What science can do
AstraZeneca Annual Report and Form 20-F Information 2015
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Welcome to the AstraZeneca
Annual Report and Form 20-F Information 2015.
Learn about our main therapy areas:
We are a global, science-led
biopharmaceutical business and
in this Annual Report we report on
the progress we made in 2015 in
pushing the boundaries of science
to deliver life-changing medicines.
AstraZeneca.
What science can do.
Pushing the
boundaries
Respiratory, Inflammation and Autoimmunity
We have pushed the boundaries of science in
respiratory disease for 40 years
See page 26
Breaking through
conventional thinking
Cardiovascular and Metabolic diseases
We take an integrated patient approach to
reduce cardiovascular morbidity and mortality
See page 30
Redefining the
treatment paradigm
Oncology
We are committed to advancing the science
of oncology
See page 34
From page 4, Pascal Soriot, our
Chief Executive Officer, reviews the
progress we made during the year
in delivering our strategy.
Our Chief Financial Officer,
Marc Dunoyer, reviews our financial
performance from page 62.
From page 82, Leif Johansson,
our Chairman, reviews how our
governance and approach to
remuneration support delivery
of the strategy.
Front cover:
New approaches in the treatment of asthma
AstraZeneca is developing a therapy aimed
at producing long-term benefit in asthma by
addressing imbalances in the immune system
that may be an underlying cause of the disease.
Rather than simply treating symptoms by
relaxing airway constriction and dampening
inflammation in the lung, this therapy aims to
target toll-like receptor 9 in dendritic cells in the
lung. This could potentially change the way
immune cells communicate with each other and
restore a healthy balance to the immune system.
Important information for readers of this Annual Report
For more information in relation to the inclusion of reported performance,
Core financial measures and constant exchange rate (CER) growth rates
as used in this Annual Report, please see the Financial Review on page
64. Throughout this Annual Report, growth rates are expressed at CER
unless otherwise stated.
Definitions
The Glossary and the Market definitions table from page 247 are
intended to provide a useful guide to terms and AstraZeneca’s definitions
of markets, as well as to 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 251.
Directors’ Report
The following sections make up the Directors’ Report, which
has been prepared in accordance with the requirements of the
Companies Act 2006:
> Business Review: Research and Development
> Resources Review: Employees
> Corporate Governance: including the Audit Committee 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
> Chief Executive Officer’s Review
> Strategy
> Therapy Area Review
> Business Review
> Resources Review
> Financial Review
Financial highlights
Contents
Total Revenue*
up 1% at CER to $24,708 million (down 7%
at actual rate of exchange)
Net cash flow from operating activities
down 53% (at actual rate of exchange) to
$3,324 million
2015
2014
2013
$24,708m
$26,547m
$25,806m
2015
2014
2013
$24.7bn
$3.3bn
$3,324m
$7,058m
$7,400m
Core operating profit
up 6% at CER to $6,902 million (down 1%
at actual rate of exchange)
Reported operating profit
up 100% at CER to $4,114 million (up 93%
at actual rate of exchange)
2015
2014
2013
$6.9bn
$6,902m
$6,937m
$8,390m
2015
2014
2013
$4.1bn
$4,114m
$2,137m
$3,712m
Strategic Report
AstraZeneca at a glance
Chief Executive Officer’s Review
Strategy
Therapy Area Review
Respiratory, Inflammation
2
4
8
24
and Autoimmunity
26
Cardiovascular and Metabolic diseases 30
Oncology
34
Business Review
42
Resources Review
52
Financial Review
62
Corporate Governance
Chairman’s Statement
Corporate Governance Overview
Board of Directors
Senior Executive Team
Corporate Governance Report
Audit Committee Report
Directors’ Remuneration Report
82
84
86
88
90
98
103
Core EPS
for the full year up 7% at CER to $4.26
(unchanged at actual rate of exchange)
Reported EPS
for the full year up 137% at CER to $2.23
(up 128% at actual rate of exchange)
2015
2014
2013
$4.26
$4.26
$4.28
$5.05
2015
2014
2013
$2.23
Financial Review from page 62
* As detailed on page 144, Total Revenue consists
of Product Sales and Externalisation Revenue.
For more information within
this Annual Report
For more information see
www.astrazeneca.com
This Annual Report is also available on our website,
www.astrazeneca.com/annualreport2015
$2.23
$0.98
$2.04
Financial Statements
Auditor’s Reports (Group)
136
Consolidated Statements
140
Group Accounting Policies
144
Notes to the Group Financial Statements 149
Group Subsidiaries and Holdings
194
Auditor’s Report (Company)
196
Company Statements
197
Company Accounting Policies
199
Notes to the Company Financial
Statements
Group Financial Record
200
202
Additional Information
Marketed Products
Development Pipeline
Patent Expiries
Risk
Geographical Review
Sustainability:
supplementary information
Financials (Prior year)
Shareholder Information
Corporate Information
Trade Marks
Glossary
Index
203
205
210
212
227
234
236
240
245
246
247
250
AstraZeneca Annual Report and Form 20-F Information 2015
1
Additional InformationFinancial StatementsCorporate GovernanceStrategic Report
Strategic Report
AstraZeneca at a glance
AstraZeneca is a global, science-led biopharmaceutical business…
…with an on-market portfolio in our chosen therapy areas.
Respiratory, Inflammation
and Autoimmunity
Cardiovascular
and Metabolic diseases
Oncology
Infection, Neuroscience
and Gastrointestinal
$4,987m
$9,489m
$2,825m
$6,340m
Product Sales
2014: $5,063m
2013: $4,677m
Highlights
Product Sales
2014: $9,802m
2013: $8,830m
Product Sales
2014: $3,027m
2013: $3,193m
Product Sales
2014: $8,203m
2013: $9,011m
> Respiratory sales up by 7%,
> Brilinta/Brilique sales up by 44%,
> Oncology sales up by 7%
including 25% in Emerging Markets,
before completion of the acquisition
of Takeda’s respiratory business
> Sales of Symbicort down by 3%
including 64% in the US
> Diabetes sales up by 26%, including
76% in Emerging Markets
> Sales of Crestor fell by 3% reflecting
competition from generic statins and
pricing pressure
> New Oncology included for the first
time (comprising Lynparza, Iressa
(US) and Tagrisso)
> Lynparza launched in 15 markets
and sales of $94 million
> Sales of Nexium declined by 26%,
including 52% in the US following
loss of exclusivity
> Sales of Seroquel XR fell by 12%
and Synagis fell by 26%
Sales and Marketing from page 48, Financial Review from page 62 and Geographical Review from page 227
We have distinctive R&D capabilities, a growing late-stage pipeline…
Main therapy areas
Opportunity-driven
Respiratory,
Inflammation and
Autoimmunity
Cardiovascular
and Metabolic
diseases
Oncology
Infection, Neuroscience
and Gastrointestinal
Small molecules
Biologics
Immunotherapies
Protein engineering
Devices
Personalised healthcare and translational science capabilities
NMEs in Phase III, pivotal Phase II
or under regulatory review
Therapy Area Review from page 24 and
Research and Development from page 42
15
2015
2014
2013
2012
2
AstraZeneca Annual Report and Form 20-F Information 2015
15
13
11
6
…and a strong global commercial presence, with strength in Emerging Markets.
North America
Europe
International and Japan
$10,007m
Product Sales
2014: $10,710m
2013: $10,328m
Employees
7,600
Highlights
$5,323m
Product Sales
2014: $6,638m
2013: $6,658m
$8,311m
Product Sales
2014: $8,747m
2013: $8,725m
5,900
21,900
> Sales in the US declined by 6% reflecting entry
of generic Nexium products and adverse Synagis
guideline changes
> Favourable performances were delivered by Brilinta,
Farxiga, Bydureon and Lynparza as well as the
acquired Respiratory medicines, Tudorza and Daliresp
> Sales in Canada grew by 4%
> Sales declined by 6%
> Strong growth for Diabetes medicines was
offset by generic competition facing Crestor and
Seroquel XR
> 14% decline in Symbicort sales reflected adverse
pricing movements driven by competition from
analogues in key markets
> Emerging Markets revenue grew by 12%
to $5,822 million, including China sales
growth of 15%
> Sales in Japan grew by 4% to $2,020 million
> Opened facility in Russia
Business Review from page 42
Our talented employees are committed to achieving our Purpose in a sustainable way…
61,500
employees worldwide
8,900
employees in R&D
12,500
employees in
Manufacturing
and Supply
Increasing our proximity to bioscience clusters and co-locating around three strategic R&D centres
> Cambridge, UK
> Gaithersburg, Maryland US
> Gothenburg, Sweden
Employees from page 52
...and our disciplined
capital allocation enables
commitment to a
progressive dividend.
$3,443m
$2.80
Net cash shareholder distributions
increased to $3,443 million
Dividend per Ordinary Share
unchanged
All growth rates at CER.
All employee numbers are approximate
as at 31 December 2015.
2015
2014
2013
$3,443m
2015
$3,242m
2014
$2,979m 2013
$2.80
$2.80
$2.80
AstraZeneca Annual Report and Form 20-F Information 2015
3
Strategic Report Strategic Report
Chief Executive Officer’s Review
2015 was an exceptional year for AstraZeneca as we
made significant progress in meeting both our near-
and longer-term strategic goals. Building on the solid
foundations of the previous two years, our success during
2015 was based on a strong commitment to our values.
It was this focus that made the year a great one for
science and patients.
It was this focus
that made the year a
great one for science
and patients.”
The first stage of our strategic journey
involved strengthening our product pipeline
and building our Growth Platforms. We are
now well into the second stage of that
journey, as we manage a transitional period
of patent expiries, and are on track to
continue driving our Growth Platforms
and launch our new products.
The increased momentum we built in
2015 was exemplified by a number of
developments towards the end of the
year in each of our main therapy areas
that will help deliver our strategy.
Leadership in Oncology
The first of those events was the approval
in November of Tagrisso in the US. This
approval marks a significant milestone in
AstraZeneca’s journey, and in our leadership
in Oncology. Tagrisso is the first treatment
approved for patients with a very specific
form of non-small cell lung cancer who
present with a genetic mutation in the
epidermal growth factor receptor but also
have a secondary mutation, T790M. Its
story is remarkable and, as shown over,
it demonstrates our ability to successfully
deliver our pipeline and, even more
importantly, offer patients a new treatment
option in a disease where very few
solutions exist.
Another significant development in
Oncology came with our agreement in
December to invest in a majority equity
stake in Acerta Pharma, a company
focused on haematology which represents
a natural fit with our existing Oncology
pipeline. The acquisition provides us with
access to acalabrutinib (ACP-196), a
potential best-in-class small molecule
oral BTK inhibitor, which is expected to
transform the treatment landscape for
B-cell malignancies, the most common
forms of blood cancers, and has potential in
solid tumours and autoimmune diseases.
The acquisition of Acerta Pharma
will also reinforce our growing position in
haematology – building on our agreement
with Celgene, in April, to develop durvalumab
across a range of blood cancers.
Innovation in Cardiovascular and
Metabolic diseases
Also in December, we completed our
acquisition of ZS Pharma. This transaction
provides access to the potassium-binding
compound ZS-9, a potential best-in-class
treatment for hyperkalaemia (high potassium
levels in the bloodstream). The acquisition
represents a good fit with our pipeline and
portfolio in Cardiovascular and Metabolic
diseases (CVMD), which focuses on
reducing morbidity, mortality and organ
damage by addressing multiple risk factors
across cardiovascular disease, diabetes
and chronic kidney disease.
4
AstraZeneca Annual Report and Form 20-F Information 2015
AstraZeneca: Values in action
Tagrisso (osimertinib) highlights how living our values can
ensure we achieve our goals. It started with inspiration
and effort of our scientists to design a compound precisely
targeting the biological dysfunction associated with a specific
form of non-small cell lung cancer. And, by putting patients
first, working collaboratively and following the science, we
delivered the fastest development journey in our history: less
than three years from first patient dosed to approval. It was
then shipped to patients in less than six hours.
Artistic impression of
osimertinib binding to
mutant EGFR.
Transforming Respiratory treatment
Another development in December, was
our agreement to acquire Takeda’s core
respiratory business. When completed, this
agreement will expand our ownership of
rights to roflumilast (Daliresp/Daxas), the
only approved oral PDE4 inhibitor for the
treatment of COPD. The agreement builds
on our acquisition from Actavis, in March,
of the rights to market Daliresp in the US.
This important agreement will also provide
us with access to other marketed medicines
that complement our growing portfolio.
Importantly, it will support our return to
growth after 2017 and our goal to transform
the way respiratory disease is treated.
Achieve scientific leadership
In addition to these developments, in the
week before Christmas, we received our
sixth approval for the year from the FDA.
Subsequently, in February 2016, we
received approval from the EU for Tagrisso
for lung cancer.
However, in what was a very busy and
successful year, my Review can only
give a flavour of what we achieved. The
2015 Strategic priorities overview, shown
on the right, lists some of our other
achievements, as well as the challenges
we faced. All these are explored in more
detail throughout our Strategic Report.
So far as achieving scientific leadership is
concerned, one measure of the distance
we have come is in the recognition we have
received through ‘high-impact’ publications
in major relevant scientific journals.
AstraZeneca people had 58 such articles
published in 2015 compared with seven
in 2010 – a more than eightfold increase.
2015 Strategic priorities overview
Achieve scientific leadership
> 6 approvals of NMEs or major LCM
Return to growth
> 1% increase in Total Revenue
projects in major markets
– Oncology: Iressa (US); Tagrisso
(AZD9291/osimertinib) (US);
Faslodex 500mg (China)
– CVMD: Bydureon Dual Pen (Japan);
Brilinta (US for treatment of history
of heart attack)
– RIA: Zurampic (US)
> 2 Phase III NME starts:
– anifrolumab for lupus
– PT010 for COPD
> 12 NME or major LCM regulatory
submissions in major markets
> Accelerated reviews included
– Brilinta FDA granted Priority Review
for PEGASUS
– Tagrisso FDA and PMDA granted
Priority Review. EMA accelerated
assessment
– FDA granted Fast Track status for
anifrolumab for systemic lupus
erythematosus; durvalumab for head
and neck cancer; and tremelimumab
for mesothelioma
> 20 projects discontinued
to $24,708 million at CER; comprising
Product Sales of $23,641 million (down 1%)
and Externalisation Revenue of
$1,067 million (up 140%)
– Based on actual exchange rates, Total
Revenue declined by 7%, reflecting the
particular weakness of key trading
currencies against the US dollar
> 11% increase in Growth Platforms revenue
contributing 57% of Total Revenue
– Respiratory: up 7%, before completion
of the acquisition of Takeda’s respiratory
business
– Brilinta/Brilique: up 44% underpinned by
a recently-extended US label and positive
CHMP opinion
– Diabetes: up 26%, including 76% in
Emerging Markets; global Farxiga/Forxiga
growth of 137%
– Emerging Markets: up 12%, including
China and Latin America each growing
by 15%
– Japan revenue: up 4%
– New Oncology: contributed $119 million,
comprising Lynparza, Iressa (US) and
Tagrisso
> US revenue was down 6% to $9,474 million;
Europe down 6% to $5,323 million; and
Established ROW was stable at
$3,022 million (at CER)
Great place to work
> Our quarterly employee survey (pulse) showed belief in our strategy stood at 89%
(compared with 86% in our 2014 all-employee survey)
> Exceeded our targets for senior leaders: women (42% versus 41%) and country of origin
from an Emerging Market or Japan (15.6% versus 13%)
> Exceeded our target by screening more than one million people in Kenya for hypertension
as part of our Healthy Heart Africa programme
AstraZeneca Annual Report and Form 20-F Information 2015
5
Strategic Report
Strategic Report
Chief Executive Officer’s Review continued
Strategic Report
In this Strategic Report, we outline our
business model, the marketplace in which
we operate and the strategic priorities we
decided upon in response to those
conditions. We define our measures of
success (our key performance indicators)
and the risks we have identified to
achieving our strategy.
Subsequent sections explore our therapy
areas as well as our business units and
the resources we are able to deploy in
their support.
We also highlight how commitment to our
values contributes to our success.
Great people are central to our
success and being a great place
to work is at the heart of our
efforts to release the talents
of our employees.
A pipeline ahead of plan
Our pipeline is also a measure of our
progress and 2015 was a year of
considerable success. Of our six approvals
for the year, the approval, in September,
of Brilinta in the US for the treatment of
patients with a history of heart attack
beyond the first year was particularly
impressive: it took just nine months to move
from the presentation of top-line PEGASUS
TIMI-54 data to launch.
During the year we also made 12 major
regulatory submissions. After our partner
Amgen decided to terminate our
collaboration on brodalumab in May, our
subsequent collaboration with Valeant,
with their specific expertise in dermatology,
enabled submissions to be made in the
US and EU by the end of the year. In July,
results of a Phase III study for selumetinib
did not meet its primary endpoint for uveal
melanoma. As for saxagliptin/dapagliflozin,
its submission in the EU and elsewhere
remains on track despite a Complete
Response Letter being received from
the FDA in October.
External recognition of the strength of our
pipeline was provided by the number of
accelerated reviews received by our
candidate drugs during the year, including
those for cancer, respiratory diseases and
lupus. Internally, six Phase III investment
decisions and 11 Phase II starts stand
testament to the quality of the projects
in development which will help deliver
sustainable growth.
Even after the approvals we received during
the year, and the 18 approvals of the last
two years, we ended 2015 with 15 projects
in late-stage development, including recently
acquired compounds. This exceeds the
target set in 2013 of nine to 10 NMEs in
Phase III/pivotal Phase II studies or under
regulatory review by 2016.
Collaboration as a way of life
2015 was also a good year for
collaborations which are an integral part
of our business model and culture. They
improve the productivity of our R&D and
help maximise the value of our pipeline.
With 10 deals we considerably exceeded
our target. Some of these, such as our
agreement with Celgene, are examples of
strategic collaborations to broaden and
accelerate the development of key pipeline
assets. This is explained in more detail in
the Business model on page 8.
As well as externalising some of our early
development projects outside our main
therapy areas, we also divest medicines that
can be better deployed by a partner with a
primary focus in that area. Examples in 2015
included the divestment of Entocort, our
gastrointestinal medicine. Both routes allow
us to leverage the capabilities and expertise
of others, focus our own resources and
deliver the greatest benefit to patients
and shareholders.
Scientific collaborations also help us
push the boundaries of science. For
example, during the year we announced
four collaborations aimed at harnessing
the power of CRISPR (clustered regularly-
interspaced short palindromic repeats),
including one with The Wellcome Trust
Sanger Institute in Cambridge, UK –
see over.
