage pipeline in alignment
with the Return to growth phase of the
Company’s strategy.
To ensure the link between executive reward
and the achievement of operating profit is
maintained, when we stop awarding shares
under the AZIP, a new PSP measure will
be adopted: Reported EBITDA (excluding
non-cash movements on fair value of
contingent consideration on business
combinations). In selecting ‘Reported’
EBITDA, the Committee has addressed a
general concern about the pharmaceutical
industry’s use of ‘core’ earnings for incentive
purposes. Further, in line with our aim to
increase transparency and accountability
in our reporting, we have disclosed the
targets for this measure at the start of the
performance period.
During the year, the Committee also
reviewed the TSR peer group used for
the PSP and has decided to increase the
number of companies that form the group
from 10 to 18. The new peer group provides
a better comparison in terms of revenue,
innovation portfolio and geographical
presence. Twenty percent of the award will
vest for median performance and 100% for
upper quartile performance. TSR ranking
within the new peer group is expected to
reward consistent strong performance and
mitigate market volatility.
The adjustment and significant simplification
of our LTI arrangements outlined above
will support a sharp focus on critical
decisions as the executive management
continues to execute AstraZeneca’s strategy
and deliver value for shareholders from its
late-stage pipeline.
Legacy AZIP awards
Although no new awards will be made
under the AZIP, awards made under
this plan in the past will continue in
operation until the end of 2019, which
is the final performance year of the AZIP
awards granted in 2016. The AZIP targets
(progressive dividend and 1.5 times
dividend cover) will remain unchanged
for all outstanding AZIP awards.
As originally operated, if an AZIP
performance test was not achieved in
any one of the four performance years,
all outstanding AZIP awards would fail,
which meant that the incentive to meet
either target for the remaining years was
rendered completely ineffective. Some of
our shareholders have told us that they are
concerned that the AZIP may incentivise too
great a focus on short-term earnings rather
than the investment needed to deliver the
value of the Company’s late-stage pipeline.
The Committee considered a number
of different ways to address this concern.
For example, the volatility of exchange rates
can have a significant impact on EPS with
the consequence that the AZIP dividend
cover target can become unachievable.
Missing the dividend cover target for this
reason would not be a fair reflection of the
underlying business performance. However,
making adjustments over the long term
to balance the impact of exchange rate
volatility across multiple markets, both
in cases where the impact is positive for
the Company as well as negative, would
introduce significant complexity to the
operation of the AZIP.
Another way to mitigate the risk of
incentivising a focus on delivering short-
term earnings would be to lower the
AZIP’s targets. However, the Committee
considered it inappropriate to reduce
the performance targets set at the time
the award was originally granted. The
Committee is satisfied that the current
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dividend level and cover targets remain
stretching and appropriate for the
three years left to run under the existing
AZIP awards.
The Committee also considered whether
changes should be made to other elements
of executive remuneration in order to
mitigate the impact of the AZIP cliff-edge
vesting but concluded that maintaining
the stretch of the original AZIP targets was
important. The Committee concluded
that since the AZIP cliff-edge vesting was
the root cause of shareholder concern,
adjusting this is the most effective way to
mitigate the risk that the AZIP could drive
sub-optimal decision making.
Ultimately, the Committee decided to
operate a simple pro rata sliding scale for
future performance years of the remaining
awards. If a performance target is missed
in any one year, instead of every outstanding
AZIP award failing, only 25% will fail reflecting
the fact that only one of the four performance
years has failed. The Committee believes
that this sliding scale directly addresses
shareholder concern and will provide a
good balance between challenging and
achievable targets.
Next steps
We remain committed to ensuring that our
remuneration arrangements support our
strategy and deliver sustainable value to our
shareholders. As such I hope that you find
this report explains clearly how we intend
to achieve this and that it gives you the
information you need to be able to support
the two remuneration resolutions that will
be put forward to a shareholder vote at the
2017 AGM (the new Remuneration Policy
and the Annual Report on Remuneration
for the year ending 31 December 2016).
Our ongoing dialogue with shareholders
is valued greatly and, as always, we
welcome your feedback on this Directors’
Remuneration Report.
Yours sincerely
Graham Chipchase
Chairman of the Remuneration Committee
2 February 2017
AstraZeneca Annual Report and Form 20-F Information 2016
105
Corporate Governance
Directors’ Remuneration Report continued
At a glance summary of Executive Directors’ remuneration
Looking ahead to 2017 – our remuneration framework
Element
Salary
Pension
Annual bonus
Structure
Opportunity
Change from 2016
Base salary, paid monthly
CEO – £1,220,000
CFO – £725,000
CEO – 30% of base salary
CFO – 24% of base salary
2.5% increase
2.5% increase
No change
No change
CEO – maximum 180% of base salary
No change
CFO – maximum 150% of base salary
No change
Allowance taken as cash in lieu of pension
participation
Quantum determined by one-year
(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:68)(cid:74)(cid:68)(cid:76)(cid:81)(cid:86)(cid:87)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:15)(cid:3)(cid:81)(cid:82)(cid:81)(cid:16)
(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:76)(cid:81)(cid:71)(cid:76)(cid:89)(cid:76)(cid:71)(cid:88)(cid:68)(cid:79)(cid:3)(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)
targets. One-third of bonus deferred into
Ordinary Shares or ADSs, which will vest
after three years
LTI
Delivered under the PSP
CEO – maximum 500% of base salary
No change
CFO – maximum 400% of base salary
Proportion vesting determined by
(cid:87)(cid:75)(cid:85)(cid:72)(cid:72)(cid:16)(cid:92)(cid:72)(cid:68)(cid:85)(cid:3)(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:68)(cid:74)(cid:68)(cid:76)(cid:81)(cid:86)(cid:87)(cid:3)(cid:430)(cid:89)(cid:72)(cid:3)
equally-weighted measures:
> Relative TSR
> Reported EBITDA
(cid:33)(cid:3)(cid:38)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)
> Return to growth
(cid:33)(cid:3)(cid:3)(cid:36)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:79)(cid:72)(cid:68)(cid:71)(cid:72)(cid:85)(cid:86)(cid:75)(cid:76)(cid:83)(cid:3)(cid:11)(cid:22)(cid:3)(cid:76)(cid:81)(cid:71)(cid:76)(cid:89)(cid:76)(cid:71)(cid:88)(cid:68)(cid:79)(cid:3)
measures)
Two-year holding period follows
performance period
14.3% increase as a consequence of
awarding shares entirely under the PSP
Awards only made under the PSP
going forward
Reported EBITDA has been introduced
(cid:68)(cid:86)(cid:3)(cid:68)(cid:3)(cid:80)(cid:72)(cid:68)(cid:86)(cid:88)(cid:85)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:36)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)
leadership measure has been reduced from
(cid:430)(cid:89)(cid:72)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:85)(cid:72)(cid:72)(cid:3)(cid:76)(cid:81)(cid:71)(cid:76)(cid:89)(cid:76)(cid:71)(cid:88)(cid:68)(cid:79)(cid:3)(cid:80)(cid:72)(cid:68)(cid:86)(cid:88)(cid:85)(cid:72)(cid:86)
For further information on these changes
see the Implementation of Remuneration
Policy in 2017 section from page 117
Our variable remuneration – 2016
2016 Annual bonus (see page 107 for further details)
Measure
Target (one-year)
Weighting
Performance
Level of award(cid:446)
(cid:36)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:42)(cid:85)(cid:82)(cid:88)(cid:83)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:86)
(cid:38)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)
Core EPS
Revenue
(cid:36)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:79)(cid:72)(cid:68)(cid:71)(cid:72)(cid:85)(cid:86)(cid:75)(cid:76)(cid:83)
5 measures
Return to growth
6 measures
10%
20%
10%
6% each
5% each
Exceeded target
Below target
Below threshold
Exceeded target
Below target
CEO – 54.4% of maximum (98%
of salary)
CFO – 58.8% of maximum (88.2%
of salary)
1 Includes assessment of Executive Director’s performance against individual objectives.
2014-2016 PSP (see page 108 for further details)
Target (three-year)
Weighting
Performance
Level of award
Measure
Relative TSR
(cid:38)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)
(cid:36)(cid:70)(cid:75)(cid:76)(cid:72)(cid:89)(cid:72)(cid:3)(cid:86)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:76)(cid:430)(cid:70)(cid:3)(cid:79)(cid:72)(cid:68)(cid:71)(cid:72)(cid:85)(cid:86)(cid:75)(cid:76)(cid:83)
5 measures
Return to growth
5 measures
2013-2016 AZIP (see page 109 for further details)
TSR performance relative to peer group
(cid:38)(cid:88)(cid:80)(cid:88)(cid:79)(cid:68)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:73)(cid:85)(cid:72)(cid:72)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)
25% each
85% of maximum
100% of maximum
100% of maximum
82% of maximum
92% of maximum
Measure
Dividend level
Dividend cover
Target (four-year)
Weighting
Performance
Level of award
Annual dividend per share of $2.80 or more
At least 1.5 calculated on the basis
of Core EPS
Both targets must be
achieved for the
award to vest
100% of maximum
100% of maximum
100% of maximum
106
AstraZeneca Annual Report and Form 20-F Information 2016
Annual Report on Remuneration
What did we pay our Directors?
Executive Directors’ single total figure remuneration (Audited)
Base Salary Taxable benefits
Annual bonus
Long-term incentives
Pension
Other
Total
(excluding
buyout
long-term
incentive)
Total
2016
£’000
2015
£’000
2016
£’000
2015
£’000
2016
£’000
2015
£’000
Regular³
2016
£’000
Regular1,3
2015
£’000
Buyout2,3
2016
£’000
Buyout3
2015
£’000
2016
£’000
2015
£’000
20163
£’000
2015
£’000
2016
£’000
2015
£’000
2016
£’000
20151
£’000
Pascal
Soriot
Marc
Dunoyer
1,190 1,167
121
115
1,167 2,042
6,910
4,289
3,623
707
694
Total
1,897 1,861
71
192
65
624 1,036
180
1,791 3,078
2,878
9,788
4,613
8,902
–
3,623
–
–
–
357
350
170
527
167
517
21
–
21
–
–
9,766
7,963 13,389
7,963
4,450 6,575
4,450
6,575
– 14,216 14,538 17,839 14,538
1(cid:3) (cid:3)(cid:55)(cid:75)(cid:72)(cid:86)(cid:72)(cid:3)(cid:430)(cid:74)(cid:88)(cid:85)(cid:72)(cid:86)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:89)(cid:76)(cid:86)(cid:72)(cid:71)(cid:3)(cid:88)(cid:86)(cid:76)(cid:81)(cid:74)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:87)(cid:88)(cid:68)(cid:79)(cid:3)(cid:86)(cid:75)(cid:68)(cid:85)(cid:72)(cid:3)(cid:83)(cid:85)(cid:76)(cid:70)(cid:72)(cid:3)(cid:82)(cid:81)(cid:3)(cid:89)(cid:72)(cid:86)(cid:87)(cid:76)(cid:81)(cid:74)(cid:17)(cid:3)(cid:55)(cid:75)(cid:72)(cid:3)(cid:430)(cid:74)(cid:88)(cid:85)(cid:72)(cid:86)(cid:3)(cid:71)(cid:76)(cid:86)(cid:70)(cid:79)(cid:82)(cid:86)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:79)(cid:68)(cid:86)(cid:87)(cid:3)(cid:92)(cid:72)(cid:68)(cid:85)(cid:350)(cid:86)(cid:3)(cid:39)(cid:76)(cid:85)(cid:72)(cid:70)(cid:87)(cid:82)(cid:85)(cid:86)(cid:350)(cid:3)(cid:53)(cid:72)(cid:80)(cid:88)(cid:81)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:53)(cid:72)(cid:83)(cid:82)(cid:85)(cid:87)(cid:3)(cid:90)(cid:72)(cid:85)(cid:72)(cid:3)(cid:69)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)(cid:82)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:89)(cid:72)(cid:85)(cid:68)(cid:74)(cid:72)(cid:3)(cid:70)(cid:79)(cid:82)(cid:86)(cid:76)(cid:81)(cid:74)(cid:3)(cid:86)(cid:75)(cid:68)(cid:85)(cid:72)(cid:3)(cid:83)(cid:85)(cid:76)(cid:70)(cid:72)(cid:3)(cid:82)(cid:89)(cid:72)(cid:85)(cid:3)
the three-month period to 31 December 2015.
2 Shares awarded to Mr Soriot in 2013 under the AZIP to compensate him for LTIs from previous employment which were forfeited on his recruitment as the Company’s CEO (as previously
disclosed to shareholders in the 2013 Directors’ Remuneration Report) and the cash equivalent of dividends accrued on those AZIP shares during the performance period, payable on vesting.
3 Cash equivalent of the dividends accrued on shares deferred under the annual bonus awarded in respect of 2012, paid during the year on the completion of the bonus share deferral period.
Notes to the Executive Directors’ single total figure remuneration table
Taxable benefits
Executive Directors may select benefits within the Company’s UK Flexible Benefits Programme or can select to take all, or any remaining
allowance after the selection of benefits, in cash. In 2016, the Executive Directors principally took the allowance in cash (£103,000 in respect
of Mr Soriot and £54,000 in respect of Mr Dunoyer) and selected other benefits including healthcare insurance, death-in-service provision
and advice in relation to tax.
C
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2016 Annual bonus
The CEO had a target annual bonus of 100% of base salary (range 0-180%) and the CFO had a target annual bonus of 90% of base salary
(range 0-150%).
One-third of the pre-tax bonuses shown will be deferred into Ordinary Shares which will vest three years from the date of deferral, subject to
continued employment. The bonus is not pensionable.
The precise targets or target ranges set at the beginning of the performance period are closely aligned to the Company’s strategic priorities,
set out in the Group scorecard. As in prior years, we have set out below the targets for 2016 in respect of the Achieve Group financial
targets element of the annual bonus and Company performance against those targets. In addition, we have provided the outcomes under
each of the Achieve scientific leadership and Return to growth targets. While, in the judgement of the Board, the targets themselves under
these areas remain commercially sensitive, we remain committed to making retrospective disclosure of these targets when they are no
longer considered to be commercially sensitive. It is anticipated that targets will be disclosed two years after the end of the performance
period (as has been done for the 2014 annual bonus targets which are set out on page 114).
The 2016 bonus for both Executive Directors was below their individual target and was determined by applying the Group scorecard
outcome directly to their target. The Group scorecard outcome was 98% and consequently the Committee determined that Mr Soriot’s
annual bonus should amount to 98% of base salary, representing 54.4% of his potential maximum, and that Mr Dunoyer’s bonus should
amount to 88.2% of base salary, representing 58.8% of his potential maximum.
1. Achieve Group financial targets
These targets are based on the Company’s key financial measures. Cash flow performance in 2016 was strong and the target was
exceeded. The Core EPS and Revenue outcomes were below target – Core EPS performance was within the performance range and
resulted in a below target payout. There will be no payout related to Revenue performance, which was below the threshold level set for
that measure.
Performance targets for 2016
Cash flow from operating activities target
Core EPS
Overall revenue
Pascal Soriot level of award
Marc Dunoyer level of award
Weighting
Target
Outcome
Performance
10%
20%
10%
$3.9bn1
$4.202
$4.5bn1
Exceeded target
$4.132
Below target
$24.3bn2
$23.5bn2
Below threshold
Pascal Soriot
level of award
Marc Dunoyer
level of award
19.0%
17.0%
0%
17.1%
15.3%
0%
£429,000 (representing 36.7% of total annual bonus outcome)
£229,000 (representing 36.7% of total annual bonus outcome)
1(cid:3) (cid:55)(cid:75)(cid:72)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:15)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:68)(cid:74)(cid:68)(cid:76)(cid:81)(cid:86)(cid:87)(cid:3)(cid:87)(cid:75)(cid:68)(cid:87)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:15)(cid:3)(cid:76)(cid:86)(cid:3)(cid:72)(cid:89)(cid:68)(cid:79)(cid:88)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:69)(cid:92)(cid:3)(cid:85)(cid:72)(cid:73)(cid:72)(cid:85)(cid:72)(cid:81)(cid:70)(cid:72)(cid:3)(cid:87)(cid:82)(cid:3)(cid:81)(cid:72)(cid:87)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:3)(cid:69)(cid:72)(cid:73)(cid:82)(cid:85)(cid:72)(cid:3)(cid:71)(cid:76)(cid:86)(cid:87)(cid:85)(cid:76)(cid:69)(cid:88)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:82)(cid:87)(cid:75)(cid:72)(cid:85)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:85)(cid:72)(cid:84)(cid:88)(cid:76)(cid:85)(cid:72)(cid:71)(cid:3)(cid:69)(cid:92)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:70)(cid:82)(cid:81)(cid:71)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:17)
2(cid:3) (cid:3)(cid:55)(cid:75)(cid:72)(cid:3)(cid:38)(cid:82)(cid:85)(cid:72)(cid:3)(cid:40)(cid:51)(cid:54)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:53)(cid:72)(cid:89)(cid:72)(cid:81)(cid:88)(cid:72)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:86)(cid:15)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:68)(cid:74)(cid:68)(cid:76)(cid:81)(cid:86)(cid:87)(cid:3)(cid:87)(cid:75)(cid:82)(cid:86)(cid:72)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:86)(cid:15)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:72)(cid:89)(cid:68)(cid:79)(cid:88)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:69)(cid:92)(cid:3)(cid:85)(cid:72)(cid:73)(cid:72)(cid:85)(cid:72)(cid:81)(cid:70)(cid:72)(cid:3)(cid:87)(cid:82)(cid:3)(cid:69)(cid:88)(cid:71)(cid:74)(cid:72)(cid:87)(cid:3)(cid:72)(cid:91)(cid:70)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:3)(cid:85)(cid:68)(cid:87)(cid:72)(cid:86)(cid:3)(cid:86)(cid:88)(cid:70)(cid:75)(cid:3)(cid:87)(cid:75)(cid:68)(cid:87)(cid:3)(cid:69)(cid:72)(cid:81)(cid:72)(cid:430)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:82)(cid:85)(cid:3)(cid:68)(cid:71)(cid:89)(cid:72)(cid:85)(cid:86)(cid:72)(cid:3)(cid:80)(cid:82)(cid:89)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:70)(cid:88)(cid:85)(cid:85)(cid:72)(cid:81)(cid:70)(cid:92)(cid:15)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)
are outside the Company’s control, do not impact reward outcomes.
AstraZeneca Annual Report and Form 20-F Information 2016
107
Corporate Governance
Annual Report on Remuneration continued
2. Achieve scientific leadership
These targets reflect the Company’s ability to deliver innovation to the market. In 2016, we continued to make progress towards achieving
scientific leadership.
The AstraZeneca pipeline includes 132 projects, of which 120 are in the clinical phase of development. There are 12 NME projects
currently in late-stage development, either in Phase III/pivotal Phase II studies or under regulatory review. During 2016, across the portfolio,
48 projects successfully progressed to their next phase. This includes four first approvals in a major market, and 15 NME progressions.
In addition, 17 projects have entered Phase I and 22 projects have been discontinued.
The Committee and the Science Committee assessed the substance of the achievements and concluded a fair and balanced outcome
was 15 Phase II starts/progressions (versus 16 as reported in the KPI section on page 16) and 13 NME and major life-cycle management
submissions (versus 14 as reported in the KPI section).
Performance targets for 2016
Phase II starts/progressions
Positive Phase III investment decisions
NME and major life-cycle management submissions
NME and major life-cycle management approvals
Clinical-stage external licensing and partnering opportunities
6% per
measure
Commercially
sensitive
until March
2019
15
7
13
11
10
Below target
Met target
Below target
Met target
Exceeded target
41.0%
36.9%
Weighting
Target
Outcome
Performance
Pascal Soriot
aggregate level of award
Marc Dunoyer
aggregate level of award
Pascal Soriot level of award
Marc Dunoyer level of award
£488,000 (representing 41.9% of total annual bonus outcome)
£261,000 (representing 41.9% of total annual bonus outcome)
3. Return to growth1
These targets are based on quantitative sales targets for 2016 relating to the Company’s Growth Platforms: Brilinta/Brilique, CVMD,
Respiratory, New Oncology, Emerging Markets, and Japan. In 2016, the New Oncology therapy area performed well, exceeding target,
and Japan met its target. The other Return to growth platform outcomes were below target reflecting a number of challenges in meeting
these stretching targets.
Performance targets for 2016
Weighting
Target
Outcome
Performance
Pascal Soriot
aggregate level of award
Marc Dunoyer
aggregate level of award
Brilinta/Brilique
CVMD
Respiratory
New Oncology
Emerging Markets
Japan
Pascal Soriot level of award
Marc Dunoyer level of award
5% per
measure
Commercially
sensitive
until March
2019
$0.9bn
$2.5bn
$4.9bn
Below target
Below target
Below target
$0.7bn
Exceeded target
$6.3bn
Below target
Met target
£250,000 (representing 21.4% of total annual bonus outcome)
$1.9bn
£134,000 (representing 21.4% of total annual bonus outcome)
21.0%
18.9%
1 In respect of the Return to growth measures only, the targets are set at budget exchange rates at the beginning of the performance period and evaluated at those rates at the end of the
performance period.
4. Individual performance
Although the performance targets in the Group scorecard drive prima facie bonus outcomes, the Committee also applies judgement to
assess the Executive Director’s individual performance.
Our Executive Directors delivered 2016 business performance in line with expectations and against stretching performance targets, while
managing a number of factors that impacted 2016 Product Sales and Total Revenue, such as pricing pressure and new competition from
Crestor generic medicines. Strong leadership from our Executive Directors has enabled significant achievements such as the strategic
prioritisation of scientific projects leading to the acceleration of a number of important opportunities and an organisational transformation
to support entrepreneurial and agile teams focused on the most critical business priorities while delivering a 12% reduction in Core SG&A
expense (9% at CER) and continuing to invest in R&D. When considering our Executive Directors’ individual performance and the business’
performance overall, the Committee decided a Group scorecard outcome of 98% represents a fair and balanced reflection of performance
in a challenging year and that no upward or downward adjustment to the bonus outcomes for either Executive Director was required.
Long-term incentives:
2014 Performance Share Plan (PSP)
92% of the PSP awards granted to Mr Soriot and Mr Dunoyer in 2014 in respect of the 2014-2016 performance period will vest in 2017.
Pascal Soriot
Marc Dunoyer
Number of shares awarded Number of shares vesting
124,066
52,254
114,140
48,073
Value vesting1
£’000
5,817
2,450
1 Based on average closing share price over the three-month period to 31 December 2016 plus accrued dividends over the vesting period.
108
AstraZeneca Annual Report and Form 20-F Information 2016
The TSR and cash flow targets were disclosed at the time of the award. The Committee has determined that the 2014 targets relating
to the Achieve scientific leadership and Return to growth elements of the PSP are no longer commercially sensitive. The targets, outcomes
and relative weighting of each of the PSP’s performance measures are set out in the tables below.
More information about the PSP is set out in the Share interests awarded in 2016 section from page 110.
1. Relative TSR
Performance measure for 2014-2016
AstraZeneca’s rank against peer group
Weighting
25%
Threshold target:
25% vesting
Median (6th)
Maximum target:
100% vesting
Above upper quartile
(2nd or above, at the
discretion of the Committee)
Outcome
2nd
Vesting (% of
maximum)
85%
Above upper quartile TSR performance achieved. In the Committee’s judgement, 85% vesting is a fair reflection of underlying business
performance and shareholder experience over the performance period. More information about the TSR performance of the Company,
including the Company’s peer group, is set out in the Total shareholder return section on page 113.
2. Cumulative cash flow
Performance target for 2014-2016
Adjusted cumulative cash flow1
Weighting
25%
Threshold target:
25% vesting
$9.0bn
Maximum target:
100% vesting
$13.0bn
Outcome
$13.3bn
Vesting (% of
maximum)
100%
1(cid:3) (cid:55)(cid:75)(cid:72)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:15)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:68)(cid:74)(cid:68)(cid:76)(cid:81)(cid:86)(cid:87)(cid:3)(cid:87)(cid:75)(cid:68)(cid:87)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:15)(cid:3)(cid:76)(cid:86)(cid:3)(cid:72)(cid:89)(cid:68)(cid:79)(cid:88)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:69)(cid:92)(cid:3)(cid:85)(cid:72)(cid:73)(cid:72)(cid:85)(cid:72)(cid:81)(cid:70)(cid:72)(cid:3)(cid:87)(cid:82)(cid:3)(cid:81)(cid:72)(cid:87)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:3)(cid:69)(cid:72)(cid:73)(cid:82)(cid:85)(cid:72)(cid:3)(cid:71)(cid:76)(cid:86)(cid:87)(cid:85)(cid:76)(cid:69)(cid:88)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:82)(cid:87)(cid:75)(cid:72)(cid:85)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:85)(cid:72)(cid:84)(cid:88)(cid:76)(cid:85)(cid:72)(cid:71)(cid:3)(cid:69)(cid:92)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:70)(cid:82)(cid:81)(cid:71)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:17)
3. Achieve scientific leadership
Performance targets for 2014-2016
NME approvals
Major life-cycle management approvals
Phase III/registration NME volume
Prospective peak-year sales from NME and major life-cycle
management approvals
Phase II starts
Weighting
Threshold target:
25% vesting
Maximum target:
100% vesting
Outcome
Vesting (% of
maximum)
5% per
measure
2
3
5
$2.0bn
12
6
6
7
9
6
15
$4.0bn
$7.0bn
100%
100%
100%
100%
16
36
100%
C
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c
e
4. Return to growth1
Performance targets for 2014-2016
Brilinta/Brilique
Diabetes franchise
Respiratory
Emerging Markets
Japan
Weighting
Threshold target:
25% vesting
Maximum target:
100% vesting
5% per
measure
$0.8bn
$2.3bn
$3.4bn
$5.0bn
$1.9bn
$1.1bn
$3.3bn
$4.8bn
$7.2bn
$2.7bn
Outcome
$0.9bn
$2.6bn
$5.3bn
$6.9bn
$2.4bn
Vesting (% of
maximum)
79%
55%
100%
94%
81%
1 The Return to growth targets are set at budget exchange rates at the beginning of the performance period and evaluated at those rates at the end of the performance period.
2013 AstraZeneca Investment Plan (AZIP)
100% of the AZIP awards granted to Mr Soriot and Mr Dunoyer in 2013 in respect of the 2013-2016 performance period will vest in 2021,
subject to continued employment. Mr Soriot’s 2013 AZIP comprised a regular award of 20,852 shares and a one-off award of 69,108
shares to compensate him for LTIs from previous employment forfeited on his recruitment as the Company’s CEO. The AZIP targets were
disclosed at the time of the award and the targets and outcomes are set out below.
Pascal Soriot
Marc Dunoyer
Number of shares awarded Number of shares vesting
89,960
8,176
89,960
8,176
1 Based on average closing share price over the three-month period to 31 December 2016 plus accrued dividends over the performance period.
Performance targets for 2013-2016
Annual dividend per share at or above $2.80
Dividend cover of 1.5 calculated on the basis of Core EPS
2013
$2.80
1.80
2014
$2.80
1.53
2015
$2.80
1.52
More information about the AZIP is set out in the Share interests awarded in 2016 section from page 110.
Value vesting1
£’000
4,716
429
Outcome
2016
$2.80
1.54
AstraZeneca Annual Report and Form 20-F Information 2016
109
Corporate Governance
Annual Report on Remuneration continued
Pension allowance
Mr Soriot’s annual pension allowance is 30% of base salary and Mr Dunoyer’s is 24% of base salary. Both Executive Directors took their
pension allowance as a cash alternative to participation in a defined contribution pension scheme.
Non-Executive Directors’ single total figure remuneration (Audited)
Leif Johansson
Geneviève Berger
Bruce Burlington
Ann Cairns
Graham Chipchase
Rudy Markham
Shriti Vadera
Marcus Wallenberg
Former Non-Executive Directors
Cori Bargmann
Jean-Philippe Courtois
Nancy Rothwell
John Varley
Total
2016
Fees
£’000
611
87
117
95
115
165
110
87
65
87
–
–
2015
Fees
£’000
609
87
114
95
107
156
108
87
59
95
35
46
2016
Total
£’000
611
87
117
95
115
165
110
87
65
87
–
–
2015
Total
£’000
609
87
114
95
107
156
108
87
59
95
35
46
1,539
1,598
1,539
1,598
Notes to the Non-Executive Directors’ single total figure remuneration table
Board fees and office costs
The Chairman’s fee includes office costs (invoiced in Swedish krona) of £36,000 for 2016, and £34,000 for 2015. Further information on the
Non-Executive Directors’ fees can be found in the Summary of Non-Executive Directors’ remuneration for 2017 section on page 119.
Board changes
Cori Bargmann and Jean-Philippe Courtois stepped down from the Board with effect from 1 October 2016 and 1 December 2016 respectively.
Share interests awarded in 2016 (Audited)
Deferred Bonus Plan
Interest awarded
Description of interest
Basis of award
Face value of award
Vesting level at threshold performance1
End of performance period2
Summary of performance measures
and targets
Pascal Soriot
Marc Dunoyer
17,352 Ordinary Shares awarded on 24 March 2016
at a grant price of 3923 pence per share.
8,798 Ordinary Shares awarded on 24 March 2016
at a grant price of 3923 pence per share.
Award over shares equal to one-third of the pre-tax annual bonus paid in respect of performance during 2015, based on
the prevailing market share price on the award date.
Automatic deferral of one-third of annual bonus into Ordinary Shares or ADSs.
£681,000
£345,000
100%
24 March 2019
No performance conditions apply, but vesting is ordinarily subject to continued employment.
1 No performance conditions apply under the Deferred Bonus Plan, other than continued employment.
2 As no performance conditions apply, this date represents the end of the holding period.
110
AstraZeneca Annual Report and Form 20-F Information 2016
C
o
r
p
o
r
a
t
e
G
o
v
e
r
n
a
n
c
e
Performance Share Plan (PSP)
Interest awarded
Description of interest
Pascal Soriot
Marc Dunoyer
129,713 Ordinary Shares awarded on 24 March 2016
at a grant price of 3923 pence per share.
54,101 Ordinary Shares awarded on 24 March 2016
at a grant price of 3923 pence per share.
An award over shares. The vesting date is the fifth anniversary of the date of grant, subject to performance over
a three-year period commencing on 1 January in the year of the award and a two-year holding period commencing three
years from the date of grant, and continued employment.
The award is expressed as a percentage of base salary. Awards are weighted 75% in favour of the PSP and 25%
in favour of the AZIP.
Basis of award
Face value of award
Vesting level at threshold performance
End of performance period
End of holding period
427.5% of base salary.
£5,087,000
300% of base salary.
£2,122,000
25%
31 December 2018
24 March 2021
Summary of performance measures
and targets
A combination of measures focused on our scientific, commercial and financial performance assessed over the relevant
three-year performance period:
Twenty five percent of the award is based on the relative TSR performance of the Company against a predetermined peer
group of global pharmaceutical companies. The rank which the Company’s TSR achieves over the performance period will
determine how many shares will vest under the part of the award subject to the TSR performance measure. Payouts against
performance in relation to TSR for PSP awards are expressed as a percentage of the maximum award currently payable,
shown within a range of 0% to 100%, as shown in the table below.
TSR ranking of the Company – PSP awards made in 2016
% of award under TSR performance measure that vests
Below median
Median
Between median and upper quartile
Upper quartile
Above upper quartile
0%
25%
Pro rata
75%
75% to 100% at the Committee’s discretion
More information about the TSR performance of the Company, including the Company’s peer group, is set out in the Total
shareholder return section on page 113.
Twenty five percent of the award is based on the achievement of a cumulative free cash flow target. The measure for the
cash flow target for the PSP awards made in 2016 is net cash flow before distributions and other adjustments required by the
performance conditions (subject to any further adjustments the Committee chooses to make using its judgement) and thus
referred to as ‘adjusted cumulative cash flow’, over the same three-year performance period as the TSR performance
measure, and the level of vesting for the part of the award subject to the cash flow performance measure is based on a
sliding scale between a threshold cash flow target and an upper target. Vesting levels in relation to the threshold target and
the upper target are shown in the table below.
Adjusted cumulative cash flow – PSP awards made in 2016
% of award under cash flow performance measure that vests
Less than $9bn
$9bn
Between $9bn and $11bn
$11bn
Between $11bn and $13.5bn
$13.5bn and above
0%
25%
Pro rata
75%
Pro rata
100%
Twenty five percent of the award is based on Return to growth measures based on achievement of an aggregate revenue
target relating to the Company’s Growth Platforms.
Aggregate revenue of Growth Platforms – PSP awards made in 2016 % of award under Return to growth performance measure that vests
$17bn
$20bn
25%
100%
Twenty five percent of the award is based on Achieve scientific leadership measures covering five areas: an NME target,
which reflects the Company’s ability to deliver innovation to the market; major life-cycle management approvals, which
represent a good proxy for near-to-mid term growth; the volume of NMEs in Phase III and their registration; a target for
peak-year sales, to track the value of pipeline output; and delivery from our research and early development organisation,
assessed by Phase II starts.
As the PSP performance measures related to Achieve scientific leadership are an indicator of the Company’s longer-term
strategic priorities, we believe that the targets/target ranges associated with them are commercially sensitive. We will make
retrospective disclosure when the targets are deemed to be no longer commercially sensitive, which we currently anticipate
to be immediately following the end of the performance period.
More information about the PSP’s performance measures is set out on page 125 of the Remuneration Policy Report.
AstraZeneca Annual Report and Form 20-F Information 2016
111
Corporate Governance
Annual Report on Remuneration continued
AstraZeneca Investment Plan (AZIP)
Interest awarded
Description of interest
Pascal Soriot
Marc Dunoyer
21,618 Ordinary Shares awarded on 24 March 2016 at a grant
price of 3923 pence per share.
9,016 Ordinary Shares awarded on 24 March 2016 at a grant
price of 3923 pence per share.
An award over shares. The vesting date is the eighth anniversary of the start of the performance period (being 1 January in any
given year), subject to performance and continued employment.
The award is expressed as a percentage of base salary. Awards are weighted 75% in favour of the PSP and 25% in favour of the AZIP.
Basis of award
Face value of award
71.25% of base salary.
£848,000
Vesting level at threshold performance
End of performance period
End of holding period
Summary of performance measures
and targets
50% of base salary.
£354,000
100%
31 December 2019
31 December 2023
Dividend and dividend cover hurdles, assessed over the relevant four-year performance period
> dividend per share of $2.80 maintained, or increased, over the performance period
> dividend cover of 1.5 maintained over the performance period, calculated on the basis of Core EPS.
If both targets are achieved in each year of the performance period, the awards will vest in full. Twenty five percent of an award
will lapse for each year in which neither, or only one, target is achieved.
More information about the AZIP’s performance hurdles is set out on page 127 of the Remuneration Policy Report.
Payments to former Directors (Audited)
No payments were made during 2016 to former Directors.
(cid:51)(cid:68)(cid:92)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:79)(cid:82)(cid:86)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:82)(cid:433)(cid:70)(cid:72)(cid:3)(cid:11)(cid:36)(cid:88)(cid:71)(cid:76)(cid:87)(cid:72)(cid:71)(cid:12)
No payments were made for loss of office during 2016.
Remuneration context and our past performance
Statement of change in remuneration of CEO compared to other employees
Salary
Taxable benefits
Annual bonus
2.0%
5.2%
(42.9)%
3.3%
3.3%
(21.5)%
Percentage change for CEO against 2015
Average percentage change for employees against 2015
The employee comparator group comprises employees in the UK, US and Sweden. We consider this to be an appropriate comparator
group because it is representative of the Group’s major science, business and enabling units, and the employee populations are well
balanced in terms of seniority and demographics. To provide a meaningful comparison of salary increases, a consistent employee
comparator group is used by which the same individuals appear in the 2015 and 2016 group.
CEO total remuneration table
Year
2016
2015
2014
2013
2012
2012
2012
2011
2010
2009
CEO
Pascal Soriot
Pascal Soriot
Pascal Soriot
Pascal Soriot
Pascal Soriot4
Simon Lowth6
David Brennan8
David Brennan
David Brennan
David Brennan
CEO single total figure
remuneration
£’000
13,3891,2
7,9633
3,507
3,344
3,6935
3,289
4,1479
7,863
9,690
5,767
Annual bonus
£’000
Annual bonus payout
against maximum
opportunity
%
1,167
2,042
1,926
1,870
335
1,034
–
1,326
1,583
1,751
54
97
94
94
68
86
– 10
74
90
100
Value of LTIs
at vest
£’000
10,5331,2
4,2893
–
–
–
1,3017
2,538
5,386
6,937
2,795
LTI vesting rates
against maximum
opportunity
%
95
78
–
–
–
387
38
62
100
62
1(cid:3) (cid:55)(cid:75)(cid:76)(cid:86)(cid:3)(cid:430)(cid:74)(cid:88)(cid:85)(cid:72)(cid:3)(cid:76)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:72)(cid:86)(cid:3)(cid:86)(cid:75)(cid:68)(cid:85)(cid:72)(cid:86)(cid:3)(cid:68)(cid:90)(cid:68)(cid:85)(cid:71)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:48)(cid:85)(cid:3)(cid:54)(cid:82)(cid:85)(cid:76)(cid:82)(cid:87)(cid:3)(cid:76)(cid:81)(cid:3)(cid:21)(cid:19)(cid:20)(cid:22)(cid:3)(cid:88)(cid:81)(cid:71)(cid:72)(cid:85)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:36)(cid:61)(cid:44)(cid:51)(cid:3)(cid:87)(cid:82)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:72)(cid:81)(cid:86)(cid:68)(cid:87)(cid:72)(cid:3)(cid:75)(cid:76)(cid:80)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:47)(cid:55)(cid:44)(cid:86)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:83)(cid:85)(cid:72)(cid:89)(cid:76)(cid:82)(cid:88)(cid:86)(cid:3)(cid:72)(cid:80)(cid:83)(cid:79)(cid:82)(cid:92)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:73)(cid:82)(cid:85)(cid:73)(cid:72)(cid:76)(cid:87)(cid:72)(cid:71)(cid:3)(cid:82)(cid:81)(cid:3)(cid:75)(cid:76)(cid:86)(cid:3)(cid:85)(cid:72)(cid:70)(cid:85)(cid:88)(cid:76)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:68)(cid:86)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:38)(cid:82)(cid:80)(cid:83)(cid:68)(cid:81)(cid:92)(cid:350)(cid:86)(cid:3)(cid:38)(cid:40)(cid:50)(cid:17)
2 Based on average closing share price over the three-month period to 31 December 2016 plus accrued dividends over the vesting and performance periods.
3(cid:3) (cid:3)(cid:55)(cid:75)(cid:72)(cid:86)(cid:72)(cid:3)(cid:430)(cid:74)(cid:88)(cid:85)(cid:72)(cid:86)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:89)(cid:76)(cid:86)(cid:72)(cid:71)(cid:3)(cid:88)(cid:86)(cid:76)(cid:81)(cid:74)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:87)(cid:88)(cid:68)(cid:79)(cid:3)(cid:86)(cid:75)(cid:68)(cid:85)(cid:72)(cid:3)(cid:83)(cid:85)(cid:76)(cid:70)(cid:72)(cid:3)(cid:82)(cid:81)(cid:3)(cid:89)(cid:72)(cid:86)(cid:87)(cid:76)(cid:81)(cid:74)(cid:17)(cid:3)(cid:55)(cid:75)(cid:72)(cid:3)(cid:430)(cid:74)(cid:88)(cid:85)(cid:72)(cid:86)(cid:3)(cid:71)(cid:76)(cid:86)(cid:70)(cid:79)(cid:82)(cid:86)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:79)(cid:68)(cid:86)(cid:87)(cid:3)(cid:92)(cid:72)(cid:68)(cid:85)(cid:350)(cid:86)(cid:3)(cid:39)(cid:76)(cid:85)(cid:72)(cid:70)(cid:87)(cid:82)(cid:85)(cid:86)(cid:350)(cid:3)(cid:53)(cid:72)(cid:80)(cid:88)(cid:81)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:53)(cid:72)(cid:83)(cid:82)(cid:85)(cid:87)(cid:3)(cid:90)(cid:72)(cid:85)(cid:72)(cid:3)(cid:69)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)(cid:82)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:89)(cid:72)(cid:85)(cid:68)(cid:74)(cid:72)(cid:3)(cid:70)(cid:79)(cid:82)(cid:86)(cid:76)(cid:81)(cid:74)(cid:3)(cid:86)(cid:75)(cid:68)(cid:85)(cid:72)(cid:3)(cid:83)(cid:85)(cid:76)(cid:70)(cid:72)(cid:3)(cid:82)(cid:89)(cid:72)(cid:85)(cid:3)
the three-month period to 31 December 2015.
4(cid:3) (cid:48)(cid:85)(cid:3)(cid:54)(cid:82)(cid:85)(cid:76)(cid:82)(cid:87)(cid:3)(cid:90)(cid:68)(cid:86)(cid:3)(cid:68)(cid:83)(cid:83)(cid:82)(cid:76)(cid:81)(cid:87)(cid:72)(cid:71)(cid:3)(cid:38)(cid:40)(cid:50)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:20)(cid:3)(cid:50)(cid:70)(cid:87)(cid:82)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:21)(cid:17)
5(cid:3) (cid:3)(cid:55)(cid:75)(cid:76)(cid:86)(cid:3)(cid:430)(cid:74)(cid:88)(cid:85)(cid:72)(cid:3)(cid:76)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:72)(cid:86)(cid:3)(cid:101)(cid:28)(cid:28)(cid:20)(cid:15)(cid:19)(cid:19)(cid:19)(cid:3)(cid:83)(cid:68)(cid:76)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:72)(cid:81)(cid:86)(cid:68)(cid:87)(cid:72)(cid:3)(cid:48)(cid:85)(cid:3)(cid:54)(cid:82)(cid:85)(cid:76)(cid:82)(cid:87)(cid:3)(cid:76)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:83)(cid:72)(cid:70)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:75)(cid:76)(cid:86)(cid:3)(cid:73)(cid:82)(cid:85)(cid:73)(cid:72)(cid:76)(cid:87)(cid:72)(cid:71)(cid:3)(cid:69)(cid:82)(cid:81)(cid:88)(cid:86)(cid:3)(cid:82)(cid:83)(cid:83)(cid:82)(cid:85)(cid:87)(cid:88)(cid:81)(cid:76)(cid:87)(cid:92)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:21)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:68)(cid:81)(cid:3)(cid:68)(cid:90)(cid:68)(cid:85)(cid:71)(cid:3)(cid:82)(cid:73)(cid:3)(cid:101)(cid:21)(cid:15)(cid:19)(cid:19)(cid:19)(cid:15)(cid:19)(cid:19)(cid:19)(cid:3)(cid:87)(cid:82)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:72)(cid:81)(cid:86)(cid:68)(cid:87)(cid:72)(cid:3)(cid:75)(cid:76)(cid:80)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:75)(cid:76)(cid:86)(cid:3)(cid:79)(cid:82)(cid:86)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:47)(cid:55)(cid:44)(cid:3)(cid:68)(cid:90)(cid:68)(cid:85)(cid:71)(cid:86)(cid:15)(cid:3)
both in respect of his previous employment.
6 Mr Lowth acted as Interim CEO from June to September 2012 inclusive.
7 Mr Lowth’s LTI awards which vested during 2012 were not awarded or received in respect of his performance as Interim CEO.
8 Mr Brennan ceased to be a Director on 1 June 2012.
9(cid:3) (cid:55)(cid:75)(cid:76)(cid:86)(cid:3)(cid:430)(cid:74)(cid:88)(cid:85)(cid:72)(cid:3)(cid:76)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:72)(cid:86)(cid:3)(cid:48)(cid:85)(cid:3)(cid:37)(cid:85)(cid:72)(cid:81)(cid:81)(cid:68)(cid:81)(cid:350)(cid:86)(cid:3)(cid:83)(cid:68)(cid:92)(cid:3)(cid:76)(cid:81)(cid:3)(cid:79)(cid:76)(cid:72)(cid:88)(cid:3)(cid:82)(cid:73)(cid:3)(cid:81)(cid:82)(cid:87)(cid:76)(cid:70)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:101)(cid:28)(cid:20)(cid:23)(cid:15)(cid:19)(cid:19)(cid:19)(cid:17)
10 Mr Brennan informed the Committee that he did not wish to be considered for a bonus in respect of that part of 2012 in which he was CEO. The Committee determined that no such bonus
would be awarded and also that there should be no bonus award relating to his contractual notice period.
112
AstraZeneca Annual Report and Form 20-F Information 2016
Total shareholder return (TSR)
The graph below compares the TSR performance of the Company over the past eight years with the TSR of the FTSE100 Index.
This graph is re-based to 100 at the start of the relevant period. As a constituent of the FTSE100, this index represents an appropriate
reference point for the Company. We have also included a ‘Pharmaceutical peers average’, which reflects the TSR of the current
comparator group and provides shareholders with additional context.
The charts below show how the Company’s TSR performance has compared with the TSR for the relevant companies in the comparator
group from the first day in the three-year performance period in respect of the PSP awards made in 2014, 2015 and 2016, and how the
Company ranks against those other companies on this basis.
To alleviate any short-term volatility, the return index is averaged in the TSR calculations for each company over the three months prior
to the start of the relevant performance period (as stipulated in the PSP rules) and, for the purposes of the charts below, over the last
three months of 2016.
TSR over an eight-year period
AstraZeneca TSR vs comparator group
1 January 2016 – 31 December 2016 (%)
275
250
225
200
175
150
125
100
Jan
09
Jan
10
Jan
11
Jan
12
Jan
13
Jan
14
Jan
15
Jan
16
Jan
17
AstraZeneca
Pharmaceutical peers average
FTSE100
30
20
10
0
-10
-20
GSK
MRK
J&J
AV
AZ
PFI
LLY
SA
RH
NOV
BMS
AstraZeneca TSR vs comparator group
1 January 2015 – 31 December 2016 (%)
AstraZeneca TSR vs comparator group
1 January 2014 – 31 December 2016 (%)
30
20
10
0
-10
-20
GSK
LLY
J&J
PFI
MRK
AZ
AV
SA
BMS
RH
NOV
70
60
50
40
30
20
10
0
LLY
AZ
MRK
AV
J&J
GSK
PFI
BMS
NOV
SA
RH
Key:
(cid:36)(cid:61)(cid:3)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:15)(cid:3)(cid:36)(cid:57)(cid:3)(cid:36)(cid:69)(cid:69)(cid:57)(cid:76)(cid:72)(cid:15)(cid:3)(cid:37)(cid:48)(cid:54)(cid:3)(cid:37)(cid:85)(cid:76)(cid:86)(cid:87)(cid:82)(cid:79)(cid:16)(cid:48)(cid:92)(cid:72)(cid:85)(cid:86)(cid:3)(cid:54)(cid:84)(cid:88)(cid:76)(cid:69)(cid:69)(cid:15)(cid:3)(cid:42)(cid:54)(cid:46)(cid:3)(cid:42)(cid:79)(cid:68)(cid:91)(cid:82)(cid:54)(cid:80)(cid:76)(cid:87)(cid:75)(cid:46)(cid:79)(cid:76)(cid:81)(cid:72)(cid:15)(cid:3)(cid:45)(cid:9)(cid:45)(cid:3)(cid:45)(cid:82)(cid:75)(cid:81)(cid:86)(cid:82)(cid:81)(cid:3)(cid:9)(cid:3)(cid:45)(cid:82)(cid:75)(cid:81)(cid:86)(cid:82)(cid:81)(cid:15)(cid:3)(cid:47)(cid:47)(cid:60)(cid:3)(cid:40)(cid:79)(cid:76)(cid:3)(cid:47)(cid:76)(cid:79)(cid:79)(cid:92)(cid:15)(cid:3)(cid:48)(cid:53)(cid:46)(cid:3)(cid:48)(cid:72)(cid:85)(cid:70)(cid:78)(cid:15)(cid:3)(cid:49)(cid:50)(cid:57)(cid:3)(cid:49)(cid:82)(cid:89)(cid:68)(cid:85)(cid:87)(cid:76)(cid:86)(cid:15)(cid:3)(cid:51)(cid:41)(cid:44)(cid:3)(cid:51)(cid:430)(cid:93)(cid:72)(cid:85)(cid:15)(cid:3)
(cid:53)(cid:43)(cid:3)(cid:53)(cid:82)(cid:70)(cid:75)(cid:72)(cid:3)(cid:43)(cid:82)(cid:79)(cid:71)(cid:76)(cid:81)(cid:74)(cid:15)(cid:3)(cid:54)(cid:36)(cid:3)(cid:54)(cid:68)(cid:81)(cid:82)(cid:430)(cid:16)(cid:36)(cid:89)(cid:72)(cid:81)(cid:87)(cid:76)(cid:86)
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AstraZeneca Annual Report and Form 20-F Information 2016
113
Corporate Governance
Annual Report on Remuneration continued
Relative importance of spend on remuneration
The table below shows the remuneration paid to all employees in the Group and expenditure on shareholder distributions through dividends.
The figures below have been calculated in accordance with the Group Accounting Policies and drawn from either the Company’s
Consolidated Statement of Comprehensive Income on page 138, or its Consolidated Statement of Cash Flows on page 141. Further
information on the Group’s Accounting Policies can be found from page 142.
Total employee remuneration
Distributions to shareholders:
– Dividends paid
2016
$m
6,284
3,561
2015
$m
6,128
3,486
Difference in spend
between years
$m
Difference in spend
between years
%
156
75
2.5
2.2
Disclosure of historic performance targets
2014 Annual bonus
In accordance with the Committee’s commitment to disclosure as set out in the 2014 Directors’ Remuneration Report, the Committee has
determined that the 2014 targets relating to the Achieve scientific leadership and Return to growth elements of the annual bonus are no
longer commercially sensitive and can therefore be disclosed. The Achieve Group financial targets were disclosed in the 2014 Directors’
Remuneration Report. Mr Soriot’s 2014 annual bonus award was 170% of base salary, and Mr Dunoyer’s award was 149.4%. The level
of award for the Executive Directors in respect of the Achieve scientific leadership performance measures was 35% of the total bonus
outcome, with the Return to growth measures contributing 22%. These figures reflect the outcome of the global Scorecard and the
Executive Directors’ individual performance against it.
1. Achieve scientific leadership
Performance measures for 2014
Phase II starts/progressions
Positive Phase III investment decisions
NME major life-cycle management submissions
NME major life-cycle management approvals
Clinical-stage external licensing and partnering opportunities
2. Return to growth1
Performance measures for 2014
Deliver Brilinta/Brilique target
Build Diabetes franchise
Deliver sales growth in Emerging Markets
Deliver Respiratory goals
Deliver Japan growth target
Target
Outcome
Performance
8
5
5
6
2
Target
$487m
$1,824m
$5,761m
$4,460m
$2,456m
13
9
6
12
3
Exceeded target
Exceeded target
Met target
Exceeded target
Met target
Outcome
$476m
$1,870m
$5,827m
$4,747m
$2,227m
Performance
Below target
Met target
Met target
Exceeded target
Below target
1 In respect of the Return to growth measures only, the targets are set at budget exchange rates at the beginning of the performance period and evaluated at those rates at the end of the
performance period.
Directors’ interests in shares (Audited)
Under the Company’s Articles all Directors must, within two months of their appointment, acquire a beneficial interest in at least 500 shares
in the Company. All of the Directors fulfil this requirement at the date of this Directors’ Remuneration Report.
In addition to this mandatory requirement, the Board imposes minimum shareholding requirements on the Executive Directors and SET
members. The CEO is required to build a shareholding and hold shares amounting to 300% of base salary, and the CFO is required to hold
shares amounting to 200% of base salary, each within five years of their dates of appointment. As at 31 December 2016, Mr Soriot and Mr
Dunoyer had fulfilled this requirement. All other SET members are required to build a shareholding over time and hold 125% of base salary
as shares while in office.
The Board also encourages each Non-Executive Director to build up, over a period of three years, a shareholding in the Company with a
value approximately equivalent to the basic annual fee for a Non-Executive Director (£75,000) or, in the case of the Chairman, approximately
equivalent to his basic annual fee (£575,000). All of the Non-Executive Directors, including the Chairman, had fulfilled this expectation as at
31 December 2016.
114
AstraZeneca Annual Report and Form 20-F Information 2016
The tables below show the interests of the Directors (including the interests of their connected persons) in Ordinary Shares as at
31 December 2016, as well as details of any Director’s interests in options over the Company’s shares. All such interests were beneficial
except as otherwise stated. No Director or senior executive beneficially owns, or has options over, 1% or more of the issued share capital of
the Company, nor do they have different voting rights from other shareholders. None of the Directors has a beneficial interest in the shares
of any of the Company’s subsidiaries. Between 31 December 2016 and 2 February 2017, there was no change in the interests in Ordinary
Shares shown in the tables below.
Executive Directors
Executive Director
Pascal Soriot
Marc Dunoyer
Shares held
Options held
Value of shares
held beneficially
as percentage
of base salary1
Shareholding
requirement
(to be built up within
5 years of date of
appointment)
326%
634%
300%
200%
Held
beneficially
87,355
101,034
Subject to
performance
conditions
418,298
177,606
Subject to
deferral
136,760
26,764
Unvested
Vested but
unexercised
Exercised
during the year
–
544
–
–
–
–
Total
642,413
305,948
1 The value of shares is based on the London Stock Exchange closing price of 4437.5 pence per Ordinary Share on 31 December 2016.
Non-Executive Directors
The Non-Executive Directors are not eligible to receive shares in the Company that are the subject of performance conditions, and have
acquired their beneficial interests in the Company’s shares using their own resources.
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Non-Executive Director
Leif Johansson
Geneviève Berger
Bruce Burlington
Ann Cairns
Graham Chipchase
Rudy Markham
Shriti Vadera
Marcus Wallenberg
Former Directors
Cori Bargmann
Jean-Philippe Courtois
Beneficial interest in
Ordinary Shares at
31 December 2015 or
(if later) appointment date
Change to beneficial interest
Beneficial interest in
Ordinary Shares at
31 December 2016 or
(if earlier) date of retirement
39,009
2,090
3,349
2,325
3,000
2,452
10,000
63,646
1,959
6,035
–
–
–
–
100
–
–
–
–
–
39,009
2,090
3,349
2,325
3,100
2,452
10,000
63,646
1,959
6,035
Governance
Committee membership
The Committee members are Graham Chipchase (Chairman of the Committee), Leif Johansson, Rudy Markham and Shriti Vadera.
The Deputy Company Secretary acts as the secretary to the Committee.
The Committee met five times in 2016. The individual attendance record of Committee members is set out on page 84. The Committee
was materially assisted, except in relation to their own remuneration, by the CEO; the CFO; the VP Finance, Group Controller; the EVP
GMD; the EVP, Human Resources; the Human Resources Vice-President, Centre of Excellence; the Executive Compensation Director;
and the Company Secretary during the year. The Committee’s independent adviser, Nicki Demby, Deloitte LLP (Deloitte) attended all
Committee meetings.
AstraZeneca Annual Report and Form 20-F Information 2016
115
Corporate Governance
Annual Report on Remuneration continued
The Committee focused on the following principal matters at its meetings held in 2016 and in January 2017:
> The terms of senior executives’ employment and remuneration packages on appointment, promotion or termination.
> The assessment of Group and individual performance against targets to determine the level of annual bonuses for performance during
2015 and to set executive bonus targets during 2016 and LTI awards to be granted during 2016.
> The assessment of performance against targets to determine the level of vesting in 2016 under the PSP and AZIP, and the setting of PSP
and AZIP performance thresholds for awards made in 2016.
> The determination of individual awards made to SET members and other participants under the Group’s main LTI plans: the PSP; the
AZIP; and the AstraZeneca Global Restricted Stock Plan.
> The determination of restricted share awards to a number of senior executives under the AstraZeneca Restricted Share Plan.
> A review of shareholder voting in respect of the Directors’ Remuneration Report 2015 (including dialogue with major shareholders).
> Consultation with major shareholders and shareholder representative bodies regarding proposals to simplify LTI plans.
> A review of a report providing an analysis of key aspects of reward across the wider Group.
> The determination of the Executive Directors’ and other SET members’ remuneration for 2016 and for 2017.
> The assessment and setting of executive bonus targets for 2017 and LTI awards to be granted in 2017.
> The annual review of the performance of the Committee.
> The review of the terms of reference of the Committee.
> The preparation, review and approval of this Directors’ Remuneration Report.
Independent adviser to the Committee
The Committee reappointed Deloitte as its independent adviser following a tender process undertaken in 2013, which involved interviews
with both the Company’s management and the Chairman of the Committee. The role as independent adviser will be re-tendered no
later than the end of 2018. Deloitte’s service to the Committee was provided on a time-spent basis at a cost to the Company of £99,000
(excluding VAT). During the year, Deloitte also provided taxation advice and other specific non-audit advisory services to the Group.
The Committee reviewed the potential for conflicts of interest and judged that there were no conflicts. Deloitte is a member of the
Remuneration Consultants’ Group, which is responsible for the stewardship and development of the voluntary code of conduct in
relation to executive remuneration consulting in the UK. The principles on which the code is based are transparency, integrity, objectivity,
competence, due care and confidentiality. Deloitte adheres to the code.
Shareholder context
At the Company’s AGM held in April 2016, the resolution to approve the Annual Report on Remuneration for the year ended 31 December
2015 was passed.
Resolution
Votes for
% for
Votes against
% against Total votes cast
Capital voted Votes withheld
Ordinary Resolution to approve the Annual Report on Remuneration
for the year ended 31 December 2015
836,396,151
89.61 96,959,428
10.39 933,355,579
73.81
3,822,290
% of Issued Share
At the Company’s AGM held in April 2014, the resolution to approve the current Remuneration Policy was passed.
Resolution
Votes for
% for
Votes against
% against Total votes cast
Capital voted Votes withheld
Ordinary Resolution to approve the Directors’ Remuneration Policy
623,298,717
85.00 110,030,311
15.00 733,329,028
58.13 166,623,018
% of Issued Share
As explained in the Annual Statement from the Chairman of the Remuneration Committee from page 103, an updated Remuneration Policy
will be proposed for approval by shareholders at the 2017 AGM.
In 2015, we simplified the PSP for awards made in 2016 by replacing the six Return to growth performance targets with one aggregate
sales target for our Growth Platforms and increased transparency in our reporting by disclosing the target for that measure at the start
of the performance period, in line with our aim to strike the right balance between transparency in our reporting on executive pay and
protecting our commercially sensitive information.
In 2016, the Chairman of the Committee consulted with our major shareholders and shareholder representative bodies on executive
remuneration. The feedback we received has informed the Committee’s approach to executive remuneration in 2017, with further detail set
out in the Annual Statement from the Chairman of the Remuneration Committee from page 103 and the Implementation of Remuneration
Policy in 2017 section from page 117.
Based on our shareholder consultation we believe that the changes made to the Committee’s approach to executive remuneration
in 2017 will closely align our reward mechanisms with the experience of shareholders. We intend to continue the dialogue with our major
shareholders and shareholder representative bodies during the course of 2017 as the Company’s strategy and business needs evolve,
to ensure executive reward remains aligned to the delivery of sustainable value for our shareholders.
116
AstraZeneca Annual Report and Form 20-F Information 2016
Service contracts
The notice periods and unexpired terms of Executive Directors’ service contracts at 31 December 2016 are shown in the table below.
AstraZeneca or the Executive Director may terminate the service contract on 12 months’ notice.
Executive Director
Pascal Soriot
Marc Dunoyer
Date of service contract
15 December 2016
6 December 2016
Unexpired term at 31 December 2016
Notice period
12 months
12 months
12 months
12 months
Terms of reference
A copy of the Committee’s terms of reference is available on our website, www.astrazeneca.com. The Committee conducted a review of its
terms of reference during 2016 and recommended minor changes including an express reference to the regular tender for the services of
the Committee’s independent adviser. The Board approved this recommendation.
Basis of preparation of this Directors’ Remuneration Report
This Directors’ Remuneration Report has been prepared in accordance with the Large and Medium-sized Companies and Groups
(Accounts and Reports) (Amendment) Regulations 2013 (the Regulations) and meets the relevant requirements of the Financial Conduct
Authority’s Listing Rules. As required by the Regulations, resolutions to approve the Annual Report on Remuneration and the Directors’
Remuneration Policy will be proposed at the AGM on 27 April 2017.
Implementation of Remuneration Policy in 2017
This section sets out how the Committee intends to implement our Remuneration Policy in 2017.
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Changes to LTI plans
From 1 January 2017, LTI plans will be simplified: no new awards will be made under the AZIP so LTI awards for Executive Directors will only
be made under the PSP. The performance measures and weightings for 2017 PSP awards are set out in the table overleaf. Taking into
account shareholder feedback, a number of changes have been made to the PSP’s performance measures:
> The level of vesting for threshold performance has been reduced from 25% to 20% of maximum for all measures.
> The TSR peer group will be increased from 10 to 18 companies. The new peer group provides a better comparison in terms of revenue,
innovative portfolio and geographical presence. The TSR peer group is set out in the Summary of Executive Directors’ remuneration for
2017 section on page 118.
> We have introduced a Reported EBITDA measure. In selecting ‘Reported’ EBITDA, the Committee has addressed a general concern
about the pharmaceutical industry’s use of ‘core’ earnings for incentive purposes. Further to this, in line with our aim to increase
transparency and accountability in our reporting, we have disclosed the targets for this measure at the start of the performance period.
> The number of measures under the Achieve scientific leadership element has been reduced from five to three measures ensuring focus
on late-stage value creation.
For AZIP awards that still have performance years to run in 2017, 2018 and 2019, the Committee is responding to concerns expressed by
some shareholders that the AZIP may incentivise decision making that is strongly focused on short-term earnings, by introducing a simple
pro rata sliding scale to assess performance for the outstanding AZIP awards. If a performance target is missed in any one year, instead
of every outstanding AZIP award failing, only 25% will fail reflecting the fact that only one of the four performance years has failed.
The Committee believes that this sliding scale directly addresses shareholder concerns and will provide a good balance between
challenging and achievable targets.
Executive Directors’ remuneration opportunity for 2017
Effective from 1 January 2017, Mr Soriot’s base salary was increased, in line with increases in the UK employee population, by 2.5%
to £1,220,000. For performance in line with the Company’s expectations, Mr Soriot’s overall remuneration opportunity will remain
unchanged at 100% of base salary for his annual bonus, and 250% of base salary for his LTI award.
Effective from 1 January 2017, Mr Dunoyer’s base salary was increased, in line with increases in the UK employee population, by 2.5%
to £725,000. For performance in line with the Company’s expectations, Mr Dunoyer’s overall remuneration opportunity will also remain
unchanged at 90% of base salary for his annual bonus, and 200% of base salary for his LTI award. Awards under the PSP have an
expected value of 50%, whereas the expected value that has been used when making AZIP awards has been 100%. A consequence
of awarding shares entirely under the PSP is that the value that could potentially be delivered to Mr Dunoyer for maximum performance
under the LTI has increased from 350% of base salary to 400% at face value. There is no increase in Mr Soriot’s maximum remuneration
opportunity under the LTI which remains at 500% at face value.
The annual bonus measures and weightings for 2017 are set out in the table overleaf and are broadly consistent with those applicable
in 2016. Individual performance for each of the Executive Directors will be assessed by reference to individual objectives in line with the
Company’s objectives for the year.
AstraZeneca Annual Report and Form 20-F Information 2016
117
Corporate Governance
Annual Report on Remuneration continued
Summary of Executive Directors’ remuneration for 2017
Base salary
Pension provision
Annual bonus target
LTI plan award
Annual bonus
Return to growth
performance measures
Pascal Soriot
£1,220,000
30% of base salary
Marc Dunoyer
£725,000
24% of base salary
100% of base salary (normal range 0-180%)
90% of base salary (normal range 0-150%)
500% of base salary
400% of base salary
Weighting
Achieve scientific leadership
performance measures
Weighting
Achieve Group financial targets
performance measures
New CVMD (including Brilinta)
NME Phase II starts/progressions
Respiratory
New Oncology
Emerging Markets
Japan
6% per
measure
NME and major life-cycle management
Phase III investment decisions
NME and major life-cycle management
regional submissions
NME and major life-cycle management
regional approvals
Acquisition, licensing and divestment deals
Cash flow
Core EPS
6% per
measure
Total Revenue
Weighting
10%
20%
10%
The measure for the cash flow target is net cash flow from operating activities less capital expenditure adding back proceeds from disposal
of intangible assets.
PSP
Performance measure
Relative TSR
Reported EBITDA1,2
Cash flow3
Return to growth2
Achieve scientific leadership:
> NME approvals
> Major life-cycle management
approvals
> Phase III registration
Weighting
Threshold target: 20% vesting
20% per
measure
Median
$12.0bn
$8.5bn
$16.5bn
6.67% per
measure
Commercially sensitive
Maximum target: 100% vesting
Upper quartile
$18.0bn
$12.0bn
$20.7bn
Commercially sensitive
1 The target is Reported EBITDA less gains on disposals of intangible assets, adjusted for the fair value movements on contingent considerations arising from revised forecasts.
2 (cid:3) (cid:3)(cid:55)(cid:75)(cid:72)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:72)(cid:85)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:68)(cid:74)(cid:68)(cid:76)(cid:81)(cid:86)(cid:87)(cid:3)(cid:87)(cid:75)(cid:82)(cid:86)(cid:72)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:86)(cid:15)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:72)(cid:89)(cid:68)(cid:79)(cid:88)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:69)(cid:92)(cid:3)(cid:85)(cid:72)(cid:73)(cid:72)(cid:85)(cid:72)(cid:81)(cid:70)(cid:72)(cid:3)(cid:87)(cid:82)(cid:3)(cid:69)(cid:88)(cid:71)(cid:74)(cid:72)(cid:87)(cid:3)(cid:72)(cid:91)(cid:70)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:3)(cid:85)(cid:68)(cid:87)(cid:72)(cid:86)(cid:3)(cid:86)(cid:88)(cid:70)(cid:75)(cid:3)(cid:87)(cid:75)(cid:68)(cid:87)(cid:3)(cid:69)(cid:72)(cid:81)(cid:72)(cid:430)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:82)(cid:85)(cid:3)(cid:68)(cid:71)(cid:89)(cid:72)(cid:85)(cid:86)(cid:72)(cid:3)(cid:80)(cid:82)(cid:89)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:70)(cid:88)(cid:85)(cid:85)(cid:72)(cid:81)(cid:70)(cid:92)(cid:15)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:82)(cid:88)(cid:87)(cid:86)(cid:76)(cid:71)(cid:72)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)
Company’s control, do not impact reward outcomes.
3 (cid:3) (cid:3)(cid:55)(cid:75)(cid:72)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:3)(cid:87)(cid:68)(cid:85)(cid:74)(cid:72)(cid:87)(cid:3)(cid:76)(cid:86)(cid:3)(cid:81)(cid:72)(cid:87)(cid:3)(cid:70)(cid:68)(cid:86)(cid:75)(cid:3)(cid:432)(cid:82)(cid:90)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:82)(cid:83)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:68)(cid:70)(cid:87)(cid:76)(cid:89)(cid:76)(cid:87)(cid:76)(cid:72)(cid:86)(cid:3)(cid:79)(cid:72)(cid:86)(cid:86)(cid:3)(cid:70)(cid:68)(cid:83)(cid:76)(cid:87)(cid:68)(cid:79)(cid:3)(cid:72)(cid:91)(cid:83)(cid:72)(cid:81)(cid:71)(cid:76)(cid:87)(cid:88)(cid:85)(cid:72)(cid:3)(cid:68)(cid:71)(cid:71)(cid:76)(cid:81)(cid:74)(cid:3)(cid:69)(cid:68)(cid:70)(cid:78)(cid:3)(cid:83)(cid:85)(cid:82)(cid:70)(cid:72)(cid:72)(cid:71)(cid:86)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:71)(cid:76)(cid:86)(cid:83)(cid:82)(cid:86)(cid:68)(cid:79)(cid:3)(cid:82)(cid:73)(cid:3)(cid:76)(cid:81)(cid:87)(cid:68)(cid:81)(cid:74)(cid:76)(cid:69)(cid:79)(cid:72)(cid:3)(cid:68)(cid:86)(cid:86)(cid:72)(cid:87)(cid:86)(cid:17)
For 2017 awards, the number of companies in the TSR group has been increased from 10 to 18 (AbbVie, Amgen, Astellas, BMS, Celgene,
Daiichi Sankyo, Lilly, Gilead, GSK, Johnson & Johnson, Merck, Novo Nordisk, Novartis, Pfizer, Roche, Sanofi, Shire and Takeda). The
Committee is of the opinion that the new peer group provides a better comparison in terms of revenue, innovative portfolio and
geographical presence.
118
AstraZeneca Annual Report and Form 20-F Information 2016
Summary of Non-Executive Directors’ remuneration for 2017
Board fees for the Non-Executive Directors, including the Chairman, were reviewed in 2016, but no changes were proposed.
The Non-Executive Director fees for 2017 (together with those for 2016) are set out below. Further information on the Non-Executive
Directors’ Board fees can be found on page 132 of the Remuneration Policy Report.
Non-Executive Director fees in 2016 and in 2017
Chairman’s fee1
Basic Non-Executive Director’s fee
Senior independent Non-Executive Director
Membership of the Audit Committee
Membership of the Remuneration Committee
Chairman of the Audit Committee or the Remuneration Committee2
Membership of the Science Committee
Chairman of the Science Committee2
1 The Chairman does not receive any additional fees for chairing, or being a member of, a committee.
2 This fee is in addition to the fee for membership of the relevant committee.
2016
£’000
575
2017
£’000
575
75
30
20
15
25
12
10
75
30
20
15
25
12
10
Additional information: Executive Directors’ share plans
Deferred Bonus Plan
The interests of Directors at 31 December 2016 in Ordinary Shares that are the subject of awards under the Deferred Bonus Plan
are shown below.
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Pascal Soriot
Award in respect of 2012 performance period
Award in respect of 2013 performance period
Award in respect of 2014 performance period
Total at 1 January 2016
Vesting of award in respect of 2012 performance period
Award in respect of 2015 performance period
Total at 31 December 2016
Marc Dunoyer
Award in respect of 2013 performance period
Award in respect of 2014 performance period
Total at 1 January 2016
Award in respect of 2015 performance period
Total at 31 December 2016
1 UK date convention applies.
3,799
15,966
13,482
33,247
(3,799)
17,352
46,800
2,679
7,111
9,790
8,798
18,588
Number of
shares
Award price
(pence)
Price
on vesting
date (pence)
2939
3904
4762
Grant date1
Vesting date1
25.02.13
28.03.14
27.03.15
25.02.16
28.03.17
27.03.18
4086.5
3923
24.03.16
24.03.19
3904
4762
3923
28.03.14
28.03.17
27.03.15
27.03.18
24.03.16
24.03.19
AstraZeneca Annual Report and Form 20-F Information 2016
119
Corporate Governance
Annual Report on Remuneration continued
Performance Share Plan (PSP)
The interests of Directors at 31 December 2016 in Ordinary Shares that are the subject of awards under the PSP are shown below.
Pascal Soriot
2013 award
2014 award
2015 award
Total at 1 January 2016
2016 award
Partial vesting of 2013 award2
Partial lapse of 2013 award
Total at 31 December 2016
Marc Dunoyer
2013 award
2014 award
2015 award
Total at 1 January 2016
2016 award
Partial vesting of 2013 award2
Partial lapse of 2013 award
Total at 31 December 2016
Number of
shares
Award price
(pence)
Price on
vesting date
(pence)
Grant date1
Vesting date1
Performance period1
3297
3904
4762
3923
3302
3904
4762
3923
125,113
124,066
104,764
353,943
129,713
(97,589)3
(27,524)
358,543
90,853
52,254
45,880
188,987
54,101
(70,866)4
(19,987)
152,235
3852
5048
11.06.13
28.03.14
27.03.15
11.06.16
28.03.17
27.03.20
01.01.13 – 31.12.15
01.01.14 – 31.12.16
01.01.15 – 31.12.17
24.03.16
24.03.21
01.01.16 – 31.12.18
01.08.13
28.03.14
27.03.15
01.08.16
28.03.17
27.03.20
01.01.13 – 31.12.15
01.01.14 – 31.12.16
01.01.15 – 31.12.17
24.03.16
24.03.21
01.01.16 – 31.12.18
1 UK date convention applies.
2 Awards granted in 2013 vested in 2016 at 78%.
3(cid:3) (cid:41)(cid:82)(cid:79)(cid:79)(cid:82)(cid:90)(cid:76)(cid:81)(cid:74)(cid:3)(cid:70)(cid:72)(cid:85)(cid:87)(cid:68)(cid:76)(cid:81)(cid:3)(cid:80)(cid:68)(cid:81)(cid:71)(cid:68)(cid:87)(cid:82)(cid:85)(cid:92)(cid:3)(cid:87)(cid:68)(cid:91)(cid:3)(cid:71)(cid:72)(cid:71)(cid:88)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:15)(cid:3)(cid:48)(cid:85)(cid:3)(cid:54)(cid:82)(cid:85)(cid:76)(cid:82)(cid:87)(cid:3)(cid:69)(cid:72)(cid:70)(cid:68)(cid:80)(cid:72)(cid:3)(cid:69)(cid:72)(cid:81)(cid:72)(cid:430)(cid:70)(cid:76)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)(cid:76)(cid:81)(cid:87)(cid:72)(cid:85)(cid:72)(cid:86)(cid:87)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:68)(cid:3)(cid:81)(cid:72)(cid:87)(cid:3)(cid:81)(cid:88)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:82)(cid:73)(cid:3)(cid:27)(cid:23)(cid:15)(cid:22)(cid:20)(cid:25)(cid:3)(cid:50)(cid:85)(cid:71)(cid:76)(cid:81)(cid:68)(cid:85)(cid:92)(cid:3)(cid:54)(cid:75)(cid:68)(cid:85)(cid:72)(cid:86)(cid:17)
4(cid:3) (cid:41)(cid:82)(cid:79)(cid:79)(cid:82)(cid:90)(cid:76)(cid:81)(cid:74)(cid:3)(cid:70)(cid:72)(cid:85)(cid:87)(cid:68)(cid:76)(cid:81)(cid:3)(cid:80)(cid:68)(cid:81)(cid:71)(cid:68)(cid:87)(cid:82)(cid:85)(cid:92)(cid:3)(cid:87)(cid:68)(cid:91)(cid:3)(cid:71)(cid:72)(cid:71)(cid:88)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:15)(cid:3)(cid:48)(cid:85)(cid:3)(cid:39)(cid:88)(cid:81)(cid:82)(cid:92)(cid:72)(cid:85)(cid:3)(cid:69)(cid:72)(cid:70)(cid:68)(cid:80)(cid:72)(cid:3)(cid:69)(cid:72)(cid:81)(cid:72)(cid:430)(cid:70)(cid:76)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)(cid:76)(cid:81)(cid:87)(cid:72)(cid:85)(cid:72)(cid:86)(cid:87)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:68)(cid:3)(cid:81)(cid:72)(cid:87)(cid:3)(cid:81)(cid:88)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:82)(cid:73)(cid:3)(cid:22)(cid:26)(cid:15)(cid:24)(cid:24)(cid:27)(cid:3)(cid:50)(cid:85)(cid:71)(cid:76)(cid:81)(cid:68)(cid:85)(cid:92)(cid:3)(cid:54)(cid:75)(cid:68)(cid:85)(cid:72)(cid:86)(cid:17)
AstraZeneca Investment Plan (AZIP)
The interests of Directors at 31 December 2016 in Ordinary Shares that are the subject of awards under the AZIP are shown below.
Pascal Soriot
2013 award2
2014 award
2015 award
Total at 1 January 2016
2016 award
Total at 31 December 2016
Marc Dunoyer
2013 award
2014 award
2015 award
Total at 1 January 2016
2016 award
Total at 31 December 2016
Number of
shares
Award price
(pence)
Grant date1
Vesting date1
Performance period1
Holding period1
89,960
20,677
17,460
128,097
21,618
149,715
8,176
8,709
7,646
24,531
9,016
33,547
3297
3904
4762
11.06.13
28.03.14
27.03.15
01.01.21
01.01.22
01.01.23
01.01.14 – 31.12.17
01.01.15 – 31.12.18
01.01.17 – 31.12.20
3923
24.03.16
01.01.24
01.01.16 – 31.12.19
3302
3904
4762
01.08.13
28.03.14
27.03.15
01.01.21
01.01.22
01.01.23
01.01.14 – 31.12.17
01.01.15 – 31.12.18
01.01.17 – 31.12.20
3923
24.03.16
01.01.24
01.01.16 – 31.12.19
1 UK date convention applies.
2 The AZIP award of 89,960 shares comprises a regular 2013 award of 20,852 shares and a previously announced award which replaces that originally made when Mr Soriot joined the Company in
October 2012.