6
AstraZeneca Annual Report and Form 20-F Information 2015
Values in action: We follow the science
Genetic engineering is not new. The Human
Genome Project produced a complete
genetic blueprint for building a human in
2003 but, until now, scientists have been
unable to manipulate genes simply and
effectively. A new technology called CRISPR
is changing that by allowing the genome
of several different species to be edited
precisely. We are using CRISPR to identify
new targets for medicines and develop new
models to test compounds which align more
closely with human disease.
Return to growth
We delivered a strong pipeline and financial
performance in 2015 as we began the next
phase in our strategic journey. As the 2015
Strategic priorities overview shows, Total
Revenue in 2015 was up 1% at CER.
The overview also shows the success
we have had with our Growth Platforms
where Product Sales grew by 11% and
represented 57% of Total Revenue.
Our top-line and gross-margin growth
underpinned continued investment in
R&D. Core R&D costs were up by 21%
in the year which reflected the investment
in the pipeline.
Investing in China for the long term
The extent of our ambition was
demonstrated by our strategic investments,
announced in December, to accelerate the
delivery of innovative medicines to patients
in China, the world’s second largest
economy and our second largest market,
and to support the delivery of our strategy.
These initiatives will see AstraZeneca
become the first multinational
pharmaceutical company operating in
China to commit to local development of
its innovative global portfolio from research
to commercialisation. Just as importantly,
these initiatives will allow us to better
integrate Chinese requirements into our
global portfolio decisions.
Great place to work
Great people are central to our success and
being a great place to work is at the heart
of our efforts to release the talents of our
employees. So, for example, during 2015,
we held over 70 People Development Week
events to help our staff take ownership
of their personal development. A talented
workforce is also diverse and I am pleased
that we managed to exceed our targets for
women and country of origin among our
senior leaders. I take pride in the fact that
our efforts are being increasingly recognised
in external awards for the work environment
we have instilled.
That environment is nurtured by our
investment in strategic R&D centres, such
as Cambridge, UK where we now have
more than 1,600 employees and where the
construction of our R&D centre and global
headquarters is progressing rapidly. These
investments help create an environment
of innovation and a focus on science and
patients. They also attract a lot of talent
from academia and other companies.
A great place to work also has to be one
where we do the right thing – for the
patients who take our medicines, as well as
the planet and society as a whole. If we are
to deliver business success over the longer
term, then sustainability has to be in our
DNA. As the Chairman outlines in more
detail in his Statement, the steps we are
taking in this regard reflect a determination
to do our fair share.
Looking ahead
The investments we made in 2015 were
designed to ensure we achieved a balance
between meeting our short-term goal of
returning to growth and then delivering
sustainable growth over the longer term as
we build a sustainable, durable and more
profitable business.
CRISPR gene
editing tool.
As we face the transitional period of patent
expiry for Crestor in the US, we’re confident
that our strong execution on strategy,
combined with the benefits of focused
investments and new launches, keeps us on
track to return to sustainable growth in line
with our targets. The weakness of key
trading currencies against the US dollar has
continued. Based on average exchange
rates in January 2016 and our published
currency sensitivities, an adverse impact
of around 3% from currency movements on
Total Revenue and Core EPS in 2016 would
be anticipated.
Appreciation
I am confident that in AstraZeneca we
have the people who can overcome our
short-term challenges and deliver longer-term
sustainable growth. In that regard I would
particularly like to welcome Pam Cheng and
Sean Bohen who joined us during the year.
In doing so, I would like to thank David Smith
and Briggs Morrison whom Pam and Sean
replaced, for the contributions they made to
our strategic journey.
In closing, I would like to pay tribute to
everyone in AstraZeneca for making 2015
a tremendous year. I have every confidence
in their ability to continue that success in the
years ahead.
Pascal Soriot
Chief Executive Officer
AstraZeneca Annual Report and Form 20-F Information 2015
7
Strategic Report Strategic Report Strategy
Business model
Our Purpose and Values drive what we do – and how we do it. This includes our
business model and our determination to create sustainable value across every
medicine’s life-cycle.
AstraZeneca’s investor proposition
How it works
Science-led biopharmaceutical
company in three therapy areas
Productive
R&D
Strong
business
Sustainable
organisation
> Platform of small
molecules and
biologics
> Sustainable model
and growing early-
stage pipeline
> Growing late-stage
pipeline with immuno-
oncology strength
> Protein engineering
> Strong portfolio of
> Innovative,
entrepreneurial
culture
> Strong talent base
> Efficient and
productive
organisation
> Balanced pipeline
to drive sustainable
growth
established products
> Global scale with
Emerging Markets
strength
> Six platforms driving
growth towards a
balanced portfolio
of primary care and
specialty care
medicines
> Durability through
devices and
companion diagnostics
Disciplined
capital allocation
Commitment to
progressive dividend
Externalisation
Our business model includes externalisation as part of our portfolio management
strategy and is a result of increasing R&D productivity and a focus on three
main therapy areas. Externalisation activities relate to specific risk- and
reward-sharing strategic collaborations that provide greater access to strong
science and broaden, accelerate and maximise the development and
commercialisation potential for some of our medicines and help bring those
medicines to patients faster. Milestone payments and royalties arising from
externalisation activities are included in the income statement as Externalisation
Revenue. Externalisation allows us to leverage the capabilities and expertise
of others, focus on our main therapy areas and deliver the greatest benefit to
patients and shareholders.
Externalisation activities in 2015 included our collaboration with Celgene,
leveraging the expertise of AstraZeneca in immuno-oncology along with the
experience of Celgene in the study and treatment of blood cancers, for the
development and commercialisation of durvalumab across a range of
haematological malignancies. Similarly, our collaboration with Lilly, entered
into in 2014, combines the scientific expertise from our two organisations and,
by sharing the risks and cost of late-stage development, aims to accelerate the
advancement of AZD3293 and progress a new approach to support the treatment
of Alzheimer’s disease patients around the world. AstraZeneca retains
significant interest, and continued participation, in the key decision making
undertaken within these strategic collaborations.
Financial Review on page 62
8
AstraZeneca Annual Report and Form 20-F Information 2015
Strategic priorities
Our strategic priorities reflect how we
aim to achieve our Purpose. They are to
Strategic priorities from page 16
Inputs
Demographic trends are favourable to our
industry’s long-term growth; while innovative
scientific research continues to deliver
new ways of fulfilling unmet medical need.
As the Marketplace section from page 12
demonstrates, however, the economic, social
and political environment presents not only
significant opportunities but challenges
as well.
To achieve our Purpose, we seek to maximise
the value of our resources, including our
employees, IP and partners.
Resources Review from page 52
We have strong commercial franchises that
focus on Respiratory, Inflammation and
Autoimmunity; Cardiovascular and Metabolic
diseases; and Oncology. We have combined a
broad portfolio of primary care and specialty
care medicines with a global reach. We
believe our capabilities, pipeline and portfolio
will enable us to build on our leading
positions in Established Markets and achieve
further growth in Emerging Markets.
Therapy Area Review from page 24
Sustainability
In the wider world from page 55
Purpose and Values
1
2
3
Achieve scientific
leadership
Return
to growth
Be a great
place to work
These priorities reflect the choices we have
made to focus our R&D and commercial
investments, prioritise and accelerate
promising assets and business development,
and transform our innovation model and the
way we work.
Business model
Outputs
We strive to operate in accordance with
a disciplined, value-creation framework
that supports investment to generate
cash flows that we return to investors
and reinvest in the business. We also
invest in targeted business development
to strengthen our portfolio, pipeline
and capabilities.
Our success depends on the creation
and protection of our IP rights.
Developing a new medicine is risky,
costly and time consuming: requiring
significant investment over many years,
with no guarantee of success. For
investments to be viable, we must
protect new medicines from being
copied for a reasonable period of time.
The loss of key product patents has
affected sales significantly in recent
years and will continue to do so.
As such, one of our main goals is to
sustain the cycle of innovation and
continually refresh our portfolio of
patented products.
Life-cycle of a medicine overleaf
How we create and sustain value over
the life-cycle of a medicine across our
chosen therapy areas
Investment in the R&D, Manufacturing and
Supply, and Sales and Marketing of innovative
medicines. This includes targeted business
development through collaboration, in-licensing
and acquisitions.
Rein v e s t m e
r e t u r ns
t o f
n
Investm
e
n
t i
n
Inputs
d
i
s
c
o
Outputs
Our
Purpose
s
e
n
i
c
i
d
e
tion of patent-protected m
a
v
e
r
y
,
d
e
v
e
l
o
p
m
e
n
t a
n
d com
mercialis
Reinvestment of returns from sales,
externalisation (see page 8) and divestments
to develop and sustain the next generation of
innovative medicines.
Returns to shareholders
Revenue from the sale of our medicines
generates cash flow, which helps us fund
business investment. It also enables us
to meet our debt service obligations and
follow our progressive dividend policy.
This involves balancing the interests
of our business, financial creditors
and shareholders.
Financial Review from page 62
Improved health
Continuous scientific innovation is vital
to achieving sustainable healthcare as it
creates value by
> improving health outcomes and
transforming patients’ lives
> enabling healthcare systems to reduce
costs and increase efficiency
> improving access to healthcare and
healthcare infrastructure
> helping develop the communities
in which we operate through local
employment and partnering.
We want to be valued and trusted by our stakeholders as a source of great medicines over the long term. To that end, our sustainability
commitments, which are driven by our Purpose and Values, underpin our business model. Those commitments are aligned to, and support
the delivery of, our business strategy.
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 every day. It reminds us why we exist as a company. It helps
us deliver benefits to patients and create value for shareholders. It also
sets the context for our employees’ activities and the roles of our
teams, partners and other collaborators.
We follow the science. We put patients first. We play to win.
We do the right thing. We are entrepreneurial.
These Values determine how we work together and the
behaviours that are integral to our drive for success. Our Values
guide our decision making, define our beliefs and foster a strong
AstraZeneca culture.
AstraZeneca Annual Report and Form 20-F Information 2015
9
Strategic Report
Strategic Report Strategy
Life-cycle of a medicine
As a global science-led biopharmaceutical company, our activities span
the entire life-cycle of a medicine from Research and Development to
Manufacturing and Supply to the global Sales and Marketing of primary
care and specialty care medicines that transform lives.
Research and development phases 10–15 years
1
3
5
Find potential medicine
> Identify unmet medical need aligned with our
three therapy areas and undertake scientific
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
> Determine likely efficacy, side effect profile
and maximum dose estimates
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
Phase III studies
> Engage in studies in a larger group of patients
to gather information about effectiveness and
safety of the medicine and evaluate the overall
benefit/risk profile
> Initiate branding for the new medicine in
> Determine approximate dosage and identify
preparation for its launch
side effects
4
Phase II studies
> Conduct studies on small- to medium-sized
groups of patients to test effectiveness and
tolerability of the medicine and determine
optimal dose
> Design Phase III studies to generate data
needed for regulatory approvals and
pricing/reimbursement globally
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
demonstrate the safety and efficacy of the
medicine to enable them to decide on whether
to grant regulatory approvals
Launch phase 5–10 years
7
8
Launch new medicine
> Raise awareness of patient benefit and
appropriate use, market and sell medicine
> Clinicians begin to prescribe medicines
and patients begin to benefit
> Continuously monitor, record and analyse
reported side effects. Review need to update
the side effect warnings to ensure that patients’
wellbeing is maintained
> Assess real-world effectiveness, and
opportunities to support patients and
prescribers, to achieve maximum benefit
from the medicine
Post-launch research and development
> Conduct studies to further understand the
benefit/risk profile of the medicine in larger
and/or additional patient populations
> 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
Post-exclusivity 20+ years
9
Post-exclusivity
> Patent expiry and generic entry
> Reinvestment of returns
Primary care and specialty care
Primary care is general healthcare provided
by doctors who ordinarily have first contact
with patients and who may have continuing
care for them. Specialty care is specific
healthcare provided by medical specialists
who do not generally have first contact with
patients. Specialty care medicines generally
treat more severe diseases and an increasing
number of specialty care medicines require
a diagnostic test for patient eligibility or to
achieve the best outcomes.
Small molecule drugs
> Typically composed of 20 to 100 atoms
with a well-defined chemical structure
> Potential for off target activity
> Manufactured through chemical
Large molecule drugs (biologics)
> Small biologics (eg peptides) typically
200 to 3,000 atoms. Large biologics
(eg antibodies), typically 5,000 to
50,000 atoms
synthesis. Identical copies can be made
> High selectivity and specificity; potentially
> Wide variety of administration routes,
such as oral, inhaled, injected or
topical delivery
immunogenic
> Manufactured in a living system such as
a microorganism, or plant or animal cells
> Administration route often intravenous,
intramuscular or other parenteral route
10
AstraZeneca Annual Report and Form 20-F Information 2015
t u r n s
e
f r
n t o
e
R ein v e st m
Investment in disc
o
v
er
y, d
e
v
e
l
o
p
m
e
n
t
a
n
d
c
o
m
m
e
r
c
i
a
l
i
s
a
t
i
o
n
o
f
p
a
t
e
n
t
-
p
r
ote
cte
d medicines
t u r n s
e
f r
n t o
e
R ein v e st m
Inputs
> Applying our resources to
meet unmet medical need
Outputs
> Returns to shareholders
> Improved health
Investment in disc
Research and dev
o
v
er
y, d
1
Find potential
medicine
e
v
e
l
o
p
m
e
n
t
elo
p
m
e
n
t
p
2
Pre-clinical
studies
h
a
s
e
s
1
0
–
1
5
y
e
a
r
s
3
Phase I
studies
4
Phase II
studies
a
n
d
c
o
m
m
e
r
c
i
a
l
i
s
a
t
i
o
n
o
f
p
a
t
e
n
t
-
p
r
ote
cte
d medicines
y
it
iv
s
u
l
c
x
e
-
t
s
o
P
s
r
a
e
y
+
0
2
9
Post-
exclusivity
Our
Purpose
8
Post-launch
research and
development
s
r
a
e
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
Research and Development from page 42
Manufacturing and Supply from page 46
Sales and Marketing from page 48
Note: This is a high-level overview of a medicine’s life-cycle
and is illustrative only. It is neither intended to, nor does
it, represent the life-cycle of any particular medicine or
of every medicine discovered and/or developed by
AstraZeneca, or the probability of success or approval
of any AstraZeneca medicine.
AstraZeneca Annual Report and Form 20-F Information 2015
11
Strategic Report
Strategic Report Strategy
Marketplace
Despite global economic, political and social challenges,
the pharmaceutical industry is expected to enjoy long-
term growth. This is due to favourable demographic
trends and significant unmet medical need.
Overview
> Global pharmaceutical sales grew by 9.5% in 2015
> The sector remains highly competitive
> Patient populations are expanding and ageing
> Non-communicable diseases kill 38 million people each year
> The costs of developing a new medicine continue to rise
> Priority Reviews and Breakthrough Therapies are becoming more prevalent
> A highly regulated sector reflects the demand for safe, effective and
high-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
84.0%
Generics constituted 84.0%
of prescriptions dispensed
in the US.
$140bn
Global investment in pharmaceutical
R&D expected to reach an estimated
$140 billion in 2015, a 30% increase
from $108 billion in 2006.
12
AstraZeneca Annual Report and Form 20-F Information 2015
The global context
According to the International Monetary
Fund (IMF), a return to robust and
synchronised global expansion remains
elusive six years after the world economy
emerged from its broadest and deepest
post-war recession. Moreover, downside
risks to the world economy appear more
pronounced, particularly for emerging
market and developing economies, and
including renewed concerns about China’s
growth potential.
The demand for healthcare, however,
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.
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 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 pages 14 and 15 shows, we expect
developing markets to continue to boost
pharmaceutical growth.
Unmet medical need
The prevalence of non-communicable
diseases (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 38 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 right, global
pharmaceutical sales grew by 9.5% in 2015.
Established Markets saw average revenue
growth of 9.3% and Emerging Markets
revenue growth at 10.3%. The US, China,
Japan, Germany and France are the world’s
top five pharmaceutical markets. In 2015,
the US had 45.7% of global sales (2014:
44.6%; 2013: 43.2%).
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
are expected to account for 46% of the
total sales revenue of the world’s top 100
pharmaceutical products, having risen from
21% 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
with more than half the Center for Drug
Evaluation and Research NME approvals
in 2015 receiving a Priority Review and,
almost a quarter having a Breakthrough
Therapy designation. Between the inception
of the Breakthrough Therapy designation
programme in October 2012 and the end of
2015, the FDA has granted more than 100
such requests, and one-third of these have
already resulted in product approvals.
Global pharmaceutical sales
World $bn
2015
2014
2013
$904bn (9.5%)
US $bn
2015
2014
2013
$413bn (12.0%)
Europe $bn
2015
2014
2013
$194bn (6.3%)
Established ROW $bn
2015
2014
2013
$100bn (4.3%)
Emerging Markets $bn
2015
2014
2013
$198bn (10.3%)
904
826
759
413
369
328
194
182
177
100
96
94
198
179
160
Data based on world market sales using AstraZeneca market
definitions as set out in the Market definitions on page 247.
Source: IMS Health, IMS Midas Quantum Q3 2015 (including
US data). Reported values and growth are based at CER. Value
figures are rounded to the nearest billion and growth
percentages are rounded to the nearest tenth.
The cost of developing new medicines
continues to rise. Global R&D investment is
expected to reach $140 billion in 2015. While
the growth rate of R&D spend has slowed in
recent years, pharmaceutical companies
continue to deliver new medicines. In 2015
the FDA approved 45 NMEs compared with
41 in 2014 and 27 in 2013. The number of
approvals in 2015 is the largest since 1996
when 59 NMEs were approved.
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.
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, passed by the
House of Representatives in July 2015, and
the related Senate Innovation for Healthier
Americans Legislative Initiative, are focused
on accelerating the discovery, development
and delivery of promising new treatments for
patients. Similarly, the PDUFA reauthorisation
legislation considered by the US Congress
in 2017 is anticipated to contain proposals
aimed at accelerating innovation and
modernising the 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
AstraZeneca Annual Report and Form 20-F Information 2015
13
Strategic Report Strategic Report Strategy
Marketplace continued
Estimated pharmaceutical sales and market growth – 2019
North America
EU
South East and East Asia
Latin America
$574bn
7.0%
$224bn
3.3%
$206bn
7.1%
$90bn
6.4%
Africa
$32bn
CIS
$27bn
Middle East
$27bn
9.6%
6.9%
7.4%
Other Europe (Non-EU countries)
$22bn
6.8%
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 piloting
of a programme to implement ‘adaptive
pathways’, or ‘staggered approval’, to
improve timely patient access to new
medicines. In Japan, the SAKIGAKE
strategy is fostering a more favourable
environment for drug development and
accelerating the availability of currently
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, proposed revisions to China’s
Drug Administration Law, which are under
review, may help address this issue.
Greater transparency and public access
to regulatory submissions that support
approval of new medicines continues
to be an area of interest. A recent example
involves the EMA policy 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.
These clinical reports include the overviews,
summaries and clinical study reports
submitted by the applicant, together with
documentation of statistical methods.
The study of paediatric populations
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 EMA’s initiative offering
free-of-charge meetings early in drug
development. Increased interest in the
availability of the paediatric rare disease
voucher programme in the US is another
noteworthy development.
Regulatory requirements for the registration
of biosimilar products continue to be
developed and become better defined.
This includes the publication of a new
pathway for China and the first biosimilar
product approval in the US. However,
significant areas of regulatory policy are
still evolving. Among these are transparency
of data 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 below.
Pricing of medicines
Pricing and reimbursement remain
challenging in many markets. Most
pharmaceutical sales are generated in
highly regulated markets where
governments, insurers and other private
payers exert various controls on pricing
and reimbursement. These include
limitations on pharmaceutical spending
and the cost of readmitting patients to
hospital. Implementation of certain reforms
and shifting market dynamics are further
constraining healthcare providers, while
difficult economic conditions burden
patients who pay out-of-pocket for
medicines. Pharmaceutical companies
are now expending significant resources
to demonstrate the economic as well as
therapeutic value of their medicines.
In the US, the Affordable Care Act (ACA)
has had a direct impact on healthcare
activities. It continues to reshape the market
through various provisions designed to
reduce cost and improve healthcare and
patient outcomes. We, along with other
pharmaceutical companies, are working
with policymakers and regulators to help
contain costs, improve outcomes and
promote an environment that fosters
medical and scientific innovation.
In Europe, governments continue to
implement 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 budget 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 a single reimbursement level (or reference)
for each drug group.
In China, pricing practices remain a priority
for regulators. Though free pricing has been
introduced, 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
14
AstraZeneca Annual Report and Form 20-F Information 2015
Japan
$82bn
1.3%
Oceania
$13bn
1.8%
Indian subcontinent
$35bn
12.3%
Estimated pharmaceutical sales – 2019. Ex-manufacturer prices
at CER. Source: IMS Health.
Estimated pharmaceutical market growth – 2014 to 2019.
Compound annual growth rate. Source: IMS Health.
pricing legislation. In Japan, mandated
biennial cuts are likely to continue. In Latin
America, pricing is increasingly controlled by
governments as, for example, in Colombia.
For more information about price controls,
reductions and US healthcare reform, and price
regulation in our major markets, please see
Geographical Review from page 227 and Risk
from page 212
Patent expiries and genericisation
Patent protection for pharmaceutical
products is finite. Patents are expiring
on some of the biggest-selling drugs ever
produced and payers, physicians and
patients have 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 2015, generics
constituted 84.0% of the market by volume
(2014: 83.4%).
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, tabletted
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.
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 27 to the
Financial Statements from page 186.
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 businesses, and
companies that produce generic medicines.
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 continued in 2015. It is
estimated that the value of mergers
announced in the healthcare sector during
the year amounted to more than $650
billion, accounting for 14% of all merger
and acquisition activity.
AstraZeneca Annual Report and Form 20-F Information 2015
15
Strategic Report Strategic Report Strategy
Strategic priorities
We are focused on
returning to growth in
our chosen therapy areas
through a science-led
innovation strategy.
This strategy is 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 programmes. It
also involves engaging
in targeted business
development and
leveraging our strong
global commercial
presence, particularly
in Emerging Markets.
What do we need to do?
How are we implementing this?
For more information
Achieve scientific leadership
Focus on innovative science in three therapy areas
Our focus is on Respiratory, Inflammation and Autoimmunity; Cardiovascular and Metabolic diseases; and Oncology. We are
Therapy Area Review from page 24
also taking an opportunity-driven approach to Infection, Neuroscience and Gastrointestinal disorders.
We are working across small molecules, biologics, immunotherapies, protein engineering and devices.
Prioritise and accelerate our pipeline
We are accelerating and investing in key R&D programmes. 15 new molecular entities (NMEs) are in Phase III/pivotal Phase II
Pipeline and Therapy Area Introduction
or under regulatory review compared with our March 2013 target of nine to 10 by the end of 2016.
from page 24
Between 2013 and the end of 2016, we have the potential for 12 to 16 Phase II starts; 14 to 16 NME and major line extension
Development Pipeline from page 205
regulatory submissions; and eight to 10 NME and major line extension regulatory approvals.
We are strengthening our early-stage pipeline through novel science and technology.
Transform our innovation and culture model
Our two autonomous biotech units, MedImmune and IMED, drive science and innovation, and GMD drives our late-stage
Research and Development from page 42
development unit.
Accelerate through business development
We are working to reinforce our therapy areas and are strengthening our portfolio and pipeline through targeted business
In the wider world from page 55
Return to growth
Focus on Growth Platforms
Brilinta/Brilique – We are working to deliver Brilinta/Brilique’s potential to reduce cardiovascular deaths through ongoing clinical
Cardiovascular and Metabolic diseases
Transform through specialty care, devices
and biologics
Be a great place to work
Evolve our culture
We are working to improve our employees’ identification with our Purpose and Values and to promote greater understanding
Employees from page 52
of and belief in our strategy.
We are investing in and implementing tailored leadership development programmes.
Simplify our business
We are developing simpler, more efficient processes and flattening our organisational structure to encourage accountability
and improve decision making and communication.
Attract and retain the best talent
We are accelerating efforts to attract diverse, top talent with new capabilities.
Deliver business success over the long term
We are supporting the sustainable delivery of our business strategy while delivering wider benefits to society and
In the wider world from page 55
the environment.
Achieve our Group
financial targets
Drive on-market value
We invest in R&D and on-market Growth Platforms to return to growth. Our aim is to deliver industry-leading productivity
Financial Review from page 62
by restructuring to create scope for investment and a flexible cost base.
Maintain a progressive dividend
Our 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.
16
AstraZeneca Annual Report and Form 20-F Information 2015
We are focusing on novel science, such as immune-mediated therapy combinations and personalised healthcare (PHC).
To increase our proximity to bioscience clusters, we are co-locating around three strategic centres in Cambridge, UK;
Gaithersburg, Maryland US; and Gothenburg, Sweden. These moves will leverage our capabilities and foster collaboration
with leading scientists and research organisations.
development, including collaborations, in-licensing and acquisitions.
We are collaborating strategically to broaden and accelerate the development of key pipeline assets (externalisation) and
divesting non-core assets to realise value.
studies and plans for market leadership.
to transform patient care.
Diabetes – We are working to maximise the potential of our broad and innovative non-insulin, anti-diabetic portfolio
Cardiovascular and Metabolic diseases
from page 30
from page 30
Emerging Markets – We are focused on delivering innovative medicines by accelerating our investment in Emerging Markets
Sales and Marketing from page 48
capabilities, with a focus on China and other leading markets, such as Russia and Brazil. We are also expanding our
commercial reach through multi-channel marketing and sales force excellence and building strong local medical and scientific
affairs teams. Transformation of our capabilities is supporting new products and improving access and affordability.
Respiratory – We are working to maximise pipeline value, devices and medicines to fulfil unmet medical need and improve
patient outcomes in asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).
Respiratory, Inflammation and
Autoimmunity from page 26
Japan – We are strengthening our Oncology franchise and working to maximise the success of our Diabetes medicines and
Sales and Marketing from page 48
established brands: Symbicort, Nexium and Crestor.
New Oncology – Became our sixth Growth Platform in January 2015 and includes Lynparza, Iressa (US) and Tagrisso. We are
Oncology from page 34
aiming to deliver six new cancer medicines to patients by 2020.
We are transforming our business to become more sustainable, durable and profitable. This involves focusing on specialty
Therapy Area Review from page 24
care medicines, devices and biologics. Biologics now account for half of the NMEs in development, potentially enhancing asset
longevity. A greater focus on innovative and differentiated delivery devices affords patient choice while ensuring product
durability. Our new specialty care portfolio is expected to balance our strength in primary care medicines.
Achieve scientific leadership
Focus on innovative science in three therapy areas
Our focus is on Respiratory, Inflammation and Autoimmunity; Cardiovascular and Metabolic diseases; and Oncology. We are
also taking an opportunity-driven approach to Infection, Neuroscience and Gastrointestinal disorders.
Therapy Area Review from page 24
What do we need to do?
How are we implementing this?
For more information
Prioritise and accelerate our pipeline
We are working across small molecules, biologics, immunotherapies, protein engineering and devices.
We are accelerating and investing in key R&D programmes. 15 new molecular entities (NMEs) are in Phase III/pivotal Phase II
or under regulatory review compared with our March 2013 target of nine to 10 by the end of 2016.
Pipeline and Therapy Area Introduction
from page 24
Between 2013 and the end of 2016, we have the potential for 12 to 16 Phase II starts; 14 to 16 NME and major line extension
regulatory submissions; and eight to 10 NME and major line extension regulatory approvals.
Development Pipeline from page 205
We are strengthening our early-stage pipeline through novel science and technology.
Transform our innovation and culture model
Our two autonomous biotech units, MedImmune and IMED, drive science and innovation, and GMD drives our late-stage
development unit.
Research and Development from page 42
Accelerate through business development
We are working to reinforce our therapy areas and are strengthening our portfolio and pipeline through targeted business
development, including collaborations, in-licensing and acquisitions.
In the wider world from page 55
We are collaborating strategically to broaden and accelerate the development of key pipeline assets (externalisation) and
divesting non-core assets to realise value.
Return to growth
Focus on Growth Platforms
Brilinta/Brilique – We are working to deliver Brilinta/Brilique’s potential to reduce cardiovascular deaths through ongoing clinical
studies and plans for market leadership.
Cardiovascular and Metabolic diseases
from page 30
We are focusing on novel science, such as immune-mediated therapy combinations and personalised healthcare (PHC).
To increase our proximity to bioscience clusters, we are co-locating around three strategic centres in Cambridge, UK;
Gaithersburg, Maryland US; and Gothenburg, Sweden. These moves will leverage our capabilities and foster collaboration
with leading scientists and research organisations.
Transform through specialty care, devices
and biologics
Be a great place to work
Evolve our culture
Diabetes – We are working to maximise the potential of our broad and innovative non-insulin, anti-diabetic portfolio
to transform patient care.
Cardiovascular and Metabolic diseases
from page 30
Emerging Markets – We are focused on delivering innovative medicines by accelerating our investment in Emerging Markets
capabilities, with a focus on China and other leading markets, such as Russia and Brazil. We are also expanding our
commercial reach through multi-channel marketing and sales force excellence and building strong local medical and scientific
affairs teams. Transformation of our capabilities is supporting new products and improving access and affordability.
Sales and Marketing from page 48
Respiratory – We are working to maximise pipeline value, devices and medicines to fulfil unmet medical need and improve
patient outcomes in asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).
Respiratory, Inflammation and
Autoimmunity from page 26
Japan – We are strengthening our Oncology franchise and working to maximise the success of our Diabetes medicines and
established brands: Symbicort, Nexium and Crestor.
Sales and Marketing from page 48
New Oncology – Became our sixth Growth Platform in January 2015 and includes Lynparza, Iressa (US) and Tagrisso. We are
aiming to deliver six new cancer medicines to patients by 2020.
Oncology from page 34
We are transforming our business to become more sustainable, durable and profitable. This involves focusing on specialty
care medicines, devices and biologics. Biologics now account for half of the NMEs in development, potentially enhancing asset
longevity. A greater focus on innovative and differentiated delivery devices affords patient choice while ensuring product
durability. Our new specialty care portfolio is expected to balance our strength in primary care medicines.
Therapy Area Review from page 24
We are working to improve our employees’ identification with our Purpose and Values and to promote greater understanding
of and belief in our strategy.
Employees from page 52
We are investing in and implementing tailored leadership development programmes.
Simplify our business
We are developing simpler, more efficient processes and flattening our organisational structure to encourage accountability
and improve decision making and communication.
Attract and retain the best talent
We are accelerating efforts to attract diverse, top talent with new capabilities.
Deliver business success over the long term
We are supporting the sustainable delivery of our business strategy while delivering wider benefits to society and
the environment.
In the wider world from page 55
Achieve our Group
financial targets
Drive on-market value
We 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 investment and a flexible cost base.
Financial Review from page 62
Maintain a progressive dividend
Our 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.
AstraZeneca Annual Report and Form 20-F Information 2015
17
Strategic Report Strategic Report Strategy
Key performance indicators
How we performed against the indicators by which we measure our success.
Achieve Group financial targets
Achieve scientific leadership
Total Revenue1
Net cash flow from operating
activities
Phase III investment decisions
NME or LCM project regulatory
submissions in major markets
Clinical-stage strategic
transactions
$24,708m $3,324m
2015
2014
2013
$24,708m
$26,547m
$25,806m
2015
2014
2013
CER growth
2015 +1%
2014 +5%
2013 -7%
Actual growth
2015 -7%
2014 +3%
2013 -9%
Actual growth
2015 -53%
2014 -5%
2013 +7%
6
2015
2014
2013
$3,324m
$7,058m
$7,400m
12
6
9
3
2015
2014
2013
10
2015
2014
2013
12
6
3
10
3
7*
Anifrolumab; AZD9291 + durvalumab;
PT010; durvalumab + tremelimumab
(NSCLC); durvalumab + tremelimumab
(bladder and head and neck); AZD9291
adjuvant.
Brilinta PEGASUS (US, EU, Japan);
CAZ AVI (EU); Tagrisso (AZD9291)
(US, EU, Japan); cediranib (EU);
saxagliptin/dapagliflozin (EU); PT003
(US); brodalumab (US, EU).
Total Revenue comprised Product
Sales of $23,641 million (down by
1%) and Externalisation Revenue of
$1,067 million (up by 140%). Decline
in Total Revenue at actual exchange
rates reflected the particular weakness
of key trading currencies against the
US dollar.
1 As detailed on page 144, Total Revenue
consists of Product Sales and
Externalisation Revenue.
Cash generated from operating
activities reflects a modest increase
in investment in working capital of
$49 million compared to a decline of
$2,508 million in 2014. Working capital
improvements made in 2014 have been
sustained minimising the impact of
increased acquired diabetes and
launch product inventory balances.
Dividend per share2
Core EPS
NME Phase II starts/
progressions
NME and major LCM regional
approvals
$2.80
$4.26
11
2015
2014
2013
$2.80
$2.80
$2.80
2015
2014
2013
$4.26
$4.28
$5.05
2015
2014
2013
6
2015
2014
2013
11
13
13
6
12
3
Dividend is consistent with the
progressive dividend policy pursuant
to which the Board intends to maintain
or grow the dividend each year.
CER growth
2015 +7%
2014 -8%
2013 -23%
Actual growth
2015 0%
2014 -15%
2013 -26%
MEDI8897; MEDI-551; MEDI7510;
AZD3241; AZD9412; AZD7594;
AZD5069; AZD9150; AZD3759;
MEDI6012; MEDI8852.
Bydureon Dual Pen (Japan); Iressa
(US); Brilinta (US for treatment of
history of heart attack); Tagrisso
(AZD9291) (US); Zurampic (US);
Faslodex 500mg (China).
Increase in Core EPS demonstrated
resilience in face of patent expiries
as we position ourselves for a return
to growth.
2 First and second interim dividend
for the year.
Financial Review from page 62
Therapy Area Review from page 24
18
AstraZeneca Annual Report and Form 20-F Information 2015
Licensing and/or acquisition
opportunities helped us achieve
our 2016 target three years ahead of
schedule and contribute to meeting
our target of sustainable delivery of
two NMEs annually by 2020.
* Four for early-stage (Phase I/II)
opportunities, and three for late-stage
(Phase II+) opportunities.
Achieve scientific leadership
Return to growth
Phase III investment decisions
NME or LCM project regulatory
submissions in major markets
Clinical-stage strategic
transactions
Brilinta/Brilique
Diabetes
Japan
10
2015
2014
2013
$619m
sales
$2,224m
sales
$2,020m
sales
10
3
7*
2015
2014
2013
$619m
$476m
$283m
2015
2014
2013
$2,224m
$1,870m
$787m
2015
2014
2013
$2,020m
$2,227m
$2,485m
Licensing and/or acquisition
opportunities helped us achieve
our 2016 target three years ahead of
schedule and contribute to meeting
our target of sustainable delivery of
two NMEs annually by 2020.
* Four for early-stage (Phase I/II)
opportunities, and three for late-stage
(Phase II+) opportunities.
CER growth
2015 +44%
2014 +70%
2013 +216%
Actual growth
2015 +30%
2014 +68%
2013 +218%
CER growth
2015 +26%
2014 +139%
2013 +75%
Actual growth
2015 +19%
2014 +138%
2013 +75%
CER growth
2015 +4%
2014 -3%
2013 +4%
Actual growth
2015 -9%
2014 -10%
2013 -14%
Growth was underpinned by
recently-extended US label and positive
CHMP opinion. Sales in the US and EU
increased by 64% and 18% respectively
and Emerging Market growth also
continued, most notably in China.
Growth of 26% delivered, including
76% in Emerging Markets. Farxiga/
Forxiga grew by 137% to $492 million,
with both US and EU growing strongly.
Growth in sales of 4% driven by
strong performance of Nexium,
Crestor, Symbicort and the Diabetes
franchise, offsetting the headwinds
from generic competition.
NME Phase II starts/
NME and major LCM regional
progressions
approvals
Emerging Markets
Respiratory
New Oncology
$5,822m
sales
$4,987m
sales
$119m
sales
2015
2014
2013
$5,822m
$5,827m
$5,389m
2015
2014
2013
$4,987m
$5,063m
$4,677m
2015
2014
2013
$119m
N/A
N/A
CER growth
2015 +12%
2014 +12%
2013 +8%
Actual growth
2015 0%
2014 +8%
2013 +6%
CER growth
2015 +7%
2014 +10%
2013 +7%
Actual growth
2015 -2%
2014 +8%
2013 +6%
New Oncology is included for the first
time (comprising Lynparza, Iressa
(US) and Tagrisso).
Contributions to growth of 12% were
generated from across the region.
Around 60% of Emerging Markets
sales were derived outside China.
Growth of 7% was driven primarily by
the performance of Pulmicort Respules
in Emerging Markets, where Pulmicort
sales grew by 35%.
Anifrolumab; AZD9291 + durvalumab;
Brilinta PEGASUS (US, EU, Japan);
PT010; durvalumab + tremelimumab
CAZ AVI (EU); Tagrisso (AZD9291)
(NSCLC); durvalumab + tremelimumab
(US, EU, Japan); cediranib (EU);
(bladder and head and neck); AZD9291
saxagliptin/dapagliflozin (EU); PT003
adjuvant.
(US); brodalumab (US, EU).