120
AstraZeneca Annual Report and Form 20-F Information 2016
Restricted Share Plan
On 1 August 2013, Mr Dunoyer was granted an award of 65,505 restricted shares at an award price of 3302 pence per share.
When Mr Dunoyer joined AstraZeneca as EVP, GPPS, he forfeited awards made to him by his previous employer. The Committee
determined that it was appropriate to compensate him for the value of those forfeited awards. AstraZeneca received an independent
assessment of their value. The restricted shares vested as follows:
> 9,103 shares vested on 15 June 2014
> 41,472 shares vested on 15 June 2015
> 11,645 shares vested on 1 August 2016 (3,285 shares lapsed).
The interests of Mr Dunoyer at 31 December 2016 in Ordinary Shares that are the subject of awards under this arrangement are
shown below.
Marc Dunoyer
Total at 1 January 2016
Partial vesting of 2013 award
Partial lapse of 2013 award
Total at 31 December 2016
Number of
shares
14,930
(11,645)1
(3,285)
0
Price on
vesting
date
(pence)
5048
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1(cid:3) (cid:41)(cid:82)(cid:79)(cid:79)(cid:82)(cid:90)(cid:76)(cid:81)(cid:74)(cid:3)(cid:70)(cid:72)(cid:85)(cid:87)(cid:68)(cid:76)(cid:81)(cid:3)(cid:80)(cid:68)(cid:81)(cid:71)(cid:68)(cid:87)(cid:82)(cid:85)(cid:92)(cid:3)(cid:87)(cid:68)(cid:91)(cid:3)(cid:71)(cid:72)(cid:71)(cid:88)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:15)(cid:3)(cid:48)(cid:85)(cid:3)(cid:39)(cid:88)(cid:81)(cid:82)(cid:92)(cid:72)(cid:85)(cid:3)(cid:69)(cid:72)(cid:70)(cid:68)(cid:80)(cid:72)(cid:3)(cid:69)(cid:72)(cid:81)(cid:72)(cid:430)(cid:70)(cid:76)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)(cid:76)(cid:81)(cid:87)(cid:72)(cid:85)(cid:72)(cid:86)(cid:87)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:68)(cid:3)(cid:81)(cid:72)(cid:87)(cid:3)(cid:81)(cid:88)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:82)(cid:73)(cid:3)(cid:25)(cid:15)(cid:20)(cid:26)(cid:21)(cid:3)(cid:50)(cid:85)(cid:71)(cid:76)(cid:81)(cid:68)(cid:85)(cid:92)(cid:3)(cid:54)(cid:75)(cid:68)(cid:85)(cid:72)(cid:86)(cid:17)
AstraZeneca 2012 Savings Related Share Option Scheme (SAYE)
The interests of Mr Dunoyer at 31 December 2016 in options to subscribe for Ordinary Shares that are the subject of awards under the
SAYE are shown below.
Marc Dunoyer
2015 award
Total at 1 January 2016
Total at 31 December 2016
1 UK date convention applies.
Number of
shares under
option
Exercise price
(pence)
Grant date1
First date
exercisable1
Last date
exercisable1
3307
28.09.15
01.12.18
31.05.19
544
544
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AstraZeneca Annual Report and Form 20-F Information 2016
121
Corporate Governance
Remuneration Policy
This section sets out the Remuneration Policy (the Policy) proposed for approval by shareholders at the Company’s AGM in April 2017.
Subject to shareholder approval, the Policy is intended to remain in effect for three years from the 2017 AGM. There are two substantive
differences between the previous policy approved by shareholders in April 2014 and the proposed Policy: (i) the level of LTI vesting at
threshold performance will be reduced from 25% to 20% of maximum; and (ii) no new awards will be made under the AZIP so, from 2017,
LTI awards for Executive Directors will only be made under the PSP. For the outstanding AZIP awards that still have performance years to
run in 2017, 2018 and 2019, a simple pro rata sliding scale will be used to assess performance against unchanged targets. In addition, the
Policy has been drafted more concisely and is shorter than the previous policy.
Setting remuneration policy
The Remuneration Committee (the Committee) is responsible for setting overall remuneration policy and makes decisions about specific
remuneration arrangements in the broader context of employee remuneration throughout the Group. Remuneration for all roles within the
organisation is benchmarked against that for comparable roles in similar organisations and in the employee’s local market to ensure the
Company is paying fairly at all levels. Executive Directors’ remuneration is benchmarked against a global pharmaceutical peer group and
the FTSE30. Each year, the Company engages with employees, either on a Group-wide basis or in the context of smaller focus groups,
to solicit feedback generally on a wide range of matters, including pay.
While the Committee does not consult employees when setting the Executive Directors’ remuneration policy, it does review Group
remuneration data annually, including ratios of average pay to senior executive pay; bonus data; and gender and geographical data in
relation to base salaries and variable compensation. Many employees are also shareholders in the Company and therefore have the
opportunity to vote at the 2017 AGM on the Policy. In reviewing the base salaries of Executive Directors, the Committee considers the
overall level of any salary increases being awarded to employees in the Executive Director’s local market in the relevant year.
In all aspects of its work, the Committee considers both the external environment in which the Company operates and the guidance issued
by organisations representing institutional shareholders. It consults the Company’s major investors on general and specific remuneration
matters and provides opportunities for representatives of those investors to meet the Chairman of the Committee and other Committee
and Board members. It is the Company’s policy to seek input from major shareholders on an ad hoc basis when significant changes
to remuneration arrangements are proposed. The Company’s shareholders are encouraged to attend the AGM and any views expressed
will be considered by Committee members. The Committee works with the Audit Committee to ensure that the Group’s remuneration
policies and practices achieve the right balance between appropriate incentives to reward good performance, management of risk,
and the pursuit of the Company’s business objectives.
Legacy arrangements
The Committee may approve remuneration payments and payments for loss of office on terms that differ to the terms in the Policy where
the terms of the payment were agreed before the Policy came into effect or were agreed at a time when the relevant individual was not a
Director of the Company (provided that, in the opinion of the Committee, the agreement was not entered into in consideration for the
individual becoming a Director of the Company). This includes the exercise of any discretion available to the Committee in connection with
such payments.
For these purposes, payments include the Committee satisfying awards of variable remuneration including share awards, in line with the
terms agreed at the time the award was granted.
Minor amendments
The Committee may make minor amendments to the arrangements for Directors described in the Policy for regulatory, exchange control,
tax or administrative purposes or to take account of a change in legislation.
122
AstraZeneca Annual Report and Form 20-F Information 2016
Remuneration Policy for Executive Directors
(cid:41)(cid:76)(cid:91)(cid:72)(cid:71)(cid:3)(cid:72)(cid:79)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:85)(cid:72)(cid:80)(cid:88)(cid:81)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:29)(cid:3)(cid:69)(cid:68)(cid:86)(cid:72)(cid:3)(cid:86)(cid:68)(cid:79)(cid:68)(cid:85)(cid:92)(cid:15)(cid:3)(cid:69)(cid:72)(cid:81)(cid:72)(cid:430)(cid:87)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:83)(cid:72)(cid:81)(cid:86)(cid:76)(cid:82)(cid:81)
Base salary
Purpose and link to strategy
Operation
Maximum opportunity
Base salary is intended to
be sufficient to attract,
retain and develop
high-calibre individuals.
Consideration is given to a number of factors, including (but not limited to):
> recognition of the value of an individual’s personal performance and
contribution to the business
> the individual’s skills and experience
> internal relativities
> conditions in the relevant external market.
While there is no formal maximum, any increases in base salary
will normally be in line with the percentage increases awarded to
the employee population within the individual’s country location.
Higher increases may be made if the Committee considers it
appropriate, for example to reflect:
> an increase in the scope and/or responsibility of the individual’s
Base salaries are normally reviewed annually with any change usually
taking effect from 1 January.
role; or
> development of the individual within the role.
Benefits
Purpose and link to strategy
Operation
Maximum opportunity
The maximum value of the benefits available will be equivalent to
the cost to the Company of the suite of benefits available in the
local market at the time.
The value of the support towards the costs of relocation,
professional fees and other costs will be the reasonable costs
associated with the Executive Director’s particular
circumstances.
The maximum value of the directors’ and officers’ liability
insurance and third party indemnity insurance is the cost at the
relevant time.
While the Committee has not set an overall level of benefit
provision, the Committee keeps the benefit policy and benefit
levels under review.
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To provide market
competitive benefits.
UK Executive Directors are provided with a fund, the value of which is
based on a range of benefits including:
Non-cash benefits are
designed to be sufficient
to attract, retain and
develop high-calibre
individuals.
> private medical insurance for partner and children
> life assurance
> permanent health insurance
> company car
> additional holidays
> other additional benefits made available by the Company from time to
time that the Committee considers appropriate based on the Executive
Director’s circumstances.
A Director may choose to take a proportion of, or the entire, fund as cash.
Non-UK-based Executive Directors will receive a range of benefits (or a
fund of equivalent value) comparable to those typically offered in their local
market. Depending on local market practices they may be able to elect to
take the fund as cash or elect to take one or more of these benefits and
take the balance as cash.
At its discretion the Committee may consider support towards the
reasonable costs associated with relocation and/or provide an allowance
towards the reasonable fees for professional services such as legal, tax,
property and financial advice. The Company may also fund the cost of a
driver and car for Executive Directors and any expenses deemed to be
taxable which are reasonably incurred in the course of the Company’s
business, together with any taxes thereon.
The Company provides directors’ and officers’ liability insurance
and an indemnity to the fullest extent permitted by law and the
Company’s Articles.
Pension
Purpose and link to strategy
Operation
Maximum opportunity
Provision of retirement
benefits to attract, retain
and develop high-calibre
individuals.
For UK-based Executive Directors, the Company provides a pension
allowance based on a percentage of base salary, which the Director
may elect to pay into a pension scheme (or an equivalent arrangement)
or take as cash. The Company will provide an amount benchmarked
to the local market.
Non-UK-based Executive Directors will receive an allowance for the
purpose of providing retirement benefits in line with local market practice.
A non-UK-based Executive Director may be offered the opportunity to
elect to take some or all of the allowance as cash.
The maximum pension allowance that may be provided to
UK-based Executive Directors is 35% of base salary. For 2017,
the CEO and CFO receive allowances of 30% and 24% of their
base salaries respectively.
The maximum value that may be provided to non-UK-based
Executive Directors will be a sum in line with local market practice.
AstraZeneca Annual Report and Form 20-F Information 2016
123
Corporate Governance
Remuneration Policy for Executive Directors continued
Variable elements of remuneration: annual bonus and long-term incentive
Annual bonus
Purpose and link to strategy
Operation and framework used to assess performance
Maximum opportunity
The maximum annual bonus amount that can be
awarded is 250% of base salary.
If the Committee believed it to be in the interests
of shareholders to award an annual bonus
of an amount exceeding the historical maximum
opportunity of 180% of base salary in the case
of the CEO and 150% of base salary in the case
of the CFO it would consult major shareholders
in advance.
The annual bonus
rewards short-term
(annual) performance
against specific Group
targets and individual
objectives.
The deferred share
element of the annual
bonus is designed to align
Executive Directors’
interests with those of
shareholders.
Performance is measured over one year and the bonus, if awarded, is paid after the
year end. Currently, two-thirds is delivered in cash and one-third is delivered in shares,
which are deferred for three years under the deferred bonus plan.
Stretching Group targets are set annually by the Committee based on the key
strategic priorities for the year. Payout levels are determined by the Committee after
the year end, based on performance against the targets as well as the Executive
Director’s individual performance.
The performance targets form a Group scorecard, which is closely aligned to the
Company’s strategy, and are designed to reward scientific, commercial and financial
success. In relation to each performance target, a threshold level of performance is
specified. If performance falls below this level there will be no payout for that
proportion of the award.
The Committee may use its discretion to ensure that a fair and balanced outcome
is achieved, taking into account the overall performance of the Company and the
experience of shareholders.
On vesting of the deferred shares, the cash value equivalent to the dividends that
would have been paid during the deferral period will be paid to the Director.
For bonuses awarded in respect of 2015 and subsequent years, the Committee
has discretion, for up to six years from the payment date, to claw-back from
individuals some or all of the cash bonus award in certain circumstances including:
(i) material restatement of the results of the Group, (ii) significant reputational damage
to the Group, or (iii) serious misconduct by the individual. However, in the case of (i)
and (ii) the Committee may only exercise its discretion for up to two years from the
payment date.
For deferred shares relating to bonuses awarded in respect of 2015 and subsequent
years, the Committee has discretion:
> to reduce or cancel any portion of an unvested deferred bonus share award in
certain circumstances (malus), including (i) material restatement of the results of the
Group, (ii) significant reputational damage to the Group, or (iii) serious misconduct
by the individual
> for up to six years from the vesting date, to claw-back from individuals some or
all of the deferred bonus share award in certain circumstances, including (i) material
restatement of the results of the Group, (ii) significant reputational damage to the
Group, or (iii) serious misconduct by the individual. However, in the case of (i) and (ii)
the Committee may only exercise its discretion for up to two years from the
vesting date.
124
AstraZeneca Annual Report and Form 20-F Information 2016
Long-term incentive (LTI)
Performance Share Plan (PSP)
Purpose and link to strategy
Operation and framework used to assess performance
Maximum opportunity
The PSP is designed to
align the variable pay of
Executive Directors with
the successful execution
of the Company’s strategy.
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The PSP provides for the grant of awards over Ordinary Shares or ADSs.
Vesting is dependent on the achievement of stretching performance targets and
continued employment, as further described in the Treatment of LTI and deferred
bonus plan awards on cessation of employment section on page 131.
The maximum market value of shares that may be
awarded under the PSP in any year is equivalent to
500% of the participant’s annual base salary at the
date of grant.
Performance targets are set by the Committee at the beginning of the relevant
performance period. They are closely aligned to the Company’s strategy and are
designed to reward scientific, commercial and financial success. Performance is
currently assessed against a combination of five measures: TSR; cash flow; reported
EBITDA; sales of medicines in key therapy areas and territories; and innovation
metrics. If the Committee was to propose any material changes to the PSP
performance targets, it would consult major shareholders in advance.
When setting performance targets, the Committee allocates such weightings to
the targets as it considers appropriate, taking into account strategic priorities.
The intention of the Committee is to exercise appropriate judgement, in particular
so that the experience of shareholders over time is taken into account.
Performance is assessed over the three-year period commencing on 1 January
in the year of grant. Shares are then subject to a two-year holding period following
the performance period, so full vesting takes place on the fifth anniversary of grant.
During the holding period, no further performance measures apply.
Payout under the PSP can range from 0% to 100% of the original award. All PSP
performance targets have a payout curve. Each payout curve is structured to suit the
objective it is intended to measure and the relationship between threshold, target and
out-performance is determined at grant.
Typically, 20% of the proportion of a PSP award linked to a performance target will
vest on the achievement of threshold level of performance and 100% will vest if the
target level of performance is achieved. For relative measures (such as relative TSR)
the threshold level of performance associated with a target will be performance at or
above median. The maximum level of performance will usually be set as achievement
of performance at the upper quartile level. Where the performance target permits,
there will be further vesting points between threshold and maximum vesting levels,
with vesting typically taking place on a straight-line basis.
The Committee may (acting fairly and reasonably) adjust or waive a performance
target if an event occurs that causes it to believe that the performance target is no
longer appropriate.
On vesting, the cash value equivalent to the dividends that would have been paid
on the vesting shares during the performance and holding periods will be paid
to the Director.
For awards granted in 2015 and for subsequent years, the Committee has discretion:
> to reduce or cancel any portion of an unvested award in certain circumstances
(malus), including (i) material restatement of the results of the Group, (ii) significant
reputational damage to the Group, or (iii) serious misconduct by the individual
> for up to six years from the third anniversary of the date of grant, to claw-back from
individuals some or all of the award in certain circumstances, including (i) material
restatement of the results of the Group, (ii) significant reputational damage to the
Group, or (iii) serious misconduct by the individual. However, in the case of (i) and (ii)
the Committee may only exercise its discretion for up to two years from the third
anniversary of the date of grant.
AstraZeneca Annual Report and Form 20-F Information 2016
125
Corporate Governance
Remuneration Policy for Executive Directors continued
Restricted shares
Purpose and link to strategy
Operation and framework used to assess performance
Maximum opportunity
There is no maximum value of an award which may
be granted.
The Committee sets the value of the award at grant,
as it considers appropriate in all the circumstances.
In certain circumstances,
typically as part of
recruitment arrangements,
an Executive Director may
be made awards of
restricted shares. This
would ordinarily be to
compensate for loss of
remuneration opportunities
suffered on leaving
previous employment.
There are ordinarily no performance measures attached to awards of restricted shares
because they are awarded for the purpose of compensating newly recruited Executive
Directors for loss of entitlements on leaving a previous employment. However, the
Committee considers whether the lost incentives were subject to performance targets
and their probability of vesting. If foregone awards were subject to performance
testing, then the compensatory AstraZeneca award is normally granted under the
PSP in order to align the performance targets attaching to the award to successful
execution of the Company’s strategy. Restricted share awards are generally used
only when the foregone compensation was not subject to performance testing.
The Committee may divide an award of restricted shares into tranches which vest
at different points and may apply performance measures bespoke to the individual
if it considers it appropriate. If it decides to attach performance conditions, the
performance conditions and performance period are defined at grant.
If no performance targets are attached to a restricted share award, it will vest in full
if the individual remains in office on the vesting date.
On vesting, the cash value equivalent to the dividends that would have been paid
during the vesting period will be paid to the Director.
There are no contractual provisions for claw-back or malus of restricted share awards.
UK employee share plans
Share Incentive Plan (SIP)
Purpose and link to strategy
Operation
Maximum opportunity
Encouraging employee
share ownership
The Company operates an HM Revenue & Customs (HMRC)-approved SIP whereby
UK employees, including Executive Directors, may elect to save a regular amount to
be used to purchase shares. The Company currently grants one matching share in
respect of every four shares purchased by the participant.
Participants may contribute up to £150 per month
from pre-tax pay or such other maximum amount as
determined by the Company within the parameters
of applicable legislation.
Save As You Earn Share Option Scheme (SAYE)
Purpose and link to strategy
Operation
Encouraging employee
share ownership
The Company operates an HMRC-approved SAYE whereby UK employees, including
Executive Directors, may save a regular amount over three or five years and are
granted options to purchase shares at the end of the saving period. A maximum
discount of 20% to the market price prevailing at the date of the commencement of
the scheme applies to the option price.
Maximum opportunity
Participants may save up to £500 per month from
post-tax pay or such other maximum amount as
determined by the Company within the parameters
of applicable legislation.
126
AstraZeneca Annual Report and Form 20-F Information 2016
Historical LTI: AstraZeneca Investment Plan (AZIP)
No further awards will be made under the AZIP.
There are three extant AZIP awards which were granted to the Executive Directors in 2014, 2015 and 2016. Vesting of these awards is
dependent on the achievement of two performance targets measured over a four-year performance period commencing on 1 January
in the year of grant. Shares are subject to a four-year holding period following the performance period, so vesting takes place on the eighth
anniversary of the start of the performance period. During the holding period, no further performance measures apply. Payout of the
award is subject to continued employment as further described in the Treatment of LTI and deferred bonus plan awards on cessation of
employment section on page 131. The performance targets are dividend level and dividend cover. If both targets are achieved in each year
of the performance period, the award will vest in full at the end of the holding period. Twenty five percent of an award will lapse for each year
in which neither or only one target is achieved.
On vesting, the cash value equivalent to the dividends that would have been paid on the vesting shares during the performance and holding
periods will be paid to the Director.
The Committee may (acting fairly and reasonably) adjust or waive a performance target if an event occurs that causes it to believe that the
performance target is no longer appropriate.
The Committee has discretion:
> to reduce or cancel any portion of an unvested award in certain circumstances (malus), including (i) material restatement of the results
of the Group, (ii) significant reputational damage to the Group, or (iii) serious misconduct by the individual
> for up to six years from the end of the performance period, to claw-back from individuals some or all of the award in certain
circumstances, including (i) in the case of material restatement of the results of the Group, (ii) significant reputational damage to the
Group, or (iii) serious misconduct by the individual. However, in the case of (i) and (ii) the Committee may only exercise its discretion
for up to two years from the end of the performance period.
(cid:39)(cid:76)(cid:428)(cid:72)(cid:85)(cid:72)(cid:81)(cid:70)(cid:72)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:85)(cid:72)(cid:80)(cid:88)(cid:81)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:83)(cid:82)(cid:79)(cid:76)(cid:70)(cid:92)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:82)(cid:87)(cid:75)(cid:72)(cid:85)(cid:3)(cid:72)(cid:80)(cid:83)(cid:79)(cid:82)(cid:92)(cid:72)(cid:72)(cid:86)
The Company’s approach to determining and reviewing the salaries of the Executive Directors and the employee population as a whole
is the same. On an annual basis the salaries for individual roles are reviewed in the context of individual sustained performance and the
external market. AstraZeneca participates in annual global compensation surveys, which provide benchmarking data for all roles within the
organisation, ensuring a robust salary review process for all employees. The Company seeks to provide an appropriate range of competitive
benefits, including pension, to all employees (including Executive Directors) in the context of their local market.
Employees at mid to senior levels globally are eligible for LTI awards in the form of the PSP and/or restricted stock units. The occupants of
approximately 700 senior roles in the Company are currently eligible for PSP awards – these are the leaders who have the ability to directly
influence the execution of the Company’s strategic goals. An LTI award may be used for the same purpose as described above on the
recruitment of employees (other than Directors) or for the retention of employees.
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AstraZeneca Annual Report and Form 20-F Information 2016
127
Corporate Governance
Remuneration Policy for Executive Directors continued
Remuneration scenarios for Executive Directors
The charts below illustrate how much the current Executive Directors could receive under different performance scenarios in 2017, assuming
a constant share price. In order to compile the charts, the following assumptions have been made:
Minimum
remuneration
> base salary is that applicable in 2017
> taxable benefits are those included in the Executive Directors’ single total figure remuneration table for 2016 as
set out on page 107
> pension of 30% of base salary for the CEO and 24% of base salary for the CFO.
Pascal Soriot
Marc Dunoyer
Base salary
£’000
Taxable benefits
£’000
1,220
725
121
71
Pension
£’000
366
174
Total
£’000
1,707
970
Remuneration for
performance in line
with the Company’s
expectations
Maximum
remuneration
> annual bonus payout equivalent to 100% of base salary for the CEO and 90% for the CFO
> LTI share award vesting at 250% of base salary for the CEO and 200% of base salary for the CFO (representing
50% of the value of the PSP award).
> annual bonus payout equivalent to 180% of base salary for the CEO and 150% for the CFO
> LTI share award vesting at 500% of base salary for the CEO and 400% for the CFO (representing 100% of the
value of the PSP award).
Pascal Soriot
Marc Dunoyer
Minimum
100%
£1.7m
Minimum
100%
In line
29% 20%
51%
£6.0m
In line
32% 21%
47%
Maximum
17%
22%
61%
£10.0m
Maximum
20%
22%
58%
£m
0
1
2
3
4
5
6
7
8
9
10
£m
0
1
2
3
4
5
£1.0m
£3.1m
£5.0m
Fixed
Annual bonus
Long-term incentive
Approach to recruitment remuneration for Executive Directors
On the recruitment of a new Executive Director, the Committee seeks to pay no more than is necessary to attract and retain the best
candidate available, aiming to put in place a remuneration package broadly in line with the arrangements of the relevant incumbent.
In order to offer a competitive package to attract the most suitable candidate, the Committee may consider providing remuneration
arrangements that exceed those of the existing Executive Directors and may agree to pay allowances to expatriates in line with the
Company’s international assignment policy to provide support towards housing, schooling and other relocation or assignment related
costs. The Committee will offer a remuneration package that it considers appropriate in the particular circumstances of the recruitment,
giving due regard to the interests of the Company’s shareholders and taking into account factors such as typical market practice,
existing arrangements for the other Executive Directors, internal relativities and market positioning.
The pharmaceutical industry is global and future Executive Directors might be recruited from organisations with pay structures and
practices that differ from AstraZeneca’s usual remuneration policy. The Committee believes that it is in the interests of shareholders for
it to retain an element of flexibility in its approach to recruitment to enable it to attract the best candidates; however, this flexibility is limited.
The Committee may find it necessary to compensate a new recruit for forfeiture of entitlements as a consequence of the recruit leaving his
or her previous employment to join AstraZeneca. Where such compensation is offered to a new recruit on his or her hire, the Committee
will explain the rationale to shareholders in a timely manner and will provide details of the arrangement. The value of such compensation
will depend upon the circumstances of the recruitment and the individual in question. The Committee will seek to offer a package weighted
towards equity in the Company; however, the precise nature of the compensation arrangement will depend on the type of entitlement being
forfeited, which the Committee will generally seek to compensate in kind. The arrangement might therefore comprise cash and/or restricted
shares and/or an LTI award. The Committee will obtain and take into account independent valuations of the forfeited entitlements to
determine the appropriate level of compensation. All other aspects of a new recruit’s compensation opportunity will be subject to the
maxima stated in the Policy. The Committee’s intention is to use buyout awards for this compensatory purpose only.
A new recruit may be granted shares under an LTI plan within the Policy or under a plan specific to that individual, as permitted under
the Financial Conduct Authority’s Listing Rules. Vesting of such awards may be subject to the achievement of performance conditions.
The precise targets and measures will depend on the objectives of the Company and the individual at the time of the recruitment and
will be determined by the Committee.
128
AstraZeneca Annual Report and Form 20-F Information 2016
Ongoing annual variable remuneration will not exceed an award which comprises up to 250% of base salary under the annual bonus,
and up to 500% of base salary under the PSP. If the Committee ever felt that it would be in the interests of shareholders to grant annual
variable awards to a new Executive Director with values exceeding the historical maximum of 680% of base salary (comprising up to
180% under the annual bonus and up to 500% in aggregate under the LTI), it would consult major shareholders in advance.
In the case of Group employees who are promoted internally to the position of Executive Director, the Committee intends to honour
all remuneration arrangements entered into before the promotion.
The Company may reimburse the costs of financial planning and tax advice.
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Service contracts for Executive Directors
Save as noted below, it is not intended that service contracts for new Executive Directors will contain terms that are materially different from
those summarised below or contained in the Policy set out in this Remuneration Policy Report. The contractual obligations below are
applicable to each of the current Executive Directors unless stated otherwise.
Notice period
The Company may terminate employment by giving not less than 12 months’ written notice. The Company may
agree on appointment that any notice given by the Company will not expire prior to the second anniversary of the
commencement date of the Executive Director’s appointment.
Executive Directors may terminate their employment on 12 months’ written notice.
Payments in
lieu of notice
The Company may terminate an Executive Director’s contract at any time with immediate effect and pay a sum in
lieu of notice. This sum will consist of (i) the base salary that they would have been entitled to receive during the
notice period and (ii) the cost to the Company of funding the flexible benefit arrangements for this period, including
the Company’s contribution in respect of pension.
Garden leave
The Company has the right to place the Executive Director on ‘garden leave’.
Summary
termination
Payments in
lieu of holiday
The Company may terminate employment summarily in particular defined circumstances such as gross
misconduct, with no further payment.
If, on termination, the Executive Director has exceeded their accrued holiday entitlement, the value of this excess
may be deducted by the Company from any sums payable. If the Executive Director has unused holiday
entitlement, the Committee has discretion to require the Executive Director to take such unused holiday during
any notice period, or make a payment in lieu of it calculated in the same way as the value of any excess holiday.
Directors’ and
officers’ liability
insurance
Directors’ and officers’ liability insurance and an indemnity to the fullest extent permitted by law and the
Company’s Articles is provided for the duration of an Executive Director’s employment and for a minimum of five
years following termination.
Deemed
treatment
under AZIP
In respect of awards made to compensate Mr Soriot for loss of remuneration opportunity at his previous employer,
if Mr Soriot gives notice of termination of his employment after the end of the performance period under the AZIP
but before the end of the holding period, the award under the AZIP will vest on the earlier of the end of the holding
period and the end of the period of 24 months from the date of cessation of employment, unless the Committee
determines otherwise.
AstraZeneca Annual Report and Form 20-F Information 2016
129
Corporate Governance
Remuneration Policy for Executive Directors continued
(cid:51)(cid:85)(cid:76)(cid:81)(cid:70)(cid:76)(cid:83)(cid:79)(cid:72)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:83)(cid:68)(cid:92)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:79)(cid:82)(cid:86)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:82)(cid:433)(cid:70)(cid:72)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:40)(cid:91)(cid:72)(cid:70)(cid:88)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:39)(cid:76)(cid:85)(cid:72)(cid:70)(cid:87)(cid:82)(cid:85)(cid:86)
The Company does not make additional payments for loss of office, other than, as appropriate, payments in lieu of notice as described on
the previous page or payments in respect of damages if the Company terminates an Executive Director’s service contract in breach of
contract (taking into account, as appropriate, the Director’s ability to mitigate his loss). The Committee has discretion to award payments in
certain circumstances, as set out below, depending on the nature of the termination and the Executive Director’s performance. The LTI
plans are governed by plan rules, which define how individual awards under those plans should be treated upon termination of employment
and corporate activity including sale of a business outside the Group. The treatment of awards in these circumstances may also be subject
to Committee discretion. Generally, awards under LTI plans will only be allowed to vest for those Executive Directors who leave the
Company by mutual agreement, for example in circumstances of ill-health, injury, disability, redundancy or retirement, or where employment
terminates by reason of the Executive Director’s death (see the table opposite for further information). In addition to any payment in lieu of
notice, the individual components of remuneration and other payments which may be payable on loss of office are set out below, subject to
the terms of any applicable bonus rules or share plan rules.
>
>
>
>
>
>
>
>
>
Annual bonus
At the discretion of the Committee, an Executive Director may receive a bonus for the performance year in which they leave the
Company. Typically this sum will reflect an on-target bonus pro-rated for the part of the year in which they worked. This will depend on
the circumstances, including an assessment of the Executive Director’s performance in the relevant period and the circumstances of
their departure and may be in such proportion of cash and/or shares as the Committee will determine. The deferred share element of
previous bonuses granted, and any deferred share element of the bonus awarded in respect of the departing year, may still vest for the
benefit of the departing Executive Director at the end of the period of deferral despite the fact that the Executive Director did not work
for the entirety of this period. The Committee has the discretion to accelerate and/or retain the deferral period and allow shares to vest
for the benefit of the Executive Director on their departure and/or in accordance with the vesting schedule as the case may be.
The Committee will decide whether it is appropriate in the circumstances for these shares to vest for the benefit of the departing
Executive Director.
LTI plans
The LTI plan rules envisage circumstances under which some, all or none of the shares held under LTI plans will vest in connection with
departure. The exact timing and number of shares vesting will depend on the circumstances, including the reason for leaving (as set out
in the table opposite) and may be subject to Committee discretion, depending on what it considers to be fair and reasonable in the
circumstances.
Restricted share awards
The treatment on termination will depend upon the terms of the individual Executive Director’s awards on recruitment. The Committee
has discretion to determine the treatment at the time of departure based on what it considers to be fair and reasonable in the
circumstances.
Non-statutory redundancy payment
Executive Directors are not entitled to non-statutory redundancy payments.
Pension contributions and other benefits
Pension contributions and other benefits for Executive Directors will be payable up to the termination date or as part of a payment
in lieu of notice as described on page 129.
Payments in relation to statutory rights
The amount considered reasonable to pay by the Committee in respect of statutory rights may be included in the overall termination
payment.
Payments required by law
The Committee reserves the right to make any other payments in connection with an Executive Director’s cessation of office or
employment where the payments are made in good faith in discharge of an existing legal obligation (or by way of damages for breach
of such an obligation) or by way of settlement of any claim arising in connection with the cessation of an Executive Director’s office
or employment. Any such payments may include but are not limited to paying any fees for outplacement assistance and/or an Executive
Director’s legal and/or professional advice fees in connection with their cessation of office or employment.
Mitigation
The departing Executive Director will be required to mitigate their loss by using reasonable efforts to secure new employment.
Professional fees
The Company may pay an amount considered reasonable by the Committee in respect of fees for legal and tax advice,
and outplacement support for the departing Executive Director.
130
AstraZeneca Annual Report and Form 20-F Information 2016
Treatment of LTI and deferred bonus plan awards on cessation of employment
Plan
Deferred bonus plan
(Annual bonus)
PSP
Termination by mutual agreement (broadly in circumstances of ill-health, injury, disability,
redundancy or retirement and in the case of death and certain corporate events eg sale
of a business outside the Group)
Awards will vest at the end of the relevant deferral period, unless the Committee
decides otherwise.
Other leaver scenarios
Ordinarily awards will lapse unless the Committee
exercises its discretion to apply the treatment for
leavers by mutual agreement.
Where cessation of employment occurs within three years of the date of grant
awards will vest, pro rata to the time elapsed between the date of grant of the
award and the date of cessation of employment, at the end of the performance
period after performance has been assessed, to the extent that the performance
target(s) measured over the performance period has been met.
Other than during a holding period, ordinarily
awards will lapse unless the Committee exercises
its discretion to preserve all or part of an award and
apply the default treatment for leavers by mutual
agreement as described in this table.
This discretion will not be exercised in the case
of dismissal for gross misconduct.
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Ordinarily awards will lapse unless the Committee
exercises its discretion to apply the default
treatment for leavers by reason of redundancy
or retirement described in this table.
However, the Committee has discretion to permit the award to vest immediately
on cessation of employment where that cessation occurred as a result of one
of the events mentioned above to the extent that the performance target(s) has,
in the opinion of the Committee, been satisfied from the date of grant to the date
of cessation of employment.
However, if the Committee believes that exceptional circumstances warrant this,
it may exercise its discretion to vest the award on another basis.
Where cessation of employment occurs during any holding period the award will
vest in respect of all the shares that continue to be subject to the award as soon
as practicable following the cessation of employment. However, the Committee
has discretion to require the award to vest only at the end of the holding period.
AZIP
Death, ill-health, injury or disability:
> in the performance period: the award will vest as soon as practicable following
the cessation of employment, pro-rated to take into account the period elapsed
between the date of grant and the date of cessation of employment relative to the
performance period and pro-rated to take into account the satisfaction of any
performance measure(s), as agreed by the Committee
> in the holding period: the award will vest in respect of all the shares that continue
to be subject to the award as soon as practicable following the cessation of
employment.
Redundancy, retirement or certain corporate events (eg sale of a business outside
the Group):
> in the performance period: the award will vest at the later of the end of the
performance period and the end of the period of 24 months from the date of
cessation of employment, to the extent any performance measures have been
met by the end of the performance period and pro-rated to take into account
the period elapsed between the date of grant and the date of cessation of
employment relative to the performance period
> in the holding period: the award will vest in respect of all shares that continue to
be subject to the award at the earlier of the end of the holding period and the end
of the period of 24 months from the date of cessation of employment. Where the
Committee terminates an Executive Director’s employment (other than for gross
misconduct) during the holding period, the awards will vest on the same basis.
In each case described above, the Committee has discretion to vest the award or
part of the award on a different basis.
Restricted shares
Awards will lapse unless the Committee exercises its discretion to preserve all
or part of an award.
In relation to awards granted on or after 3 February 2014 and, where that award
was granted at the time of the Executive Director’s recruitment to the Company
in compensation for any awards or bonuses forfeited at his previous employer,
the award will vest on the date his employment ceases, pro-rated to take into
account the period elapsed between the date of grant and the date of cessation
of employment, unless the Committee decides not to pro-rate or to pro-rate on
some other basis.
Ordinarily awards will lapse unless the Committee
exercises its discretion to preserve all or part of
an award.
AstraZeneca Annual Report and Form 20-F Information 2016
131
Corporate Governance
Remuneration Policy for Non-Executive Directors
Non-Executive Directors, including the Chairman, receive annual Board fees. With the exception of the Chairman, Non-Executive Directors
receive additional fees for membership and chairmanship of Board Committees and for holding the position of Senior independent
Non-Executive Director. Non-Executive Directors are not eligible for performance-related bonuses or the grant of share awards or options.
No pension contributions are made on their behalf. The annual Board fees applicable to Non-Executive Directors are set out in the Annual
Report on Remuneration. Changes to these fees in future years will be set out in the corresponding year’s Annual Report. The remuneration
of Non-Executive Directors (excluding the Chairman) is determined by the Chairman and the Executive Directors. The remuneration of the
Chairman is determined by the other members of the Committee and the Senior independent Non-Executive Director.
Annual Board fees
Purpose and link to strategy
Operation
The annual fees are
intended to be sufficient
to attract, retain and
develop high-calibre
individuals.
Board fees for Non-Executive Directors are subject to periodic review and may be increased in the
future to ensure that they remain sufficient to attract high-calibre individuals while remaining fair and
proportionate. Although Non-Executive Directors currently receive their fees in cash, the Company
may pay part or all of their fees in the form of shares.
Non-Executive Directors are eligible to receive a base fee and additional fees where appropriate to
reflect any additional time commitment or duties (eg being the chairman of a committee). The fee
structure is set out in the Annual Report on Remuneration.
(cid:37)(cid:72)(cid:81)(cid:72)(cid:430)(cid:87)(cid:86)
Purpose and link to strategy
Operation
Intended to attract and
retain high-calibre
individuals.
The Company also provides directors’ and officers’ liability insurance and an indemnity to the fullest
extent permitted by law and the Company’s Articles and may also reimburse the costs of financial
planning and tax advice.
Other costs and expenses
Purpose and link to strategy
Operation
Intended to reimburse
individuals for legitimately
incurred costs and
expenses.
In addition to the Chairman’s fee, a proportion of the office costs of the Chairman are reimbursed.
In 2016, this amounted to £36,000. The amount of office costs to be reimbursed each year will be
determined at the discretion of the Committee, based on an assessment of the reasonable
requirements of the Chairman. The Committee has the discretion to approve contributions by the
Company to office costs of other Non-Executive Directors in circumstances where such payments
are deemed proportionate and reasonable.
The Company will pay for all travel (including travel to the Company’s offices), hotel and other
expenses reasonably incurred by Non-Executive Directors in the course of the Company’s business,
for example, professional fees such as secretarial support, and reimbursement for domestic security
arrangements such as lights and alarms following a security assessment.
There are no contractual provisions for claw-back or malus of other costs and expenses.
Maximum opportunity
Under Articles 89 and 90 of the
Company’s Articles, as approved
by the Company’s shareholders,
the ordinary remuneration of the
Non-Executive Directors for
their services shall not exceed in
aggregate £2,250,000 per annum
and any Non-Executive Director who
serves on any Board committee may
be paid such extra remuneration as
the Board may determine.
Maximum opportunity
The maximum amount payable in
respect of these costs and cost of
insurance will be the reimbursement
of the Directors’ benefits grossed up
for any tax payable by the individual.
Maximum opportunity
The maximum amounts payable in
respect of these costs and expenses
will be the reimbursement of the
Directors’ costs and expenses
grossed up for any tax payable by
the individual.
Letters of appointment
None of the Non-Executive Directors has a service contract but each has a letter of appointment. In accordance with the Company’s
Articles, following their appointment all Directors must retire at each AGM and may present themselves for re-election. The Company is
mindful of the director independence provisions of the UK Corporate Governance Code and, in this regard, a Non-Executive Director’s
overall tenure will not normally exceed nine years. The Chairman may terminate his appointment at any time, on three months’ notice.
None of the other Non-Executive Directors have a notice period or any provision in their letters of appointment giving them a right to
compensation upon early termination of appointment.
On behalf of the Board
A C N Kemp
Company Secretary
2 February 2017
132
AstraZeneca Annual Report and Form 20-F Information 2016
Preparation of the Financial Statements
(cid:68)(cid:81)(cid:71)(cid:98)(cid:39)(cid:76)(cid:85)(cid:72)(cid:70)(cid:87)(cid:82)(cid:85)(cid:86)(cid:350)(cid:98)(cid:53)(cid:72)(cid:86)(cid:83)(cid:82)(cid:81)(cid:86)(cid:76)(cid:69)(cid:76)(cid:79)(cid:76)(cid:87)(cid:76)(cid:72)(cid:86)
Directors’ responsibility statement
pursuant to DTR 4
The Directors confirm that to the best of
our knowledge:
> The Financial Statements, prepared in
accordance with the applicable set of
accounting standards, give a true and
fair view of the assets, liabilities, financial
position and profit or loss of the Company
and the undertakings included in the
consolidation taken as a whole.
> The Directors’ Report includes a fair review
of the development and performance of
the business and the position of the issuer
and the undertakings included in the
consolidation taken as a whole, together
with a description of the principal risks
and uncertainties that they face.
On behalf of the Board of Directors on
2 February 2017
Pascal Soriot
Director
The Directors are responsible for preparing this
Annual Report and Form 20-F Information and
the Group and Parent Company Financial
Statements in accordance with applicable law
and regulations.
Company law requires the Directors to
prepare Group and Parent Company Financial
Statements for each financial year. Under that
law they are required to prepare the Group
Financial Statements in accordance with
IFRSs as adopted by the EU and applicable
law and have elected to prepare the Parent
Company Financial Statements in accordance
with UK Accounting Standards, including
FRS 101 ‘Reduced Disclosure Framework’
and applicable law.
Under company law, the Directors must not
approve the Financial Statements unless they
are satisfied that they give a true and fair view
of the state of affairs of the Group and Parent
Company and of their profit or loss for that
period. In preparing each of the Group and
Parent Company Financial Statements, the
Directors are required to:
> select suitable accounting policies and
then apply them consistently
> make judgements and estimates that
are reasonable and prudent
> for the Group Financial Statements,
state whether they have been prepared
in accordance with IFRSs as adopted by
the EU
> for the Parent Company Financial
Statements, state whether FRS 101 has
been followed, subject to any material
departures disclosed and explained in the
Parent Company Financial Statements
> prepare the Financial Statements on the
going concern basis unless it is inappropriate
to presume that the Group and the Parent
Company will continue in business.
The Directors are responsible for keeping
adequate accounting records that are
sufficient to show and explain the Parent
Company’s transactions and disclose with
reasonable accuracy at any time the financial
position of the Parent Company and enable
them to ensure that its Financial Statements
comply with the Companies Act 2006. They
have general responsibility for taking such steps
as are reasonably open to them to safeguard
the assets of the Group and to prevent and
detect fraud and other irregularities.
Under applicable law and regulations, the
Directors are also responsible for preparing a
Directors’ Report, Strategic Report, Directors’
Remuneration Report, Corporate Governance
Report and Audit Committee Report that
comply with that law and those regulations.
The Directors are responsible for the
maintenance and integrity of the corporate and
financial information included on our website.
Legislation in the UK governing the preparation
and dissemination of Financial Statements
may differ from legislation in other jurisdictions.
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Directors’ Responsibilities for, and Report on,
(cid:44)(cid:81)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:79)(cid:98)(cid:38)(cid:82)(cid:81)(cid:87)(cid:85)(cid:82)(cid:79)(cid:3)(cid:82)(cid:89)(cid:72)(cid:85)(cid:3)(cid:41)(cid:76)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:53)(cid:72)(cid:83)(cid:82)(cid:85)(cid:87)(cid:76)(cid:81)(cid:74)
The Directors are responsible for establishing
and maintaining adequate internal control
over financial reporting. AstraZeneca’s
internal control over financial reporting is
designed to provide reasonable assurance
over the reliability of financial reporting and
the preparation of consolidated Financial
Statements in accordance with generally
accepted accounting principles.
Due to its inherent limitations, internal control
over financial reporting may not prevent or
detect misstatements. Projections of any
evaluation of effectiveness to future periods are
subject to the risks that controls may become
inadequate because of changes in conditions
or that the degree of compliance with the
policies or procedures may deteriorate.
The Directors assessed the effectiveness of
AstraZeneca’s internal control over financial
reporting as at 31 December 2016 based on
the criteria set forth by the Committee of
Sponsoring Organizations of the Treadway
Commission in Internal Control-Integrated
Framework (2013). Based on this assessment,
the Directors believe that, as at 31 December
2016, the internal control over financial
reporting is effective based on those criteria.
KPMG LLP, an independent registered public
accounting firm, has audited the effectiveness
of internal control over financial reporting as at
31 December 2016 and, as explained on page
134, has issued an unqualified report thereon.
AstraZeneca Annual Report and Form 20-F Information 2016
133
Financial Statements
Auditor’s Reports on the Financial Statements
(cid:68)(cid:81)(cid:71)(cid:98)(cid:82)(cid:81)(cid:98)(cid:44)(cid:81)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:79)(cid:3)(cid:38)(cid:82)(cid:81)(cid:87)(cid:85)(cid:82)(cid:79)(cid:3)(cid:82)(cid:89)(cid:72)(cid:85)(cid:3)(cid:41)(cid:76)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:53)(cid:72)(cid:83)(cid:82)(cid:85)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)
(Sarbanes-Oxley Act Section 404)
The report set out below is provided in
compliance with International Standards on
Auditing (UK and Ireland). KPMG LLP has also
issued reports in accordance with standards
of the Public Company Accounting Oversight
Board in the US, which will be included in the
Annual Report on Form 20-F to be filed with
the US Securities and Exchange Commission.
Those reports are unqualified and include
opinions on the Group Financial Statements
and on the effectiveness of internal control
over financial reporting as at 31 December
2016 (Sarbanes-Oxley Act Section 404).
The Directors’ statement on internal control
over financial reporting is set out on page
133. KPMG LLP has also reported separately
on the Company Financial Statements of
AstraZeneca PLC and on the information in
the Directors’ Remuneration Report that is
described as having been audited. This audit
report is set out on page 197.
Independent Auditor’s Report to the
(cid:48)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:86)(cid:98)(cid:82)(cid:73)(cid:98)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:51)(cid:47)(cid:38)(cid:3)(cid:82)(cid:81)(cid:79)(cid:92)
Opinions and conclusions
(cid:68)(cid:85)(cid:76)(cid:86)(cid:76)(cid:81)(cid:74)(cid:98)(cid:73)(cid:85)(cid:82)(cid:80)(cid:98)(cid:82)(cid:88)(cid:85)(cid:3)(cid:68)(cid:88)(cid:71)(cid:76)(cid:87)
1 Our opinion on the Group Financial
Statements is unmodified
We have audited the Group Financial
Statements of AstraZeneca PLC for the
year ended 31 December 2016 set out on
pages 138 to 196. In our opinion the Group
Financial Statements:
> give a true and fair view of the state of the
Group’s affairs as at 31 December 2016
and of its profit for the year then ended;
> have been properly prepared in accordance
with International Financial Reporting
Standards (IFRSs) as adopted by the
European Union (EU); and
> have been prepared in accordance with the
requirements of the Companies Act 2006
and Article 4 of the IAS Regulation.
2 Separate opinion in relation to IFRSs as
issued by the International Accounting
Standards Board (IASB)
As explained in the Group accounting policies
section of the Group Financial Statements
set out on pages 142 to 146, the Group, in
addition to complying with its legal obligation
to apply IFRSs as adopted by the EU, has also
applied IFRSs as issued by the IASB.
In our opinion, the Group Financial Statements
comply with IFRSs as issued by the IASB.
3 Our assessment of risks
of material misstatement
We summarise below the risks of material
misstatement that had the greatest effect on our
audit (in decreasing order of audit significance),
our key audit procedures to address those
risks and our findings from those procedures in
order that the Company’s members as a body
may better understand the process by which
we arrived at our audit opinion. Our findings
are based on procedures undertaken in the
context of and solely for the purpose of our
statutory audit opinion on the Group Financial
Statements as a whole and consequently
are incidental to that opinion, and we do
not express discrete opinions on separate
elements of the Group Financial Statements.
Rebates and chargebacks in the US
($2,812m) (2015: $3,307m) Risk vs 2015: (cid:379)(cid:377)
Refer to page 98 (Audit Committee Report),
page 142 (accounting policy) and page 77
(financial risk management).
The risk
The Group makes sales to customers in
the United States of America (‘US’) that fall
under certain commercial and governmental
reimbursement schemes, of which the most
significant are Medicaid and Medicare.
The resulting rebates and chargebacks,
which are deducted in arriving at revenue, are
complex and require significant judgement
and estimation in establishing an appropriate
accrual at year-end.
Our response
Our principal audit procedures included
testing the Group’s controls surrounding the
deductions made to US revenue for rebates
and chargebacks, and key manual and
systems-based controls in the order-to-cash
transaction cycle. Our audit work involved
testing key controls including reconciliations
between sales systems and the general ledger
and those over claims, credits and system
accrual rates. We also assessed the accuracy
of the calculation of the accrual, corroborated
inputs and key assumptions, both to internal
and independent sources including sales
contracts with customers, performed an
analysis of the accrual balance and deductions
to sales year on year, corroborating movements
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AstraZeneca Annual Report and Form 20-F Information 2016
compared with expectations and payment
claims, and considered the historical accuracy
of the accrual. We also assessed the adequacy
of the Group’s disclosure of its rebates and
chargebacks policy, the judgement involved,
and other related disclosures.
Our findings
In determining the appropriateness of the
deductions made in relation to US rebates and
chargebacks, there is room for judgement and
we found that within that, the assumptions used
and the resulting estimates were balanced
(2015: balanced). We also found no errors in
the year-end US rebate accrual calculations.
We found the disclosures on US rebates and
chargebacks to be ample (2015: proportionate).
Carrying value of intangible assets
($27,586m) (2015: $22,646m)
Risk vs 2015: (cid:379)(cid:377)
Refer to page 98 (Audit Committee Report),
page 145 (accounting policy), page 157
(financial disclosures) and page 80 (financial
risk management).
The risk
The Group has significant intangible assets
arising from the acquisition of products both
launched and in development. Recoverability
of these assets is based on forecasting and
discounting future cash flows, which are
inherently highly judgemental. For products
in development, the main risk is achieving
successful trial results and obtaining required
clinical and regulatory approvals. For
launched products, the key risk is the ability
to successfully commercialise the individual
product concerned.
Our response
Our principal audit procedures included testing
the Group’s controls surrounding intangible
asset impairments and evaluating the
Group’s assumptions used in assessing the
recoverability of intangible assets, in particular,
revenue and cash flow projections and the
probability of obtaining regulatory approval for
in-development assets. We also performed
sensitivity analysis over individual intangible
asset models, where we considered there to
be a higher risk of impairment, to assess the
level of sensitivity to key assumptions and focus
our work in those areas. Our procedures for
products in development included assessing
the reasonableness of the Group’s assumptions
regarding probability of obtaining regulatory
approval through consideration of the current
phase of development and comparison to
industry practice. We also interviewed a range
of key research, development, and commercial
personnel to corroborate these assumptions.
For both launched and in-development
products we challenged management’s
key assumptions regarding the size of the
therapeutic area market and the product’s
projected share of this market through
both discussion with a range of commercial
personnel and comparison to external
scientific literature and market research. Our
procedures also included challenging internally
generated evidence by reviewing analyst
forecasts, and retrospective assessment of the
accuracy of the Group’s projections. We also
assessed the adequacy of related disclosures
in the Group’s financial statements.
Our findings
We found the Group’s assumptions and
the resulting estimates to be balanced
(2015: balanced). We found that the disclosures
proportionately (2015: proportionately)
describe the inherent degree of subjectivity
in the estimates and the potential impact on
future periods of revisions to these estimates.
Acquisition of Acerta Pharma (Intangible
asset – $7,307m; option liability – $1,901m)
(2015: n/a) (New risk)
Refer to page 143 (accounting policy),
page 173 (financial disclosures) and page 79
(financial risk management).
The risk
In February 2016, the Group completed
the acquisition of 55% of Acerta Pharma.
The acquisition agreement included a
mechanism providing Acerta shareholders
the option to sell, and the Group the option to
buy, the outstanding 45% of shares in Acerta.
There is significant judgement involved in
selecting the underlying assumptions used
to value both the acalabrutinib asset in
development and the option liability
identified and recognised on acquisition.
The assumptions with the greatest impact on
the valuations are the discount rate and
probability that acalabrutinib obtains approval
in the US and Europe.
authorities and courts. We also assessed the
adequacy of the Group’s disclosures in respect
of tax and uncertain tax positions.
Our response
Our principal audit procedures included testing
the Group’s controls surrounding the selection
and review of significant assumptions within
the forecast cash flows used for the valuation
of each of the acalabrutinib asset and option
liability. We engaged our valuation specialists to
assist in our review of the discount rate, which
involved comparing the methodology used
to the methodology KPMG would apply in a
similar transaction and challenging the market
inputs used based on observed market data.
In addition, we challenged the probability of
obtaining regulatory approval by interviewing
a range of key research, development, and
commercial personnel as well as corroborating
the outcome of acalabrutinib’s Phase I/II clinical
trials. We considered whether adjustments to
the original valuations were appropriate in light
of additional information about assumptions
that have become available in the measurement
period to date. We also assessed the adequacy
of the Group’s disclosure of the judgements
involved in valuing the acalabrutinib asset and
the option liability, and related disclosures.
Our findings
We found the Group’s assumptions and the
resulting estimates to be balanced. We found
that the disclosures proportionately describe
the nature of the transaction, the judgements
taken, and their impact on the valuation of
the acalabrutinib asset and the option
liability recognised.
Tax provisioning ($1,327m) (2015: $1,734m)
Risk vs 2015: (cid:379)(cid:377)
Refer to page 98 (Audit Committee Report),
page 143 (accounting policy), page 191
(financial disclosures) and page 81 (financial
risk management).
The risk
Due to the Group operating in a number of
different tax jurisdictions and the complexities
of transfer pricing and other international tax
legislation, accruals for tax contingencies
require the Directors to make judgements and
estimates in relation to subjective tax issues
and exposures.
Our response
In this area our principal audit procedures
included testing the Group’s controls
surrounding tax provisioning, reviewing
settlement correspondence between the
Group and the relevant tax authorities,
and the assistance of our own local and
international tax specialists in analysing
and challenging the assumptions used by
management to determine tax provisions,
based on our knowledge and experience of
the application of the relevant legislation by
Our findings
We found the Group’s estimate of the
amounts to be recognised as tax liabilities
to be conservative (2015: conservative) and
that the disclosures provide a proportionate
(2015: proportionate) description of the current
status of uncertain tax positions.
Litigation and contingent liabilities
(provisions of $438m) (2015: $357m)
Risk vs 2015: (cid:379)(cid:377)
Refer to page 98 (Audit Committee Report),
page 145 (accounting policy), page 185
(financial disclosures) and page 80 (financial
risk management).
The risk
In the normal course of business, litigation and
contingent liabilities may arise from product-
specific and general legal proceedings, from
guarantees or from government investigations.
The amounts involved are potentially material
and the application of accounting standards to
determine the amount, if any, to be provided
as a liability is inherently subjective.
Our response
Having made enquiries of Directors and
in-house legal counsel to obtain their view
on the status of significant legal matters, our
principal audit procedures included testing
the Group’s controls surrounding litigation
and contingent liabilities, obtaining formal
confirmations from the Group’s external
counsel for all significant legal cases, and
discussions with external counsel where
necessary. In addition we used our own
forensic and compliance specialists to assess
the Group’s compliance reports to identify
actual and potential non-compliance with
laws and regulations, both those specific to
the Group’s business and those relating to
the conduct of business generally. We then
analysed correspondence with regulators,
considered legal expenses incurred during
the year, monitored external sources
and considered assessments made by
management of the probability of defending
any litigation and the reliability of estimating
any obligation. We also assessed whether the
Group’s disclosures detailing significant legal
proceedings adequately disclose the potential
liabilities of the Group.
Our findings
Whilst the outcome of these litigation matters
is inherently uncertain in each case, we found
that the Group applied balanced judgements
(2015: balanced), on a case by case basis, in
assessing whether or not a provision should
be recognised. We found that the assumptions
used and the resulting liability recorded to be
balanced (2015: balanced). We found that the
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Financial Statements
Group gives ample disclosure (2015: ample)
on the potential liability in excess of that
recognised in the Financial Statements and the
significant but unquantifiable contingent liability
in respect of these litigation matters.
Post-retirement benefits ($2,186m)
(2015: $1,974m) Risk vs 2015: (cid:379)(cid:377)
Refer to page 101 (Audit Committee Report),
page 143 (accounting policy), page 165
(financial disclosures) and page 80 (financial
risk management).
The risk
Significant estimates are made in valuing the
Group’s post-retirement defined benefit plans.
Small changes in assumptions and estimates
used to value the Group’s net pension deficit
could have a significant effect on the results
and financial position of the Group.
Our response
Our principal audit procedures included the
testing of the Group’s controls surrounding
the valuation of the post-retirement defined
benefit plans and the challenge of key
assumptions, being the discount rate, inflation
rate and mortality/life expectancy, which are
included in the valuation calculations of the
Group’s retirement benefit obligations in
countries with significant defined benefit
pension plans, with the assistance of our
own actuarial specialists. This involved a
comparison of these key assumptions used
against our own internal benchmarks and
externally derived data. We also assessed
the adequacy of the Group’s disclosures in
respect of post-retirement benefits.
Our findings
Overall, we found the key assumptions used
in, and the resulting estimate of, the valuation
of retirement benefit obligations within the
Group to be mildly optimistic (2015: mildly
optimistic). We found the disclosures in
respect of post-retirement benefits to be
proportionate (2015: proportionate).
Overall findings
In reaching our audit opinion on the Group
Financial Statements we took into account the
findings that we describe above and those for
other, lower risk areas. Overall the findings from
across the whole audit are that, although the
Group Financial Statements uses estimates that
are mainly balanced, there is one conservative
estimate and one mildly optimistic estimate.
However, compared with materiality and
considering the qualitative aspects of the Group
Financial Statements as a whole, our opinion on
the Group Financial Statements is unmodified.
4 Our application of materiality and an
overview of the scope of our audit
The materiality for the Group Financial
Statements as a whole was set at $146m
(2015: $140m), determined with reference to
a benchmark of Group profit before taxation,
normalised to exclude this year’s asset
Materiality for the Group Financial Statements
Pro(cid:430)t before tax plus
impairments and contingent
consideration revaluations
Materiality
$2,936m
$146m Whole (cid:430)nancial
statements materiality
$7.3m Misstatements reported
to the Audit Committee
Scoping and coverage
Group revenue (%)
Audits for
group reporting
purposes 77%
(cid:54)(cid:83)(cid:72)(cid:70)(cid:76)(cid:430)(cid:72)(cid:71)(cid:3)(cid:85)(cid:76)(cid:86)(cid:78)(cid:16)
focused audit
procedures 19%
Components’ absolute
(cid:83)(cid:85)(cid:82)(cid:430)(cid:87)(cid:86)(cid:18)(cid:11)(cid:79)(cid:82)(cid:86)(cid:86)(cid:72)(cid:86)(cid:12) (%)
Audits for group
reporting purposes
62%
(cid:54)(cid:83)(cid:72)(cid:70)(cid:76)(cid:430)(cid:72)(cid:71)(cid:3)(cid:85)(cid:76)(cid:86)(cid:78)(cid:16)
focused audit
procedures 28%
Group total assets (%)
Audits for
group reporting
purposes 91%
(cid:54)(cid:83)(cid:72)(cid:70)(cid:76)(cid:430)(cid:72)(cid:71)(cid:3)(cid:85)(cid:76)(cid:86)(cid:78)(cid:16)
focused audit
procedures 2%
impairments and fair value movement and
discount unwind on contingent consideration
as disclosed in Notes 9 and 18, which are
specifically audited, of which it represents
5.0% (2015: 5.0%).
We report to the Audit Committee any
corrected or uncorrected identified
misstatements exceeding $7.3m (2015: $7.0m)
(0.25% of normalised Group profit before
taxation), in addition to other identified
misstatements that warranted reporting on
qualitative grounds.
The Group operates a significant number
of entities, of which there are 191 (2015: 181)
located in 67 (2015: 65) countries around the
globe. The Operating Segment disclosures
in Note 6 set out the individual significance of
each geographical region.
We performed audits for Group reporting
purposes at 11 components (2015: nine)
and specified risk-focused audit procedures
at three (2015: two) standalone components
as well as at 33 (2015: 33) components
serviced by the Group’s shared service
centres. The latter 36 (2015: 35) components
were not individually financially significant
enough to require an audit for Group reporting
purposes, but were included in the scope of
our audit in order to provide further coverage
over relevant account balances.
The Group operates four principal shared
service centres (both in-house and outsourced)
in the UK, Malaysia, Romania and India, which
process a substantial proportion of the Group’s
transactions. The outputs from the shared
service centres are included in the financial
information of the reporting components they
service and therefore they are not separate
reporting components. Each of the service
centres is subject to specified risk-focused
audit procedures, predominantly the testing
of transaction processing and review controls.
Additional procedures are performed by
component audit teams at certain reporting
components to address the audit risks not
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AstraZeneca Annual Report and Form 20-F Information 2016
covered by the work performed over the
shared service centres. These procedures
are designed to address the risk of material
misstatement identified through our Group
risk assessment processes.
This resulted in the coverage shown in
the opposite charts. For the remaining
components, we performed analysis at the
Group level to re-examine our assessment
that there were no significant risks of material
misstatement within them.
The Group audit team instructed component
and shared service centre auditors as to the
significant areas to be covered, including
the relevant risks detailed above and the
information to be reported back. The Group
audit team approved the component
materiality levels, which ranged from $9m to
$80m, having regard to the mix of size and risk
profile of the Group across the components.
The work on all components in scope of our
work, other than on the Parent Company,
was performed by component and shared
service centre auditors. The audit of the Parent
Company and consolidation was performed
by the Group audit team.
The Group audit team visited six (2015: five)
component locations, during the year, in the
UK, Sweden, Japan, China, Malaysia, and the
United States to discuss and challenge key
risks and audit strategy. Video or telephone
conference meetings were also held with all
Group reporting component auditors and
shared service auditors throughout the
audit. At these visits and meetings, the audit
approach, findings and observations reported
to the Group audit team were discussed in
more detail, and any further work required by
the Group audit team was then performed by
the component auditor.
6 We have nothing to report on the
8 Other matter – we have reported
disclosures of principal risks
Based on the knowledge we acquired during
our audit, we have nothing material to add or
draw attention to in relation to:
> the Directors’ statement of Risk overview
on pages 20 to 22, concerning the principal
risks, their management, and, based on
that, the Directors’ assessment and
expectations of the Group’s continuing
in operation over the three years to
31 December 2019; or
> the disclosures in the Group Accounting
Policies concerning the use of the going
concern basis of accounting.
7 We have nothing to report in respect of the
matters on which we are required to report
by exception
Under ISAs (UK and Ireland) we are required
to report to you if, based on the knowledge
we acquired during our audit, we have
identified other information in this Annual
Report that contains a material inconsistency
with either that knowledge or the Financial
Statements, a material misstatement of fact,
or that is otherwise misleading.
In particular, we are required to report to you if:
> we have identified material inconsistencies
between the knowledge we acquired during
our audit and the Directors’ statement that
they consider that the Annual Report and
Financial Statements taken as a whole is
fair, balanced and understandable and
provides the information necessary for
shareholders to assess the Group’s position
and performance, business model and
strategy; or
> the Audit Committee Report does
not appropriately address matters
communicated by us to the Audit Committee.
separately on the Parent Company
Financial Statements
We have reported separately on the
Parent Company Financial Statements
of AstraZeneca PLC for the year ended
31 December 2016 and on the information
in the Directors’ Remuneration Report that
is described as having been audited.
Scope and responsibilities
As explained more fully in the Directors’
Responsibilities Statement set out on
page 133, the Directors are responsible for the
preparation of the Financial Statements and
for being satisfied that they give a true and
fair view. A description of the scope of an
audit of financial statements is provided on
the Financial Reporting Council’s website
at www.frc.org.uk/auditscopeukprivate.
This report is made solely to the Company’s
members as a body and is subject to
important explanations and disclaimers
regarding our responsibilities, published
on our website at www.kpmg.com/uk/
auditscopeukco2014b, which are incorporated
into this report as if set out in full and should
be read to provide an understanding of the
purpose of this report, the work we have
undertaken and the basis of our opinions.
Antony Cates (Senior Statutory Auditor)
for and on behalf of KPMG LLP,
Statutory Auditor
Chartered Accountants
15 Canada Square
London
E14 5GL
2 February 2017
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5 Our opinion on the other matter prescribed
by the Companies Act 2006 is unmodified
Under the Companies Act 2006 we are
required to report to you if, in our opinion:
In our opinion the information given in the
Strategic Report and the Directors’ Report
for the financial year for which the Financial
Statements are prepared is consistent with the
Group Financial Statements.
> certain disclosures of Directors’ remuneration
specified by law are not made; or
> we have not received all the information and
explanations we require for our audit.
Based solely on the work required to be
undertaken in the course of the audit of the
Financial Statements and from reading the
Strategic Report and the Directors’ Report:
> we have not identified material
misstatements in those reports; and
> in our opinion, those reports have been
prepared in accordance with the
Companies Act 2006.
Under the Listing Rules we are required
to review:
> the Directors’ statements, set out on
pages 96 and 22, in relation to going
concern and longer-term viability; and
> the part of the Corporate Governance
Report on pages 82 to 97 relating to
the Company’s compliance with the 11
provisions of the 2014 UK Corporate
Governance Code specified for our review.
We have nothing to report in respect of the
above responsibilities.
AstraZeneca Annual Report and Form 20-F Information 2016
137
Financial Statements
Consolidated Statement of Comprehensive Income
for the year ended 31 December
Product Sales
Externalisation Revenue
Total Revenue
Cost of sales
Gross profit
Distribution costs
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Operating profit
Finance income
Finance expense
Share of after tax losses in associates and joint ventures
Profit before tax
Taxation
Profit for the period
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability
Tax on items that will not be reclassified to profit or loss
Items that may be reclassified subsequently to profit or loss:
Foreign exchange arising on consolidation
Foreign exchange arising on designating borrowings in net investment hedges
Fair value movements on cash flow hedges
Fair value movements on cash flow hedges transferred to profit and loss
Fair value movements on derivatives designated in net investment hedges
Amortisation of loss on cash flow hedge
Net available for sale gains/(losses) taken to equity
Tax on items that may be reclassified subsequently to profit or loss
Other comprehensive income for the period, net of tax
Total comprehensive income for the period
Profit attributable to:
Owners of the Parent
Non-controlling interests
Total comprehensive income attributable to:
Owners of the Parent
Non-controlling interests
Basic earnings per $0.25 Ordinary Share
Diluted earnings per $0.25 Ordinary Share
Weighted average number of Ordinary Shares in issue (millions)
Diluted weighted average number of Ordinary Shares in issue (millions)
Notes
1
1
2
2
2
3
3
10
4
20
4
21
21
21
4
24
24
5
5
5
5
2016
$m
21,319
1,683
23,002
(4,126)
18,876
(326)
(5,890)
(9,413)
1,655
4,902
67
(1,384)
(33)
3,552
(146)
3,406
(575)
136
(439)
(1,050)
(591)
(115)
195
(4)
1
139
86
(1,339)
(1,778)
1,628
3,499
(93)
1,722
(94)
$2.77
$2.76
1,265
1,266
2015
$m
23,641
1,067
24,708
(4,646)
20,062
(339)
(5,997)
(11,112)
1,500
4,114
46
(1,075)
(16)
3,069
(243)
2,826
652
(199)
453
(528)
(333)
–
–
14
1
(32)
87
(791)
(338)
2,488
2,825
1
2,488
–
$2.23
$2.23
1,264
1,265
2014
$m
26,095
452
26,547
(5,842)
20,705
(324)
(5,579)
(13,000)
335
2,137
78
(963)
(6)
1,246
(11)
1,235
(766)
216
(550)
(823)
(529)
–
–
100
1
245
50
(956)
(1,506)
(271)
1,233
2
(266)
(5)
$0.98
$0.98
1,262
1,264
Dividends declared and paid in the period
23
3,540
3,537
3,532
All activities were in respect of continuing operations.
$m means millions of US dollars.
138
AstraZeneca Annual Report and Form 20-F Information 2016
Consolidated Statement of Financial Position
at 31 December
Assets
Non-current assets
Property, plant and equipment
Goodwill
Intangible assets
Investments in associates and joint ventures
Other investments
Derivative financial instruments
Other receivables
Deferred tax assets
Current assets
Inventories
Trade and other receivables
Other investments
Derivative financial instruments
Income tax receivable
Cash and cash equivalents
Total assets
Liabilities
Current liabilities
Interest-bearing loans and borrowings
Trade and other payables
Derivative financial instruments
Provisions
Income tax payable
Non-current liabilities
Interest-bearing loans and borrowings
Derivative financial instruments
Deferred tax liabilities
Retirement benefit obligations
Provisions
Other payables
Total liabilities
Net assets
Equity
Capital and reserves attributable to equity holders of the Company
Share capital
Share premium account
Capital redemption reserve
Merger reserve
Other reserves
Retained earnings
Non-controlling interests
Total equity
Notes
2016
$m
2015
Restated*
$m
7
8
9
10
11
12
13
4
14
15
11
12
16
17
18
12
19
17
12
4
20
19
18
22
21
21
24
6,848
11,658
27,586
99
727
343
901
1,102
49,264
2,334
4,573
884
27
426
5,018
13,262
62,526
(2,307)
(10,486)
(18)
(1,065)
(1,380)
(15,256)
(14,501)
(117)
(3,956)
(2,186)
(353)
(9,488)
(30,601)
(45,857)
16,669
316
4,351
153
448
1,446
8,140
14,854
1,815
16,669
6,413
11,800
22,646
85
458
446
907
1,294
44,049
2,143
6,622
613
2
387
6,240
16,007
60,056
(916)
(11,663)
(9)
(798)
(1,483)
(14,869)
(14,137)
(1)
(2,665)
(1,974)
(444)
(7,457)
(26,678)
(41,547)
18,509
316
4,304
153
448
1,435
11,834
18,490
19
18,509
2014
$m
6,010
11,550
20,981
59
502
465
1,112
1,219
41,898
1,960
7,232
795
21
329
6,360
16,697
58,595
(2,446)
(11,886)
(21)
(623)
(2,354)
(17,330)
(8,397)
–
(1,796)
(2,951)
(484)
(7,991)
(21,619)
(38,949)
19,646
316
4,261
153
448
1,420
13,029
19,627
19
19,646
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
* (cid:21)(cid:19)(cid:20)(cid:24)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:68)(cid:85)(cid:68)(cid:87)(cid:76)(cid:89)(cid:72)(cid:86)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:87)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:85)(cid:72)(cid:73)(cid:79)(cid:72)(cid:70)(cid:87)(cid:3)(cid:68)(cid:81)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:84)(cid:88)(cid:76)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:61)(cid:54)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:11)(cid:86)(cid:72)(cid:72)(cid:3)(cid:49)(cid:82)(cid:87)(cid:72)(cid:98)(cid:21)(cid:24)(cid:12)(cid:17)
The Financial Statements from pages 138 to 196 were approved by the Board on 2 February 2017 and were signed on its behalf by
Pascal Soriot
Director
Marc Dunoyer
Director
AstraZeneca Annual Report and Form 20-F Information 2016
139
Financial Statements
Consolidated Statement of Changes in Equity
for the year ended 31 December
At 1 January 2014
Profit for the period
Other comprehensive income
Transfer to other reserves1
Transactions with owners
Dividends
Issue of Ordinary Shares
Share-based payments
Transfer from non-controlling interests to payables
True-up to Astra AB non-controlling interest buy out
Net movement
At 31 December 2014
Profit for the period
Other comprehensive income
Transfer to other reserves1
Transactions with owners
Dividends
Issue of Ordinary Shares
Share-based payments
Net movement
At 31 December 2015
Profit for the period
Other comprehensive income
Transfer to other reserves1
Transactions with owners
Dividends
Dividends paid by subsidiary to non-controlling interest
Acerta put option (Note 24)
Changes in non-controlling interest (Note 25)
Issue of Ordinary Shares
Share-based payments
Net movement
At 31 December 2016
Share
capital
$m
315
Share
premium
account
$m
3,983
Capital
redemption
reserve
$m
153
Merger
reserve
$m
433
Other
reserves
$m
1,380
Total
attributable
to owners
$m
Non-
controlling
interests
$m
Retained
earnings
$m
16,960
1,233
(1,499)
(40)
23,224
1,233
(1,499)
–
–
–
–
–
1
–
–
–
1
316
–
–
–
–
–
–
–
–
–
–
–
278
–
–
–
278
4,261
–
–
–
–
43
–
43
–
–
–
–
–
–
–
–
–
153
–
–
–
–
–
–
–
–
–
–
–
–
–
–
15
15
448
–
–
–
–
–
–
–
316
4,304
153
448
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
47
–
47
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
40
–
–
–
–
–
40
1,420
–
–
15
–
–
–
15
1,435
–
–
11
–
–
–
–
–
–
(3,532)
(3,532)
–
(93)
–
–
279
(93)
–
15
(3,931)
(3,597)
13,029
2,825
(337)
(15)
19,627
2,825
(337)
–
(3,537)
(3,537)
–
(131)
(1,195)
11,834
3,499
43
(131)
(1,137)
18,490
3,499
(1,777)
(1,777)
(11)
–
(3,540)
(3,540)
–
–
(1,825)
(1,825)
–
–
(40)
–
47
(40)
316
4,351
153
448
1,446
8,140
14,854
11
(3,694)
(3,636)
Total
equity
$m
23,253
1,235
(1,506)
–
(3,532)
279
(93)
(5)
15
(3,607)
19,646
2,826
(338)
–
(3,537)
43
(131)
(1,137)
18,509
3,406
(1,778)
–
(3,540)
(13)
(1,825)
1,903
47
(40)
(1,840)
16,669
29
2
(7)
–
–
–
–
(5)
–
(10)
19
1
(1)
–
–
–
–
–
19
(93)
(1)
–
–
(13)
–
1,903
–
–
1,796
1,815
1 Amounts charged or credited to other reserves relate to exchange adjustments arising on goodwill.
140
AstraZeneca Annual Report and Form 20-F Information 2016
Consolidated Statement of Cash Flows
for the year ended 31 December
Notes
3
10
2
18
25
18
10
Cash flows from operating activities
Profit before tax
Finance income and expense
Share of after tax losses of associates and joint ventures
Depreciation, amortisation and impairment
Decrease in trade and other receivables
(Increase)/decrease in inventories
(Decrease)/increase in trade and other payables and provisions
Gains on disposal of intangible assets
Fair value movements on contingent consideration arising from business combinations
Non-cash and other movements
Cash generated from operations
Interest paid
Tax paid
Net cash inflow from operating activities
Cash flows from investing activities
Upfront payments on business combinations
Payment of contingent consideration from business combinations
Purchase of property, plant and equipment
Disposal of property, plant and equipment
Purchase of intangible assets
Disposal of intangible assets
Purchase of non-current asset investments
Disposal of non-current asset investments
Movement in short-term investments and fixed deposits
Payments to joint ventures
Interest received
Payments made by subsidiaries to non-controlling interests
Net cash outflow from investing activities
Net cash inflow/(outflow) before financing activities
Cash flows from financing activities
Proceeds from issue of share capital
Repayment of obligations under finance leases
Issue of loans
Repayment of loans
Dividends paid
Hedge contracts relating to dividend payments
Payments to acquire non-controlling interests
Movement in short-term borrowings
Net cash (outflow)/inflow from financing activities
Net decrease in cash and cash equivalents in the period
Cash and cash equivalents at the beginning of the period
Exchange rate effects
Cash and cash equivalents at the end of the period
16
2016
$m
3,552
1,317
33
2,357
1,610
(343)
(341)
(1,301)
(1,158)
(492)
5,234
(677)
(412)
4,145
(2,564)
(293)
(1,446)
82
(868)
1,427
(230)
3
(166)
(41)
140
(13)
(3,969)
176
47
(16)
2,491
–
(3,561)
18
–
(303)
(1,324)
(1,148)
6,051
21
4,924
2015
$m
3,069
1,029
16
2,852
152
(315)
114
(961)
(432)
(350)
5,174
(496)
(1,354)
3,324
(2,446)
(579)
(1,328)
47
(1,460)
1,130
(57)
93
283
(45)
123
–
(4,239)
(915)
43
(42)
5,928
(884)
(3,486)
(51)
–
(630)
878
(37)
6,164
(76)
6,051
2014
$m
1,246
885
6
3,282
311
108
2,089
–
512
353
8,792
(533)
(1,201)
7,058
(3,804)
(657)
(1,012)
158
(1,740)
–
(130)
59
34
(70)
140
(10)
(7,032)
26
279
(36)
919
(750)
(3,521)
(14)
(102)
520
(2,705)
(2,679)
8,995
(152)
6,164
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
AstraZeneca Annual Report and Form 20-F Information 2016
141
Financial Statements
Group Accounting Policies
Basis of accounting and preparation
(cid:82)(cid:73)(cid:98)(cid:73)(cid:76)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:76)(cid:81)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)
The Consolidated Financial Statements
have been prepared under the historical cost
convention, modified to include revaluation
to fair value of certain financial instruments
as described below, in accordance with
the Companies Act 2006 and International
Financial Reporting Standards (IFRSs) as
adopted by the EU (adopted IFRSs) in response
to the IAS regulation (EC 1606/2002). The
Consolidated Financial Statements also comply
fully with IFRSs as issued by the International
Accounting Standards Board (IASB).