12
6
9
3
2015
2014
2013
6
2015
2014
2013
11
13
13
12
6
3
6
12
3
6
2015
2014
2013
11
2015
2014
2013
MEDI8897; MEDI-551; MEDI7510;
Bydureon Dual Pen (Japan); Iressa
AZD3241; AZD9412; AZD7594;
AZD5069; AZD9150; AZD3759;
MEDI6012; MEDI8852.
(US); Brilinta (US for treatment of
history of heart attack); Tagrisso
(AZD9291) (US); Zurampic (US);
Faslodex 500mg (China).
Therapy Area Review from page 24
Sales and Marketing from page 48 and Geographical Review from page 227
AstraZeneca Annual Report and Form 20-F Information 2015
19
Strategic Report Strategic Report Strategy
Key performance indicators continued
Be a great place to work
Organisational structure –
percentage of employees within six
management steps of the CEO
Employee belief in our strategy
Employees who would recommend
AstraZeneca as a great place to work
71%
2015
2014
2013
89%
83%
71%
75%
70%
2015
2014
2013
89%1
86%2
84%3
2015
2014
2013
83%1
82%2
N/A
This is a key indicator of our progress
in driving accountability and
improving decision making
and communication.
This is a key indicator of employee
engagement.
This is a key indicator of whether
employees believe AstraZeneca is
a great place to work.
1 Source: January 2016 pulse survey across a
1 Source: January 2016 pulse survey across a
sample of the organisation.
sample of the organisation.
2 Source: Global FOCUS all-employee survey.
3 Source: January 2014 pulse survey across a
sample of the organisation.
2 Source: Global FOCUS all-employee survey.
Employees from page 52
Do business sustainably
Dow Jones Sustainability
Index ranking
Confirmed breaches of external
sales and marketing codes or
regulations globally
Operational carbon footprint1
11confirmed breaches
704 kt CO2e
Top 5%
of companies
2015
2014
2013
Screening, diagnosis and
treatment of hypertension as
part of Healthy Heart Africa
programme
1 million
patients
84%
79%
85%
2015
2014
2013
11
6
11
2015
2014
2013
704 kt CO2e
735 kt CO2e
704 kt CO2e
2015
2014
2013
1m
N/A
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 84%.
Continue to report and learn from
confirmed breaches of external codes
arising from external scrutiny and
voluntary disclosure by AstraZeneca.
Our 2015 operational carbon footprint
met our target emission of 714 kt CO2e
and represents a 21.2% reduction from
our 2010 baseline. Our overall target of
a 20% reduction from a 2010 baseline
of 893 kt CO2e by the end of 2015 has
been achieved.
In our first full year of Healthy Heart
Africa, we exceeded our 2015 target
by screening one million patients in
Kenya for hypertension during
demonstration projects.
Sustainability from page 55
1 Operational carbon footprint is emissions
from all sources, excluding those from
patient use of our inhalers.
20
AstraZeneca Annual Report and Form 20-F Information 2015
Risk overview
What may challenge the delivery of our strategic priorities.
Oversight and monitoring
Board: defines the Group’s risk appetite,
which enables the Group, in both
quantitative and qualitative terms,
to judge the level of risk it is prepared
to take in achieving its overall objectives.
SET: responsible for overseeing and
monitoring the effectiveness of the risk
management processes implemented
by management.
Management: 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.
Managing risk
As a global, science-led biopharmaceutical
business, we face a diverse range of
risks and uncertainties. These could
adversely affect our business. Our
approach to risk management is therefore
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.
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 robust
processes and clear accountabilities, as
described below, provide it with adequate
information on the Principal Risks and
uncertainties we face.
Risk management embedded in
business processes
We strive to embed sound risk management
in our strategy, planning, budgeting and
performance management processes.
The Board has defined the Group’s risk
appetite, expressing 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.
Annually, the Group develops a long-term
business plan to support the delivery of its
strategy. The Board reviews this to ensure
that the plan conforms to its risk appetite.
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.
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 that is shared
with the Board, Audit Committee and SET.
Quarterly, each SET function identifies any
changes to these risks, its mitigation plans
and new and emerging risks. The quarterly
updates 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.
We also develop 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 2018 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-term strategic plan
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
captures risks to the sales and cost
forecasts at a market and SET function level
and 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
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.
AstraZeneca Annual Report and Form 20-F Information 2015
21
Strategic Report Strategic Report Strategy
Risk overview continued
Principal Risks
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.
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 significant financial, R&D and other resources.
A project may fail or be delayed at any stage of the process due to a number
of factors, which could reduce our long-term growth, revenue and profit
Meet quality, regulatory and
ethical drug approval and
disclosure requirements
Secure and protect product IP
Commercialisation
Delays in regulatory reviews and approvals impact patients and market access,
and can materially affect our business or financial results
Discovering and developing medicines requires a significant investment of resources.
For this to be a viable investment, through generation of sufficient revenues, new
medicines must be safeguarded from being copied with a reasonable amount
of certainty for a reasonable amount of time
Management actions
Trend versus prior year
Link to strategy
> Prioritise and accelerate our pipeline
> Strengthen pipeline through acquisitions, licensing and collaborations
> Focus on innovative science in three therapy areas
Increasing importance of pipeline
contribution given loss of exclusivity
on key brands
> 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
Trend key
Increasing risk
Decreasing risk
Unchanged
Externally driven demand,
pricing, access and competitive
pressures
Operating in over 100 countries, we are subject to political, socio-economic and
financial factors both globally and in individual countries. There can be additional
pressure from governments and other healthcare payers on medicine prices and sales
in response to recessionary pressures, reducing our revenue, profits and cash flow
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
> Focus on Growth Platforms
> Demonstrating value of medicines/health economics
> Global footprint
> Diversified portfolio
> Focus on Growth Platforms
and alliances
> Accelerate through business development and strategic collaborations
Global economic conditions placing
downwards pressure on healthcare
spending and therefore revenue
Loss of exclusivity on key brands
increases challenge to achieve our
short- to medium-term targets
Supply chain and business execution
Strategy key
Maintain supply of compliant,
quality product
Delays or interruptions in supply can lead to recalls, product shortages, regulatory
action, reputational harm and lost sales
Achieve scientific leadership
Return to growth
Be a great place to work
Achieve Group financial targets
Information technology and
data security and privacy
Significant disruption to our IT systems, including breaches of data security or
failure to integrate new systems, could harm our reputation and materially affect
our financial condition or results of 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 medium term. Failure to engage our employees could
impact productivity and turnover. Both could adversely affect the achievement of our
strategic objectives
Legal, regulatory and compliance
Safety and efficacy of marketed
products
Patient safety is very important to us and we strive to minimise the risks and
maximise the benefits of our medicines. Failure to do this could adversely impact
our reputation, our business and the results of operations, and could lead to product
liability claims
Defence of product, pricing and
practices litigation
Investigations or legal proceedings could be costly, divert management attention
or damage our reputation and demand for our products. Unfavourable resolutions
could subject us to criminal liability, fines or penalties, adversely affecting our
financial results
Meet regulatory and ethical
expectations on commercial
practices and scientific
exchanges
Economic and financial
Achieve strategic plans and
meet targets and expectations
Further information on our key
risk management and assurance
processes can be found in Risk
from pages 212 to 226 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
22
AstraZeneca Annual Report and Form 20-F Information 2015
Any failure to comply with applicable laws, rules and regulations may result in civil
and/or criminal legal proceedings and/or regulatory sanctions, fines or penalties,
impacting financial results
> Strong ethical and compliance culture
> Established compliance framework in place including annual Code of Conduct training
for all employees
Failure to successfully implement our business strategy may frustrate the
achievement of our financial or other targets or expectations. This failure could,
in turn, damage our reputation and materially affect our business, financial
position or results of operations
> Focus on Growth Platforms
> Focus on innovative science in three therapy areas
> Strengthen pipeline through acquisitions, licensing and collaborations
> Appropriate capital structure and balance sheet
> Portfolio-driven decision making process governed by committees
Increasing government and regulatory
scrutiny and evolving compliance
challenges as complexity of business
relationships increases
Increasing requirement to balance long-
and short-term investments as we
navigate a period of loss of exclusivity
on key brands
> Business continuity and resilience initiatives, disaster and data recovery
Supply chain evolving to incorporate
new supply chains and to support
> Contingency plans including dual sourcing, multiple suppliers and stock levels
product launches
and emergency response plans
> Quality management systems
> Disaster and data recovery plans
> Strategies to secure critical systems and processes
> Appropriate project governance structure and oversight
> Regular review of strategic initiatives by appropriate senior executive and Board
Ongoing restructuring and footprint
projects including Cambridge relocation
Several key transformational
programmes involving large IT-related
aspects
in the UK
in the UK
Ongoing restructuring and footprint
projects including Cambridge relocation
level committees
> Evolve our culture
> Focus on simplification
> Development of our employees
> Robust processes and systems in place to manage patient safety and efficacy trends as
well as externally reported risks through regulatory agencies and other parties. This
includes a comprehensive pharmacovigilance programme supplemented by close
monitoring and review of adverse events
> Combined internal and external counsel management
Risk category and Principal Risks
Context/potential impact
Product pipeline and intellectual property
Management actions
Trend versus prior year
Link to strategy
Delivery of pipeline and new
The development of any pharmaceutical product candidate is a complex, risky
products
and lengthy process involving significant financial, R&D and other resources.
A project may fail or be delayed at any stage of the process due to a number
of factors, which could reduce our long-term growth, revenue and profit
> Prioritise and accelerate our pipeline
> Strengthen pipeline through acquisitions, licensing and collaborations
> Focus on innovative science in three therapy areas
Increasing importance of pipeline
contribution given loss of exclusivity
on key brands
Meet quality, regulatory and
Delays in regulatory reviews and approvals impact patients and market access,
and can materially affect our business or financial results
ethical drug approval and
disclosure requirements
> 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
Secure and protect product IP
Discovering and developing medicines requires a significant investment of resources.
> Active management of IP rights
For this to be a viable investment, through generation of sufficient revenues, new
medicines must be safeguarded from being copied with a reasonable amount
of certainty for a reasonable amount of time
Commercialisation
Externally driven demand,
Operating in over 100 countries, we are subject to political, socio-economic and
pricing, access and competitive
financial factors both globally and in individual countries. There can be additional
pressures
pressure from governments and other healthcare payers on medicine prices and sales
in response to recessionary pressures, reducing our revenue, profits and cash flow
> Focus on Growth Platforms
> Demonstrating value of medicines/health economics
> Global footprint
> Diversified portfolio
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
> Focus on Growth Platforms
> Accelerate through business development and strategic collaborations
recoup the costs in launching it
and alliances
Supply chain and business execution
quality product
action, reputational harm and lost sales
Maintain supply of compliant,
Delays or interruptions in supply can lead to recalls, product shortages, regulatory
> Business continuity and resilience initiatives, disaster and data recovery
and emergency response plans
> Contingency plans including dual sourcing, multiple suppliers and stock levels
> Quality management systems
Information technology and
Significant disruption to our IT systems, including breaches of data security or
data security and privacy
failure to integrate new systems, could harm our reputation and materially affect
> Disaster and data recovery plans
> Strategies to secure critical systems and processes
our financial condition or results of 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.
> Appropriate project governance structure and oversight
> Regular review of strategic initiatives by appropriate senior executive and Board
All could adversely impact the value of the initiative
Attract, develop, engage and
Failure to attract and retain highly skilled personnel may weaken our succession
retain talented and capable
plans for critical positions in the medium term. Failure to engage our employees could
employees at all levels
impact productivity and turnover. Both could adversely affect the achievement of our
level committees
> Evolve our culture
> Focus on simplification
> Development of our employees
Global economic conditions placing
downwards pressure on healthcare
spending and therefore revenue
Loss of exclusivity on key brands
increases challenge to achieve our
short- to medium-term targets
Supply chain evolving to incorporate
new supply chains and to support
product launches
Several key transformational
programmes involving large IT-related
aspects
Ongoing restructuring and footprint
projects including Cambridge relocation
in the UK
Ongoing restructuring and footprint
projects including Cambridge relocation
in the UK
Legal, regulatory and compliance
strategic objectives
Safety and efficacy of marketed
Patient safety is very important to us and we strive to minimise the risks and
products
maximise the benefits of our medicines. Failure to do this could adversely impact
our reputation, our business and the results of operations, and could lead to product
Defence of product, pricing and
Investigations or legal proceedings could be costly, divert management attention
practices litigation
or damage our reputation and demand for our products. Unfavourable resolutions
could subject us to criminal liability, fines or penalties, adversely affecting our
liability claims
financial results
> Robust processes and systems in place to manage patient safety and efficacy trends as
well as externally reported risks through regulatory agencies and other parties. This
includes a comprehensive pharmacovigilance programme supplemented by close
monitoring and review of adverse events
> Combined internal and external counsel management
Meet regulatory and ethical
Any failure to comply with applicable laws, rules and regulations may result in civil
expectations on commercial
and/or criminal legal proceedings and/or regulatory sanctions, fines or penalties,
> Strong ethical and compliance culture
> Established compliance framework in place including annual Code of Conduct training
for all employees
practices and scientific
impacting financial results
exchanges
Economic and financial
Achieve strategic plans and
Failure to successfully implement our business strategy may frustrate the
meet targets and expectations
achievement of our financial or other targets or expectations. This failure could,
in turn, damage our reputation and materially affect our business, financial
position or results of operations
> Focus on Growth Platforms
> Focus on innovative science in three therapy areas
> Strengthen pipeline through acquisitions, licensing and collaborations
> Appropriate capital structure and balance sheet
> Portfolio-driven decision making process governed by committees
Increasing government and regulatory
scrutiny and evolving compliance
challenges as complexity of business
relationships increases
Increasing requirement 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 2015
23
Strategic Report
Strategic Report Therapy Area Review
Pipeline and Therapy Area Introduction
Our business model describes how we create and sustain value over the life-cycle
of a medicine across our therapy areas. In this section, we review our therapy areas,
including our portfolio of marketed products, pipeline projects, strategic priorities,
capabilities, resources and business development activities.
Overview
As outlined in Strategic priorities from page
16, a key element of our drive to achieve
scientific leadership is our focus on
innovative science in three therapy areas:
Respiratory, Inflammation and Autoimmunity
(RIA); Cardiovascular and Metabolic
diseases (CVMD); and Oncology. We
apply our distinctive capabilities to small
molecules, biologics, immunotherapies,
protein engineering technologies and
delivery devices across these therapy
areas. Our goal is to deliver life-changing
medicines to patients while creating value
for shareholders. Our approach to Infection,
Neuroscience and Gastrointestinal (ING)
is opportunity-driven.
Our Global Product and Portfolio Strategy
group (GPPS) leads our therapy area
Key pipeline
progressions
Phase III NME
starts
Product
Achievement
anifrolumab
Phase III programme commenced for systemic lupus
erythematosus
PT010
Phase III programme commenced for COPD
Expedited review
Brilinta
FDA granted Priority Review for PEGASUS
Tagrisso
(AZD9291)
anifrolumab
FDA and PMDA granted Priority Review. EMA accelerated
assessment
FDA granted Fast Track status for systemic lupus
erythematosus
durvalumab
FDA granted Fast Track status for head and neck cancer
tremelimumab
FDA granted Fast Track status for mesothelioma
Regulatory filings
Brilinta
cediranib
PT003
Tagrisso
(AZD9291)
CAZ AVI
saxagliptin/
dapagliflozin FDC
Regulatory submissions accepted in US, EU and Japan for
Brilinta to reduce the rate of cardiovascular death, myocardial
infarction (MI) and stroke in patients with acute coronary
syndrome or a history of MI
MAA accepted by EMA for treatment of recurrent platinum-
sensitive ovarian cancer
NDA accepted by FDA for treatment of COPD
Regulatory submission accepted by the FDA, EMA and PMDA
for treatment of 2nd line or greater EGFRm T790M NSCLC
MAA accepted by EMA for treatment of serious bacterial
infection, including complicated intra-abdominal infection and
complicated urinary tract infection
MAA accepted by EMA for treatment of Type 2 diabetes
Regional
approvals
brodalumab
Regulatory submission accepted by EMA and FDA for psoriasis
Bydureon Pen
Japanese regulatory approval for treatment of Type 2 diabetes
Iressa
Brilinta
Tagrisso
(AZD9291)
Zurampic
(lesinurad)
US regulatory approval for treatment of EGFRm NSCLC
Regulatory approval in US for Brilinta to reduce the rate of
cardiovascular death, MI and stroke in patients with acute
coronary syndrome or a history of MI
Regulatory approval in US for treatment of 2nd line or greater
EGFRm T790M NSCLC; CHMP issues Positive Opinion to EMA
and EU approval received in February 2016
Regulatory approval in US; CHMP issues Positive Opinion
to EMA
Faslodex 500mg
Regulatory approval in China for breast cancer
Discontinued
projects
20 projects discontinued
24
AstraZeneca Annual Report and Form 20-F Information 2015
activities. GPPS also serves as the bridge
between our R&D and Sales and Marketing
functions and works to provide strategic
direction from early-stage research to
commercialisation. It also helps us to
integrate our corporate, portfolio, therapy
area and product strategies. This, in turn,
drives scientific innovation, prioritises
investment, supports the growth of our
therapy areas, and accelerates business
development. GPPS also works closely with
healthcare providers, regulatory authorities
and payers to ensure our medicines help
to fulfil unmet medical need and provide
economic as well as therapeutic benefits.
Putting patients first
In keeping with our value of putting patients
first, we formed a Patient Centricity team in
2015 to better connect patients with our
science and to help ensure we deliver
medicines they value. In 2015, we connected
with more than 30,000 patients through our
new alliance with PatientsLikeMe, a virtual
patient community, and are exploring similar
partnerships with other organisations to
ensure we understand our patients’
requirements better.
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 more information on our potential
new products and product life-cycle
developments, please see the therapy
area pipeline tables on pages 26, 30, 34
to 35, and 39 and the Development Pipeline
table from page 205. For information on
patent expiries of our key marketed
products, please see Patent Expiries
from page 210.
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 overview
Our pipeline includes 146 projects of which 125 are in the clinical phase of development.
Phase I
44
Phase II
33
Late-stage development
LCM projects
35
34
> 44 projects in Phase I including:
> 33 projects in Phase II,
> 35 projects in late-stage
> 34 LCM projects*
– 34 NMEs
– 3 significant additional
indications for projects that
have reached Phase III
– 7 oncology combination projects
including:
– 26 NMEs
– 5 significant additional
indications for projects that
have reached Phase III
– 2 oncology combination
projects
development, either in Phase
III/pivotal Phase II studies or
under regulatory review:
– 15 NMEs
– 13 projects exploring
additional indications for
these NMEs
– 6 projects already approved
or launched in the EU,
China, Japan and/or the US
– MEDI-550 pandemic
influenza vaccine pending
acceptance of regulatory
submission
* Only includes material projects.