During the year, the Group has adopted
the amendments to IFRS 11 Accounting for
Acquisitions of Interests in Joint Operations,
amendments to IAS 16 ‘Property, Plant and
Equipment’ and IAS 38 ‘Intangible Assets’
Clarification of Acceptable Methods of
Depreciation and Amortisation, and
amendments to IAS 1 Disclosure Initiative,
which were all effective for periods beginning
on or after 1 January 2016.
The adoption has not had a significant impact
on the Group’s profit for the period, net assets
or cash flows.
The Company has elected to prepare the
Company Financial Statements in accordance
with UK Accounting Standards, including
FRS 101 ‘Reduced Disclosure Framework’.
These are presented on pages 198 to 202 and
the Accounting Policies in respect of Company
information are set out on page 200.
The Consolidated Financial Statements
are presented in US dollars, which is the
Company’s functional currency.
In preparing their individual Financial
Statements, the accounting policies of
some overseas subsidiaries do not conform
with IASB issued IFRSs. Therefore, where
appropriate, adjustments are made in order
to present the Consolidated Financial
Statements on a consistent basis.
Basis for preparation of Financial
Statements on a going concern basis
Information on the business environment
AstraZeneca operates in, including the factors
underpinning the pharmaceutical industry’s
future growth prospects, is included in the
Strategic Report. Details of the product
portfolio of the Group (including patent
expiry dates for key marketed products),
our approach to product development and
our development pipeline are covered in detail
with additional information by Therapy Area in
the Strategic Report and Directors’ Report.
The financial position of the Group, its cash
flows, liquidity position and borrowing facilities
are described in the Financial Review from
page 62. In addition, Note 26 to the Financial
Statements includes the Group’s objectives,
policies and processes for managing its
capital, its financial risk management objectives,
details of its financial instruments and hedging
activities and its exposures to credit, market
and liquidity risk. Further details of the Group’s
cash balances and borrowings are included in
Notes 16 and 17 to the Financial Statements.
The Group has considerable financial resources
available. As at 31 December 2016, the Group
has $5.7bn in financial resources (cash
balances of $5.0bn and undrawn committed
bank facilities of $3.0bn that are available until
April 2020, with only $2.3bn of debt due within
one year). The Group’s revenues are largely
derived from sales of products which are
covered by patents which provide a relatively
high level of resilience and predictability to
cash inflows, although our revenue is expected
to continue to be significantly impacted by
the expiry of patents over the medium term.
In addition, government price interventions in
response to budgetary constraints are
expected to continue to adversely affect
revenues in many of our mature markets.
However, we anticipate new revenue streams
from both recently launched medicines and
products in development, and the Group
has a wide diversity of customers and
suppliers across different geographic areas.
Consequently, the Directors believe that,
overall, the Group is well placed to manage
its business risks successfully.
After making enquiries, the Directors have a
reasonable expectation that the Company
and the Group have adequate resources to
continue in operational existence for the
foreseeable future. Accordingly, they continue
to adopt the going concern basis in preparing
the Annual Report and Financial Statements.
Estimates and judgements
The preparation of the Financial Statements in
conformity with generally accepted accounting
principles requires management to make
estimates and judgements that affect the
reported amounts of assets and liabilities at
the date of the Financial Statements and the
reported amounts of revenues and expenses
during the reporting period. Actual results
could differ from those estimates.
Judgements include matters such as the
determination of operating segments while
estimates focus on areas such as carrying
values, estimated useful lives, potential
obligations and contingent consideration.
AstraZeneca’s management considers the
following to be the most important accounting
policies in the context of the Group’s operations.
The accounting policy descriptions set out
the areas where judgements and estimates
need exercising, the most significant of
which are revenue recognition, research and
development (including impairment reviews
of associated intangible assets), business
combinations and goodwill, litigation and
environmental liabilities, employee benefits
and taxation.
Further information on estimates and critical
judgements made in applying accounting
policies, including details of significant methods
and assumptions used, is detailed in the
Financial Review from page 62 and is included
in Notes 4, 8, 9, 20, 25 and 28 to the Financial
Statements. Financial risk management
policies are detailed in Note 26.
Revenue
Revenues comprise Product Sales
and Externalisation Revenue.
Revenues exclude inter-company revenues
and value-added taxes.
Product Sales
Product Sales represent net invoice value less
estimated rebates, returns and chargebacks.
Sales are recognised when the significant
risks and rewards of ownership have been
transferred to a third party. In general, this is
upon delivery of the products to wholesalers.
In markets where returns are significant
(currently only in the US), estimates of returns
are accounted for at the point revenue is
recognised. In markets where returns are not
significant, they are recorded when returned.
For the US market, we estimate the quantity
and value of goods which may ultimately
be returned at the point of sale. Our returns
accruals are based on actual experience
over the preceding 12 months for established
products together with market-related
information such as estimated stock levels
at wholesalers and competitor activity which
we receive via third party information services.
For newly launched products, we use rates
based on our experience with similar products
or a predetermined percentage.
When a product faces generic competition,
particular attention is given to the possible
levels of returns and, in cases where the
circumstances are such that the level of returns
(and, hence, revenue) cannot be measured
reliably, revenues are only recognised when
the right of return expires, which is generally on
ultimate prescription of the product to patients.
142
AstraZeneca Annual Report and Form 20-F Information 2016
Externalisation Revenue
Externalisation Revenue includes income from
collaborative arrangements on the Group’s
products where the Group retains a significant
ongoing interest and there is no derecognition
of an intangible asset. These may include
development arrangements, commercialisation
arrangements and collaborations.
Income may take the form of upfront access
fees, milestones and/or sales royalties.
Generally, upfront access fees are recognised
upon delivery of the access. Where the Group
provides ongoing services, revenue in respect
of this element will be recognised over the
duration of those services. Milestones and sales
royalties are recognised when virtually certain
and the amount can be reliably estimated.
Further detail on key judgements and
estimates is included in the Financial Review
from page 62.
Research and development
Research expenditure is recognised in profit in
the year in which it is incurred.
Internal development expenditure is capitalised
only if it meets the recognition criteria of IAS 38
‘Intangible Assets’. Where regulatory and other
uncertainties are such that the criteria are not
met, the expenditure is recognised in profit
and this is almost invariably the case prior to
approval of the drug by the relevant regulatory
authority. Where, however, recognition criteria
are met, intangible assets are capitalised and
amortised on a straight-line basis over their
useful economic lives from product launch.
At 31 December 2016, no amounts have met
recognition criteria.
Payments to in-license products and
compounds from third parties for new research
and development projects (in process research
and development), generally taking the form
of upfront payments and milestones, are
capitalised. Where payments made to
third parties represent future research and
development activities, an evaluation is made
as to the nature of the payments. Such
payments are expensed if they represent
compensation for subcontracted research
and development services not resulting in a
transfer of intellectual property. By contrast,
payments are capitalised if they represent
compensation for the transfer of intellectual
property developed at the risk of the third
party. Since acquired products and
compounds will only generate sales and
cash inflows following launch, our policy is to
minimise the period between final approval
and launch if it is within AstraZeneca’s control
to do so. Assets capitalised are amortised, on
a straight-line basis, over their useful economic
lives from product launch. Under this policy, it
is not possible to determine precise economic
lives for individual classes of intangible assets.
However, lives do not exceed 25 years.
Intangible assets relating to products in
development are subject to impairment testing
annually. All intangible assets are tested for
impairment when there are indications that the
carrying value may not be recoverable. Any
impairment losses are recognised immediately
in profit. Intangible assets relating to products
which fail during development (or for which
development ceases for other reasons) are
tested for impairment at the point of
termination and are written down to their
recoverable amount (which is usually nil).
If, subsequent to an impairment loss being
recognised, development restarts or other
facts and circumstances change indicating
that the impairment is less or no longer exists,
the value of the asset is re-estimated and its
carrying value is increased to the recoverable
amount, but not exceeding the original value,
by recognising an impairment reversal in profit.
Business combinations and goodwill
On the acquisition of a business, fair values
are attributed to the identifiable assets and
liabilities and contingent liabilities unless the
fair value cannot be measured reliably, in which
case the value is subsumed into goodwill.
Where the Group fully acquires, through
a business combination, assets that were
previously held in joint operations, the Group
has elected not to uplift the book value of the
existing interest in the asset held in the joint
operation to fair value at the date full control is
taken. Where fair values of acquired contingent
liabilities cannot be measured reliably, the
assumed contingent liability is not recognised
but is disclosed in the same manner as other
contingent liabilities.
Where not all of the equity of a subsidiary
is acquired the non-controlling interest is
recognised either at fair value or at the
non-controlling interest’s proportionate
share of the net assets of the subsidiary,
on a case-by-case basis. Put options over
non-controlling interests are recognised as
a financial liability, with a corresponding entry
in either retained earnings or against
non-controlling interest reserves on a
case-by-case basis.
Future contingent elements of consideration,
which may include development and launch
milestones, revenue threshold milestones
and revenue-based royalties, are fair valued
at the date of acquisition using decision-tree
analysis with key inputs including probability
of success, consideration of potential delays
and revenue projections based on the Group’s
internal forecasts. Unsettled amounts of
consideration are held at fair value within
payables with changes in fair value recognised
immediately in profit.
Goodwill is the difference between the fair value
of the consideration and the fair value of net
assets acquired.
Goodwill arising on acquisitions is capitalised
and subject to an impairment review, both
annually and when there is an indication that
the carrying value may not be recoverable.
Between 1 January 1998 and 31 December
2002, goodwill was amortised over its
estimated useful life; such amortisation
ceased on 31 December 2002.
The Group’s policy up to and including
1997 was to eliminate goodwill arising upon
acquisitions against reserves. Under IFRS 1
‘First-time Adoption of International Financial
Reporting Standards’ and IFRS 3 ‘Business
Combinations’, such goodwill will remain
eliminated against reserves.
Joint arrangements and associates
The Group has arrangements over which it
has joint control and which qualify as joint
operations or joint ventures under IFRS 11
‘Joint Arrangements’. For joint operations, the
Group recognises its share of revenue that it
earns from the joint operations and its share of
expenses incurred. The Group also recognises
the assets associated with the joint operations
that it controls and the liabilities it incurs under
the joint arrangement. For joint ventures and
associates, the Group recognises its interest
in the joint venture as an investment and uses
the equity method of accounting.
Employee benefits
The Group accounts for pensions and other
employee benefits (principally healthcare)
under IAS 19 ‘Employee Benefits’. In respect
of defined benefit plans, obligations are
measured at discounted present value while
plan assets are measured at fair value. The
operating and financing costs of such plans
are recognised separately in profit; current
service costs are spread systematically over
the lives of employees and financing costs are
recognised in full in the periods in which they
arise. Remeasurements of the net defined
pension liability, including actuarial gains and
losses, are recognised immediately in other
comprehensive income.
Where the calculation results in a surplus to
the Group, the recognised asset is limited
to the present value of any available future
refunds from the plan or reductions in future
contributions to the plan. Payments to defined
contribution plans are recognised in profit as
they fall due.
Taxation
The current tax payable is based on taxable
profit for the year. Taxable profit differs from
reported profit because taxable profit excludes
items that are either never taxable or tax
deductible or items that are taxable or tax
deductible in a different period. The Group’s
current tax assets and liabilities are calculated
using tax rates that have been enacted or
substantively enacted by the reporting date.
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Financial Statements
Deferred tax is provided using the balance
sheet liability method, providing for temporary
differences between the carrying amounts
of assets and liabilities for financial reporting
purposes and the amounts used for taxation
purposes. Deferred tax assets are recognised
to the extent that it is probable that taxable
profit will be available against which the asset
can be utilised. This requires judgements to
be made in respect of the availability of future
taxable income.
No deferred tax asset or liability is recognised
in respect of temporary differences associated
with investments in subsidiaries and branches
where the Group is able to control the timing
of reversal of the temporary differences and it
is probable that the temporary differences will
not reverse in the foreseeable future.
The Group’s deferred tax assets and liabilities
are calculated using tax rates that are
expected to apply in the period when the
liability is settled or the asset realised based
on tax rates that have been enacted or
substantively enacted by the reporting date.
Accruals for tax contingencies require
management to make judgements and
estimates of exposures in relation to tax audit
issues. Tax benefits are not recognised unless
the tax positions will probably be sustained
based upon management’s interpretation
of applicable laws and regulations. Once
considered to be probable, management
reviews each material tax benefit to assess
whether a provision should be taken against
full recognition of that benefit on the basis of
potential settlement through negotiation and/or
litigation. Accruals for tax contingencies are
measured using the single best estimate of
likely outcome approach. Any liability to pay
interest on tax liabilities is provided for in the
tax charge. See Note 28 to the Financial
Statements for further details.
Share-based payments
All plans are assessed and have been
classified as equity settled. The grant date
fair value of employee share plan awards is
calculated using a modified version of the
binomial model. In accordance with IFRS 2
‘Share-based Payment’, the resulting cost is
recognised in profit over the vesting period
of the awards, being the period in which the
services are received. The value of the charge
is adjusted to reflect expected and actual
levels of awards vesting, except where the
failure to vest is as a result of not meeting
a market condition. Cancellations of equity
instruments are treated as an acceleration of
the vesting period and any outstanding charge
is recognised in profit immediately.
Property, plant and equipment
The Group’s policy is to write off the difference
between the cost of each item of property,
plant and equipment and its residual value over
its estimated useful life on a straight-line basis.
Assets under construction are not depreciated.
Reviews are made annually of the estimated
remaining lives and residual values of individual
productive assets, taking account of
commercial and technological obsolescence
as well as normal wear and tear. Under this
policy it becomes impractical to calculate
average asset lives exactly. However, the total
lives range from approximately 10 to 50 years
for buildings, and three to 15 years for plant
and equipment. All items of property, plant
and equipment are tested for impairment
when there are indications that the carrying
value may not be recoverable. Any impairment
losses are recognised immediately in profit.
Borrowing costs
The Group has no borrowing costs with
respect to the acquisition or construction
of qualifying assets. All other borrowing
costs are recognised in profit as incurred
and in accordance with the effective interest
rate method.
Leases
Leases are classified as finance leases if they
transfer substantially all the risks and rewards
incidental to ownership, otherwise they are
classified as operating leases. Assets and
liabilities arising on finance leases are initially
recognised at fair value or, if lower, the present
value of the minimum lease payments.
The discount rate used in calculating the
present value of the minimum lease payments
is the interest rate implicit in the lease. Finance
charges under finance leases are allocated
to each reporting period so as to produce
a constant periodic rate of interest on the
remaining balance of the finance liability.
Rentals under operating leases are charged
to profit on a straight-line basis.
Subsidiaries
A subsidiary is an entity controlled, directly
or indirectly, by AstraZeneca PLC. Control is
regarded as the exposure or rights to the
variable returns of the entity when combined
with the power to affect those returns.
The financial results of subsidiaries are
consolidated from the date control is
obtained until the date that control ceases.
Inventories
Inventories are stated at the lower of cost and
net realisable value. The first in, first out or an
average method of valuation is used. For
finished goods and work in progress, cost
includes directly attributable costs and certain
overhead expenses (including depreciation).
Selling expenses and certain other overhead
expenses (principally central administration
costs) are excluded. Net realisable value is
determined as estimated selling price less all
estimated costs of completion and costs to be
incurred in selling and distribution.
Write-downs of inventory occur in the general
course of business and are recognised in cost
of sales.
Trade and other receivables
Financial assets included in trade and other
receivables are recognised initially at fair value.
Subsequent to initial recognition they are
measured at amortised cost using the effective
interest rate method, less any impairment
losses. Trade receivables that are subject to
debt factoring arrangements are derecognised
if they meet the conditions for derecognition
detailed in IAS 39 ‘Financial Instruments:
Recognition and Measurement’.
Trade and other payables
Financial liabilities included in trade and other
payables are recognised initially at fair value.
Subsequent to initial recognition they are
measured at amortised cost using the effective
interest rate method.
Financial instruments
The Group’s financial instruments include
interests in leases, trade and other receivables
and payables, liabilities for contingent
consideration under business combinations,
and rights and obligations under employee
benefit plans which are dealt with in specific
accounting policies.
The Group’s other financial instruments include:
> cash and cash equivalents
> fixed deposits
> other investments
> bank and other borrowings
> derivatives.
Cash and cash equivalents
Cash and cash equivalents comprise cash
in hand, current balances with banks and
similar institutions and highly liquid investments
with maturities of three months or less when
acquired. They are readily convertible into
known amounts of cash and are held at
amortised cost.
Fixed deposits
Fixed deposits, principally comprising funds
held with banks and other financial institutions,
are initially measured at fair value, plus direct
transaction costs, and are subsequently
measured at amortised cost using the effective
interest rate method at each reporting date.
Changes in carrying value are recognised
in profit.
Other investments
Where investments have been classified as
held for trading, they are measured initially at
fair value and subsequently remeasured to fair
value at each reporting date. Changes in fair
value are recognised in profit.
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In all other circumstances, the investments
are classified as ‘available for sale’, initially
measured at fair value (including direct
transaction costs) and subsequently
remeasured to fair value at each reporting date.
Changes in carrying value due to changes in
exchange rates on monetary available for sale
investments or impairments are recognised
in profit with other operating income and
expense. All other changes in fair value are
recognised in other comprehensive income.
Impairments are recorded in profit when there
is a decline in the value of an investment that
is deemed to be other than temporary. On
disposal of the investment, the cumulative
amount recognised in other comprehensive
income is recognised in profit as part of the
gain or loss on disposal.
Bank and other borrowings
The Group uses derivatives, principally
interest rate swaps, to hedge the interest rate
exposure inherent in a portion of its fixed
interest rate debt. In such cases the Group will
either designate the debt as fair value through
profit or loss when certain criteria are met or
as the hedged item under a fair value hedge.
If the debt instrument is designated as fair
value through profit or loss, the debt is initially
measured at fair value (with direct transaction
costs being included in profit as an expense)
and is remeasured to fair value at each
reporting date with changes in carrying value
being recognised in profit (along with changes
in the fair value of the related derivative).
Such a designation has been made where this
significantly reduces an accounting mismatch
which would result from recognising gains and
losses on different bases.
If the debt is designated as the hedged item
under a fair value hedge, the debt is initially
measured at fair value (with direct transaction
costs being amortised over the life of the debt),
and is remeasured for fair value changes in
respect of the hedged risk at each reporting
date with changes in carrying value being
recognised in profit (along with changes in the
fair value of the related derivative).
If the debt is designated in a cash flow hedge,
the debt is measured at amortised cost
(with gains or losses taken to profit and
direct transaction costs being amortised over
the life of the debt). The related derivative is
remeasured for fair value changes at each
reporting date with the portion of the gain or
loss on the derivative that is determined to
be an effective hedge recognised in other
comprehensive income. The amounts that
have been recognised in other comprehensive
income are reclassified to profit in the same
period that the hedged forecast cash flows
affect profit.
Other interest-bearing loans are initially
measured at fair value (with direct transaction
costs being amortised over the life of the bond)
and are subsequently measured at amortised
cost using the effective interest rate method at
each reporting date. Changes in carrying value
are recognised in profit.
Derivatives
Derivatives are initially measured at fair value
(with direct transaction costs being included
in profit as an expense) and are subsequently
remeasured to fair value at each reporting
date. Changes in carrying value are
recognised in profit.
Foreign currencies
Foreign currency transactions, being
transactions denominated in a currency other
than an individual Group entity’s functional
currency, are translated into the relevant
functional currencies of individual Group entities
at average rates for the relevant monthly
accounting periods, which approximate to
actual rates.
Monetary assets and liabilities arising from
foreign currency transactions are retranslated
at exchange rates prevailing at the reporting
date. Exchange gains and losses on loans
and on short-term foreign currency borrowings
and deposits are included within finance
expense. Exchange differences on all other
foreign currency transactions are recognised in
operating profit in the individual Group entity’s
accounting records.
Non-monetary items arising from foreign
currency transactions are not retranslated in the
individual Group entity’s accounting records.
In the Consolidated Financial Statements,
income and expense items for Group entities
with a functional currency other than US dollars
are translated into US dollars at average
exchange rates, which approximate to actual
rates, for the relevant accounting periods.
Assets and liabilities are translated at the
US dollar exchange rates prevailing at the
reporting date. Exchange differences arising
on consolidation are recognised in other
comprehensive income.
If certain criteria are met, non-US dollar
denominated loans or derivatives are
designated as net investment hedges of
foreign operations. Exchange differences
arising on retranslation of net investments,
and of foreign currency loans which are
designated in an effective net investment
hedge relationship, are recognised in other
comprehensive income in the Consolidated
Financial Statements. Foreign exchange
derivatives hedging net investments in foreign
operations are carried at fair value. Effective
fair value movements are recognised in
other comprehensive income, with any
ineffectiveness taken to profit. Gains and
losses accumulated in the translation reserve
will be recycled to profit when the foreign
operation is sold.
Litigation and environmental liabilities
AstraZeneca is involved in legal disputes, the
settlement of which may involve cost to the
Group. Provision is made where an adverse
outcome is probable and associated costs,
including related legal costs, can be estimated
reliably. In other cases, appropriate disclosures
are included.
Where it is considered that the Group is
more likely than not to prevail, or in the rare
circumstances where the amount of the legal
liability cannot be estimated reliably, legal costs
involved in defending the claim are charged to
profit as they are incurred.
Where it is considered that the Group has
a valid contract which provides the right to
reimbursement (from insurance or otherwise)
of legal costs and/or all or part of any loss
incurred or for which a provision has been
established, the best estimate of the amount
expected to be received is recognised as an
asset only when it is virtually certain.
AstraZeneca is exposed to environmental
liabilities relating to its past operations,
principally in respect of soil and groundwater
remediation costs. Provisions for these costs
are made when there is a present obligation
and where it is probable that expenditure on
remedial work will be required and a reliable
estimate can be made of the cost. Provisions
are discounted where the effect is material.
Impairment
The carrying values of non-financial assets,
other than inventories and deferred tax assets,
are reviewed at least annually to determine
whether there is any indication of impairment.
For goodwill, intangible assets under
development and for any other assets where
such indication exists, the asset’s recoverable
amount is estimated based on the greater of
its value in use and its fair value less cost to
sell. In assessing value in use, the estimated
future cash flows, adjusted for the risks
specific to each asset, are discounted to
their present value using a discount rate that
reflects current market assessments of the
time value of money, the general risks affecting
the pharmaceutical industry and other risks
specific to each asset. For the purpose of
impairment testing, assets are grouped
together into the smallest group of assets that
generates cash inflows from continuing use
that are largely independent of the cash flows
of other assets. Impairment losses are
recognised immediately in profit.
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145
revenue and income streams including, but
not limited to, the impact on revenue from
collaborative arrangements, licence income
and milestone revenues.
IFRS 16 ‘Leases’ was issued by the IASB in
January 2016 and is effective for accounting
periods beginning on or after 1 January 2019.
The new standard will replace IAS 17 ‘Leases’
and will eliminate the classification of leases as
either operating leases or finance leases and,
instead, introduce a single lessee accounting
model. The standard has yet to be endorsed by
the EU. The adoption of IFRS 16 is not expected
to have a significant impact on the Group’s net
results or net assets, although the full impact
will be subject to further assessment.
In addition, the following amendments have
been issued:
> Amendments to IFRS 10 and IAS 28 Sale or
Contribution of Assets between an Investor
and its Associate or Joint Venture. The IASB
has deferred these amendments until a date
to be determined by the IASB, although
early application is permitted.
> Amendments to IAS 12 Recognition of
Deferred Tax Assets for Unrealised Losses,
effective for periods beginning on or after
1 January 2017.
> Amendments to IAS 7 Disclosure Initiative,
effective for periods beginning on or after
1 January 2017.
> Amendments to IFRS 2 Classification and
Measurement of Share-based Payment
Transactions, effective for periods beginning
on or after 1 January 2018.
The above amendments are not expected
to have a significant impact on the Group’s
net results, net assets or disclosures.
The amendments have yet to be endorsed
by the EU.
Financial Statements
International accounting transition
On transition to using adopted IFRSs in the
year ended 31 December 2005, the Group
took advantage of several optional exemptions
available in IFRS 1 ‘First-time Adoption of
International Financial Reporting Standards’.
The major impacts which are of continuing
importance are detailed below:
> Business combinations – IFRS 3 ‘Business
Combinations’ has been applied from
1 January 2003, the date of transition,
rather than being applied fully retrospectively.
As a result, the combination of Astra and
Zeneca is still accounted for as a merger,
rather than through purchase accounting.
If purchase accounting had been adopted,
Zeneca would have been deemed to have
acquired Astra.
> Cumulative exchange differences – the
Group chose to set the cumulative
exchange difference reserve at 1 January
2003 to nil.
Applicable accounting standards and
interpretations issued but not yet adopted
IFRS 9 ‘Financial Instruments’ was finalised
by the IASB in July 2014 and is effective for
accounting periods beginning on or after
1 January 2018. The new standard will replace
existing accounting standards. It is applicable
to financial assets and liabilities, and will
introduce changes to existing accounting
concerning classification and measurement,
impairment (introducing an expected-loss
method), hedge accounting, and on the
treatment of gains arising from the impact of
credit risk on the measurement of liabilities
held at fair value. The standard was endorsed
by the EU on 22 November 2016. The adoption
of IFRS 9 is not expected to have a significant
impact on the Group’s net results or net
assets, although the full impact will be subject
to further assessment. The Group will early
adopt the treatment of fair value changes
arising from changes in own credit risk from
1 January 2017.
IFRS 15 ‘Revenue from Contracts with
Customers’ was issued by the IASB in May
2014. It is effective for accounting periods
beginning on or after 1 January 2018. The
new standard will replace existing accounting
standards, and provides enhanced detail on
the principle of recognising revenue to reflect
the transfer of goods and services to
customers at a value which the Company
expects to be entitled to receive. The standard
also updates revenue disclosure requirements.
The standard was endorsed by the EU on
22 September 2016. The adoption of IFRS 15
is not expected to have a significant impact
on the Group’s recognition of Product Sales.
The Group is continuing to assess the impact
of IFRS 15 on the results of the Group for other
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Notes to the Group Financial Statements
1 Revenue
Product Sales
Oncology:
Faslodex
Zoladex
Iressa
Tagrisso
Casodex
Arimidex
Lynparza
Others
Cardiovascular and Metabolic Diseases:
Crestor
Brilinta
Farxiga
Seloken/Toprol-XL
Onglyza
Bydureon
Atacand
Byetta
Plendil
Tenormin
Others
Respiratory:
Symbicort
Pulmicort
Tudorza/Eklira
Daliresp/Daxas
Rhinocort
Others
Other:
Nexium
Seroquel XR
Synagis
Local Anaesthetics
Losec/Prilosec
Seroquel IR
Merrem
Diprivan
FluMist/Fluenz
Others
Product Sales
2016
$m
830
816
513
423
247
232
218
104
2015
$m
704
816
543
19
267
250
94
132
2014
$m
720
924
623
–
320
298
–
142
3,383
2,825
3,027
3,401
5,017
5,512
839
835
737
720
578
315
254
136
106
195
619
492
710
786
580
358
316
234
118
259
476
225
758
820
440
501
327
249
161
333
8,116
9,489
9,802
2,989
1,061
170
154
112
267
3,394
1,014
190
104
120
165
3,801
946
13
–
139
164
4,753
4,987
5,063
2,032
735
677
329
276
231
201
143
104
339
2,496
1,025
662
404
340
250
241
200
288
434
3,655
1,224
900
488
422
178
253
252
295
536
5,067
21,319
6,340
23,641
8,203
26,095
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Externalisation Revenue
Externalisation Revenue in 2016 was $1,683m (2015: $1,067m; 2014: $452m).
In 2016, Externalisation Revenue includes $520m from Aspen Global Incorporated for our anaesthetics medicines portfolio, $298m from the sale of
commercialisation rights for Plendil in China to China Medical System Holdings Ltd, and $175m from Aralez Pharmaceuticals Inc. for the US rights
to Toprol-XL.
In 2015, Externalisation Revenue includes $450m on entering into a collaboration with Celgene on durvalumab, $200m on entering into a collaboration
with Daiichi Sankyo on Movantik and $100m on entering into a collaboration with Valeant on brodalumab.
In 2014, Externalisation Revenue includes $250m from a licence agreement with Pfizer on Nexium OTC.
Royalty income of $119m (2015: $87m; 2014: $53m) is included in Externalisation Revenue.
AstraZeneca Annual Report and Form 20-F Information 2016
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Financial Statements
2 Operating profit
Operating profit includes the following significant items:
Selling, general and administrative costs
In 2016, selling, general and administrative costs includes a credit of $999m (2015: credit of $378m; 2014: charge of $529m) resulting from changes
in the fair value of contingent consideration arising from the acquisition of the diabetes alliance with BMS. These adjustments reflect revised estimates
for future sales performance for the products acquired and, as a result, revised estimates for future royalties payable.
In 2016, selling, general and administrative costs also includes a total of $223m (2015: $313m) of legal provisions relating to a number of legal
proceedings in various jurisdictions in relation to several marketed products.
In July 2014, the US Internal Revenue Service issued final regulations that affected the recognition of the annual Branded Pharmaceutical Fee,
imposed by the health care reform legislation in 2010. As a result, entities covered by the legislation now accrue for the obligation as each sale
occurs. AstraZeneca recorded a catch-up charge of $226m in 2014 to reflect this new basis, $113m of which was recorded in selling, general
and administrative costs and $113m as a deduction from revenue.
Further details of impairment charges for 2016, 2015 and 2014 are included in Notes 7 and 9.
Other operating income and expense
Royalties
Income
Amortisation
Impairment of intangible assets
Gains on disposal of intangible assets
Net gains/(losses) on disposal of other non-current assets
Other income
Other expense
Other operating income and expense
2016
$m
406
(86)
–
1,301
29
146
(141)
1,655
2015
$m
322
(114)
(64)
961
85
327
(17)
1,500
2014
$m
533
(212)
(18)
–
(235)
290
(23)
335
Royalty amortisation and impairment relates to income streams acquired with MedImmune and amounts relating to our arrangements with Merck.
Gains on disposal of intangible assets in 2016 includes $368m on the disposal of the small molecule antibiotics business in most markets outside
the US, $321m on the disposal of Rest of World rights to Rhinocort Aqua, $231m on the disposal of global rights to MEDI2070 and $183m on the
disposal of Rest of World rights to Imdur.
Gains on disposal of intangible assets in 2015 includes $380m on the disposal of US rights to Entocort, $215m on the disposal of Rest of World
rights to Entocort, $193m on the disposal of global rights to Myalept and $165m on the disposal of global rights to Caprelsa.
Net losses on disposal of non-current assets in 2014 included a loss of $292m on disposal of Alderley Park.
Restructuring costs
The tables below show the costs that have been charged in respect of restructuring programmes by cost category and type. Severance provisions
are detailed in Note 19.
Cost of sales
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Total charge
Severance costs
Accelerated depreciation and impairment
Relocation costs
Loss on disposal of Alderley Park
Other
Total charge
2016
$m
130
178
823
(24)
1,107
2016
$m
505
46
18
–
538
1,107
2015
$m
158
258
618
–
2014
$m
107
497
662
292
1,034
1,558
2015
$m
298
81
34
–
621
1,034
2014
$m
246
153
209
292
658
1,558
Other costs are those incurred in designing and implementing the Group’s various restructuring initiatives including costs of decommissioning sites
impacted by changes to our global footprint, temporary leave costs during relocation, internal project costs, and external consultancy fees.
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2 Operating profit continued
Financial instruments
Included within operating profit are the following net gains and losses on financial instruments:
Losses on forward foreign exchange contracts
Gains/(losses) on receivables and payables
Gains and losses on available for sale investments
Total
2016
$m
(216)
132
–
(84)
2015
$m
(22)
(36)
74
16
2014
$m
(98)
(64)
31
(131)
Gains and losses on available for sale investments includes no gains or losses (2015: gains of $43m; 2014: gains of $9m) which have been reclassified
from other comprehensive income.
3 Finance income and expense
Finance income
Returns on fixed deposits and equity securities
Returns on short-term deposits
Fair value gains on debt and interest rate swaps
Net exchange gains
Discount unwind on other long-term assets
Total
Finance expense
Interest on debt and commercial paper
Interest on overdrafts, finance leases and other financing costs
Net interest on post-employment defined benefit plan net liabilities (Note 20)
Net exchange losses
Discount unwind on contingent consideration arising from business combinations (Note 18)
Discount unwind on other long-term liabilities
Fair value losses on debt and interest rate swaps
Total
Net finance expense
Financial instruments
Included within finance income and expense are the following net gains and losses on financial instruments:
Interest and fair value adjustments in respect of debt designated at fair value through profit or loss, net of derivatives
Interest and changes in carrying values of debt designated as hedged items, net of derivatives
Interest and fair value changes on fixed and short-term deposits, equity securities and other derivatives
Interest on debt, overdrafts, finance leases and commercial paper held at amortised cost
2016
$m
8
35
–
8
16
67
(565)
(52)
(63)
–
(497)
(190)
(17)
(1,384)
(1,317)
2016
$m
(14)
(21)
74
(553)
2015
$m
8
28
10
–
–
46
(361)
(31)
(77)
(36)
(524)
(46)
–
(1,075)
(1,029)
2015
$m
6
(10)
46
(384)
2014
$m
10
23
16
29
–
78
(383)
(35)
(92)
–
(391)
(62)
–
(963)
(885)
2014
$m
(7)
8
45
(415)
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
Fair value losses of $29m (2015: $30m fair value losses; 2014: $29m fair value losses) on interest rate fair value hedging instruments and $30m fair
value gains (2015: $30m fair value gains; 2014: $29m fair value gains) on the related hedged items have been included within interest and changes
in carrying values of debt designated as hedged items, net of derivatives. All fair value hedge relationships were effective during the year.
Fair value losses of $12m (2015: $5m fair value losses; 2014: $4m fair value losses) on derivatives related to debt instruments designated at fair value
through profit or loss and $9m fair value gains (2015: $15m fair value gains; 2014: $3m fair value gains) on debt instruments designated at fair value
through profit or loss have been included within interest and fair value adjustments in respect of debt designated at fair value through profit or loss,
net of derivatives. Ineffectiveness on the net investment hedge taken to profit was $nil (2015: $nil; 2014: $nil).
AstraZeneca Annual Report and Form 20-F Information 2016
149
Financial Statements
4 Taxation
Taxation recognised in the profit for the period in the consolidated statement of comprehensive income is as follows:
Current tax expense
Current year
Adjustment to prior years
Total
Deferred tax expense
Origination and reversal of temporary differences
Adjustment to prior years
Total
Taxation recognised in the profit for the period
Taxation relating to components of other comprehensive income is as follows:
Current and deferred tax
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit liability
Deferred tax impact of reduction in UK tax rate
Share-based payments
Total
Items that may be reclassified subsequently to profit or loss:
Foreign exchange arising on consolidation
Foreign exchange arising on designating borrowings in net investment hedges
Net available for sale (gains)/losses recognised in other comprehensive income
Other
Total
Taxation relating to components of other comprehensive income
2016
$m
384
(14)
370
(94)
(130)
(224)
146
2016
$m
110
(25)
51
136
63
83
(61)
1
86
222
2015
$m
1,037
(404)
633
(482)
92
(390)
243
2015
$m
(133)
(58)
(8)
(199)
(8)
80
14
1
87
(112)
2014
$m
981
(109)
872
(833)
(28)
(861)
11
2014
$m
182
–
34
216
(39)
150
(64)
3
50
266
The reported tax rate of 4% for the year ended 31 December 2016 benefited from a $453m adjustment following agreements between the Canadian
tax authority and the UK and Swedish tax authorities in respect of transfer pricing arrangements for the 13-year period from 2004 to 2016. Excluding
these effects, the reported tax rate for the year was 17%.
The cash tax paid for the year was $412m which was 12% of profit before tax. Cash tax was lower in 2016 due to refunds arising in relation to
agreement of prior period tax liabilities and audit settlements.
Taxation has been provided at current rates on the profits earned for the periods covered by the Group Financial Statements. The 2016 prior period
current tax adjustment relates mainly to net reductions in provisions for tax contingencies totalling $67m and tax accrual to tax return adjustments.
The 2015 prior period current tax adjustment relates mainly to a $186m tax benefit following agreement of US federal tax liabilities of open years to
2008, net reductions in provisions for tax contingencies totalling $259m and tax accrual to tax return adjustments. The 2014 prior period current tax
adjustment relates mainly to a reduction in provisions for tax contingencies, including a benefit of $117m arising from the inter-governmental
agreement of a transfer pricing matter, partially offset by tax accrual to tax return adjustments.
The 2016 prior period deferred tax adjustments relate mainly to tax accrual to tax return adjustments and releases in provisions for tax
contingencies. The 2015 and 2014 prior period deferred tax adjustments relate mainly to tax accrual to tax return adjustments.
To the extent that dividends remitted from overseas subsidiaries, joint ventures and associates are expected to result in additional taxes, appropriate
amounts have been provided for. No deferred tax has been provided for unremitted earnings of Group companies overseas as these are considered
permanently employed in the business of these companies. Unremitted earnings may be liable to overseas taxes and/or UK taxation (after allowing for
double tax relief) if distributed as dividends. The aggregate amount of temporary differences associated with investments in subsidiaries and branches
for which deferred tax liabilities have not been recognised totalled approximately $6,884m at 31 December 2016 (2015: $6,957m; 2014: $6,128m).
Factors affecting future tax charges
As a group with worldwide operations, AstraZeneca is subject to several factors that may affect future tax charges, principally the levels and mix
of profitability in different jurisdictions, transfer pricing regulations, tax rates imposed and tax regime reforms. In 2016, the UK Government enacted
legislation to reduce the main rate of UK Statutory Corporation Tax to 17% by 2020. Details of material tax exposures and items currently under
audit and negotiation are set out in Note 28.
150
AstraZeneca Annual Report and Form 20-F Information 2016
4 Taxation continued
Tax reconciliation to UK statutory rate
The table below reconciles the UK statutory tax charge to the Group’s total tax charge.
Profit before tax
Notional taxation charge at UK corporation tax rate of 20% (2015: 20.25%; 2014: 21.5%)
Differences in effective overseas tax rates
Deferred tax (credit)/charge relating to reduction in UK and other tax rates1
Unrecognised deferred tax asset2
Items not deductible for tax purposes
Items not chargeable for tax purposes
Other items3
Adjustments in respect of prior periods4
Total tax charge for the year
2016
$m
3,552
710
(233)
(16)
242
132
(7)
(538)
(144)
146
2015
$m
3,069
621
(144)
(25)
149
29
–
(75)
(312)
243
2014
$m
1,246
268
(195)
23
34
50
(39)
7
(137)
11
1 The 2016 item relates to the reduction in the UK Statutory Corporation Tax rate from 18% to 17% effective from 1 April 2020. The 2015 item relates to the reduction in the UK Statutory Corporation
Tax rate from 20% to 18% previously announced to be effective from 1 April 2020. The 2014 item relates to the reduction in the UK Statutory Corporation Tax rate from 23% to 20% effective from
1 April 2015.
2 Includes an amount of $122m in relation to a write down of a previously recognised deferred tax asset.
3 Other items relate to the release of tax contingencies following agreements between the Canadian tax authority and the UK and Swedish tax authorities in respect of transfer pricing arrangements
for the 13-year period from 2004 to 2016 (credit of $453m) and release of certain tax contingencies following the expiry of the relevant statute of limitations (credit of $280m) partially offset by
provision build for transfer pricing contingencies (charge of $195m). Other items in 2015 included the impact of internal transfers of intellectual property (tax charge of $181m) and the release
of certain tax contingencies following the expiry of the relevant statute of limitations (tax credit of $256m). Other items in 2014 included the impact of internal transfers of intellectual property
including recognition of deferred tax benefits acquired as part of a business combination (tax charge of $304m), and the release of certain tax contingencies following the expiry of the relevant
(cid:86)(cid:87)(cid:68)(cid:87)(cid:88)(cid:87)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:79)(cid:76)(cid:80)(cid:76)(cid:87)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:11)(cid:87)(cid:68)(cid:91)(cid:3)(cid:70)(cid:85)(cid:72)(cid:71)(cid:76)(cid:87)(cid:86)(cid:3)(cid:82)(cid:73)(cid:98)(cid:7)(cid:21)(cid:28)(cid:26)(cid:80)(cid:12)(cid:17)
4 (cid:41)(cid:88)(cid:85)(cid:87)(cid:75)(cid:72)(cid:85)(cid:3)(cid:71)(cid:72)(cid:87)(cid:68)(cid:76)(cid:79)(cid:3)(cid:72)(cid:91)(cid:83)(cid:79)(cid:68)(cid:76)(cid:81)(cid:76)(cid:81)(cid:74)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:83)(cid:72)(cid:70)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:83)(cid:85)(cid:76)(cid:82)(cid:85)(cid:3)(cid:83)(cid:72)(cid:85)(cid:76)(cid:82)(cid:71)(cid:86)(cid:3)(cid:76)(cid:86)(cid:3)(cid:86)(cid:72)(cid:87)(cid:3)(cid:82)(cid:88)(cid:87)(cid:3)(cid:68)(cid:69)(cid:82)(cid:89)(cid:72)(cid:3)(cid:82)(cid:81)(cid:3)(cid:83)(cid:68)(cid:74)(cid:72)(cid:98)(cid:20)(cid:24)(cid:19)(cid:17)
AstraZeneca is domiciled in the UK but operates in other countries where the tax rates and tax laws are different to those in the UK. The impact
of differences in effective overseas tax rates on the Group’s overall tax charge is noted above. Profits arising from our manufacturing operation in
Puerto Rico are granted special status and are taxed at a reduced rate compared with the normal rate of tax in that territory under a tax incentive
grant continuing until 2031.
Deferred tax
The movements in the net deferred tax balance during the year are as follows:
Pension and
post-retirement
benefits
$m
Intercompany
inventory
transfers
$m
Losses and
tax credits
carried forward3
$m
Accrued
expenses
and other
$m
Net deferred tax balance at 1 January 2014
Taxation expense
Other comprehensive income
Additions through business combinations4
Exchange
Net deferred tax balance at 31 December 2014
Taxation expense
Other comprehensive income
Additions through business combinations (restated)5
Exchange
Net deferred tax balance at 31 December 2015 (restated)5
Income statement
Other comprehensive income
Additions through business combinations6
Exchange
Other movements7
Net deferred tax balance at 31 December 20168
Intangibles,
property, plant
& equipment1
$m
(3,064)
543
150
(147)
40
(2,478)
355
80
(1,206)
(12)
(3,261)
(132)
83
(1,827)
(1)
(11)
(5,149)
510
(4)
215
–
(93)
628
30
(198)
–
(33)
427
11
101
–
(74)
–
465
Untaxed
reserves2
$m
(1,114)
368
–
–
168
(578)
(156)
–
–
42
(692)
(53)
–
–
48
–
736
(6)
–
(35)
(65)
630
156
–
–
(48)
738
314
–
–
(38)
–
573
(44)
–
–
(4)
525
58
–
229
(8)
804
151
–
50
(1)
–
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
Total
$m
(1,622)
861
330
(145)
(1)
(577)
390
(127)
(977)
(80)
(1,371)
224
160
(1,777)
(79)
(11)
(2,854)
737
4
(35)
37
(47)
696
(53)
(9)
–
(21)
613
(67)
(24)
–
(13)
–
509
1,014
(697)
1,004
1 Includes deferred tax on contingent liabilities in respect of intangibles.
2 Untaxed reserves relate to taxable profits where the tax liability is deferred to later periods.
3 Includes losses and tax credits carried forward which will expire within nine to 20 years.
4 The deferred tax liability of $145m relates to the acquisition of BMS’s share of Global Diabetes Alliance Assets ($28m) and the acquisition of Definiens Group ($117m).
5 (cid:55)(cid:75)(cid:72)(cid:3)(cid:71)(cid:72)(cid:73)(cid:72)(cid:85)(cid:85)(cid:72)(cid:71)(cid:3)(cid:87)(cid:68)(cid:91)(cid:3)(cid:79)(cid:76)(cid:68)(cid:69)(cid:76)(cid:79)(cid:76)(cid:87)(cid:92)(cid:3)(cid:82)(cid:73)(cid:3)(cid:7)(cid:28)(cid:26)(cid:26)(cid:80)(cid:3)(cid:85)(cid:72)(cid:79)(cid:68)(cid:87)(cid:72)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:84)(cid:88)(cid:76)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:82)(cid:73)(cid:3)(cid:61)(cid:54)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:15)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:75)(cid:68)(cid:86)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:87)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:11)(cid:86)(cid:72)(cid:72)(cid:3)(cid:49)(cid:82)(cid:87)(cid:72)(cid:98)(cid:21)(cid:24)(cid:12)(cid:17)
6 The deferred tax liability of $1,777m relates to the acquisition of Acerta Pharma.
7 (cid:36)(cid:85)(cid:76)(cid:86)(cid:76)(cid:81)(cid:74)(cid:3)(cid:82)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:71)(cid:72)(cid:70)(cid:82)(cid:81)(cid:86)(cid:82)(cid:79)(cid:76)(cid:71)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:82)(cid:73)(cid:3)(cid:40)(cid:81)(cid:87)(cid:68)(cid:86)(cid:76)(cid:86)(cid:3)(cid:68)(cid:86)(cid:3)(cid:71)(cid:72)(cid:87)(cid:68)(cid:76)(cid:79)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:49)(cid:82)(cid:87)(cid:72)(cid:98)(cid:20)(cid:19)(cid:17)
8 (cid:55)(cid:75)(cid:72)(cid:3)(cid:56)(cid:46)(cid:3)(cid:75)(cid:68)(cid:71)(cid:3)(cid:68)(cid:3)(cid:81)(cid:72)(cid:87)(cid:3)(cid:71)(cid:72)(cid:73)(cid:72)(cid:85)(cid:85)(cid:72)(cid:71)(cid:3)(cid:87)(cid:68)(cid:91)(cid:3)(cid:68)(cid:86)(cid:86)(cid:72)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:7)(cid:20)(cid:26)(cid:21)(cid:80)(cid:3)(cid:68)(cid:86)(cid:3)(cid:68)(cid:87)(cid:3)(cid:22)(cid:20)(cid:98)(cid:39)(cid:72)(cid:70)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:15)(cid:3)(cid:80)(cid:68)(cid:76)(cid:81)(cid:79)(cid:92)(cid:3)(cid:76)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:83)(cid:72)(cid:70)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:83)(cid:72)(cid:81)(cid:86)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:83)(cid:82)(cid:86)(cid:87)(cid:16)(cid:85)(cid:72)(cid:87)(cid:76)(cid:85)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:69)(cid:72)(cid:81)(cid:72)(cid:73)(cid:76)(cid:87)(cid:86)(cid:15)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:75)(cid:68)(cid:86)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:70)(cid:82)(cid:74)(cid:81)(cid:76)(cid:86)(cid:72)(cid:71)(cid:3)(cid:82)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:69)(cid:68)(cid:86)(cid:76)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:86)(cid:88)(cid:73)(cid:73)(cid:76)(cid:70)(cid:76)(cid:72)(cid:81)(cid:87)(cid:3)(cid:73)(cid:82)(cid:85)(cid:72)(cid:70)(cid:68)(cid:86)(cid:87)(cid:3)
future taxable profits against which the deductible temporary differences can be utilised.
AstraZeneca Annual Report and Form 20-F Information 2016
151
Financial Statements
4 Taxation continued
The net deferred tax balance, before the offset of balances within countries, consists of:
Intangibles,
property, plant
& equipment
$m
Pension and
post-retirement
benefits
$m
Intercompany
inventory
transfers
$m
Untaxed
reserves
$m
Losses and
tax credits
carried forward
$m
Accrued
expenses
and other
$m
Deferred tax assets at 31 December 2014
Deferred tax liabilities at 31 December 2014
Net deferred tax balance at 31 December 2014
Deferred tax assets at 31 December 2015 (restated)*
Deferred tax liabilities at 31 December 2015
Net deferred tax balance at 31 December 2015 (restated)*
Deferred tax assets at 31 December 2016
Deferred tax liabilities at 31 December 2016
Net deferred tax balance at 31 December 2016
1,212
(3,690)
(2,478)
1,055
(4,316)
(3,261)
875
(6,024)
(5,149)
631
(3)
628
430
(3)
427
465
–
465
657
(27)
630
780
(42)
738
1,014
–
1,014
–
(578)
(578)
–
(692)
(692)
–
(697)
(697)
525
–
525
804
–
804
1,004
–
1,004
838
(142)
696
732
(119)
613
629
(120)
509
* (cid:21)(cid:19)(cid:20)(cid:24)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:68)(cid:85)(cid:68)(cid:87)(cid:76)(cid:89)(cid:72)(cid:86)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:87)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:85)(cid:72)(cid:73)(cid:79)(cid:72)(cid:70)(cid:87)(cid:3)(cid:68)(cid:81)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:84)(cid:88)(cid:76)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:61)(cid:54)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:11)(cid:86)(cid:72)(cid:72)(cid:3)(cid:49)(cid:82)(cid:87)(cid:72)(cid:98)(cid:21)(cid:24)(cid:12)(cid:17)
Analysed in the statement of financial position, after offset of balances within countries, as:
Deferred tax assets
Deferred tax liabilities
Net deferred tax balance
2016
$m
1,102
(3,956)
(2,854)
2015
Restated*
$m
1,294
(2,665)
(1,371)
Total
$m
3,863
(4,440)
(577)
3,801
(5,172)
(1,371)
3,987
(6,841)
(2,854)
2014
$m
1,219
(1,796)
(577)
* (cid:21)(cid:19)(cid:20)(cid:24)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:68)(cid:85)(cid:68)(cid:87)(cid:76)(cid:89)(cid:72)(cid:86)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:87)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:85)(cid:72)(cid:73)(cid:79)(cid:72)(cid:70)(cid:87)(cid:3)(cid:68)(cid:81)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:84)(cid:88)(cid:76)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:61)(cid:54)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:11)(cid:86)(cid:72)(cid:72)(cid:3)(cid:49)(cid:82)(cid:87)(cid:72)(cid:98)(cid:21)(cid:24)(cid:12)(cid:17)
Unrecognised deferred tax assets
Deferred tax assets of $542m have not been recognised in respect of deductible temporary differences (2015: $414m; 2014: $216m) because it is
not probable that future taxable profit will be available against which the Group can utilise the benefits therefrom.
5 Earnings per $0.25 Ordinary Share
Profit for the year attributable to equity holders ($m)
Basic earnings per Ordinary Share
Diluted earnings per Ordinary Share
Weighted average number of Ordinary Shares in issue for basic earnings (millions)
Dilutive impact of share options outstanding (millions)
Diluted weighted average number of Ordinary Shares in issue (millions)
The earnings figures used in the calculations above are post-tax.
2016
3,499
$2.77
$2.76
1,265
1
1,266
2015
2,825
$2.23
$2.23
1,264
1
1,265
2014
1,233
$0.98
$0.98
1,262
2
1,264
6 Segment information
AstraZeneca is engaged in a single business activity of biopharmaceuticals and the Group does not have multiple operating segments.
AstraZeneca’s biopharmaceuticals business consists of the discovery and development of new products, which are then manufactured, marketed
and sold. All of these functional activities take place (and are managed) globally on a highly integrated basis. These individual functional areas are
not managed separately.
The SET, established and chaired by the CEO, is the vehicle through which he exercises the authority delegated to him from the Board for the
management, development and performance of our business. It is considered that the SET is AstraZeneca’s chief operating decision making
body (as defined by IFRS 8 ‘Operating Segments’). The operation of the SET is principally driven by the management of the commercial operations,
R&D, and manufacturing and supply. In addition to the CEO, CFO, the General Counsel and the Chief Compliance Officer, the SET comprises 10
Executive Vice-Presidents representing IMED, MedImmune, Global Medicines Development, North America, Europe, International East, International
West, GPPS, Operations & Information Technology, and Human Resources. All significant operating decisions are taken by the SET. While members
of the SET have responsibility for implementation of decisions in their respective areas, operating decision making is at SET level as a whole. Where
necessary, these are implemented through cross-functional sub-committees that consider the Group-wide impact of a new decision. For example,
product launch decisions would be initially considered by the SET and, on approval, passed to an appropriate sub-team for implementation.
The impacts of being able to develop, produce, deliver and commercialise a wide range of pharmaceutical products drive the SET decision
making process.
152
AstraZeneca Annual Report and Form 20-F Information 2016
6 Segment information continued
In assessing performance, the SET reviews financial information on an integrated basis for the Group as a whole, substantially in the form of, and
on the same basis as, the Group’s IFRS Financial Statements. The high upfront cost of discovering and developing new products coupled with the
relatively insignificant and stable unit cost of production means that there is not the clear link that exists in many manufacturing businesses between
the revenue generated on an individual product sale and the associated cost and hence margin generated on a product. Consequently, the profitability
of individual drugs or classes of drugs is not considered a key measure of performance for the business and is not monitored by the SET.
Resources are allocated on a Group-wide basis according to need. In particular, capital expenditure, in-licensing, and R&D resources are allocated
between activities on merit, based on overall therapeutic considerations and strategy under the aegis of the Group’s Early Stage Product
Committees and a single Late Stage Product Committee.
Geographic areas
The following tables show information by geographic area and, for Total Revenue and property, plant and equipment, material countries. The figures
show the Total Revenue, operating profit and profit before tax made by companies located in that area/country, together with segment assets,
segment assets acquired, net operating assets, and property, plant and equipment owned by the same companies; export sales and the related
profit are included in the area/country where the legal entity resides and from which those sales were made.
UK
External
Intra-Group
Continental Europe
Belgium
France
Germany
Italy
Spain
Sweden
Others
Intra-Group
The Americas
Canada
US
Others
Intra-Group
Asia, Africa & Australasia
Australia
China
Japan
Others
Intra-Group
Continuing operations
Intra-Group eliminations
Total Revenue
2016
$m
1,849
7,503
9,352
163
899
615
529
440
1,522
1,412
4,108
9,688
495
7,828
846
3,487
2015
$m
2,176
6,001
8,177
176
1,015
608
544
426
645
1,448
4,664
9,526
530
9,949
1,018
2,167
12,656
13,664
385
2,650
2,145
1,224
85
6,489
38,185
(15,183)
23,002
435
2,548
1,985
1,205
46
6,219
37,586
(12,878)
24,708
Total Revenue
2014
$m
1,878
4,718
6,596
260
1,325
687
688
495
639
1,794
4,763
10,651
583
10,692
1,165
2,346
14,786
657
2,228
2,202
1,254
56
6,397
38,430
(11,883)
26,547
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
Export sales from the UK totalled $8,421m for the year ended 31 December 2016 (2015: $6,851m; 2014: $5,709m). Intra-Group pricing is determined
on an arm’s length basis.
AstraZeneca Annual Report and Form 20-F Information 2016
153
Financial Statements
6 Segment information continued
UK
Continental Europe
The Americas
Asia, Africa & Australasia
Continuing operations
UK
Continental Europe
The Americas
Asia, Africa & Australasia
Continuing operations
UK
Continental Europe
The Americas
Asia, Africa & Australasia
Continuing operations
2016
$m
(526)
3,695
1,259
474
4,902
2016
$m
5,127
15,731
26,044
917
47,819
2016
$m
362
8,494
688
129
9,673
Operating (loss)/profit
(Loss)/profit before tax
2015
$m
(743)
3,412
1,101
344
4,114
2015
Restated*
$m
6,251
8,690
26,431
937
42,309
2015
Restated*
$m
1,478
653
4,147
172
6,450
2014
$m
(851)
1,780
818
390
2,137
2016
$m
(950)
3,136
919
447
3,552
2015
$m
(1,113)
3,023
821
338
3,069
2014
$m
(1,174)
1,477
549
394
1,246
Non-current assets1
Total assets
2014
$m
5,826
8,764
24,750
874
40,214
2016
$m
12,704
18,174
28,792
2,856
62,526
2015
Restated*
$m
14,712
10,636
31,536
3,172
60,056
2014
$m
14,926
11,184
29,324
3,161
58,595
Assets acquired 2
Net operating assets3
2014
$m
2,703
6,362
2,732
199
11,996
2016
$m
3,306
8,479
20,969
1,030
33,784
2015
$m
3,713
3,704
22,334
1,458
31,209
2014
$m
3,002
4,110
20,190
1,570
28,872
* (cid:21)(cid:19)(cid:20)(cid:24)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:68)(cid:85)(cid:68)(cid:87)(cid:76)(cid:89)(cid:72)(cid:86)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:87)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:85)(cid:72)(cid:73)(cid:79)(cid:72)(cid:70)(cid:87)(cid:3)(cid:68)(cid:81)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:84)(cid:88)(cid:76)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:61)(cid:54)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:11)(cid:86)(cid:72)(cid:72)(cid:3)(cid:49)(cid:82)(cid:87)(cid:72)(cid:98)(cid:21)(cid:24)(cid:12)(cid:17)
1 Non-current assets exclude deferred tax assets and derivative financial instruments.
2 Included in Assets acquired are those assets that are expected to be used during more than one period (property, plant and equipment, goodwill and intangible assets).
3 Net operating assets exclude short-term investments, cash, short-term borrowings, loans, derivative financial instruments, retirement benefit obligations and non-operating receivables
(cid:68)(cid:81)(cid:71)(cid:98)(cid:83)(cid:68)(cid:92)(cid:68)(cid:69)(cid:79)(cid:72)(cid:86)(cid:17)
UK
Sweden
US
Rest of the world
Continuing operations
Geographic markets
The table below shows Product Sales in each geographic market in which customers are located.
UK
Continental Europe
The Americas
Asia, Africa & Australasia
Continuing operations
2016
$m
1,026
1,142
3,233
1,447
6,848
2016
$m
487
4,987
8,717
7,128
21,319
Property, plant and equipment
2015
$m
1,024
1,023
2,986
1,380
6,413
2015
$m
588
5,180
11,031
6,842
23,641
2014
$m
824
971
2,830
1,385
6,010
2014
$m
773
6,394
11,892
7,036
26,095
Product Sales are recognised when the significant risks and rewards of ownership have been transferred to a third party. In general this is upon
delivery of the products to wholesalers. Transactions with one wholesaler (2015: two; 2014: two) individually represented greater than 10% of Product
Sales. The value of these transactions recorded as Product Sales were $2,851m (2015: $3,458m and $2,757m; 2014: $3,261m and $2,674m).
154
AstraZeneca Annual Report and Form 20-F Information 2016
7 Property, plant and equipment
Cost
At 1 January 2014
Capital expenditure
Additions through business combinations (Note 25)
Transfers in from other non-current assets
Transfer of assets into use
Disposals and other movements
Exchange adjustments
At 31 December 2014
Capital expenditure
Additions through business combinations (Note 25)
Transfer of assets into use
Disposals and other movements
Exchange adjustments
At 31 December 2015
Capital expenditure
Transfer of assets into use
Disposals and other movements
Exchange adjustments
At 31 December 2016
Depreciation
At 1 January 2014
Charge for year
Disposals and other movements
Exchange adjustments
At 31 December 2014
Charge for year
Impairment
Disposals and other movements
Exchange adjustments
At 31 December 2015
Charge for year
Impairment
Disposals and other movements
Exchange adjustments
At 31 December 2016
Net book value
At 31 December 2014
At 31 December 2015
At 31 December 2016
Land and
buildings
$m
Plant and
equipment
$m
Assets in course
of construction
$m
Total property,
plant and
equipment
$m
5,683
8,453
34
213
156
136
(976)
(334)
4,912
23
21
269
(239)
(174)
4,812
29
222
(236)
(211)
4,616
2,952
252
(639)
(214)
2,351
198
9
(203)
(102)
2,253
185
2
(222)
(126)
2,092
2,561
2,559
2,524
184
206
124
405
(962)
(698)
7,712
223
–
359
(442)
(384)
7,468
206
109
(700)
(540)
771
874
96
70
(541)
(27)
(123)
1,120
1,155
–
(628)
(3)
(76)
1,568
1,214
(331)
(16)
(143)
14,907
1,092
515
350
–
(1,965)
(1,155)
13,744
1,401
21
–
(684)
(634)
13,848
1,449
–
(952)
(894)
6,543
2,292
13,451
6,137
524
(744)
(534)
5,383
479
19
(411)
(288)
5,182
424
–
(656)
(439)
4,511
2,329
2,286
2,032
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
1,120
1,568
2,292
9,089
776
(1,383)
(748)
7,734
677
28
(614)
(390)
7,435
609
2
(878)
(565)
6,603
6,010
6,413
6,848
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
Impairment charges in 2015 were attributable to assets dedicated to the production and manufacture of Caprelsa, for which global product rights
were divested during the year, and to strategy changes affecting manufacturing operations in the US. These charges have been recognised in cost
of sales.
The net book value of land and buildings comprised:
Freeholds
Leaseholds
2016
$m
2,326
198
2015
$m
2,432
127
2014
$m
2,489
72
Included within plant and equipment are Information Technology assets held under finance leases with a net book value of $43m (2015: $70m;
2014: $74m).
AstraZeneca Annual Report and Form 20-F Information 2016
155
Financial Statements
8 Goodwill
Cost
At 1 January
Additions through business combinations (Note 25)
Exchange and other adjustments
At 31 December
Amortisation and impairment losses
At 1 January
Exchange and other adjustments
At 31 December
Net book value at 31 December
2016
$m
12,113
19
(163)
11,969
313
(2)
311
2015
Restated*
$m
11,868
388
(143)
12,113
318
(5)
313
2014
$m
10,307
1,841
(280)
11,868
326
(8)
318
11,658
11,800
11,550
* (cid:21)(cid:19)(cid:20)(cid:24)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:68)(cid:85)(cid:68)(cid:87)(cid:76)(cid:89)(cid:72)(cid:86)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:87)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:85)(cid:72)(cid:73)(cid:79)(cid:72)(cid:70)(cid:87)(cid:3)(cid:68)(cid:81)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:84)(cid:88)(cid:76)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:61)(cid:54)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:11)(cid:86)(cid:72)(cid:72)(cid:3)(cid:49)(cid:82)(cid:87)(cid:72)(cid:98)(cid:21)(cid:24)(cid:12)(cid:17)
For the purpose of impairment testing of goodwill, the Group is regarded as a single cash-generating unit.
The recoverable amount is based on value in use using discounted risk-adjusted projections of the Group’s pre-tax cash flows over 10 years which
is considered by the Board as a reasonable period given the long development and life-cycle of a medicine. The projections include assumptions
about product launches, competition from rival products and pricing policy as well as the possibility of generics entering the market. In setting these
assumptions we consider our past experience, external sources of information (including information on expected increases and ageing of the
populations in our established markets and the expanding patient population in newer markets), our knowledge of competitor activity and our
assessment of future changes in the pharmaceutical industry. The 10-year period is covered by internal budgets and forecasts. Given that internal
budgets and forecasts are prepared for all projections, no general growth rates are used to extrapolate internal budgets and forecasts for the
purposes of determining value in use. No terminal value is included as these cash flows are more than sufficient to establish that an impairment
does not exist. The methods used to determine recoverable amounts have remained consistent with the prior year.
In arriving at value in use, we disaggregate our projected pre-tax cash flows into groups reflecting similar risks and tax effects. For each group of
cash flows we use an appropriate discount rate reflecting those risks and tax effects. In arriving at the appropriate discount rate for each group of
cash flows, we adjust AstraZeneca’s post-tax weighted average cost of capital (7.0% for 2016, 2015 and 2014) to reflect the impact of risks relevant
to that group of assets, the time value of money and tax effects. The weighted average pre-tax discount rate we used was approximately 10%
(2015: 10%; 2014: 10%).
As a further check, we compare our market capitalisation to the book value of our net assets and this indicates significant surplus at 31 December
2016 (and 31 December 2015 and 31 December 2014).
No goodwill impairment was identified.
The Group has also performed sensitivity analysis calculations on the projections used and discount rate applied. The Directors have concluded
that, given the significant headroom that exists, and the results of the sensitivity analysis performed, there is no significant risk that reasonable
changes in any key assumptions would cause the carrying value of goodwill to exceed its value in use.
156
AstraZeneca Annual Report and Form 20-F Information 2016
9 Intangible assets
Cost
At 1 January 2014
Additions through business combinations (Note 25)
Additions – separately acquired
Disposals
Exchange and other adjustments
At 31 December 2014
Additions through business combinations (Note 25)
Additions – separately acquired
Disposals
Exchange and other adjustments
At 31 December 2015
Additions through business combinations (Note 25)
Additions – separately acquired
Disposals
Exchange and other adjustments
At 31 December 2016
Amortisation and impairment losses
At 1 January 2014
Amortisation for year
Impairment
Disposals
Exchange and other adjustments
At 31 December 2014
Amortisation for year
Impairment
Disposals
Exchange and other adjustments
At 31 December 2015
Amortisation for year
Impairment
Disposals
Exchange and other adjustments
At 31 December 2016
Net book value
At 31 December 2014
At 31 December 2015
At 31 December 2016
Other intangibles consist mainly of licensing and rights to contractual income streams.
Product,
marketing and
distribution rights
$m
Other
intangibles
$m
Software
development
costs
$m
25,553
6,926
907
(23)
(1,464)
31,899
3,162
1,341
(198)
(886)
35,318
7,307
789
(339)
(1,472)
41,603
10,944
2,008
81
(23)
(465)
12,545
1,718
143
(31)
(271)
14,104
1,454
43
(25)
(481)
2,499
575
25
–
(287)
2,812
–
60
(4)
(73)
2,795
–
32
(15)
(232)
2,580
1,682
193
18
–
(240)
1,653
174
–
(2)
(52)
1,773
162
1
(15)
(85)
15,095
1,836
19,354
21,214
26,508
1,159
1,022
744
2,090
–
115
(41)
(138)
2,026
–
77
(14)
(70)
2,019
–
77
(141)
(127)
1,828
1,469
183
23
(41)
(76)
1,558
107
5
(14)
(47)
1,609
85
1
(124)
(77)
1,494
468
410
334
Total
$m
30,142
7,501
1,047
(64)
(1,889)
36,737
3,162
1,478
(216)
(1,029)
40,132
7,307
898
(495)
(1,831)
46,011
14,095
2,384
122
(64)
(781)
15,756
1,999
148
(47)
(370)
17,486
1,701
45
(164)
(643)
18,425
20,981
22,646
27,586
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
AstraZeneca Annual Report and Form 20-F Information 2016
157
Financial Statements
9 Intangible assets continued
Amortisation charges are recognised in profit as follows:
Year ended 31 December 2014
Cost of sales
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Total
Year ended 31 December 2015
Cost of sales
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Total
Year ended 31 December 2016
Cost of sales
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Total
Impairment charges are recognised in profit as follows:
Year ended 31 December 2014
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Total
Year ended 31 December 2015
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Total
Year ended 31 December 2016
Research and development expense
Selling, general and administrative costs
Total
Product,
marketing and
distribution rights
$m
Other
intangibles
$m
Software
development
costs
$m
701
–
1,203
104
2,008
369
–
1,321
28
1,718
124
–
1,327
3
1,454
–
60
25
108
193
–
57
31
86
174
–
48
31
83
162
–
–
183
–
183
–
–
107
–
107
–
–
85
–
85
Product,
marketing and
distribution rights
$m
Other
intangibles
$m
Software
development
costs
$m
81
–
–
81
79
–
64
143
32
11
43
–
–
18
18
–
–
–
–
1
–
1
–
23
–
23
–
5
–
5
–
1
1
Total
$m
701
60
1,411
212
2,384
369
57
1,459
114
1,999
124
48
1,443
86
1,701
Total
$m
81
23
18
122
79
5
64
148
33
12
45
Impairment charges and reversals
Impairment charges relate to the termination, or reassessment of the likelihood of success, of several individual projects, none of which had significant
capitalised values.
The write downs in value of intangible assets, other than those arising from termination of R&D activities, were determined based on value in use
calculations using discounted risk-adjusted projections of the products’ expected post-tax cash flows over a period reflecting the patent-protected
lives of the individual products. The full period of projections is covered by internal budgets and forecasts. In arriving at the appropriate discount rate
to use for each product, we adjust AstraZeneca’s post-tax weighted average cost of capital (7.0% for 2016, 2015 and 2014) to reflect the impact of
risks and tax effects specific to the individual products. The weighted average pre-tax discount rate we used was approximately 13% (2015: 13%;
2014: 13%).
By their nature, the value in use calculations are sensitive to the underlying methods, assumptions and estimates. Consistent with prior years, as
part of the impairment review process, management has identified that reasonably possible changes in certain key assumptions may cause the
carrying amount of the intangible assets to exceed the recoverable amount. At 31 December 2016, the Group held intangible assets for products in
development of $14,261m (2015: $8,732m; 2014: $6,598m), for which the most sensitive assumption is the probability of technical success, and
intangible assets for launched products of $12,991m (2015: $13,504m; 2014: $13,915m), for which the most sensitive assumptions are the projected
market share of the therapeutic area and expected pricing. In particular, where a trial is unsuccessful and there is no alternative use for the development
asset, this will result in a full impairment. As detailed in Note 25, we have recognised significant intangible assets for late stage development
programmes and launched products on business combinations at their fair value at acquisition. Management has identified that the impairment
review calculations on these assets, in particular those from Acerta Pharma, ZS Pharma, BMS’s share of the Global Diabetes Alliance and Almirall’s
respiratory franchise, are especially sensitive to the key assumptions noted above. Given their nature, impairment adjustments triggered by future
events that have yet to occur may be material. In addition, there is a significant risk that impairments recognised in any one period may be subject
to material adjustments in future periods.
158
AstraZeneca Annual Report and Form 20-F Information 2016
9 Intangible assets continued
Significant assets
Intangible assets arising from the acquisition of Acerta Pharma1
Intangible assets arising from the acquisition of ZS Pharma1
RSV franchise assets arising from the acquisition of MedImmune
Intangible assets arising from the restructuring of a joint venture with Merck
Farxiga/Forxiga intangible assets acquired from BMS
Intangible assets arising from the acquisition of Ardea
Intangible assets acquired from Almirall and Actavis
Bydureon intangible assets acquired from BMS
Onglyza intangible assets acquired from BMS
Other diabetes intangible assets acquired from BMS
Intangible assets arising from the acquisition of Pearl Therapeutics1
Intangible assets arising from the acquisition of Omthera1
Intangible assets arising from the acquisition of Amplimmune1
Intangible assets arising from the acquisition of Takeda
FluMist intangible assets arising from the acquisition of MedImmune
Roxadustat intangible assets acquired from FibroGen1
1 Assets in development are not amortised but are tested annually for impairment.
All the assets listed above are classified as Product, marketing and distribution rights.
10 Investments in associates and joint ventures
At 1 January
Additions
Share of after tax losses
Exchange adjustments
At 31 December
Carrying value
$m
Remaining amortisation
period
7,307
3,162
2,503
1,587
1,427
1,359
1,318
1,161
1,055
1,235
877
533
470
456
415
301
Not amortised
Not amortised
9 years
2 to 14 years
11 years
11 years
3 to 22 years
14 years
7 years
6 to 17 years
Not amortised
Not amortised
Not amortised
3 to 8 years
15 years
Not amortised
2016
$m
85
65
(33)
(18)
99
2015
$m
59
45
(16)
(3)
85
2014
$m
–
70
(6)
(5)
59
In 2015, AstraZeneca established the subsidiaries Entasis Therapeutics Ltd and Entasis Therapeutics Inc. (collectively known as ‘Entasis’) for the
development of early stage infection assets. On 29 March 2016, Entasis closed a Series B financing, raising $25m from four third-party investors.
Under the funding agreement, a new board of directors was appointed, and a voting rights agreement was put in place committing to reduce
AstraZeneca’s voting interest to approximately 49%. Since AstraZeneca no longer has overall control of Entasis, it is now treated as an associate
rather than a wholly owned subsidiary of the Group. The results of Entasis were deconsolidated from the Group on 29 March, with an investment
in associate of $24m recognised. There was no gain or loss recognised on deconsolidation.
On 1 December 2015, AstraZeneca entered into a joint venture agreement with Fujifilm Kyowa Kirin Biologics Co., Ltd. to develop a biosimilar using the
combined capabilities of the two parties. The agreement resulted in the formation of a joint venture entity based in the UK, Centus Biotherapeutics
Limited. AstraZeneca contributed $45m in cash to the joint venture entity and has a 50% interest in the joint venture. An additional contribution of
$10m was made in 2016.
On 30 April 2014, AstraZeneca entered into a joint venture agreement with Samsung Biologics Co., Ltd. to develop a biosimilar using the combined
capabilities of the two parties. The agreement resulted in the formation of a joint venture entity based in the UK, Archigen Biotech Limited, with a
branch in South Korea. AstraZeneca contributed $70m in cash to the joint venture entity and has a 50% interest in the joint venture. An additional
contribution of $30m was made in 2016.
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All investments are accounted for using the equity method.
Aggregated summarised financial information for the associate and joint venture entities is set out below.
Non-current assets
Current assets
Current liabilities
Net assets
Amount attributable to AstraZeneca
Exchange adjustments
Carrying value of investments in associate and joint ventures
2016
$m
144
128
(20)
252
125
(26)
99
2015
$m
123
75
(11)
187
93
(8)
85
2014
$m
76
58
(6)
128
64
(5)
59
AstraZeneca Annual Report and Form 20-F Information 2016
159
Financial Statements
11 Other investments
Non-current investments
Equity securities available for sale
Total
Current investments
Equity securities and bonds available for sale
Fixed deposits
Total
2016
$m
727
727
847
37
884
2015
$m
458
458
548
65
613
2014
$m
502
502
775
20
795
The equity securities and bonds available for sale in current investments include $nil (2015: $467m; 2014: $775m) held in a custody account. Further
details of this custody account are included in Note 20.
Impairment charges of $21m in respect of available for sale securities are included in other operating income and expense (2015: $17m; 2014: $23m).
Equity securities and bonds available for sale are held at fair value. The fair value of listed investments is based on year end quoted market prices.
For unlisted investments whose fair value cannot be reliably measured, cost is considered to approximate to fair value. Fixed deposits are held at
amortised cost with carrying value being a reasonable approximation of fair value given their short-term nature.
None of the financial assets or liabilities have been reclassified in the year.
Fair value hierarchy
The table below analyses equity securities and bonds available for sale, contained within other investments and carried at fair value, by valuation
method. The different levels have been defined as follows:
> Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities.
> Level 2: inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (ie as prices) or indirectly
(ie derived from prices).
> Level 3: inputs for the asset or liability that are not based on observable market data (unobservable inputs).
Level 1
Level 2
Level 3
Total
2016
$m
933
–
641
1,574
2015
$m
654
–
352
1,006
2014
$m
927
–
350
1,277
Equity securities available for sale that are analysed at Level 3 include investments in private biotech companies. In the absence of specific market data,
these unlisted investments are held at cost, adjusted as necessary for impairments and revaluations on new funding rounds, which approximates to
fair value. Movements in Level 3 investments are detailed below.
At 1 January
Additions
Revaluations
Transfers out
Disposals
Impairments and exchange adjustments
At 31 December
2016
$m
352
210
110
(12)
(2)
(17)
641
2015
$m
350
49
–
(22)
(6)
(19)
352
2014
$m
209
107
95
(35)
–
(26)
350
Assets are transferred in or out of Level 3 on the date of the event or change in circumstances that caused the transfer.
160
AstraZeneca Annual Report and Form 20-F Information 2016
12 Derivative financial instruments
Interest rate swaps designated in a fair value hedge
Interest rate swaps related to instruments designated at fair value through profit and loss
Cross currency swaps designated in a net investment hedge
Other derivatives
31 December 2014
Interest rate swaps designated in a fair value hedge
Interest rate swaps related to instruments designated at fair value through profit and loss
Cross currency swaps designated in a net investment hedge
Other derivatives
31 December 2015
Interest rate swaps designated in a fair value hedge
Interest rate swaps related to instruments designated at fair value through profit and loss
Cross currency swaps designated in a net investment hedge
Cross currency swaps designated in a cashflow hedge
Other derivatives
31 December 2016
Non-current
assets
$m
Current
assets
$m
Current
liabilities
$m
Non-current
liabilities
$m
79
82
304
–
465
–
–
–
21
21
–
–
–
(21)
(21)
–
–
–
–
–
Non-current
assets
$m
Current
assets
$m
Current
liabilities
$m
Non-current
liabilities
$m
49
77
320
–
446
–
–
–
2
2
–
–
–
(9)
(9)
–
–
–
(1)
(1)
Non-current
assets
$m
Current
assets
$m
Current
liabilities
$m
Non-current
liabilities
$m
–
65
278
–
–
343
19
–
–
–
8
27
–
–
–
–
(18)
(18)
(2)
–
–
(115)
–
(117)
Total
$m
79
82
304
–
465
Total
$m
49
77
320
(8)
438
Total
$m
17
65
278
(115)
(10)
235
All derivatives are held at fair value and fall within Level 2 of the fair value hierarchy as defined in Note 11. None of the derivatives have been reclassified
in the year.
The fair value of interest rate swaps and cross-currency swaps is estimated using appropriate zero coupon curve valuation techniques to discount
future contractual cash flows based on rates at current year end.
The fair value of forward foreign exchange contracts and currency options are estimated by cash flow accounting models using appropriate yield
curves based on market forward foreign exchange rates at the year end. The majority of forward foreign exchange contracts for existing transactions
had maturities of less than one month from year end.
The interest rates used to discount future cash flows for fair value adjustments, where applicable, are based on market swap curves at the reporting
date, and were as follows.
Derivatives
2016
2015
2014
1.5% to 2.2% 1.2% to 2.1% 1.2% to 2.3%
13 Non-current other receivables
Non-current other receivables of $901m (2015: $907m; 2014: $1,112m) include a prepayment of $380m (2015: $617m; 2014: $906m) which represents
the long-term element of minimum contractual royalties payable to Shionogi under the global licence agreement for Crestor, which was renegotiated
in December 2013. The resulting modified royalty structure, which includes fixed minimum and maximum payments in years until 2020, has resulted
in the Group recognising liabilities, and corresponding prepayments, for the discounted value of total minimum payments. The current portion of the
prepayment is $116m (2015: $260m; 2014: $323m) and is reported in amounts due within one year (see Note 15).
Non-current other receivables also include $178m (2015: $158m; 2014: $150m) prepayments in relation to our research collaboration with Moderna
Therapeutics and $175m (2015: $nil; 2014: $nil) receivable related to the disposal of the small molecule antibiotics business.
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14 Inventories
Raw materials and consumables
Inventories in process
Finished goods and goods for resale
Inventories
2016
$m
811
1,060
463
2,334
2015
$m
960
545
638
2,143
2014
$m
663
501
796
1,960
The Group recognised $2,644m (2015: $2,942m; 2014: $3,214m) of inventories as an expense within cost of sales during the year.
Inventory write-offs in the year amounted to $198m (2015: $112m; 2014: $126m).
AstraZeneca Annual Report and Form 20-F Information 2016
161
Financial Statements
15 Current trade and other receivables
Amounts due within one year
Trade receivables
Less: Amounts provided for doubtful debts (Note 26)
Other receivables
Prepayments and accrued income
Amounts due after more than one year
Other receivables
Prepayments and accrued income
Trade and other receivables
2016
$m
2,625
(42)
2,583
852
879
4,314
140
119
259
4,573
2015
$m
4,685
(52)
4,633
543
1,268
6,444
28
150
178
6,622
All financial assets included within current trade and other receivables are held at amortised costs with carrying value being a reasonable
approximation of fair value.
16 Cash and cash equivalents
Cash at bank and in hand
Short-term deposits
Cash and cash equivalents
Unsecured bank overdrafts
Cash and cash equivalents in the cash flow statement
2016
$m
782
4,236
5,018
(94)
4,924
2015
$m
1,250
4,990
6,240
(189)
6,051
2014
$m
4,816
(54)
4,762
1,050
1,262
7,074
22
136
158
7,232
2014
$m
1,009
5,351
6,360
(196)
6,164
The Group holds $91m (2015: $110m; 2014: $114m) of cash and cash equivalents which is required to meet insurance solvency, capital and security
requirements, and which, as a result, is not readily available for the general purposes of the Group.
Cash and cash equivalents are held at amortised cost. Fair value approximates to carrying value.
17 Interest-bearing loans and borrowings
Current liabilities
Bank overdrafts
Finance leases
5.125% Non-callable bond
5.9% Callable bond
Other loans (Commercial paper)
Total
Non-current liabilities
Finance leases
5.9% Callable bond
Floating rate notes
1.75% Callable bond
1.95% Callable bond
2.375% Callable bond
0.875% Non-callable bond
0.25% Callable bond
7% Guaranteed debentures
0.75% Callable bond
3.375% Callable bond
1.25% Callable bond
5.75% Non-callable bond
6.45% Callable bond
4% Callable bond
4.375% Callable bond
Other loans
Total
euros
US dollars
US dollars
US dollars
US dollars
US dollars
US dollars
euros
euros
US dollars
euros
US dollars
euros
pounds sterling
US dollars
US dollars
US dollars
Repayment
dates
On demand
2015
2017
Within one year
2017
2018
2018
2019
2020
2021
2021
2023
2024
2025
2028
2031
2037
2042
2045
2016
$m
94
87
–
1,769
357
2,307
6
–
399
998
998
1,589
782
522
350
937
1,976
827
426
2,719
986
979
7
2015
$m
189
67
–
–
660
916
28
1,796
399
997
997
1,586
812
–
355
–
1,971
–
515
2,719
986
976
–
2014
$m
196
48
912
–
1,290
2,446
60
1,825
–
–
996
–
902
–
370
–
–
–
540
2,718
986
–
–
14,501
14,137
8,397
All loans and borrowings above are unsecured, except for finance leases which are secured against the Information Technology assets to which they
relate (see Note 7).
162
AstraZeneca Annual Report and Form 20-F Information 2016
17 Interest-bearing loans and borrowings continued
Set out below is a comparison by category of carrying values and fair values of all the Group’s interest-bearing loans and borrowings.
2014
Overdrafts
Finance leases due within one year
Finance leases due after more than one year
Loans due within one year
Loans due after more than one year
Total at 31 December 2014
2015
Overdrafts
Finance leases due within one year
Finance leases due after more than one year
Loans due within one year
Loans due after more than one year
Total at 31 December 2015
2016
Overdrafts
Finance leases due within one year
Finance leases due after more than one year
Loans due within one year
Loans due after more than one year
Total at 31 December 2016
Instruments in a
fair value hedge
relationship1
$m
Instruments
designated
at fair value2
$m
Instruments
designated in
cash flow hedge3
$m
Amortised
cost4
$m
–
–
–
–
828
828
–
–
–
–
1,398
1,398
–
–
–
770
598
1,368
–
–
–
–
370
370
–
–
–
–
355
355
–
–
–
–
350
350
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
2,286
2,286
196
48
60
2,202
7,139
9,645
189
67
28
660
12,356
13,300
94
87
6
1,356
11,261
12,804
Total
carrying
value
$m
196
48
60
2,202
8,337
10,843
189
67
28
660
14,109
15,053
94
87
6
2,126
14,495
16,808
Fair
value
$m
196
48
60
2,202
9,662
12,168
189
67
28
660
15,132
16,076
94
87
6
2,161
15,826
18,174
1 Instruments designated as hedged items in fair value hedge relationships with respect to interest rate risk include a designated portion of the US dollar 5.9% Callable bond repayable in 2017,
(cid:68)(cid:81)(cid:71)(cid:98)(cid:68)(cid:98)(cid:83)(cid:82)(cid:85)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:3)(cid:71)(cid:82)(cid:79)(cid:79)(cid:68)(cid:85)(cid:3)(cid:20)(cid:17)(cid:26)(cid:24)(cid:8)(cid:3)(cid:38)(cid:68)(cid:79)(cid:79)(cid:68)(cid:69)(cid:79)(cid:72)(cid:3)(cid:69)(cid:82)(cid:81)(cid:71)(cid:3)(cid:85)(cid:72)(cid:83)(cid:68)(cid:92)(cid:68)(cid:69)(cid:79)(cid:72)(cid:3)(cid:76)(cid:81)(cid:3)(cid:21)(cid:19)(cid:20)(cid:27)(cid:17)
2 Instruments designated at fair value through profit or loss include the US dollar 7% guaranteed debentures repayable in 2023.
3 Instruments designated in a cash flow hedge include the euro 0.25%, euro 0.75% and euro 1.25% Callable bonds repayable in 2021, 2024 and 2028 respectively.
4 (cid:44)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:72)(cid:71)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:76)(cid:81)(cid:3)(cid:69)(cid:82)(cid:85)(cid:85)(cid:82)(cid:90)(cid:76)(cid:81)(cid:74)(cid:86)(cid:3)(cid:75)(cid:72)(cid:79)(cid:71)(cid:3)(cid:68)(cid:87)(cid:3)(cid:68)(cid:80)(cid:82)(cid:85)(cid:87)(cid:76)(cid:86)(cid:72)(cid:71)(cid:3)(cid:70)(cid:82)(cid:86)(cid:87)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:68)(cid:80)(cid:82)(cid:88)(cid:81)(cid:87)(cid:86)(cid:3)(cid:71)(cid:72)(cid:86)(cid:76)(cid:74)(cid:81)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:68)(cid:86)(cid:3)(cid:75)(cid:72)(cid:71)(cid:74)(cid:72)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:81)(cid:72)(cid:87)(cid:3)(cid:76)(cid:81)(cid:89)(cid:72)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:73)(cid:82)(cid:85)(cid:72)(cid:76)(cid:74)(cid:81)(cid:3)(cid:82)(cid:83)(cid:72)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:82)(cid:73)(cid:3)(cid:7)(cid:20)(cid:15)(cid:21)(cid:19)(cid:27)(cid:80)(cid:3)(cid:11)(cid:21)(cid:19)(cid:20)(cid:24)(cid:29)(cid:98)(cid:7)(cid:20)(cid:15)(cid:22)(cid:21)(cid:26)(cid:80)(cid:30)(cid:3)(cid:21)(cid:19)(cid:20)(cid:23)(cid:29)(cid:98)(cid:7)(cid:20)(cid:15)(cid:23)(cid:24)(cid:22)(cid:80)(cid:12)(cid:3)(cid:75)(cid:72)(cid:79)(cid:71)(cid:3)(cid:68)(cid:87)(cid:3)(cid:68)(cid:80)(cid:82)(cid:85)(cid:87)(cid:76)(cid:86)(cid:72)(cid:71)(cid:3)(cid:70)(cid:82)(cid:86)(cid:87)(cid:17)(cid:3)
(cid:55)(cid:75)(cid:72)(cid:3)(cid:73)(cid:68)(cid:76)(cid:85)(cid:3)(cid:89)(cid:68)(cid:79)(cid:88)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:86)(cid:72)(cid:3)(cid:69)(cid:82)(cid:85)(cid:85)(cid:82)(cid:90)(cid:76)(cid:81)(cid:74)(cid:86)(cid:3)(cid:90)(cid:68)(cid:86)(cid:3)(cid:7)(cid:20)(cid:15)(cid:23)(cid:19)(cid:19)(cid:80)(cid:3)(cid:68)(cid:87)(cid:3)(cid:22)(cid:20)(cid:98)(cid:39)(cid:72)(cid:70)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:3)(cid:11)(cid:21)(cid:19)(cid:20)(cid:24)(cid:29)(cid:98)(cid:7)(cid:20)(cid:15)(cid:24)(cid:20)(cid:25)(cid:80)(cid:30)(cid:3)(cid:21)(cid:19)(cid:20)(cid:23)(cid:29)(cid:98)(cid:7)(cid:20)(cid:15)(cid:25)(cid:23)(cid:20)(cid:80)(cid:12)(cid:17)
The fair value of fixed-rate publicly traded debt is based on year end quoted market prices; the fair value of floating rate debt is nominal value, as mark
to market differences would be minimal given the frequency of resets. The carrying value of loans designated at fair value through profit or loss is the
fair value; this falls within the Level 1 valuation method as defined in Note 11. For loans designated in a fair value hedge relationship, carrying value is
initially measured at fair value and remeasured for fair value changes in respect of the hedged risk at each reporting date. All other loans are held at
amortised cost. Fair values, as disclosed in the table above, are all determined using the Level 1 valuation method as defined in Note 11, with the
exception of overdrafts and finance leases, where fair value approximates to carrying values.
A loss of $8m was made during the year on the fair value of bonds designated at fair value through profit or loss, due to decreased credit risk. A gain
of $40m has been made on these bonds since designation due to increased credit risk. Changes in credit risk had no material effect on any other
financial assets and liabilities recognised at fair value in the Group Financial Statements. The change in fair value attributable to changes in credit risk
is calculated as the change in fair value not attributable to market risk. The amount payable at maturity on bonds designated at fair value through
profit or loss is $288m.
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The interest rates used to discount future cash flows for fair value adjustments, where applicable, are based on market swap curves at the reporting
date, and were as follows:
Loans and borrowings
2016
2015
2014
1.5% to 2.2% 1.2% to 2.1% 1.2% to 2.3%
AstraZeneca Annual Report and Form 20-F Information 2016
163
Financial Statements
18 Trade and other payables
Current liabilities
Trade payables
Value added and payroll taxes and social security
Rebates and chargebacks
Accruals
Contingent consideration
Other payables
Total
Non-current liabilities
Accruals
Contingent consideration
Other payables
Total
2016
$m
2,990
240
2,812
2,855
527
1,062
2015
$m
3,469
207
3,307
2,983
396
1,301
10,486
11,663
292
4,930
4,266
9,488
256
6,015
1,186
7,457
2014
$m
3,492
201
3,530
3,231
347
1,085
11,886
219
6,552
1,220
7,991
Non-current other payables includes $1,901m arising from the put option over the non-controlling interest in Acerta Pharma (see Note 24). The put
option liability is remeasured each period based on the latest assessment of the expected redemption amount, with remeasurements taken to
selling, general and administrative costs (see Note 2). Interest arising from amortising the liability is included within Finance expense (see Note 3).
With the exception of contingent consideration payables of $5,457m (2015: $6,411m; 2014: $6,899m) held within other payables, that arose on
business combinations (see Note 25), and which are held at fair value within Level 3 of the fair value hierarchy as defined in Note 11, all other financial
liabilities are held at amortised cost with carrying value being a reasonable approximation of fair value.
Contingent consideration
At 1 January
Additions arising on business combinations (Note 25)
Settlements
Revaluations
Discount unwind
Foreign exchange
At 31 December
2016
$m
6,411
–
(293)
(1,158)
497
–
5,457
2015
$m
6,899
–
(579)
(432)
524
(1)
6,411
2014
$m
514
6,138
(657)
512
391
1
6,899
As detailed in Note 25, contingent consideration arising from business combinations is fair valued using decision-tree analysis, with key inputs
including the probability of success, consideration of potential delays and the expected levels of future revenues.
Revaluations of contingent consideration are recognised in selling, general and administrative costs and include a decrease of $999m in 2016
(2015: a decrease of $378m; 2014: an increase of $529m) based on revised milestone probabilities, and revenue and royalty forecasts, relating
to the acquisition of BMS’s share of the Global Diabetes Alliance.
Management has identified that reasonably possible changes in certain key assumptions including the likelihood of achieving successful trial results,
obtaining regulatory approval, the projected market share of the therapeutic area and expected pricing for launched products may cause the
calculated fair value of the above contingent consideration to vary materially in future years.
The maximum development and sales milestones payable under outstanding contingent consideration arrangements arising on business
combinations are as follows:
Acquisitions
Spirogen
Amplimmune
Omthera Pharmaceuticals
Pearl Therapeutics
BMS’s share of Global Diabetes Alliance
Almirall
Definiens
Year
2013
2013
2013
2013
2014
2014
2014
Nature of
contingent consideration
Maximum future milestones
$m
Milestones
Milestones
Milestones
Milestones
Milestones and royalties
Milestones and royalties
Milestones
216
275
120
465
700
1,005
150
As detailed in Note 25, the amount of royalties payable under the arrangements is inherently uncertain and difficult to predict, given the direct link
to future sales and the range of outcomes cannot be reliably estimated. The maximum amount of royalties payable in each year is with reference to
net sales.
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19 Provisions
At 1 January 2014
Additions arising on business acquisitions
Charge for year
Cash paid
Reversals
Exchange and other movements
At 31 December 2014
Additions arising on business acquisitions
Charge for year
Cash paid
Reversals
Exchange and other movements
At 31 December 2015
Charge for year
Cash paid
Reversals
Exchange and other movements
At 31 December 2016
Due within one year
Due after more than one year
Total
Severance
$m
Environmental
$m
Employee
benefits
$m
771
39
254
(472)
(21)
(45)
526
–
338
(408)
(40)
(13)
403
578
(433)
(40)
(21)
487
87
–
15
(17)
–
(1)
84
–
8
(25)
–
–
67
11
(19)
–
–
59
152
–
8
(16)
–
19
163
–
7
(12)
–
–
158
6
(21)
–
–
143
Legal
$m
59
–
91
(71)
(4)
(1)
74
–
313
(69)
–
39
357
223
(126)
–
(16)
438
2016
$m
1,065
353
1,418
Other
provisions
$m
320
–
66
(57)
(39)
(30)
260
10
40
(43)
(12)
2
257
170
(87)
(39)
(10)
291
2015
$m
798
444
1,242
Total
$m
1,389
39
434
(633)
(64)
(58)
1,107
10
706
(557)
(52)
28
1,242
988
(686)
(79)
(47)
1,418
2014
$m
623
484
1,107
AstraZeneca is undergoing a global restructuring initiative which involves rationalisation of the global supply chain, the sales and marketing
organisation, IT and business support infrastructure, and R&D. Employee costs in connection with the initiatives are recognised in severance
provisions. Final severance costs are often subject to the completion of the requisite consultations on the areas impacted.
Details of the environmental and legal provisions are provided in Note 28.
Employee benefit provisions include the Deferred Bonus Plan. Further details are included in Note 27.
Other provisions comprise amounts relating to specific contractual or constructive obligations and disputes.
No provision has been released or applied for any purpose other than that for which it was established.
20 Post-retirement benefits
Pensions
Background
The Company and most of its subsidiaries offer retirement plans which cover the majority of employees in the Group. Many of these plans are
‘defined contribution’, where AstraZeneca’s contribution and resulting charge is fixed at a set level or is a set percentage of employees’ pay.
However, several plans, mainly in the UK, the US and Sweden, are ‘defined benefit’, where benefits are based on employees’ length of service and
linked to their salary. The major defined benefit plans, apart from the collectively bargained Swedish plan (which is still open to employees born before
1979), have been closed to new entrants since 2000. During 2010, following consultation with its UK employees’ representatives, AstraZeneca
introduced a freeze on pensionable pay at 30 June 2010 levels for defined benefit members of the UK Pension Fund.
The major defined benefit plans are funded through separate, fiduciary-administered assets. The cash funding of the plans, which may from time
to time involve special payments, is designed, in consultation with independent qualified actuaries, to ensure that the assets together with future
contributions should be sufficient to meet future obligations. The funding is monitored rigorously by AstraZeneca and appropriate fiduciaries including
with reference to AstraZeneca’s credit rating, market capitalisation, cash flows and the solvency and maturity of the relevant pension scheme.
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20 Post-retirement benefits continued
Financing principles
92% of the Company’s defined benefit obligations at 31 December 2016 are in schemes within the UK, the US and Sweden. In these countries,
the pension obligations are funded with reference to the following financing principles:
> The Company has a fundamental belief in funding the benefits it promises to employees.
> The Company considers its pension arrangements in the context of its broader capital structure. In general, it does not believe in committing
excessive capital for funding while it has better uses of capital within the business nor does it wish to generate surpluses.
> The pension funds are not part of the Company’s core business. The Company believes in taking some measured and rewarded risks with the
investments underlying the funding, subject to a long-term plan to reduce those risks when opportunities arise.
> The Company recognises that deciding to hold certain investments may cause volatility in the funding position. The Company would not wish
to amend its contribution level for relatively small deviations from its preferred funding level, because it is expected that there will be short-term
volatility, but it is prepared to react appropriately to more significant deviations.
> The Company proactively engages with local Fiduciary Bodies to provide oversight and input in relation to funding and investment strategy and
to help facilitate liability management exercises appropriate to each pension plan.
> The Company considers the use of alternative methods of providing security that do not require immediate cash funding but help mitigate
exposure of the pension arrangement to the credit risk of the Company.
These principles are appropriate to AstraZeneca’s business at the present date; should circumstances change they may require review.
AstraZeneca has developed a long-term funding framework to implement these principles, which targets full funding on a low risk funding measure
over the long term, as the pension funds mature. This framework determines the cash contributions payable to the pension funds, but does not
affect the IAS 19 liabilities.
UK
With regard to the Company’s UK defined benefit pension fund, the above principles are modified in light of the UK regulatory requirements
(summarised below) and resulting discussions with the Pension Fund Trustee.
Role of Trustees (UK)
The UK Pension Fund is governed and administered by a corporate Trustee which is legally separate from the Company. The Trustee Directors are
comprised of representatives appointed by both the employer and employees, and include an independent professional Trustee Director. The Trustee
Directors are required by law to act in the interest of all relevant beneficiaries and are responsible in particular for the asset investment policy and the
day-to-day administration of the benefits. They are also responsible for jointly agreeing with the employer the level of contributions due to the UK
Pension Fund (see below).
Funding requirements (UK)
UK legislation requires that pension schemes are funded prudently (ie to a level in excess of the current expected cost of providing benefits). On a
triennial basis, the Trustee and the Company must agree the contributions required (if any) to ensure the Fund is fully funded over time on a suitable
prudent measure. The last full actuarial valuation of the AstraZeneca Pension Fund was carried out by a qualified actuary as at 31 March 2013. An
updated actuarial valuation as at 31 March 2016 is in the process of being finalised with discussions ongoing between the Trustee and the Company.
A lump sum contribution of £51m ($72m) was made to help narrow the deficit in March 2016, with a further £51m contribution due before
31 March 2017.
The Company entered into a long-term funding agreement with the Trustee on 21 October 2016. Under this agreement, the Company will grant a
charge in favour of the Trustee over the new Cambridge Biomedical Campus, which would crystallise only in the event of the Company’s insolvency.
This charge will provide security in respect of future UK Pension Fund contributions and replaces a charge over assets in a ring-fenced custodial
account held by AstraZeneca with HSBC. Since the Trustee’s charge over this custodial account has been released, these assets are now available
for the Company to use in the business.
Under the funding assumptions used to set the statutory funding target, the key assumptions as at 31 March 2013 were as follows: long-term UK price
inflation set at 3.55% per annum, salary increases at 0% per annum (as a result of pensionable pay levels being frozen in 2010), pension increases at
3.2% per annum and investment returns at 4.86% per annum. The resulting valuation of the Fund’s liabilities on that basis were £4,887m ($5,997m)
compared to a market value of assets at 31 March 2013 of £4,394m ($5,392m).
Under the governing documentation of the UK Pension Fund, any future surplus in the Fund would be returnable to AstraZeneca by refund assuming
gradual settlement of the liabilities over the lifetime of the Fund. As such, there are no adjustments required in respect of IFRIC 14 ‘IAS 19 – The
Limit on a Defined Benefit Asset, Minimum Funding Requirements and their Interaction’.
Liability Management Exercises (UK)
During 2016, the Company conducted a Pensions Increase Exchange (‘PIE’) exercise in two stages. This exercise offers certain pensioner members
the option of taking a higher amount of pension right away, in exchange for giving up any potential future inflation linked increases on all, or part of
their pension. Stage 1 was completed in 2016. Stage 2 commenced in 2016 and is due to complete by the end of June 2017.
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20 Post-retirement benefits continued
Regulation (UK)
The UK pensions market is regulated by the Pensions Regulator whose statutory objectives and regulatory powers are described on its website,
www.thepensionsregulator.gov.uk.
Rest of Group
The IAS 19 positions for the US and Sweden as at 31 December 2016 are shown below. These plans account for 29% of the Group’s defined benefit
obligations. The US and Sweden pension funds are governed by fiduciary bodies with responsibility for the investment policies of those funds. These
plans are funded in line with the Company’s financing principles and contributions are paid as prescribed by the long-term funding framework.
> The US defined benefits programme was actuarially revalued at 31 December 2016, when plan obligations were $1,795m and plan assets were
$1,563m. This includes obligations in respect of the non-qualified plan which is largely unfunded.
> The Swedish defined benefits programme was actuarially revalued at 31 December 2016, when plan obligations were estimated to amount to
$1,521m and plan assets were $1,009m.
On current bases, it is expected that contributions (excluding those in respect of past service deficit contributions) during the year ending 31 December
2017 for the three main countries will be approximately $55m.
Post-retirement benefits other than pensions
In the US, and to a lesser extent in certain other countries, AstraZeneca’s employment practices include the provision of healthcare and life assurance
benefits for retired employees. As at 31 December 2016, some 3,283 retired employees and covered dependants currently benefit from these
provisions and some 10,381 current employees will be eligible on their retirement. AstraZeneca accrues for the present value of such retiree
obligations over the working life of the employee. In practice, these benefits will be funded with reference to the financing principles.
The cost of post-retirement benefits other than pensions for the Group in 2016 was $17m (2015: $23m; 2014: $20m). Plan assets were $285m and
plan obligations were $309m at 31 December 2016. These benefit plans have been included in the disclosure of post-retirement benefits under IAS 19.
Financial assumptions
Qualified independent actuaries have updated the actuarial valuations under IAS 19 of the major defined benefit schemes operated by the Group to
31 December 2016. The assumptions used by the actuaries are chosen from a range of possible actuarial assumptions which, due to the long-term
nature of the schemes, may not necessarily be borne out in practice. These assumptions were as follows:
Inflation assumption
Rate of increase in salaries
Rate of increase in pensions in payment
Discount rate
1 (cid:51)(cid:72)(cid:81)(cid:86)(cid:76)(cid:82)(cid:81)(cid:68)(cid:69)(cid:79)(cid:72)(cid:3)(cid:83)(cid:68)(cid:92)(cid:3)(cid:73)(cid:85)(cid:82)(cid:93)(cid:72)(cid:81)(cid:3)(cid:68)(cid:87)(cid:3)(cid:22)(cid:19)(cid:3)(cid:45)(cid:88)(cid:81)(cid:72)(cid:3)(cid:21)(cid:19)(cid:20)(cid:19)(cid:3)(cid:79)(cid:72)(cid:89)(cid:72)(cid:79)(cid:86)(cid:3)(cid:73)(cid:82)(cid:79)(cid:79)(cid:82)(cid:90)(cid:76)(cid:81)(cid:74)(cid:3)(cid:56)(cid:46)(cid:3)(cid:73)(cid:88)(cid:81)(cid:71)(cid:3)(cid:70)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:86)(cid:17)
2016
2015
UK
Rest of Group
UK
Rest of Group
3.2%
–1
3.0%
2.7%
2.1%
3.1%
0.9%
3.3%
3.0%
–1
3.0%
3.8%
2.1%
3.0%
0.8%
3.8%
Discount rate and methodology changes
Over 2016, the Company’s discount rates were based on yields on long-term AA-rated fixed income instruments, using a single discount rate for each
pension plan to value the defined benefit obligations, service cost and interest cost. The discount rate was based on the duration of cash flows
underlying the defined benefit obligations. From 2017, for the largest plans, the Company will move to a multiple discount rate approach. This will
result in separate discount rates for defined benefit obligations, service cost and interest cost. This change had no effect on the 2016 expense, and
will not affect the future measurement of the defined benefit obligations, but will impact the service cost and interest cost in future years.
Demographic assumptions
The mortality assumptions are based on country-specific mortality tables. These are compared to actual AstraZeneca experience and adjusted
where sufficient data is available. Additional allowance for future improvements in life expectancy is included for all major schemes where there is
credible data to support this continuing trend.
The table below illustrates life expectancy assumptions at age 65 for male members retiring in 2016 and members expected to retire in 2036
(2015: 2015 and 2035 respectively).
Country
UK
US
Sweden
Life expectancy assumption for a male member retiring at age 65
2016
23.3
22.4
21.8
2036
24.6
23.9
23.6
2015
23.2
22.9
20.5
2035
24.5
24.4
22.4
The Company adopted the CMI 2015 Mortality Projections Model with a 1% long-term improvement rate in 2015.
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20 Post-retirement benefits continued
Risks associated with the Company’s defined benefit pensions
The UK defined benefit plan accounts for 63% of the Group’s defined benefit obligations and exposes the Company to a number of risks, the most
significant of which are:
Risk
Description
Mitigation
Volatile asset
returns
The Defined Benefit Obligation (DBO) is calculated using
a discount rate set with reference to AA-rated corporate
bond yields; asset returns that differ from the discount rate
will create an element of volatility in the solvency ratio.
The UK Pension Fund holds a significant proportion (around
72.5%) in growth assets. Although these growth assets are
expected to outperform corporate bonds in the long term,
they can lead to volatility and mismatching risk in the short
term. The allocation to growth assets is monitored to ensure
it remains appropriate given the UK Pension Fund’s
long-term objectives.
In order to mitigate investment risk, changes to investment
strategy, including to the portfolio of growth assets, were
completed during 2016 to establish a suitably diversified range
of asset classes, return drivers and investment managers.
The investment strategy will continue to evolve to further
improve the expected risk/return profile as opportunities arise.
The Trustee has hedged the vast majority (over 90%) of
unintended non-sterling, overseas currency risk within the
UK Pension Fund assets.
Changes in
bond yields
A decrease in corporate bond yields will increase the
present value placed on the DBO for accounting purposes.
Inflation risk
A significant proportion of the DBO is indexed in line with
price inflation (specifically inflation in the UK Retail Price
Index) and higher inflation will lead to higher liabilities
(although, in most cases, this is capped at an annual
increase of 5%).
Life expectancy
The majority of the UK Pension Fund’s obligations are to
provide benefits for the life of the member, so increases in
life expectancy will result in an increase in the liabilities.
The interest rate hedge of the UK Pension Fund significantly
increased in 2016 via additional investments in gilts and interest
rate derivatives. The hedge is set at 75% of total assets and
protects to some degree against falling interest rates
(approximately 55% hedged at the end of 2015).
Note that there are some differences in the bonds and
instruments held by the UK Pension Fund to hedge interest
rate risk on the statutory and long-term funding basis (gilts)
and the bonds analysed to set the DBO discount rate on
an accounting basis (AA corporate bonds). As such, there
remains some mismatching risk on an accounting basis
should yields on gilts and swaps diverge compared to
corporate bonds (ie the ‘credit spread’ between gilts and
corporate bonds narrows). The UK Pension Fund retains
some exposure to corporate bonds to help mitigate this risk.
The UK Pension Fund holds index-linked gilts and derivative
instruments such as swaps, which provide a hedge against
higher-than-expected inflation increases on the DBO.
The inflation hedge of the UK Pension Fund significantly
increased in 2016 via additional investments in such assets,
so that overall, the hedge is approximately 75% as a proportion
of total assets (approximately 60% hedged at the end of 2015).
The PIE exercise will further reduce the inflation sensitivity of the
liabilities and mitigate this risk.
The UK Pension Fund entered into a longevity swap during
2013 which provides hedging against the longevity risk of
increasing life expectancy over the next 77 years for around
10,000 of the UK Pension Fund’s current pensioners and covers
$2.4bn of the UK Pension Fund’s liabilities. A one-year increase
in life expectancy will result in a $200m increase in pension
fund assets.
Other risks
There are a number of other risks of running the UK Pension Fund including operational risks (such as paying out the wrong benefits) and legislative
risks (such as the government increasing the burden on pension funds through new legislation). These are mitigated in so far as possible via the
governance structure in place which oversees and administers the pension funds.
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20 Post-retirement benefits continued
Post-retirement scheme deficit
The assets and obligations of the defined benefit schemes operated by the Company at 31 December 2016, as calculated in accordance with
IAS 19, are shown below. The fair values of the schemes’ assets are not intended to be realised in the short term and may be subject to significant
change before they are realised. The present value of the schemes’ obligations is derived from cash flow projections over long periods and is
therefore inherently uncertain.
Scheme assets
Equity: Global (exc Emerging markets)
Equity: Emerging markets
Government bonds: Global (exc Emerging markets)
Government bonds: Emerging markets
Investment grade corporate bonds (AAA-BBB):
Global (exc Emerging markets)
Investment grade corporate bonds (AAA-BBB): Emerging markets
Other corporate bonds: Global (exc Emerging markets)
Other corporate bonds: Emerging markets
Derivatives: Interest rate contracts
Derivatives: Inflation rate contracts
Derivatives: Foreign exchange contracts
Derivatives: Other
Derivatives: Longevity swap
Investment funds: Private equity funds (no quoted market price)
Investment funds: Hedge funds
Investment funds: Other
Cash and cash equivalents
Others
Total fair value of scheme assets1
Scheme obligations
Present value of scheme obligations in respect of:
Active membership
Deferred membership
Pensioners
Total value of scheme obligations
Deficit in the scheme as recognised in the
Consolidated Statement of Financial Position
1 (cid:44)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:86)(cid:70)(cid:75)(cid:72)(cid:80)(cid:72)(cid:3)(cid:68)(cid:86)(cid:86)(cid:72)(cid:87)(cid:86)(cid:3)(cid:76)(cid:86)(cid:3)(cid:7)(cid:81)(cid:76)(cid:79)(cid:3)(cid:11)(cid:21)(cid:19)(cid:20)(cid:24)(cid:29)(cid:98)(cid:7)(cid:81)(cid:76)(cid:79)(cid:12)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:38)(cid:82)(cid:80)(cid:83)(cid:68)(cid:81)(cid:92)(cid:350)(cid:86)(cid:3)(cid:82)(cid:90)(cid:81)(cid:3)(cid:68)(cid:86)(cid:86)(cid:72)(cid:87)(cid:86)(cid:17)
Fair value of scheme assets
At beginning of year
Interest income on scheme assets
Expenses
Actuarial gains/(losses)
Exchange adjustments
Employer contributions
Participant contributions
Settlements
Benefits paid
Scheme assets’ fair value at end of year
UK
$m
Rest of Group
$m
704
158
1,624
–
83
9
222
114
(43)
(63)
32
(7)
(43)
–
1,133
1,751
211
252
6,137
(679)
(1,806)
(4,633)
(7,118)
769
–
124
2
951
–
112
2
(4)
(13)
3
–
–
1
360
287
141
244
2,979
(1,590)
(1,046)
(1,548)
(4,184)
2016
Total
$m
1,473
158
1,748
2
1,034
9
334
116
(47)
(76)
35
(7)
(43)
1
1,493
2,038
352
496
9,116
UK
$m
Rest of Group
$m
1,362
140
1,614
3
2,273
30
61
23
(111)
(92)
(84)
(140)
(37)
–
531
390
436
68
770
1
421
59
940
–
6
2
(32)
9
3
–
–
–
154
373
159
89
2015
Total
$m
2,132
141
2,035
62
3,213
30
67
25
(143)
(83)
(81)
(140)
(37)
–
685
763
595
157
6,467
2,954
9,421
(2,269)
(2,852)
(6,181)
(11,302)
(1,094)
(1,862)
(4,495)
(7,451)
(1,420)
(986)
(1,538)
(3,944)
(2,514)
(2,848)
(6,033)
(11,395)
(981)
(1,205)
(2,186)
(984)
(990)
(1,974)
UK
$m
Rest of Group
$m
6,467
221
(5)
858
(1,228)
130
4
–
(310)
6,137
2,954
104
(9)
84
(26)
62
–
–
(190)
2,979
2016
Total
$m
9,421
325
(14)
942
(1,254)
192
4
–
(500)
9,116
UK
$m
7,311
257
(5)
(375)
(311)
360
5
(447)
(328)
6,467
Rest of Group
$m
3,235
100
(10)
(64)
(97)
42
–
–
(252)
2,954
2015
Total
$m
10,546
357
(15)
(439)
(408)
402
5
(447)
(580)
9,421
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The actual return on the plan assets was a gain of $1,267m (2015: loss of $82m).
AstraZeneca Annual Report and Form 20-F Information 2016
169
Financial Statements
20 Post-retirement benefits continued
Movement in post-retirement scheme obligations
Present value of obligations in scheme at beginning of year
(7,451)
(3,944)
UK
$m
Rest of Group
$m
Current service cost
Past service credit/(cost)
Participant contributions
Benefits paid
Interest expense on post-retirement scheme obligations
Actuarial (losses)/gains
Settlements
Exchange adjustments
Present value of obligations in scheme at end of year
The obligations arise from the following plans:
(20)
27
(4)
310
(253)
(1,189)
–
1,462
(7,118)
(82)
15
(4)
190
(135)
(328)
–
104
(4,184)
UK
$m
Rest of Group
$m
2016
Total
$m
(11,395)
(102)
42
(8)
500
(388)
(1,517)
–
1,566
(11,302)
2016
Total
$m
UK
$m
Rest of Group
$m
(8,842)
(34)
(44)
(5)
328
(301)
613
447
387
(4,655)
(105)
16
–
252
(133)
478
–
203
2015
Total
$m
(13,497)
(139)
(28)
(5)
580
(434)
1,091
447
590
(7,451)
(3,944)
(11,395)
UK
$m
Rest of Group
$m
2015
Total
$m
Funded – pension schemes
Funded – post-retirement healthcare
Unfunded – pension schemes
Unfunded – post-retirement healthcare
Total
(7,101)
(3,309)
(10,410)
(7,429)
(3,142)
(10,571)
–
–
(17)
(7,118)
(279)
(583)
(13)
(279)
(583)
(30)
(4,184)
(11,302)
–
–
(22)
(7,451)
(281)
(506)
(15)
(281)
(506)
(37)
(3,944)
(11,395)
The weighted average duration of the post-retirement scheme obligations in the UK is 18 years and 15 years in the Rest of Group.
Consolidated Statement of Comprehensive Income disclosures
The amounts that have been charged to the Consolidated Statement of Comprehensive Income, in respect of defined benefit schemes for the year
ended 31 December 2016, are set out below.
Operating profit
Current service cost
Past service credit/(cost)
Expenses
Total charge to operating profit
Finance expense
Interest income on scheme assets
Interest expense on post-retirement scheme obligations
Net interest on post-employment
defined benefit plan liabilities
Charge before taxation
Other comprehensive income
Difference between the actual return and the
expected return on the post-retirement scheme assets
Experience gains/(losses) arising on the
post-retirement scheme obligations
Changes in financial assumptions underlying the
present value of the post-retirement scheme obligations
Changes in demographic assumptions
Remeasurement of the defined benefit liability
UK
$m
Rest of Group
$m
(20)
27
(5)
2
221
(253)
(32)
(30)
858
220
(1,409)
–
(331)
(82)
15
(9)
(76)
104
(135)
(31)
(107)
84
(6)
(377)
55
(244)
2016
Total
$m
(102)
42
(14)
(74)
325
(388)
(63)
(137)
942
214
(1,786)
55
(575)
UK
$m
(34)
(44)
(5)
(83)
257
(301)
(44)
(127)
(375)
3
370
240
238
Rest of Group
$m
(105)
16
(10)
(99)
100
(133)
(33)
(132)
(64)
56
386
36
414
2015
Total
$m
(139)
(28)
(15)
(182)
357
(434)
(77)
(259)
(439)
59
756
276
652
Past service credit in 2016 includes a credit to operating income of £54m ($74m) arising from the PIE exercise in the UK, as referred to in the Liability
Management Exercises section on page 166, and a credit to operating income of $16m arising from a restructuring programme in the US which will
involuntarily terminate certain targeted participants in the Defined Benefit Pension Plan, AZ Supplemental Plan and the VEBA Retiree Health Plan.
The past service credit in 2016 has been partially offset by costs predominantly related to enhanced pensions in early retirement in the UK and Sweden.
Group costs in respect of defined contribution schemes during the year were $352m (2015: $302m).
2015 settlements included $447m relating to the removal of the Investment Account (defined contribution) section of the UK Pension Fund from both
the UK assets and liabilities with a net impact of $nil on the overall deficit.
170
AstraZeneca Annual Report and Form 20-F Information 2016
20 Post-retirement benefits continued
Rate sensitivities
The following table shows the US dollar effect of a change in the significant actuarial assumptions used to determine the retirement benefits obligations
in our three main defined benefit pension obligation countries.
Discount rate
UK ($m)
US ($m)
Sweden ($m)
Total ($m)
Inflation rate1
UK ($m)
US ($m)
Sweden ($m)
Total ($m)
Rate of increase in salaries
UK ($m)
US ($m)
Sweden ($m)
Total ($m)
Mortality rate
UK ($m)
US ($m)
Sweden ($m)
Total ($m)
+0.5%
546
107
128
781
+0.5%
(510)
(12)
(147)
(669)
+0.5%
–
(9)
(33)
(42)
+1 year
(300)2
(27)
(57)
(384)
2016
-0.5%
(712)
(114)
(149)
(975)
2016
-0.5%
486
12
127
625
2016
-0.5%
–
9
30
39
2016
-1 year
2923
28
57
377
+0.5%
530
111
143
784
+0.5%
(525)
(14)
(159)
(698)
+0.5%
–
(12)
(66)
(78)
+1 year
(313)
(24)
(63)
(400)
2015
-0.5%
(600)
(118)
(164)
(882)
2015
-0.5%
517
15
140
672
2015
-0.5%
–
12
58
70
2015
-1 year
314
25
62
401
1 Rate of increase in pensions in payment follows inflation.
2 Of the $300m increase, $200m is covered by the longevity swap.
3 Of the $292m decrease, $196m is covered by the longevity swap.
The sensitivity to the financial assumptions shown above has been estimated taking into account the approximate duration of the liabilities and the
overall profile of the plan membership. The sensitivity to the life expectancy assumption has been estimated based on the distribution of the plan
cash flows.
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a
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t
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AstraZeneca Annual Report and Form 20-F Information 2016
171
Financial Statements
21 Reserves
Retained earnings
The cumulative amount of goodwill written off directly to reserves resulting from acquisitions, net of disposals, amounted to $613m (2015: $624m;
2014: $639m) using year end rates of exchange. At 31 December 2016, 276,303 shares, at a cost of $19m, have been deducted from retained
earnings (2015: 49,105 shares, at a cost of $4m; 2014: 168,388 shares, at a cost of $10m).
There are no significant statutory or contractual restrictions on the distribution of current profits of subsidiaries; undistributed profits of prior years
are, in the main, permanently employed in the businesses of these companies. The undistributed income of AstraZeneca companies overseas
might be liable to overseas taxes and/or UK taxation (after allowing for double taxation relief) if they were to be distributed as dividends (see Note 4).
Cumulative translation differences included within retained earnings
At 1 January
Foreign exchange arising on consolidation
Exchange adjustments on goodwill (recorded against other reserves)
Foreign exchange arising on designating borrowings in net investment hedges
Fair value movement on derivatives designated in net investment hedges
Net exchange movement in retained earnings
At 31 December
2016
$m
(372)
(1,050)
(11)
(591)
(4)
(1,656)
(2,028)
2015
$m
490
(528)
(15)
(333)
14
(862)
(372)
2014
$m
1,782
(823)
(40)
(529)
100
(1,292)
490
Cumulative amounts with respect to cash flow hedges included within retained earnings are $80m (2015: $nil; 2014: $nil).
Other reserves
The other reserves arose from the cancellation of £1,255m of share premium account by the Company in 1993 and the redenomination of share
capital ($157m) in 1999. The reserves are available for writing off goodwill arising on consolidation and, subject to guarantees given to preserve
creditors at the date of the court order, are available for distribution.
22 Share capital of the Company
Issued Ordinary Shares ($0.25 each)
Redeemable Preference Shares (£1 each – £50,000)
At 31 December
Allotted, called-up and fully paid
2016
$m
316
–
316
2015
$m
316
–
316
2014
$m
316
–
316
The Redeemable Preference Shares carry limited class voting rights and no dividend rights. This class of shares is capable of redemption at par at
the option of the Company on the giving of seven days’ written notice to the registered holder of the shares.
The movements in the number of Ordinary Shares during the year can be summarised as follows:
At 1 January
Issues of shares (share schemes)
At 31 December
No. of shares
2016
2015
2014
1,264,122,670
1,263,143,338
1,257,170,087
1,106,754
979,332
5,973,251
1,265,229,424
1,264,122,670
1,263,143,338
Details of Directors’ interests in shares are shown in the Directors’ Remuneration Report from page 103.
Share repurchases
No Ordinary Shares were repurchased by the Company in 2016 (2015: nil; 2014: nil).
Shares held by subsidiaries
No shares in the Company were held by subsidiaries in any year.
23 Dividends to shareholders
Final
Interim
Total
2016
Per share
$1.90
$0.90
$2.80
2015
Per share
$1.90
$0.90
$2.80
2014
Per share
$1.90
$0.90
$2.80
2016
$m
2,402
1,138
3,540
2015
$m
2,400
1,137
3,537
2014
$m
2,395
1,137
3,532
The second interim dividend, to be confirmed as final, is $1.90 per Ordinary Share and $2,404m in total. This will be payable on 20 March 2017.
On payment of the dividends, exchange losses of $3m (2015: $nil; 2014: losses of $3m) arose. These exchange losses are included in Note 3.
172
AstraZeneca Annual Report and Form 20-F Information 2016
24 Non-controlling interests
Following the acquisition of a majority stake in Acerta Pharma on 2 February 2016, the Group Financial Statements at 31 December 2016 reflect
equity of $1,808m and total comprehensive income of $95m attributable to the non-controlling interests, held by other parties, of Acerta Pharma
B.V. and its subsidiaries. The following summarised financial information, for Acerta Pharma B.V. and its subsidiaries, is presented on a stand-alone
basis since the acquisition date, and before the impact of Group-related adjustments:
Total Revenue
Loss after tax
Other comprehensive income
Total comprehensive income
Non-current assets
Current assets
Total assets
Current liabilities
Total liabilities
Net liabilities
Net cash outflow from operating activities
Net cash inflow from investing activities
Decrease in cash and cash equivalents in the year
2016
$m
–
(212)
–
(212)
2016
$m
73
79
152
(171)
(171)
(19)
2016
$m
(223)
139
(84)
The non-controlling interest in Acerta Pharma is subject to a put option, exercisable by the minority shareholders at certain points in the future, not
earlier than the commercial launch of acalabrutinib. This put option gives rise to a liability which is recorded at the present value of the expected
redemption amount, calculated using a simulation model based on forecast revenue and earnings of Acerta Pharma, and is recorded within
Non-current other payables (see Note 18). The corresponding debit has been recorded in retained earnings.
25 Acquisitions of business operations
2016 Acquisitions
Acerta Pharma
On 2 February 2016, AstraZeneca completed an agreement to invest in a majority equity stake in Acerta Pharma, a privately-owned biopharmaceutical
company based in the Netherlands and US. The transaction provides AstraZeneca with a potential best-in-class irreversible oral Bruton’s tyrosine
kinase (BTK) inhibitor, acalabrutinib (ACP-196), currently in Phase III development for B-cell blood cancers and in Phase I/II clinical trials in multiple
solid tumours. Acerta Pharma has approximately 150 employees.
Under the terms of the agreement, AstraZeneca has acquired 55% of the issued share capital of Acerta Pharma for an upfront payment of $2.5bn.
A further payment of $1.5bn will be paid either on receipt of the first regulatory approval for acalabrutinib for any indication in the US, or the end of
2018, depending on which is first. The agreement also includes options which, if exercised, provide the opportunity for Acerta Pharma’s shareholders
to sell, and AstraZeneca to buy, the remaining 45% of shares in Acerta Pharma. The options can be exercised at various points in time, conditional
on the first approval of acalabrutinib in both the US and Europe and when the extent of the commercial opportunity has been fully established, at a
price of approximately $3bn net of certain costs and payments incurred by AstraZeneca and net of agreed future adjusting items, using a pre-agreed
pricing mechanism.
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i
a
l
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t
a
t
e
m
e
n
t
s
The acquiring entity within the Group was a Swedish krona functional currency subsidiary. Foreign currency risk arises from the retranslation of the
US dollar denominated liabilities arising from the transaction. To manage this foreign currency risk these liabilities have been designated as the
hedge instrument in a net investment hedge of the Group’s underlying US dollar net investments. Exchange differences on the retranslation of the
contingent consideration liability are recognised in other comprehensive income to the extent that the hedge is effective. Any ineffectiveness is
taken to profit.
AstraZeneca’s 55% holding is a controlling interest and Acerta Pharma’s combination of intangible product rights with an established workforce and
their operating processes requires that the transaction is accounted for as a business combination in accordance with IFRS 3.
Goodwill is principally attributable to the value of the specialist know-how inherent in the acquired workforce and the accounting for deferred taxes.
Goodwill is not expected to be deductible for tax purposes.
Acerta Pharma’s results have been consolidated into the Group’s results from 2 February 2016. From the period from acquisition to 31 December
2016, Acerta Pharma had no revenues and its loss after tax was $212m.
If the acquisition had taken effect at the beginning of the reporting period in which the acquisition occurred (1 January 2016), on a pro forma basis,
the revenue of the combined Group for 2016 would have been unchanged and the profit after tax would have been $3,367m. This pro forma
information does not purport to represent the results of the combined Group that actually would have occurred had the acquisition taken place
on 1 January 2016 and should not be taken to be representative of future results.
AstraZeneca Annual Report and Form 20-F Information 2016
173
Financial Statements
25 Acquisitions of business operations continued
The fair values assigned to the Acerta Pharma business combination completed in 2016 were:
Non-current assets
Intangible assets (Note 9)
Current assets
Current liabilities
Non-current liabilities
Deferred tax liabilities
Total net assets acquired
Non-controlling interests
Goodwill (Note 8)
Fair value of total consideration
Less: fair value of deferred consideration
Total upfront consideration
Less: cash and cash equivalents acquired
Net cash outflow
Acquisition costs were immaterial.
Fair value
$m
7,307
253
(90)
(1,777)
5,693
(1,903)
19
3,809
(1,332)
2,477
(94)
2,383
2015 Acquisitions
ZS Pharma
On 17 December 2015, AstraZeneca completed the acquisition of ZS Pharma, a biopharmaceutical company based in San Mateo, California.
ZS Pharma uses its proprietary ion-trap technology to develop novel treatments for hyperkalaemia, a serious condition of elevated potassium in
the bloodstream, typically associated with chronic kidney disease (CKD) and chronic heart failure (CHF).
The acquisition gives AstraZeneca access to the potassium-binding compound ZS-9, a potential best-in-class treatment for hyperkalaemia.
ZS Pharma represents a strong fit with AstraZeneca’s pipeline and portfolio in Cardiovascular & Metabolic Disease, one of the Company’s three
main therapy areas. AstraZeneca’s strategy focuses on reducing morbidity, mortality and organ damage by addressing multiple risk factors across
cardiovascular disease, diabetes and chronic kidney disease. ZS-9 complements the Company’s increasing focus on CKD and CHF, including the
investigational medicine roxadustat, which is currently in Phase III development for patients with anaemia associated with CKD, as well as its leading
Diabetes portfolio.
Under the terms of the agreement, AstraZeneca acquired 100% of the share capital of ZS Pharma for $90 per share in an all-cash transaction,
or approximately $2.7bn in aggregate transaction value.
ZS Pharma has around 200 employees across three sites in California, Texas and Colorado. The combination of intangible product rights with
an established workforce and their associated operating processes, principally those related to research and development and manufacturing,
requires that the transaction is accounted for as a business combination in accordance with IFRS 3.
Goodwill is principally attributable to the commercial synergies AstraZeneca expects to be able to realise upon launch of ZS-9, the value of the
specialist know-how inherent in the acquired workforce and the accounting for deferred taxes. Goodwill is not expected to be deductible for
tax purposes.
ZS Pharma’s results have been consolidated into the Group’s results from 17 December 2015. From the period from acquisition to 31 December
2015, ZS Pharma’s revenues and loss were immaterial.
If the acquisition had taken effect at the beginning of the reporting period in which the acquisition occurred (1 January 2015), on a pro forma basis,
the revenue of the combined Group for 2015 would have been unchanged and the profit after tax would have been $2,702m. This pro forma
information does not purport to represent the results of the combined Group that actually would have occurred had the acquisition taken place on
1 January 2015 and should not be taken to be representative of future results.
Given the proximity of the completion of the transaction to the date the 2015 Financial Statements were approved, the finalisation of the accounting
entries for this transaction was not complete. Our provisional assessment of the fair values of the assets and liabilities acquired, as detailed in the
2015 Financial Statements, was revised during 2016 as a result of new information obtained about facts and circumstances that existed at the date
of acquisition that impact the value of deferred tax. This has resulted in a reduction to both deferred tax liabilities and goodwill of $68m.
174
AstraZeneca Annual Report and Form 20-F Information 2016
25 Acquisitions of business operations continued
The final fair values assigned to the ZS Pharma business combination are detailed below:
Non-current assets
Intangible assets (Note 9)
Property, plant and equipment (Note 7)
Current assets
Current liabilities
Non-current liabilities
Deferred tax liabilities
Other liabilities
Total net assets acquired
Goodwill (Note 8)
Total upfront consideration
Less: cash and cash equivalents acquired
Less: upfront consideration settled in January 2016
Net cash outflow
Acquisition costs were immaterial.
Fair value
$m
3,162
21
3,183
169
(50)
(977)
(13)
(990)
2,312
388
2,700
(73)
(181)
2,446
2014 Acquisitions
BMS’s share of Global Diabetes Alliance Assets
On 1 February 2014, AstraZeneca completed the acquisition of BMS’s interests in the companies’ diabetes alliance. The acquisition provided
AstraZeneca with 100% ownership of the intellectual property and global rights for the development, manufacture and commercialisation of the
diabetes business, including Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin HCl extended release), Komboglyze (saxagliptin and
metformin HCl), Farxiga (dapagliflozin, marketed as Forxiga outside the US), Byetta (exenatide), Bydureon (exenatide extended release for injectable
suspension), Myalept (metreleptin) and Symlin (pramlintide acetate).
The transaction consolidated worldwide ownership of the diabetes business within AstraZeneca, leveraging its primary and specialty care capabilities
and its geographical reach, especially in emerging markets. The transaction included the acquisition of 100% of the share capital of Amylin
Pharmaceuticals, LLC, and the asset purchase of the additional intellectual property and global rights not already owned by AstraZeneca, for the
development, manufacture and commercialisation of Onglyza, Kombiglyze XR, Komboglyze and Farxiga, including associated BMS employees.
This combination of intangible product rights and manufacturing assets with an established workforce and their associated operating processes,
principally those related to the global manufacturing and selling and marketing operations, required that the acquisition be accounted for as a
business combination in accordance with IFRS 3.
Upfront consideration for the acquisition of $2.7bn was paid on 1 February 2014, with further payments of up to $1.4bn being payable for future
regulatory, launch and sales-related milestones as well as various sales-related royalty payments up until 2025. The amount of royalties payable
under the agreement is inherently uncertain and difficult to predict, given the direct link to future sales and the range of outcomes cannot be reliably
estimated. The maximum amount payable in each year is with reference to net sales. AstraZeneca also agreed to make payments up to $225m
when certain additional assets are transferred. Contingent consideration was fair valued using decision-tree analysis, with key inputs including the
probability of success, consideration of potential delays and the expected levels of future revenues. In accordance with IFRS 3, the fair value of
contingent consideration, including future royalties, was recognised immediately as a liability.
The acquiring entity within the Group was a Swedish krona functional currency subsidiary. Foreign currency risk arises from the retranslation of the
US dollar denominated contingent consideration. To manage this foreign currency risk the contingent consideration liability has been designated as
the hedge instrument in a net investment hedge of the Group’s underlying US dollar net investments. Exchange differences on the retranslation of
the contingent consideration liability are recognised in other comprehensive income to the extent that the hedge is effective. Any ineffectiveness is
taken to profit.
In addition to the acquired interests, AstraZeneca entered into certain agreements with BMS to maintain the manufacturing and supply chain of
the full portfolio of diabetes products and to deliver specified clinical trials with an agreed number of R&D and manufacturing employees dedicated
to diabetes remaining with BMS to progress the diabetes portfolio and support the transition for these areas. Payments by AstraZeneca to BMS
in relation to these arrangements are expensed as incurred. No amounts were recognised in the initial acquisition accounting in relation to these
arrangements but were separated, at fair value, from the business combination accounting.
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The terms of the agreement partially reflected settlement of the launch and sales-related milestones under the pre-existing Onglyza and Farxiga
collaboration agreements, which were terminated in relation to the acquisition. The expected value of those pre-existing milestones was $0.3bn
and was recognised as a separate component of consideration and excluded from the business combination accounting. Subsequently, these
separate intangible assets have been recognised.
Goodwill of $1,530m arising on the transaction is underpinned by a number of elements, which individually cannot be quantified. Most significant
among these are the synergies AstraZeneca expects to be able to generate through more efficient manufacturing processes and the incremental
value accessible through strategic and operational independence upon taking full control of the alliance. Goodwill of $1.5bn is expected to be
deductible for tax purposes.
AstraZeneca Annual Report and Form 20-F Information 2016
175
Financial Statements
25 Acquisitions of business operations continued
The fair value of receivables acquired as part of the acquisition approximated the gross contractual amounts receivable. There were no significant
amounts which were not expected to be collected.
The results from the additional acquired interests in the diabetes alliance were consolidated into the Group’s results from 1 February 2014, which
added revenue of $895m in the period to 31 December 2014. Due to the highly integrated nature of the diabetes alliance, and the fact that it is not
operated through a separate legal entity, the incremental direct costs associated with the additional acquired interest are not separately identifiable
and it is impracticable therefore to disclose the profit or loss recognised in the period since acquisition.
If the acquisition had taken effect at the beginning of the reporting period in which the acquisition occurred (1 January 2014), on a pro forma basis,
the revenue of the combined Group for 2014 would have been $26,174m. As detailed above, it is impracticable to disclose a pro forma profit after
tax. This pro forma information does not purport to represent the results of the combined Group that actually would have occurred had the
acquisition taken place on 1 January 2014 and should not be taken to be representative of future results.
Almirall
On 31 October 2014, the Group completed the agreement with Almirall to transfer the rights to Almirall’s respiratory franchise to AstraZeneca.
The transaction provided AstraZeneca with 100% of the rights for the development and commercialisation of Almirall’s existing proprietary respiratory
business, including rights to revenues from Almirall’s existing collaborations, as well as its pipeline of investigational novel therapies. The franchise
includes Eklira (aclidinium); Duaklir Genuair, the combination of aclidinium with formoterol which had been filed for registration in the EU and developed
in the US (EU approval received in November 2014); LAS100977 (abediterol), a once-daily long-acting beta2-agonist (LABA) in Phase II; an M3
antagonist beta2-agonist (MABA) platform in pre-clinical development (LAS191351, LAS194871) and Phase I (LAS190792); and multiple pre-clinical
programmes. Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, also transferred to AstraZeneca.
In addition, Almirall employees dedicated to the respiratory business, including Almirall Sofotec employees, transferred to AstraZeneca.
Upfront consideration for the acquisition of $878m was paid in November 2014, with further payments of up to $1.22bn being payable for future
development, launch, and sales-related milestones. AstraZeneca also agreed to make various sales-related royalty payments. The amount of royalties
payable under the agreement is inherently uncertain and difficult to predict, given the direct link to future sales and the range of outcomes cannot be
reliably estimated. The maximum amount payable in each year is with reference to net sales. Contingent consideration was fair valued using decision-
tree analysis, with key inputs including the probability of success, consideration of potential delays and the expected levels of future revenues.
The acquiring entity within the Group was a pounds sterling functional currency subsidiary. Foreign currency risk arises from the retranslation of the
contingent consideration. To manage this foreign currency risk the contingent consideration liability has been designated as the hedge instrument
in a net investment hedge. Exchange differences on the retranslation of the contingent consideration liability are recognised in other comprehensive
income to the extent that the hedge is effective. Any ineffectiveness is taken to profit.
Almirall’s pipeline of novel respiratory assets and its device capabilities further strengthen AstraZeneca’s Respiratory portfolio, which includes
Symbicort and Pulmicort, as well as the investigational medicines in development. The addition of aclidinium and the combination of aclidinium
with formoterol, both in proprietary Genuair device, allows AstraZeneca to offer patients a choice between dry powder inhaler and metered-dose
inhaler devices across a range of molecules and combinations.
The combination of intangible product rights with an established workforce and their associated operating processes, principally those related to
the selling and marketing operations, requires that the transaction is accounted for as a business combination in accordance with IFRS 3.
Goodwill of $311m is underpinned by a number of elements, which individually cannot be quantified. Most significant among these is the premium
attributable to the significant competitive advantage associated with AstraZeneca’s complementary portfolio and that attributable to a highly skilled
workforce. Goodwill of $0.3bn is expected to be deductible for tax purposes.
Almirall’s respiratory franchise results were consolidated into the Group’s results from 31 October 2014. For the period from acquisition to
31 December 2014, Almirall’s respiratory franchise revenues were $13m. Due to the highly integrated nature of the respiratory franchise, and the
fact that it is not operated through a separate legal entity, the incremental direct costs associated with the acquired interest are not separately
identifiable and it is impracticable therefore to disclose the profit or loss recognised in the period since acquisition.
If the acquisition had taken effect at the beginning of the reporting period in which the acquisition occurred (1 January 2014), on a pro forma basis,
the revenue of the combined Group for 2014 would have been $26,198m. As detailed above, it is impracticable to disclose a pro forma profit after
tax. This pro forma information does not purport to represent the results of the combined Group that actually would have occurred had the
acquisition taken place on 1 January 2014 and should not be taken to be representative of future results.
Definiens
On 25 November 2014, AstraZeneca completed the acquisition of Definiens Group, a privately-held German company focused on imaging and data
analysis technology, known as Tissue Phenomics™, which dramatically improves the identification of biomarkers in tumour tissue.
Definiens’ technology provides detailed cell-by-cell readouts from target structures on tissue slides and allows the correlation of this information
with data derived from other sources, generating new knowledge and supporting better decisions in research, diagnostics and therapy.
AstraZeneca acquired 100% of Definiens’ shares for an upfront consideration of $150m and contingent consideration of up to $150m based on
reaching three predetermined development milestones. Contingent consideration was fair valued using decision-tree analysis, with key inputs
including the probability of success and consideration of potential delays.
176
AstraZeneca Annual Report and Form 20-F Information 2016
25 Acquisitions of business operations continued
The acquiring entity within the Group was a pounds sterling functional currency subsidiary. Foreign currency risk arises from the retranslation of the
US dollar denominated contingent consideration. To manage this foreign currency risk the contingent consideration liability has been designated as
the hedge instrument in a net investment hedge of the Group’s underlying US dollar net investments. Exchange differences on the retranslation of
the contingent consideration liability are recognised in other comprehensive income to the extent that the hedge is effective. Any ineffectiveness is
taken to profit.
Definiens’ results were consolidated into the Group’s results from 25 November 2014. For the period from acquisition to 31 December 2014, Definiens’
revenues were immaterial, in the context of the Group’s revenues, and its loss after tax was immaterial.
If the acquisition had taken effect at the beginning of the reporting period in which the acquisition occurred (1 January 2014), on a pro forma basis,
the revenue of the combined Group for 2014 would have been unchanged and the change in profit after tax would have been immaterial. This pro
forma information does not purport to represent the results of the combined Group that actually would have occurred had the acquisition taken
place on 1 January 2014 and should not be taken to be representative of future results.
The fair values assigned to the business combinations completed in 2014 were:
2014 acquisitions
Non-current assets
Intangible assets (Note 9)
Property, plant and equipment (Note 7)
Current assets
Current liabilities
Non-current liabilities
Total net assets acquired
Goodwill (Note 8)
Fair value of total consideration
Less: fair value of contingent consideration (Note 18)
Total upfront consideration
Less: cash and cash equivalents acquired
Net cash outflow
BMS’s share of
Global Diabetes
Alliance Assets
$m
5,746
478
6,224
480
(278)
(84)
6,342
1,530
7,872
(5,169)
2,703
–
2,703
Almirall
$m
1,400
37
1,437
24
(2)
(11)
1,448
311
1,759
(881)
878
(2)
876
Definiens
$m
355
–
355
–
–
(117)
238
–
238
(88)
150
–
150
Total
$m
7,501
515
8,016
504
(280)
(212)
8,028
1,841
9,869
(6,138)
3,731
(2)
3,729
Acquisition costs arising on acquisitions in 2014 were immaterial.
26 Financial risk management objectives and policies
The Group’s principal financial instruments, other than derivatives, comprise bank overdrafts, finance leases, loans, current and non-current
investments, cash and short-term deposits. The main purpose of these financial instruments is to manage the Group’s funding and liquidity
requirements. The Group has other financial assets and liabilities such as trade receivables and trade payables, which arise directly from
its operations.
The principal financial risks to which the Group is exposed are those of liquidity, interest rate, foreign currency and credit. Each of these is managed
in accordance with Board-approved policies. These policies are set out below.
The Group uses foreign currency borrowings, foreign currency forwards and swaps, currency options, cross-currency swaps and interest rate swaps
for the purpose of hedging its foreign currency and interest rate risks. The Group may designate certain financial instruments as fair value hedges,
cash flow hedges or net investment hedges in accordance with IAS 39. Key controls applied to transactions in derivative financial instruments are:
to use only instruments where good market liquidity exists, to revalue all financial instruments regularly using current market rates and to sell options
only to offset previously purchased options or as part of a risk management strategy. The Group is not a net seller of options, and does not use
derivative financial instruments for speculative purposes.
Capital management
The capital structure of the Group consists of shareholders’ equity (Note 22), debt (Note 17) and cash (Note 16). For the foreseeable future, the Board
will maintain a capital structure that supports the Group’s strategic objectives through:
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> managing funding and liquidity risk
> optimising shareholder return
> maintaining a strong, investment-grade credit rating.
The Group utilises factoring arrangements for selected trade receivables. These factoring arrangements qualify for full derecognition of the associated
trade receivables under IAS 39.
Funding and liquidity risk are reviewed regularly by the Board and managed in accordance with policies described below.
The Board’s distribution policy comprises a regular cash dividend and, subject to business needs, a share repurchase component. The Board
regularly reviews its shareholders’ return strategy, and in 2012 decided to suspend share repurchases in order to retain strategic flexibility.
The Group’s net debt position (loans and borrowings net of cash and cash equivalents, current investments and derivative financial instruments)
has increased from a net debt position of $7,762m at the beginning of the year to a net debt position of $10,657m at 31 December 2016, primarily
as a result of increased outflows from investing activities, including acquisitions.
AstraZeneca Annual Report and Form 20-F Information 2016
177
Financial Statements
26 Financial risk management objectives and policies continued
Liquidity risk
The Board reviews the Group’s ongoing liquidity risks annually as part of the planning process and on an ad hoc basis. The Board considers
short-term requirements against available sources of funding, taking into account forecast cash flows. The Group manages liquidity risk by
maintaining access to a number of sources of funding which are sufficient to meet anticipated funding requirements. Specifically, the Group uses US
commercial paper, committed bank facilities and cash resources to manage short-term liquidity and manages long-term liquidity by raising funds
through the capital markets. The Group is assigned short-term credit ratings of P-2 by Moody’s and A-2 by Standard and Poor’s. The Group’s
long-term credit rating is A3 stable outlook by Moody’s and A- stable outlook by Standard and Poor’s.
In addition to cash and cash equivalents of $5,018m, fixed deposits of $37m, less overdrafts of $94m at 31 December 2016, the Group has
committed bank facilities of $3bn available to manage liquidity. At 31 December 2016, the Group has issued $3,494m under a Euro Medium Term
Note programme and $12,763m under a SEC-registered programme. The Group regularly monitors the credit standing of the banking group and
currently does not anticipate any issue with drawing on the committed facilities should this be necessary. The committed facilities of $3bn mature
in April 2021 and were undrawn at 31 December 2016.
The maturity profile of the anticipated future contractual cash flows including interest in relation to the Group’s financial liabilities, on an undiscounted
basis and which, therefore, differs from both the carrying value and fair value, is as follows:
Within one year
In one to two years
In two to three years
In three to four years
In four to five years
In more than five years
Effect of interest
Effect of discounting, fair values and issue costs
31 December 2014
Within one year
In one to two years
In two to three years
In three to four years
In four to five years
In more than five years
Effect of interest
Effect of discounting, fair values and issue costs
31 December 2015
Within one year
In one to two years
In two to three years
In three to four years
In four to five years
In more than five years
Effect of interest
Effect of discounting, fair values and issue costs
31 December 2016
Bank
overdrafts
and other
loans
$m
1,488
–
–
–
–
–
1,488
(2)
–
1,486
Bank
overdrafts
and other
loans
$m
851
–
–
–
–
–
851
(2)
–
849
Bank
overdrafts
and other
loans
$m
455
–
–
–
7
–
Bonds
$m
1,490
401
2,151
298
1,298
10,135
15,773
(6,461)
(63)
9,249
Bonds
$m
568
2,318
1,865
1,444
2,025
14,192
22,412
(8,194)
(109)
14,109
Bonds
$m
2,374
1,921
1,500
2,080
1,756
14,796
462
24,427
(4)
–
(8,111)
(59)
458
16,257
Trade
and other
payables
$m
11,909
1,720
936
924
1,323
7,002
23,814
–
(3,937)
19,877
Trade
and other
payables
$m
11,701
1,522
1,110
1,277
2,187
5,313
23,110
–
(3,990)
19,120
Total
non-derivative
financial
instruments
$m
Interest
rate swaps
$m
Cross-
currency
swaps
$m
Total
derivative
financial
instruments
$m
14,932
2,166
3,118
1,230
2,622
17,137
41,205
(6,485)
(4,000)
30,720
(52)
(52)
(52)
(16)
(16)
(62)
(250)
250
(161)
(161)
(16)
(16)
(16)
(19)
(325)
–
(392)
83
5
(304)
(68)
(68)
(68)
(35)
(341)
(62)
(642)
333
(156)
(465)
Total
non-derivative
financial
instruments
$m
Interest
rate swaps
$m
Cross-
currency
swaps
$m
Total
derivative
financial
instruments
$m
13,186
3,881
2,997
2,731
4,214
19,505
46,514
(8,242)
(4,099)
34,173
(54)
(54)
(19)
(15)
(15)
(44)
(201)
201
(126)
(126)
(17)
(17)
(26)
(330)
–
–
(390)
67
3
(320)
(71)
(71)
(45)
(345)
(15)
(44)
(591)
268
(123)
(446)
Trade
and other
payables
$m
Total
non-derivative
financial
instruments
$m
10,566
13,437
4,986
1,144
1,666
877
3,624
22,863
–
(2,889)
19,974
6,931
2,660
3,756
2,643
18,420
47,847
(8,117)
(2,948)
36,782
Interest
rate swaps
$m
Cross-
currency
swaps
$m
Total
derivative
financial
instruments
$m
(54)
(19)
(15)
(15)
(15)
(30)
(148)
148
(82)
(82)
32
12
(216)
47
86
320
281
(351)
(93)
(163)
(22)
(7)
(231)
32
71
290
133
(203)
(175)
(245)
Finance
leases
$m
45
45
31
8
1
–
130
(22)
–
108
Finance
leases
$m
66
41
22
10
2
–
141
(46)
–
95
Finance
leases
$m
42
24
16
10
3
–
95
(2)
–
93
Total
$m
14,864
2,098
3,050
1,195
2,281
17,075
40,563
(6,152)
(4,156)
30,255
Total
$m
13,115
3,810
2,952
2,386
4,199
19,461
45,923
(7,974)
(4,222)
33,727
Total
$m
13,415
6,924
2,429
3,788
2,714
18,710
47,980
(8,320)
(3,123)
36,537
178
AstraZeneca Annual Report and Form 20-F Information 2016
26 Financial risk management objectives and policies continued
Where interest payments are on a floating rate basis, it is assumed that rates will remain unchanged from the last business day of each year ended
31 December.
It is not expected that the cash flows in the maturity profile could occur significantly earlier or at significantly different amounts, with the exception of
$5,457m of contingent consideration and $1,901m arising from the put option over the non-controlling interest in Acerta Pharma, both held within
other payables (see Note 18).
Market risk
Interest rate risk
The Group maintains a mix of fixed and floating rate debt. The portion of fixed rate debt was approved by the Board and any variation requires
Board approval.
A significant portion of the Group’s long-term debt is held at fixed rates of interest. The Group uses interest rate swaps and forward rate agreements
to manage this mix.
At 31 December 2016, the Group held interest rate swaps with a notional value of $1.6bn, converting the 7% guaranteed debentures payable in
2023 to floating rates, partially converting the 5.9% callable bond maturing in 2017 to floating rates and partially converting the 1.75% callable bond
maturing in 2018 to floating rates. No new interest rate swaps were entered into during 2016. At 31 December 2016, swaps with a notional value of
$1.35bn were designated in fair value hedge relationships and swaps with a notional value of $0.29bn related to debt designated as fair value through
profit or loss. Designated hedges are expected to be effective and therefore the impact of ineffectiveness on profit is not expected to be material.
The accounting treatment for fair value hedges and debt designated as fair value through profit or loss is disclosed in the Group Accounting Policies
section from page 142.
The majority of surplus cash is currently invested in US dollar liquidity funds earning floating rates of interest.
The interest rate profile of the Group’s interest-bearing financial instruments is set out below. In the case of current and non-current financial liabilities,
the classification includes the impact of interest rate swaps which convert the debt to floating rate.
Financial liabilities
Interest-bearing loans and borrowings
Current
Non-current
Total
Financial assets
Fixed deposits
Cash and cash equivalents
Total
Fixed rate
$m
Floating rate
$m
1,086
13,154
14,240
–
–
–
1,221
1,347
2,568
37
5,018
5,055
2016
Total
$m
2,307
14,501
16,808
37
5,018
5,055
Fixed rate
$m
Floating rate
$m
67
11,986
12,053
–
–
–
849
2,151
3,000
65
6,240
6,305
2015
Total
$m
916
14,137
15,053
65
6,240
6,305
Fixed rate
$m
Floating rate
$m
960
7,199
8,159
–
–
–
1,486
1,198
2,684
20
6,360
6,380
2014
Total
$m
2,446
8,397
10,843
20
6,360
6,380
In addition to the financial assets above, there are $5,519m (2015: $6,494m; 2014: $7,576m) of other current and non-current asset investments and
other financial assets on which no interest is received.
Foreign currency risk
The US dollar is the Group’s most significant currency. As a consequence, the Group results are presented in US dollars and exposures are managed
against US dollars accordingly.
Translational
Approximately 66% of Group external sales in 2016 were denominated in currencies other than the US dollar, while a significant proportion of
manufacturing, and research and development costs were denominated in pounds sterling and Swedish krona. Surplus cash generated by
business units is substantially converted to, and held centrally in, US dollars. As a result, operating profit and total cash flow in US dollars will be
affected by movements in exchange rates.