For those of our products subject to
litigation, information about material legal
proceedings can be found in Note 27 to
the Financial Statements from page 186.
Details of relevant risks are set out in
Risk from page 212
Development pipeline
The Development pipeline overview above
summarises our development pipeline as at
31 December 2015.
We continue to maintain a clinical portfolio
of more than 100 projects, and are making
significant progress in advancing our
late-stage programmes through regulatory
approval. The portfolio has reached a
steady state, with new project starts and
progressions netted out against project
termination and rationalisation decisions.
Twenty projects were discontinued in
2015, 11 for poorer than anticipated safety
and efficacy results, eight as a result of
strategic shift in the environment or portfolio
prioritisation, and one because of a change
in regulatory requirements.
During 2015, 18 NMEs progressed to their
next phase of development. We also started
a number of oncology trials during the
course of the year, of which 12 were
oncology combination trials. Importantly,
many of our late-stage programmes
achieved key milestones, with 12 NME or
major LCM regulatory submissions within
the year, and six major approvals. Expedited
regulatory reviews indicate the degree of
medical need that many of these
programmes aim to address.
Progress against targets
We remain on track to meet the pipeline
aspirations that we have previously
communicated for the period from 2013
to the end of 2016: 12 to 16 Phase II starts;
14 to 16 NME and line extension regulatory
submissions; and eight to 10 NME and line
extension regulatory approvals. Moreover,
we had 15 NME projects in pivotal studies
or under regulatory review at the end of
2015, versus 13 at the end of 2014. This
demonstrates the sustainability of our
pipeline and our ability to deliver new
medicines to patients.
For more information on the risks associated
with biologics and our products, please see Risk
from page 212
Global Product Sales by therapy area
Cardiovascular and Metabolic diseases
Oncology
Respiratory, Inflammation and Autoimmunity
Infection, Neuroscience and Gastrointestinal
Total
Actual
growth
%
2015
CER
growth
%
(3)
(7)
(2)
(23)
(9)
4
7
7
(16)
(1)
Sales
$m
9,489
2,825
4,987
6,340
23,641
Sales
$m
9,802
3,027
5,063
8,203
26,095
Actual
growth
%
2014
CER
growth
%
11
(5)
8
(9)
1
12
(2)
10
(7)
3
Sales
$m
8,830
3,193
4,677
9,011
25,711
Actual
growth
%
(7)
(9)
6
(14)
(8)
2013
CER
growth
%
(6)
(2)
7
(13)
(6)
AstraZeneca Annual Report and Form 20-F Information 2015
25
Strategic Report Strategic Report Therapy Area Review
Therapy area world market
(MAT/Q3/15)
$102.0bn
Annual worldwide market value
Respiratory
Asthma $21.6bn
Chronic obstructive
pulmonary disease
(COPD) $16.0bn
Idiopathic
pulmonary
fibrosis (IPF) $0.2bn
Other $24.2bn
Inflammation
and Autoimmunity
Gout $1.3bn
Psoriasis $6.6bn
Psoriatic arthritis
$4.7bn
Rheumatoid arthritis
$18.9bn
Systemic lupus
erythematosus
(SLE) $1.1bn
IBD $7.4bn
Respiratory, Inflammation
and Autoimmunity
2015 was a year of robust performance and significant
pipeline evolution with inhaled therapies and biologics
for asthma and COPD. We also have promising assets
in the inflammatory and autoimmune disease areas.
Our strategic priorities
We have an industry-leading pipeline in
Respiratory, which is an important platform
for our return to growth. Our goal is to
establish a leading position in asthma and
COPD treatment, by delivering a range
of differentiated inhaled therapies, novel
combinations and devices, and biologics.
In Inflammation and Autoimmunity, we
aim to develop innovative, first- and
best-in-class therapies.
Asthma and COPD
Asthma is a common and chronic condition
that affects the lungs’ airways. Inflammation
and narrowing of the airways may cause
wheezing, breathlessness, chest tightness
and coughing. Asthma is a major cause of
chronic morbidity. Asthma that is not well
controlled by existing treatments remains
a significant unmet medical need.
Currently, fixed-dose combinations (FDCs)
of an inhaled corticosteroid (ICS) with
a long-acting beta2-agonist (LABA) such
as Symbicort help treat moderate-to-severe
asthma. We are exploring the use of
Symbicort dosed ‘as needed’ in mild
asthma patients. For specific patient groups,
including more severe, refractory patients
who experience severe or frequent
exacerbations and a reduced quality of life,
our effort is focused on developing targeted
biologic therapies. We are also placing
emphasis on better understanding patient
phenotypes to enable targeted therapies
and to go beyond symptom control.
COPD is a progressive and chronic disease.
It includes various lung conditions, such
as chronic bronchitis and emphysema.
Currently, medication has only a limited
impact on the course of COPD and the
prognosis for patients remains poor.
Respiratory, Inflammation and Autoimmunity
Phase I
Phase II
Phase III
Small molecule
Large molecule
Small molecule
Large molecule
Small molecule
lesinurad
+ allopurinol
AZD1419#
+
MEDI4920
— abediterol
— AZD9412#
➔ PT003 GFF
(COPD)
— MEDI5872#
— AZD7594
➔ mavrilimumab# — PT010
(COPD)
AZD7986
+ MEDI7836
+ AZD7624
— abrilumab#
— Zurampic (US)
AZD8871
AZD8999
AZD9567
+ anifrolumab#
(subcutaneous)
+
RDEA3170
— MEDI9929#
—
+
PT010
(asthma)
—
tralokinumab
(atopic dermatitis)
MEDI2070#
MEDI-551#
(neuromyelitis optica)
anifrolumab#
(lupus nephritis)
(gout)
—
+
—
➔
+
F
➔
Large molecule
brodalumab#
(psoriasis)
benralizumab#
(severe asthma)
benralizumab#
(COPD)
tralokinumab
(severe asthma)
anifrolumab#
(SLE)
LCM Projects
Small molecule
F
Duaklir Genuair
Symbicort
SYGMA
—
Symbicort
Breath Actuated Inhaler
—
—
—
—
➔
Key
+ Addition
— No change
➔ Progression
Approved/launched
# Partnered product
F New filing
26
AstraZeneca Annual Report and Form 20-F Information 2015
Pushing the
boundaries
For 40 years, AstraZeneca has pushed the
boundaries of science and helped millions of
patients with respiratory disease. Now in RIA,
we are advancing a pipeline of inhaled and
biologic treatments, drug combinations and
devices, and other therapies that aim to transform
disease management.
AstraZeneca is
developing a TLR-9
receptor agonist (shown
here) aimed at producing
long-term benefit in
asthma by addressing
imbalances in the
immune system that
may be an underlying
cause of the disease.
AstraZeneca Annual Report and Form 20-F Information 2015
27
Strategic Report Therapy Area Review
Respiratory, Inflammation
and Autoimmunity continued
Our marketed products
> Accolate (zafirlukast)
> Bricanyl Respules (terbutaline)
> Bricanyl Turbuhaler (terbutaline)1
> Daliresp/Daxas (roflumilast)
> Duaklir Genuair (aclidinium/formoterol)
> Eklira Genuair/Tudorza/Bretaris (aclidinium)1
> Oxis Turbuhaler (formoterol)1
> Pulmicort Turbuhaler/
Pulmicort Flexhaler (budesonide)
> Pulmicort Respules (budesonide)2
> Rhinocort (budesonide)
> Symbicort pMDI (budesonide/formoterol)
> Symbicort Turbuhaler (budesonide/formoterol)1
1 In a dry powder inhaler.
2 budesonide inhalation suspension.
Full product information on page 203
329m
The global prevalence of COPD is
estimated to be 329 million people and
WHO predicts that COPD will become
the third leading cause of death
worldwide by 2030.
Source: Vos et al 2012 WHO.
Values in action: Follow the science
Patients with SLE or lupus have only seen
one new treatment for their disease in almost
60 years and clinical development remains
challenging. With anifrolumab, we followed
the science behind the potential therapeutic
benefits of blocking the interferon pathway
as a new treatment strategy. Our Phase II
data confirmed this approach and the FDA
has granted the anifrolumab SLE
programme Fast Track designation.
The aim of COPD treatments is to reduce
symptoms and prevent exacerbations.
A class of FDCs of a long-acting muscarinic
antagonist (LAMA) and LABA, known
as LAMA/LABAs, is likely to become a
1st line therapy for symptomatic moderate-
to-severe COPD patients. For patients
who have either experienced or have a
high risk of experiencing exacerbations,
an ICS/LABA FDC such as Symbicort
is recommended.
Our 2015 focus
Our Symbicort products improve the health
of COPD and asthma patients by providing
rapid relief of symptoms and long-term
anti-inflammatory control. We continue
to invest in this brand and are exploring a
new indication in mild asthma through the
SYGMA trial programme, enhancing our
inhaled devices and patient support
programmes, and by expanding indications
such as the recently approved change to
the Symbicort Turbuhaler label in Europe
to include more moderate COPD patients.
Pulmicort is a leading ICS therapy for
asthma. Despite generic competition in
many Established Markets, sales continue
to grow, driven by Emerging Markets. More
information about litigation relating to
Pulmicort Respules can be found in Note 27
to the Financial Statements from page 186.
In 2015, we launched Duaklir Genuair (a
LAMA/LABA) for maintenance symptom
control in COPD patients. Our portfolio also
includes Eklira Genuair (aclidinium, a LAMA)
for patients with symptomatic mild-to-
moderate COPD. In February 2015, we
announced an agreement with Actavis
to acquire the rights to its branded
respiratory business in the US and Canada.
This included the rights to develop and
commercialise on-market products Tudorza
Pressair (aclidinium, a LAMA) and Daliresp
(a PDE4 inhibitor) for COPD. In December
2015, we announced that we had entered
into a definitive agreement to acquire the
core respiratory business of Takeda.
The deal includes the acquisition of non-US
rights to Daliresp, which is known as Daxas
in certain countries. The transaction is
anticipated to close in early 2016.
In the pipeline
We received positive results from
the Phase III PINNACLE programme
investigating the potential of PT003 to
improve lung function in patients with
COPD. PT003 is a twice-daily, fixed-dose
combination of glycopyrronium (a LAMA)
and formoterol fumarate (a LABA). PT003
is the first LAMA/LABA combination to be
delivered in a pressurised metered-dose
inhaler (pMDI), using the proprietary
porous particle co-suspension technology
developed by Pearl Therapeutics. We are
also developing PT010 as a twice-daily
triple combination LAMA/LABA/ICS
(composed of glycopyrronium, formoterol
and budesonide, a key component of
Symbicort) in a pMDI device for severe
COPD. It has progressed to Phase III in
COPD and may be one of the first products
to deliver the three therapeutic agents via
one inhaler.
Benralizumab is a biologic (MAb) in Phase III
development for the treatment of severe
uncontrolled asthma and COPD. It targets
the IL-5 receptor and depletes eosinophils,
which play a key role in inflammatory
respiratory disease. The global Phase III
results for benralizumab in severe asthma
are expected in 2016. We anticipate making
US and European regulatory submissions
later in 2016. Phase III results and regulatory
filing in COPD are expected in 2018.
Tralokinumab is a MAb that binds to IL-13.
Phase II data from tralokinumab suggest
that IL-13 neutralisation can 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 early 2017.
Inflammation and Autoimmunity
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
deposits of urate crystals) formation.
28
AstraZeneca Annual Report and Form 20-F Information 2015
Systemic lupus erythematosus (SLE), or
lupus, is an autoimmune disease. It occurs
when the immune system produces
antibodies that, instead of targeting viruses
or other foreign invaders, attack healthy
tissue in the body 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. Current treatment of
SLE focuses on suppressing symptoms and
controlling disease flares and, in the case of
lupus nephritis, preventing renal failure.
Although a biologic medicine was launched
for SLE in 2011, most therapies used are
off-label and significant unmet medical need
remains. Most emerging biologics are likely
to be used in combination with standard
therapies, such as corticosteroids and
immunosuppressants.
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 125
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.
Rheumatoid arthritis is currently treated with
generic disease-modifying anti-rheumatic
agents and, where appropriate, biologics.
There is a need for novel treatments, since
only about a third of patients treated with
biologics achieve their treatment goals.
Although tumour necrosis factor (TNF)
alpha-blockers are currently the primary
treatment for rheumatoid arthritis, use of
other biologic approaches is expected
to increase. Novel oral drugs targeting
intra-cellular signalling pathways may
provide anti-TNF-like levels of efficacy
and potentially more convenient dosing,
especially in patients who do not use
injectable biologics.
In the pipeline
We are strengthening our pipeline and
improving treatment options and clinical
outcomes for patients with inflammation
and autoimmunity diseases. Completion
of four Phase II trials (anifrolumab and
mavrilimumab, and two RDEA3170 trials
in Japan and the US), two Phase III trial
programmes (brodalumab and Zurampic)
along with the initiation of various Phase II
trials, demonstrates the success of our R&D
efforts to deliver new medicines quickly.
In December 2015, the FDA approved
Zurampic 200mg tablets in combination
with a xanthine oxidase inhibitor (XOI) for the
treatment of hyperuricemia associated with
gout in patients who have not achieved
target serum uric acid (sUA) levels with an
XOI alone. Also in December 2015, the
Committee for Medicinal Products for
Human Use (CHMP) of the EMA adopted
a Positive Opinion recommending the
marketing authorisation of Zurampic 200mg
tablets for the adjunctive treatment of
hyperuricemia in adult gout patients (with
or without tophi) who have not achieved
target sUA levels with an adequate dose
of an XOI alone.
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 sUA.
RDEA3170 is a potent selective uric acid
reabsorption inhibitor, also intended for use
as a combination urate-lowering therapy
with XOIs. RDEA3170 is our lead
investigational urate-lowering therapy (ULT)
in Asia and is entering Phase IIb in both
Japan and the US.
Anifrolumab is a developmental MAb that
targets the type I interferon (IFN) receptor
inhibiting the activity of all type I IFNs, which
play a central role in lupus. Phase II trial
results presented in November
demonstrated that anifrolumab significantly
reduced disease activity in moderate-to-
severe SLE patients as measured by several
300m
It is estimated that approximately
300 million people worldwide
suffer from asthma.
Source: Massoli et al, 2004.
SLE composite endpoints. It also improved
symptoms of lupus such as rash and
arthritis. Anifrolumab is currently in Phase III
development for SLE. A Phase II trial in
lupus nephritis and Phase I subcutaneous
administration study were initiated in late
2015. The FDA assigned anifrolumab Fast
Track designation for SLE, which facilitates
the development and expedites the review
process of medicine candidates that treat
serious conditions and fill an unmet medical
need. Sifalimumab is a developmental MAb
that specifically blocks the action of
interferon alpha. Driven by data from the
Phase II trials in SLE for both sifalimumab
and anifrolumab, we have progressed
anifrolumab into Phase III and therefore we
do not intend to further develop sifalimumab
in SLE.
Brodalumab is a human MAb that targets
the interleukin-17 (IL-17) receptor to treat
moderate-to-severe psoriasis. The Phase III
programme in psoriasis included three
studies evaluating treatment with
brodalumab, two of which compared
brodalumab with ustekinumab and/or
placebo. Results from all three clinical trials
showed that all primary and secondary
endpoints were met. Brodalumab showed
superiority to ustekinumab in both
comparative studies. In May 2015, Amgen
terminated its participation in the co-
development and commercialisation of
brodalumab. In September 2015, we
announced a collaboration agreement with
Valeant. This granted an exclusive licence
for Valeant, as an expert in dermatology, to
develop and commercialise brodalumab
globally except in Japan and certain Asian
countries. AstraZeneca submitted global
regulatory filings on behalf of Valeant for
brodalumab in psoriasis in late 2015.
Valeant assumes decision making on future
development and all development costs
associated with the regulatory approval
for brodalumab.
Mavrilimumab, an investigational MAb
that inhibits a key pathway in the
development of rheumatoid arthritis,
achieved its primary endpoints in a Phase
IIb study. Results, which were announced
in May 2014, showed that mavrilimumab
improved signs and symptoms of
rheumatoid arthritis, measures of disability
and patient-reported outcomes.
AstraZeneca Annual Report and Form 20-F Information 2015
29
Strategic Report Strategic Report Therapy Area Review
Cardiovascular
and Metabolic diseases
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.
Therapy area world market
(MAT/Q3/15)
$173.0bn
Annual worldwide market value
High blood pressure
$38.9bn
Abnormal levels of
blood cholesterol
$26.8bn
Diabetes $58.7bn
Thrombosis $8.8bn
Other $39.8bn
Our strategic priorities
Our strategy and focus is on bringing
life-changing medicines to patients to
reduce morbidity, mortality and organ
damage by addressing multiple risk
factors across cardiovascular (CV) disease,
including thrombosis (blood clotting),
atherosclerosis (hardening of the arteries),
dyslipidaemia (abnormal levels of blood
lipids), and hypertension, diabetes and
chronic kidney disease (CKD).
Despite improvements in the diagnosis and
treatment of CVMD, unmet medical need
remains high. The prevalence of these
diseases and associated complications
continues to increase worldwide.
We invest heavily in clinical development
and life-cycle management. Nearly 60,000
patients participate in our R&D-led CV trials
at more than 5,700 sites worldwide. We are
also concentrating on diabetes research,
which includes more than 50 clinical studies
worldwide with an enrolment target of nearly
40,000 patients.
disease and with Professor Doug Melton,
Harvard Stem Cell Institute, applying
revolutionary techniques transforming
human stem cells into beta cells that
secrete insulin.
We are expanding our core capabilities and
research programmes into new modalities
and regenerative medicine. Our aim is to
provide new treatment paradigms for heart
failure, diabetes and CKD. To help achieve
scientific leadership, we are engaging in
collaborations that focus on scientific
innovation in CVMD. For example, in 2015,
we entered into collaborations with the
French National Institute of Health and
Medical Research (Inserm) to investigate
new therapeutic approaches to Type 2
diabetes and CKD, with the University of
Michigan to advance the treatment of CKD
through the improved understanding of the
For information on our CV collaborations,
please see the Research and Development section
from pages 42 to 45
Cardiovascular disease
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.
Cardiovascular and Metabolic diseases (CVMD)
Phase I
Phase II
Phase III
Applications
under review
LCM projects
Small molecule
Large molecule
Large molecule
Small molecule
Small molecule
AZD4076
+ MEDI8111
— MEDI6012
➔ Brilinta/Brilique — ZS-9
+ Brilinta/Brilique —
EUCLID
Farxiga/Forxiga* —
DECLARE-TIMI 58
MEDI0382
MEDI4166
+
+
Epanova#
(approved but not
launched)
Farxiga/Forxiga* —
roxadustat#
—
Key
+ Addition
— No change
➔ Progression
Approved/launched
F New filing
# Partnered product
*
Farxiga in the US; Forxiga
in the rest of the world
** Kombiglyze XR in the US;
Komboglyze in the EU
30
AstraZeneca Annual Report and Form 20-F Information 2015
Brilinta/Brilique F
PEGASUS-TIMI 54
Farxiga/Forxiga* —
Type 1 diabetes
Brilinta/Brilique —
SOCRATES
Kombiglyze XR/ —
Komboglyze**
Brilinta/Brilique —
THEMIS
Onglyza
SAVOR-TIMI 53
Brilinta/Brilique
HESTIA
+
saxagliptin/
dapagliflozin FDC
Bydureon
EXSCEL
—
Xigduo XR/
Xigduo
—
F
—
Bydureon
Dual Chamber Pen
Bydureon
weekly suspension
Epanova
STRENGTH
—
—
Breaking through
conventional
thinking
Because we know that cardiovascular
disease (CVD) is a well-known
consequence of diabetes and chronic
kidney disease (CKD), AstraZeneca
takes an integrated patient approach
and seeks to further reduce
cardiovascular (CV) morbidity and
mortality, and organ damage by
addressing multiple CV risk factors.
Pancreatic beta cells at different
stages of regeneration: AstraZeneca
is investing in research that could
stimulate the regeneration of beta
cells in the pancreas with the aim
of stopping the progression of, or
reversing, the course of diabetes.
AstraZeneca Annual Report and Form 20-F Information 2015
31
Strategic Report Therapy Area Review
Cardiovascular
and Metabolic diseases continued
Our marketed products
Cardiovascular disease
> Atacand1/Atacand HCT/Atacand Plus
(candesartan cilexetil)
> Brilinta/Brilique (ticagrelor)
> Crestor 2 (rosuvastatin calcium)
> Plendil (felodipine)
> Seloken/Toprol-XL (metoprolol succinate)
> Tenormin3 (atenolol)
> Zestril4 (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)
> Symlin (pramlintide acetate)
> Xigduo (dapagliflozin and metformin HCI)
> Xigduo XR (dapagliflozin and metformin HCI)
Full product information on page 203
1 Licensed from Takeda Chemicals Industries Ltd.
2 Licensed from Shionogi. The extension of the global
licence agreement with Shionogi for Crestor and the
modification of the royalty structure became effective
1 January 2014.
3 Divested US rights to Tenormin to Alvogen Pharma
US Inc. effective 9 January 2015.
4 Licensed from Merck. Divested US rights to Zestril to
Alvogen Pharma US Inc. effective 9 January 2015.
Values in action: We play to win
Acquiring ZS Pharma gave us access to the
potassium-binding compound ZS-9,
a potential best-in-class treatment for
hyperkalaemia (high potassium levels)
which affects more than three million people
in the US alone who suffer from chronic
kidney disease and chronic heart disease.
With submissions under way, we expect
ZS-9 to accelerate our return to growth.
Our 2015 focus
Brilinta/Brilique, one of our Growth Platforms,
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. It is
currently under regulatory review in three
additional countries. Since launch, more
than one million patients have been treated
with Brilinta/Brilique, and it has been
included in 12 major ACS treatment
guidelines globally. In August 2015, the
European Society of Cardiology updated
NSTE-ACS guidelines and continued to
recommend ticagrelor over clopidogrel in
ACS for all patients at moderate-to-high
risk of ischaemic events, regardless of initial
treatment strategy and including those
pre-treated with clopidogrel.
The PEGASUS-TIMI 54 study investigated
the efficacy and safety of ticagrelor at both
60mg and 90mg twice daily, plus low-dose
aspirin, compared to placebo plus low-dose
aspirin, for the long-term prevention of
atherothrombotic events in patients who
had suffered a heart attack one to three
years prior to study enrolment. Both 90mg
and 60mg study doses of ticagrelor with
aspirin significantly reduced the primary
composite endpoint of CV death, myocardial
infarction (MI, also known as heart attack)
or stroke compared to placebo and aspirin.
The full results of the study were published
in the New England Journal of Medicine
in March 2015.
In September 2015, the FDA approved a
new 60mg dosage strength for Brilinta
to be used in patients with a history of heart
attack beyond the initial one-year treatment
with Brilinta 90mg to reduce the rate of
cardiovascular death, MI and stroke in
patients with ACS. In December, CHMP
of the EMA adopted a Positive Opinion
recommending approval of Brilique 60mg
for the treatment of patients with a history
of heart attack and at high risk of having a
further coronary event. The opinion states
that treatment may be started as continuation
therapy after an initial one-year treatment
with dual anti-platelet therapy. In the US, we
are in early stages of patent litigation against
multiple generic companies after they sent
so-called ‘Paragraph IV notices’ challenging
patents listed in the FDA Orange Book with
reference to Brilinta.
The SOCRATES trial evaluating the efficacy
of Brilinta/Brilique compared to aspirin in
reducing thrombotic events in patients with
acute ischaemic stroke and high-risk
transient ischaemic attack, saw its last
patient randomised in November 2015. This
trial is scheduled to report data in the first half
of 2016. SOCRATES involves 13,200 patients
in 33 countries and is part of the broader
PARTHENON life-cycle programme for
Brilinta/Brilique (discussed further overleaf).
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 existing
paediatric exclusivity period expires
on 8 July 2016. Subsequently, generic
competition from various companies
is expected in the US market. Actavis
is permitted to begin selling generic
rosuvastatin in the US in May 2016 as
the result of a litigation settlement with
AstraZeneca. Patents protecting Crestor
have been challenged in various
jurisdictions. Details of these matters
are included in Note 27 to the Financial
Statements, from page 186.
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
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.*
415 million people worldwide have diabetes;
WHO projects that diabetes will be the
seventh leading cause of death in 2030.**
* Source: WHO Factsheet 2015 (data from 2012).
** Source: IDF Atlas 2015 and WHO Factsheet 2015.
32
AstraZeneca Annual Report and Form 20-F Information 2015
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).
Clinical studies
In addition to the PEGASUS and SOCRATES
trial described above, Brilinta/Brilique is
being studied in two other clinical trails
under the PARTHENON programme.
PARTHENON is AstraZeneca’s largest ever
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.
AstraZeneca continues to explore the unmet
medical need in cholesterol management,
building on the well-established clinical trial
programme for Crestor. Crestor has been
studied in more than 120 ongoing or
completed clinical trials and involving more
than 67,000 patients worldwide over the
past 13 years.
We are also committed to further evaluating
the clinical profile of Epanova and identifying
other patient groups it may benefit.
AstraZeneca recently commenced a
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 cardiovascular 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.
Our 2015 focus
AstraZeneca is focused on redefining the
Type 2 diabetes treatment approach and
harnessing complementary mechanisms
of action, as well as evaluating potential
cardiovascular outcomes benefit. Our
current portfolio is well-positioned to enable
combination treatment, and data from our
Phase III programmes is expected to further
support the outcomes benefits of the
new class.
We have a broad anti-diabetes portfolio
with products in the three fastest growing
classes of diabetes treatments (SGLT2,
GLP-1 and DPP-4).
In 2015, 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
50 countries. It is under regulatory review
in 20 additional countries.
Xigduo is approved in 33 countries,
including the US with Xigduo XR (ongoing
approvals in 2016 expected). In 2015, we
continued to see the approval and launch of
the Bydureon Pen, which is now launched
in 17 countries globally, 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
after they sent so-called ‘Paragraph IV
notices’ challenging patents listed in the FDA
Orange Book with reference to Onglyza. A
trial is scheduled to take place during 2016.
In April 2015, an FDA Endocrinologic and
Metabolic Drugs Advisory Committee voted
13 to one that the results of the Saxagliptin
Assessment of Vascular Outcomes
Recorded in Patients with Diabetes Mellitus
(SAVOR) study demonstrated that the use of
saxagliptin in patients with Type 2 diabetes
has an acceptable cardiovascular risk
profile. AstraZeneca will conduct further
investigation to better understand the signal
of hospitalisation for heart failure found in
the SAVOR results.
In the pipeline
We are developing an FDC of saxagliptin
and dapagliflozin, which combines two
complementary mechanisms designed to
help more patients with Type 2 diabetes
reach their treatment goals. In October 2015,
AstraZeneca received a Complete Response
Letter (CRL) from the FDA regarding the
NDA for the investigational FDC of saxagliptin
and dapagliflozin for the treatment of adult
patients with Type 2 diabetes. The CRL
states that more clinical data are required
to support the application. We are working
closely with the FDA to determine the
appropriate next steps for the NDA and
remain committed to the development of
saxagliptin and dapagliflozin. We will file
additional clinical data from a study which
is now completed and continue our
conversations with the FDA.
This announcement does not affect
interactions with other health authorities as
part of these application procedures for the
FDC, including an ongoing review by the EU
for the FDC.
The Phase III programme for a once-weekly
suspension of Bydureon continues
to progress.
Through our strategic collaboration with
FibroGen and Astellas, we continue to
develop roxadustat, a potential first-in-class
oral compound 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
and China, and is just completing Phase II
in Japan. The Phase III programme consists
of seven 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.
In December 2015, we acquired ZS Pharma
to strengthen our CVMD portfolio. This
provided us access to ZS-9, a potential
best-in-class treatment for hyperkalaemia
which complements our increasing focus on
CKD. ZS-9 has been submitted for approval
in the US, EU and Australia. In November
2015, data presented at the American
Society of Nephrology meeting showed
positive interim results from ZS005,
a long-term safety study of ZS-9.
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 anti-diabetes
therapy, continued in 2015.
The trial will enrol approximately 17,000 adult
patients with Type 2 diabetes. DECLARE
was fully enrolled in 2015 and is expected
to be completed in 2019.
The Exenatide Study of Cardiovascular
Event Lowering (EXSCEL) study also
continued during 2015. This study, which
began in 2010 and is expected to end in
2017 is evaluating the impact of Bydureon,
in addition to usual care on CV outcomes
in patients with Type 2 diabetes.
AstraZeneca Annual Report and Form 20-F Information 2015
33
Strategic Report Strategic Report Therapy Area Review
Therapy area world market
(MAT/Q3/15)
$72.2bn
Annual worldwide market value
Chemotherapy
$19.2bn
Hormonal therapies
$10.0bn
Monoclonal
antibodies (MAbs)
$22.4bn
Small molecule
tyrosine kinase
inhibitors (TKIs)
$18.6bn
Immunotherapies
$2.0bn
Oncology
Our combination-focused pipeline exploits the power
of four scientific platforms, and we are driven by an
ambition to help eliminate cancer as a cause of death
through scientific discovery and collaborations.
Our strategic priorities
For more than 40 years we have developed
cancer drugs. Many of these have increased
survival rates for patients around the world.
Significant unmet medical need remains for
therapies that increase survival, cure rates
and time to recurrence. Our vision is to help
meet this need by redefining the cancer
treatment paradigm. We are doing this
through scientific innovation, accelerated
clinical programmes and collaboration.
Several submissions are under way and we
aim to deliver at least four new cancer
therapies 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
approaches: immunotherapy, tumour drivers
and resistance mechanisms, DNA damage
repair, and antibody-drug conjugates.
Oncology
Phase I
Small molecule
Large molecule
AZD0156
+ MEDI0562#
Combination
molecules
+ Tagrisso
(AZD9291)
combination
TATTON
Phase II
Small molecule
Large molecule
Combination
molecules
—
AZD1775#
— MEDI-551#
— AZD5069
+ durvalumab#
AZD9150#
+ durvalumab#
— durvalumab#
+ tremelimumab
(gastric cancer)
AZD2811
+ MEDI0639#
— durvalumab# —
AZD2014
— MEDI-573#
AZD5312#
— MEDI0680
— durvalumab# —
+ Iressa
+ dabrafenib
+ trametinib
➔
durvalumab# —
Tagrisso
(AZD9291)
BLOOM
AZD3759
BLOOM
AZD6738
— MEDI1873
+ durvalumab# —
AZD4547
+ MEDI0680
AZD8186
— MEDI3617#
— durvalumab#
+
AZD5363#
—
—
AZD8835
— MEDI4276
+ MEDI6383#
+ durvalumab# —
+ tremelimumab
(solid tumours)
savolitinib#
—
AZD9150#
— MEDI-565#
— MEDI-551#
+ rituximab
—
selumetinib# —
AZD9496
— MEDI6383#
—
MEDI9197
+ MEDI9447
+
durvalumab# —
34
AstraZeneca Annual Report and Form 20-F Information 2015
+
+
Phase III
Small molecule
Large molecule
LCM projects
Small molecule
cediranib
ICON6
F
durvalumab#
HAWK
+
durvalumab#
+ tremelimumab
+
Faslodex
FALCON
—
Tagrisso
(AZD9291)
+
Combination
molecules
+ durvalumab#
CAURAL
selumetinib# —
ASTRA
durvalumab# —
PACIFIC
selumetinib# —
SELECT-1
moxetumomab# —
Tagrisso
(AZD9291)
AURA, AURA 2
F
tremelimumab —
DETERMINE
acalabrutinib
+
Tagrisso
(AZD9291)
AURA 3
—
Key
+ Addition
— No change
➔ Progression
Approved/launched
F New filing
# Partnered product
Combination
molecules
ALPS
durvalumab#
+ tremelimumab
+
Lynparza
GOLD
ARCTIC
durvalumab#
+ tremelimumab
+
Lynparza
OlympiA
CONDOR
durvalumab#
+ tremelimumab
+
Lynparza
OlympiAD
DANUBE
EAGLE
durvalumab#
+ tremelimumab
+
Lynparza
POLO
durvalumab#
+ tremelimumab
+
Lynparza
SOLO-1
KESTREL
durvalumab#
+ tremelimumab
+
Lynparza
SOLO-2
MYSTIC
durvalumab#
+ tremelimumab
+
Lynparza
SOLO-3
NEPTUNE
Lynparza
prostate (Phase II)
Tagrisso
(AZD9291)
FLAURA
Tagrisso
(AZD9291)
ADAURA
—
—
—
+
—
—
+
—
➔
+
Redefining
the treatment
paradigm
Even as research and development continues to
break boundaries in how we understand and fight
cancer, there are still more than eight million lives
lost every year to the disease. At AstraZeneca,
we are committed to advancing the science of
oncology to deliver life-changing medicines to
people most in need.
Oncology
Phase I
Small molecule
Large molecule
Small molecule
Large molecule
Small molecule
Large molecule
Phase II
Phase III
AZD0156
+ MEDI0562#
+ Tagrisso
—
AZD1775#
— MEDI-551#
— AZD5069
+
cediranib
F
durvalumab#
+
AZD2811
+ MEDI0639#
— durvalumab# —
AZD2014
— MEDI-573#
— durvalumab#
+
selumetinib# —
durvalumab# —
AZD5312#
— MEDI0680
— durvalumab# —
➔
durvalumab# —
selumetinib# —
moxetumomab# —
Combination
molecules
+ durvalumab#
AZD9150#
+ durvalumab#
+ tremelimumab
(gastric cancer)
ICON6
HAWK
ASTRA
PACIFIC
SELECT-1
F
tremelimumab —
DETERMINE
Tagrisso
(AZD9291)
AURA, AURA 2
acalabrutinib
+
Tagrisso
(AZD9291)
AURA 3
—
Combination
molecules
(AZD9291)
combination
TATTON
+ dabrafenib
+ trametinib
+ Iressa
+ MEDI0680
+ MEDI6383#
+ tremelimumab
(solid tumours)
+ rituximab
Tagrisso
(AZD9291)
BLOOM
AZD3759
BLOOM
—
—
AZD6738
— MEDI1873
+ durvalumab# —
AZD4547
AZD8186
— MEDI3617#
— durvalumab#
+
AZD5363#
AZD8835
— MEDI4276
+ durvalumab# —
savolitinib#
—
AZD9150#
— MEDI-565#
— MEDI-551#
—
selumetinib# —
AZD9496
— MEDI6383#
—
MEDI9197
+ MEDI9447
+
durvalumab# —
Combination
molecules
durvalumab#
+ tremelimumab
ALPS
durvalumab#
+ tremelimumab
ARCTIC
durvalumab#
+ tremelimumab
CONDOR
durvalumab#
+ tremelimumab
DANUBE
durvalumab#
+ tremelimumab
EAGLE
durvalumab#
+ tremelimumab
KESTREL
durvalumab#
+ tremelimumab
MYSTIC
durvalumab#
+ tremelimumab
NEPTUNE
LCM projects
Small molecule
+
+
+
+
+
+
+
+
Faslodex
FALCON
Lynparza
GOLD
Lynparza
OlympiA
Lynparza
OlympiAD
Lynparza
POLO
Lynparza
SOLO-1
Lynparza
SOLO-2
Lynparza
SOLO-3
—
—
—
—
+
—
—
+
Lynparza
prostate (Phase II)
—
Tagrisso
(AZD9291)
FLAURA
Tagrisso
(AZD9291)
ADAURA
➔
+
Combination
molecules
Tagrisso
(AZD9291)
+ durvalumab#
CAURAL
+
Antibody that blocks
inhibitory signals from
the tumour to cells
of the immune system
resulting in enhanced
anti-tumour immunity.
AstraZeneca Annual Report and Form 20-F Information 2015
35
Strategic Report Therapy Area Review
Oncology continued
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 204
Values in action: We follow the science
The DNA inside our cells, our genetic
blueprint, is continually being damaged by
environmental factors, ultraviolet light and
even natural growth and division. Cells
contain multiple repair mechanisms to fix
damage to DNA strands because, if this
isn’t repaired, the cells die. Cancer cells
very commonly have one repair mechanism
missing or not functioning, which creates
an ‘Achilles Heel’ – making them sensitive
to being killed if another repair mechanism
is targeted by a medicine. Our scientists
are exploiting this ‘Achilles Heel’ of
sensitivity to develop new medicines which
specifically block DNA repair and cause
cancer cells to die, while sparing the
normal cells which have multiple repair
mechanisms intact. One such treatment is
Lynparza which blocks PARP – a protein
involved in DNA repair in cancer cells that
already have loss of the BRCA protein
which is a critical part of the ‘homologous
repair’ pathway.
It received US approval in July 2015.
Iressa is also the first EGFR-TKI to include
blood-based diagnostic testing where
a suitable tumour sample is not available
in its European label.
Faslodex 500mg is approved in more than
80 countries, including the EU, the US
and Japan. We are currently exploring the
efficacy and safety of Faslodex 500mg
compared with Arimidex in the 1st line
advanced breast cancer setting (hormone-
naïve patients) in the Phase III FALCON
trial. We are engaged in patent litigation,
including in the US and Europe, in relation
to generic challenges to Faslodex. Details
of litigation relating to Faslodex are included
in Note 27 to the Financial Statements
from page 186.