This currency exposure is managed centrally, based on forecast cash flows. The impact of movements in exchange rates is mitigated significantly
by the correlations which exist between the major currencies to which the Group is exposed and the US dollar. Monitoring of currency exposures
and correlations is undertaken on a regular basis and hedging is subject to pre-execution approval.
As at 31 December 2016, 2.5% of interest-bearing loans and borrowings were denominated in pounds sterling and 18.3% were denominated in
euros. Where there is non-US dollar debt and an underlying net investment of that amount in the same currency, the Group applies net investment
hedging. Exchange differences on the retranslation of debt designated as net investment hedges are recognised in other comprehensive income
to the extent that the hedge is effective. Any ineffectiveness is taken to profit.
In 2016, the Group issued €2.2bn of bonds in the euro debt capital markets with maturities of 5, 8 and 12 years. The Group entered into
cross-currency swaps to convert the proceeds into fixed US dollar debt with a weighted average interest rate of 2.69% and maturities equal to the
bonds. These instruments were designated in a cash flow hedge. To the extent that the hedge is effective, fair value movements on the revaluation
of cross-currency swaps designated in a cash flow hedge are taken to other comprehensive income. Any ineffectiveness is taken to profit.
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AstraZeneca Annual Report and Form 20-F Information 2016
179
Financial Statements
26 Financial risk management objectives and policies continued
In 2016, the Group entered into a cross-currency swap to convert an additional $69m into fixed Chinese renminbi debt maturing in 2026. This
instrument was designated in a net investment hedge against the foreign currency risk of the Group’s renminbi net assets. Fair value movements
on the revaluation of the cross-currency swaps are recognised in other comprehensive income to the extent that the hedge is effective. Any
ineffectiveness is taken to profit.
Foreign currency risk arises when the Group has intercompany funding and investments in certain subsidiaries operating in countries with exchange
controls. The most significant risk in this respect is Venezuela, where the Group has approximately $104m equivalent of local currency cash, on
which there have been delays in obtaining approval for remittance outside the country.
The official exchange rate for essential goods and services is VEF 10/$ (the DIPRO rate) as published by CENCOEX (the National Foreign Trade
Center). Alternative exchange rates include the SIMADI (Sistema Marginal de Divisas) rate, which was introduced in 2015. At 31 December 2016,
the SIMADI rate was VEF 673.76/$ (31 December 2015: VEF 199.7/$).
For 2016, the Group used the DIPRO rate for the consolidation of the financial statements of the Venezuelan subsidiaries. The Group believes that
this rate represents the most appropriate rate for consolidation as it reflects their best expectation of the rate at which profits will be remitted.
The Group has restructured $153m of intercompany trading balances in order to manage the FX retranslation risk should the DIPRO rate increase
over the next 12 months. Had the Group applied the SIMADI rate for the consolidation of the financial statements of the Venezuelan subsidiaries,
the Group would be exposed to a potential income statement devaluation loss of $15m on its total intercompany balances and the local currency
cash would be reduced to $2m on consolidation.
Transactional
One hundred percent of the Group’s major transactional currency exposures on working capital balances, which typically extend for up to three
months, are hedged, where practicable, using forward foreign exchange contracts against individual Group companies’ reporting currency. In addition,
the Group’s external dividend, which is paid principally in pounds sterling and Swedish krona, is fully hedged from announcement to payment date.
Foreign exchange gains and losses on forward contracts transacted for transactional hedging are taken to profit.
Sensitivity analysis
The sensitivity analysis set out below summarises the sensitivity of the market value of our financial instruments to hypothetical changes in market
rates and prices. The range of variables chosen for the sensitivity analysis reflects our view of changes which are reasonably possible over a
one-year period. Market values are the present value of future cash flows based on market rates and prices at the valuation date. For long-term
debt, an increase in interest rates results in a decline in the fair value of debt.
The sensitivity analysis assumes an instantaneous 100 basis point change in interest rates in all currencies from their levels at 31 December 2016,
with all other variables held constant. Based on the composition of our long-term debt portfolio as at 31 December 2016, a 1% increase in interest
rates would result in an additional $26m in interest expense being incurred per year. The exchange rate sensitivity analysis assumes an instantaneous
10% change in foreign currency exchange rates from their levels at 31 December 2016, with all other variables held constant. The +10% case
assumes a 10% strengthening of the US dollar against all other currencies and the -10% case assumes a 10% weakening of the US dollar.
Each incremental 10% movement in foreign currency exchange rates would have approximately the same effect as the initial 10% detailed in the table
below and each 1% change in interest rates would have approximately the same effect as the 1% detailed in the table below.
31 December 2014
Increase/(decrease) in fair value of financial instruments ($m)
Impact on profit: (loss)/gain ($m)
Impact on equity: gain/(loss) ($m)
31 December 2015
Increase/(decrease) in fair value of financial instruments ($m)
Impact on profit: (loss)/gain ($m)
Impact on equity: gain/(loss) ($m)
31 December 2016
Increase/(decrease) in fair value of financial instruments ($m)
Impact on profit: (loss)/gain ($m)
Impact on equity: gain/(loss) ($m)
+1%
844
–
–
+1%
997
–
–
+1%
1,249
–
–
Interest rates
Exchange rates
-1%
(856)
–
–
+10%
85
(247)
332
-10%
(85)
247
(332)
Interest rates
Exchange rates
-1%
(1,150)
–
–
+10%
136
(91)
227
-10%
(136)
91
(227)
Interest rates
Exchange rates
-1%
(1,390)
–
–
+10%
180
(24)
204
-10%
(180)
24
(204)
There has been no change in the methods and assumptions used in preparing the above sensitivity analysis over the three-year period.
180
AstraZeneca Annual Report and Form 20-F Information 2016
26 Financial risk management objectives and policies continued
Credit risk
The Group is exposed to credit risk on financial assets, such as cash balances (including fixed deposits and cash and cash equivalents), derivative
instruments, trade and other receivables. The Group is also exposed in its net asset position to its own credit risk in respect of the 2023 debentures
which are accounted for at fair value through profit or loss.
Trade and other receivables
Trade receivable exposures are managed locally in the operating units where they arise and credit limits are set as deemed appropriate for the
customer. The Group is exposed to customers ranging from government-backed agencies and large private wholesalers to privately owned
pharmacies, and the underlying local economic and sovereign risks vary throughout the world. Where appropriate, the Group endeavours to
minimise risks by the use of trade finance instruments such as letters of credit and insurance. The Group establishes an allowance for impairment
that represents its estimate of incurred losses in respect of specific trade and other receivables where it is deemed that a receivable may not be
recoverable. When the debt is deemed irrecoverable, the allowance account is written off against the underlying receivable.
In the US, sales to three wholesalers accounted for approximately 83% of US sales (2015: three wholesalers accounted for approximately 84%;
2014: three wholesalers accounted for approximately 75%).
The ageing of trade receivables at the reporting date was:
Not past due
Past due 0-90 days
Past due 90-180 days
Past due > 180 days
Movements in provisions for trade receivables
At 1 January
Income statement
Amounts utilised, exchange and other movements
At 31 December
2016
$m
2,559
14
–
10
2,583
2016
$m
52
–
(10)
42
2015
$m
4,388
189
21
35
4,633
2015
$m
54
2
(4)
52
2014
$m
4,316
354
75
17
4,762
2014
$m
64
(2)
(8)
54
The allowance for impairment has been calculated based on past experience and is in relation to specific customers. Given the profile of our
customers, including large wholesalers and government-backed agencies, no further credit risk has been identified with the trade receivables
not past due other than those balances for which an allowance has been made. The income statement charge is recorded in selling, general and
administrative costs.
Other financial assets
The Group may hold significant cash balances as part of its normal operations, with the amount of cash held at any point reflecting the level of cash
flow generated by the business and the timing of the use of that cash. The majority of excess cash is centralised within the Group treasury entity
and is subject to counterparty risk on the principal invested. This risk is mitigated through a policy of prioritising security and liquidity over return,
and as such cash is only invested in high credit quality investments. Counterparty limits are set according to the assessed risk of each counterparty
and exposures are monitored against these limits on a regular basis. The majority of the Group’s cash is invested in US dollar AAA-rated liquidity
funds, fully collateralised repurchase agreements, fixed income securities and short-term bank deposits.
The most significant concentration of financial credit risk at 31 December 2016 was $3,440m invested in five AAA-rated liquidity funds. The liquidity
fund portfolios are managed by the related external third party fund managers to maintain the AAA rating. No more than 15% of fund value is invested
within each individual fund. There were no other significant concentrations of financial credit risk at the reporting date.
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At 31 December 2016, the Group had investments of $950m (2015: $1,050m; 2014: $300m) in short-term repurchase agreements, which are fully
collateralised investments. In the event of any default, ownership of the collateral would revert to the Group and would be readily convertible to
cash. The value of the collateral held at 31 December 2016 was $951m (2015: $1,098m; 2014: $316m).
All financial derivatives are transacted with commercial banks, in line with standard market practice. The Group has agreements with some bank
counterparties whereby the parties agree to post cash collateral, for the benefit of the other, equivalent to the market valuation of the derivative
positions above a predetermined threshold. The carrying value of such cash collateral held by the Group at 31 December 2016 was $242m
(2015: $451m; 2014: $457m).
AstraZeneca Annual Report and Form 20-F Information 2016
181
Financial Statements
27 Employee costs and share plans for employees
Employee costs
The average number of people, to the nearest hundred, employed by the Group is set out in the table below. In accordance with the Companies
Act 2006, this includes part-time employees.
Employees
UK
Continental Europe
The Americas
Asia, Africa & Australasia
Continuing operations
2016
2015
2014
7,000
14,700
17,800
22,000
61,500
7,100
14,800
17,500
20,700
60,100
7,200
13,800
16,800
18,100
55,900
Geographical distribution described in the table above is by location of legal entity employing staff. Certain staff will spend some or all of their
activity in a different location.
The number of people employed by the Group at the end of 2016 was 59,700 (2015: 61,500; 2014: 57,500).
The costs incurred during the year in respect of these employees were:
Salaries
Social security costs
Pension costs
Other employment costs
Total
2016
$m
4,664
584
426
610
6,284
2015
$m
4,603
567
484
474
6,128
2014
$m
4,657
664
459
499
6,279
Severance costs of $578m are not included above (2015: $338m; 2014: $254m).
The Directors believe that, together with the basic salary system, the Group’s employee incentive schemes provide competitive and market-related
packages to motivate employees. They should also align the interests of employees with those of shareholders, as a whole, through long-term
share ownership in the Company. The Group’s current UK, Swedish and US schemes are described below; other arrangements apply elsewhere.
Bonus plans
The AstraZeneca UK Performance Bonus Plan
Employees of participating AstraZeneca UK companies are invited to participate in this bonus plan, which rewards strong individual performance.
Bonuses are paid in cash.
The AstraZeneca Executive Annual Bonus Scheme
This scheme is a performance bonus scheme for Directors and senior employees who do not participate in the AstraZeneca UK Performance
Bonus Plan. Annual bonuses are paid in cash and reflect both corporate and individual performance measures. The Remuneration Committee has
discretion to reduce or withhold bonuses if business performance falls sufficiently short of expectations in any year such as to make the payment of
bonuses inappropriate.
The AstraZeneca Deferred Bonus Plan
This plan was introduced in 2006 and is used to defer a portion of the bonus earned under the AstraZeneca Executive Annual Bonus Scheme into
Ordinary Shares in the Company for a period of three years. The plan currently operates only in respect of Executive Directors and members of the
SET. Awards of shares under this plan are typically made in March each year, the first award having been made in February 2006. Further details of
this plan can be found in the Directors’ Remuneration Report from page 103.
Sweden
In Sweden, an all-employee performance bonus plan is in operation, which rewards strong individual performance. Bonuses are paid 50% into a
fund investing in AstraZeneca equities and 50% in cash. The AstraZeneca Executive Annual Bonus Scheme, the AstraZeneca Performance Share
Plan and the AstraZeneca Global Restricted Stock Plan all operate in respect of relevant AstraZeneca employees in Sweden.
US
In the US, there are two all-employee short-term or annual performance bonus plans in operation to differentiate and reward strong individual
performance. Annual bonuses are paid in cash. There is also one senior staff long-term incentive scheme, under which 91 participants may be
eligible for awards granted as AstraZeneca ADSs. AstraZeneca ADSs necessary to satisfy the awards are purchased in the market or funded via a
share trust. The AstraZeneca Performance Share Plan and the AstraZeneca Global Restricted Stock Plan operate in respect of relevant employees
in the US.
182
AstraZeneca Annual Report and Form 20-F Information 2016
27 Employee costs and share plans for employees continued
Share plans
The charge for share-based payments in respect of share plans is $241m (2015: $211m; 2014: $178m). The plans are equity settled.
The AstraZeneca UK All-Employee Share Plan
The Company offers UK employees the opportunity to buy Partnership Shares (Ordinary Shares). Employees may invest up to £1,800 over a 12 month
accumulation period and purchase Partnership Shares in the Company with the total proceeds at the end of the period. The purchase price for the
shares is the lower of the price at the beginning or the end of the 12-month period. In 2010, the Company introduced a Matching Share element,
the first award of which was made in 2011. Currently one Matching Share is awarded for every four Partnership Shares purchased. Partnership
Shares and Matching Shares are held in the HM Revenue & Customs (HMRC)-approved All-Employee Share Plan. At the Company’s AGM in 2002,
shareholders approved the issue of new shares for the purposes of the All-Employee Share Plan.
The AstraZeneca Performance Share Plan
This plan was approved by shareholders in 2005 for a period of 10 years. Generally, awards could be granted at any time, but not during a closed
period of the Company. The first grant of awards was made in June 2005 and the last grant of awards was made in March 2014. Awards granted
under the plan vest after three years and can be subject to the achievement of performance conditions. The Remuneration Committee has
responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated, including agreeing
performance targets and which employees would be invited to participate. The plan has been replaced by the AstraZeneca 2014 Performance
Share Plan.
Shares awarded in February 2014
Shares awarded in March 2014
1 Weighted average fair value.
Shares
’000
37
2,368
WAFV1
pence
N/A
1952
WAFV1
$
30.55
32.34
The AstraZeneca 2014 Performance Share Plan (PSP)
This plan was approved by shareholders in 2014 for a period of 10 years and replaces the AstraZeneca Performance Share Plan. Generally, awards
can be granted at any time, but not during a closed period of the Company. The first grant of awards was made in May 2014. Awards granted under
the plan vest after three years, or in the case of Executive Directors, after an additional two-year holding period, and can be subject to the achievement
of performance conditions. For awards granted to all participants in 2016, vesting is subject to a combination of measures focused on scientific
leadership, revenue growth and financial performance. The Remuneration Committee has responsibility for agreeing any awards under the plan
and for setting the policy for the way in which the plan should be operated, including agreeing performance targets and which employees should
be invited to participate. Further details of this plan can be found in the Directors’ Remuneration Report from page 103. The main grant of awards
in 2016 under the plan took place in March with further grants in May and August.
Shares awarded in May 2014
Shares awarded in August 2014
Shares awarded in September 2014
Shares awarded in November 2014
Shares awarded in March 2015
Shares awarded in June 2015
Shares awarded in August 2015
Shares awarded in September 2015
Shares awarded in November 2015
Shares awarded in March 2016
Shares awarded in May 2016
Shares awarded in August 2016
Shares
’000
12
141
40
2
2,223
36
152
8
7
2,673
24
67
WAFV
pence
2133
2156
2250
N/A
2381
2087
2123
N/A
2178
1962
1935
2536
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
WAFV
$
35.75
35.79
N/A
36.62
35.29
33.05
33.21
32.32
33.31
28.19
28.64
33.58
The AstraZeneca Investment Plan (AZIP)
This plan was introduced in 2010 and approved by shareholders at the 2010 AGM. The grant of awards in 2016 took place in March. Awards granted
under the plan vest after eight years and are subject to performance conditions measured over a period of between three and eight years. For awards
granted in 2016, the performance conditions relate to the annual dividend paid to shareholders and dividend cover over a four-year performance
period. The awards are then subject to a four-year holding period before they can vest. The Remuneration Committee has responsibility for agreeing
any awards under the plan and for setting the policy for the way in which the plan should be operated, including agreeing performance targets and
which employees should be invited to participate. Further details of this plan can be found in the Directors’ Remuneration Report from page 103.
Shares awarded in March 2014
Shares awarded in September 2014
Shares awarded in March 2015
Shares awarded in August 2015
Shares awarded in March 2016
Shares
’000
67
7
64
4
84
WAFV
pence
3904
4499
4762
N/A
3923
WAFV
$
64.68
N/A
70.58
66.42
56.38
AstraZeneca Annual Report and Form 20-F Information 2016
183
Financial Statements
27 Employee costs and share plans for employees continued
The AstraZeneca Global Restricted Stock Plan
This plan was introduced in 2010. The main grant of awards in 2016 under the plan was in March, with a further, smaller grant in August. This plan
provides for the grant of restricted stock unit (RSU) awards to selected below SET-level employees and is used in conjunction with the AstraZeneca
Performance Share Plan to provide a mix of RSUs and performance shares. Awards typically vest on the third anniversary of the date of grant and
are contingent on continued employment with the Company. The Remuneration Committee has responsibility for agreeing any awards under the
plan and for setting the policy for the way in which the plan should be operated.
Shares awarded in March 2014
Shares awarded in August 2014
Shares awarded in March 2015
Shares awarded in August 2015
Shares awarded in March 2016
Shares awarded in August 2016
Shares
’000
2,076
25
1,966
17
2,695
122
WAFV
pence
3904
4312
4762
4245
3923
5071
WAFV
$
64.68
71.57
70.58
66.42
56.38
67.16
The AstraZeneca Restricted Share Plan
This plan was introduced in 2008 and provides for the grant of restricted share awards to key employees, excluding Executive Directors. Awards
are made on an ad hoc basis with variable vesting dates. The plan has been used four times in 2016 to make awards to 714 employees. The
Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should
be operated.
Shares awarded in February 2014
Shares awarded in March 2014
Shares awarded in May 2014
Shares awarded in August 2014
Shares awarded in September 2014
Shares awarded in November 2014
Shares awarded in March 2015
Shares awarded in June 2015
Shares awarded in August 2015
Shares awarded in September 2015
Shares awarded in November 2015
Shares awarded in March 2016
Shares awarded in May 2016
Shares awarded in August 2016
Shares awarded in November 2016
Shares
’000
115
155
134
72
64
9
164
69
31
41
41
809
335
37
14
WAFV
pence
4042
N/A
4265
4312
4499
4672
4762
4174
4245
4199
4355
3923
3869
5071
4233
WAFV
$
61.10
64.68
71.50
71.57
74.05
73.23
70.58
66.09
66.42
64.64
66.62
56.38
57.28
67.16
53.42
The fair values were determined using a modified version of the binomial model. This method incorporated expected dividends but no other features
into the measurements of fair value. The grant date fair values of share awards disclosed in this section do not take account of service and non-market
related performance conditions.
184
AstraZeneca Annual Report and Form 20-F Information 2016
28 Commitments and contingent liabilities
Commitments
Contracts placed for future capital expenditure on property, plant and equipment and software development costs not
provided for in these accounts
2016
$m
2015
$m
2014
$m
629
518
438
Guarantees and contingencies arising in the ordinary course of business, for which no security has been given, are not expected to result in any
material financial loss.
Research and development collaboration payments
The Group has various ongoing collaborations, including in-licensing and similar arrangements with development partners. Such collaborations may
require the Group to make payments on achievement of stages of development, launch or revenue milestones, although the Group generally has the
right to terminate these agreements at no cost. The Group recognises research and development milestones as intangible assets once it is committed
to payment, which is generally when the Group reaches set trigger points in the development cycle. Revenue-related milestones are recognised as
intangible assets on product launch at a value based on the Group’s long-term revenue forecasts for the related product. The table below indicates
potential development and revenue-related payments that the Group may be required to make under such collaborations.
Future potential research and development milestone payments
Future potential revenue milestone payments
Total
$m
6,651
5,259
Under 1 year
$m
Years 1 and 2
$m
Years 3 and 4
$m
412
77
1,286
143
647
970
Years 5
and greater
$m
4,306
4,069
The table includes all potential payments for achievement of milestones under ongoing research and development arrangements. Revenue-related
milestone payments represent the maximum possible amount payable on achievement of specified levels of revenue as set out in individual contract
agreements, but exclude variable payments that are based on unit sales (eg royalty-type payments) which are expensed as the associated sale is
recognised. The table excludes any payments already capitalised in the Financial Statements for the year ended 31 December 2016.
The future payments we disclose represent contracted payments and, as such, are not discounted and are not risk adjusted. As detailed in the
Risk section from page 214, the development of any pharmaceutical product candidate is a complex and risky process that may fail at any stage
in the development process due to a number of factors (including items such as failure to obtain regulatory approval, unfavourable data from key
studies, adverse reactions to the product candidate or indications of other safety concerns). The timing of the payments is based on the Group’s
current best estimate of achievement of the relevant milestone.
Environmental costs and liabilities
The Group’s expenditure on environmental protection, including both capital and revenue items, relates to costs that are necessary for implementing
internal systems and programmes, and meeting legal and regulatory requirements for processes and products. This includes investment to conserve
natural resources and otherwise minimise the impact of our activities on the environment.
They are an integral part of normal ongoing expenditure for carrying out the Group’s research, manufacturing and commercial operations and are
not separated from overall operating and development costs. There are no known changes in legal, regulatory or other requirements resulting in
material changes to the levels of expenditure for 2014, 2015 or 2016.
In addition to expenditure for meeting current and foreseen environmental protection requirements, the Group incurs costs in investigating and
cleaning up land and groundwater contamination. In particular, AstraZeneca has environmental liabilities at some currently or formerly owned,
leased and third party sites.
In the US, Zeneca Inc., and/or its indemnitees, have been named as potentially responsible parties (PRPs) or defendants at approximately 14 sites
where Zeneca Inc. is likely to incur future environmental investigation, remediation, operation and maintenance costs under federal, state, statutory or
common law environmental liability allocation schemes (together, US Environmental Consequences). Similarly, Stauffer Management Company LLC
(SMC), which was established in 1987 to own and manage certain assets of Stauffer Chemical Company acquired that year, and/or its indemnitees,
have been named as PRPs or defendants at 34 sites where SMC is likely to incur US Environmental Consequences.
AstraZeneca has also given indemnities to third parties for a number of sites outside the US. These environmental liabilities arise from legacy
operations that are not currently part of the Group’s business and, at most of these sites, remediation, where required, is either completed or
nearing completion. AstraZeneca has made provisions for the estimated costs of future environmental investigation, remediation, operation and
maintenance activity beyond normal ongoing expenditure for maintaining the Group’s R&D and manufacturing capacity and product ranges, where
a present obligation exists, it is probable that such costs will be incurred and they can be estimated reliably. With respect to such estimated future
costs, there were provisions at 31 December 2016 in the aggregate of $59m (2015: $67m; 2014: $84m), mainly relating to the US. Where we are
jointly liable or otherwise have cost-sharing agreements with third parties, we reflect only our share of the obligation. Where the liability is insured in
part or in whole by insurance or other arrangements for reimbursement, an asset is recognised to the extent that this recovery is virtually certain.
It is possible that AstraZeneca could incur future environmental costs beyond the extent of our current provisions. The extent of such possible
additional costs is inherently difficult to estimate due to a number of factors, including: (1) the nature and extent of claims that may be asserted
in the future; (2) whether AstraZeneca has or will have any legal obligation with respect to asserted or unasserted claims; (3) the type of remedial
action, if any, that may be selected at sites where the remedy is presently not known; (4) the potential for recoveries from or allocation of liability to
third parties; and (5) the length of time that the environmental investigation, remediation and liability allocation process can take. Notwithstanding
and subject to the foregoing, we estimate the potential additional loss for future environmental investigation, remediation, remedial operation
and maintenance activity above and beyond our provisions to be, in aggregate, between $85m and $141m (2015: $71m and $119m; 2014: $50m
and $80m), which relates mainly to the US.
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AstraZeneca Annual Report and Form 20-F Information 2016
185
Financial Statements
28 Commitments and contingent
liabilities continued
Legal proceedings
AstraZeneca is involved in various legal
proceedings considered typical to its business,
including actual or threatened litigation and/or
actual or potential government investigations
relating to employment matters, product
liability, commercial disputes, pricing, sales
and marketing practices, infringement of IP
rights, and the validity of certain patents and
competition laws. The more significant matters
are discussed below.
Most of the claims involve highly complex
issues. Often these issues are subject to
substantial uncertainties and, therefore, the
probability of a loss, if any, being sustained
and an estimate of the amount of any loss is
difficult to ascertain. Consequently, for a
majority of these claims, it is not possible to
make a reasonable estimate of the expected
financial effect, if any, that will result from
ultimate resolution of the proceedings. In these
cases, AstraZeneca discloses information with
respect to the nature and facts of the cases.
With respect to each of the legal proceedings
described below, other than those for which
provision has been made, we are unable to
make estimates of the possible loss or range
of possible losses at this stage, other than as
set forth in this section. We also do not believe
that disclosure of the amount sought by
plaintiffs, if known, would be meaningful with
respect to those legal proceedings. This is due
to a number of factors, including (1) the stage
of the proceedings (in many cases trial dates
have not been set) and the overall length and
extent of pre-trial discovery; (2) the entitlement
of the parties to an action to appeal a decision;
(3) clarity as to theories of liability, damages
and governing law; (4) uncertainties in timing of
litigation; and (5) the possible need for further
legal proceedings to establish the appropriate
amount of damages, if any.
While there can be no assurance regarding
the outcome of any of the legal proceedings
referred to in this Note 28, based on
management’s current and considered view
of each situation, we do not currently expect
them to have a material adverse effect on our
financial position. This position could of course
change over time, not least because of the
factors referred to above.
In cases that have been settled or adjudicated,
or where quantifiable fines and penalties have
been assessed and which are not subject to
appeal (or other similar forms of relief), or where
a loss is probable and we are able to make a
reasonable estimate of the loss, we generally
indicate the loss absorbed or make a provision
for our best estimate of the expected loss.
Where it is considered that the Group is more
likely than not to prevail, legal costs involved in
defending the claim are charged to profit as
they are incurred.
Where it is considered that the Group has
a valid contract which provides the right to
reimbursement (from insurance or otherwise)
of legal costs and/or all or part of any loss
incurred or for which a provision has been
established, and we consider recovery to
be virtually certain, the best estimate of the
amount expected to be received is recognised
as an asset.
Assessments as to whether or not to recognise
provisions or assets, and of the amounts
concerned, usually involve a series of
complex judgements about future events
and can rely heavily on estimates and
assumptions. AstraZeneca believes that the
provisions recorded are adequate based on
currently available information and that the
insurance recoveries recorded will be received.
However, given the inherent uncertainties
involved in assessing the outcomes of these
cases, and in estimating the amount of the
potential losses and the associated insurance
recoveries, we could in the future incur
judgments or insurance settlements that
could have a material adverse effect on our
results in any particular period.
IP claims include challenges to the Group’s
patents on various products or processes
and assertions of non-infringement of patents.
A loss in any of these cases could result in loss
of patent protection on the related product.
The consequences of any such loss could be
a significant decrease in product sales, which
could have a material adverse effect on our
results. The lawsuits filed by AstraZeneca for
patent infringement against companies that
have filed ANDAs in the US, seeking to market
generic forms of products sold by the Group
prior to the expiry of the applicable patents
covering these products, typically also involve
allegations of non-infringement, invalidity and
unenforceability of these patents by the
ANDA filers. In the event that the Group is
unsuccessful in these actions or the statutory
30-month stay expires before a ruling is
obtained, the ANDA filers involved will also have
the ability, subject to FDA approval, to introduce
generic versions of the product concerned.
AstraZeneca has full confidence in, and will
vigorously defend and enforce, its IP.
Over the course of the past several years,
including in 2016, a significant number of
commercial litigation claims in which
AstraZeneca is involved have been resolved,
particularly in the US, thereby reducing
potential contingent liability exposure arising
from such litigation. Similarly, in part due to
patent litigation and settlement developments,
greater certainty has been achieved regarding
possible generic entry dates with respect
to some of our patented products. At the
same time, like other companies in the
pharmaceutical sector and other industries,
AstraZeneca continues to be subject to
government investigations around the world.
Patent litigation
Brilinta (ticagrelor)
US patent proceedings
In 2015, in response to Paragraph IV notices
challenging patents listed in the FDA Orange
Book with reference to Brilinta, AstraZeneca
filed separate patent infringement lawsuits
against ANDA filers seeking to market
ticagrelor. Proceedings are ongoing in the
US District Court for the District of Delaware.
Trial is scheduled for March and April 2018.
Byetta (exenatide)
US patent proceedings
In 2014, in the US District Court for the District
of Delaware (the District Court), AstraZeneca
filed a patent infringement lawsuit in
response to a Paragraph IV notice from Teva
Pharmaceuticals USA, Inc. (Teva) relating to
patents listed in the FDA Orange Book with
reference to Byetta. In June 2016, AstraZeneca
settled the patent litigation against Teva. The
District Court entered a consent judgment
which will enjoin Teva from launching its
proposed exenatide product until October
2017, subject to regulatory approval.
Separately, in December 2015, AstraZeneca
filed a patent infringement lawsuit in response
to a Paragraph IV notice from Amneal
Pharmaceuticals LLC in the District Court.
Trial is scheduled for December 2017.
In November 2015, Sanofi-Aventis U.S. LLC
and Sanofi-Aventis Deutschland GmbH
(together, Sanofi) served AstraZeneca with
a complaint for declaratory judgment that
Sanofi’s proposed lixisenatide product would
not infringe three AstraZeneca patents.
Sanofi also alleged invalidity of the patents.
Separately, in December 2015, Sanofi filed
petitions in the US Patent Trial and Appeals
Board (PTAB) for inter partes review of certain
patents at issue in the above-referenced
District Court litigations. In October 2016,
AstraZeneca and Sanofi settled the District
Court and PTAB proceedings. Sanofi’s claims
have been dismissed.
Crestor (rosuvastatin calcium)
US patent proceedings
AstraZeneca has been a defendant in three
patent infringement lawsuits in the US District
Court for the District of South Carolina (the
District Court) which, among other things,
claimed that AstraZeneca’s Crestor sales
induce infringement of the plaintiffs’ patents.
The first lawsuit, filed in April 2011 by plaintiff
Palmetto Pharmaceuticals, LLC (Palmetto),
was dismissed by the District Court in
December 2015 with judgment entered in
186
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28 Commitments and contingent
liabilities continued
AstraZeneca’s favour. Palmetto subsequently
appealed. In December 2016, the Federal
Circuit Court of Appeals affirmed the District
Court’s order dismissing the lawsuit.
The other two lawsuits were filed by
co-plaintiffs Medical University of South
Carolina Foundation for Research Development
and Charleston Medical Therapeutics, Inc.
(together, CMT) in July and December 2013
and subsequently consolidated. In February
2016, the District Court granted AstraZeneca’s
motion for summary judgment and dismissed
the two consolidated lawsuits, and CMT
appealed. In July 2016, AstraZeneca and
CMT jointly filed a stipulated dismissal of
CMT’s appeal.
Patent proceedings outside the US
In Australia, AstraZeneca was unsuccessful in
defending the validity of certain Crestor patents,
at trial and on appeal. The patent litigation
concluded in September 2015. A provision
was taken in 2015 in respect of claims from
generic entities which were prevented by
court order from launching their products in
Australia before AstraZeneca’s patents were
subsequently found to be invalid. In April 2016,
AstraZeneca was notified that the
Commonwealth of Australia also intended
to pursue a claim against AstraZeneca in
relation to alleged losses it suffered in
connection with the same patent litigation
and the Commonwealth formally joined the
proceedings in November 2016. AstraZeneca
has updated its provisions accordingly.
In France, in February 2016, Biogaran S.A.S.
(Biogaran) obtained a marketing authorisation
for its rosuvastatin zinc product. In April 2016,
AstraZeneca and Shionogi Seiyaku Kabushiki
Kaisha (Shionogi) sought a preliminary
injunction to prevent Biogaran from launching
its product. In July 2016, the Paris Court of
First Instance declined to issue a preliminary
injunction. AstraZeneca and Shionogi
appealed, however, the parties settled the
preliminary proceedings before the appeal
hearing. AstraZeneca and Shionogi have
commenced patent infringement proceedings
against Biogaran relying on infringement of the
supplementary protection certificate related to
the Crestor substance patent (European
Patent No. EP 0521471).
In Japan, in March 2015, an individual filed a
patent invalidation request with the Japanese
Patent Office (JPO) in relation to the Crestor
substance patent (Japanese Patent No. JP
2648897). In July 2016, the JPO dismissed
the request. The individual appealed to the
Intellectual Property High Court of Japan
(the High Court) with the intervention of Nippon
Chemiphar Co. Ltd (Nippon). In addition,
Nippon has commenced a separate patent
invalidation request with the JPO in relation to
the Crestor substance patent. In November
2016, the JPO refused Nippon’s request.
Nippon has appealed to the High Court.
In the Netherlands, in April 2014, AstraZeneca
received a writ of summons from Resolution
Chemicals Ltd (Resolution) alleging partial
invalidity and non-infringement of the
supplementary protection certificate (SPC)
related to the Crestor substance patent
(European Patent No. EP 0521471). In July
2015, the District Court of the Hague
determined that the SPC does not extend to
zinc salts of rosuvastatin and that Resolution’s
rosuvastatin zinc product does not infringe the
SPC. In February 2016, the Court of Appeal of
the Hague overturned the decision and found
that Resolution’s product does infringe the
SPC. Resolution appealed, and a hearing was
held before the Supreme Court in December
2016. A decision is pending.
In Switzerland, in May 2016, Mepha Pharma AG
challenged the validity of the supplementary
protection certificate related to the Crestor
substance patent (European Patent No. EP
0521471). AstraZeneca has responded.
In the UK, in October 2015, Resolution
commenced an action in the UK Patent Court
alleging partial invalidity and non-infringement
of the supplementary protection certificate
related to the Crestor substance patent
(European Patent No. EP 0521471). The case
has been stayed.
Daliresp (roflumilast)
US patent proceedings
In 2015, in response to Paragraph IV notices
challenging patents listed in the FDA Orange
Book with reference to Daliresp, AstraZeneca
filed separate patent infringement lawsuits
against ANDA filers seeking to market
roflumilast. Proceedings are ongoing in the
US District Court for the District of New Jersey.
No trial date has been set.
Faslodex (fulvestrant)
US patent proceedings
AstraZeneca has filed patent infringement
lawsuits in the US District Court in New Jersey
(the District Court) relating to four patents listed
in the FDA Orange Book with reference to
Faslodex after AstraZeneca received seven
Paragraph IV notices relating to six ANDAs
seeking FDA approval to market generic
versions of Faslodex prior to the expiration of
AstraZeneca’s patents. In July 2016,
AstraZeneca settled one of these, the lawsuit
brought against Sandoz, Inc. (Sandoz), and the
District Court entered a consent judgment,
which includes an injunction preventing
Sandoz from launching a generic fulvestrant
product until 25 March 2019, or earlier in
certain circumstances. In August and
December 2016, AstraZeneca settled the
lawsuits against three additional ANDA filers,
and the District Court also entered consent
judgments ending those lawsuits. The related
lawsuit in the US District Court in West Virginia,
that had been stayed pending the District
Court lawsuits, was also settled and dismissed
pursuant to a consent judgment. AstraZeneca
continues to litigate in the District Court against
two ANDA filers.
In July 2016, AstraZeneca was served with
four petitions for inter partes review by the
Patent Trial and Appeal Board (PTAB) relating
to each of the four Orange Book-listed
patents. In December 2016, the PTAB issued
an order denying institution of the first of the
four petitions. In January 2017, the PTAB
terminated the remaining petitions at the
request of the parties.
Patent proceedings outside the US
In Germany, in July 2015, AstraZeneca was
served with complaints filed by Hexal AG
(Hexal) and ratiopharm GmbH (ratiopharm)
requesting the revocation of the German part
of European Patent No. EP 1250138 (the ’138
Patent). In January 2017, the German Federal
Patent Court declared the patent invalid.
AstraZeneca intends to appeal. In January
2017, the Regional Court of Düsseldorf lifted a
provisional injunction based on the ’138 Patent
which had been in place against Hexal since
February 2016. Hexal is also seeking to lift
the provisional injunction based on European
Patent No. EP 2266573. In January 2017,
the Higher Regional Court of Düsseldorf
suspended the effects of a provisional
injunction based on the ’138 Patent which
had been in place against ratiopharm since
September 2016.
In Spain, in January 2016, the Barcelona
Commercial Court ordered a preliminary
injunction based on European Patent No. EP
1250138 and European Patent No. EP
2266573, preventing Sandoz Farmacéutica,
S.A. from launching generic Faslodex in Spain.
Sandoz Farmacéutica, S.A. appealed.
In October 2015, Hexal filed a notice of
opposition against European Patent No.
EP 2266573, granted in June 2015, at the
European Patent Office. In February and
March 2016, further oppositions were filed
by Actavis Group PTC ehf, Fresenius Kabi
Deutschland GmbH, Intas Pharmaceuticals
Ltd. and Teva Pharmaceutical Industries Ltd.
An oral hearing has been scheduled for
May 2017.
In China, in March 2014, AstraZeneca received
a request for invalidation of the Faslodex
formulation patent CN01803546.9 filed by
Jiangsu Hansoh Pharmaceutical Co. Ltd. at
the Chinese Patent Office. In September 2014,
the Patent Re-examination Board of the
Chinese Patent Board declared the patent
invalid. AstraZeneca appealed to the Beijing IP
Court and the appeal was rejected in April
2016. AstraZeneca appealed this decision to
AstraZeneca Annual Report and Form 20-F Information 2016
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28 Commitments and contingent
liabilities continued
the Beijing Higher People’s Court and the
appeal was rejected in December 2016.
AstraZeneca is considering its options.
In Brazil, in February 2013, Eurofarma
Laboratorios S.A. (Eurofarma) filed a nullity
action against a formulation patent for Faslodex
in the 31st Specialized Intellectual Property
Federal Court of Rio de Janeiro (the Court).
In October 2015, the Court ruled in Eurofarma’s
favour and invalidated AstraZeneca’s patent. In
November 2015, AstraZeneca appealed the
decision and the appeal remains pending.
Losec/Prilosec (omeprazole)
Patent proceedings outside the US
In Canada, in 2004, AstraZeneca brought
proceedings against Apotex Inc. (Apotex) for
infringement of several patents related to
Losec. In February 2015, the Federal Court
of Canada found that Apotex had infringed
AstraZeneca’s Losec formulation patent
(Canadian Patent No. 1,292,693). Apotex
appealed. In January 2017, the Federal Court
of Appeal (the Appeal Court) upheld the trial
court’s findings of infringement and validity.
However, the Appeal Court upheld one aspect
of Apotex’s appeal relating to a limitation
period defence, which may lower the amount
of damages owed by Apotex. A reference to
determine patent infringement damages is
scheduled to commence in February 2017.
Movantik/Movantig (naloxegol)
US patent proceedings
In 2015, Neptune Generics LLC, filed a petition
seeking inter partes review with the Patent
Office challenging the validity of a patent listed
in the FDA Orange Book with reference to
Movantik (US Patent No. 7,786,133). In April
2016, the Patent Trial and Appeal Board
denied the petition.
Patent proceedings outside the US
In Europe, Generics (UK) Ltd (trading as
Mylan) filed an opposition to the grant of
European Patent No. EP 1694363 with the
European Patent Office (EPO). In February
2016, the Opposition Division of the EPO
upheld the patent as granted, and dismissed
the opposition.
In Europe, in September 2016, Generics (UK)
Ltd; ABG Patentes, SL; and Stada Arzneimittel
AG filed oppositions to the grant of European
Patent No. EP 2621496 with the European
Patent Office. The Patent’s proprietors
(AstraZeneca AB and Nektar Therapeutics)
have been invited to file a response to the
Statements of Opposition.
Nexium (esomeprazole magnesium)
US patent proceedings
Several separate Nexium, Nexium oral
suspension and Nexium 24HR (OTC) patent
litigations are ongoing in the US District Court
for the District of New Jersey. Proceedings
are at various stages and no trial dates have
been set.
Patent proceedings outside the US
In Canada, in July 2014, the Federal Court
found the Nexium substance patent (Canadian
Patent No. 2,139,653) invalid and not infringed
by Apotex Inc. In July 2015, AstraZeneca’s
appeal was dismissed. AstraZeneca was
granted leave to appeal to the Supreme Court
of Canada and a hearing was held in
November 2016. A decision is pending.
Onglyza (saxagliptin) and Kombiglyze
(saxagliptin and metformin)
US patent proceedings
AstraZeneca initiated patent infringement
proceedings against various entities in the
US District Court for the District of Delaware
(the District Court) after those entities had
submitted ANDAs containing a Paragraph IV
Certification alleging that US Patent No.
RE44,186, listed in the FDA Orange Book
with reference to Onglyza and Kombiglyze XR,
is invalid and/or will not be infringed by the
products as described in their ANDAs.
A trial was held in September 2016 against
Wockhardt Bio AG and Wockhardt USA LLC,
Sun Pharma Global FZE, Sun Pharmaceutical
Industries Ltd, Amneal Pharmaceuticals LLC,
Mylan Pharmaceuticals Inc., Aurobindo Pharma
Ltd., Aurobindo Pharma U.S.A., Inc., Actavis
Laboratories FL, Inc. and Watson Laboratories,
Inc. A decision is awaited. In September 2016,
Apotex Corp. and Apotex, Inc. agreed to be
bound by the District Court’s decision.
In June 2016, the US Court of Appeals for the
Federal Circuit denied Mylan Pharmaceuticals
Inc. (Mylan) petition for rehearing en banc of
the decision affirming the denial of Mylan’s
motion to dismiss for lack of jurisdiction. In
September 2016, Mylan filed a petition for writ
of certiorari with the Supreme Court of the
United States seeking an appeal of that decision
and, in January 2017, that petition was denied.
In May 2016, the US Patent and Trademark
Office (USPTO) instituted an inter partes review
brought by Mylan Pharmaceutical Inc. (the
Mylan IPR) challenging the validity of US Patent
No. RE44,186 (the ’186 Patent). Subsequently,
Wockhardt Bio AG, Teva Pharmaceuticals
USA, Inc., Sun Pharmaceutical Industries, Ltd.,
Sun Pharma Global FZE and Amneal
Pharmaceuticals LLC also filed petitions for
inter partes review challenging the validity of
the ’186 Patent and joined the Mylan IPR.
A hearing in the Mylan IPR was held in January
2017. A decision is awaited.
Pulmicort Respules (budesonide
inhalation suspension)
US patent proceedings
In February 2015, the US District Court for the
District of New Jersey (the District Court)
determined that the asserted claims of US
Patent No. 7,524,834 were invalid and denied
AstraZeneca’s motion for an injunction against
Apotex, Inc. and Apotex Corp., Breath Limited,
Sandoz, Inc. and Watson Laboratories, Inc.
(together, the Generic Challengers) pending
an appeal of the District Court’s decision.
AstraZeneca appealed that decision to the
US Court of Appeals for the Federal Circuit
(the Court of Appeals) and filed an Emergency
Motion for an Injunction Pending Appeal.
The Court of Appeals granted AstraZeneca’s
motion and issued an injunction against the
Generic Challengers pending appeal. In May
2015, the Court of Appeals affirmed the
District Court’s decision and lifted the
injunction that was issued. Since 2009, various
injunctions were issued in this matter. Damages
claims based on those injunctions have been
filed and a provision has been taken.
Seroquel XR (quetiapine fumarate)
Patent proceedings outside the US
In Denmark, in June 2016, following a
challenge to the validity of the formulation
patent covering Seroquel XR by Teva Denmark
A/S and Accord Healthcare Ltd., the Danish
Maritime and Commercial High Court found
the Seroquel XR formulation patent invalid.
In France, in April 2015, Mylan SAS (Mylan)
brought a patent invalidation action against
AstraZeneca’s French designation of the
Seroquel XR formulation patent. In July 2016,
the Tribunal de grande instance de Paris found
the Seroquel XR formulation patent invalid.
In Spain, in May 2016, the Supreme Court
affirmed a decision from October 2013
which found the Seroquel XR formulation
patent invalid. The generic challengers were
Accord Healthcare S.L.U. and Sandoz
Farmacéutica, S.A.
In Sweden, in May 2016, following a challenge
to the validity of the formulation patent covering
Seroquel XR by Sandoz A/S, the Stockholm
District Court found the Seroquel XR
formulation patent invalid.
In various countries in Europe generic entities
have claimed, or may claim, damages relating to
preliminary injunctions issued in those countries
that prevented generic Seroquel XR sales by
those entities. A provision has been taken.
Synagis (palivizumab)
US patent proceedings
In December 2016, UCB BioPharma SPRL
filed a complaint against MedImmune in the
US District Court for the District of Delaware
alleging infringement of US Patent No.
7,566,771. The complaint relates to a
royalty-bearing licence between Celltech
R&D LTD and MedImmune which was
terminated by MedImmune in 2010.
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Tagrisso (osimertinib)
Patent proceedings outside the US
In Europe, in October 2016, Stada Arzneimittel
AG filed an opposition to the grant of European
Patent No. EP 2736895.
Vimovo (naproxen/
esomeprazole magnesium)
Patent proceedings outside the US
In Canada, in January 2015, AstraZeneca
received two notices of allegation from
Mylan Pharmaceuticals ULC. In response,
AstraZeneca and Pozen Inc. (now Aralez
Pharmaceuticals Inc.), the licensee and patent
holder, respectively, commenced proceedings
in relation to the Vimovo formulation patent
(Canadian Patent No. 2,449,098). A hearing
was held in November 2016 and a decision
is pending.
Product liability litigation
Byetta/Bydureon (exenatide)
Amylin Pharmaceuticals, LLC, a wholly owned
subsidiary of AstraZeneca, and/or AstraZeneca
are among multiple defendants in various
lawsuits filed in federal and state courts in
the US involving claims of physical injury
from treatment with Byetta and/or Bydureon.
The lawsuits allege several types of injuries
including pancreatitis, pancreatic cancer,
thyroid cancer, and kidney cancer.
A multidistrict litigation was established in the
US District Court for the Southern District of
California (the District Court) in regard to the
alleged pancreatic cancer cases in federal
courts. Further, a coordinated proceeding
has been established in Los Angeles,
California in regard to the various lawsuits in
California state courts.
In November 2015, the District Court granted
the defendants’ motion for summary judgment
and dismissed all claims alleging pancreatic
cancer that accrued prior to 11 September
2015. A similar motion was granted in favour
of the defendants in the California state
coordinated proceeding, and judgment was
entered in May 2016. Plaintiffs have appealed
both rulings.
A single case alleging similar claims that was
pending in Alabama state court is now resolved.
Crestor (rosuvastatin calcium)
AstraZeneca is defending a number of lawsuits
in the US alleging multiple types of injuries
caused by the use of Crestor, including
diabetes mellitus, various cardiac injuries,
rhabdomyolysis, and/or liver and kidney injuries.
The claims of approximately 600 plaintiffs,
comprising approximately 100 California
residents and approximately 500 non-
California residents, were aggregated in one
coordinated proceeding in Los Angeles,
California. The claims of approximately 600
additional non-California plaintiffs were also
pending in California state court. In October
2014, the coordination judge dismissed the
claims of the non-California plaintiffs whose
claims were in the coordinated proceeding.
The plaintiffs appealed the October 2014 order
dismissing the non-California plaintiffs from the
proceeding. In July 2016, the Court of Appeal
in California dismissed the plaintiffs’ appeal,
effectively dismissing the claims of all of the
non-California residents from California state
court, leaving the option of re-filing in the
plaintiffs’ home states. The claims of
approximately 30 plaintiffs remain pending in
California state court.
Farxiga (dapagliflozin)
AstraZeneca has been named as a defendant
in lawsuits in the US involving plaintiffs claiming
physical injury, including diabetic ketoacidosis
and kidney failure, from treatment with Farxiga
and/or Xigduo XR. Cases with these allegations
have been filed in several jurisdictions in the
US. In October 2016, one of these cases
was dismissed with prejudice in favour of
AstraZeneca. Since then, several other cases
have been dismissed, either voluntarily or by
the courts. Motions to dismiss are pending in
many of the jurisdictions where AstraZeneca
has been served.
Counsel for plaintiffs in a product liability action
pertaining to Invokana (a product in the same
class as Farxiga) filed a motion with the Judicial
Panel on Multidistrict Litigation (JPML) seeking
transfer of any currently pending cases as well
as any similar, subsequently filed cases to
a coordinated and consolidated pre-trial
multidistrict litigation (MDL) proceeding on
a class-wide basis. In December 2016, the
JPML granted an MDL to only those plaintiffs
alleging injury from Invokana.
Nexium and Prilosec (esomeprazole
and omeprazole)
AstraZeneca has been defending product
liability lawsuits brought in US federal and state
courts by approximately 1,900 plaintiffs who
alleged that Nexium caused osteoporotic
injuries, such as bone deterioration, loss of
bone density and/or bone fractures, but all
such claims have now been dismissed with
judgment entered in AstraZeneca’s favour.
Approximately 270 plaintiffs appealed the
dismissal of their claims to the US Court of
Appeals for the Ninth Circuit, and fewer than
40 plaintiffs appealed the dismissal of their
claims to the California Second Appellate
Division. In October 2016, the US Court of
Appeals for the Ninth Circuit affirmed the
dismissal of the approximately 270 claims in
federal court. In January 2017, the California
Second Appellate Division affirmed the
dismissal of the fewer than 40 cases in
California state court.
AstraZeneca is defending various lawsuits
in the US involving multiple plaintiffs claiming
that they have been diagnosed with kidney
injuries following treatment with proton pump
inhibitors, including Nexium and Prilosec.
In October 2016, counsel for some of these
plaintiffs filed a motion with the Judicial Panel
on Multidistrict Litigation seeking transfer of
any currently pending federal court cases as
well as any similar, subsequently filed cases
to a coordinated and consolidated pre-trial
multidistrict litigation proceeding.
Onglyza/Kombiglyze (saxagliptin)
Amylin Pharmaceuticals, LLC, a wholly owned
subsidiary of AstraZeneca, and/or AstraZeneca
are among multiple defendants in various
lawsuits filed in federal and state courts in
the US involving multiple plaintiffs claiming
pancreatic injuries, heart failure, cardiac failure
and/or death injuries from treatment with
Onglyza or Kombiglyze. In May 2016, a federal
judge in California granted AstraZeneca’s
motion for summary judgment and dismissed
the claims of 14 plaintiffs who alleged
pancreatic injuries, including pancreatic
cancer, from treatment with either Onglyza or
Kombiglyze. No similar claims remain actively
pending in any US jurisdiction.
In October 2016, the claims of 14 plaintiffs
alleging heart failure, cardiac failure and/or
death from treatment with either Onglyza or
Kombiglyze were dismissed in response to
motions filed by AstraZeneca. Approximately
85 plaintiffs’ claims currently remain in active
litigation. In December 2016, plaintiffs in the
California Superior Court filed a Petition for
Coordination with the Judicial Council of
California requesting that all similar, currently
pending or subsequently filed cases in
California be coordinated for pre-trial purposes.
Seroquel IR (quetiapine fumarate)
AstraZeneca has resolved all active claims with
regard to the Seroquel product liability litigation
in the US.
Synagis (palivizumab)
AstraZeneca and MedImmune were named as
defendants in a lawsuit filed in the US District
Court for the Middle District of Louisiana
involving two plaintiffs alleging wrongful death
from treatment with Synagis. In July 2016, the
plaintiffs dismissed their claims voluntarily.
Commercial litigation
Crestor (rosuvastatin calcium)
Qui tam litigation
In the US, in January and February 2014,
AstraZeneca was served with lawsuits filed in
the US District Court for the District of Delaware
under the qui tam (whistleblower) provisions of
the federal False Claims Act and related state
statutes, alleging that AstraZeneca directed
certain employees to promote Crestor off-label
and provided unlawful remuneration to
physicians in connection with the promotion
of Crestor. The DOJ and all US states have
declined to intervene in the lawsuits. This
litigation has been stayed pending trial court
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disposition or earlier resolution of the Texas
Attorney General litigation involving Crestor
disclosed below.
Texas Attorney General Litigation
In the US, in January 2015, following a previously
disclosed investigation by the State of Texas
into AstraZeneca’s sales and marketing
activities involving Crestor, AstraZeneca was
served with a lawsuit in which the Texas
Attorney General’s office intervened in a state
whistleblower action pending in Travis County
Court, Texas. The lawsuit alleges that
AstraZeneca engaged in inappropriate
promotion of Crestor and improperly
influenced the formulary status of Crestor.
Israel
In Israel, in November 2012, a Motion to Certify
a Claim as a Class Action and Statement of
Claim (together, a Motion to Certify) were filed
in the District Court in Tel Aviv, Jaffa, (the
District Court) against AstraZeneca and four
other pharmaceutical companies for alleged
deception and failure to disclose material facts
to consumers regarding potential adverse
events associated with certain drugs, including
Crestor. In July 2013, an amended Motion to
Certify containing similar allegations to those
in the first action were filed in the same
District Court against the same defendants.
In November 2016, the plaintiff filed a motion
to withdraw from the action, which the District
Court granted in December 2016. This matter
has now concluded.
Citizen’s Petition
In the US, in May 2016, AstraZeneca filed a
Citizen’s Petition with the FDA requesting that
the FDA not approve any pending generic
ANDAs for rosuvastatin until the expiration of
the paediatric orphan exclusivity for Crestor.
In June 2016, AstraZeneca filed its Complaint
for Declaratory and Injunctive Relief and an
Application for a Temporary Restraining Order
(TRO) with the US District Court for the District
of Columbia (the District Court) requesting that
the District Court prohibit the FDA from granting
final approval to any pending ANDAs for
generic versions of Crestor until the expiration
of paediatric orphan exclusivity. In July 2016,
the District Court denied AstraZeneca’s
application for a TRO. In August 2016, the
District Court entered an order dismissing the
case without prejudice. This matter is
now concluded.
Nexium (esomeprazole magnesium)
Consumer litigation
In the US, AstraZeneca has been a defendant
in a class action filed in Delaware State Court
(the State Court) alleging that AstraZeneca’s
promotion, advertising and pricing of Nexium
to physicians, consumers and third party
payers was unfair, unlawful and deceptive.
In July 2015, the State Court granted
AstraZeneca’s motion to dismiss and entered
judgment in AstraZeneca’s favour. In April
2016, the Delaware Supreme Court affirmed
the dismissal.
to intervene in the lawsuits. This litigation has
been stayed pending trial court disposition or
earlier resolution of the Texas Attorney General
litigation involving Seroquel disclosed below.
Settlement anti-trust litigation
In the US, AstraZeneca is a defendant in a
multidistrict litigation class action and individual
lawsuit alleging that AstraZeneca’s settlements
of certain patent litigation in the US relating to
Nexium violated US antitrust law and various
state laws. A trial in the US District Court for
the District of Massachusetts commenced in
October 2014 and, in December 2014, a jury
returned a verdict in favour of AstraZeneca and
entered judgment in favour of AstraZeneca in
September 2015. The plaintiffs appealed that
judgment and, in November 2016, the US
Court of Appeals for the First Circuit affirmed.
The plaintiffs petitioned for rehearing and
rehearing en banc, both of which were denied
in January 2017.
Trademark litigation
AstraZeneca filed separate complaints in the
US District Court for the District of Delaware
against Camber Pharmaceuticals, Inc. and
Dr. Reddy’s Laboratories, Inc. to enforce
certain AstraZeneca trademark rights related
to Nexium and Prilosec. These matters have
been successfully resolved.
Seroquel IR (quetiapine fumarate) and
Seroquel XR (quetiapine fumarate)
Mississippi Attorney General Investigation
In relation to the state law claims brought by
State Attorneys General in the US generally
alleging that AstraZeneca made false and/or
misleading statements in marketing and
promoting Seroquel, AstraZeneca’s remaining
case with the Attorney General of Mississippi
has been resolved and the matter has been
dismissed. This matter is now concluded.
Qui tam litigation in New York
In the US, in September 2015, AstraZeneca
was served with a lawsuit filed in US Federal
Court in New York under the qui tam
(whistleblower) provisions of the federal and
certain state False Claims Acts. The lawsuit
alleges that AstraZeneca misrepresented the
safety profile of, and improperly promoted,
Seroquel IR and Seroquel XR. The US
government and the named states have
declined to intervene in this case.
Qui tam litigation in Delaware
In the US, in April 2014, AstraZeneca was
served with lawsuits filed in the US District
Court for the District of Delaware under the qui
tam (whistleblower) provisions of the federal
False Claims Act and related state statutes,
alleging that AstraZeneca directed certain
employees to promote Seroquel IR and
Seroquel XR off-label and provided unlawful
remuneration to physicians in connection with
the promotion of Seroquel IR and Seroquel
XR. The DOJ and all US states have declined
Texas Attorney General Litigation
In the US, in October 2014, following a
previously disclosed investigation by the
State of Texas into AstraZeneca’s sales and
marketing activities involving Seroquel, the
Texas Attorney General’s Office intervened
in a state whistleblower action pending in
Travis County Court, Texas. The lawsuit
alleges that AstraZeneca engaged in
inappropriate promotion of Seroquel and
made improper payments intended to
influence the formulary status of Seroquel.
Toprol-XL (metoprolol succinate)
In the US, in March 2015, AstraZeneca was
served with a state court complaint filed by
the Attorney General for the State of Louisiana
alleging that, in connection with enforcement
of its patents for Toprol-XL, it had engaged in
unlawful monopolisation and unfair trade
practices, causing the state government to pay
increased prices for Toprol-XL. In February
2016, the Louisiana state court heard oral
argument on AstraZeneca’s motion to dismiss
and ordered the dismissal of the complaint
with prejudice and judgment in AstraZeneca’s
favour. The State is appealing the dismissal.
Other commercial litigation
Ocimum Lawsuit
In the US, in December 2015, AstraZeneca
was served with a complaint filed by Ocimum
Biosciences, Ltd. (Ocimum) in the Superior
Court for the State of Delaware that alleges,
among other things, breaches of contractual
obligations and misappropriation of trade
secrets, relating to a now terminated 2001
licensing agreement between AstraZeneca
and Gene Logic, Inc. (Gene Logic), the rights
to which Ocimum purports to have acquired
from Gene Logic.
Pearl Therapeutics
In the US, AstraZeneca was served with a
complaint filed in Delaware State Court by
the former shareholders of Pearl Therapeutics,
Inc. (Pearl) that alleged, among other things,
breaches of contractual obligations relating to a
2013 merger agreement between AstraZeneca
and Pearl. This case was resolved in September
2016. This matter is now concluded.
Telephone Consumer Protection Act
litigation
In the US, in December 2016, AstraZeneca
and several other entities were served with a
complaint filed in the US District Court for the
Southern District of Florida (the District Court)
that alleges, among other things, violations of
the Telephone Consumer Protection Act
caused by the sending of unsolicited
advertisements by facsimile. AstraZeneca’s
motion to dismiss is pending. Plaintiff also
190
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liabilities continued
made a motion for class certification, which, in
January 2017, was denied without prejudice by
the District Court.
Government investigations/proceedings
Synagis (palivizumab)
In the US, in June 2011, MedImmune received
a demand from the US Attorney’s Office for
the Southern District of New York requesting
certain documents related to the sales and
marketing activities of Synagis. In July 2011,
MedImmune received a similar court order to
produce documents from the Office of the
Attorney General for the State of New York
Medicaid and Fraud Control Unit pursuant to
what the government attorneys advised was a
joint investigation. MedImmune is cooperating
with these inquiries.
In May 2012, MedImmune received a
subpoena duces tecum from the Office of
Attorney General for the State of Florida
Medicaid and Fraud Control Unit requesting
certain documents related to the sales and
marketing activities of Synagis. MedImmune
has accepted receipt of the request and has
coordinated with the Florida government to
provide the appropriate responses and
cooperate with any related investigation.
AstraZeneca is unaware of the nature or focus
of the investigation, however, based on the
nature of the requests, it appears to be similar
to the inquiry from the State of New York
(which is described above).
Other government investigations/proceedings
Foreign Corrupt Practices Act
In connection with investigations into anti-bribery
and corruption issues in the pharmaceutical
industry, AstraZeneca received inquiries from
enforcement agencies, including the DOJ and
the SEC, regarding, among other things, sales
practices, internal controls, certain distributors
and interactions with healthcare providers and
other government officials in several countries.
In August 2016, AstraZeneca entered into a
civil settlement with the SEC to resolve these
inquiries. The DOJ has informed AstraZeneca
that it has closed its inquiry into this matter.
Additional government inquiries
As is true for most, if not all, major prescription
pharmaceutical companies operating in the
US, AstraZeneca is currently involved in
multiple US federal and state inquiries into
drug marketing and pricing practices. In
addition to the investigations described above,
various federal and state law enforcement
offices have, from time to time, requested
information from the Group. There have been
no material developments in those matters.
Tax
Where tax exposures can be quantified, an
accrual is made based on best estimates and
management’s judgement. Details of the
movements in relation to material tax exposures
are discussed below. As accruals can be built
up over a long period of time but the ultimate
resolution of tax exposures usually occurs
at a point in time, and given the inherent
uncertainties in assessing the outcomes of
these exposures (which sometimes can be
binary in nature), we could, in future periods,
experience adjustments to these accruals
that have a material positive or negative effect
on our results in any particular period.
AstraZeneca faces a number of audits in
jurisdictions around the world and, in some
cases, is in dispute with the tax authorities.
The issues under discussion are often complex
and can require many years to resolve. Accruals
for tax contingencies require management to
make estimates and judgements with respect
to the ultimate outcome of a tax audit, and
actual results could vary from these estimates.
Transfer pricing and other
international tax contingencies
The total net accrual included in the Group
Financial Statements to cover the worldwide
exposure to transfer pricing audits is $320m,
a decrease of $41m compared with 2015
mainly due to the release of the net accrual
following agreements between the Canadian
and the UK and Swedish tax authorities in
respect of transfer pricing arrangements for the
13-year period 2004 to 2016, partially offset by
increases in accruals for transfer pricing
contingencies and exchange rate effects.
Management continues to believe that
AstraZeneca’s positions on all its transfer
pricing audits and disputes are robust and
that AstraZeneca is appropriately provided,
including the assessment where corresponding
relief will be available. For transfer pricing audits
where AstraZeneca and the tax authorities are
in dispute, AstraZeneca estimates the potential
for reasonably possible additional losses
above and beyond the amount provided to
be up to $184m (2015: $357m; 2014: $521m),
however, management believes that it is unlikely
that these additional losses will arise. It is
possible that some of these contingencies
may reduce in the future to the extent that any
tax authority challenge is unsuccessful, or
matters lapse following expiry of the relevant
statutes of limitation resulting in a reduction in
the tax charge in future periods.
Other tax contingencies
Included in the tax accrual is $1,007m relating
to a number of other tax contingencies, a
decrease of $366m mainly due to releases
following expiry of statute of limitations, audit
settlements and exchange rate effects offset by
the impact of an additional year of transactions
relating to contingencies for which accruals
had already been established. For these tax
exposures, AstraZeneca does not expect
material additional losses. It is, however,
possible that some of these contingencies
may reduce in the future if any tax authority
challenge is unsuccessful or matters lapse
following expiry of the relevant statutes of
limitation resulting in a reduction in the tax
charge in future periods.
Timing of cash flows and interest
It is not possible to estimate the timing of
tax cash flows in relation to each outcome,
however, it is anticipated that a number of
significant disputes may be resolved over
the next one to two years. Included in the
provision is an amount of interest of $142m
(2015: $174m; 2014: $227m). Interest is
accrued as a tax expense.
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Total rentals under operating leases charged to profit were as follows:
Operating leases
2016
$m
174
2015
$m
185
2014
$m
185
The future minimum lease payments under operating leases that have initial or remaining terms in excess of one year at 31 December 2016 were as
follows:
Obligations under leases comprise:
Not later than one year
Later than one year and not later than five years
Later than five years
Total future minimum lease payments
2016
$m
98
247
96
441
2015
$m
95
245
69
409
2014
$m
100
247
91
438
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Financial Statements
30 Statutory and other information
Fees payable to KPMG LLP and its associates:
Group audit fee
Fees payable to KPMG LLP and its associates for other services:
The audit of subsidiaries pursuant to legislation
Audit-related assurance services
Tax compliance services
Other assurance services
Fees payable to KPMG LLP in respect of the Group’s pension schemes:
The audit of subsidiaries’ pension schemes
2016
$m
2.8
5.4
2.5
–
0.2
0.6
11.5
2015
$m
3.2
5.4
2.5
0.1
0.5
0.6
12.3
2014
$m
2.5
5.0
2.5
0.3
0.5
0.5
11.3
Audit-related assurance services include fees of $1.8m (2015: $1.8m; 2014: $1.8m) in respect of section 404 of the Sarbanes-Oxley Act.
Related party transactions
The Group had no material related party transactions which might reasonably be expected to influence decisions made by the users of these
Financial Statements.
Key management personnel compensation
Key management personnel are defined for the purpose of disclosure under IAS 24 ‘Related Party Disclosures’ as the members of the Board and
the members of the SET.
Short-term employee benefits
Post-employment benefits
Share-based payments
2016
$’000
23,725
2,407
20,377
46,509
2015
$’000
29,265
2,636
17,885
49,786
2014
$’000
30,252
2,265
20,253
52,770
Total remuneration is included within employee costs (see Note 27). Further details of Directors’ emoluments are included in the Directors’
Remuneration Report from pages 103 to 132.
31 Subsequent events
There were no material subsequent events.
192
AstraZeneca Annual Report and Form 20-F Information 2016
Group Subsidiaries and Holdings
In accordance with section 409 of the Companies Act 2006 a full list of subsidiaries, partnerships, associates, joint ventures and joint arrangements,
the country of incorporation, registered office address, and the effective percentage of equity owned as at 31 December 2016 are disclosed below.
Unless otherwise stated the share capital disclosed comprises ordinary shares which are indirectly held by AstraZeneca PLC.
Unless otherwise stated the accounting year ends of subsidiaries are 31 December. The Group Financial Statements consolidate the Financial
Statements of the Company and its subsidiaries at 31 December 2016.
At 31 December 2016
Wholly owned subsidiaries
Argentina
AstraZeneca S.A.
Vedia 3616-Piso 8, Ciudad de
Buenos Aires, Argentina
Australia
AstraZeneca Holdings Pty Limited
AstraZeneca PTY Limited
Pharmaceutical Manufacturing
Company Pty Limited
Pharmaceutical Manufacturing
Division Pty Limited
66 Talavera Road, Macquarie Park NSW
2113, Australia
Austria
AstraZeneca Österreich GmbH
A-1030 Wien, Schwarzenbergplatz 7, Austria
Belgium
AstraZeneca S.A. / N.V.
Egide Van Ophemstraat 110 1180
Brussels, Belgium
Brazil
AstraZeneca do Brasil Limitada
Rod. Raposo Tavares, KM 26, 9, Cotia, Brazil
100
100
100
100
100
100
100
Bulgaria
AstraZeneca Bulgaria EOOD
100
36 Dragan Tzankov Blvd., District Izgrev,
Sofia, 1057, Bulgaria
Canada
AstraZeneca Canada Inc.1
1004 Middlegate Road, Ontario, L4Y 1M4,
Canada
Cayman Islands
AZ Reinsurance Limited
94 Solaris Avenue, Second Floor, Camana Bay,
Grand Cayman, Cayman Islands
Chile
AstraZeneca S.A.
AstraZeneca Farmaceutica Chile Limitada
Av. Isadora Goyenechea 2939, of .201,
Santiago de Chile, Chile
100
100
100
100
Percentage of
voting share
capital held
At 31 December 2016
AstraZeneca (Wuxi) Trading Co. Ltd
2F, Building 4, No 2 Huangshan Road,
Wuxi, Jiangsu Province, China
Percentage of
voting share
capital held
At 31 December 2016
100
France
AstraZeneca S.A.S.
AstraZeneca Finance S.A.S.
AstraZeneca Investment (China) Co., Ltd
100
AstraZeneca Holding France S.A.S.
Percentage of
voting share
capital held
100
100
100
100
No.199 Liangjing Road, ZhangJiang
Hi-tech Park, Shanghai, China
AstraZeneca Pharmaceutical
(China) Co. Ltd
No 88 Yaocheng Avenue, Taizhou,
Jiangsu Province, China
Colombia
AstraZeneca Colombia S.A.
Carrera 7 No. 71-21, Torre A, Piso 19,
Santafe de Bogota, Colombia
AstraZeneca Reims S.A.S.
Tour Carpe Diem – 31, Place des Corolles,
92400 Courbevoie, France
100
AstraZeneca Dunkerque Production SCS
100
224 Avenue de la Dordogne, 59640
Dunkerque, France
Germany
100
AstraZeneca Holding GmbH
AstraZeneca GmbH
Tinsdaler Weg 183, Wedel, D-22880, Germany
Sofotec GmbH
Benzstrasse 1-3, 61352, Bad Homburg
v.d. Hohe, Germany
Definiens AG
Bernhard-Wicki-Straße 5, 80636, Munich,
Germany
100
100
100
100
100
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
Costa Rica
AstraZeneca CAMCAR Costa Rica, S.A.
100
Escazu, Guachipelin, Centro Corporativo Plaza Roble,
Edificio Los Balcones, Segundo Nivel,
San Jose, Costa Rica
Croatia
AstraZeneca d.o.o.
Radnicka cesta 80/11, 10000 Zagreb, Croatia
100
Czech Republic
100
Greece
AstraZeneca S.A.
Theotokopoulou 4 & Astronafton, Athens,
151 25, Greece
Hong Kong
AstraZeneca Hong Kong Limited
100
18/F., Shui On Centre, 6-8 Harbour Road,
Wanchai, Hong Kong
Hungary
AstraZeneca Kft
2nd floor, 134-146 building B, Bocskai str.,
Budapest, 1113, Hungary
100
India
AstraZeneca India Private Limited2
100
12th Mile on Bellary Road, Venkatala, Opp. BSF
(Border Security Force), Yelahanka, Bangalore-560 063,
India
AstraZeneca Czech Republic, s.r.o.
100
Smichov Gate – Prague, Plzenska 3217/16,
Prague 5, 150 00, Czech Republic
Denmark
AstraZeneca A/S
Arne Jacobsens Allé 13, DK-2300,
Copenhagen S, Denmark
Egypt
AstraZeneca Egypt for
Pharmaceutical Industries JSC
Villa 133, Road 90 North, New Cairo, Egypt
Drimex LLC
Villa 47, Road 270, New Maadi, Cairo 11435, Egypt
AstraZeneca Egypt for Trading LLC
100
100
100
100
14C Ahmed Kamel Street, New Maadi, Cairo, Egypt
Iran
Estonia
AstraZeneca Eesti OÜ
Jarvevana tee 9, II korrus, Tallinn, 11314, Estonia
100
100
AstraZeneca Pars Company
100
No.4, Mahshahr Street, Karimkhan Street,
Tehran, 15847-38515, Islamic Republic of Iran
Ireland
AstraZeneca Pharmaceuticals (Ireland)
Designated Activity Company
100
4th Floor, South Bank House, Barrow Street,
Dublin, 4, Republic of Ireland
AstraZeneca Annual Report and Form 20-F Information 2016
193
China
AstraZeneca Pharmaceuticals Co., Limited.
100
No 2 Huangshan Road, Wuxi,
Jiangsu Province, China
Finland
AstraZeneca OY.
Itsehallintokuja 4, Espoo, 02600, Finland
Financial Statements
At 31 December 2016
Israel
AstraZeneca Israel Ltd
13 Zarcin St., Ra’anana 43662, Israel
Italy
Simesa SpA
AstraZeneca SpA
Palazzo Ferraris, via Ludovico il Moro 6/c
20080, Basiglio (Milan), Italy
Japan
AstraZeneca K.K.
3-1, Ofuka-cho, Kita-ku, Osaka, Japan
Chaka Place, Ground Floor, Argwings
Kodhek, Nairobi, Kenya
Latvia
AstraZeneca Latvija SIA
Skanstes iela 54, Riga, LV-1013, Latvia
Lithuania
AstraZeneca Lietuva UAB
Jasinkio 16A, Vilnius, LT-03163, Lithuania
(cid:47)(cid:88)(cid:91)(cid:72)(cid:80)(cid:69)(cid:82)(cid:88)(cid:85)(cid:74)
AstraZeneca Luxembourg S.A.
Am Brill 7 B – L-3961 Ehlange – Grand
Duchy du Luxembourg, Luxembourg
Malaysia
Kenya
AstraZeneca Pharmaceuticals Limited
100
Percentage of
voting share
capital held
100
100
100
At 31 December 2016
AstraZeneca Sigma B.V.
AstraZeneca Zeta B.V.
Percentage of
voting share
capital held
100
100
PO Box 283, 2700 AG Zoetermeer, Louis
Pasteurlaan 5, 2719 EE, Zoetermeer, The Netherlands
At 31 December 2016
Puerto Rico
Percentage of
voting share
capital held
IPR Pharmaceuticals, Inc.
100
San Isidro Industrial Park, Road 188, Lot 17,
Canóvanas, PR 00729, Puerto Rico
MedImmune Pharma B.V.
Lagelandsweeg 78, 6545 CG Nijmegen,
The Netherlands
New Zealand
AstraZeneca Limited
Level 2, 347-351 Parnell Rd, Parnell,
Auckland, 1052, New Zealand
100
Nigeria
AstraZeneca Nigeria Limited
No.9 Joel Ogunaike Street, GRA Ikeja,
Lagos, Nigeria
Norway
AstraZeneca AS
100
Grensveien 92, Box 6050 Etterstad,
NO-0602 Oslo, Norway
100
Romania
AstraZeneca Pharma S.R.L.
100
12 Menuetului Street, Bucharest Business Park,
Building D, West Wing, 1st Floor, Sector 1,
Bucharest, 013713, Romania
100
Russia
AstraZeneca Industries, LLC
AstraZeneca Pharmaceuticals, LLC
100
100
100
125284, Begovaya str, 3, block 1,
Moscow, Russian Federation
Singapore
AstraZeneca Singapore Pte Limited
100
100
10 Kallang Avenue #12-10, Aperia Tower 2,
339510, Singapore
South Africa
Astra Pharmaceuticals (Pty) Limited
AstraZeneca Pharmaceuticals (Pty)
Limited
100
100
Pakistan
100
AstraZeneca Pharmaceuticals Pakistan
(Private) Limited
100
Office No 1, 2nd Floor, Sasi Arcade, Block 7,
Main Clifton Road, Karachi, Pakistan
17 Georgian Crescent West, Northdowns Office Park,
Bryanston, 2041, South Africa
100
Panama
South Korea
AstraZeneca CAMCAR, S.A.
Bodega #1, Parque Logistico MIT, Carretera
Hacia Coco Solo, Colon, Panama
100
AstraZeneca Korea Co. Ltd
100
Shincheon-dong, Luther Building 17fl. 42,
Shincheon-ro2-gil, Songpa-gu, Seoul, Republic of Korea
AstraZeneca Asia-Pacific Business
Services Sdn Bhd
Peru
100
Level 8, Unit 8.01-8.05 Menara UAC, Jalan PJU 7/5,
Multiara Damansara 47800 Petaling Jaya, Selangor,
Malaysia
AstraZeneca Peru S.A.
Av. El Derby 055, Torre 2. Piso 5. Of. 503.
Santiago de Surco, Lima, Peru
AstraZeneca Sdn Bhd
100
Philippines
Spain
100
AstraZeneca Farmaceutica Spain S.A.
AstraZeneca Farmaceutica Holding Spain,
S.A.
Laboratorio Beta, S.A.
Laboratorio Lailan, S.A.
Level 12, Surian Tower, No. 1 Jalan PJU
7/3, Mutiara Damansara, 47810 Petaling
Jaya, Selangor, Malaysia
(cid:48)(cid:72)(cid:91)(cid:76)(cid:70)(cid:82)
AstraZeneca, S.A. de C.V.
Av. Periferico Sur 4305 interior 5, Colonia
Jardines en la Montana, Mexico City, Tlalpan
Distrito Federal, CP14210, Mexico
AstraZeneca Pharmaceuticals (Phils.) Inc.