Zoladex continues to be a significant asset
to our in line portfolio and a driver of our
prostate cancer and breast cancer portfolios.
Lynparza is an oral PARP inhibitor approved
in 36 countries 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.
Tagrisso is the first approved EGFR-TKI
indicated for patients with metastatic EGFR
T790M mutation-positive NSCLC. This
indication was approved in November 2015
under the FDA’s Accelerated Approval
Programme based on tumour response rate
and duration of response. Conversion to full
approval for this indication is contingent
upon verification and description of clinical
benefit in confirmatory trials.
In December 2015, Tagrisso received a
Positive Opinion by CHMP for the treatment
of adult patients with locally advanced or
metastatic EGFR T790M mutation-positive
NSCLC. In Japan, Tagrisso was granted
Priority Review by the PMDA. Interactions
with regulatory authorities in the rest of the
world are ongoing.
> 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 repair: 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 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.
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 2015 focus
Our marketed oncology products generated
sales of more than $2.8 billion worldwide
in 2015. We continue to explore ways to
maximise the benefit of our medicines
for patients.
Iressa was the first EGFR-TKI to be
approved in advanced NSCLC. Now
approved in 90 countries, it is the leading
EGFR-TKI for patients with advanced
EGFRm NSCLC in Europe and Asia.
36
AstraZeneca Annual Report and Form 20-F Information 2015
Tumour drivers and resistance
mechanisms franchise
> Tagrisso (AZD9291) 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 and immunotherapies
are under investigation.
> Selumetinib is a mitogen-activated protein
kinase inhibitor in Phase III development
for 2nd line Kirsten rat sarcoma viral
oncogene homolog (KRAS) mutant
NSCLC. The selumetinib programme also
includes a Phase III study for adjuvant
differentiated thyroid cancer and a Phase
II study for 2nd line KRAS mutation not
detected NSCLC.
> 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.
> 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.
In the pipeline
Our Oncology pipeline continued to
progress in 2015. It now includes five NMEs
in late-stage development and another 26
NMEs in Phases I and II. 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 include:
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 and
Tagrisso. The lung cancer programme
includes studies in the 1st line, 2nd line
and 3rd line setting. Additional registration
studies are progressing in squamous cell
carcinoma of the head and neck (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.
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).
> Tremelimumab, an anti-Cytotoxic
T-Lymphocyte-Associated protein 4
antibody, is being investigated as a
monotherapy in a pivotal study for the
treatment of malignant mesothelioma.
> 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.
> Some of our 2015 strategic collaborations
include:
– A collaboration with Immunocore,
a UK-based biotechnology company,
to combine durvalumab (PD-L1) with
IMCgp100, Immunocore’s lead T-cell
receptor-based investigational
therapeutic, for the treatment of
patients with metastatic myeloma.
– A collaboration between MedImmune
and Innate Pharma, a biopharmaceutical
company focused on cancer and
inflammation. The aim is to accelerate
and broaden the development of
Innate’s proprietary anti-NKG2A
antibody (IPH2201), including in
combination with durvalumab (PD-L1)
across a broad range of solid tumours.
– A collaboration between MedImmune
and Mirati Therapeutics, an oncology
company focused on genetic and
epigenetic drivers of cancer. We are
evaluating the safety and efficacy of
durvalumab (PD-L1) in combination
with mocetinostat, Mirati Therapeutics’
investigational spectrum-selective
histone deacetylase inhibitor.
– An agreement with Heptares under
which AstraZeneca will acquire
exclusive global rights to develop,
manufacture and commercialise the
adenosine A2A receptor antagonist,
HTL-1071.
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).
AstraZeneca Annual Report and Form 20-F Information 2015
37
Strategic Report Strategic Report Therapy Area Review
Oncology continued
DNA damage repair franchise
> Lynparza (olaparib) is being evaluated in
a broad range of Phase III trials, including
advanced gastric cancer, BRCAm
adjuvant and metastatic breast cancer,
gBRCAm pancreatic cancer, and
gBRCAm ovarian cancer. Lynparza
is also in Phase II development for
prostate cancer.
> AZD1775 is a Wee1 inhibitor in Phase II
development for ovarian and other
solid tumours.
> Phase I clinical studies are progressing
for the ATR inhibitor AZD6738 (2nd line
gastric cancer with Lynparza and also
in combination with ionizing radiation
in solid tumours) and the ATM inhibitor
AZD0156 (for the treatment of gastric
and colorectal cancers).
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.
> A strategic collaboration with Tanabe
Research Laboratories (TRL), a subsidiary
of Mitsubishi Tanabe Pharma Corporation,
is looking at ways to combine
MedImmune’s pyrrolobenzodiazepine
based cytotoxic molecules and linker
technology with TRL’s antibodies. The aim
is to generate monospecific and bispecific
conjugates (ADCs) for a broad range of
cancer types.
Our Oncology collaborations
Collaboration is key to accessing the best
science and technology, achieving scientific
leadership and delivering innovative,
life-changing medicines. In 2015, we
continued to strengthen our portfolio and
accelerate clinical programmes through
acquisitions and collaborations.
In December 2015, we announced entry
into an agreement to invest in a majority
equity stake in Acerta Pharma. 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.
For more information please see Note 30
to the Financial Statements on page 193
Earlier in 2015, we established several
collaborations that reflect the attractiveness
of our immuno-oncology portfolio, as
demonstrated by:
> Our externalisation agreement with
Celgene, a global leader in haematological
cancers, for the development and
commercialisation of durvalumab,
anti-programmed death-ligand 1 antibody
(PD-L1) across a range of blood cancers,
including non-Hodgkin lymphoma (NHL),
myelodysplastic syndromes and multiple
myeloma.
Institutes of Health (NIH), to advance
early-stage research and development
in immunotherapy and tumour-targeted
therapies for cancer.
> A five-year collaboration between
MedImmune and the University of
Cambridge’s Department of Chemical
Engineering and Biotechnology (CEB)
designed to generate breakthrough
research in biopharmaceutical
development, including activities in
cell engineering and formulation and
analytical science.
> A five-year agreement with the University
of Manchester to harness clinical
bioinformatics to deliver personalised
healthcare for cancer patients. The
research will be carried out in partnership
with the state-of-the-art clinical trials unit
of The Christie National Health Service
(NHS) Foundation Trust, which is at the
forefront of experimental cancer medicine
in the UK.
> The expansion of our existing immuno-
> A licence agreement and collaboration
oncology collaboration with Lilly to further
explore novel combinations across the
companies’ complementary portfolios.
This collaboration will include evaluations
of the safety and efficacy of durvalumab
(PD-L1), with select Lilly agents targeting
the immune system or tumour drivers and
resistance mechanisms.
> Our collaboration with Juno Therapeutics,
a biopharmaceutical company. This
focuses on re-engaging the body’s
immune system to treat cancer and to
evaluate safety, assess tolerability, and
preliminary efficacy of durvalumab
combinations with CD19-directed
chimeric antigen receptor (CAR) T-cell
candidates for patients with NHL.
In addition to the collaborations mentioned
above, during 2015 we have also entered
into a range of collaborations in early
science with several scientific and research
institutions and biotechnology and
diagnostic companies. These additional
collaborations include:
> Two Co-operative Research and
Development Agreements between
MedImmune and the National Cancer
Institute (NCI), a part of the National
between MedImmune and Inovio
Pharmaceuticals, a biotechnology
company developing DNA-based
immunotherapies for cancer and
infectious diseases, to acquire
exclusive rights to Inovio’s INO-3112
immunotherapy. This agent targets
cancers caused by the human
papillomavirus (HPV) types 16 and 18
and is in Phase I/II development for
cervical, and head and neck cancers.
MedImmune intends to study INO-3112
in combination with selected
immunotherapy molecules within
its pipeline in HPV-driven cancers.
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).
38
AstraZeneca Annual Report and Form 20-F Information 2015
Infection, Neuroscience
and Gastrointestinal
Our opportunity-driven strategy seeks to maximise the
value of our pipeline and portfolio through focused R&D,
licensing and collaboration. In 2015, we made progress
in developing several assets and launched Movantik/
Moventig in the US, Canada and in key markets across
the EU. In partnership with Lilly, we also made advances
in clinical trials for our BACE inhibitor, AZD3293, a
potential treatment for Alzheimer’s disease.
Infection
We have a long history in the fields of
Infection, Neuroscience, and
Gastrointestinal (ING) diseases, which
represent a significant area of unmet
medical need for patients around the world.
We group these fields into one therapy area.
This helps to support existing medicines,
develop and commercialise new therapies,
prioritise resources, enable effective and
efficient investment and maximise value for
patients and shareholders. In February
2015, we created a new company, Entasis
Therapeutics, to develop programmes in
our small molecule early-stage anti-infective
portfolio. In July 2015, we also announced
the creation of a new antibiotics organisation
in order to develop and commercialise
effective antibiotics to combat the growth
of resistant infections.
Our strategic priorities
Our focus in Infection is on respiratory
viruses and serious bacterial infections.
Our differentiated and leading on-market
portfolio and pipeline were active in 2015.
Influenza virus
Seasonal influenza is a serious public health
problem that causes severe illness and
death in high-risk populations. Clinical data
from Fluenz Tetra/FluMist Quadrivalent has
demonstrated superiority to traditional
inactivated influenza vaccines in children.
In addition to being used in the UK’s
largest vaccination programme to date,
Fluenz Tetra was included in Finland’s
National Immunization Program for the
2015/2016 influenza season. The regulatory
filing in Australia in July 2015 followed on
from the submission of an EU pandemic live
Infection, Neuroscience and Gastrointestinal
attenuated influenza vaccine MAA for a
global influenza pandemic virus in March
2015. In September 2015, AstraZeneca
entered into an agreement with Daiichi
Sankyo for the development and
commercialisation of FluMist Quadrivalent
in Japan. We continue to engage in
discussions with other governments to help
protect children against influenza, the most
common vaccine-preventable disease in the
developed world.
Respiratory syncytial virus
Since its approval in 1998, Synagis has
helped protect more than 2.8 million babies
globally against respiratory syncytial virus
(RSV). RSV affects approximately half of all
infants in their first year of life. It is the leading
cause of hospitalisations and admissions to
paediatric intensive care units. 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. In July 2014, the
American Academy of Pediatrics Committee
on Infectious Diseases (COID) issued
guidance to further restrict premature infants
from eligibility for preventive therapy with
Synagis. A majority of the payers in the US
implemented these guidelines this year. As a
result, demand in the US was adversely
impacted with the majority of the impact
seen in the 2014 to 2015 season, when
volume declined approximately 40% versus
the prior season. The 2015 to 2016 season
started in November in most parts of the US
and season to-date volume has been in line
with expectations. We have not seen a
direct replication of these guidelines in other
countries at a national level.
Phase II
LCM projects
Applications under
review
Large molecule
Small molecule
Large molecule
Small molecule
— MEDI3902
— CXL#
— MEDI4893
— linaclotide#
AZD8108
— MEDI1814
— AZD3241
➔ MEDI7510
AZD3293#
— MEDI8897
➔ Nexium
(paediatrics)
➔ Nexium
(stress ulcer prophylaxis)
F CAZ AVI#
(serious infection)
—
CAZ AVI#
(HAP/VAP)
—
MEDI-550*
F
F
F
—
MEDI8852
➔ Diprivan
— Zinforo
Phase I
Small molecule
ATM AVI#
Key
— No change
➔ Progression
F New filing
# Partnered product
*
Regulatory acceptance
is anticipated in H1 2016
AstraZeneca Annual Report and Form 20-F Information 2015
39
Strategic Report Therapy Area Review
Infection, Neuroscience
and Gastrointestinal continued
Our marketed products
Infection
> Fluenz/FluMist1 (influenza vaccine live)
> Fluenz Tetra/FluMist Quadrivalent1,2
(influenza vaccine live)
> Merrem/Meronem3 (meropenem)
> Synagis4 (palivizumab)
> Zinforo5 (ceftaroline fosamil)
Full product information on page 204
1 Intra-nasal.
2 Daiichi Sankyo holds rights to Fluenz Tetra/FluMist
Quadrivalent in Japan.
3 Licensed from Dainippon Sumitomo Pharmaceuticals
Co., Limited.
4 US rights only. AbbVie holds rights to Synagis outside
the US.
5 Licensed from Forest (now a wholly-owned subsidiary
of Allergan). AstraZeneca holds global rights, excluding
the US, Canada and Japan.
Neuroscience
> Diprivan (propofol)
> EMLA (lidocaine and prilocaine)
> Movantik/Moventig (naloxegol)
> Naropin (ropivacaine)
> Seroquel IR (quetiapine fumarate)
> Seroquel XR (quetiapine fumarate)
> Vimovo1 (naproxen and esomeprazole
magnesium)
> Xylocaine (lidocaine)
> Zomig (zolmitriptan)
Full product information on page 204
1 Licensed from Pozen. Divested US rights to Horizon
Pharma USA, Inc. effective 22 November 2013.
Gastrointestinal
> Losec/Prilosec (omeprazole)
> Nexium (esomeprazole magnesium)
Full product information on page 204
In 2015, we strengthened our leadership
position in RSV, securing FDA Fast Track
designation for MEDI8897, a MAb that may
require dosing only once per RSV season.
We also launched Phase IIa clinical trials.
Additionally, we launched Phase II clinical
trials to assess the efficacy of MEDI7510,
MedImmune’s RSV sF antigen plus the
synthetic molecule GLA, for the prevention
of acute RSV-associated respiratory illness
in older adults.
threatening bacterial infections. ASPR’s
Biomedical Advanced Research and
Development Authority (BARDA) and
AstraZeneca will manage and fund the
portfolio over the next five years. In the
arrangement, BARDA initially will provide
$50 million towards ATM AVI development
and could provide up to a total of $170
million for development of additional
products in the portfolio during the
five-year period.
Serious bacterial infections
Governments increasingly recognise
antibiotic or anti-microbial resistance as
a major public health threat. We have a
broad and innovative portfolio of medicines
for serious Gram-positive and Gram-
negative bacterial infections. We are now
developing additional medicines to fight
these infections. As bacteria develop
resistance to current antibiotics, deadly
infections could, again, become
uncontrollable. In May 2015, AstraZeneca
submitted a filing to the EMA for CAZ AVI,
an innovative combination of ceftazidime
and avibactam. We are seeking full
approvals for complicated intra-abdominal
infections (cIAI), complicated urinary
tract infections (cUTI), and nosocomial
pneumonia (NP) (including hospital-acquired
pneumonia and ventilator-associated
pneumonia). In April 2015, we announced
full Phase III results from CAZ AVI
pivotal studies RECLAIM-1, -2, and -3
and REPRISE, with positive Phase III
cUTI results for RECAPTURE-1 and -2
announced in September. During the year,
we launched antibiotic Zinforo in Mexico;
the product is now available in 34 markets.
In addition to CAZ AVI in our late-stage
pipeline, we are developing aztreonam
avibactam (ATM AVI), a Phase I compound
being developed jointly with Forest (now
a wholly-owned subsidiary of Allergan).
It targets Gram-negative bacteria with
a metallo-beta-lactamase resistance
mechanism. This bacteria is endemic in
India and spreading throughout the world.
In September 2015, AstraZeneca entered
into a public-private partnership agreement
with the US Department of Health and
Human Services’ Office of the Assistant
Secretary for Preparedness and Response
(ASPR) to develop a portfolio of medicines,
of which ATM AVI is the first candidate
medicine in the portfolio, to combat
bioterrorism threats and other life-
Neuroscience
Our strategic priorities
We have a long history in anaesthesia
and analgesia, and a sizeable business
in psychiatry rooted in Seroquel IR and
Seroquel XR. The patent protecting the
active ingredient in Seroquel IR and
Seroquel XR, quetiapine, expired worldwide
in 2012. However, in most European
countries, the formulation patent covering
Seroquel XR does not expire until 2017. As
such, Seroquel XR remains a key product.
We are vigorously defending the patent
protecting Seroquel XR. The patent,
however, has been subject to various
challenges and revocations. Details of
litigation relating to Seroquel XR are
included in Note 27 to the Financial
Statements from page 186.
Values in action: We are entrepreneurial
The antibiotics organisation has been
created with a clear vision – to be a
global leader in the development and
commercialisation of life-saving
antibiotics by 2020. With the formation of
this separate and dedicated unit, we will
focus on the fast growing global health
threat of multidrug resistant bacterial
infections and continue to bring scientific
innovation from our antibiotics portfolio
to doctors and patients around the world.
40
AstraZeneca Annual Report and Form 20-F Information 2015
Neurology
Alzheimer’s disease remains one of the
largest areas of unmet medical need and
continues to generate significant social and
scientific interest. To address this, in addition
to our BACE inhibitor, AZD3293, which is
currently advancing in our externalisation
collaboration with Lilly in Phase II/III clinical
trials as a potential treatment for Alzheimer’s
disease, we continued to develop MEDI1814
in Phase I clinical trials. We also entered into
multiple collaborations with academic and
scientific institutions to advance disease
understanding and identify potential new
medicines. For example, we started a
collaboration with the University of
Cambridge (focusing on advancing research
in neurodegenerative diseases), and
continued to work with the Karolinska
Institutet (Sweden), the Banner Alzheimer’s
Institute (US), the National Institute of
Radiological Sciences (Japan) and
Vanderbilt University (US), focusing on
psychosis and other neuropsychiatric
symptoms associated with major brain
diseases, such as Alzheimer’s disease
and schizophrenia. We also renewed or
continued our collaborations with the
Lieber Institute for Brain Development
(US) and Tufts University (US), focusing
on understanding brain diseases and
disorders, including Alzheimer’s disease
and autism spectrum disorders. In another
collaboration, we joined the Medical
Research Council Dementias Platform
UK, a large public-private partnership, to
accelerate and share dementia research.
In addition, we are developing AZD3241,
a myeloperoxidase inhibitor, to potentially
delay progression of disability in patients
with multiple system atrophy. The National
Institute on Drug Abuse in the US is
conducting and funding a Phase II trial of
AZD8529 in smoking cessation. AZD7325
is in a clinical trial sponsored by the National
Institute of Mental Health in the US to be
tested as a potential treatment for autism
spectrum disorders.
Pain control
Our anaesthesia portfolio consists of
various compounds, including an
intravenous general anaesthetic/
sedative and local anaesthetics available
in different formulations. The portfolio
includes injectables, creams, gels, sprays
and suppositories.
Biologics are an emerging treatment for
pain control. We are exploring treatments in
focused pain areas, with patients selected
on the basis of their characteristic symptoms.