100
Laboratorio Odin, S.A.
16th Floors, Net Cube Center, corner 3rd Avenue
& 30th St., E-Square Zone, Crescent Park W,
Taguig, Metro Manila, 1634, Philippines
Laboratorio Tau S.A.
Parque Norte, Edificio Álamo, C/Serrano Galvache no
56., 28033 Madrid, Spain
100
Poland
Sweden
AstraZeneca Pharma Poland Sp.z.o.o.
100
Astra Export & Trading Aktiebolag
Postepu 14, 02-676, Warszawa, Poland
AstraZeneca Health Care S.A. de C.V.
100
Portugal
Avenida Lomas Verdes 67 Colonia Lomas
Verdes, Naucalpan de Juarez, CP 53120, Mexico
Astra Alpha Produtos Farmaceuticos Lda
AstraZeneca Produtos Farmaceuticos Lda
Morocco
Novastra Promoção e Comércio
Farmacêutico Lda
AstraZeneca Maroc SARLAU
100
Novastuart Produtos Farmaceuticos Lda
92 Boulevard Anfa ETG 2 Casablanca
20000, Morocco
The Netherlands
AstraZeneca B.V.
AstraZeneca Continent B.V.
AstraZeneca Gamma B.V.
AstraZeneca Holdings B.V.
AstraZeneca Jota B.V.
AstraZeneca Rho B.V.
100
100
100
100
100
100
Stuart-Produtos Farmacêuticos Lda
Zeneca Epsilon – Produtos
Farmacêuticos Lda
Zenecapharma Produtos
Farmaceuticos Lda
Rua Humberto Madeira, No 7, Queluz de
Baixo, 2730-097, Barcarena, Portugal
194
AstraZeneca Annual Report and Form 20-F Information 2016
100
100
100
100
100
100
100
Astra Lakemedel Aktiebolag
AstraZeneca AB
AstraZeneca Biotech AB
AstraZeneca BioVentureHub AB
AstraZeneca Holding Aktiebolag3
AstraZeneca International Holdings
Aktiebolag4
AstraZeneca Nordic AB
AstraZeneca Pharmaceuticals Aktiebolag
AstraZeneca Sodertalje 2 AB
Stuart Pharma Aktiebolag
Tika Lakemedel Aktiebolag
SE-151 85 Sodertalje, Sweden
Aktiebolaget Hassle
Symbicom Aktiebolag4
431 83 MoIndal, Sweden
Astra Tech International Aktiebolag
Box 14, 431 21 MoIndal, Sweden
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
At 31 December 2016
Switzerland
AstraZeneca AG
AstraZeneca, Grafenauweg 10, CH-6301,
Zug, Switzerland
Spirogen Sarl4
Rue du Grand-Chêne 5, CH-1003
Lausanne, Switzerland
Percentage of
voting share
capital held
100
100
Taiwan
AstraZeneca Taiwan Limited1
100
21st Floor, Taipei Metro Building 207, Tun Hwa South
Road, SEC 2 Taipei, Taiwan, Republic of China
Thailand
At 31 December 2016
AstraZeneca Treasury Limited4
AstraZeneca UK Limited
AstraZeneca US Investments Limited3
Ayzee 1 Limited
AYZEE 2 Limited
AYZEE 3 Limited
AYZEE 4 Limited
AZENCO2 Limited
AZENCO4 Limited
Cambridge Antibody Technology
Group Limited
KuDOS Horsham Limited
KuDOS Pharmaceuticals Limited
Meronem Group Limited
AstraZeneca (Thailand) Limited
100
Zenco (No 8) Limited
Asia Centre 19th floor, 173/20, South Sathorn Rd,
Khwaeng Thungmahamek, Khet Sathorn,
Bangkok, 10120, Thailand
Tunisia
AstraZeneca Tunisie SaRL
100
Lot n°1.5.5 les jardins du lac,
bloc B les berges du lac Tunis, Tunisia
Turkey
AstraZeneca Ilac Sanayi ve Ticaret Limited
Sirketi
100
Zeneca Finance (Netherlands) Company
1 Francis Crick Avenue,
Cambridge Biomedical Campus,
Cambridge, CB2 0AA, United Kingdom
MedImmune Limited
Milstein Building, Granta Park, Cambridge,
CB21 6GH, United Kingdom
MedImmune U.K. Limited
Plot 6, Renaissance Way, Boulevard Park,
Liverpool, L24 9JW, United Kingdom
United States
Amylin Pharmaceuticals LLC5
AstraZeneca Collaboration Ventures LLC5
100
AstraZeneca Pharmaceuticals, LP6
YKB Plaza, B Blok, Kat:3-4,
Levent/Be s ¸ikta s ¸, Istanbul, Turkey
Zeneca Ilac Sanayi Ve Ticaret Anonim
Sirketi
Büyükdere Cad., Y.K.B. Plaza, B Blok,
Kat:4, Levent/Be s ¸ikta s ¸, Istanbul, Turkey
Ukraine
AstraZeneca Ukraina LLC
Ukraine, 04080 Kyiv, 15/15, V. Khvoyky str.
United Arab Emirates
AstraZeneca FZ-LLC
P.O. Box 27614, Block D, Dubai Healthcare City,
Oud Mehta Road, Dubai, United Arab Emirates
United Kingdom
AlphaCore Pharma Limited
Ardea Biosciences Limited
Arrow Therapeutics Limited
Astra Pharmaceuticals Limited
AstraPharm4
AstraZeneca China UK Limited
AstraZeneca Death In Service
Trustee Limited
AstraZeneca Employee Share Trust Limited
AstraZeneca Finance Limited
AstraZeneca Insurance Company Limited
AstraZeneca Intermediate Holdings Limited3
AstraZeneca Investments Limited
AstraZeneca Japan Limited
AstraZeneca Nominees Limited
AstraZeneca Quest Limited
AstraZeneca Share Trust Limited
AstraZeneca Sweden Investments Limited
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
AstraZeneca, LLC5
AstraZeneca, LP6
Atkemix Nine Inc.
Atkemix Ten Inc.
BMS Holdco Inc.
Corpus Christi Holdings Inc.
Omthera Pharmaceuticals Inc.
Stauffer Management Company LLC5
Zeneca Holdings Inc.
Zeneca Inc.
Zeneca Wilmington Inc.3
1800 Concord Pike, Wilmington DE
19850, United States
ZS Pharma Inc.
1100 Park Place, Suite 300, San Mateo,
CA 94403, United States
AlphaCore Pharma, LLC5
333 Parkland Plaza, Suite 5, Ann Arbor,
MI 48103, United States
Amylin Ohio LLC5
8814 Trade Port Drive, West Chester,
OH 45011, United States
Ardea Biosciences, Inc.
4939 Directors Place, San Diego, CA
92121, United States
Percentage of
voting share
capital held
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
Percentage of
voting share
capital held
At 31 December 2016
MedImmune Biologics Inc.
MedImmune, LLC5
MedImmune Ventures, Inc.
MedImmune, One MedImmune Way,
Gaithersburg, Maryland 20878,
United States
Optein, Inc.
2711 Centerville Road, Suite 400,
Wilmington, Delaware 1989, United States
Pearl Therapeutics, Inc.
200 Saginaw Drive, Redwood City CA
94063, United States
Uruguay
AstraZeneca S.A.1
Yaguarón 1407 of 1205, Montevideo, Uruguay
Venezuela
AstraZeneca Venezuela S.A.
Av. Principal De la Castellana, Cruce con calle,
Jose Angel Lamas Piso 14, Venezuela
Gotland Pharma S.A.
Av. La Castellana, Torre La Castellana, Piso 5,
Oficina 5-G, 5-H, 5-I, Urbanización La Castellana,
Municipio Chacao, Estado Bolivariano de Miranda,
Venezuela
100
100
100
100
100
100
100
100
Subsidiaries where the effective
(cid:76)(cid:81)(cid:87)(cid:72)(cid:85)(cid:72)(cid:86)(cid:87)(cid:98)(cid:76)(cid:86)(cid:98)(cid:79)(cid:72)(cid:86)(cid:86)(cid:3)(cid:87)(cid:75)(cid:68)(cid:81)(cid:3)(cid:20)(cid:19)(cid:19)(cid:8)
Algeria
SPA AstraZeneca Al Djazair7
65.77%
No 20 Zone Macro Economique, dar El
Medina-Hydra, Alger, Algeria
`
India
AstraZeneca Pharma India Limited2
75%
Block N1, 12th Floor, Manyata Embassy
Business Park, Rachenahalli, Outer Ring
Road, Bangalore-560 045, India
Indonesia
P.T. AstraZeneca Indonesia
95%
Perkantoran Hijau Arkadia Tower F,
3rd Floor, JI. T.B. Simatupang Kav. 88,
Jakarta, 12520, Indonesia
i
F
n
a
n
c
i
a
l
S
t
a
t
e
m
e
n
t
s
The Netherlands
Acerta Pharma B.V.
Molenstraat 110, 5342CC Oss, The Netherlands
Aspire Therapeutics B.V.
Kloosterstraat 9, 5349 AB, Oss, The Netherlands
United Kingdom
I.C. Insurance Holdings Limited
(In Liquidation)
55%
55%
51%
100
c/o Deloitte LLP, PO Box 500,
2 Hardman Street, Manchester M60 2AT
AZ-Mont Insurance Company
100
76 St Paul Street, Suite 500, 05401-4477, United States
Definiens Inc.
100
1808 Aston Avenue, Suite 190, Carlsbad,
CA 92008, United States
AstraZeneca Annual Report and Form 20-F Information 2016
195
Percentage of
voting share
capital held
At 31 December 2016
Regulus Therapeutics Inc.
Percentage of
voting share
capital held
6.7%
0.17%
10614 Science Center Dr.,
San Diego, CA 92121, United States
VentiRx Pharmaceuticals, Inc.10
12%
1191 Second Avenue, Suite 1105,
Seattle, WA 98101, United States
1 Ownership held in ordinary and special shares.
2 Accounting year end is 31 March.
3 Directly held by AstraZeneca PLC.
4 Ownership held in class A and class B shares.
5 Ownership held as membership interest.
6 Ownership held as partnership interest.
7 Ownership held in class A shares.
8 Ownership held in preference, deferred and ordinary shares.
9 Ownership held in class B preference shares.
10 Ownership held in class A preference shares.
11 Ownership held in class B ordinary shares, class C ordinary
shares, and class D ordinary shares.
12 Ownership held in class A voting and class A non-voting
shares.
13 Ownership held in class A voting preference shares, class A
non-voting preference shares, and class B voting preference
shares.
14 Ownership held in class C preference shares.
15 Ownership held in class D preference shares.
16 Ownership held in class A preference shares and class B
preference shares.
17 Ownership held in class D preference shares and class E
preference shares.
Financial Statements
At 31 December 2016
United States
Percentage of
voting share
capital held
Advent Healthcare & Life Sciences III-A
Limited Partnership
75 State Street, Boston, 02109, United States
Acerta Pharma LLC
1509 Industrial Road, San Carlos,
CA 94070, United States
Joint Ventures
China
At 31 December 2016
United Kingdom
Silence Therapeutics PLC
60%
27 Eastcastle Street, London, W1W 8DH,
United Kingdom
55%
United States
Affinita Biotech, Inc.12
16.23%
329 Oyster Point Blvd., 3rd Floor, South
San Francisco, CA 94080, United States
Albireo Pharma, Inc.13
15.89%
WuXi MedImmune Biopharmaceutical
Co. Limited
50 Milk Street, 16th Floor,
Boston, MA 02109, United States
50%
Room 1902, 19/F, Lee Garden One, Hysan Avenue,
Causeway Bay, Hong Kong
Biodesix Inc.
United Kingdom
Archigen Biotech Limited7
Centus Biotherapeutics Limited7
1 Francis Crick Avenue,
Cambridge Biomedical Campus,
Cambridge, CB2 0AA, United Kingdom
2970 Wilderness Place Suite 100, Boulder,
CO 80301, United States
50%
50%
BlinkBio Inc.9
25 Health Sciences Drive, Mailbox 123,
Stony Brook, NY 11790, United States
Catabasis Pharmaceuticals, Inc.
10.7%
United States
Montrose Chemical Corporation of California
50%
Suite 380, 600 Ericksen Ave N/A,
Bainbridge Island, United States
Significant Holdings
United Kingdom
Apollo Therapeutics LLP
Stevenage Biosciences Catalyst,
Gunnels Wood Road, Stevenage,
Hertfordshire, SG1 2FX, United Kingdom
Entasis Therapeutics Limited8
2 Kingdom Street, London, W2 6BD,
United Kingdom
United States
One Kendall Square Bldg. 1400E,
Suite B14202, Cambridge, MA 02139,
United States
Cerapedics, Inc.14
11025 Dover St #1600,
Broomfield, CO 80021, United States
Cordivia Corporation
25%
1209 Orange Street,
Wilmington, DE 19801, United States
Elusys Therapeutics, Inc.15
25 Riverside Drive Unit One,
Pine Brook, NJ 07058, United States
49%
FibroGen, Inc.
409 Illinois St., San Francisco,
CA 94158, United States
0.3%
18.49%
8.61%
19.9%
7.2%
1.8%
C.C.Global Chemicals Company
37.5%
G1 Therapeutics, Inc.16
18.03%
PO Box 7, MS2901, Texas, TX76101-0007,
United States
Associated Holdings
Australia
Armaron Bio Ltd9
Level 1/120 Jolimont Road, East
Melbourne 3002 VIC, Australia
British Virgin Islands
Biohaven Pharmaceuticals
Holding Company Ltd.10
79 T.W. Alexander Drive, 4401 Research
Commons Suite 105, Research Triangle
Park, NC 7709, United States
Hydra Biosciences Inc.
4.27%
17.43%
45 Moulton Street,
Cambridge, MA 02138, United States
Inotek Pharmaceuticals Corporation
7.3%
91 Hartwell Ave 2nd Floor,
Lexington, MA 02421, United States
5%
Millendo Therapeutics, Inc.9
8.45%
P.O. Box 173, Kingston Chambers,
Road Town, Tortola, British Virgin Islands
301 North Main Street, Suite 100,
Ann Arbor, MI 48104, United States
New Zealand
Adherium Limited
Level 2, 204 Quay Street, Auckland, 1010,
New Zealand
Switzerland
ADC Therapeutics Sàrl Switzerland11
8.84%
Biopôle, Route de la Corniche 3B, 1066
Epalinges, Switzerland
Moderna Therapeutics Inc.17
7%
5.6%
320 Bent Street, Cambridge, MA 02141,
United States
PhaseBio Pharmaceuticals, Inc.14
14.5%
One Great Valley, Parkway, Suite 30,
Malvern, PA 19355, United States
Rani Therapeutics, L.L.C.14
1%
2051 Ringwood Ave, San Jose, CA 95116,
United States
196
AstraZeneca Annual Report and Form 20-F Information 2016
Independent Auditor’s Report to the
(cid:48)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:86)(cid:98)(cid:82)(cid:73)(cid:98)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:51)(cid:47)(cid:38)(cid:3)(cid:82)(cid:81)(cid:79)(cid:92)
Opinions and conclusions
(cid:68)(cid:85)(cid:76)(cid:86)(cid:76)(cid:81)(cid:74)(cid:98)(cid:73)(cid:85)(cid:82)(cid:80)(cid:98)(cid:82)(cid:88)(cid:85)(cid:3)(cid:68)(cid:88)(cid:71)(cid:76)(cid:87)
1 Our opinion on the Parent Company
Financial Statements is unmodified
We have audited the Parent Company
Financial Statements of AstraZeneca PLC for
the year ended 31 December 2016 set out on
pages 198 to 202. In our opinion the Parent
Company Financial Statements:
> give a true and fair view of the state of the
Company’s affairs as at 31 December 2016
> have been properly prepared in
accordance with UK Accounting Standards,
including FRS 101 ‘Reduced Disclosure
Framework’; and
> have been prepared in accordance with the
requirements of the Companies Act 2006.
3 We have nothing to report in respect of
the matters on which we are required to
report by exception
The Companies Act 2006 requires us to report
to you if, in our opinion:
> adequate accounting records have not been
kept by the Parent Company, or returns
adequate for our audit have not been
received from branches not visited by us; or
> the Parent Company Financial Statements
and the part of the Directors’ Remuneration
Report to be audited are not in agreement
with the accounting records and returns; or
> certain disclosures of Directors’ remuneration
specified by law are not made; or
> we have not received all the information and
explanations we require for our audit.
2 Our opinion on other matters prescribed
by the Companies Act 2006 is unmodified
We have nothing to report in respect of the
above responsibilities.
In our opinion:
> the part of the Directors’ Remuneration
Report to be audited has been properly
prepared in accordance with the
Companies Act 2006; and
> the information given in the Strategic Report
and the Directors’ Report for the financial
year for which the Financial Statements
are prepared is consistent with the Parent
Company Financial Statements.
4 Other matter – we have reported separately
on the Group Financial Statements
We have reported separately on the Group
Financial Statements of AstraZeneca PLC
for the year ended 31 December 2016.
Scope and responsibilities
As explained more fully in the Directors’
Responsibilities Statement set out on page 133,
the Directors are responsible for the preparation
of the Parent Company Financial Statements
and for being satisfied that they give a true
and fair view. A description of the scope of
an audit of financial statements is provided on
the Financial Reporting Council’s website at
www.frc.org.uk/auditscopeukprivate. This
report is made solely to the Company’s
members as a body and is subject to important
explanations and disclaimers regarding our
responsibilities, published on our website
www.kpmg.com/uk/auditscopeukco2014a,
which are incorporated into this report as if
set out in full and should be read to provide an
understanding of the purpose of this report,
the work we have undertaken and the basis
of our opinions.
Antony Cates (Senior Statutory Auditor)
for and on behalf of KPMG LLP,
Statutory Auditor
Chartered Accountants
15 Canada Square, London, E14 5GL
2 February 2017
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AstraZeneca Annual Report and Form 20-F Information 2016
197
Financial Statements
Company Balance Sheet
at 31 December
AstraZeneca PLC
Fixed assets
Fixed asset investments
Current assets
Debtors – other
Debtors – amounts owed by Group undertakings
Creditors: Amounts falling due within one year
Non-trade creditors
Interest-bearing loans and borrowings
Net current assets
Total assets less current liabilities
Creditors: Amounts falling due after more than one year
Amounts owed to Group undertakings
Interest-bearing loans and borrowings
Net assets
Capital and reserves
Called-up share capital
Share premium account
Capital redemption reserve
Other reserves
Profit and loss account
Shareholders’ funds
$m means millions of US dollars.
Notes
2016
$m
2015
$m
1
30,449
30,047
2
3
3
3
4
14
8,935
8,949
(518)
(1,749)
(2,267)
6,682
37,131
(283)
(14,138)
(14,421)
22,710
316
4,351
153
2,583
15,307
22,710
15
7,283
7,298
(814)
–
(814)
6,484
36,531
(283)
(13,705)
(13,988)
22,543
316
4,304
153
2,623
15,147
22,543
The Company Financial Statements from page 198 to 202 were approved by the Board on 2 February 2017 and were signed on its behalf by
Pascal Soriot
Director
Marc Dunoyer
Director
Company’s registered number 02723534
198
AstraZeneca Annual Report and Form 20-F Information 2016
Statement of Changes in Equity
for the year ended 31 December
At 1 January 2015
Total comprehensive income for the period
Profit for the period
Amortisation of loss on cash flow hedge
Total comprehensive income for the period
Transactions with owners, recorded directly in equity
Dividends
Equity-settled share-based payment transactions
Issue of Ordinary Shares
Total contributions by and distributions to owners
At 31 December 2015
Total comprehensive income for the period
Profit for the period
Amortisation of loss on cash flow hedge
Total comprehensive income for the period
Transactions with owners, recorded directly in equity
Dividends
Equity-settled share-based payment transactions
Issue of Ordinary Shares
Total contributions by and distributions to owners
At 31 December 2016
Share
capital
$m
316
Share
premium
account
$m
4,261
Capital
redemption
reserve
$m
153
Other
reserves
$m
2,754
Profit and
loss account
$m
16,709
–
–
–
–
–
–
–
316
–
–
–
–
–
–
–
–
–
–
–
–
43
43
4,304
–
–
–
–
–
47
47
–
–
–
–
–
–
–
153
–
–
–
–
–
–
–
–
–
–
–
(131)
–
(131)
2,623
–
–
–
–
(40)
–
(40)
316
4,351
153
2,583
Total
equity
$m
24,193
1,974
1
1,975
(3,537)
(131)
43
(3,625)
22,543
3,699
1
3,700
1,974
1
1,975
(3,537)
–
–
(3,537)
15,147
3,699
1
3,700
(3,540)
(3,540)
–
–
(3,540)
15,307
(40)
47
(3,533)
22,710
At 31 December 2016, $15,307m (2015: $15,147m) of the profit and loss account reserve was available for distribution. Included in other reserves
is a special reserve of $157m (2015: $157m), arising on the redenomination of share capital in 1999.
Included within other reserves at 31 December 2016 is $742m (2015: $782m) in respect of cumulative share-based payment awards. These
amounts are not available for distribution.
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AstraZeneca Annual Report and Form 20-F Information 2016
199
measured using the single best estimate of
likely outcome approach. Any liability to
interest on tax liabilities is provided for in the
tax charge.
Investments
Fixed asset investments, including investments
in subsidiaries, are stated at cost and reviewed
for impairment if there are indications that the
carrying value may not be recoverable.
Share-based payments
The issuance by the Company to employees
of its subsidiaries of a grant of awards over
the Company’s shares, represents additional
capital contributions by the Company to
its subsidiaries. An additional investment in
subsidiaries results in a corresponding
increase in shareholders’ equity. The additional
capital contribution is based on the fair value of
the grant issued, allocated over the underlying
grant’s vesting period, less the market cost
of shares charged to subsidiaries in settlement
of such share awards.
Financial instruments
Loans and other receivables are held at
amortised cost. Long-term loans payable
are held at amortised cost.
Litigation
Through the normal course of business,
the AstraZeneca Group is involved in legal
disputes, the settlement of which may involve
cost to the Company. Provision is made
where an adverse outcome is probable and
associated costs can be estimated reliably.
In other cases, appropriate descriptions
are included.
Financial Statements
Company Accounting Policies
Basis of presentation of
(cid:73)(cid:76)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:98)(cid:76)(cid:81)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)
These financial statements were prepared
in accordance with FRS 101 ‘Reduced
Disclosure Framework’.
In preparing these financial statements,
the Company applied the recognition,
measurement and disclosure requirements
of International Financial Reporting Standards
as adopted by the EU (‘Adopted IFRSs’), but
makes amendments where necessary in order
to comply with Companies Act 2006 and has
set out below where advantage of the FRS 101
disclosure exemptions has been taken.
In these financial statements, the Company
has applied the exemptions available under
FRS 101 in respect of the following disclosures:
> Statement of Cash Flows and related notes
> comparative period reconciliations for
share capital
> disclosures in respect of transactions
with wholly owned subsidiaries
> disclosures in respect of
capital management
> the effects of new but not yet effective IFRSs
> disclosures in respect of the compensation
of Key Management Personnel.
As the Group Financial Statements (presented
on pages 138 to 196) include the equivalent
disclosures, the Company has also taken
the exemptions under FRS 101 available in
respect of the following disclosures:
> IFRS 2 Share-based Payment in respect
of group settled share-based payments.
No individual profit and loss account is
prepared as provided by section 408 of
the Companies Act 2006. The Company
proposes to continue to adopt the reduced
disclosure framework of FRS 101 in its next
financial statements.
The accounting policies set out below
have, unless otherwise stated, been applied
consistently to all periods presented in these
financial statements.
Basis of accounting
The Company Financial Statements are
prepared under the historical cost convention,
in accordance with the Companies Act 2006.
The Group Financial Statements are presented
on pages 138 to 196 and have been prepared
in accordance with IFRSs as adopted by the
EU and as issued by the IASB and in
accordance with the Group Accounting
Policies set out on pages 142 to 146.
The following paragraphs describe the
main accounting policies, which have been
applied consistently.
Foreign currencies
Profit and loss account items in foreign
currencies are translated into US dollars at
average rates for the relevant accounting
periods. Assets and liabilities are translated
at exchange rates prevailing at the date of the
Company Balance Sheet. Exchange gains
and losses on loans and on short-term
foreign currency borrowings and deposits are
included within net interest payable. Exchange
differences on all other transactions, except
relevant foreign currency loans, are taken to
operating profit.
Taxation
The current tax payable is based on taxable
profit for the year. Taxable profit differs from
reported profit because taxable profit excludes
items that are either never taxable or tax
deductible or items that are taxable or tax
deductible in a different period. The Company’s
current tax assets and liabilities are calculated
using tax rates that have been enacted or
substantively enacted by the reporting date.
Deferred tax is provided using the balance
sheet liability method, providing for temporary
differences between the carrying amounts of
assets and liabilities for financial reporting
purposes and the amounts used for taxation
purposes. Deferred tax assets are recognised
to the extent that it is probable that taxable
profit will be available against which the asset
can be utilised. This requires judgements to be
made in respect of the availability of future
taxable income.
No deferred tax asset or liability is recognised
in respect of temporary differences associated
with investments in subsidiaries and branches
where the Company is able to control the timing
of reversal of the temporary differences and it
is probable that the temporary differences will
not reverse in the foreseeable future.
The Company’s deferred tax assets and
liabilities are calculated using tax rates that
are expected to apply in the period when
the liability is settled or the asset realised
based on tax rates that have been enacted or
substantively enacted by the reporting date.
Accruals for tax contingencies require
management to make judgements and
estimates of exposures in relation to tax audit
issues. Tax benefits are not recognised unless
the tax positions will probably be sustained
based upon management’s interpretation
of applicable laws and regulations. Once
considered to be probable, management
reviews each material tax benefit to assess
whether a provision should be taken against
full recognition of that benefit on the basis of
potential settlement through negotiation and/or
litigation. Accruals for tax contingencies are
200
AstraZeneca Annual Report and Form 20-F Information 2016
Notes to the Company Financial Statements
1 Fixed asset investments
At 1 January 2016
Additions
Transfer to current assets
Capital reimbursement
Exchange
Amortisation
At 31 December 2016
A list of subsidiaries is included on pages 193 to 196.
2 Non-trade creditors
Amounts due within one year
Short-term borrowings
Other creditors
Amounts owed to Group undertakings
3 Loans
Amounts due within one year
Interest-bearing loans and borrowings (unsecured)
5.9% Callable bond
Amounts due after more than one year
Amounts owed to Group undertakings (unsecured)
7.2% Loan
Interest-bearing loans and borrowings (unsecured)
5.9% Callable bond
Floating rate notes
1.75% Callable bond
1.95% Callable bond
2.375% Callable bond
0.875% Non-callable bond
0.25% Callable bond
0.75% Callable bond
3.375% Callable bond
1.25% Callable bond
5.75% Non-callable bond
6.45% Callable bond
4% Callable bond
4.375% Callable bond
Loans or instalments thereof are repayable:
After five years from balance sheet date
From two to five years
From one to two years
Within one year
Total unsecured
Investments in subsidiaries
Shares
$m
16,053
–
–
(27)
–
–
Loans
$m
13,994
2,480
(1,749)
–
(307)
5
Total
$m
30,047
2,480
(1,749)
(27)
(307)
5
16,026
14,423
30,449
Repayment
dates
US dollars
2017
US dollars
US dollars
US dollars
US dollars
US dollars
US dollars
euros
euros
euros
US dollars
euros
pounds sterling
US dollars
US dollars
US dollars
2023
2017
2018
2018
2019
2020
2021
2021
2024
2025
2028
2031
2037
2042
2045
2016
$m
371
140
7
518
2016
$m
1,749
1,749
283
–
399
998
998
1,589
782
522
937
1,976
827
426
2,719
986
979
2015
$m
679
128
7
814
2015
$m
–
–
283
1,747
399
997
997
1,586
812
–
–
1,971
–
515
2,719
986
976
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14,138
13,705
2016
$m
9,133
3,891
1,397
1,749
16,170
2015
$m
8,262
3,979
1,747
–
13,988
With the exception of the 2018 floating rate notes, all loans are at fixed interest rates. Accordingly, the fair values of the loans will change as market
rates change. However, since the loans are held at amortised cost, changes in interest rates and the credit rating of the Company do not have any
effect on the Company’s net assets.
AstraZeneca Annual Report and Form 20-F Information 2016
201
Financial Statements
4 Share capital
Details of share capital movements in the year and share option schemes are included in Note 22 to the Group Financial Statements.
5 Contingent liabilities
In addition to the matter disclosed below, there are other cases where the Company is named as a party to legal proceedings. These include the
Nexium and Farxiga product liability litigations, each of which are described more fully in Note 28 to the Group Financial Statements.
Foreign Corrupt Practices Act
In connection with investigations into anti-bribery and corruption issues in the pharmaceutical industry, AstraZeneca has received inquiries from
enforcement agencies, including the DOJ and the SEC, regarding, among other things, sales practices, internal controls, certain distributors and
interactions with healthcare providers and other government officials in several countries. In August 2016, AstraZeneca entered into a civil settlement
with the SEC to resolve these inquiries. The DOJ has informed AstraZeneca that it has closed its inquiry into this matter.
Other
The Company has guaranteed the external borrowing of a subsidiary in the amount of $286m.
6 Statutory and other information
The Directors were paid by another Group company in 2016 and 2015.
7 Subsequent events
On 31 January 2017, the Company received a dividend from a subsidiary of $1,623m.
202
AstraZeneca Annual Report and Form 20-F Information 2016
Group Financial Record
For the year ended 31 December
Revenue and profits
Product Sales
Externalisation Revenue
Cost of sales
Distribution costs
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Operating profit
Finance income
Finance expense
Share of after tax losses in associates and joint ventures
Profit before tax
Taxation
Profit for the period
Other comprehensive income for the period, net of tax
Total comprehensive income for the period
Profit attributable to:
Owners of the Parent
Non-controlling interests
Earnings per share
Basic earnings per $0.25 Ordinary Share
Diluted earnings per $0.25 Ordinary Share
Dividends
Return on revenues
Operating profit as a percentage of Total Revenue
Ratio of earnings to fixed charges
At 31 December
Statement of Financial Position
Property, plant and equipment, goodwill and intangible assets
Other investments and non-current receivables
Deferred tax assets
Current assets
Total assets
Current liabilities
Non-current liabilities
Net assets
Share capital
Reserves attributable to equity holders of the Company
Non-controlling interests
Total equity and reserves
2012
$m
27,973
451
(5,393)
(320)
(5,243)
(9,839)
519
8,148
42
(544)
–
7,646
(1,376)
6,270
135
6,405
6,240
30
$4.95
$4.94
$2.85
28.7%
19.9
2012
$m
32,435
940
1,111
19,048
53,534
(13,903)
(15,685)
23,946
312
23,419
215
23,946
2013
$m
25,711
95
(5,261)
(306)
(4,821)
2014
$m
26,095
452
(5,842)
(324)
(5,579)
(12,206)
(13,000)
500
3,712
50
(495)
–
3,267
(696)
2,571
(113)
2,458
2,556
15
$2.04
$2.04
$2.80
14.4%
9.9
2013
$m
31,846
2,513
1,205
20,335
55,899
(16,051)
(16,595)
23,253
315
22,909
29
23,253
335
2,137
78
(963)
(6)
1,246
(11)
1,235
(1,506)
(271)
1,233
2
$0.98
$0.98
$2.80
8.0%
6.1
2014
$m
38,541
2,138
1,219
16,697
58,595
(17,330)
(21,619)
19,646
316
19,311
19
19,646
2015
$m
23,641
1,067
(4,646)
(339)
(5,997)
(11,112)
1,500
4,114
46
(1,075)
(16)
3,069
(243)
2,826
(338)
2,488
2,825
1
$2.23
$2.23
$2.80
16.7%
11.3
2015
Restated*
$m
40,859
1,896
1,294
16,007
60,056
(14,869)
(26,678)
18,509
316
18,174
19
18,509
2016
$m
21,319
1,683
(4,126)
(326)
(5,890)
(9,413)
1,655
4,902
67
(1,384)
(33)
3,552
(146)
3,406
(1,778)
1,628
3,499
(93)
$2.77
$2.76
$2.80
21.3%
8.9
2016
$m
46,092
2,070
1,102
13,262
62,526
(15,256)
(30,601)
16,669
316
14,538
1,815
16,669
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* (cid:21)(cid:19)(cid:20)(cid:24)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:68)(cid:85)(cid:68)(cid:87)(cid:76)(cid:89)(cid:72)(cid:86)(cid:3)(cid:75)(cid:68)(cid:89)(cid:72)(cid:3)(cid:69)(cid:72)(cid:72)(cid:81)(cid:3)(cid:85)(cid:72)(cid:86)(cid:87)(cid:68)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:85)(cid:72)(cid:73)(cid:79)(cid:72)(cid:70)(cid:87)(cid:3)(cid:68)(cid:81)(cid:3)(cid:68)(cid:71)(cid:77)(cid:88)(cid:86)(cid:87)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:68)(cid:70)(cid:84)(cid:88)(cid:76)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:61)(cid:54)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:11)(cid:86)(cid:72)(cid:72)(cid:3)(cid:49)(cid:82)(cid:87)(cid:72)(cid:98)(cid:21)(cid:24)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:83)(cid:68)(cid:74)(cid:72)(cid:3)(cid:20)(cid:26)(cid:22)(cid:12)(cid:17)
For the year ended 31 December
Cash flows
Net cash inflow/(outflow) from:
Operating activities
Investing activities
Financing activities
2012
$m
2013
$m
2014
$m
2015
$m
2016
$m
6,948
(1,859)
(4,923)
166
7,400
(2,889)
(3,047)
1,464
7,058
(7,032)
(2,705)
(2,679)
3,324
(4,239)
878
(37)
4,145
(3,969)
(1,324)
(1,148)
For the purpose of computing the ratio of earnings to fixed charges, earnings consist of the income from continuing ordinary activities before
taxation of Group companies and income received from companies owned 50% or less, plus fixed charges. Fixed charges consist of interest on
all indebtedness, amortisation of debt discount and expense, and that portion of rental expense representative of the interest factor.
AstraZeneca Annual Report and Form 20-F Information 2016
203
Additional Information
Development Pipeline
as at 31 December 2016
Includes AstraZeneca sponsored or directed trials only.
Phase III/Pivotal Phase II/Registration
(cid:49)(cid:72)(cid:90)(cid:3)(cid:48)(cid:82)(cid:79)(cid:72)(cid:70)(cid:88)(cid:79)(cid:68)(cid:85)(cid:3)(cid:40)(cid:81)(cid:87)(cid:76)(cid:87)(cid:76)(cid:72)(cid:86)(cid:3)(cid:11)(cid:49)(cid:48)(cid:40)(cid:86)(cid:12)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:68)(cid:71)(cid:71)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:79)(cid:3)(cid:76)(cid:81)(cid:71)(cid:76)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)
Regulatory submission dates shown for assets in Phase III and beyond. As disclosure of compound information is balanced by the business
need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed at this time.
Compound
Oncology
Mechanism
Area Under Investigation
Tagrisso
AURA, AURA2, (AURA17 Asia
regional)
EGFR inhibitor
≥2nd line advanced EGFRm
T790M NSCLC
Tagrisso
AURA3
EGFR inhibitor
durvalumab#
PD-L1 MAb
≥2nd line advanced EGFRm
T790M NSCLC
≥2nd line advanced bladder
cancer
acalabrutinib#
BTK inhibitor
B-cell malignancy
acalabrutinib#
BTK inhibitor
1st line CLL
acalabrutinib#
BTK inhibitor
r/r CLL, high risk
Q1 2015
Q3 2015
Q4 2015
Date
Commenced
Phase
Estimated Regulatory Acceptance Date/Submission Status
US
EU
Japan
China
Launched
Accepted
Launched
(Accelerated
assessment)
Accepted
Launched
(Breakthrough
Therapy,
Priority Review,
Orphan Drug)
Accepted
(Priority
Review)
Accepted
(Breakthrough
Therapy &
Priority Review)
H1 2017
(Orphan Drug)
2020
(Orphan Drug)
2020
(Orphan Drug)
2020
(Orphan Drug)
2020
(Orphan Drug)
2018
2018
(Orphan Drug)
2018
(Orphan Drug)
selumetinib
ASTRA
moxetumomab pasudotox#
PLAIT
durvalumab#
PACIFIC
durvalumab# + tremelimumab
ARCTIC
durvalumab# + tremelimumab
MYSTIC
durvalumab# + tremelimumab
NEPTUNE
durvalumab# + tremelimumab
KESTREL
durvalumab# + tremelimumab
EAGLE
durvalumab# + tremelimumab
DANUBE
MEK inhibitor
differentiated thyroid cancer
Q3 2013
anti-CD22 recombinant
immunotoxin
hairy cell leukaemia
Q2 2013
PD-L1 MAb
stage III NSCLC
Q2 2014
H2 2017
H2 2017
H2 2017
PD-L1 MAb + CTLA-4 MAb
3rd line NSCLC
Q2 2015
H2 2017
H2 2017
H2 2017
PD-L1 MAb + CTLA-4 MAb
1st line NSCLC
Q3 2015
H2 2017
H2 2017
H2 2017
PD-L1 MAb + CTLA-4 MAb
1st line NSCLC
PD-L1 MAb + CTLA-4 MAb
1st line HNSCC
PD-L1 MAb + CTLA-4 MAb
2nd line HNSCC
Q4 2015
Q4 2015
Q4 2015
PD-L1 MAb + CTLA-4 MAb
1st line bladder cancer
Q4 2015
2019
2018
2018
2018
2019
2019
2020
2018
2018
2018
2018
2018
2018
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Compound
Mechanism
Area Under Investigation
Cardiovascular & Metabolic Disease
Date
Commenced
Phase
Estimated Regulatory Acceptance Date/Submission Status
US
EU
Japan
China
Brilinta1
Farxiga2
Epanova
ZS-9 (sodium zirconium
cyclosilicate)
roxadustat# OLYMPUS (US)
ROCKIES (US)
Respiratory
P2Y12 receptor antagonist
arterial thrombosis
SGLT2 inhibitor
Type 2 diabetes
omega-3 carboxylic acids
severe hypertriglyceridaemia
potassium binder
hyperkalaemia
Launched
Launched
Approved
Accepted
Launched
Approved
Launched
Launched
Launched
Accepted
2018
Accepted
hypoxia-inducible factor prolyl
hydroxylase inhibitor
anaemia in CKD/ESRD
Q3 2014
2018
Initiated3
Bevespi Aerosphere (PT003)
LABA/LAMA
IL-5R MAb
COPD
severe asthma
Launched4
H1 2017
2018
Accepted
Accepted
H1 2017
2018
2020
benralizumab#
CALIMA
SIROCCO
ZONDA
BISE
BORA
GREGALE
benralizumab#
TERRANOVA
GALATHEA
PT010
tralokinumab
STRATOS 1,2
TROPOS
MESOS
Other
anifrolumab#
TULIP
AZD3293#
AMARANTH
DAYBREAK-ALZ
IL-5R MAb
COPD
Q3 2014
2018
2018
2019
LABA/LAMA/ICS
IL-13 MAb
COPD
severe asthma
Q3 2015
Q3 2014
2018
2018
2018
2018
2018
2018
2019
IFN-alphaR MAb
systemic lupus erythematosus
Q3 2015
beta-secretase inhibitor
Alzheimer’s disease
Q2 2016
2019
(Fast Track)
2020
(Fast Track)
2019
2019
2020
2020
# Collaboration.
1 Brilinta in the US and Japan; Brilique in ROW.
2 Farxiga in the US; Forxiga in ROW.
3 Rolling New Drug Application (NDA) regulatory submission initiated in Q4 2016.
4 Bevespi Aerosphere(cid:3)(cid:11)(cid:74)(cid:79)(cid:92)(cid:70)(cid:82)(cid:83)(cid:92)(cid:85)(cid:85)(cid:82)(cid:79)(cid:68)(cid:87)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:73)(cid:82)(cid:85)(cid:80)(cid:82)(cid:87)(cid:72)(cid:85)(cid:82)(cid:79)(cid:3)(cid:73)(cid:88)(cid:80)(cid:68)(cid:85)(cid:68)(cid:87)(cid:72)(cid:12)(cid:3)(cid:76)(cid:81)(cid:75)(cid:68)(cid:79)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:72)(cid:85)(cid:82)(cid:86)(cid:82)(cid:79)(cid:3)(cid:90)(cid:68)(cid:86)(cid:3)(cid:79)(cid:68)(cid:88)(cid:81)(cid:70)(cid:75)(cid:72)(cid:71)(cid:3)(cid:70)(cid:82)(cid:80)(cid:80)(cid:72)(cid:85)(cid:70)(cid:76)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)(cid:76)(cid:81)(cid:98)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:3)(cid:76)(cid:81)(cid:3)(cid:45)(cid:68)(cid:81)(cid:88)(cid:68)(cid:85)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:26)(cid:17)
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Additional Information
Development Pipeline continued
Phases I and II
(cid:49)(cid:48)(cid:40)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:68)(cid:71)(cid:71)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:79)(cid:3)(cid:76)(cid:81)(cid:71)(cid:76)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)
Compound
Mechanism
Area Under Investigation
Phase
Oncology
durvalumab#
durvalumab# + tremelimumab
durvalumab# + tremelimumab
durvalumab# + AZD5069
durvalumab# + AZD9150#
durvalumab# + dabrafenib + trametinib
durvalumab# + AZD1775#
durvalumab# + MEDI0680
durvalumab# or durvalumab# +
(tremelimumab or AZD9150#)
durvalumab# + Iressa
durvalumab# + MEDI0562#
durvalumab# + MEDI9447
durvalumab# + monalizumab
durvalumab# + selumetinib
durvalumab# + tremelimumab
tremelimumab + MEDI0562#
Lynparza + AZD6738
Lynparza + AZD1775#
savolitinib#
Tagrisso + (selumetinib# or savolitinib#)
TATTON
Tagrisso BLOOM
AZD1775# + chemotherapy
AZD1775#
vistusertib (AZD2014)
AZD5363#
AZD4547
MEDI-573#
AZD0156
AZD2811#
AZD4635
AZD6738
AZD8186
AZD9150#
AZD9496
MEDI-565#
MEDI0562#
MEDI0680
MEDI1873
MEDI4276
MEDI9197#
MEDI9447
Cardiovascular & Metabolic Disease
MEDI0382
MEDI4166
MEDI6012
AZD4076
AZD4831
AZD5718
AZD8601#
MEDI8111
PD-L1 MAb
PD-L1 MAb + CTLA-4 MAb
PD-L1 MAb + CTLA-4 MAb
PD-L1 MAb + CXCR2
PD-L1 MAb + STAT3 inhibitor
PD-L1 MAb + BRAF inhibitor + MEK inhibitor
PD-L1 MAb + Wee1 inhibitor
PD-L1 MAb + PD-1 MAb
PD-L1 MAb or PD-L1 MAb +
(CTLA-4 MAb or STAT3 inhibitor)
PD-L1 MAb + EGFR inhibitor
PD-L1 MAb + humanised OX40 agonist
PD-L1 MAb + CD73 MAb
PD-L1 MAb + NKG2a MAb
PD-L1 MAb + MEK inhibitor
PD-L1 MAb + CTLA-4 MAb
CTLA-4 MAb + humanised OX40 agonist
PARP inhibitor + ATR inhibitor
PARP inhibitor + Wee1 inhibitor
MET inhibitor
EGFR inhibitor + (MEK inhibitor or MET inhibitor)
EGFR inhibitor
Wee1 inhibitor + chemotherapy
Wee1 inhibitor
mTOR inhibitor
AKT inhibitor
FGFR inhibitor
IGF MAb
ATM inhibitor
Aurora B inhibitor
A2aR inhibitor
ATR inhibitor
PI3k inhibitor
STAT3 inhibitor
selective oestrogen receptor downregulator
(SERD)
CEA BiTE MAb
humanised OX40 agonist
PD-1 MAb
GITR agonist fusion protein
HER2 bispecific ADC MAb
TLR 7/8 agonist
CD73 MAb
solid tumours
hepatocellular carcinoma (liver cancer)
gastric cancer
HNSCC
melanoma
solid tumours
solid tumours
diffuse large B-cell lymphoma
NSCLC
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
gastric cancer
solid tumours
papillary renal cell carcinoma
advanced EGFRm NSCLC
CNS metastases in advanced EGFRm NSCLC
ovarian cancer
solid tumours
solid tumours
breast cancer
solid tumours
metastatic breast cancer
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
haematological malignancies
ER + breast cancer
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
GLP-1/glucagon dual agonist
diabetes/obesity
PCSK9/GLP-1 MAb + peptide fusion
diabetes/cardiovascular
LCAT
anti-miR103/107 oligonucleotide
myeloperoxidase
FLAP
VEGF-A
Rh-factor II
ACS
non-alcoholic fatty liver disease/non-alcoholic
steatohepatitis (NASH)
heart failure with a preserved ejection fraction
CAD
cardiovascular
trauma/bleeding
II
II
II
II
II
I
I
I
I
I
I
I
I
I
I
II
I
II
II
II
II
II
II
II
II
II
I
I
I
I
I
I
I
I
I
I
I
I
I
I
II
II
II
II
I
I
I
I
Date
Commenced
Phase
Q3 2014
Q4 2016
Q2 2015
Q3 2015
Q1 2014
Q4 2015
Q3 2016
Q3 2016
Q2 2014
Q2 2016
Q1 2016
Q1 2016
Q4 2015
Q4 2013
Q2 2016
Q3 2016
Q3 2015
Q2 2014
Q2 2016
Q4 2015
Q4 2012
Q1 2016
Q1 2013
Q1 2014
Q4 2011
Q2 2012
Q4 2015
Q4 2015
Q2 2016
Q4 2013
Q2 2013
Q1 2012
Q4 2014
Q1 2011
Q1 2015
Q4 2013
Q4 2015
Q4 2015
Q4 2015
Q3 2015
Q3 2016
Q1 2016
Q4 2015
Q4 2016
Q3 2016
Q1 2016
Q1 2017
Q1 2014
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AZD7594 + abediterol#
inhaled SGRM + LABA
Compound
Respiratory
tezepelumab#
abediterol#
AZD7594
AZD9412#
PT010
AZD1419#
AZD8871#
AZD0284
AZD5634
AZD7986#
AZD9567
Other
anifrolumab#
anifrolumab#
inebilizumab#
mavrilimumab#
verinurad1
MEDI5872#
AZD3241
MEDI3902
MEDI4893
MEDI8852
MEDI8897#
MEDI0700#
MEDI1814#2
MEDI4920
MEDI7352
MEDI7734
MEDI9314
Mechanism
Area Under Investigation
Phase
TSLP MAb
LABA
inhaled SGRM
inhaled interferon beta
LABA/LAMA/ICS
TLR9 agonist
MABA
inhaled RORg
inhaled ENaC
DPP1
oral SGRM
IFN-alphaR MAb
IFN-alphaR MAb
CD19 MAb
GM-CSFR MAb
selective uric acid reabsorption
inhibitor (URAT-1)
B7RP1 MAb
myeloperoxidase inhibitor
Psl/PcrV bispecific MAb
MAb binding to S. aureus toxin
influenza A MAb
RSV MAb-YTE
asthma/atopic dermatitis
asthma/COPD
asthma/COPD
asthma/COPD
asthma
asthma
COPD
psoriasis
cystic fibrosis
asthma/COPD
COPD
rheumatoid arthritis
lupus nephritis
systemic lupus erythematosus (subcutaneous)
neuromyelitis optica
rheumatoid arthritis
chronic treatment of hyperuricemia
in patients with gout
primary Sjögren’s syndrome
multiple system atrophy
prevention of nosocomial pseudomonas
pneumonia
hospital-acquired pneumonia/serious S. aureus
infection
influenza A treatment
passive RSV prophylaxis
BAFF/B7RP1 bispecific MAb
systemic lupus erythematosus
amyloid beta MAb
Alzheimer’s disease
anti-CD40L-Tn3 fusion protein
primary Sjögren’s syndrome
NGF/TNF bispecific MAb
ILT7 MAb
IL-4R MAb
osteoarthritis pain
myositis
atopic dermatitis
# Collaboration.
1 Planning to initiate a programme for CKD.
2 Co-development collaboration with Lilly for MEDI1814.
II
II
II
II
II
II
II
I
I
I
I
I
II
I
II
II
II
II
II
II
II
II
II
I
I
I
I
I
I
Date
Commenced
Phase
Q2 2014
Q4 2007
Q3 2015
Q3 2015
Q2 2014
Q4 2016
Q1 2017
Q4 2016
Q1 2016
Q4 2016
Q4 2014
Q4 2015
Q4 2015
Q4 2015
Q1 2015
(Orphan Drug)
Q1 2010
Q3 2013
Q3 2016
Q2 2015
(Orphan Drug)
Q2 2016
(Fast Track, US)
Q4 2014
(Fast Track, US)
Q4 2015
(Fast Track, US)
Q1 2015
(Fast Track, US)
Q1 2016
Q2 2014
Q2 2014
Q1 2016
Q3 2016
Q1 2016
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Additional Information
Development Pipeline continued
(cid:54)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:3)(cid:47)(cid:76)(cid:73)(cid:72)(cid:16)(cid:38)(cid:92)(cid:70)(cid:79)(cid:72)(cid:3)(cid:48)(cid:68)(cid:81)(cid:68)(cid:74)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87)
Compound
Oncology
Faslodex
FALCON
Lynparza OlympiAD
Lynparza
SOLO-2
Lynparza
SOLO-1
Lynparza
SOLO-3
Lynparza
POLO
Lynparza
Lynparza
OlympiA
Tagrisso
FLAURA
Tagrisso
ADAURA
Mechanism
Area Under Investigation
Date
Commenced
Phase
Estimated Regulatory Acceptance Date/Submission Status
US
EU
Japan
China
oestrogen receptor antagonist 1st line hormone receptor +ve advanced
Accepted
Accepted
Accepted
H2 2017
breast cancer
PARP inhibitor
PARP inhibitor
gBRCA metastatic breast cancer
2nd line or greater BRCAm PSR ovarian
cancer, maintenance monotherapy
Q2 2014
Q3 2013
H2 2017
H2 2017
H2 2017
H1 2017
(Fast Track)
H1 2017
H2 2017
PARP inhibitor
1st line BRCAm ovarian cancer
Q3 2013
2018
2018
2018
PARP inhibitor
gBRCA PSR ovarian cancer
Q1 2015
2018
PARP inhibitor
pancreatic cancer
Q1 2015
2018
2018
PARP inhibitor
prostate cancer
Q3 2014 (Breakthrough
Therapy)
PARP inhibitor
gBRCA adjuvant breast cancer
Q2 2014
2020
2020
2020
EGFR inhibitor
1st line advanced EGFRm NSCLC
Q1 2015
H2 2017
H2 2017
H2 2017
H2 2017
EGFR inhibitor
adjuvant EGFRm NSCLC
Q4 2015
2022
2022
2022
2022
Cardiovascular & Metabolic Disease
Brilinta1
PEGASUS-TIMI 54
P2Y12 receptor antagonist
outcomes trial in patients with prior
myocardial infarction
Brilinta1
THEMIS
Brilinta1
HESTIA
P2Y12 receptor antagonist
P2Y12 receptor antagonist
outcomes trial in patients with Type 2
diabetes and CAD, but without a
previous history of myocardial infarction
or stroke
prevention of vaso-occlusive crises in
paediatric patients with sickle cell disease
Onglyza
SAVOR-TIMI 53
Kombiglyze XR/Komboglyze2 DPP-4 inhibitor/metformin FDC Type 2 diabetes
DPP-4 inhibitor
Type 2 diabetes outcomes trial
Launched
Approved
Accepted
Launched
(Priority
Review)
Q1 2014
2018
2018
2018
2019
Q1 2014
2020
2020
Launched
Launched
Accepted
Launched
Launched
Accepted
Farxiga3
DECLARE-TIMI 58
Farxiga3
Xigduo XR/Xigduo4
Qtern (saxagliptin/
dapagliflozin FDC)
Bydureon weekly
suspension
SGLT2 inhibitor
Type 2 diabetes outcomes trial
Q2 2013
2020
2020
SGLT2 inhibitor
Type 1 diabetes
SGLT2 inhibitor/metformin FDC Type 2 diabetes
DPP-4 inhibitor/
SGLT2 inhibitor FDC
Type 2 diabetes
Q4 2014
2018
2018
2018
Launched
Launched
Accepted
Approved
GLP-1 receptor agonist
Type 2 diabetes
Q1 2013
H1 2017
H2 2017
Bydureon EXSCEL
GLP-1 receptor agonist
Type 2 diabetes outcomes trial
Q2 2010
Q4 2014
2018
2020
2018
2020
2020
2018
2020
omega-3 carboxylic acids
outcomes trial in statin-treated
patients at high CV risk, with persistent
hypertriglyceridaemia plus low
HDL-cholesterol
ICS/LABA
as-needed use in mild asthma
Q4 2014
2018
ICS/LABA
LAMA/LABA
breath actuated inhaler asthma/COPD
COPD
2018
2018
Launched
proton pump inhibitor
stress ulcer prophylaxis
proton pump inhibitor
paediatrics
GC-C receptor peptide agonist
irritable bowel syndrome with
constipation (IBS-C)
Launched
Launched
Accepted
2019
2019
Submitted
Accepted
Epanova
STRENGTH
Respiratory
Symbicort
SYGMA
Symbicort
Duaklir Genuair#
Other
Nexium
Nexium
linaclotide#
# Collaboration.
1 Brilinta in the US and Japan; Brilique in ROW.
2 Kombiglyze XR in the US; Komboglyze in the EU.
3 Farxiga in the US; Forxiga in ROW.
4 Xigduo XR in the US; Xigduo in the EU.
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Terminations
NME/Line Extension
LCM
NME
NME
NME
LCM
NME
NME
LCM
NME
NME
NME
NME
LCM
LCM
NME
LCM
NME
NME
NME
NME
NME
NME
¶ Registrational Phase II trial.
# Partnered and/or in collaboration.
Compound
inebilizumab# (MEDI-551) + rituximab
AZD5312#
AZD8835
tremelimumab¶
DETERMINE
Tagrisso + durvalumab
CAURAL
abrilumab#
AZD8999
Brilinta/Brilique SOCRATES
MEDI7836
MEDI6383#
durvalumab# + MEDI6383#
MEDI0639
Epanova/Farxiga
Lynparza GOLD
AZD7624
Brilinta EUCLID
inebilizumab
MEDI3617#
cediranib ICON 6
selumetinib#
SELECT-1
durvalumab# + tremelimumab
ALPS¶
MEDI7510
Reason for Discontinuation
Area Under Investigation
Safety/efficacy
Safety/efficacy
Safety/efficacy
Safety/efficacy
Safety/efficacy
Strategic
Strategic
Safety/efficacy
Safety/efficacy
Strategic
Strategic
Safety/efficacy
Safety/efficacy
Safety/efficacy
Safety/efficacy
Safety/efficacy
Safety/efficacy
Safety/efficacy
Regulatory
Safety/efficacy
Safety/efficacy
Safety/efficacy
haematological malignancies
solid tumours
solid tumour
mesothelioma 2nd/3rd line
≥2nd line advanced EGFRm T790M
NSCLC
Crohn’s disease/ulcerative colitis
COPD
outcomes trial in patients with stroke or TIA
asthma
solid tumours
solid tumours
solid tumours
non-alcoholic fatty liver disease/
non-alcoholic steatohepatitis (NASH)
2nd line gastric cancer
COPD
peripheral artery disease
diffuse large B-cell lymphoma
solid tumours
PSR ovarian cancer
2nd line KRASm NSCLC
metastatic pancreatic ductal carcinoma
prevention of RSV disease in older patients
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Additional Information
Development Pipeline continued
Completed Projects/Divestitures
Compound
Diprivan#1
Zurampic2
Zurampic + allopurinol FDC2
MEDI-550
tralokinumab3
brodalumab4
AMAGINE-1,2,3
MEDI2070#5
Zinforo#6
Zavicefta#6
(CAZ AVI)
Zavicefta#6
(CAZ AVI)
ATM AVI#6
CXL#6
AZD8108
durvalumab#
HAWK¶7
durvalumab# + tremelimumab
CONDOR¶7
Mechanism
Area Under Investigation
sedative and anaesthetic
conscious sedation
Completed/
Divested
Divested
Estimated Regulatory Submission Acceptance†
US
EU
Japan
China
N/A
Launched
Accepted
Launched
selective uric acid reabsorption
inhibitor (URAT-1)
chronic treatment of hyperuricemia
in patients with gout
Completed/
Divested
Launched
Approved
N/A
N/A
selective uric acid reabsorption
inhibitor (URAT-1) + xanthine
oxidase inhibitor FDC
pandemic influenza virus
vaccine
IL-13 MAb
IL-17R MAb
IL-23 MAb
extended spectrum
cephalosporin with affinity to
penicillin-binding proteins
chronic treatment of hyperuricemia
in patients with gout
Divested
pandemic influenza prophylaxis
Completed
N/A
Approved
N/A
N/A
atopic dermatitis
psoriasis
Crohn’s disease
pneumonia/skin infections
Divested
Divested
Divested
Divested
N/A
Launched
N/A Submitted
cephalosporin/beta lactamase
inhibitor
hospital-acquired pneumonia/
ventilator-associated pneumonia
cephalosporin/beta lactamase
inhibitor
serious infections, complicated
intra-abdominal infection,
complicated urinary tract infection
Divested
N/A
Approved
Divested
N/A
Approved
N/A
N/A
monobactam/beta lactamase
inhibitor
beta lactamase inhibitor/
cephalosporin
targeted serious bacterial infections
Divested
methicillin-resistant S. aureus
Divested
NMDA antagonist
PD-L1 MAb
suicidal ideation
Divested
2nd line HNSCC (PD-L1 positive)
Completed
PD-L1 MAb + CTLA-4 MAb
2nd line HNSCC (PD-L1 negative)
Completed
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
# Partnered and/or in collaboration.
† US and EU dates correspond to anticipated acceptance of the regulatory submission.
¶ Registrational Phase II trial.
¹ AstraZeneca announced it entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for its global anaesthetics portfolio outside of the US
on 9 June 2016.
2 AstraZeneca has granted Ironwood Pharmaceuticals, Inc. exclusive US rights (26 April 2016) and Grünenthal GmbH exclusive rights in Europe and Latin America (2 June 2016). Zurampic
launched in US on 3 October 2016.
3 AstraZeneca entered into a licensing agreement with LEO Pharma (1 July 2016, completed on 16 August 2016).
4 AstraZeneca and Valeant agreed to terminate the licence for Valeant’s right to develop and commercialise brodalumab in Europe. AstraZeneca entered into an agreement with LEO Pharma
for the exclusive licence to brodalumab in Europe (1 July 2016).
5 AstraZeneca licensing agreement with Allergan.
6(cid:3) (cid:3)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:70)(cid:82)(cid:80)(cid:83)(cid:79)(cid:72)(cid:87)(cid:72)(cid:71)(cid:3)(cid:87)(cid:85)(cid:68)(cid:81)(cid:86)(cid:68)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:51)(cid:430)(cid:93)(cid:72)(cid:85)(cid:3)(cid:87)(cid:82)(cid:3)(cid:86)(cid:72)(cid:79)(cid:79)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:70)(cid:82)(cid:80)(cid:80)(cid:72)(cid:85)(cid:70)(cid:76)(cid:68)(cid:79)(cid:76)(cid:86)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:71)(cid:72)(cid:89)(cid:72)(cid:79)(cid:82)(cid:83)(cid:80)(cid:72)(cid:81)(cid:87)(cid:3)(cid:85)(cid:76)(cid:74)(cid:75)(cid:87)(cid:86)(cid:3)(cid:87)(cid:82)(cid:3)(cid:76)(cid:87)(cid:86)(cid:3)(cid:79)(cid:68)(cid:87)(cid:72)(cid:16)(cid:86)(cid:87)(cid:68)(cid:74)(cid:72)(cid:15)(cid:3)(cid:86)(cid:80)(cid:68)(cid:79)(cid:79)(cid:3)(cid:80)(cid:82)(cid:79)(cid:72)(cid:70)(cid:88)(cid:79)(cid:72)(cid:3)(cid:68)(cid:81)(cid:87)(cid:76)(cid:69)(cid:76)(cid:82)(cid:87)(cid:76)(cid:70)(cid:86)(cid:3)(cid:69)(cid:88)(cid:86)(cid:76)(cid:81)(cid:72)(cid:86)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:80)(cid:82)(cid:86)(cid:87)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:86)(cid:3)(cid:74)(cid:79)(cid:82)(cid:69)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)(cid:82)(cid:88)(cid:87)(cid:86)(cid:76)(cid:71)(cid:72)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:17)(cid:3)
7 Registrational studies now complete (data will contribute towards subsequent HNSCC regulatory submissions).
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Patent Expiries of Key Marketed Products
Patents covering our products are or may be challenged by third parties. Generic products may be launched ‘at risk’ and our
patents may be revoked, circumvented or found not to be infringed. For more information, please see Risk from page 214. Many of
our products are subject to challenges by third parties. Details of material challenges by third parties can be found in Note 28 to the
Financial Statements from page 185. The expiry dates shown below include granted SPC/PTE and/or Paediatric Exclusivity periods
(as appropriate), but do not include projected expiry dates based on pending applications for these exclusivities unless asterisked.
(In Europe, the exact SPC situation may vary by country as different Patent Offices grant SPCs at different rates.) Expiry dates in red
relate to new chemical entity or antibody patents, the remaining dates relate to other patents. A number of our products are subject
to generic competition in one or more markets. Further information can be found in the Geographical Review from page 226.
Key marketed
products
Atacand3
Brilinta/Brilique
Bydureon
Byetta
Crestor
Daliresp/Daxas
Duaklir
Faslodex
Farxiga/Forxiga
Description
An angiotensin II antagonist for the
1st line treatment of hypertension and
symptomatic heart failure
An oral P2Y12 platelet inhibitor for
acute coronary syndromes (ACS)
or extended therapy in high-risk
patients with a history of myocardial
infarction (MI)
A once-weekly injectable glucagon-
like peptide-1 (GLP-1) receptor
agonist available as a single-dose tray
or a single-dose pen indicated to
improve glycaemic control, in adults
with Type 2 diabetes
A twice-daily injectable GLP-1
receptor agonist indicated to improve
glycaemic control in adults with Type
2 diabetes
A statin for dyslipidaemia and
hypercholesterolaemia
An oral PDE4 (phosphodiesterase-4)
inhibitor for adults with severe COPD
to decrease their number of
exacerbations (US only)
A fixed-dose combination of a
long-acting muscarinic antagonist
(LAMA) and a long-acting
beta2-adrenergic receptor agonist
(LABA) for the maintenance treatment
of COPD
An injectable estrogen receptor
antagonist. It is used for the
treatment of hormone receptor
positive advanced breast cancer
for post-menopausal women
whose disease has progressed
following treatment with prior
endocrine therapy
A selective inhibitor of human
sodium-glucose co-transporter 2
(SGLT2 inhibitor) indicated as an
adjunct to diet and exercise to
improve glycaemic control in adult
patients with Type 2 diabetes
US
expired
China
4
EU1
expired
Japan
2016
2015
2014
2016
4
36
34
44
97
US
Product Sales
($m)
Aggregate Revenue for
China, Japan and Europe2
Product Sales
($m)
2015
106
2014
169
2018-2019,
2024*,
2021-2030
2018-2019,
2021
2018-2024,
20215
2018-2019,
2024*,
2021-2027
348
240
146
347
268
245
2018-2028
2020-2028
2017-2028
2018-2028
463
482
374
109
90
62
2017-2020
2020
2017-2021
2018-2020
164
209
199
62
86
107
2018-20226
2020-2021 2017, 2020
2017,
2021-2023
1,223
2,844
2,918
1,698
1,642
1,931
2020,
2023-2024
2023 20197, 2023
2023
134
104
2020, 2025*,
2022-20278
2020,
2022-2027
2025,
2022-2029
2025,
2021-2029
–
–
–
–
15
–
62
26
–
–
20219
2021
2026
438
356
340
311
269
305
2020, 2026* 2020-2023,
2028
2020-2028*
2020-2025,
2028
358
229
120
175
121
66
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Additional Information
Patent Expiries of Key Marketed Products continued
Key marketed
products
Iressa
Kombiglyze XR
Komboglyze
Lynparza
Movantik/Moventig
Nexium
Onglyza
Pulmicort
Seloken/Toprol-XL
Description
An epidermal growth factor
receptor-tyrosine kinase inhibitor
(EGFR-TKI) that acts to block signals
for cancer cell growth and survival in
advanced non-small cell lung cancer
(NSCLC)
Combines saxagliptin (Onglyza)
and extended release metformin
(metformin XR) in a once-daily tablet
for Type 2 diabetes
Combines saxagliptin (Onglyza)
and metformin immediate release
(metformin IR) in a twice-daily tablet
for Type 2 diabetes
An oral poly ADP-ribose polymerase
(PARP) inhibitor currently only
approved as a capsule formulation.
It is approved in the EU for the
treatment of adult patients with
platinum-sensitive relapsed
BRCA-mutated (germline and/or
somatic) high-grade serous epithelial
ovarian, fallopian tube or primary
peritoneal cancer. It is approved in
the US for the treatment of patients
with germline BRCA-mutated
advanced ovarian cancer who have
been treated with three or more prior
lines of chemotherapy
A once-daily, peripherally-acting
mu-opioid receptor antagonist
approved for the treatment of
opioid-induced constipation (OIC) in
adult patients. The indication varies
by jurisdiction
A proton pump inhibitor used to treat
acid-related diseases
US
201710
China
EU1
Japan
2016
2015
2014
2023 201911, 2023
2018, 2023
23
6
–
US
Product Sales
($m)
Aggregate Revenue for
China, Japan and Europe2
Product Sales
($m)
2015
396
2014
467
2016
358
2021-2023,
2025
2021, 2025 2021-2026,
2025
145
154
159
–
–
–
8
2021, 2025 2021-2026,
2025
–
–
2022-2024,
2028*,
2024-2031
2021-2024,
2024-2027
2021-2029,
2024-2027
2021-2024,
2024-2027
127
70
–
–
49
48
40
81
23
–
2022-2027,
2028*, 2032
2024 2022-2024,
2029*14
2022-2024
90
28
–
–
–
–
2018-202015
2018-2019
2018
2018,
2018-2019
526
870
1,821
975
985
1,015
An oral dipeptidyl peptidase 4
(DPP-4) inhibitor for Type 2 diabetes
2021-2024*,
2018-2028
2021, 2025 2021-2025*,
2025
12
231
266
322
119
124
129
An inhaled corticosteroid for
maintenance treatment of asthma
A beta-blocker once-daily tablet for
control of hypertension, heart failure
and angina
2018-201916
201817
201817
201817
174
200
211
732
662
574
expired
expired
expired
expired
95
89
91
462
436
438
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US
201718
China
2017
EU1
2017
Japan
19
2016
515
2015
716
2014
738
2016
134
US
Product Sales
($m)
Aggregate Revenue for
China, Japan and Europe2
Product Sales
($m)
2015
201
2014
342
2017-202920
201821 2018-201921 2017-202021
1,242
1,520
1,511
1,276
1,375
1,756
2023
2023
2023
325
285
499
352
377
401
Key marketed
products
Seroquel XR
Symbicort
Synagis
Tagrisso
Tudorza/Eklira
Genuair
Xigduo
Zoladex
Description
Generally approved for the treatment
of schizophrenia, bipolar disorder,
major depressive disorder and,
on a more limited basis, for
generalised anxiety disorder
A combination of an inhaled
corticosteroid and a fast onset LABA
for maintenance treatment of asthma
and COPD
A humanised MAb used to prevent
serious lower respiratory tract
disease caused by respiratory
syncytial virus (RSV) in paediatric
patients at high risk of acquiring
RSV disease
An EGFR-TKI indicated for patients
with metastatic EGFR T790M
mutation-positive NSCLC
Combines dapagliflozin (Farxiga/
Forxiga), an SGLT2 inhibitor, and
metformin IR, in a twice-daily tablet
to improve glycaemic control in adult
patients with Type 2 diabetes who
are inadequately controlled by
metformin alone
A luteinising hormone-releasing
hormone (LHRH) agonist used to
treat prostate cancer, breast cancer
and certain benign gynaecological
disorders
A LAMA for the maintenance
treatment of COPD
2020, 2025*,
2022-2027
2020,
2022-2027
2025,
2022-2029
2025,
2021-2029
2020, 2026*
2020-2023 2020-2028
2020-2025,
2030
2032, 2035
2032, 2035 2032, 2035 2032, 2034*,
2035
254
15
–
–
2
158
4
–
84
40
77
21
13
12
77
99
103
32
2022
2021
2021
2021
35
28
26
498
485
544
* Date represents expiry of any granted SPC/PTE and/or Paediatric Exclusivity periods.
1 Expiry in major EU markets.
2(cid:3) (cid:55)(cid:75)(cid:72)(cid:3)(cid:51)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:3)(cid:54)(cid:68)(cid:79)(cid:72)(cid:86)(cid:3)(cid:85)(cid:72)(cid:432)(cid:72)(cid:70)(cid:87)(cid:72)(cid:71)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:40)(cid:88)(cid:85)(cid:82)(cid:83)(cid:72)(cid:3)(cid:53)(cid:72)(cid:74)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:86)(cid:3)(cid:71)(cid:72)(cid:430)(cid:81)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:48)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:3)(cid:71)(cid:72)(cid:430)(cid:81)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:82)(cid:81)(cid:3)(cid:83)(cid:68)(cid:74)(cid:72)(cid:3)(cid:21)(cid:22)(cid:28)(cid:17)
3 Atacand HCT in US.
4 Takeda retained rights.
5(cid:3) (cid:55)(cid:75)(cid:72)(cid:3)(cid:83)(cid:68)(cid:87)(cid:72)(cid:81)(cid:87)(cid:3)(cid:90)(cid:68)(cid:86)(cid:3)(cid:85)(cid:72)(cid:89)(cid:82)(cid:78)(cid:72)(cid:71)(cid:3)(cid:71)(cid:88)(cid:85)(cid:76)(cid:81)(cid:74)(cid:3)(cid:82)(cid:83)(cid:83)(cid:82)(cid:86)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:83)(cid:85)(cid:82)(cid:70)(cid:72)(cid:72)(cid:71)(cid:76)(cid:81)(cid:74)(cid:86)(cid:3)(cid:68)(cid:87)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:40)(cid:88)(cid:85)(cid:82)(cid:83)(cid:72)(cid:68)(cid:81)(cid:3)(cid:51)(cid:68)(cid:87)(cid:72)(cid:81)(cid:87)(cid:3)(cid:50)(cid:433)(cid:70)(cid:72)(cid:3)(cid:11)(cid:40)(cid:51)(cid:50)(cid:12)(cid:17)(cid:3)(cid:55)(cid:75)(cid:72)(cid:3)(cid:83)(cid:68)(cid:87)(cid:72)(cid:81)(cid:87)(cid:72)(cid:72)(cid:3)(cid:75)(cid:68)(cid:86)(cid:3)(cid:68)(cid:83)(cid:83)(cid:72)(cid:68)(cid:79)(cid:72)(cid:71)(cid:3)(cid:87)(cid:75)(cid:68)(cid:87)(cid:3)(cid:71)(cid:72)(cid:70)(cid:76)(cid:86)(cid:76)(cid:82)(cid:81)(cid:17)
6 A settlement agreement in the US permitted Watson Laboratories, Inc. and Actavis, Inc. (together, Watson) to begin selling its generic version of Crestor(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:76)(cid:87)(cid:86)(cid:3)(cid:85)(cid:82)(cid:86)(cid:88)(cid:89)(cid:68)(cid:86)(cid:87)(cid:68)(cid:87)(cid:76)(cid:81)(cid:3)(cid:93)(cid:76)(cid:81)(cid:70)(cid:3)(cid:83)(cid:85)(cid:82)(cid:71)(cid:88)(cid:70)(cid:87)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)
(cid:21)(cid:98)(cid:48)(cid:68)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:17)
7 There is eight years’ data exclusivity and two years’ market exclusivity for Daxas in the EU to 5 July 2020.
8(cid:3) (cid:49)(cid:82)(cid:87)(cid:3)(cid:430)(cid:79)(cid:72)(cid:71)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:68)(cid:83)(cid:83)(cid:85)(cid:82)(cid:89)(cid:68)(cid:79)(cid:3)(cid:76)(cid:81)(cid:3)(cid:56)(cid:54)(cid:17)
9(cid:3) (cid:54)(cid:72)(cid:87)(cid:87)(cid:79)(cid:72)(cid:71)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:54)(cid:68)(cid:81)(cid:71)(cid:82)(cid:93)(cid:15)(cid:3)(cid:44)(cid:81)(cid:70)(cid:17)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:68)(cid:3)(cid:79)(cid:76)(cid:70)(cid:72)(cid:81)(cid:86)(cid:72)(cid:71)(cid:3)(cid:72)(cid:81)(cid:87)(cid:85)(cid:92)(cid:3)(cid:71)(cid:68)(cid:87)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:21)(cid:24)(cid:3)(cid:48)(cid:68)(cid:85)(cid:70)(cid:75)(cid:3)(cid:21)(cid:19)(cid:20)(cid:28)(cid:17)
10 In the US, Iressa has seven years’ orphan drug exclusivity to 13 July 2022.
11 SPCs expire 2 March 2019. There is eight years’ data exclusivity and two years’ market exclusivity for Iressa in the EU to 24 June 2019.
12 AstraZeneca does not have commercialisation rights.
13 Komboglyze/Kombiglyze XR revenue is included in the Onglyza(cid:3)(cid:85)(cid:72)(cid:89)(cid:72)(cid:81)(cid:88)(cid:72)(cid:3)(cid:430)(cid:74)(cid:88)(cid:85)(cid:72)(cid:17)
14(cid:3)(cid:51)(cid:85)(cid:82)(cid:54)(cid:87)(cid:85)(cid:68)(cid:78)(cid:68)(cid:81)(cid:3)(cid:42)(cid:85)(cid:82)(cid:88)(cid:83)(cid:3)(cid:11)(cid:68)(cid:3)(cid:86)(cid:88)(cid:69)(cid:86)(cid:76)(cid:71)(cid:76)(cid:68)(cid:85)(cid:92)(cid:3)(cid:82)(cid:73)(cid:3)(cid:46)(cid:92)(cid:82)(cid:90)(cid:68)(cid:3)(cid:43)(cid:68)(cid:78)(cid:78)(cid:82)(cid:3)(cid:46)(cid:76)(cid:85)(cid:76)(cid:81)(cid:3)(cid:38)(cid:82)(cid:17)(cid:3)(cid:47)(cid:87)(cid:71)(cid:12)(cid:3)(cid:76)(cid:86)(cid:3)(cid:72)(cid:91)(cid:70)(cid:79)(cid:88)(cid:86)(cid:76)(cid:89)(cid:72)(cid:79)(cid:92)(cid:3)(cid:79)(cid:76)(cid:70)(cid:72)(cid:81)(cid:86)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:40)(cid:56)(cid:15)(cid:3)(cid:44)(cid:70)(cid:72)(cid:79)(cid:68)(cid:81)(cid:71)(cid:15)(cid:3)(cid:49)(cid:82)(cid:85)(cid:90)(cid:68)(cid:92)(cid:15)(cid:3)(cid:54)(cid:90)(cid:76)(cid:87)(cid:93)(cid:72)(cid:85)(cid:79)(cid:68)(cid:81)(cid:71)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:47)(cid:76)(cid:72)(cid:70)(cid:75)(cid:87)(cid:72)(cid:81)(cid:86)(cid:87)(cid:72)(cid:76)(cid:81)(cid:17)
15 Licence agreements with Teva and Ranbaxy Pharmaceuticals Inc. and other generic companies allow each to launch a generic version in the US from May 2014, subject to regulatory approval.
16 A licence agreement with Teva permits its ongoing sale in the US of a generic version from December 2009. The 2018 expiry relates to the Flexhaler device, while the 2019 expiry relates to the
formulation in the Flexhaler presentation and also to Respules.
17 The 2018 expiry relates to the formulation in the Turbuhaler presentation and to a process useful for the Respules product.
18 Licence agreements with various generics companies allowed launches of generic versions of Seroquel XR in the US as of 1 November 2016.
19 Rights licensed to Astellas.
20 Patent expiry dates relate to the Symbicort pMDI product. The six months of paediatric exclusivity that have been granted are not included as they are not yet included in the Orange Book.
21 Patent expiry dates relate to the Symbicort Turbuhaler product.
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213
Additional Information
Risk
Risks and uncertainties
Operating in the pharmaceutical sector carries various inherent risks and uncertainties that may affect our business. In this section,
we describe the risks and uncertainties that we consider material to our business in that they may have a significant effect on our financial
condition, results of operations, and/or reputation.
These risks are not listed in any particular order of priority and have been categorised consistently with the Principal Risks detailed from
page 20. Other risks, unknown or not currently considered material, could have a similar effect. We believe that the forward-looking
statements about AstraZeneca in this Annual Report, identified by words such as ‘anticipates’, ‘believes’, ‘expects’ and ‘intends’, and
that include, among other things, Future prospects in the Financial Review on page 76, are based on reasonable assumptions. However,
forward-looking statements involve inherent risks and uncertainties such as those summarised below. They relate to events that may
occur in the future, that may be influenced by factors beyond our control and that may have actual outcomes materially different from
our expectations.
Product pipeline and IP risks
Impact
Failure or delay in delivery of pipeline or launch of new products
Our continued success depends on the development and successful
launch of innovative new drugs.
The development of pharmaceutical product candidates is a complex,
risky and lengthy process involving significant financial, R&D and other
resources. It may fail at any stage of the process due to various factors,
including failure to obtain the required regulatory or marketing approvals
for the product candidate or for its manufacturing facilities, unfavourable
clinical efficacy data, safety concerns, failure to demonstrate adequate
cost-effective benefits to regulatory authorities and/or payers and the
emergence of competing products. More details of projects that have
suffered setbacks or failures during 2016 can be found in the Therapy
Area Review.
The anticipated launch dates of major new products significantly affect our
business, including investment in large clinical studies, the manufacture of
pre-launch product stocks, investment in marketing materials pre-launch,
sales force training and the timing of anticipated future revenue streams
from new Product Sales. Launch dates are primarily driven by our
development programmes and the demands from various factors,
including adverse findings in pre-clinical or clinical studies, regulatory
demands, price negotiation, competitor activity and technology transfer.
More complex and stringent regulations govern the manufacturing and
supply of biologics products, thus impacting the production and release
schedules of such products more significantly.
In addition to developing products in-house, we also expand our product
portfolio and geographical presence through licensing arrangements and
strategic collaborations, which are key to growing and strengthening our
business. The success of such arrangements is largely dependent on the
technology and other IP rights we acquire, and the resources, efforts and
skills of our partners. Disputes or difficulties in our relationship with our
collaborators or partners may arise, for example, due to conflicting priorities
or conflicts of interest between parties.
In many cases we make milestone payments well in advance of the
commercialisation of the products, with no assurance that we will recoup
these payments.
We experience strong competition from other pharmaceutical companies
in respect of licensing arrangements, strategic collaborations, and
acquisition targets.
Failure or delay in development of new product candidates that achieve
the expected commercial success could frustrate the achievement
of development targets, adversely affect the reputation of our R&D
capabilities, and is likely to materially adversely affect our business and
results of operations. See also Failure to achieve strategic plans or meet
targets and expectations on page 223.
Since our business model and strategy rely on the success of relatively
few compounds, the failure of any in line production may have a significant
negative effect on our business or results of operations.
Significant delays to anticipated launch dates of new products could
have a material adverse effect on our financial position and/or results of
operations. For example, for the launch of products that are seasonal in
nature, delays in regulatory approvals or manufacturing difficulties may
delay launch to the next season which, in turn, may significantly reduce
the return on costs incurred in preparing for the launch for that season.
Furthermore, in immuno-oncology speed to market is critical given the
large number of clinical trials being conducted by other companies.
In addition, a delayed launch may lead to increased costs if, for example,
marketing and sales efforts need to be rescheduled or performed for
longer than expected.
Failure to complete collaborative projects in a timely, cost-effective manner
may limit our ability to access a greater portfolio of products, IP technology
and shared expertise. Disputes and difficulties with our partners may erode
or eliminate the benefits of our alliances and collaborations. In addition,
failure to perform on the part of parties to externalisation transactions may
diminish the future value of those transactions. Delay of launch can also
erode the term of patent exclusivity.
Competition from other pharmaceutical companies means that we may
be unsuccessful in implementing some of our intended projects or we
may have to pay a significant premium over book or market values for
our acquisitions.
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Product pipeline and IP risks
Impact
Difficulties in obtaining or maintaining regulatory drug approval for products
Delays in regulatory reviews and approvals could delay our ability to
market our products and may adversely affect our revenue. In addition,
post-approval requirements, including additional clinical trials, could result
in increased costs, and may impact the labelling and approval status of
currently marketed products.
We are subject to strict controls on the commercialisation processes for
our pharmaceutical products, including their development, manufacture,
distribution and marketing. The criteria for establishing safety, efficacy and
quality, which are essential for securing marketing approvals, may vary by
country and by region. Regulators can refuse to grant approval or may
require additional data before approval is granted, even though the
medicine may already be launched in other countries.
Factors, including advances in science and technology, evolving regulatory
science, and different approaches to benefit/risk tolerance by regulatory
authorities, the general public, and other third party public interest groups
influence the initial approvability of new drugs. While we seek to manage
many of these risks, unanticipated and unpredictable policymaking by
governments and regulators, limited regulatory authority resources or
conflicting priorities often lead to severe delays in regulatory approvals.
We may be required to conduct additional clinical trials after a drug’s
approval because a regulatory authority may have a concern that impacts
the benefit/risk profile of one of our marketed drugs or drugs currently
in development. For our marketed drugs, new data and meta-analyses
have the potential to drive changes in the approval status or labelling. In
addition, recent years have seen an increase in post-marketing regulatory
requirements and commitments, and an increased call for third party
access to regulatory and clinical trial data packages for independent
analysis and interpretation, and broader data transparency. Such
transparency, while important, could lead to inappropriate or incorrect
data analyses which may damage the integrity of our products and our
Company’s reputation.
Failure to obtain and enforce effective IP protection
A pharmaceutical product is protected from being copied for a limited
period of time under certain patent rights and/or related IP rights, such
as Regulatory Data Protection or Orphan Drug status. Typically, products
protected by such rights generate significantly higher revenues than those
not protected. Our ability to obtain, maintain and enforce patents and other
IP rights in relation to our products is an important element in protecting
and recouping our investment in R&D and creating long-term value for
the business. Some countries in which we operate do not offer robust IP
protection. This may be because IP laws are still developing, the scope
of those laws is limited or the political environment does not support
such legislation.
Limitations on the availability of patent protection, the ability to obtain
related IP rights or the use of compulsory licensing in certain countries
in which we operate could allow for earlier entry of generic or biosimilar
competitor products. This could have a material adverse effect on the
pricing and sales of our products and, consequently, could materially
adversely affect our revenues.
More information about protecting our IP, the risk of patent litigation and
the early loss of IP rights is contained in the Intellectual Property section on
page 57, the Competitive pressures including expiry or loss of IP rights and
generic competition risk on page 216 and Note 28 to the Financial
Statements from page 185.
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215
Additional Information
Risk continued
Commercialisation risks
Impact
Competitive pressures including expiry or loss of IP rights and generic competition
If we are not successful in obtaining, maintaining, defending or enforcing
our exclusive rights to market our products, particularly in the US where
we achieve our highest Product Sales, our revenue and margins could be
materially adversely affected. In addition, unsuccessful assertion of our IP
rights may lead to damages or other liabilities to third parties that could
materially adversely affect our financial performance.
Third parties may be awarded remedies for alleged infringement of their IP,
for example injunctions and damages for alleged patent infringement. In the
US, courts may order enhanced (ie up to treble) damages for alleged wilful
infringement of patents. From time to time we may acquire licences,
discontinue activities and/or modify processes to avoid claims of patent
infringement. These steps could entail significant costs and our revenue
and margins could be materially adversely affected.
Unfavourable resolution of current and potential future patent litigation may
require us to make significant provisions in our accounts relating to legal
proceedings and/or could materially adversely affect our financial condition
or results of operations.
A pharmaceutical product competes with other products marketed by
research-based pharmaceutical companies and with generic or biosimilar
drugs marketed by generic drug manufacturers.
Approval of competitive products for the same or similar indication as one
of our products may result in immediate and significant decreases in
our revenues.
Generic versions of products, including biosimilars, are often sold at lower
prices than branded products, as the manufacturer does not have to
recoup the significant cost of R&D investment and market development.
Expiry or loss of IP rights can materially adversely affect our revenues
and financial condition due to the launch of cheaper generic copies of
the product in the country where the rights have expired or been lost
(see the table in the Patent Expiries of Key Marketed Products section
from page 211). For example in 2016, our US Product Sales of Crestor fell
to $1,223 million (2015: $2,844 million), following the launch of generics.
Additionally, the expiry or loss of patents covering other innovator
companies’ products may also lead to increased competition and pricing
pressure for our own, still-patented products in the same product class due
to the availability of lower priced generic products in that product class.
Generic manufacturers may also take advantage of the failure of certain
countries to properly enforce Regulatory Data Protection or other related IP
rights and may launch generics during this protected period. This is a
particular risk in some Emerging Markets where appropriate patent
protection or other related IP rights may be difficult to obtain or enforce.
Various regulatory authorities are implementing or considering abbreviated
approval processes for biosimilars, allowing quicker entry to market for
such products and earlier than anticipated competition for patented
biologics.
As well as facing generic competition upon expiry or loss of IP rights, we
also face the risk that generic drug manufacturers seek to market generic
versions of our products prior to expiries of our patents and/or the
Regulatory Exclusivity periods. For example, we are currently facing
challenges from numerous generic drug manufacturers regarding our
patents relating to key products, including Brilinta, Faslodex, Byetta,
Daliresp, Onglyza and Crestor.
IP rights protecting our products may be challenged by external parties.
We expect our most valuable products to receive the greatest number
of challenges. Despite our efforts to establish and defend robust patent
protection for our products, we bear the risk that courts may decide that
our IP rights are invalid and/or that third parties do not infringe our asserted
IP rights.
Where we assert our IP rights but are ultimately unsuccessful, third
parties may seek damages, alleging, for example, that they have been
inappropriately restrained from entering the market. In such cases,
we bear the risk that we incur liabilities to those third parties.
We also bear the risk that we may be found to infringe patents owned
or licensed by third parties, including research-based and generic
pharmaceutical companies and individuals. These third parties may seek
remedies for patent infringement, including injunctions (for example,
preventing the marketing of one of our products) and damages.
Details of material patent litigation matters can be found in Note 28 to the
Financial Statements from page 185.
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Commercialisation risks
Impact
Price controls and reductions
Most of our key markets have experienced the implementation of various
cost control or reimbursement mechanisms for pharmaceutical products.
In the US, there is significant pricing pressure driven by payer consolidation,
restrictive reimbursement policies, and cost control tools, such as
exclusionary formularies and price protection clauses. Many formularies
employ ‘generic first’ strategies and/or require physicians to obtain prior
approval for the use of a branded medicine where a generic alternative
exists. These mechanisms can be used by payers to limit the use of
branded products and put pressure on manufacturers to reduce net prices.
In addition, patients are seeing changes in the design of their health plan
benefits and may experience variation in how their plans cover their
medications, including increases in the out-of-pocket payments for their
branded medications. Patient out-of-pocket spending is generally in the
form of a co-payment or co-insurance, but there is a growing trend towards
high deductible health plans that require that patients pay the full list price
of their drugs and services until they meet certain out-of-pocket thresholds.
Ongoing scrutiny of the US pharmaceutical industry, focused largely on
pricing, is placing increased emphasis on the value of medications. This
scrutiny will likely continue across many stakeholders, including
policymakers and legislators.
Due to these pricing pressures, there can be no certainty that we
will be able to charge prices for a product that, in a particular country
or in the aggregate, enable us to earn an adequate return on our product
investment. These pressures, including the increasingly restrictive
reimbursement policies to which we are subject, could materially
adversely affect our business or results of operations.
We expect these pricing pressures will continue and may increase.
The continued disparities in EU and US pricing systems could lead
to marked price differentials between regions, which, by way of the
implementation of existing or new reference pricing mechanisms,
increases the pricing pressure affecting the industry. The importation
of pharmaceutical products from countries where prices are low due
to government price controls, or other market dynamics, to countries
where prices for those products are higher, is already prevalent and may
increase. Strengthened collaboration by governments may accelerate
the development of further cost-containment policies (such as joint
procurement). Increased and simplified access to national and regional
prices in markets and the publication of these prices in centralised
databases have facilitated the uptake and efficiency of price referencing
across the world.
The new US political leadership has initiated various legislative and policy
processes that could affect the ACA. US prescription drug costs and
importation policies could be among the policy proposals considered in
initial steps to repeal and replace the ACA. In addition to addressing the
ACA directly, lawmaker and policymaker proposals are also discussing a
variety of other related changes relating to, for example, tax and Medicare
reform. For more information, please see Pricing of medicines in the
Marketplace section from page 13. Currently it is difficult to predict what
specific proposals may be directed at existing laws and regulations
(including the ACA or the Medicare Part D program) and to determine the
implications for the healthcare system and pharmaceutical industry. This
uncertainty could impact our ability to execute our plans, strategies, and
business operations. However, significantly modifying existing laws and
regulations, including the ACA and those relating to drug pricing and
importation, could affect private health insurance, coverage through
Medicaid and the health insurance exchange marketplaces, Medicare
coverage and savings provisions, and other facets of the US healthcare
market, with potentially significant impacts on the pharmaceutical industry.
In Europe, the industry continues to be exposed to various ad hoc
cost-containment measures and reference pricing mechanisms, which
impact prices. There is a trend towards increasing transparency and
comparison of prices among EU Member States which may eventually
lead to a change in the overall pricing and reimbursement landscape.
In Emerging Markets, governments are increasingly controlling pricing
in the self-pay sector and favouring locally manufactured drugs. In addition,
the emergence of price referencing is seen in some markets.
Concurrently, many markets are adopting the use of Health Technology
Assessment (HTA) to provide a rigorous evaluation of the clinical efficacy
of a product at, or post, launch. HTA evaluations are also increasingly
being used to assess the clinical effect, as well as cost-effectiveness,
of products in a particular health system. This comes as payers and
policymakers attempt to increase efficiencies in the use and choice of
pharmaceutical products.
A summary of the principal aspects of price regulation and how pricing
pressures are affecting our business in our most important markets is set
out in Pricing of medicines in the Marketplace section from page 13 and
overleaf in the following risk factor.
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217
Additional Information
Risk continued
Commercialisation risks
Impact
Deterioration of, or failure to improve, socio-economic conditions, and
situations and/or resulting events, depending on their severity, could
adversely affect our supply and/or distribution chain in the affected
countries and the ability of customers or ultimate payers to purchase our
medicines. This could adversely affect our business or results of operations.
While we have adopted cash management and treasury policies to
manage the risk of not being able to access a sustainable flow of liquid
funds (see the Financial risk management policies section of the Financial
Review from page 76), we cannot be certain that these will be as effective
as they are intended to be, in particular in the event of a global liquidity
crisis. In addition, open positions where we are owed money and
investments we have made in financial and non-financial institutions or
money market funds cannot be guaranteed to be recoverable. Additionally,
if we need access to external sources of financing to sustain and/or grow
our business, such as the debt or equity capital financial markets, this may
not be available on commercially acceptable terms, if at all, in the event of
a severe and/or sustained economic downturn. This may, for instance, be
the case in the event of any default by the Company on its debt obligations,
which may materially adversely affect our ability to secure debt funding in
the future or our financial condition in general. Further information on debt
funding arrangements is contained in the Financial risk management
policies section of the Financial Review from page 76.
It is too early to judge the impact of Brexit as it is unclear as to the trading
relationships the UK will be able to negotiate with the EU and other
significant trading partners. Any deterioration in market access or trading
terms including customs duties, VAT or other tariffs that constitute real cost
or delay to the movement of goods and increased administration may
materially adversely impact our financial performance.
Economic, regulatory and political pressures
Operating in over 100 countries, we are subject to political, socio-economic
and financial factors both globally and in individual countries.
A sustained global economic downturn may further exacerbate pressure
from governments and other healthcare payers on medicine prices and
volumes of sales in response to pressures on budgets, and may cause a
slowdown or a decline in growth in some markets. Those most severely
impacted by the economic downturn may seek alternative ways to settle
their debts through, for example, the issuance of government bonds which
might trade at a discount to the face value of the debt. Other customers
may cease to trade, which may result in losses from writing off debts,
or a reduction in demand for products.
We are highly dependent on being able to access a sustainable flow of
liquid funds due to the high fixed costs of operating our business and the
long and uncertain development cycles of our products. In a sustained
economic downturn, financial institutions with whom we deal may cease to
trade and there can be no guarantee that we will be able to access monies
owed to us without a protracted, expensive and uncertain process, if at all.
More than 90% of our cash investments are managed centrally and are
invested in collateralised bank deposits, fixed income securities in
government, financial and non-financial securities and AAA credit rated
institutional money market funds. Money market funds are backed by
institutions in the US and the EU, which, in turn, invest in other funds,
including sovereign funds. This means our credit exposure is a mix of
US and EU sovereign default risk, financial institution and non-financial
institution default risk.
On 23 June 2016, the UK held a remain-or-leave referendum on the
UK’s membership within the EU, the outcome of which was a decision
for the UK to exit from the EU (Brexit). A process of negotiation will likely
determine the future terms of the UK’s relationship with the EU, as well
as whether the UK will be able to continue to benefit from the EU’s free
trade and similar arrangements. Until the Brexit negotiation process is
initiated and completed, it is difficult to anticipate the potential impact on
AstraZeneca’s market share, sales, profitability and results of operations.
The Group operates from a global footprint and retains flexibility to adapt
to changing circumstances. The uncertainty before, during and after the
period of negotiation is also expected to increase volatility and may have
an economic impact, particularly in the UK and Eurozone. The Board
reviews the potential impact of Brexit as an integral part of its Principal
Risks (as outlined from page 20) rather than as a stand-alone risk. As the
process of Brexit evolves, the Board will continue to assess its impact
on the Company.
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Commercialisation risks
Impact
Failures or delays in the quality and execution of our commercial strategies
Commercial success of our Growth Platforms are critical factors in
sustaining or increasing global Product Sales and replacing lost Product
Sales due to patent expiry. The successful launch of a new pharmaceutical
product involves substantial investment in sales and marketing activities,
launch stocks and other items. We may ultimately be unable to achieve
commercial success for various reasons including difficulties in
manufacturing sufficient quantities of the product candidate for
development or commercialisation in a timely manner, the impact of price
control measures imposed by governments and healthcare authorities,
the outcome of negotiations with third party payers, erosion of IP rights,
including infringement by third parties, failure to show a differentiated
product profile and changes in prescribing habits.
The commercialisation of biologics is often more complex than for small
molecule pharmaceutical products, primarily due to differences in the
mode of administration, technical aspects of the product, and rapidly
changing distribution and reimbursement environments.
We face particular challenges in Emerging Markets, including:
> More volatile economic conditions and/or political environments.
> Competition from multinational and local companies with existing
market presence.
> The need to identify and to leverage appropriate opportunities for sales
and marketing.
> Poor IP protection.
> Inadequate protection against crime (including counterfeiting, corruption
and fraud).
> The need to impose developed market compliance standards.
> The need to meet a more diverse range of national regulatory, clinical,
manufacturing and distribution requirements.
> Potential inadvertent breaches of local and international law.
> Not being able to recruit appropriately skilled and experienced
personnel.
> Difficulty in identifying the most effective sales and marketing channels
and routes to market.
> Intervention by national governments or regulators restricting market
access and/or introducing adverse price controls.
> Difficulty in managing local partnerships such as co-promotion and
co-marketing; both driving performance and adhering to AstraZeneca’s
compliance standards which are often higher than the market norm.
> Difficulties in cash repatriation due to strict foreign currency controls
and lack of hard currency reserves in some Emerging Markets.
> Complexity inherent within a direct exports business from UK and
Sweden operations to countries where we do not have a legal entity.
We may also seek to acquire complementary businesses or enter into other
strategic transactions. The integration of an acquired business could
involve incurring significant debt and unknown or contingent liabilities, as
well as having a negative effect on our reported results of operations from
acquisition-related charges, amortisation of expenses related to intangibles
and charges for the implementation of long-term assets.
We may also experience difficulties in integrating geographically separated
organisations, systems and facilities, and personnel with different
organisational cultures. Disputes or difficulties in our relationship with our
collaborators or partners may also arise, often due to conflicting priorities
or conflicts of interest between parties.
Failure to execute our commercial strategies could materially adversely
impact our business or results of operations.
If a new product does not succeed as anticipated or its rate of sales growth
is slower than anticipated, there is a risk that we may be unable to fully
recoup the costs incurred in launching it, which could materially adversely
affect our business or results of operations.
Due to the complexity of the commercialisation process for biologics, the
methods of distributing and marketing biologics could materially adversely
impact our revenues from the sales of biologics medicines, such as
Synagis and FluMist/Fluenz.
The failure to exploit potential opportunities appropriately in Emerging
Markets or materialisation of the risks and challenges of doing business
in such markets, including inadequate protection against crime (including
counterfeiting, corruption and fraud) or inadvertent breaches of local and
international law may materially adversely affect our reputation, business
or results of operations.
Integration processes may also result in business disruption, diversion of
management resources, the loss of key employees and other issues, such
as a failure to integrate IT and other systems.
The incurrence of significant debt or liabilities due to the integration of
an acquired business could cause deterioration in our credit rating and
result in increased borrowing costs and interest expense. We may issue
additional shares to pay for acquired businesses, which would result
in the dilution of our then existing shareholders.
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AstraZeneca Annual Report and Form 20-F Information 2016
219
Additional Information
Risk continued
Supply chain and business execution risks
Impact
Difficulties with manufacturing and supply, forecasting, distribution or third
party suppliers may result in product shortages, which may lead to lost
Product Sales and materially adversely affect our reputation and revenues.
Even slight variations in components or any part of the manufacturing
process may lead to a product that is non-compliant and does not meet
quality standards. This could lead to recalls, spoilage, product shortage,
regulatory action and/or reputational harm.
Failure to maintain supply of compliant, quality product
We may experience difficulties, delays and interruptions in the
manufacturing and supply of our products for various reasons, including:
> Demand significantly in excess of forecast demand, which may lead
to supply shortages (this is particularly challenging before launch).
> Supply chain disruptions, including those due to natural or man-made
disasters at one of our facilities or at a critical supplier or vendor.
> Delays in construction of new facilities or the expansion of existing
facilities, including those intended to support future demand for our
products (the complexities associated with biologics facilities, especially
for drug substance, increases the probability of delay).
> The inability to supply products due to a product quality failure or
regulatory agency compliance action such as licence withdrawal,
product recall or product seizure.
> Other manufacturing or distribution problems, including changes in
manufacturing production sites, limits to manufacturing capacity due
to regulatory requirements, changes in the types of products produced,
or physical limitations or other business interruptions that could impact
continuous supply.
We increasingly rely on third parties for the timely supply of goods, such
as raw materials (for example, the API in some of our medicines and
drug substances and/or finished drug products for some of our biologics
medicines), equipment, formulated drugs and packaging, and services,
all of which are key to our operations. Many of these goods are difficult
to substitute in a timely manner or at all. We expect that external capacity
for biologics drug substance production will remain constrained for the next
few years and, accordingly, may not be readily available for supplementary
production in the event that we experience an unforeseen need for
such capacity.
Illegal trade in our products
The illegal trade in pharmaceutical products is widely recognised by
industry, non-governmental organisations and governmental authorities
to be increasing. Illegal trade includes counterfeiting, theft and illegal
diversion (that is, when our products are found in a market where we did
not send them and where they are not approved or not permitted/allowed
to be sold). There is a risk to public health when illegally traded products
enter the supply chain, as well as associated financial risk. Authorities and
the public expect us to help reduce opportunities for illegal trade in our
products through securing the integrity of our supply chain, surveillance,
investigation and supporting legal action against those found to be
engaged in illegal trade.
Public loss of confidence in the integrity of pharmaceutical products
as a result of illegal trade could materially adversely affect our reputation
and financial performance. In addition, undue or misplaced concern
about this issue may cause some patients to stop taking their medicines,
with consequential risks to their health. Authorities may take action,
financial or otherwise, if they believe we are liable for breaches in our
own supply chains.
There is also a direct financial loss when, for example, counterfeit and/or
illegally diverted products replace sales of genuine products or genuine
products are recalled following discovery of counterfeit products.
Reliance on third party goods and services
Many of our business-critical operations, including certain R&D processes,
IT systems, HR, finance, tax and accounting services have been
outsourced to third party providers. We are thus heavily reliant on these
third parties not just to deliver timely and high quality services but also to
comply with applicable laws and regulations and adhere to our ethical
business expectations from third party providers.
The failure of outsource providers to deliver timely services, and to the
required level of quality, or the failure of outsource providers to cooperate with
each other, could materially adversely affect our financial condition or results of
operations. Moreover, the failure of these third parties to operate in an ethical
manner could adversely impact our reputation both internally and externally
or even result in non-compliance with applicable laws and regulations.
Our business and financial results could be materially adversely affected
by disruptions caused by our failure to successfully manage either the
integration of outsourced services or the transition process of insourcing
services from third parties. For instance, insourcing some of the previously
outsourced services into our service centre in Chennai, India and
Guadalajara, Mexico may result in deterioration of the quality of service
or deployment of resources by these third parties.
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Supply chain and business execution risks
Impact
Failure of information security, data protection and cybercrime
We are dependent on effective IT systems. These systems support key
business functions such as our R&D, manufacturing, supply chain and
sales capabilities and are an important means of safeguarding and
communicating data, including critical or sensitive information, the
confidentiality and integrity of which we rely on.
Examples of sensitive information that we protect include clinical trial
records (patient names and treatments), personal information (employee
bank details, home address), IP related to manufacturing process and
compliance, key research science techniques, AstraZeneca property
(theft) and privileged access (rights to perform IT tasks).
The size and complexity of our IT systems, and those of our third party
vendors (including outsource providers) with whom we contract, have
significantly increased over the past decade and this makes such systems
potentially vulnerable to service interruptions and security breaches from
attacks by malicious third parties, or from intentional or inadvertent actions
by our employees or vendors.
Significant changes in the business footprint and the implementation of the
IT strategy, including the creation and use of captive offshore Global
Technology Centres, could lead to temporary loss of capability.
We increasingly use the internet, digital content, social media, mobile
applications and other forms of new technology to communicate internally
and externally. The accessibility and instantaneous nature of interactions
with such media may facilitate or exacerbate the risk of data leakages from
within AstraZeneca. It may also lead to false or misleading statements
being made about AstraZeneca, which may damage our reputation. As
existing social media platforms expand and evolve and new social media
platforms emerge, it becomes increasingly challenging to identify new
points of entry and to put structures in place to secure and protect
information.
Failure of critical processes
Unexpected events and/or events beyond our control could result in the
failure of critical processes within the Company or at third parties on whom
we are reliant.
The business faces threats to business continuity from many directions.
Examples of material threats include:
> Disruption to our business if there is instability in a particular geographic
region, including as a result of war, terrorism, riots, unstable
governments, civil insurrection or social unrest.
> Natural disasters in areas of the world prone to extreme weather events
and earthquakes.
> Cyber threats similar to those detailed in the Failure of information
security, data protection and cybercrime section above.
Any expected gains from productivity initiatives are uncertain
We continue to implement various productivity initiatives and restructuring
programmes with the aim of enhancing the long-term efficiency of the
business. However, anticipated cost savings and other benefits from these
programmes are based on estimates and the actual savings may vary
significantly. In particular, these cost-reduction measures are often based
on current conditions and cannot always take into account any future
changes to the pharmaceutical industry or our operations, including new
business developments or wage or price increases.
Any significant disruption to these IT systems, including breaches of data
security or cybersecurity, or failure to integrate new and existing IT systems,
could harm our reputation and materially adversely affect our financial
condition or results of operations.
While we invest heavily in the protection of our data and IT, we may be
unable to prevent breakdowns or breaches in our systems that could
result in disclosure of confidential information, damage to our reputation,
regulatory penalties, financial losses and/or other costs.
The inability to effectively back up and restore data could lead to
permanent loss of data that could result in non-compliance with
applicable laws and regulations.
We and our vendors could be susceptible to third party attacks on our
information security systems. Such attacks are of ever-increasing levels of
sophistication and are made by groups and individuals with a wide range
of motives and expertise, including criminal groups, ‘hacktivists’ and others.
From time to time we experience intrusions, including as a result of
computer-related malware.
Inappropriate use of certain media vehicles could lead to the unauthorised
or unintentional public disclosure of sensitive information (such as
personally identifiable information on employees, healthcare professionals
or patients, such as those enrolled in our clinical trials), which may damage
our reputation, adversely affect our business or results of operations and
expose us to legal risks and/or additional legal obligations. Similarly, the
involuntary public disclosure of commercially sensitive information or an
information loss could adversely affect our business or results of
operations. In addition, negative posts or comments about us (or, for
example, the safety of our products) on social media websites or other
digital channels could harm our reputation.
Failure of critical processes may result in an inability to research,
manufacture or supply products to patients. AstraZeneca has developed
a Business Resilience framework which is designed to mitigate such risks.
However, there is no guarantee that these measures will be sufficient to
prevent business interruption.
This may expose the Company to litigation and/or regulatory action which
may result in fines, loss of revenue and adversely affect the Company’s
financial results.
Our failure to successfully implement these planned cost-reduction
measures, either through the successful implementation of employee
relations processes (including consultation, engagement, talent
management, recruitment and retention), or the possibility that these efforts
do not generate the level of cost savings we anticipate, could materially
adversely affect our business or results of operations.
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Failure to attract and retain key personnel, and engage successfully with our employees
We rely heavily on recruiting and retaining talented employees with a
diverse range of skills and capabilities to meet our strategic objectives.
We face intense competition for well-qualified individuals, as the supply of
people with specific skills and significant leadership potential or in specific
geographic regions may be limited.
The successful delivery of our business objectives is dependent on high
levels of engagement, commitment and motivation of the workforce.
The inability to attract and retain highly skilled personnel may weaken our
succession plans for critical positions in the medium term, may materially
adversely affect the implementation of our strategic objectives and could
ultimately impact our business or results of operations.
Failure to engage effectively with our employees could lead to business
disruption in our day-to-day operations, reduce levels of productivity and/or
increase levels of voluntary turnover, all of which could ultimately materially
adversely affect our business or results of operations.
AstraZeneca Annual Report and Form 20-F Information 2016
221
Additional Information
Risk continued
Legal, regulatory and compliance risks
Impact
Failure to comply with applicable laws, rules and regulations; manage
our liabilities; or to adequately anticipate or proactively manage emerging
policy and legal developments could materially adversely affect our
licence to operate, or results of operations; adversely affect our reputation;
cause harm to people or the environment; and/or lead to fines or other
penalties. For example, once a product has been approved for marketing
by the regulatory authorities, it is subject to continuing control and
regulation, such as the manner of its manufacture, distribution, marketing
and safety surveillance. If regulatory issues concerning compliance
with environmental, current Good Manufacturing Practice or safety
monitoring regulations for pharmaceutical products (often referred to as
pharmacovigilance) arise, this could lead to loss of product approvals,
product recalls and seizures, and interruption of production, which could
create product shortages and delays in new product approvals, and
negatively impact patient access.
Failure to adhere to applicable laws, rules and regulations
Our many business operations are subject to a wide range of laws, rules
and regulations from governmental and non-governmental bodies around
the world.
Any failure to comply with these applicable laws, rules and regulations
may result in us being investigated by relevant agencies and authorities
and/or in legal proceedings being filed against us. Such investigations
or proceedings could result in us becoming subject to civil or criminal
sanctions and/or being forced to pay fines or damages. Relevant
authorities have wide-ranging administrative powers to deal with any
failure to comply with continuing regulatory oversight and this could
affect us, whether such failure is our own or that of our contractors or
external partners.
Material examples of statutes, rules and regulations impacting business
operations include:
> Compliance with Good Manufacturing Practice.
> Local, national and international environment or occupational health
and safety laws and regulations.
> Trade control laws governing our imports and exports including
nationally and internationally recognised trade agreements, embargoes,
trade and economic sanctions and anti-boycott requirements.
> Competition laws and regulations, including challenges from competition
authorities to patent settlement agreements and private damages
actions.
> Rules and regulations established to promote ethical supply chain
management.
> Financial regulations including, but not limited to, external financial
reporting, taxation and money laundering.
> Employment practices.
> Disclosure of payments to healthcare professionals under the Sunshine
Act and EFPIA legislation.
> Appropriate disclosure of community support, patient group support
and product donations.
We have environmental and/or occupational health and safety-related
liabilities at some current, formerly owned, leased and third party sites. For
more information on the most significant of these and for details on other
significant litigation matters, please refer to Note 28 to the Financial
Statements from page 185.
Safety and efficacy of marketed products is questioned
Our ability to accurately assess, prior to launch, the eventual efficacy or
safety of a new product once in broader clinical use can only be based on
data available at that time, which is inherently limited due to relatively short
periods of product testing and relatively small clinical study patient samples.
Serious safety concerns or adverse events relating to our products could
lead to product recalls, seizures, loss of product approvals and interruption
of supply and could materially adversely impact patient access, our
reputation and financial revenues.
Any unforeseen safety concerns or adverse events relating to our products
or failure to comply with laws, rules and regulations relating to provision of
appropriate warnings concerning the dangers and risks of our products
that result in injuries could expose us to large product liability damages
claims, settlements and awards, particularly in the US. Adverse publicity
relating to the safety of a product or of other competing products may
increase the risk of product liability claims.
Details of material product liability litigation matters can be found in Note 28
to the Financial Statements from page 185.
Significant product liability claims could also arise which could be costly,
divert management attention or damage our reputation and demand for
our products.
Unfavourable resolution of such current and similar future product liability
claims could subject us to enhanced damages, require us to make
significant provisions in our accounts relating to legal proceedings and
could materially adversely affect our financial condition or results of
operations, particularly where such circumstances are not covered by
insurance. For more information, see the Limited third party insurance
coverage risk on page 224.
222
AstraZeneca Annual Report and Form 20-F Information 2016
Legal, regulatory and compliance risks
Impact
Adverse outcome of litigation and/or governmental investigations
We may be subject to various product liability, consumer commercial,
anti-trust, environmental, employment or tax litigation or other legal
proceedings and governmental investigations. Litigation, particularly in the
US, is inherently unpredictable and unexpectedly high awards for damages
can result from an adverse verdict. In many cases, plaintiffs may claim
enhanced damages in extremely high amounts. In particular, the marketing,
promotional, clinical and pricing practices of pharmaceutical manufacturers,
as well as the manner in which manufacturers interact with purchasers,
prescribers and patients, are subject to extensive regulation, litigation and
governmental investigation. Many companies, including AstraZeneca, have
been subject to claims related to these practices asserted by federal and
state governmental authorities and private payers and consumers, which
have resulted in substantial expense and other significant consequences.
Note 28 to the Financial Statements from page 185 describes the material
legal proceedings in which we are currently involved.
Governmental investigations, for example under the Foreign Corrupt
Practices Act or federal or state False Claims Acts or other types
of legal proceedings, regardless of their outcome, could be costly, divert
management attention, or damage our reputation and demand for our
products. Unfavourable resolution of current and similar future proceedings
against us could subject us to criminal liability, fines, penalties or other
monetary or non-monetary remedies, including enhanced damages,
require us to make significant provisions in our accounts relating to legal
proceedings and could materially adversely affect our business or results
of operations.
Failure to adhere to increasingly stringent anti-bribery and anti-corruption legislation
Despite taking measures to prevent breaches of applicable anti-bribery
and anti-corruption laws by our personnel and associated third parties,
breaches may still occur, potentially resulting in the imposition of significant
penalties, such as fines, the requirement to comply with monitoring or
self-reporting obligations, or debarment or exclusion from government
sales or reimbursement programmes, any of which could materially
adversely affect our reputation, business or results of operations.
There is an increasing global focus on the implementation and enforcement
of anti-bribery and anti-corruption legislation.
In the UK, the Bribery Act 2010 has extensive extra territorial application,
and imposes organisational liability for any bribe paid by persons or entities
associated with an organisation where the organisation failed to have
adequate preventative controls in place at the time of the offence. In the
US, there has been significant enforcement activity in respect of the Foreign
Corrupt Practices Act by the SEC and DOJ against US companies and
non-US companies listed in the US. China, Brazil, India and other countries
are also enforcing their own anti-bribery laws more aggressively and/or
adopting tougher new measures.
We have been the subject of anti-corruption investigations and there can
be no assurance that we will not, from time to time, continue to be subject
to informal enquiries and formal investigations from governmental agencies.
In the context of our business, governmental officials interact with us in
various roles that are important to our operations, such as in the capacity
of a regulator, partner or healthcare payer, reimburser or prescriber, among
others. Details of these matters are included in Note 28 to the Financial
Statements from page 185.
(cid:40)(cid:70)(cid:82)(cid:81)(cid:82)(cid:80)(cid:76)(cid:70)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:85)(cid:76)(cid:86)(cid:78)(cid:86)(cid:3)
Impact
Failure to achieve strategic plans or meet targets and expectations
We may from time to time communicate our business strategy or our
targets or expectations regarding our future financial or other performance
(for example, the expectations described in Future prospects in the
Financial Review on page 76). All such statements are of a forward-looking
nature and are based on assumptions and judgements we make, all of
which are subject to significant inherent risks and uncertainties, including
those that we are unaware of and/or that are beyond our control.
Any failure to successfully implement our business strategy, whether
determined by internal or external risk factors, may frustrate the
achievement of our financial or other targets or expectations and, in turn,
materially damage our brand and materially adversely affect our business,
financial position or results of operations.
There can be no guarantee that our financial targets or expectations will
materialise on the expected timeline or at all. Actual results may deviate
materially and adversely from any such target or expectation, including if
one or more of the assumptions or judgements underlying any such target
or expectation proves to be incorrect in whole or in part.
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AstraZeneca Annual Report and Form 20-F Information 2016
223
Additional Information
Risk continued
(cid:40)(cid:70)(cid:82)(cid:81)(cid:82)(cid:80)(cid:76)(cid:70)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:85)(cid:76)(cid:86)(cid:78)(cid:86)(cid:3)
Impact
Unexpected deterioration in the Company’s financial position
A wide range of financial risks could result in a material deterioration in the
Company’s financial position.
As a global business, currency fluctuations can significantly affect our
results of operations, which are reported in US dollars. Approximately 35%
of our global 2016 Product Sales were in the US, which is expected to
remain our largest single market for the foreseeable future. Product Sales
in other countries are predominantly in currencies other than the US dollar,
including the euro, Japanese yen, Chinese renminbi and Australian dollar.
Our consolidated balance sheet contains significant investments in
intangible assets, including goodwill. The nature of the biopharmaceutical
business is high risk and requires that we invest in a large number of
projects in an effort to develop a successful portfolio of approved products.
Our ability to realise value on these significant investments is often
contingent upon, among other things, regulatory approvals, market
acceptance, competition and legal developments. As such, in the course
of our many acquisitions and R&D activities, we expect that some of our
intangible assets will become impaired and be written off at some time in
the future.
Inherent variability of biologics manufacturing increases the risk of write-offs
of these product batches. Due to the value of the materials used, the
carrying amount of biological products is much higher than that of small
molecule products. As we continue to grow our biologics business, we also
increase the risk of potential impairment charges.
In recent years, the costs associated with product liability litigation
have increased the cost of, and narrowed the coverage afforded by,
pharmaceutical companies’ product liability insurance. To contain
insurance costs, we have continued to adjust our coverage profile,
accepting a greater degree of uninsured exposure. The Company has
not held any material product liability insurance since February 2006. In
addition, where claims are made under insurance policies, insurers may
reserve the right to deny coverage on various grounds. For example,
product liability litigation cases relating to Crestor and Nexium in the US
are not covered by third party product liability insurance. See Note 28
to the Financial Statements from page 185 for details.
The integrated nature of our worldwide operations can produce conflicting
claims from revenue authorities as to the profits to be taxed in individual
countries. The majority of the jurisdictions in which we operate have
double tax treaties with other foreign jurisdictions, which provide a
framework for mitigating the incidence of double taxation on our
revenues and capital gains.
The Company’s worldwide operations are taxed under laws in the
jurisdictions in which they operate. International standards governing the
global tax environment regularly change. The Organisation for Economic
Co-operation and Development (OECD) has proposed a number of
changes under the Base Erosion and Profit Shifting (BEPS) Action Plans.
Our defined benefit pension obligations are largely backed by assets
invested across the broad investment market. Our most significant
obligations relate to defined benefit pension funds in the UK, Sweden
and the US. The largest obligation is in the UK.
Movements in the exchange rates used to translate foreign currencies into
US dollars may materially adversely affect our financial condition or results
of operations. Some of our subsidiaries import and export goods and
services in currencies other than their own functional currency, and so
the financial results of such subsidiaries could be affected by currency
fluctuations arising between the transaction and settlement dates. In
addition, there are foreign exchange differences arising on the translation
of investments in subsidiaries.
We have significant investments in goodwill and intangible assets as
a result of our acquisitions of various businesses and our purchases
of certain assets, such as product development and marketing rights.
Impairment losses may materially adversely affect our financial condition
or results of operations. Details of the carrying values of goodwill and
intangible assets, and the estimates and assumptions we make in our
impairment testing, are included in Notes 8 and 9 to the Financial
Statements from page 156.
Financial liabilities arising due to product liability or other litigation, in respect
of which we do not have insurance coverage, or if an insurer’s denial of
coverage is ultimately upheld, could require us to make significant
provisions relating to legal proceedings and could materially adversely
affect our financial condition or results of operations.
For more information, please see the Adverse outcome of litigation and/or
governmental investigations risk on page 223.
The resolution of tax disputes regarding the profits to be taxed in individual
territories can result in a reallocation of profits between jurisdictions and an
increase or decrease in related tax costs, and has the potential to affect our
cash flows, EPS and post-tax earnings. Claims, regardless of their merits or
their outcome, are costly, divert management attention and may adversely
affect our reputation.
If any double tax treaties should be withdrawn or amended, especially in a
territory where a member of the AstraZeneca Group is involved in a taxation
dispute with a tax authority in relation to cross-border transactions, such
withdrawal or amendment could materially adversely affect our financial
condition or results of operations, as could a negative outcome of a tax
dispute or a failure by tax authorities to agree through competent authority
proceedings. See the Financial risk management policies section of the
Financial Review on page 76 for tax risk management policies and Note 28
to the Financial Statements from page 185 for details of current tax disputes.
Changes in tax regimes could result in a material impact on the Company’s
cash tax liabilities and tax charge, resulting in either an increase or a
reduction in financial results depending upon the nature of the change.
We represent views to the OECD, governments and tax authorities through
public consultations to ensure international institutions and governments
understand the business implications of proposed law changes. Specific
OECD BEPS recommendations that we expect to impact the Company
include changes to patent box regimes, restrictions of interest deductibility
and revised transfer pricing guidelines.
Sustained falls in asset values could reduce pension fund solvency levels,
which may result in requirements for additional cash, restricting the cash
available for our business. Changes to funding regulations for defined
benefit pensions may also result in a requirement for additional cash
contributions by the Company. If the present value of the liabilities
increase due to a sustained low interest rate environment, an increase in
expectations of future inflation, or an improvement in member longevity
(above that already assumed), this could also reduce pension fund
solvency ratios. The likely increase in the IAS 19 accounting deficit
generated by any of these factors may cause the credit rating agencies
to review our credit rating, with the potential to negatively affect our ability
to raise debt and the price of new debt issuances. See Note 20 to the
Financial Statements from page 165 for further details of the Group’s
pension obligations.
224
AstraZeneca Annual Report and Form 20-F Information 2016
(cid:40)(cid:70)(cid:82)(cid:81)(cid:82)(cid:80)(cid:76)(cid:70)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:85)(cid:76)(cid:86)(cid:78)(cid:86)(cid:3)
Impact
Failure in financial control or the occurrence of fraud
Effective internal controls are necessary for us to provide reliable financial
reports and are designed to prevent and detect fraud. Lapses in controls
and procedures could undermine the ability to prevent fraud or provide
accurate disclosure of financial information on a timely basis. Testing of our
internal controls can provide only reasonable assurance with respect to the
preparation and fair presentation of financial statements and may not
prevent or detect misstatements or fraud.
Significant resources may be required to remediate any lapse or deficiency
in internal controls.
Any such deficiency may also trigger investigations by a number of
organisations, for example, the SEC, the DOJ or the SFO and may result
in fines being levied against the Company or individual directors.
Serious fraud may lead to potential prosecution or even imprisonment
of senior management.
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AstraZeneca Annual Report and Form 20-F Information 2016
225
Additional Information
Geographical Review
This section contains further information about the performance of our products within
(cid:87)(cid:75)(cid:72)(cid:3)(cid:74)(cid:72)(cid:82)(cid:74)(cid:85)(cid:68)(cid:83)(cid:75)(cid:76)(cid:70)(cid:68)(cid:79)(cid:3)(cid:68)(cid:85)(cid:72)(cid:68)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:90)(cid:75)(cid:76)(cid:70)(cid:75)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:86)(cid:68)(cid:79)(cid:72)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:72)(cid:428)(cid:82)(cid:85)(cid:87)(cid:86)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:73)(cid:82)(cid:70)(cid:88)(cid:86)(cid:72)(cid:71)(cid:17)(cid:3)(cid:54)(cid:68)(cid:79)(cid:72)(cid:86)(cid:3)
relates to Product Sales.
Total Oncology
3,383
2016
Oncology:
Faslodex
Zoladex
Iressa
Tagrisso
Casodex
Arimidex
Lynparza
Others
Cardiovascular & Metabolic
Disease:
Crestor
Brilinta
Farxiga
Seloken/Toprol-XL
Onglyza
Bydureon
Atacand
Byetta
Others
Total Cardiovascular &
Metabolic Disease
Respiratory:
Symbicort
Pulmicort
Tudorza/Eklira
Daliresp/Daxas
Duaklir
Others
Total Respiratory
Other:
Nexium
Seroquel XR
Synagis
Losec/Prilosec
FluMist/Fluenz
Movantik/Moventig
Others
Total Other
Total Product Sales
Sales
$m
Actual
%
World
CER
%
US
Sales
$m
Actual
%
Sales
$m
Actual
%
Europe
CER
%
Established ROW
Emerging Markets
Sales
$m
Actual
%
CER
%
Sales
$m
Actual
%
CER
%
830
816
513
423
247
232
218
104
18
–
(6)
19
–
(5)
438
35
23
n/m
n/m
254
(7)
(7)
(9)
(6)
n/m
n/m
(21)
20
(26)
20
2
14
127
–
893
3,401
839
835
737
720
578
315
254
437
(32)
36
70
4
(8)
–
(13)
(20)
(28)
(32)
1,223
39
72
9
(6)
–
(8)
(19)
(26)
348
457
95
376
463
36
164
40
23
25
n/m
n/m
100
(26)
81
n/m
74
(57)
45
75
7
(10)
(4)
6
(22)
(27)
228
156
120
76
27
37
81
8
733
866
258
187
90
132
100
97
45
119
10
(8)
(7)
11
(4)
(5)
n/m
n/m
(7)
(24)
(7)
(24)
n/m
n/m
(65)
16
(65)
18
(5)
12
48
(6)
(6)
22
(8)
(26)
(17)
(4)
15
52
(5)
(5)
23
(8)
(25)
(17)
68
270
137
83
111
71
3
71
814
591
44
58
16
70
11
20
21
50
26
(1)
–
100
(15)
(10)
15
(7)
(8)
100
(23)
(18)
n/m
n/m
18
11
7
2
4
19
81
33
6
38
(20)
(5)
(14)
(5)
22
72
25
11
25
(20)
(9)
(21)
96
355
233
10
107
110
7
25
943
721
189
133
536
142
4
162
24
228
10
3
(14)
100
1
7
n/m
(17)
–
5
69
82
4
(11)
(50)
(17)
–
(35)
25
6
(10)
100
8
15
n/m
(13)
6
12
80
96
12
(4)
(25)
(9)
13
(30)
8,116
(14)
(13)
3,202
(31)
1,894
–
1
881
6
(1)
2,139
1
8
2,989
1,061
170
154
63
316
4,753
2,032
735
677
276
104
91
1,152
5,067
21,319
(10)
1,242
(12)
5
(11)
48
8
(9)
48
n/m
n/m
22
(5)
27
(3)
(19)
(28)
2
(19)
(64)
(18)
(27)
2
(17)
(59)
n/m
n/m
174
77
134
–
11
1,638
554
515
325
10
33
90
(23)
(20)
(10)
(20)
(19)
(8)
105
1,632
7,365
(18)
(13)
(25)
29
–
(39)
(16)
(39)
(28)
14
(44)
(84)
n/m
(54)
(31)
(22)
909
99
83
15
60
118
1,284
251
134
352
83
64
–
269
1,153
5,064
(15)
(15)
8
100
n/m
34
(7)
(12)
(33)
(7)
(14)
(16)
–
(27)
(18)
(5)
(12)
(14)
9
100
n/m
38
(4)
(11)
(32)
(7)
(13)
3
–
(21)
(15)
(3)
436
90
9
1
2
50
588
537
17
–
55
6
–
198
813
3,096
8
2
–
n/m
n/m
108
12
(2)
(32)
–
(26)
(14)
–
(29)
(13)
2
5
(3)
–
n/m
n/m
108
402
698
1
4
1
137
8
1,243
(10)
(32)
–
(31)
(14)
–
(27)
(17)
(4)
690
69
–
128
1
1
580
1,469
5,794
2
15
–
n/m
–
8
10
(9)
(17)
–
(15)
10
21
n/m
n/m
n/m
13
17
(3)
(7)
–
(9)
n/m
n/m
–
(9)
(9)
–
–
(4)
(4)
6
226
AstraZeneca Annual Report and Form 20-F Information 2016
Total Oncology
2,825
2015
Oncology:
Faslodex
Zoladex
Iressa
Tagrisso
Casodex
Arimidex
Lynparza
Others
Cardiovascular & Metabolic
Disease:
Crestor
Brilinta
Farxiga
Seloken/Toprol-XL
Onglyza
Bydureon
Atacand
Byetta
Others
Total Cardiovascular &
Metabolic Disease
Respiratory:
Symbicort
Pulmicort
Tudorza/Eklira
Daliresp/Daxas
Duaklir
Others
Total Respiratory
Other:
Nexium
Seroquel XR
Synagis
Losec/Prilosec
FluMist/Fluenz
Movantik/Moventig
Others
Total Other
Total Product Sales
Sales
$m
Actual
%
US
Actual
%
Sales
$m
Actual
%
Europe
CER
%
Established ROW
Emerging Markets
Sales
$m
Actual
%
CER
%
Sales
$m
Actual
%
CER
%
World
CER
%
9
7
(2)
(2)
(12)
(13)
n/m
n/m
(17)
(16)
(6)
(5)
n/m
n/m
(7)
(7)
6
7
(9)
30
119
(6)
(4)
32
(29)
(3)
(18)
(3)
44
137
4
2
35
(15)
2
(10)
Sales
$m
356
28
6
15
1
19
70
19
514
2,844
240
261
89
420
482
34
209
55
704
816
543
19
267
250
94
132
5,017
619
492
710
786
580
358
316
611
5
8
n/m
n/m
(80)
27
n/m
(24)
25
(3)
64
114
(2)
(13)
29
(23)
5
(28)
207
171
128
4
30
49
23
23
635
916
230
126
97
141
81
105
62
143
(15)
(24)
(22)
n/m
(29)
(36)
n/m
(30)
(19)
(24)
–
91
(22)
(9)
42
(38)
(23)
(29)
2
(12)
(8)
n/m
(14)
(24)
n/m
(18)
(4)
(9)
18
126
(6)
8
65
(26)
(11)
(15)
54
272
137
–
131
79
–
60
733
571
37
32
12
66
8
26
22
60
(8)
(16)
(23)
–
(22)
(27)
–
25
(17)
(14)
12
88
(37)
12
60
(40)
(19)
(26)
5
(2)
(10)
–
(11)
(17)
–
44
(4)
(1)
33
124
(26)
27
80
(30)
(7)
(15)
87
345
272
–
105
103
1
30
943
686
112
73
512
159
9
193
23
353
9,489
(3)
4
4,634
4
1,901
(17)
(1)
834
(12)
1
2,120
–
3,394
1,014
190
104
27
258
4,987
2,496
1,025
662
340
288
29
1,500
6,340
23,641
(11)
7
n/m
n/m
n/m
(15)
(2)
(32)
(16)
(26)
(19)
(2)
(3)
15
n/m
n/m
n/m
(5)
7
(26)
(12)
(26)
(10)
–
n/m
n/m
(12)
(23)
(9)
–
(16)
(1)
1,520
200
103
104
–
18
1,945
902
716
285
18
206
28
226
2,381
9,474
1
(5)
n/m
n/m
–
(31)
11
(52)
(3)
(43)
(32)
(6)
n/m
50
(32)
(6)
1,076
117
76
–
26
88
1,383
284
202
377
97
76
1
367
1,404
5,323
(26)
(28)
(14)
(13)
n/m
n/m
–
n/m
(20)
(21)
(23)
(41)
(6)
(25)
9
–
n/m
(6)
(7)
(7)
(30)
(6)
(10)
16
n/m
n/m
404
88
9
–
1
25
527
549
25
–
74
7
–
(28)
(23)
(20)
(15)
(13)
(6)
273
928
3,022
(12)
(9)
2
4
n/m
n/m
–
–
n/m
n/m
394
609
2
–
–
(7)
(9)
(9)
(43)
–
(30)
–
–
(17)
(15)
(14)
4
5
127
1,132
5
(34)
–
(19)
14
–
(3)
(1)
–
761
82
–
151
(1)
–
634
1,627
5,822
14
(2)
(3)
–
1
4
n/m
(17)
–
49
27
4
–
9
16
n/m
–
18
(6)
70
2
91
n/m
n/m
(2)
27
9
41
125
150
(21)
15
(9)
6
28
(4)
30
(3)
11
22
35
n/m
n/m
–
–
(9)
15
(6)
(18)
–
(5)
–
–
(1)
25
3
(1)
–
(1)
(100)
(100)
–
(12)
(9)
–
–
1
2
12
All commentary in this section relates to
Product Sales. The market definitions used
in the geographical areas review below are
defined in the Glossary on page 239.
2016 in brief
Sales decreased 10% (CER: decreased 8%)
in the year to $21,319 million (2015: $23,641
million; 2014: $26,095 million).
In 2016, sales in the US decreased 22%
to $7,365 million (2015: $9,474 million; 2014:
$10,120 million). The decline in US sales
reflected the competition from generic
Crestor medicines that entered the US
market from July 2016. Unfavourable
managed-care pricing and continued
competitive intensity also impacted the
sales of Symbicort.
Sales in Europe decreased 5% (CER:
decreased 3%) to $5,064 million in the year
(2015: $5,323 million; 2014: $6,638 million).
Strong growth in sales of Forxiga, up 48%
(CER: up 52%) to $187 million (2015: $126
million; 2014: $66 million), and Brilique, up
12% (CER: up 15%) to $258 million (2015:
$230 million; 2014: $231 million), was more
than offset by a 15% decrease in Symbicort
sales (CER: 12% decrease) to $909 million
(2015: $1,076 million; 2014: $1,462 million).
However, Symbicort maintained its position
as the number one ICS/LABA medicine by
volume, despite competition from analogue
medicines. Lynparza and Tagrisso sales
increased to $81 million (2015: $23 million;
2014: $nil) and $76 million (2015: $4 million;
2014: $nil) respectively.
Sales in the Established Rest of World
(ROW) in 2016 increased 2% (CER:
decreased 4%) to $3,096 million (2015:
$3,022 million; 2014: $3,510 million). Sales of
Forxiga in Established ROW increased 81%
(CER: increased 72%), to $58 million (2015:
$32 million; 2014: $17 million). Nexium sales
decreased 2% (CER: decreased 10%) to
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$537 million (2015: $549 million; 2014: $606
million). Japan sales increased 8% (CER:
decreased 3%) to $2,184 million (2015:
$2,020 million; 2014: $2,227 million),
reflecting the biennial price reduction
effective from April 2016 of around 6% after
eliminating the exchange rate impact. The
CER percentage decline in Japan was partly
mitigated by stable sales of Crestor of $521
million (2015: $468 million; 2014: $502
million) in the year. Since the launch of
Tagrisso in Japan in March 2016, sales
amounted to $82 million (2015 & 2014: $nil).
Sales growth for the year in Emerging
Markets remained stable (CER: increased
6%) at $5,794 million (2015: $5,822 million;
2014: $5,827 million). Sales growth was
impacted by challenging macro-economic
conditions in Latin America, such as the
current economic situation in Venezuela,
where ex-Brazil sales decreased 20% (CER:
decreased 7%) to $516 million (2015: $643
million; 2014: $730 million). The effects of
significant reductions in Saudi Arabian
governmental healthcare spending, as well
as the reduction of AstraZeneca’s activities
in Venezuela, also adversely impacted sales.
China sales increased 4% (CER: increased
10%) to $2,636 million (2015: $2,530 million;
2014: $2,242 million), and represent 45% of
the Group’s Emerging Markets sales. Sales
in Brazil decreased 9% (CER: increased 2%)
to $348 million (2015: $381 million; 2014:
$451 million). The increase after eliminating
exchange rate impacts reflects the strong
performances of Forxiga, which increased
40% (CER: increased 50%) to $28 million
(2015: $20 million; 2014: $5 million),
Oncology medicines, which decreased 8%
(CER: increased 1%) to $82 million (2015:
$89 million; 2014: $99 million), and Seloken,
which decreased 6% (CER: increased 6%)
to $63 million (2015: $67 million; 2014: $84
million). Russia sales increased 1% (CER:
increased 13%) to $233 million (2015: $231
million; 2014: $312 million), led by strong
performances in Cardiovascular & Metabolic
Disease medicine sales, which increased
23% (CER: increased 38%) to $80 million
(2015: $65 million; 2014: $89 million).
2015 in brief
Product Sales decreased 9% (CER:
decreased 1%) in the year to $23,641 million
(2014: $26,095 million; 2013: $25,711 million).
In 2015, sales in the US decreased 6% to
$9,474 million (2014: $10,120 million; 2013:
$9,691 million). Declines in revenue from
Nexium, Crestor and Synagis were partially
offset by strong performance of our Growth
Platforms, including Farxiga, Bydureon and
Brilinta, the launches of Lynparza and
Tagrisso as well as the impact of completing
the acquisition of Actavis’s rights to Tudorza
and Daliresp in the US.
Sales in Europe decreased 20% (CER:
decreased 6%) to $5,323 million in the year
(2014: $6,638 million; 2013: $6,658 million).
Strong growth from the Diabetes portfolio
was more than offset by pricing pressure and
continued generic competition facing Crestor,
Nexium and Seroquel XR. A 26% decrease
(CER: decrease of 14%) in Symbicort sales to
$1,076 million (2014: $1,462 million; 2013:
$1,502 million) reflected adverse pricing
movements driven by competition from
analogues in key markets. Also, Lynparza
was launched in Europe in 2015.
Sales in the Established ROW decreased
14% (CER: stable) to $3,022 million (2014:
$3,510 million; 2013: $3,973 million). Japan
sales decreased 9% (CER: increased 4%) to
$2,020 million (2014: $2,227 million; 2013:
$2,485 million). After eliminating the
exchange rate impact, sales were driven
by strong growth of Crestor and Nexium,
though there was a decline in the sales of
Symbicort. Canada sales decreased 10%
(CER: increased 4%) to $533 million (2014:
$590 million; 2013: $637 million) in the year,
driven by increased sales of Onglyza and
Symbicort after exchange rate effects.
Emerging Markets sales in the year remained
stable (CER: increased 12%) at $5,822 million
(2014: $5,827 million; 2013: $5,389 million),
with contributions to CER growth emanating
from across the region. Around 60% of
Emerging Markets sales were derived
outside of China in the year. China sales in
the year increased 13% (CER: increased
15%) to $2,530 million (2014: $2,242 million;
2013: $1,840 million), while Brazil sales
decreased 16% (CER: increased 16%) to
$381 million (2014: $451 million; 2013: $447
million) and Russia sales decreased 26%
(CER: increased 21%) to $231 million (2014:
$312 million; 2013: $310 million).
Sales by region
US
Sales in the US decreased 22% to
$7,365 million (2015: $9,474 million; 2014:
$10,120 million).
Oncology
Oncology sales in the US increased 74%
to $893 million (2015: $514 million; 2014:
$411 million). An increase in Tagrisso and
Lynparza sales, which were launched in
2015, contributed to this.
Faslodex sales increased 23% to $438
million (2015: $356 million; 2014: $340
million), mainly driven by an expanded
label in March 2016, in combination with
palbociclib, for 2nd line advanced or
metastatic breast cancer.
Sales of Tagrisso were $254 million
(2015: $15 million; 2014: $nil). On 29
September 2016, a third party, blood-based
companion-diagnostic test for Tagrisso
was approved in the US. The test is
designed to confirm the presence of
a T790M mutation in patients.
Lynparza sales increased 81% to $127
million (2015: $70 million; 2014: $nil),
reflecting high market-penetration rates.
Zoladex sales increased 25% to $35 million
(2015: $28 million; 2014: $26 million).
Cardiovascular & Metabolic Disease
Cardiovascular & Metabolic Disease sales
in the US decreased 31% to $3,202 million
(2015: $4,634 million; 2014: $4,451 million),
primarily due to the decline in Crestor sales.
Crestor sales decreased 57% to $1,223
million (2015: $2,844 million; 2014: $2,918
million), reflecting the market entry of Crestor
generic medicines.
Brilinta sales increased 45% to $348 million
(2015: $240 million; 2014: $146 million),
reflecting updated preferred guidelines
regarding acute coronary syndrome
treatment from the American College
of Cardiology and the American Heart
Association; Brilinta remained the branded
oral anti-platelet market leader in the US.
Sales of Farxiga in the US increased 75%
to $457 million (2015: $261 million; 2014:
$122 million), primarily reflecting overall
market growth and a higher net price.
A stronger emphasis on promotional activity
and improved levels of patient access
resulted in market-share growth.
Onglyza sales decreased 10% to $376
million (2015: $420 million; 2014: $481
million), as the Company prioritised sales
and marketing resources towards Farxiga.
Continued competitive pressures in the
DPP-4 class led to lower market share but
were partially offset by reduced levels of
utilisation of patient-access programmes.
Combined sales for Bydureon/Byetta were
$627 million (2015: $691 million; 2014: $573
million). Bydureon sales decreased 4% to
$463 million (2015: $482 million; 2014: $374
million), representing 74% of total Bydureon/
Byetta US sales. Approximately 75% of
sales came from the new dual-chamber pen
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AstraZeneca Annual Report and Form 20-F Information 2016
compared to the prior tray presentation. The
decrease in Byetta sales of 22% to $164
million (2015: $209 million; 2014: $199
million) was attributed to the Company’s
promotional focus on Bydureon. The decline
in both Bydureon and Byetta US sales
reflected lower net pricing.
Respiratory
Respiratory sales in the US decreased 16%
to $1,638 million (2015: $1,945 million; 2014:
$1,748 million). Declines in Symbicort and
Tudorza sales were offset by growth in
Daliresp sales.
Symbicort sales decreased 18% to $1,242
million (2015: $1,520 million; 2014: $1,511
million). This primarily reflected the impact
of the effects of pricing pressure from
managed-care access within the ICS/LABA
class. Competition also remained intense
from other classes.
Sales of Tudorza decreased 25% to
$77 million (2015: $103 million; 2014: $nil),
reflecting adverse market demand, limited
Medicare Part D access and the focus on
the launch of Bevespi.
Daliresp sales increased 29% to $134 million
(2015: $104 million; 2014: $nil) driven
primarily by favourable market penetration.
US sales represented 87% of global sales.
Other
Other sales in the US decreased 31% to
$1,632 million (2015: $2,381 million; 2014:
$3,510 million).
Nexium sales decreased 39% to $554
million (2015: $902 million; 2014: $1,876
million), reflecting lower demand and
inventory de-stocking, which followed the
loss of exclusivity in 2015.
Sales of Seroquel XR decreased 28%
to $515 million (2015: $716 million; 2014:
$738 million) as since 1 November 2016,
two companies have launched licensed
generic medicines in the US.
Synagis sales increased 14% to $325 million
(2015: $285 million; 2014: $499 million), due
to greater market demand.
Sales of FluMist decreased 84% to $33
million (2015: $206 million; 2014: $218
million). The Company confirmed on 23
June 2016 that the Advisory Committee
on Immunization Practices (ACIP) of the US
Centers for Disease Control and Prevention
had provided its interim recommendation
not to use FluMist Quadrivalent Live
Attenuated Influenza Vaccine (FluMist
Quadrivalent) in the US for the 2016 to 2017
influenza season.
Europe
Sales in Europe decreased 5% (CER:
decreased 3%) to $5,064 million in the year
(2015: $5,323 million; 2014: $6,638 million).
Oncology
Total Oncology sales in Europe increased
16% (CER: increased 18%) to $733 million
(2015: $635 million; 2014: $788 million),
driven by new product launches.
Sales of Faslodex increased 10% (CER:
increased 11%) to $228 million (2015: $207
million; 2014: $245 million) due to early line
use with palbociclib. Tagrisso sales in
Europe were $76 million (2015: $4 million;
2014: $nil), following regulatory approval
in the EU during the year.
Sales of Zoladex decreased 8% (CER:
decreased 4%) to $156 million (2015: $171
million; 2014: $226 million), and Iressa sales
decreased 7% (CER: decreased 5%) to $120
million (2015: $128 million; 2014: $166 million).
However, Lynparza sales increased to
$81 million (2015: $23 million; 2014: $nil),
following several successful launches.
Cardiovascular & Metabolic Disease
Cardiovascular & Metabolic Disease sales
in Europe were $1,894 million (2015: $1,901
million; 2014: $2,283 million), consistent with
prior year at actual rate of exchange but
a 1% increase at CER. The decrease
in Crestor sales was partly offset by an
increase in Brilique and Forxiga sales.
Crestor sales decreased 5% (CER:
decreased 4%) to $866 million (2015: $916
million; 2014: $1,200 million), reflecting the
increasing use of generic medicines.
Sales of Brilique in Europe increased 12%
(CER: increased 15%) to $258 million (2015:
$230 million; 2014: $231 million), reflecting
indication leadership across a number of
markets. In the year, the German Institute for
Quality and Efficiency in Healthcare (IQWiG)
gave its assessment of the additional benefit
from Brilique at the 60mg dose as tested
in the PEGASUS trial, as did the National
Institute for Health and Clinical Excellence
in England, UK.
Forxiga sales increased 48% (CER:
increased 52%) to $187 million (2015: $126
million; 2014: $66 million), as the medicine
continued to lead the growing class.
Onglyza sales decreased 6% (CER:
decreased 5%) to $132 million (2015:
$141 million; 2014: $155 million), reflecting
the Company’s focus on Forxiga.
Sales of Bydureon/Byetta increased 1%
(CER: increased 3%) to $145 million (2015:
$143 million; 2014: $138 million), reflecting
the Company’s ongoing effort to expand
its Diabetes presence.
Respiratory
Respiratory sales in Europe amounted to
$1,284 million in 2016 (2015: $1,383 million;
2014: $1,747 million), a decrease of 7%
(CER: decrease of 4%). The reduction was
driven by reduced Symbicort sales, offset
by new Daxas sales.
Symbicort sales decreased 15% (CER:
decreased 12%) to $909 million (2015: $1,076
million; 2014: $1,462 million), primarily a result
of competition from branded and analogue
medicines. European rights to Daxas were
added in May 2016; sales amounted to $15
million (2015 and 2014: $nil).
Other
Total Other sales in Europe amounted to
$1,153 million (2015: $1,404 million; 2014:
$1,820 million), a decrease of 18% (CER:
decrease of 15%).
Sales of Nexium decreased 12% (CER:
decreased 11%) to $251 million (2015: $284
million; 2014: $368 million) and Seroquel XR
sales decreased 33% (CER: decreased
32%) to $134 million (2015: $202 million;
2014: $343 million); declines reflect the
impact of generic competition.
Established Rest of World
Sales in the Established ROW increased
2% (CER: decreased 4%) to $3,096 million
(2015: $3,022 million; 2014: $3,510 million).
Oncology
Oncology sales in Established ROW
increased 11% (CER: increased 2%) to
$814 million (2015: $733 million; 2014:
$883 million). The negative impact of generic
competition on our non-promoted legacy
Oncology product was offset by new sales
of Tagrisso.
On 27 December 2016, a third party,
blood-based companion-diagnostic test
for Tagrisso was approved in Japan.
The test is designed to confirm the
presence of a T790M mutation in patients.
Sales of Tagrisso in Japan were $82 million
(2015 and 2014: $nil).
Sales of Faslodex increased 26% (CER:
increased 15%) to $68 million (2015: $54
million; 2014: $59 million). This was due to
an increase in demand in Japan, where
sales increased 24% (CER: increased
12%) to $63 million (2015: $51 million; 2014:
$56 million).
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Cardiovascular & Metabolic Disease
Cardiovascular & Metabolic Disease
sales in Established ROW increased 6%
(CER: decreased 1%) to $881 million
(2015: $834 million; 2014: $951 million).
This primarily consists of Crestor sales of
$591 million (2015: $571 million; 2014:
$667 million), Onglyza sales of $70 million
(2015: $66 million; 2014: $59 million),
and Forxiga sales of $58 million (2015:
$32 million; 2014: $17 million).
Crestor consolidated its position as the
leading statin in Japan, with sales growth
of 11% (CER: stable) to $521 million (2015:
$468 million; 2014: $502 million), driven by
an increase in volume.
Respiratory
Respiratory sales in Established ROW
increased 12% (CER: increased 8%) to
$588 million (2015: $527 million; 2014:
$582 million). Symbicort sales increased 8%
(CER: increased 5%) to $436 million (2015:
$404 million; 2014: $458 million).
Other
Total Other sales in Established ROW
decreased 13% (CER: decreased 17%)
to $813 million (2015: $928 million;
2014: $1,094 million).
Notably, Japan sales of Nexium increased
8% (CER: decreased 4%) to $436 million
(2015: $405 million; 2014: $358 million).
After eliminating the exchange rate impact,
the decrease in sales reflects the mandated
biennial price reduction, effective from
April 2016.
Emerging Markets
Sales in Emerging Markets remained stable
(CER: increased 6%) at $5,794 million (2015:
$5,822 million; 2014: $5,827 million).
Oncology
Oncology sales in Emerging Markets
remained stable (CER: increased 6%) at
$943 million (2015: $943 million; 2014:
$945 million).
Sales of Faslodex increased 10% (CER:
increased 25%) to $96 million (2015:
$87 million; 2014: $76 million), which was
supported by China sales of $20 million
(2015: $11 million; 2014: $7 million).
Sales of Iressa decreased 14% (CER:
decreased 10%) to $233 million (2015:
$272 million; 2014: $280 million). China sales
of Iressa decreased 21% (CER: decreased
16%) to $116 million (2015: $146 million;
2014: $142 million), as a result of the price
reset following national reimbursement listing
obtained in June 2016. Strong competition
from branded medicines in Korea also
contributed to the decline.
Regulatory approvals for Tagrisso were
granted in a number of markets, including
Brazil, Hong Kong, Singapore, Taiwan and
the United Arab Emirates.
Cardiovascular & Metabolic Disease
Cardiovascular & Metabolic Disease sales
in Emerging Markets increased 1% (CER:
increased 8%), to $2,139 million (2015:
$2,120 million; 2014: $2,117 million).
Crestor sales in Emerging Markets
increased 5% (CER: increased 12%)
to $721 million (2015: $686 million; 2014:
$727 million), reflecting growth in China
of 21% (CER: growth of 27%) and growth
in Russia of 16% (CER: growth of 28%).
Sales of Brilique increased 69% (CER:
increased 80%) to $189 million (2015:
$112 million; 2014: $66 million), with
China sales more than doubling. China
represented 47% of Emerging Markets
sales of the medicine at $89 million (2015:
$38 million; 2014: $15 million), despite the
medicine not being included on the National
Reimbursement Drug List. Growth was
underpinned by a combination of strong
levels of hospital-listing expansion and
increased use in existing hospitals.
Sales of Forxiga increased 82% (CER:
increase 96%) to $133 million (2015:
$73 million; 2014: $20 million), driven by
ongoing launches and improved access.
In particular, strong performances were
seen in the Asia Pacific region, which
increased 100% (CER: increased 108%)
to $52 million (2015: $26 million; 2014:
$5 million), Brazil, which increased 40%
(CER: increased 50%), and the Middle East,
Africa and Others region increased to $32
million (2015: $15 million; 2014: $2 million).
Sales of Byetta remained stable (CER:
increased 13%) to $24 million (2015:
$23 million; 2014: $20 million), and sales
of Bydureon decreased 50% (CER:
decreased 25%) to $4 million (2015:
$9 million; 2014: $4 million). On 10 October
2016, AstraZeneca entered into a strategic
collaboration with 3SBio Inc. (3SBio) for
the rights to commercialise Bydureon
and Byetta in the Chinese market. The
agreement allowed the Company to benefit
from 3SBio’s established local expertise
in injectable medicines and focus on oral
Type 2 diabetes medicines.
On 29 February 2016, the Company sold
the commercialisation rights for Plendil in
China; sales in Emerging Markets for Plendil
amounted to $119 million (2015: $213 million;
2014: $221 million).
Respiratory
Respiratory sales in Emerging Markets
increased 10% (CER: increased 17%) to
$1,243 million (2015: $1,132 million; 2014:
$986 million).
Sales of Symbicort increased 2% (CER:
increased 10%) to $402 million (2015:
$394 million; 2014: $370 million). Sales in
China increased 26% (CER: increased 32%)
to $156 million (2015: $124 million; 2014:
$91 million), which was offset by a 12%
decrease (CER: increase of 12%) in
Latin America (ex-Brazil), where sales
were $37 million (2015: $42 million; 2014:
$57 million).
Strong underlying volume growth of
Pulmicort in Emerging Markets drove
a 15% sales increase (CER: 21% sales
increase) to $698 million (2015: $609 million;
2014: $476 million). China sales increased
18% (CER: increased 24%) to $570 million
(2015: $485 million; 2014: $348 million),
and represented 54% of sales of Pulmicort.
Volume demand in China partly reflected
the long-term increase of acute COPD and
paediatric asthma. AstraZeneca continued
its expansion of treatment centres and
provided increased access to home-based
patient-care systems.
Other
Other sales in Emerging Markets decreased
9% (CER: decreased 4%) to $1,469 million
(2015: $1,627 million; 2014: $1,779 million),
reflecting declines in Nexium sales, which
decreased 9% (CER: decreased 3%) to
$690 million (2015: $761 million; 2014:
$805 million), and Seroquel XR sales, which
decreased 17% (CER: decreased 7%) to
$69 million (2015: $82 million; 2014:
$99 million).
Sales of other products within this therapy
area decreased 9% (CER: decreased
4%) to $580 million (2015: $634 million;
2014: $717 million). This includes the
anaesthetics portfolio sales of $258 million
(2015: $261 million; 2014: $305 million),
which was disposed of on 1 September
2016, and Merrem sales of $181 million
(2015: $199 million; 2014: $211 million),
which was disposed of along with other
products on 23 December 2016.
230
AstraZeneca Annual Report and Form 20-F Information 2016
Sustainability: supplementary information
Summary information about our
commitment and performance in key areas
is introduced on page 43 and is integrated
into the relevant sections of this Annual
Report. Further information about these
and other areas is available on our website,
www.astrazeneca.com.
A core element of our business strategy
is value-creating business development
activity that strengthens our pipeline and
accelerates growth. This includes targeted
acquisitions. When we acquire companies
we aim to align standards of responsible
business and incorporate the companies
in the setting of targets and measurement
of performance.
Benchmarking
Our DJSI performance was summarised on
page 44. We achieved a total score of 86%
(2015: 84%) compared with a sector best
score of 89%. Sector best scores attained
for five criteria: Occupational Health and
Safety (88%), Code of Conduct (100%),
Marketing Practices (93%), Climate Strategy
(100%) and Health Outcomes Contribution
(100%). We increased individual scores for
11 out of 22 criteria for 2016: Risk & Crisis
Management, Marketing Practices, Tax
Management, Climate Strategy,
Environmental Reporting, Operational
Eco-efficiency, Human Capital
Development, Talent Attraction & Retention,
Corporate Citizenship & Philanthropy,
Occupational Health & Safety and
Addressing the Cost Burden.
External assurance
Bureau Veritas has provided independent
external assurance to a limited level on the
following sustainability information contained
within this Annual Report:
The full assurance statement, which
includes Bureau Veritas’s scope of work,
methodology, overall opinion, and limitations
and exclusions, is available on our website,
www.astrazeneca.com.
> Sustainability, page 43
> Sustainability framework, page 43
> Benchmarking and assurance, page 44
> Responsible research, page 47
> Healthy Heart Africa, page 49
> Pricing and access to healthcare, page 51
> Sales and marketing ethics, page 52
> Working with suppliers, page 52
> Safety, health and wellbeing, page 53
> Community investment, page 53
> Develop a strong and diverse pipeline
of leaders, page 55
> Human rights, page 56
> Managing change, page 57
> Employee relations, page 57
> Natural resource efficiency, page 60
> Following the science to protect the
environment, page 61
Based on the evidence provided and
subject to the scope, objectives and
limitations defined in the full assurance
statement, nothing has come to the
attention of Bureau Veritas causing them
to believe that the sustainability information
contained within this Annual Report is
materially misstated. Bureau Veritas is a
professional services company that has
a long history of providing independent
assurance services in environmental, health,
safety, social and ethical management
and disclosure.
Carbon reporting
The table below provides data on our global
greenhouse gas emissions for 2016. The
data coverage includes 100% of our owned
and controlled sites globally. In 2015, data
was recalculated to include acquired sites
that form part of the 2016 to 2025 strategy
baseline. We have reported on all of the
emission sources required under the Quoted
Companies Greenhouse Gas Emissions
(Directors’ Reports) Regulations 2013. These
sources fall within our consolidated Financial
Statements. We do not have responsibility for
any emission sources that are not included in
our consolidated Financial Statements.
We have used the GHG Protocol Corporate
Accounting and Reporting Standard
(revised edition). Emission factors for
electricity have been derived from the
International Energy Agency, USEPA eGRID
and the EU RE:DISS II databases and for all
other fuels and emission sources from the
2006 IPCC Guidelines for National
Greenhouse Gas Inventories.
Bureau Veritas has undertaken a limited
assurance on the 2016 GHG emissions
data. The assurance statement, including
scope, methodology, overall opinion, and
limitations and exclusions, is available on
our website, www.astrazeneca.com.
Carbon reporting
Global greenhouse gas emissions data for the period 1 January 2016 to 31 December 2016
Emissions from:
Scope 1: Combustion of fuel and operation of facilities2
2016
2015
2014
20131
Tonnes of CO2e
329,140
338,038
328,722
318,626
Scope 2 (Market-based): Electricity (net of market instruments), heat, steam and cooling purchased for own use3
219,574
351,471
N/A
N/A
Scope 2 (Location-based): Electricity, heat, steam and cooling purchased for own use3
292,363
287,903
290,288
274,399
Company’s chosen intensity measurement:
Scope 1 + Scope 2 (Market-based) emissions reported above normalised to million US dollar revenue
Scope 3 Total: Emissions from all 15 Greenhouse Gas Protocol Scope 3 Categories4 (one year in arrears)
Scope 3 in our Operational Footprint:
Supply chain emissions: Upstream emissions from personal air travel, goods transport, waste incineration, and first tier active
pharmaceutical ingredients and formulation & packaging suppliers (>90% of category spend, energy only); Downstream
emissions from HFA propellants released during patient use of our inhaled medicines
2016-2025 Strategy ‘Operational Footprint’ KPI: Scope 1 + Scope 2 (Market-based) + our Operational Footprint Scope 3
sources. Baseline year is 2015
2016-2025 Strategy Scope 3 intensity measurement KPI: Scope 3 emissions from all 15 Greenhouse Gas
Protocol Scope 3 Categories normalised to million US dollar revenue. Baseline year is 2015 (one year in arrears)
23.9
27.9
7,661,092 6,310,359
1,108,204 1,053,690
1,656,917
1,743,199
333
255
N/A
N/A
N/A
N/A
N/A
A
d
d
i
t
i
o
n
a
l
I
n
f
o
r
m
a
t
i
o
n
N/A
N/A
N/A
N/A
N/A
1(cid:3) (cid:3)(cid:53)(cid:72)(cid:74)(cid:88)(cid:79)(cid:68)(cid:85)(cid:3)(cid:85)(cid:72)(cid:89)(cid:76)(cid:72)(cid:90)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:71)(cid:68)(cid:87)(cid:68)(cid:3)(cid:76)(cid:86)(cid:3)(cid:70)(cid:68)(cid:85)(cid:85)(cid:76)(cid:72)(cid:71)(cid:3)(cid:82)(cid:88)(cid:87)(cid:3)(cid:87)(cid:82)(cid:3)(cid:72)(cid:81)(cid:86)(cid:88)(cid:85)(cid:72)(cid:3)(cid:68)(cid:70)(cid:70)(cid:88)(cid:85)(cid:68)(cid:70)(cid:92)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:70)(cid:82)(cid:81)(cid:86)(cid:76)(cid:86)(cid:87)(cid:72)(cid:81)(cid:70)(cid:92)(cid:17)(cid:3)(cid:55)(cid:75)(cid:76)(cid:86)(cid:3)(cid:75)(cid:68)(cid:86)(cid:3)(cid:79)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:86)(cid:79)(cid:76)(cid:74)(cid:75)(cid:87)(cid:3)(cid:70)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:71)(cid:68)(cid:87)(cid:68)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:83)(cid:85)(cid:72)(cid:89)(cid:76)(cid:82)(cid:88)(cid:86)(cid:3)(cid:92)(cid:72)(cid:68)(cid:85)(cid:86)(cid:17)(cid:3)(cid:49)(cid:82)(cid:81)(cid:72)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:70)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:86)(cid:3)(cid:76)(cid:86)(cid:3)(cid:86)(cid:87)(cid:68)(cid:87)(cid:76)(cid:86)(cid:87)(cid:76)(cid:70)(cid:68)(cid:79)(cid:79)(cid:92)(cid:3)(cid:86)(cid:76)(cid:74)(cid:81)(cid:76)(cid:430)(cid:70)(cid:68)(cid:81)(cid:87)(cid:17)(cid:3)(cid:55)(cid:75)(cid:72)(cid:98)(cid:71)(cid:68)(cid:87)(cid:68)(cid:3)
quoted in this Annual Report are generated from the revised data.
2(cid:3) (cid:3)(cid:44)(cid:81)(cid:70)(cid:79)(cid:88)(cid:71)(cid:72)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:76)(cid:86)(cid:3)(cid:86)(cid:72)(cid:70)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:74)(cid:85)(cid:72)(cid:72)(cid:81)(cid:75)(cid:82)(cid:88)(cid:86)(cid:72)(cid:3)(cid:74)(cid:68)(cid:86)(cid:72)(cid:86)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:71)(cid:76)(cid:85)(cid:72)(cid:70)(cid:87)(cid:3)(cid:73)(cid:88)(cid:72)(cid:79)(cid:3)(cid:70)(cid:82)(cid:80)(cid:69)(cid:88)(cid:86)(cid:87)(cid:76)(cid:82)(cid:81)(cid:15)(cid:3)(cid:83)(cid:85)(cid:82)(cid:70)(cid:72)(cid:86)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:72)(cid:81)(cid:74)(cid:76)(cid:81)(cid:72)(cid:72)(cid:85)(cid:76)(cid:81)(cid:74)(cid:3)(cid:72)(cid:80)(cid:76)(cid:86)(cid:86)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:68)(cid:87)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:86)(cid:76)(cid:87)(cid:72)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:73)(cid:88)(cid:72)(cid:79)(cid:3)(cid:88)(cid:86)(cid:72)(cid:3)(cid:76)(cid:81)(cid:3)(cid:82)(cid:88)(cid:85)(cid:3)(cid:89)(cid:72)(cid:75)(cid:76)(cid:70)(cid:79)(cid:72)(cid:3)(cid:432)(cid:72)(cid:72)(cid:87)(cid:17)(cid:3)
3 Greenhouse gases from imported electricity are calculated using the GHG Protocol Scope 2 Guidance (January 2015) requiring the dual reporting using two emissions factors for each site –
(cid:80)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:16)(cid:69)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:79)(cid:82)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:16)(cid:69)(cid:68)(cid:86)(cid:72)(cid:71)(cid:17)(cid:3)(cid:47)(cid:82)(cid:70)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:16)(cid:69)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)(cid:73)(cid:68)(cid:70)(cid:87)(cid:82)(cid:85)(cid:86)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:74)(cid:85)(cid:76)(cid:71)(cid:3)(cid:68)(cid:89)(cid:72)(cid:85)(cid:68)(cid:74)(cid:72)(cid:3)(cid:72)(cid:80)(cid:76)(cid:86)(cid:86)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:73)(cid:68)(cid:70)(cid:87)(cid:82)(cid:85)(cid:3)(cid:73)(cid:82)(cid:85)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:85)(cid:92)(cid:3)(cid:11)(cid:82)(cid:85)(cid:3)(cid:86)(cid:88)(cid:69)(cid:85)(cid:72)(cid:74)(cid:76)(cid:82)(cid:81)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:12)(cid:3)(cid:87)(cid:75)(cid:68)(cid:87)(cid:3)(cid:68)(cid:3)(cid:86)(cid:76)(cid:87)(cid:72)(cid:3)(cid:76)(cid:86)(cid:3)(cid:76)(cid:81)(cid:17)(cid:3)(cid:48)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:16)(cid:69)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)(cid:73)(cid:68)(cid:70)(cid:87)(cid:82)(cid:85)(cid:86)(cid:3)(cid:68)(cid:85)(cid:72)(cid:3)(cid:80)(cid:82)(cid:85)(cid:72)(cid:3)(cid:86)(cid:83)(cid:72)(cid:70)(cid:76)(cid:430)(cid:70)(cid:3)
(cid:87)(cid:82)(cid:98)(cid:87)(cid:75)(cid:72)(cid:3)(cid:86)(cid:76)(cid:87)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:79)(cid:82)(cid:70)(cid:68)(cid:79)(cid:3)(cid:72)(cid:81)(cid:72)(cid:85)(cid:74)(cid:92)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:15)(cid:3)(cid:87)(cid:68)(cid:78)(cid:76)(cid:81)(cid:74)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:88)(cid:81)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:85)(cid:72)(cid:86)(cid:76)(cid:71)(cid:88)(cid:68)(cid:79)(cid:3)(cid:72)(cid:81)(cid:72)(cid:85)(cid:74)(cid:92)(cid:3)(cid:80)(cid:76)(cid:91)(cid:3)(cid:68)(cid:3)(cid:86)(cid:76)(cid:87)(cid:72)(cid:3)(cid:76)(cid:86)(cid:3)(cid:86)(cid:82)(cid:88)(cid:85)(cid:70)(cid:76)(cid:81)(cid:74)(cid:3)(cid:83)(cid:82)(cid:90)(cid:72)(cid:85)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:68)(cid:81)(cid:92)(cid:3)(cid:70)(cid:72)(cid:85)(cid:87)(cid:76)(cid:430)(cid:72)(cid:71)(cid:3)(cid:85)(cid:72)(cid:81)(cid:72)(cid:90)(cid:68)(cid:69)(cid:79)(cid:72)(cid:3)(cid:83)(cid:82)(cid:90)(cid:72)(cid:85)(cid:3)(cid:83)(cid:88)(cid:85)(cid:70)(cid:75)(cid:68)(cid:86)(cid:72)(cid:71)(cid:3)(cid:69)(cid:92)(cid:3)(cid:68)(cid:3)(cid:86)(cid:76)(cid:87)(cid:72)(cid:17)
4 GHG Protocol Scope 3 Categories: Purchased goods and services; Capital goods; Fuel- and energy-related activities; Upstream transportation and distribution; Waste generated in operations;
Business travel; Employee commuting; Upstream leased assets; Downstream transportation and distribution; Processing of sold products; Use of sold products; End-of-life treatment of sold
products; Downstream leased assets; Franchises; Investments.
AstraZeneca Annual Report and Form 20-F Information 2016
231
Additional Information
Shareholder Information
AstraZeneca PLC share listings and prices
Ordinary Shares in issue – millions
At year end
Weighted average for year
Stock market price – per Ordinary Share
Highest (pence)
Lowest (pence)
At year end (pence)
Percentage analysis of issued share capital at 31 December
By size of account
Number of Ordinary Shares
1 – 250
251 – 500
501 – 1,000
1,001 – 5,000
5,001 – 10,000
10,001 – 50,000
50,001 – 1,000,000
Over 1,000,0001
2012
2013
2014
2015
2016
1,247
1,261
3111.5
2591.0
2909.5
1,257
1,252
3612.0
2909.5
3574.5
1,263
1,262
4823.5
3549.5
4555.5
1,264
1,264
4863.0
3903.5
4616.5
1,265
1,265
5220.0
3774.0
4437.5
2012
%
0.6
0.7
0.8
1.1
0.2
1.0
12.6
83.0
2013
%
0.5
0.6
0.8
1.1
0.2
1.0
12.3
83.5
2014
%
0.5
0.6
0.7
1.0
0.2
1.0
13.3
82.7
2015
%
0.5
0.6
0.7
0.9
0.2
0.9
13.0
83.2
2016
%
0.5
0.5
0.6
0.8
0.2
0.9
12.3
84.2
1 Includes Euroclear and ADR holdings.
At 31 December 2016, the Company had
90,113 registered holders of 1,265,229,424
Ordinary Shares. There were 107,074
holders of Ordinary Shares held under the
Euroclear Services Agreement, representing
10.4% of the issued share capital of the
Company and 1,880 registered holders of
ADSs, representing 14.5% of the issued
share capital of the Company. With effect
from 27 July 2015, the Company’s ADS ratio
changed to two ADSs per one Ordinary
Share. The former ratio was one ADS per
one Ordinary Share. The Company’s ADS
depositary is Citibank, N.A. (Citibank).
Citibank succeeded JPMorgan Chase Bank
as depositary of the ADSs.
In 1999, in connection with the merger
between Astra and Zeneca through which
the Company was formed, the Company’s
share capital was redenominated in US
dollars. On 6 April 1999, Zeneca shares
were cancelled and US dollar shares issued,
credited as fully paid on the basis of one
dollar share for each Zeneca share then
held. This was achieved by a reduction of
capital under section 135 of the Companies
Act 1985. Upon the reduction of capital
becoming effective, all issued and unissued
Zeneca shares were cancelled and the sum
arising as a result of the share cancellation
credited to a special reserve, which was
converted into US dollars at the rate of
exchange prevailing on the record date. This
US dollar reserve was then applied in paying
up, at par, newly created US dollar shares.
At the same time as the US dollar shares
were issued, the Company issued 50,000
Redeemable Preference Shares for cash,
at par. The Redeemable Preference Shares
carry limited class voting rights, no dividend
rights and are capable of redemption, at par,
at the option of the Company on the giving
of seven days’ written notice to the
registered holder of the Redeemable
Preference Shares.
A total of 826 million Ordinary Shares were
issued to Astra shareholders who accepted
the merger offer before the final closing
date, 21 May 1999. The Company received
acceptances from Astra shareholders
representing 99.6% of Astra’s shares and
the remaining 0.4% was acquired in 2000,
for cash.
Since April 1999, following the merger of
Astra and Zeneca, the principal markets for
trading in the shares of the Company are
the LSE, the SSE and the NYSE. The table
overleaf sets out, for 2015 and 2016, the
reported high and low share prices of the
Company, on the following bases:
> For shares listed on the LSE, the reported
high and low middle market closing
quotations are derived from the Daily
Official List.
> For shares listed on the SSE, the high and
low closing sales prices are as stated in
the Official List.
> For ADSs listed on the NYSE, the
reported high and low sales prices are as
reported by Dow Jones (ADR quotations).
232
AstraZeneca Annual Report and Form 20-F Information 2016
2015
2016
– Quarter 1
– Quarter 2
– Quarter 3
– Quarter 4
– Quarter 1
– Quarter 2
– Quarter 3
– Quarter 4
– July
– August
– September
– October
– November
– December
Ordinary LSE
Ordinary SSE
ADS
High (pence)
Low (pence)
High (SEK)
Low (SEK)
High (US$)
Low (US$)
4847.0
4863.0
4424.5
4627.5
4562.0
4467.0
5220.0
5096.0
5048.0
5220.0
5170.0
5096.0
4575.5
4437.5
4272.0
4019.0
3903.5
3947.0
3890.0
3774.0
4469.5
4007.0
4469.5
4909.0
4819.0
4588.0
4149.5
4007.0
625.0
638.0
603.0
597.5
584.0
592.0
556.0
581.5
542.5
552.5
556.0
581.5
562.5
507.0
538.0
522.5
508.5
509.0
452.8
458.2
456.6
448.5
456.6
470.7
465.0
448.5
466.9
475.6
72.22
73.35
34.541
34.77
33.90
30.25
34.50
33.00
34.29
34.50
34.28
33.00
28.95
27.86
64.44
63.71
30.281
30.47
27.95
27.26
29.97
25.81
29.97
32.81
32.20
28.32
26.14
25.81
1(cid:3) (cid:3)(cid:58)(cid:76)(cid:87)(cid:75)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:3)(cid:73)(cid:85)(cid:82)(cid:80)(cid:3)(cid:21)(cid:26)(cid:3)(cid:45)(cid:88)(cid:79)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:24)(cid:15)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:38)(cid:82)(cid:80)(cid:83)(cid:68)(cid:81)(cid:92)(cid:350)(cid:86)(cid:3)(cid:36)(cid:39)(cid:54)(cid:3)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:3)(cid:90)(cid:68)(cid:86)(cid:3)(cid:70)(cid:75)(cid:68)(cid:81)(cid:74)(cid:72)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:87)(cid:90)(cid:82)(cid:3)(cid:36)(cid:39)(cid:54)(cid:86)(cid:3)(cid:83)(cid:72)(cid:85)(cid:3)(cid:82)(cid:81)(cid:72)(cid:3)(cid:50)(cid:85)(cid:71)(cid:76)(cid:81)(cid:68)(cid:85)(cid:92)(cid:3)(cid:54)(cid:75)(cid:68)(cid:85)(cid:72)(cid:17)(cid:3)(cid:55)(cid:75)(cid:72)(cid:3)(cid:73)(cid:82)(cid:85)(cid:80)(cid:72)(cid:85)(cid:3)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:3)(cid:90)(cid:68)(cid:86)(cid:3)(cid:82)(cid:81)(cid:72)(cid:3)(cid:36)(cid:39)(cid:54)(cid:3)(cid:83)(cid:72)(cid:85)(cid:3)(cid:82)(cid:81)(cid:72)(cid:3)(cid:50)(cid:85)(cid:71)(cid:76)(cid:81)(cid:68)(cid:85)(cid:92)(cid:3)(cid:54)(cid:75)(cid:68)(cid:85)(cid:72)(cid:17)
Major shareholdings
At 31 December 2016, the following persons had disclosed an interest in the issued Ordinary Share capital of the Company in accordance
with the requirements of rules 5.1.2 or 5.1.5 of the UK Listing Authority’s Disclosure Guidance and Transparency Rules:
Shareholder
BlackRock, Inc.
Investor AB
The Capital Group Companies, Inc.
Number of
Ordinary Shares
Date of
disclosure to
Company1
100,885,181 8 December 2009
51,587,810
2 February 2012
37,925,813
17 July 2015
Number of Ordinary
Shares disclosed as a
percentage of
issued share
capital at
31 December 2016
7.97
4.08
3.00
1 Since the date of disclosure to the Company, the interest of any person listed above in Ordinary Shares may have increased or decreased. No requirement to notify the Company of any increase or
(cid:71)(cid:72)(cid:70)(cid:85)(cid:72)(cid:68)(cid:86)(cid:72)(cid:3)(cid:68)(cid:85)(cid:76)(cid:86)(cid:72)(cid:86)(cid:3)(cid:88)(cid:81)(cid:79)(cid:72)(cid:86)(cid:86)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:75)(cid:82)(cid:79)(cid:71)(cid:76)(cid:81)(cid:74)(cid:3)(cid:83)(cid:68)(cid:86)(cid:86)(cid:72)(cid:86)(cid:3)(cid:68)(cid:3)(cid:81)(cid:82)(cid:87)(cid:76)(cid:430)(cid:68)(cid:69)(cid:79)(cid:72)(cid:3)(cid:87)(cid:75)(cid:85)(cid:72)(cid:86)(cid:75)(cid:82)(cid:79)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:68)(cid:70)(cid:70)(cid:82)(cid:85)(cid:71)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:90)(cid:76)(cid:87)(cid:75)(cid:3)(cid:85)(cid:88)(cid:79)(cid:72)(cid:86)(cid:3)(cid:24)(cid:17)(cid:20)(cid:17)(cid:21)(cid:3)(cid:82)(cid:85)(cid:3)(cid:24)(cid:17)(cid:20)(cid:17)(cid:24)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:46)(cid:3)(cid:47)(cid:76)(cid:86)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:36)(cid:88)(cid:87)(cid:75)(cid:82)(cid:85)(cid:76)(cid:87)(cid:92)(cid:350)(cid:86)(cid:3)(cid:39)(cid:76)(cid:86)(cid:70)(cid:79)(cid:82)(cid:86)(cid:88)(cid:85)(cid:72)(cid:3)(cid:42)(cid:88)(cid:76)(cid:71)(cid:68)(cid:81)(cid:70)(cid:72)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:55)(cid:85)(cid:68)(cid:81)(cid:86)(cid:83)(cid:68)(cid:85)(cid:72)(cid:81)(cid:70)(cid:92)(cid:3)(cid:53)(cid:88)(cid:79)(cid:72)(cid:86)(cid:17)
So far as the Company is aware, no other person held a notifiable interest in the issued Ordinary Share capital of the Company.
No changes to major shareholdings were disclosed to the Company between 31 December 2016 and 31 January 2017. Any changes
between 31 January 2017 and 28 February 2017 will be set out in the Notice of Annual General Meeting 2017 and Shareholders’ Circular.
Changes in the percentage ownerships disclosed by major shareholders during the past three years are set out below. Major shareholders
do not have different voting rights.
Shareholder
BlackRock, Inc.
Investor AB
The Capital Group Companies, Inc.
Invesco Limited
Axa SA
31 January
2017
31 January
2016
31 January
2015
31 January
2014
7.97
4.08
3.00
< 5.00
< 3.00
7.98
4.08
3.00
< 5.00
< 3.00
7.99
4.08
< 3.00
< 5.00
< 3.00
8.01
4.09
3.01
5.78
4.52
ADSs evidenced by ADRs issued by Citibank, as depositary, are listed on the NYSE. At 31 January 2017, the proportion of Ordinary Shares
represented by ADSs was 14.5% of the Ordinary Shares outstanding.
Number of registered holders of Ordinary Shares at 31 January 2017:
> In the US: 700
> Total: 89,953
Number of record holders of ADRs at 31 January 2017:
> In the US: 1,859
> Total: 1,884
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233
Additional Information
Shareholder Information continued
So far as the Company is aware, it is
neither directly nor indirectly owned or
controlled by one or more corporations
or by any government.
The Company does not know of any
arrangements, the operation of which
might result in a change in the control
of the Company.
Dividend payments
For Ordinary Shares listed on the LSE
and the SSE, the record date for the
second interim dividend for 2016, payable
on 20 March 2017, is 17 February 2017
and the ex-dividend date is 16 February
2017. For ADRs listed on the NYSE, the
record date is 17 February 2017 and the
ex-dividend date is 15 February 2017.
At 31 January 2017, the total amount of
the Company’s voting securities owned by
Directors and officers of the Company was:
The record date for the first interim dividend
for 2017, payable on 11 September 2017,
is 11 August 2017.
Title of class
Ordinary Shares
Amount
owned
Percentage
of class
636,639
0.05
Future dividends will normally be paid
as follows:
Related party transactions
During the period 1 January 2017 to
31 January 2017, there were no transactions,
loans, or proposed transactions between
the Company and any related parties which
were material to either the Company or the
related party, or which were unusual in their
nature or conditions (see also Note 30 to the
Financial Statements from page 192).
Options to purchase securities from
registrant or subsidiaries
(a) At 31 January 2017, options outstanding
to subscribe for Ordinary Shares were:
Number of shares
2,827,110
Subscription
price (pence)
Normal
expiry date
1882–3929
2017–2022
The weighted average subscription price of
options outstanding at 31 January 2017 was
2857 pence. All options were granted under
Company employee share schemes.
(b) Included in paragraph (a) are options
granted to Directors and officers of the
Company as follows:
Number of shares
2,495
Subscription
price (pence)
Normal
expiry date
3307–3599 2018–2021
(c) Included in paragraph (b) are options
granted to individually named Directors.
Details of these option holdings at
31 December 2016 are shown in the
Remuneration Report on page 115.
During the period 1 January 2017 to
31 January 2017, no Director exercised
any options.
> First interim: Announced in July/August
and paid in September.
> Second interim: Announced in January/
February and paid in March.
Shareview
The Company’s shareholders with
internet access may visit the website,
www.shareview.co.uk, and register their
details to create a portfolio. Shareview is
a free and secure online service from the
Company’s registrar, Equiniti, which gives
access to shareholdings, including balance
movements, indicative share prices and
information about recent dividends.
ShareGift
The Company welcomes and values all
of its shareholders, no matter how many
or how few shares they own. However,
shareholders who have only a small number
of shares whose value makes it uneconomic
to sell them, either now or at some stage in
the future, may wish to consider donating
them to charity through ShareGift, an
independent charity share donation
scheme. One feature of the scheme is
that there is no gain or loss for UK capital
gains tax purposes on gifts of shares
through ShareGift, and it may now also
be possible to obtain UK income tax relief
on the donation. Further information about
ShareGift can be found on its website,
www.sharegift.org, or by contacting
ShareGift on 020 7930 3737 or at 17 Carlton
House Terrace, London SW1Y 5AH.
ShareGift is administered by The Orr
Mackintosh Foundation, registered charity
number 1052686. More information about
the UK tax position on gifts of shares to
ShareGift can be obtained from HM
Revenue & Customs on its website,
www.hmrc.gov.uk.
The Unclaimed Assets Register
The Company supplies unclaimed dividend
data to the Unclaimed Assets Register
(UAR), which provides investors who have
lost track of shareholdings with an
opportunity to search the UAR’s database
of unclaimed financial assets on payment of
a small fixed fee. The UAR donates part of
the search fee to charity. The UAR can be
contacted on 0844 481 8180 or at
uarenquiries@uk.experian.com.
Results
Unaudited trading results of AstraZeneca
in respect of the first three months of 2017
will be published on 27 April 2017 and
results in respect of the first six months of
2017 will be published on 27 July 2017.
Documents on display
The Articles and other documents
concerning the Company which are referred
to in this Annual Report may be inspected at
the Company’s registered office at 1 Francis
Crick Avenue, Cambridge Biomedical
Campus, Cambridge CB2 0AA, UK.
Taxation for US persons
The following summary of material UK and
US federal income tax consequences of
ownership of Ordinary Shares or ADRs
held as capital assets by the US holders
described below is based on current UK
and US federal income tax law, including the
US/UK double taxation convention relating
to income and capital gains, which
entered into force on 31 March 2003 (the
Convention). This summary does not
describe all of the tax consequences that
may be relevant in light of the US holders’
particular circumstances and tax
consequences applicable to US holders
subject to special rules (such as certain
financial institutions, entities treated as
partnerships for US federal income tax
purposes, persons whose functional
currency for US federal income tax
purposes is not the US dollar, tax-exempt
entities, persons subject to alternative
minimum tax, persons subject to the
Medicare contribution tax on ‘net
investment income’, or persons holding
Ordinary Shares or ADRs in connection with
a trade or business conducted outside of
234
AstraZeneca Annual Report and Form 20-F Information 2016
the US). US holders are urged to consult
their tax advisers regarding the UK and
US federal income tax consequences
of the ownership and disposition of
Ordinary Shares or ADRs in their
particular circumstances.
This summary is based in part on
representations of Citibank as depositary
for ADRs and assumes that each obligation
in the deposit agreement among the
Company and the depositary and the
holders from time to time of ADRs and any
related agreements will be performed in
accordance with its terms. The US Treasury
has expressed concerns that parties to
whom American depositary shares are
released before shares are delivered to the
depositary (pre-release), or intermediaries
in the chain of ownership between holders
and the issuer of the security underlying
the American depositary shares, may be
taking actions that are inconsistent with
the claiming, by US holders of American
depositary shares, of foreign tax credits for
US federal income tax purposes. Such
actions would also be inconsistent with the
claiming of the reduced tax rates, described
below, applicable to dividends received
by certain non-corporate US holders.
Accordingly, the availability of the reduced
tax rates for dividends received by certain
non-corporate US holders could be affected
by actions that may be taken by parties to
whom ADRs are pre-released.
For the purposes of this summary, the term
‘US holder’ means a beneficial owner of
Ordinary Shares or ADRs that is, for US
federal income tax purposes, a citizen or
resident of the US, a corporation (or other
entity taxable as a corporation) created or
organised in or under the laws of the US,
any state in the US or the District of
Columbia, or an estate or trust, the income
of which is subject to US federal income
taxation regardless of its source.
This summary assumes that we are not,
and will not become, a passive foreign
investment company, as discussed below.
UK and US income taxation of
dividends
The UK does not currently impose a
withholding tax on dividends paid by
a UK company, such as the Company.
For US federal income tax purposes,
distributions paid by the Company to a
US holder are included in gross income
as foreign source ordinary dividend income
to the extent paid out of the Company’s
current or accumulated earnings and profits,
calculated in accordance with US federal
income tax principles. The Company does
not maintain calculations of its earnings and
profits under US federal income tax
principles and so it is expected that
distributions generally will be reported to
US holders as dividends. The amount
of the dividend will be the US dollar amount
received by the depositary for US holders of
ADRs (or, in the case of Ordinary Shares,
the US dollar value of the foreign currency
payment, determined at the spot rate of the
relevant foreign currency on the date the
dividend is received by the US holders,
regardless of whether the dividend is
converted into US dollars), and it will not be
eligible for the dividends received deduction
generally available to US corporations. If the
dividend is converted into US dollars on the
date of receipt, US holders of Ordinary
Shares generally should not be required to
recognise foreign currency gains or losses
in respect of the dividend income. They may
have foreign currency gain or loss (taxable
at the rates applicable to ordinary income)
if the amount of such dividend is converted
into US dollars after the date of its receipt.
Subject to applicable limitations and the
discussion above regarding concerns
expressed by the US Treasury, dividends
received by certain non-corporate US
holders of Ordinary Shares or ADRs may
be taxable at favourable US federal income
tax rates. US holders should consult their
own tax advisers to determine whether they
are subject to any special rules which may
limit their ability to be taxed at these
favourable rates.
Taxation on capital gains
Under present English law, individuals
who are neither resident nor ordinarily
resident in the UK, and companies which
are not resident in the UK, will not be liable
for UK tax on capital gains made on the
disposal of their Ordinary Shares or ADRs,
unless such Ordinary Shares or ADRs
are held in connection with a trade,
profession or vocation carried on in the
UK through a branch or agency or other
permanent establishment.
A US holder will generally recognise US
source capital gains or losses for US federal
income tax purposes on the sale or
exchange of Ordinary Shares or ADRs in an
amount equal to the difference between the
US dollar amount realised and such holder’s
US dollar tax basis in the Ordinary Shares or
ADRs. US holders should consult their own
tax advisers about the treatment of capital
gains, which may be taxed at lower rates
than ordinary income for non-corporate US
holders and capital losses, the deductibility
of which may be subject to limitations.
Passive Foreign Investment Company
(PFIC) rules
We believe that we were not a PFIC for
US federal income tax purposes for the year
ended 31 December 2016. However, since
PFIC status depends on the composition
of our income and assets, and the market
value of our assets (including, among
others, less than 25% owned equity
investments), from time to time, there can
be no assurance that we will not be
considered a PFIC for any taxable year. If we
were treated as a PFIC for any taxable year
during which Ordinary Shares or ADRs were
held, certain adverse tax consequences
could apply to US holders.
Information reporting and backup
withholding
Payments of dividends and sales proceeds
that are made within the US or through
certain US-related financial intermediaries
may be subject to information reporting and
backup withholding, unless: (i) the US holder
is a corporation or other exempt recipient; or
(ii) in the case of backup withholding, the
US holder provides a correct taxpayer
identification number and certifies that
it is not subject to backup withholding.
The amount of any backup withholding
from a payment to a US holder will be
allowed as a credit against the holder’s
US federal income tax liability and may
entitle the holder to a refund, provided that
the required information is timely supplied
to the US Internal Revenue Service (IRS).
Certain US holders who are individuals (and
certain entities closely-held by individuals),
may be required to report information
relating to securities issued by non-US
persons (or foreign accounts through which
the securities are held), generally on IRS
Form 8938, subject to certain exceptions
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235
Additional Information
Shareholder Information continued
(including an exception for securities held
in accounts maintained by US financial
institutions). US holders should consult
their tax advisers regarding their reporting
obligations with respect to the Ordinary
Shares or ADRs.
UK inheritance tax
Under the current Double Taxation (Estates)
Convention (the Estate Tax Convention)
between the US and the UK, Ordinary
Shares or ADRs held by an individual
shareholder who is domiciled for the
purposes of the Estate Tax Convention in
the US, and is not for the purposes of the
Estate Tax Convention a national of the
UK, will generally not be subject to UK
inheritance tax on the individual’s death or
on a chargeable gift of the Ordinary Shares
or ADRs during the individual’s lifetime,
provided that any applicable US federal
gift or estate tax liability is paid, unless the
Ordinary Shares or ADRs are part of
the business property of a permanent
establishment of the individual in the UK or,
in the case of a shareholder who performs
independent personal services, pertain
to a fixed base situated in the UK. Where
the Ordinary Shares or ADRs have been
placed in trust by a settlor who, at the
time of settlement, was a US domiciled
shareholder, the Ordinary Shares or
ADRs will generally not be subject to UK
inheritance tax unless the settlor, at the time
of settlement, was a UK national, or the
Ordinary Shares or ADRs are part of the
business property of a permanent
establishment of the individual in the UK or,
in the case of a shareholder who performs
independent personal services, pertain
to a fixed base situated in the UK. In the
exceptional case where the Ordinary Shares
or ADRs are subject to both UK inheritance
tax and US federal gift or estate tax, the
Estate Tax Convention generally provides
for double taxation to be relieved by means
of credit relief.
UK stamp duty reserve tax
and stamp duty
A charge to UK stamp duty or UK stamp
duty reserve tax (SDRT) may arise on the
deposit of Ordinary Shares in connection
with the creation of ADRs. The rate of stamp
duty or SDRT will generally be 1.5% of the
value of the consideration or, in some
circumstances, the value of the Ordinary
Shares. There is no 1.5% SDRT charge on
the issue of Ordinary Shares (or, where it is
integral to the raising of new capital, the
transfer of Ordinary Shares) into the ADR
arrangement.
No UK stamp duty will be payable on the
acquisition or transfer of existing ADRs
provided that any instrument of transfer or
written agreement to transfer is executed
outside the UK and remains at all times
outside the UK. An agreement for the
transfer of ADRs will not give rise to a
liability for SDRT.
A transfer of, or an agreement to, transfer
Ordinary Shares will generally be subject
to UK stamp duty or SDRT at 0.5% of the
amount or value of any consideration,
provided, in the case of stamp duty, it is
rounded to the nearest £5.
Transfers of Ordinary Shares into CREST
will generally not be subject to stamp duty
or SDRT, unless such a transfer is made for
a consideration in money or money’s worth,
in which case a liability to SDRT will arise,
usually at the rate of 0.5% of the value
of the consideration. Paperless transfers
of Ordinary Shares within CREST are
generally liable to SDRT at the rate of 0.5%
of the value of the consideration. CREST is
obliged to collect SDRT from the purchaser
on relevant transactions settled within
the system.
Exchange controls and other
(cid:79)(cid:76)(cid:80)(cid:76)(cid:87)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)(cid:3)(cid:68)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:86)(cid:72)(cid:70)(cid:88)(cid:85)(cid:76)(cid:87)(cid:92)(cid:3)(cid:75)(cid:82)(cid:79)(cid:71)(cid:72)(cid:85)(cid:86)
There are no governmental laws, decrees
or regulations in the UK restricting the
import or export of capital or affecting the
remittance of dividends, interest or other
payments to non-resident holders of
Ordinary Shares or ADRs.
There are no limitations under English law
or the Articles on the right of non-resident or
foreign owners to be the registered holders
of, or to exercise voting rights in relation to,
Ordinary Shares or ADRs or to be registered
holders of notes or debentures of Zeneca
Wilmington Inc. or the Company.
Exchange rates
The following information relating to average and spot exchange rates used by AstraZeneca is provided for convenience:
Average rates (statement of comprehensive income, statement of cash flows)
2014
2015
2016
End of year spot rates (statement of financial position)
2014
2015
2016
Compliance requirements under Listing Rule 9.8.4
Other than as set out below, the Company has nothing to report under Listing Rule 9.8.4
Item
Location of details in Annual Report
Details of any long-term incentive schemes
Note 27 of the Financial Statements and Directors’ Remuneration Report
Shareholder waiver of dividends
Page 96 in the Corporate Governance Report
SEK/US$
US$/GBP
6.7901
8.3950
8.5286
7.7451
8.4114
9.1162
1.6532
1.5357
1.3673
1.5559
1.4816
1.2272
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Corporate Information
History and development of the
Company
AstraZeneca PLC was incorporated in
England and Wales on 17 June 1992 under
the Companies Act 1985. It is a public
limited company domiciled in the UK. The
Company’s registered number is 2723534
and its registered office is at 1 Francis Crick
Avenue, Cambridge Biomedical Campus,
Cambridge CB2 0AA, UK (telephone
+44 20 3749 5000). From February 1993
until April 1999, the Company was called
Zeneca Group PLC. On 6 April 1999,
the Company changed its name to
AstraZeneca PLC.
The Company was formed when the
pharmaceutical, agrochemical and specialty
chemical businesses of Imperial Chemical
Industries PLC were demerged in 1993.
In 1999, the Company sold the specialty
chemical business. Also in 1999, the
Company merged with Astra of Sweden.
In 2000, it demerged the agrochemical
business and merged it with the similar
business of Novartis to form a new
company called Syngenta AG.
In 2007, the Group acquired MedImmune,
a biologics and vaccines business based
in the US.
Articles
The current Articles were adopted by
shareholders at the Company’s AGM held
on 24 April 2015.
Objects
The Company’s objects are unrestricted.
Any amendment to the Articles requires
the approval of shareholders by a special
resolution at a general meeting of
the Company.
Directors
The Board has the authority to manage
the business of the Company, for example,
through powers to allot and repurchase
its shares, subject where required to
shareholder resolutions. Subject to certain
exceptions, Directors do not have power to
vote at Board meetings on matters in which
they have a material interest.
The quorum for meetings of the Board is a
majority of the full Board, of whom at least
four must be Non-Executive Directors. In the
absence of a quorum, the Directors do not
have power to determine compensation
arrangements for themselves or any
member of the Board.
The Board may exercise all the powers of
the Company to borrow money. Variation
of these borrowing powers would require
the passing of a special resolution of the
Company’s shareholders.
> Subject to the provisions of the
Companies Act 2006, the Company
has the right to redeem the Redeemable
Preference Shares at any time on giving
not less than seven days’ written notice.
All Directors must retire from office at the
Company’s AGM each year and may present
themselves for election or re-election.
Directors are not prohibited, upon reaching
a particular age, from submitting themselves
for election or re-election.
Within two months of the date of their
appointment, Directors are required to
beneficially own Ordinary Shares of an
aggregate nominal amount of at least $125,
which currently represents 500 shares.
Rights, preferences and restrictions
attaching to shares
As at 31 December 2016, the Company
had 1,265,229,424 Ordinary Shares and
50,000 Redeemable Preference Shares
in issue. The Ordinary Shares represent
99.98% and the Redeemable Preference
Shares represent 0.02% of the Company’s
total share capital (these percentages
have been calculated by reference to the
closing mid-point US$/GBP exchange rate
on 31 December 2016 as published
in the London edition of the Financial
Times newspaper).
As agreed by the shareholders at the
Company’s AGM held on 29 April 2010,
the Articles were amended with immediate
effect to remove the requirement for the
Company to have an authorised share
capital, the concept of which was abolished
under the Companies Act 2006. Each
Ordinary Share carries the right to vote at
general meetings of the Company. The rights
and restrictions attaching to the Redeemable
Preference Shares differ from those
attaching to Ordinary Shares as follows:
> The Redeemable Preference Shares carry
no rights to receive dividends.
> The holders of Redeemable Preference
Shares have no rights to receive notices
of, attend or vote at general meetings
except in certain limited circumstances.
They have one vote for every 50,000
Redeemable Preference Shares held.
> On a distribution of assets of the
Company, on a winding-up or other return
of capital (subject to certain exceptions),
the holders of Redeemable Preference
Shares have priority over the holders of
Ordinary Shares to receive the capital
paid up on those shares.
There are no specific restrictions on
the transfer of shares in the Company,
which is governed by the Articles and
prevailing legislation.
The Company is not aware of any
agreements between holders of shares that
may result in restrictions on the transfer of
shares or that may result in restrictions on
voting rights. The Company is also not
aware of any arrangements under which
financial rights are held by a person other
than the holder of the shares.
Action necessary to change the rights
of shareholders
In order to vary the rights attached to any
class of shares, the consent in writing of the
holders of three-quarters in nominal value
of the issued shares of that class or the
sanction of a special resolution passed at a
general meeting of such holders is required.
General meetings
AGMs require 21 clear days’ notice to
shareholders. Subject to the Companies
Act 2006, other general meetings require
14 clear days’ notice.
For all general meetings, a quorum of
two shareholders present in person or by
proxy, and entitled to vote on the business
transacted, is required unless each of
the two persons present is a corporate
representative of the same corporation; or
each of the two persons present is a proxy
of the same shareholder.
Shareholders and their duly appointed
proxies and corporate representatives are
entitled to be admitted to general meetings.
Limitations on the rights to own shares
There are no limitations on the rights to
own shares.
Property
Substantially all of our properties are held
freehold, free of material encumbrances and
are fit for their purpose.
For more information please refer to Note 7
to the Group Financial Statements on
page 155.
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AstraZeneca Annual Report and Form 20-F Information 2016
237
Additional Information
Trade Marks
AstraZeneca, the AstraZeneca logotype, and the AstraZeneca symbol are all trade marks of the Group.
The following brand names which appear in italics in this Annual Report are trade marks of the Group:
Trade mark
Accolate1
Arimidex
Atacand
Atacand HCT
Atacand Plus
Bevespi Aerosphere
Bricanyl
Brilinta
Brilique
Bydureon
Byetta
Caprelsa2
Carbocaine
Casodex
Citanest
Cosudex
Crestor
Daliresp
Daxas
Diprivan
EMLA
Entocort3
Farxiga
Faslodex
Fluenz
FluMist
Forxiga
Genuair
Imdur 4
Iressa
Kombiglyze
Komboglyze
Losec
Lynparza
Marcaine
Meronem5
Merrem5
Movantik
Moventig
Myalept6
Naropin
Nexium
Nolvadex
Onglyza
Oxis Turbuhaler
Plendil
Pressair
Prilosec
Pulmicort
Pulmicort Flexhaler
Pulmicort Respules
Pulmicort Turbuhaler
Qtern
Respules
Rhinocort7
Rhinocort Aqua7
Seloken
Seroquel
Seroquel XR
Symbicort
Symbicort SMART
Symbicort Turbuhaler
Symlin
Synagis8
Tagrisso
Tenormin9
Toprol-XL
Turbuhaler
Vimovo
Xigduo
Xylocaine
Xylocard
Xyloproct
Zavicefta10
Zestril 9
Zoladex
Zomig
Zurampic
1(cid:3) (cid:3)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:68)(cid:86)(cid:86)(cid:76)(cid:74)(cid:81)(cid:72)(cid:71)(cid:3)(cid:87)(cid:75)(cid:76)(cid:86)(cid:3)(cid:87)(cid:85)(cid:68)(cid:71)(cid:72)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:3)(cid:87)(cid:82)(cid:3)(cid:51)(cid:68)(cid:85)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:70)(cid:72)(cid:88)(cid:87)(cid:76)(cid:70)(cid:68)(cid:79)(cid:86)(cid:3)(cid:44)(cid:81)(cid:70)(cid:17)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:24)(cid:3)(cid:45)(cid:68)(cid:81)(cid:88)(cid:68)(cid:85)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:24)(cid:17)
2(cid:3) (cid:3)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:68)(cid:86)(cid:86)(cid:76)(cid:74)(cid:81)(cid:72)(cid:71)(cid:3)(cid:87)(cid:75)(cid:76)(cid:86)(cid:3)(cid:87)(cid:85)(cid:68)(cid:71)(cid:72)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:3)(cid:87)(cid:82)(cid:3)(cid:42)(cid:72)(cid:81)(cid:93)(cid:92)(cid:80)(cid:72)(cid:3)(cid:38)(cid:82)(cid:85)(cid:83)(cid:82)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:22)(cid:19)(cid:3)(cid:54)(cid:72)(cid:83)(cid:87)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:24)(cid:17)
3(cid:3) (cid:3)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:68)(cid:86)(cid:86)(cid:76)(cid:74)(cid:81)(cid:72)(cid:71)(cid:3)(cid:87)(cid:75)(cid:76)(cid:86)(cid:3)(cid:87)(cid:85)(cid:68)(cid:71)(cid:72)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:3)(cid:87)(cid:82)(cid:3)(cid:40)(cid:79)(cid:68)(cid:81)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:44)(cid:81)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:79)(cid:3)(cid:47)(cid:76)(cid:80)(cid:76)(cid:87)(cid:72)(cid:71)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:20)(cid:24)(cid:3)(cid:39)(cid:72)(cid:70)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:24)(cid:15)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:85)(cid:72)(cid:86)(cid:87)(cid:3)(cid:82)(cid:73)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:90)(cid:82)(cid:85)(cid:79)(cid:71)(cid:3)(cid:87)(cid:82)(cid:3)(cid:55)(cid:76)(cid:79)(cid:79)(cid:82)(cid:87)(cid:86)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:36)(cid:42)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:20)(cid:25)(cid:3)(cid:45)(cid:88)(cid:79)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:24)(cid:17)(cid:3)
4(cid:3) (cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:68)(cid:86)(cid:86)(cid:76)(cid:74)(cid:81)(cid:72)(cid:71)(cid:3)(cid:87)(cid:75)(cid:76)(cid:86)(cid:3)(cid:87)(cid:85)(cid:68)(cid:71)(cid:72)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:3)(cid:87)(cid:82)(cid:3)(cid:40)(cid:89)(cid:72)(cid:85)(cid:72)(cid:86)(cid:87)(cid:3)(cid:41)(cid:88)(cid:87)(cid:88)(cid:85)(cid:72)(cid:3)(cid:47)(cid:76)(cid:80)(cid:76)(cid:87)(cid:72)(cid:71)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:20)(cid:3)(cid:48)(cid:68)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:17)
5 AstraZeneca assigned Meronem and Merrem(cid:3)(cid:87)(cid:82)(cid:3)(cid:51)(cid:430)(cid:93)(cid:72)(cid:85)(cid:3)(cid:44)(cid:81)(cid:70)(cid:17)(cid:3)(cid:76)(cid:81)(cid:3)(cid:80)(cid:82)(cid:86)(cid:87)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:86)(cid:3)(cid:82)(cid:88)(cid:87)(cid:86)(cid:76)(cid:71)(cid:72)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:21)(cid:22)(cid:3)(cid:39)(cid:72)(cid:70)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:17)(cid:3)
6(cid:3) (cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:68)(cid:86)(cid:86)(cid:76)(cid:74)(cid:81)(cid:72)(cid:71)(cid:3)(cid:87)(cid:75)(cid:76)(cid:86)(cid:3)(cid:87)(cid:85)(cid:68)(cid:71)(cid:72)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:3)(cid:87)(cid:82)(cid:3)(cid:36)(cid:72)(cid:74)(cid:72)(cid:85)(cid:76)(cid:82)(cid:81)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:28)(cid:3)(cid:45)(cid:68)(cid:81)(cid:88)(cid:68)(cid:85)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:24)(cid:17)
7 AstraZeneca assigned Rhinocort and Rhinocort Aqua(cid:3)(cid:87)(cid:82)(cid:3)(cid:38)(cid:76)(cid:79)(cid:68)(cid:74)(cid:3)(cid:42)(cid:80)(cid:69)(cid:43)(cid:3)(cid:44)(cid:81)(cid:87)(cid:72)(cid:85)(cid:81)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:68)(cid:79)(cid:3)(cid:82)(cid:88)(cid:87)(cid:86)(cid:76)(cid:71)(cid:72)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:24)(cid:3)(cid:39)(cid:72)(cid:70)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:17)
8 AstraZeneca owns this trade mark in the US only. AbbVie owns it in the rest of the world.
9(cid:3) (cid:3)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:68)(cid:86)(cid:86)(cid:76)(cid:74)(cid:81)(cid:72)(cid:71)(cid:3)(cid:87)(cid:75)(cid:72)(cid:86)(cid:72)(cid:3)(cid:87)(cid:85)(cid:68)(cid:71)(cid:72)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:86)(cid:3)(cid:76)(cid:81)(cid:3)(cid:87)(cid:75)(cid:72)(cid:3)(cid:56)(cid:54)(cid:3)(cid:87)(cid:82)(cid:3)(cid:36)(cid:79)(cid:89)(cid:82)(cid:74)(cid:72)(cid:81)(cid:3)(cid:51)(cid:75)(cid:68)(cid:85)(cid:80)(cid:68)(cid:3)(cid:56)(cid:54)(cid:3)(cid:44)(cid:81)(cid:70)(cid:17)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:28)(cid:3)(cid:45)(cid:68)(cid:81)(cid:88)(cid:68)(cid:85)(cid:92)(cid:3)(cid:21)(cid:19)(cid:20)(cid:24)(cid:17)
10(cid:3)(cid:36)(cid:86)(cid:87)(cid:85)(cid:68)(cid:61)(cid:72)(cid:81)(cid:72)(cid:70)(cid:68)(cid:3)(cid:68)(cid:86)(cid:86)(cid:76)(cid:74)(cid:81)(cid:72)(cid:71)(cid:3)(cid:87)(cid:75)(cid:76)(cid:86)(cid:3)(cid:87)(cid:85)(cid:68)(cid:71)(cid:72)(cid:3)(cid:80)(cid:68)(cid:85)(cid:78)(cid:3)(cid:87)(cid:82)(cid:3)(cid:51)(cid:430)(cid:93)(cid:72)(cid:85)(cid:3)(cid:44)(cid:81)(cid:70)(cid:17)(cid:3)(cid:72)(cid:428)(cid:72)(cid:70)(cid:87)(cid:76)(cid:89)(cid:72)(cid:3)(cid:21)(cid:22)(cid:3)(cid:39)(cid:72)(cid:70)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85)(cid:3)(cid:21)(cid:19)(cid:20)(cid:25)(cid:17)(cid:3)
The following brand names which appear in italics in this Annual Report are trade marks licensed to the Group by the entities set out below:
Trade mark
Duaklir
Eklira
Epanova
Tudorza
Zinforo
Licensor or Owner
Almirall, S.A.
Almirall, S.A.
Chrysalis Pharma AG
Almirall, S.A.
Forest Laboratories Holdings Limited
The following brand names which appear in italics throughout this Annual Report are not owned by or licensed to the Group and are owned
by the entities set out below:
Trade mark
Lipitor
Owner
Pfizer Ireland Pharmaceuticals
messenger RNA Therapeutics
Moderna Therapeutics, Inc.
Vidaza
Celgene Corporation
238
AstraZeneca Annual Report and Form 20-F Information 2016
Glossary
(cid:48)(cid:68)(cid:85)(cid:78)(cid:72)(cid:87)(cid:3)(cid:71)(cid:72)(cid:430)(cid:81)(cid:76)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)
Region
US
Europe
Established ROW
Emerging Markets
Country
US
Albania*
Austria
Belgium
Czech Republic
Denmark
Estonia*
Bosnia and Herzegovina*
Finland
Bulgaria
Croatia
Cyprus*
Australia
Canada
Algeria
Argentina
Aruba*
Bahamas*
Bahrain*
Barbados*
Belarus*
Belize*
Bermuda*
Brazil
Chile
China
Colombia
France
Germany
Greece
Japan
New Zealand
Costa Rica
Cuba*
Dominican Republic*
Ecuador
Egypt
El Salvador
Georgia*
Guatemala
Honduras
Hong Kong
India
Indonesia
Iran*
Hungary
Iceland*
Ireland
Israel*
Italy
Latvia*
Lithuania*
Iraq*
Jamaica*
Jordan*
Kazakhstan
Kuwait*
Lebanon*
Libya*
Malaysia
Mexico
Morocco*
Netherlands Antilles*
Nicaragua
Oman*
Luxembourg*
Malta*
Netherlands
Norway
Poland
Portugal*
Romania
Other Africa*
Pakistan*
Palestine*
Panama
Peru
Philippines
Qatar*
Russia
Saudi Arabia
Singapore
South Africa
South Korea
Sri Lanka*
Serbia and Montenegro*
Slovakia
Slovenia*
Spain
Sweden
Switzerland
UK
Sudan*
Syria*
Taiwan
Thailand
Trinidad and Tobago*
Tunisia*
Turkey
Ukraine*
United Arab Emirates
Uruguay*
Venezuela*
Vietnam*
Yemen*
* IMS Health, IMS Midas Quantum Q3 2016 data is not available or AstraZeneca does not subscribe for IMS Health quarterly data for these countries.
The above table is not an exhaustive list of all the countries in which AstraZeneca operates, and excludes countries with revenue in 2016 of
less than $1 million.
Established Markets means US, Europe and Established ROW.
North America means US and Canada.
Other Established ROW means Australia and New Zealand.
Other Emerging Markets means all Emerging Markets except China.
Other Africa includes Angola, Botswana, Ethiopia, Ghana, Kenya, Mauritius, Mozambique, Namibia, Nigeria, Swaziland, Tanzania, Uganda,
Zambia and Zimbabwe.
Asia Area comprises India, Indonesia, Malaysia, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand and Vietnam.
US equivalents
Terms used in this Annual Report
Accruals
Allotted
Called-up share capital
Creditors
Debtors
Earnings
Employee share schemes
Fixed asset investments
Freehold
Interest payable
Loans
Prepayments
Profit
Profit and loss account
Share premium account
Short-term investments
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US equivalent or brief description
Accrued expenses
Issued
Issued share capital
Liabilities/payables
Receivables and prepaid expenses
Net income
Employee stock benefit plans
Non-current investments
Ownership with absolute rights in perpetuity
Interest expense
Long-term debt
Prepaid expenses
Income
Income statement/consolidated statement of comprehensive income
Premiums paid in excess of par value of Ordinary Shares
Redeemable securities and short-term deposits
AstraZeneca Annual Report and Form 20-F Information 2016
239
Additional Information
Glossary continued
The following abbreviations and expressions
have the following meanings when used in this
Annual Report:
Abbott – Abbott Laboratories.
Celgene – Celgene International Sàrl/Celgene
Corporation.
CEO – the Chief Executive Officer of the
Company.
AbbVie – AbbVie Inc.
CER – constant exchange rates.
FRC – Financial Reporting Council.
GAAP – Generally Accepted Accounting
Principles.
GMD – Global Medicines Development.
GPPS – Global Product and Portfolio Strategy.
gross margin – the margin, as a percentage, by
which sales exceed the cost of sales, calculated
by dividing the difference between the two by the
sales figure.
Group – AstraZeneca PLC and its subsidiaries.
CFDA – China Food and Drug Administration.
CFO – the Chief Financial Officer of the
Company.
CHMP – the Committee for Medicinal Products
for Human Use.
Cilag – Cilag GmbH International.
GSK – GlaxoSmithKline plc.
CIS – Commonwealth of Independent States.
HHA – Healthy Heart Africa programme.
CMS – China Medical System Holdings Ltd.
HR – human resources.
Code of Conduct – the Group’s Code of
Conduct.
Company or Parent Company – AstraZeneca
PLC (formerly Zeneca Group PLC (Zeneca)).
COPD – chronic obstructive pulmonary disease.
CREST – UK-based securities settlement
system.
CRL – Complete Response Letter.
CROs – contract research organisations.
IA – the Group’s Internal Audit Services function.
IAS – International Accounting Standards.
IAS 19 – IAS 19 ‘Employee Benefits’.
IAS 32 – IAS 32 ‘Financial Instruments:
Presentation’.
IAS 39 – IAS 39 ‘Financial Instruments:
Recognition and Measurement’.
IASB – International Accounting Standards
Board.
CRUK – Cancer Research UK.
ICS – inhaled corticosteroid.
CV – cardiovascular.
CVMD – Cardiovascular & Metabolic Disease.
Daiichi Sankyo – Daiichi Sankyo, Inc.
Definiens – Definiens AG.
IFPMA – International Federation of
Pharmaceutical Manufacturers and Associations.
IFRS – International Financial Reporting
Standards or International Financial Reporting
Standard, as the context requires.
Director – a director of the Company.
IFRS 8 – IFRS 8 ‘Operating Segments’.
DJSI – Dow Jones Sustainability Index.
DOJ – the United States Department of Justice.
DTR – UK Disclosure Guidance and
Transparency Rules.
IMED – Innovative Medicines and Early
Development.
Incyte – Incyte Corporation.
Innate Pharma – Innate Pharma S.A.
earnings per share (EPS) – profit for the year
after tax and non-controlling interests, divided by
the weighted average number of Ordinary Shares
in issue during the year.
IO – immuno-oncology.
IP – intellectual property.
Ironwood – Ironwood Pharmaceuticals, Inc.
ACA (Affordable Care Act) – the US Patient
Protection and Affordable Care Act which was
signed into law on 23 March 2010 as amended
by the Health Care and Education Reconciliation
Act which was signed into law on 30 March 2010.
Acerta Pharma – Acerta Pharma B.V.
ACS – acute coronary syndromes.
Actavis – Actavis plc.
ADC Therapeutics – ADC Therapeutics Sàrl.
ADR – an American Depositary Receipt
evidencing title to an ADS.
ADS – an American Depositary Share
representing one underlying Ordinary Share.
Aegerion – Aegerion Pharmaceuticals, Inc.
AGM – an Annual General Meeting of the
Company.
Allergan – Allergan plc.
Almirall – Almirall, S.A.
Amgen – Amgen, Inc.
Amplimmune – Amplimmune, Inc.
Amylin – Amylin Pharmaceuticals, LLC (formerly
Amylin Pharmaceuticals, Inc.).
ANDA – an abbreviated new drug application,
which is a marketing approval application for a
generic drug submitted to the FDA.
Annual Report – this Annual Report and Form
20-F Information 2016.
API – active pharmaceutical ingredient.
Aralez – Aralez Pharmaceuticals Trading DAC.
Ardea – Ardea Biosciences, Inc.
Articles – the Articles of Association of the
Company.
Aspen – Aspen Global Incorporated.
EC – European Commission.
IS – information services.
Astellas – Astellas Pharma Inc.
Astra – Astra AB, being the company with whom
the Company merged in 1999.
AstraZeneca – the Company and its
subsidiaries.
AZIP – AstraZeneca Investment Plan.
BACE – beta secretase cleaving enzyme.
biologic(s) – a class of drugs that are produced
in living cells.
biosimilars – a copy of a biologic that is
sufficiently similar to meet regulatory
requirements.
BMS – Bristol-Myers Squibb Company.
Board – the Board of Directors of the Company.
Bureau Veritas – Bureau Veritas UK Limited.
CDP – a not-for-profit that runs the global
disclosure system for investors, companies,
cities, states and regions to manage their
environmental impacts.
EFPIA – European Federation of Pharmaceutical
Industries and Associations.
EGFR – epidermal growth factor receptor.
EMA – European Medicines Agency.
EPO – European Patent Office.
ESPC – Early Stage Product Committee.
ESRD – end-stage renal disease.
EVP – Executive Vice-President.
EU – the European Union.
FDA – the US Food and Drug Administration,
which is part of the US Department of Health and
Human Services Agency, which is the regulatory
authority for all pharmaceuticals (including
biologics and vaccines) and medical devices in
the US.
FDC – fixed-dose combination.
FibroGen – FibroGen, Inc.
ISAs – International Standards on Auditing.
IT – information technology.
KPI – key performance indicator.
krona or SEK – references to the currency of
Sweden.
Kyowa Hakko Kirin – Kyowa Hakko Kirin Co.,
Ltd.
LABA – long-acting beta2-agonist.
LAMA – long-acting muscarinic antagonist.
LCM projects – significant life-cycle
management projects (as determined by potential
revenue generation), or line extensions.
Lean – means enhancing value for customers
with fewer resources.
LEO Pharma – LEO Pharma A/S.
Lilly – Eli Lilly and Company.
LSPC – Late Stage Product Committee.
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LTI – long-term incentive, in the context of share
plan remuneration arrangements.
PhRMA – Pharmaceutical Research and
Manufacturers of America.
MAA – a marketing authorisation application,
which is an application for authorisation to place
medical products on the market. This is a specific
term used in the EU and European Economic
Area markets.
MAb – monoclonal antibody, a biologic that is
specific, that is, it binds to and attacks one
particular antigen.
major market – US, EU, Japan (JP) and
China (CN).
MAT – moving annual total.
MedImmune – MedImmune, LLC (formerly
MedImmune, Inc.).
Merck – Merck Sharp & Dohme Corp. (formerly
Merck & Co., Inc.).
MI – myocardial infarction.
Moderna – Moderna Therapeutics, Inc.
NCD – non-communicable disease.
NDA – a new drug application to the FDA for
approval to market a new medicine in the US.
NME – new molecular entity.
Novartis – Novartis Pharma AG.
NSAID – a non-steroidal anti-inflammatory drug.
NSCLC – non-small cell lung cancer.
NSTE-ACS – non-ST-Elevation acute coronary
syndromes.
NYSE – the New York Stock Exchange.
n/m – not meaningful.
OECD – the Organisation for Economic
Cooperation and Development.
Omthera – Omthera Pharmaceuticals, Inc.
operating profit – sales, less cost of sales, less
operating costs, plus operating income.
Ordinary Share – an ordinary share of $0.25
each in the share capital of the Company.
Orphan Drug – a drug which has been
approved for use in a relatively low-incidence
indication (an orphan indication) and has been
rewarded with a period of market exclusivity; the
period of exclusivity and the available orphan
indications vary between markets.
OTC – over-the-counter.
Paediatric Exclusivity – in the US, a six-month
period of exclusivity to market a drug which is
awarded by the FDA in return for certain
paediatric clinical studies using that drug. This
six-month period runs from the date of relevant
patent expiry. Analogous provisions are available
in certain other territories (such as European
Supplementary Protection Certificate (SPC)
paediatric extensions).
PARP – an oral poly ADP-ribose polymerase.
PD-L1 – an anti-programmed death-ligand 1.
Pearl Therapeutics – Pearl Therapeutics, Inc.
Pfizer – Pfizer, Inc.
Phase I – the phase of clinical research where a
new drug or treatment is tested in small groups of
people (20 to 80) to check that the drug can
achieve appropriate concentrations in the body,
determine a safe dosage range and identify side
effects. This phase includes healthy volunteer
studies.
Phase II – the phase of clinical research
which includes the controlled clinical activities
conducted to evaluate the effectiveness of the
drug in patients with the disease under study and
to begin to determine the safety profile of the
drug. Phase II studies are typically conducted in
small or medium sized groups of patients and
can be divided into Phase IIa studies, which tend
to be designed to assess dosing requirements,
and Phase IIb studies, which tend to assess
safety and efficacy.
Phase III – the phase of clinical research which
is performed to gather additional information
about effectiveness and safety of the drug, often
in a comparative setting, to evaluate the overall
benefit/risk profile of the drug. Phase III studies
usually include between several hundred and
several thousand patients.
PHC – personalised healthcare.
PMDA – Pharmaceuticals and Medical Devices
Agency of Japan.
pMDI – pressurised metered-dose inhaler.
PMI – process mass intensity.
pound sterling, £, GBP or pence – references
to the currency of the UK.
Pozen – POZEN, Inc.
primary care – general healthcare provided by
physicians who ordinarily have first contact with
patients and who may have continuing care for
them.
Proof of Concept – data demonstrating that a
candidate drug results in a clinical change on an
acceptable endpoint or surrogate in patients with
the disease.
PSP – AstraZeneca Performance Share Plan.
PTE – Patent Term Extension, an extension
of up to five years in the term of a US patent
relating to a drug which compensates for delays
in marketing resulting from the need to obtain
FDA approval. The analogous right in the EU
is an SPC.
Qiagen – Qiagen NV.
R&D – research and development.
Redeemable Preference Share – a
redeemable preference share of £1 each in the
share capital of the Company.
Regulatory Data Protection (RDP) – see the
Intellectual Property section on page 57.
Regulatory Exclusivity – any of the IP rights
arising from generation of clinical data and
includes Regulatory Data Protection, Paediatric
Exclusivity and Orphan Drug status.
RNA – ribonucleic acid
Roche – F. Hoffmann-La Roche AG.
ROW – rest of world.
RSV – respiratory syncytial virus.
Sanofi – SANOFI S.A.
Sarbanes-Oxley Act – the US Sarbanes-Oxley
Act of 2002.
SDRT – UK stamp duty reserve tax.
SEC – the US Securities and Exchange
Commission, the governmental agency that
regulates the US securities industry and stock
markets.
Seroquel – Seroquel IR and Seroquel XR.
SET – Senior Executive Team.
SG&A costs – selling, general and administrative
costs.
SGLT2 – sodium-glucose co-transporter 2.
SHE – Safety, Health and Environment.
Shionogi – Shionogi & Co. Ltd.
SLE – systemic lupus erythematosus.
SPC – supplementary protection certificate
specialty care – specific healthcare provided by
medical specialists who do not generally have
first contact with patients.
Spirogen – Spirogen Sàrl.
SSE – the Stockholm Stock Exchange.
Takeda – Takeda Pharmaceutical Company
Limited.
Teva – Teva Pharmaceuticals USA, Inc.
Total Revenue – the sum of Product Sales and
Externalisation Revenue.
TSR – total shareholder return, being the total
return on a share over a period of time, including
dividends reinvested.
UK – United Kingdom of Great Britain and
Northern Ireland.
UK Corporate Governance Code – the UK
Corporate Governance Code published by the
FRC in September 2014 that sets out standards
of good practice in corporate governance for
the UK.
US – United States of America.
US dollar, US$, USD or $ – references to the
currency of the US.
Valeant – Valeant Holdings Ireland/Valeant
Pharmaceutical International, Inc.
WHO – World Health Organization, the United
Nations’ specialised agency for health.
YHP – Young Health Programme.
ZS Pharma – ZS Pharma, Inc.
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241
Additional Information
Index
Accounting policies
Acerta Pharma
Acquisitions
Affordable Care Act
Almirall
Animal research
Annual General Meeting
Articles of Association
AstraZeneca at a glance
Audit Committee
Audit Committee Report
Bioethics
Biologics
BMS
Board of Directors
Brilinta/Brilique
Business model
Cambridge
Capitalisation and shareholder return
Cardiovascular and Metabolic diseases
Cash and cash equivalents
Chairman’s Statement
Chief Executive Officer’s Review
Clinical trials
Code of Conduct
Commitments and contingent liabilities
Community investment
Company history
Compliance and Internal Audit Services
Consolidated Statements
Corporate Governance
Corporate Information
Corporate Integrity Agreement
Definiens
Development pipeline
Diabetes
Directors’ interest in shares
Directors’ responsibility statement
Diversity
Dividends
Earnings per Ordinary Share
Employee costs and share plans for employees
Employees
Environmental impact
Ethics
Externalisation
Finance income and expense
Financial instruments
Financial position 2016
Financial Review
Financial risk management
Financial Statements 2016
Financial summary
Gender diversity
Geographical Review
Global pharmaceutical sales
Glossary
Group Financial Record
Group Subsidiaries and Holdings
Growth Platforms
Healthy Heart Africa programme
Human Rights
Independent auditor’s report
Infection, Neuroscience and Gastrointestinal
77, 142, 200
26, 29, 62-74, 173
173-177
13, 49, 82
68, 72, 176
48
97, 105, 237
237
2-3
84, 98-102
98-102
47-48
12, 15
63-69, 175
86-87
31-33
8-10
7
76
30-34
162
82-83
4-6
8-9, 46-48
52, 95-96
185-191
53
237
95
138-141
82-131
237
98
176-177
23, 204-210
32-34
114-115
133
55-56, 90-91
3, 76, 96, 172
152
182-184
52-57
60-61
52, 95
23-24, 67
149
149
72
62-81
76-77, 177-181
133-192
1
55-56
226-230
11-12
239-241
203
193-196
17
49
56-67
134-137
See Other Disease Areas
Information Technology
Intangible assets
Intellectual Property
Interest-bearing loans and borrowings
Key performance indicators
Leases
Life-cycle of a medicine
Litigation
Lynparza
Manufacturing and Supply
Market definitions
Marketplace
Modern Slavery Act
Oncology
Operating profit
Operational overview
Other Disease Areas
Other investments
PARTHENON programme
Patent Expiries
Patents
Patient safety
Personalised healthcare
Physician Payments Sunshine Act
Political donations
Post-retirement benefits
Product revenue information
Property, plant and equipment
Provisions
Regulatory requirements
Related party transactions
Relations with shareholders
Remuneration
Remuneration Policy
Research and Development
Reserves
Respiratory
Restructuring
Results of operations 2016
Risk
Sales and Marketing
Sales by geographical area
Sales by therapy area
Sarbanes-Oxley Act
Science Committee
Segment information
Senior management (SET)
Share capital
Share repurchase
Shareholder distributions
Shareholder information
Strategic priorities
Sustainability: supplementary information
Tagrisso
Takeda
Taxation
Taxation information for shareholders
Therapy Area Overview and Pipeline
Trade and other payables
Trade and other receivables
Trade marks
Values and Purpose
Young Health Programme
ZS Pharma
60
73, 80, 101, 134-135, 143, 157-159
57
162-163
16-19
144, 146, 191
8-9
20, 80, 101, 135, 145, 185-200
26-29
58-59
239
11-15
56
25-29
1, 62-65, 148-149
2-3
38-41
144, 160
33
15, 211-213
See Intellectual Property
47-48
46
52
97
80, 136, 165-171
226-230
73
165
13-14
192, 234
93
103-121
122-132
45-48
172
37
43, 69, 148
65
20-22, 214-225
48-51
226-230
23, 226-230
81
93-94
152-153
85, 88-89
172
76, 172
3, 76, 96
232-236
2, 5, 16-19
231
4-5, 26-29
24, 36-37, 57
69, 76, 81, 143, 150-152, 200
234-236
23-41
72, 144, 164
72, 144, 162, 181
238
8
53
34, 62-73, 174-175
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Important information for readers of this Annual Report
AstraZeneca websites
Information on or accessible through our
websites, including www.astrazeneca.com,
www.astrazenecaclinicaltrials.com and
www.medimmune.com, does not form part
of and is not incorporated into this Annual
Report.
External/third party websites
Information on or accessible through any
third party or external website does not form
part of and is not incorporated into this
Annual Report.
Figures
Figures in parentheses in tables and in the
Financial Statements are used to represent
negative numbers.
Inclusion of Reported performance,
(cid:38)(cid:82)(cid:85)(cid:72)(cid:3)(cid:430)(cid:81)(cid:68)(cid:81)(cid:70)(cid:76)(cid:68)(cid:79)(cid:3)(cid:80)(cid:72)(cid:68)(cid:86)(cid:88)(cid:85)(cid:72)(cid:86)(cid:3)(cid:68)(cid:81)(cid:71)(cid:3)(cid:70)(cid:82)(cid:81)(cid:86)(cid:87)(cid:68)(cid:81)(cid:87)(cid:3)
exchange rate growth rates
AstraZeneca’s determination of non-GAAP
measures together with our presentation of
them within our financial information may
differ from similarly titled non-GAAP
measures of other companies.
Statements of competitive position,
growth rates and sales
In this Annual Report, except as otherwise
stated, market information regarding the
position of our business or products relative
to its or their competition is based upon
published statistical sales data for the
12 months ended 30 September 2016
obtained from IMS Health, a leading supplier
of statistical data to the pharmaceutical
industry. Unless otherwise noted, for the
US, dispensed new or total prescription
data and audited sales data are taken,
respectively, from IMS Health National
Prescription Audit and IMS National Sales
Perspectives for the 12 months ended
31 December 2016; such data is not
adjusted for Medicaid and similar rebates.
Except as otherwise stated, these market
share and industry data from IMS Health
have been derived by comparing our sales
revenue with competitors’ and total market
sales revenues for that period, and except
as otherwise stated, growth rates are given
at CER. For the purposes of this Annual
Report, unless otherwise stated, references
to the world pharmaceutical market or
similar phrases are to the 54 countries
contained in the IMS Health database,
which amounted to approximately 96%
(in value) of the countries audited by
IMS Health.
Cautionary statement regarding
forward-looking statements
The purpose of this Annual Report is to
provide information to the members of the
Company. The Company and its Directors,
employees, agents and advisers do not
accept or assume responsibility to any other
person to whom this Annual Report is
shown or into whose hands it may come
and any such responsibility or liability is
expressly disclaimed. In order, among other
things, to utilise the ‘safe harbour’ provisions
of the US Private Securities Litigation
Reform Act of 1995 and the UK Companies
Act 2006, we are providing the following
cautionary statement: This Annual Report
contains certain forward-looking statements
with respect to the operations, performance
and financial condition of the Group,
including, among other things, statements
about expected revenues, margins,
earnings per share or other financial or other
measures. Forward-looking statements are
statements relating to the future which are
based on information available at the time
such statements are made, including
information relating to risks and uncertainties.
Although we believe that the forward-
looking statements in this Annual Report
are based on reasonable assumptions, the
matters discussed in the forward-looking
statements may be influenced by factors
that could cause actual outcomes and
results to be materially different from those
expressed or implied by these statements.
The forward-looking statements reflect
knowledge and information available at the
date of the preparation of this Annual Report
and the Company undertakes no obligation
to update these forward-looking statements.
We identify the forward-looking statements
by using the words ‘anticipates’, ‘believes’,
‘expects’, ‘intends’ and similar expressions
in such statements. Important factors that
could cause actual results to differ materially
from those contained in forward-looking
statements, certain of which are beyond our
control, include, among other things, those
factors identified in the Risk section from
page 214 of this Annual Report. Nothing in
this Annual Report should be construed as
a profit forecast.
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243
Additional Information
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headquarters
AstraZeneca PLC
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UK
Tel: +44 (0)20 3749 5000
Investor relations
UK: as above
US:
Investor Relations
AstraZeneca Pharmaceuticals LP
One MedImmune Way
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US
Tel: +1 (301) 398 0000
For more information please see
www.astrazeneca.com
Registrar
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex BN99 6DA
UK
Tel: (freephone in the UK) 0800 389 1580
Tel: (outside the UK) +44 (0)121 415 7033
Swedish Central Securities Depository
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PO Box 191
SE-101 23 Stockholm
Sweden
Tel: +46 (0)8 402 9000
US Depositary
Citibank Shareholder Services
PO Box 43077
Providence
RI 02940-3077
US
Tel: (toll free in the US) +1 (888) 697 8018
Tel: (outside the US) +1 (781) 575 4555
citibank@shareholders-online.com
244
AstraZeneca Annual Report and Form 20-F Information 2016
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