Movantik/Moventig is the first orally
administered, once-daily, peripherally-
acting mu-opioid receptor antagonist to
be approved for the treatment of opioid-
induced constipation (OIC) in adult patients.
The indication varies by jurisdiction. OIC is
the most common side effect of chronic
use of opioid pain medicines. These are
taken by over 69 million people worldwide,
and the incidence of OIC in patients with
chronic pain varies and has been suggested
to be as high as 81%. Of these patients,
only about half achieve desired treatment
outcomes with current options, such as
OTC and prescription laxatives, which
treat general constipation symptoms.
Movantik/Moventig was developed using
Nektar Therapeutics’ oral small molecule
polymer conjugate technology as part
of a 2009 licence agreement with
Nektar Therapeutics.
In March 2015, AstraZeneca announced
a co-commercialisation agreement with
Daiichi Sankyo, for Movantik in the US, in
line with delivering on our externalisation
strategy to create value from the science
that exists in the product pipeline. The brand
launched in the US, UK, Canada, Sweden,
Denmark, Norway, Finland and Germany in
2015. Additional launches will occur through
the first half of 2016.
Gastrointestinal
Our strategic priorities
Nexium remains one of the most used
therapies in the world. In 2015, its use
continued to grow in markets including
China and Japan. Demand for Nexium in
China is expected to grow significantly and
will complement its position in Japan as the
top-selling medicine in its class.
Nexium is generally subject to generic
competition in Europe. In the US, we
expected the first generic entry in 2014 but
that did not occur. In January 2015, Teva
received approval from the FDA to market
a generic version of Nexium. Since then,
Mylan, Hetero/Camber, Dr Reddy Labs
and Torrent received approval for generic
versions of Nexium. Nexium is also subject
Values in action: We play to win
In 2015, we made Movantik/Moventig, the
first peripherally-acting mu-opioid receptor
antagonist (PAMORA), available to patients
suffering from opioid-induced constipation
in the US, Canada, UK, Germany, Ireland
and the Nordic countries.
to generic competition in Australia, where
the first generic entry occurred in August
2014. Patents protecting Nexium have
been subject to a number of challenges
in different jurisdictions. Details of these
matters are included in Note 27 to the
Financial Statements from page 186.
Pfizer acquired the exclusive global rights
to market Nexium for OTC indications
worldwide in 2012, and launched OTC
Nexium 20mg in the US and Europe in 2014.
In July 2015, we announced the completion
of an agreement with Tillotts Pharma,
part of the Zeria Group. This covered the
divestment of global rights, outside the US,
to Entocort (budesonide), a gastroenterology
medicine for patients with mild-to-moderate
Crohn’s disease and ulcerative colitis.
In December 2015, we entered into an
agreement with Perrigo for the divestment
of US rights to Entocort, granting Perrigo
the rights to sell Entocort capsules and the
authorised generic Entocort capsules
marketed by Par Pharmaceuticals.
AstraZeneca Annual Report and Form 20-F Information 2015
41
Strategic Report Strategic Report Business Review
Research and Development
We are investing in key programmes and focused
business development, as well as using our distinctive
capabilities to push the boundaries of science to deliver
life-changing medicines.
Overview
> Focused on science-led innovation across small molecules, biologics,
immunotherapies, protein engineering and devices
> Strengthened our pipeline, portfolio and capabilities in 2015 through focused
investment and business development
> Simplified programmes, processes and systems while prioritising resources
towards late-stage development
> Launched seven diagnostic tests linked to our products in line with our personalised
healthcare (PHC) strategy
> Promoted open innovation and collaboration by co-locating to strategic R&D centres
and collaborating with leading research organisations
> Published 58 articles in ‘high-impact’ publications compared to seven in 2010
> Committed to working responsibly and in accordance with our global
bioethics standards
58
7
Record number of
‘high-impact’ publications
Launched seven diagnostic
tests linked to our products
Achieve scientific leadership
As outlined in Strategic priorities from page
16, achieving scientific leadership is critical
to our success.
During 2015, we
> continued to redeploy R&D spend
towards late-stage development
> further expanded our immuno-oncology
research and development activities
> entered into numerous strategic
collaborations to access novel science
and technology.
Our biotech-style operating model enables
us to access the best science, both internal
and external, which is a prerequisite for
achieving scientific leadership. Further, our
productivity and pipeline continue to benefit
from investments in key capabilities, such as
payer partnering, PHC, predictive science
and clinical trial design.
In recent years, we have created a leaner,
simpler and smaller organisation, focused
on driving distinctive science across our key
therapy areas. We have also made progress
in co-locating our teams to our strategic
R&D centres. The move to Gaithersburg,
Maryland US is complete and the move to
Cambridge, UK is progressing rapidly with
1,600 roles now located in Cambridge
where the new R&D centre and corporate
headquarters is under construction.
Research and early clinical
development
Our two biotech units conduct innovative
discovery research and early-stage
development from initial target selection to
Phase II trial completion. Our IMED biotech
unit focuses on scientific advances in small
42
AstraZeneca Annual Report and Form 20-F Information 2015
molecules, oligonucleotides and other
emerging technologies and drug discovery
platforms. The MedImmune biotech unit is
responsible for global biologics research
and early-stage development. Both units
are responsible for delivering projects to our
Global Medicines Development (GMD) unit
for late-stage development.
Working collaboratively and fostering
open innovation
In order to enhance our innovation
capabilities and ensure that we have
access to the best science, we are open
to exploring new and different kinds of
collaborations. Current small molecule
partnership models include in-licensing
of new chemical modalities and platforms;
partnerships to leverage our compound
collection to uncover novel target
opportunities; and strategic collaborations
designed to build our understanding of the
mechanisms of disease. In biologics, we
are actively engaged in strategic university
research collaborations, clinical partnerships
designed to explore the full potential of our
immuno-oncology assets, and numerous
in-licensing and joint development
arrangements. In both biotech units our
scientists work side-by-side with partner
scientists, advancing science together as
a single team.
In 2015, our IMED biotech unit announced
several scientific collaborations. A number
of collaborations enhanced the use of
clustered regularly-interspaced short
palindromic repeats (CRISPR) technologies
across our discovery platforms, including
those with the Innovative Genomics
Initiative, the Whitehead Institute at the
Massachusetts Centre for Technology,
The Sanger Institute and Thermo Fisher
Scientific. We also expanded our
collaboration with Ionis Pharmaceuticals Inc.
to discover and develop antisense therapies
for cardiovascular, metabolic and renal
diseases. MedImmune also forged several
key collaborations in 2015, including a
research collaboration with Joslin Diabetes
Center to develop new medicines to treat
diabetes, obesity, and related metabolic
disorders. In addition, we launched a
biotherapeutics research centre in
collaboration with Cambridge Research
UK. MedImmune was also very active in
finalising collaborations to maximise the
value of the immuno-oncology portfolio,
such as through the externalisation
collaboration with Celgene to extend our
extensive anti PD-L1 inhibitor programme,
durvalumab, into trials for serious blood
cancers. The recent exchange of chemical
compounds with Sanofi is an example of
our open innovation collaborations.
For more information on our collaborations
please refer to the Oncology section from pages
34 to 38
Scientific innovation is the life-blood of
PHC. We are now expanding the benefits
of PHC to patients in all core disease areas,
such as asthma, where we are developing
diagnostics for periostin and DPP-4 for
potential use with tralokinumab (with Abbott)
and lupus, where we are evaluating a
type-I-IFN-inducible gene signature for
use with anifrolumab (with Qiagen).
To better understand the biology of disease,
our biotech units announced the first wave
of projects from our joint venture with the
MRC Laboratory of Molecular Biology and
have agreed to support more than 80 PhD
scholarships and eight clinical lectureships
with the University of Cambridge.
Additionally, and through our IMED open
innovation portal, our teams reviewed more
than 350 proposals for new drug projects
in 2015.
For an analysis of our R&D spend, please see
Infrastructure on page 61
Our personalised healthcare strategy
2015 saw us using the science of PHC to
match many more patients to AstraZeneca
medicines from which they are most likely to
benefit. We launched seven diagnostic tests
linked to our products – a total of 11 in two
years. Three of our products (Iressa,
Lynparza and Tagrisso) are now coupled
with companion diagnostic tests that select
patients for therapy based on their
molecular profiles. PHC expanded in our
clinical pipeline to over 80% – with over 60
planned drug launches by 2024 requiring
a diagnostic test.
Our increasing investment in diagnostic
partnerships achieved two world firsts:
the EGFR mutation test for Tagrisso is the
first diagnostic test for both circulating
tumour DNA and tumour tissue (EU, with
Roche Molecular Systems), while our
PD-L1 Class I diagnostic (with Ventana)
was the first immuno-oncology test
launched in the US. In addition, we
launched tests for tumour BRCA analysis
for Lynparza (EU, with Myriad); for EGFR
T790M for Tagrisso (US, with Roche
Molecular Systems); for circulating tumour
DNA EGFR for Iressa (EU, with Qiagen);
and for PD-L1 (EU, with Ventana).
Oncology from page 34
Respiratory, Inflammation
and Autoimmunity from page 26
Looking ahead, we announced a
collaboration with the Montreal Heart
Institute to search the genomes of up to
80,000 patients for genes associated with
cardiovascular diseases and diabetes.
Finally, our membership of the GENE
Consortium, a public-private consortium
with Genomics England in the UK, is aimed
at accelerating the development of new
diagnostics and treatments arising from
the 100,000 Genomes Project.
Cardiovascular and Metabolic diseases
from page 30
Late-stage development
GMD is our R&D function focused on
large Phase III clinical trial programmes
across our therapy areas that support the
approval, launch and reimbursement
of new medicines, as well as life-cycle
management. GMD also delivers studies
that demonstrate evidence of how our
medicines work in the ‘real world’ to help
healthcare professionals and payers
understand the therapeutic as well as
economic value of our medicines. During
2015, we have continued to sharpen focus
on our three therapy areas by identifying
opportunities to collaborate on developing
assets within our late-stage pipeline – for
example, an externalisation agreement for
the development of brodalumab for patients
with psoriasis and the divestment of one of
our established products Caprelsa, as a
treatment for rare diseases.
Accelerating the pipeline and
increasing efficiency
GMD is pushing boundaries to help ensure
new treatments get to patients more quickly
and still safely. Improvements include the
development and use of smart clinical trials,
data-modelling techniques and proactive
AstraZeneca Annual Report and Form 20-F Information 2015
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Strategic Report Strategic Report Business Review
Research and Development continued
Values in action: We put patients first
Personalised healthcare aims to match
medicines to patients who will benefit
from them most. Advances in science
mean we can now design diagnostic tests
to tell us how individual patients are
likely to respond to a medicine before
prescribing it. We are also using new
technology, such as blood-based tests in
lung cancer, so that this science reaches
more patients. Developing medicines in
this way helps deliver the right medicine
to the right patient and means better,
more effective treatment.
regulatory approaches, as well as
accelerating drug formulation and supply
chain solutions. Examples in 2015 included
presenting regulators with scientific rationale
based on robust early clinical data in
respect of Tagrisso, while fast delivery times
to secure data from PEGASUS-TIMI 54, our
21,000-patient study for Brilinta, supported
wider approvals in the US and additional
regulatory submissions in the EU and US.
GMD has created dedicated oncology
delivery teams and recruited more medical
expertise to bring potential new cancer
treatments to patients more quickly, where
there is significant unmet medical need.
See Therapy Area Review from page 24
GMD also pursues opportunities to
simplify processes to increase efficiency
and productivity. A new information
management system for all regulatory
submissions, registrations and product
changes provides improved access to
documentation. We have also completed
the outsourcing of routine regulatory
maintenance and publishing tasks to a
data-handling provider, so our internal
resources can focus solely on activities to
support our regulatory submission priorities.
In clinical operations, we are adopting new
technology and approaches to improve
monitoring of clinical trials and ensure
patients are protected.
Investment in disease area and scientific
capabilities
With the consolidation of R&D activities to
strategic centres, we continue to hire new
employees to strengthen our disease area
expertise and technical capabilities. This
helps to meet the needs of our expanded
late-stage portfolio and support the
increasing number of clinical trials.
Payer and real-world evidence capabilities
are helping us to show how our medicines
may improve outcomes compared to
other treatments, and to demonstrate how
they may reduce the need for hospital
or specialist care, and make a difference
to patients’ lives.
We continue to engage with medical
experts to provide important insight into our
drug programmes. Such engagements will
help ensure our medicines address the
needs of patients as well as healthcare
professionals. In support of this as
detailed in the Pipeline and Therapy Area
Introduction on page 24, we have signed
an agreement with PatientsLikeMe.
Our scientific reputation
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 a record
number of ‘high-impact’ publications
with 58 manuscripts in peer-reviewed
journals with impact factor exceeding
15 (Thomson Reuters 5yr IF score). This
represents an eight-fold improvement
since our drive to publish in ‘high-impact’
journals in 2010, and demonstrates
recognition of the quality of our science
by industry and academic peers.
Responsible research†
We are committed to achieving scientific
leadership and delivering life-changing
medicines in a trustworthy and ethical
manner. Our global standards of bioethics
apply to all our research activity, whether
conducted by us or third parties on
our behalf.
Patient safety
Patient safety is very important to us and
we strive to minimise the risks and maximise
the benefits of our medicines. Through a
pharmacovigilance programme, we monitor
our medicines 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 also work
with regulatory authorities worldwide to raise
pharmacovigilance awareness.
Our patient safety team helps 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
44
AstraZeneca Annual Report and Form 20-F Information 2015
Animal research
We are committed to helping the public
understand our use of animals in research
and our methods for reducing, refining,
or replacing them. Our commitment is
reflected in our Global Bioethics Policy, and
along with other signatories, progress has
been published in the 2015 Annual Report
on the ‘Concordat on Openness in Animal
Research in the UK’.
In response to a routine internal audit
of our animal welfare assurance, we have
improved our governance structure by
providing a single point of accountability
with oversight across AstraZeneca effective
1 January 2016. Our approach will provide
consistent implementation of policies and
procedures, and will ensure that all new
organisations that join AstraZeneca have
support in fulfilling their obligations under
the Code of Conduct.
Further information on our governance
structure can be found on our website,
www.astrazeneca.com
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 2015, we
used 182,055 animals in-house (2014:
194,162). In addition, 33,220 animals were
used by CROs on our behalf (2014: 15,634).
† For further information on AstraZeneca’s approach
to doing business sustainably please refer to
In the wider world from page 55 and on our website,
www.astrazeneca.com.
safety manager. Our Chief Medical Officer
has accountability for the benefit/risk profiles
of our products in development and on the
market. He provides medical oversight and
enforces risk assessment processes to
facilitate efficient and informed safety
decision making.
Clinical trials and transparency
In 2015, we conducted clinical trials at
multiple sites in various countries and
regions as shown in the chart over.
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 for determining
where we locate clinical trials 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 2015,
approximately 36% of patients in our small
molecule studies and 56% 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 also engage and collaborate with
external scientific experts to support the
design and interpretation of these clinical
studies. Committees oversee study
execution and progress, and we frequently
collaborate with academic research
organisations, particularly for larger
multicentre outcome trials.
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.
For more information, please see our
website, www.astrazeneca.com, or our clinical
trials website, www.astrazenecaclinicaltrials.com
During 2015, we implemented a number
of changes in response to the new EU
Clinical Trial Regulation, EMA’s Policy 70
and the EFPIA/PhRMA Responsible Data
Sharing principles.
Clinical trials by region
Europe
US/Canada
Asia Pacific
Central/Eastern Europe
Japan
Latin America
Middle East and Africa
Small
molecule Biologics
16%
26%
15%
27%
3%
10%
3%
14%
34%
6%
25%
12%
7%
2%
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, thereby
helping to develop effective, new and
personalised medicines.
In carrying out this important area of
research, we maintain policies and
processes to ensure that we both 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 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, AstraZeneca
may use human fetal tissue or embryonic
stem cells. 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.
AstraZeneca also insists its 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.
AstraZeneca Annual Report and Form 20-F Information 2015
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Strategic Report
Strategic Report Business Review
Manufacturing and Supply
Our new strategic framework provides a focus for our
investments to help ensure we are able to respond to
patient and market needs for our medicines.
Overview
> Developed a new transformational operations 2020 strategy focused on helping
AstraZeneca to achieve its strategic purpose
> Opened our new facility in Russia to supply local markets better
> Announced plans to invest more than $285 million in our Sweden biologics centre,
and acquired a facility in the US to meet growing demand for manufacturing biologics
> Continued to combine internal capabilities with cost-efficient external resources using
established process for third party risk management including suppliers, their
partners and local business development partners
$285m
Plan to invest more than
$285 million in our
Sweden biologics centre
11,236
Undertook 11,236
risk assessments
in 2015
46
AstraZeneca Annual Report and Form 20-F Information 2015
New operations strategy
In 2015, we developed a new
transformational strategic framework for
Global Operations to help ensure we are fit
for the future. Our strategy, which is focused
around a set of strategic imperatives and
strong foundations, will drive our thinking
and actions in the years ahead as we strive
to become more agile, flexible and able to
respond to patient and market needs.
New manufacturing facilities
Following the successful introduction of our
Taizhou facility in China at the end of 2014,
regulatory validation work continues at our
Vorsino facility in Russia, which opened in
2015. This marks the largest foreign
investment in the construction of a new
pharmaceutical plant in Russia. First
commercial production is scheduled to
commence in early 2016, improving our
ability to supply local markets. Also during
2015, we announced major investment
plans to develop our capability in biologics,
including the acquisition of Amgen’s facility
in Boulder, Colorado in the US, as well
as a $285 million investment in a new
manufacturing facility in Södertälje, Sweden.
These projects, in addition to a previously
announced expansion plan at Frederick,
Maryland US, will increase production
capacity to support the growing demand
for biologics, which represents half of our
development pipeline.
Innovation
Partnerships and innovation are playing
an increasingly important role for Operations
in delivering medicines to patients. New
science, and ways of working are continually
assessed, with pilots progressed to
challenge established practices. During
2015, we have seen innovative practices
Values in action: We put patients first
We have established a secure and low-cost supply
chain in support of our Healthy Heart Africa programme
(see page 51). Understanding the patient’s circumstances
was key as we worked to enable access to, and
affordability of, high-quality anti-hypertensives to
middle- and lower-income patients. We are working
with our distributors and NGO partners to gather and
share reliable data so that we can respond to changing
patient needs.
employed around readiness for launch
of Tagrisso, while our Healthy Heart Africa
programme has been further developed
as we aim to reach 10 million patients
across Africa. Further pilots are already
under development for 2016, as we
look to improve the end-to-end supply
chain performance.
Product quality and supply chain
We are committed to high product quality,
which underpins the safety and efficacy of
our medicines. To help assure compliance
and quality, we maintain a comprehensive
quality management system.
In 2015, we hosted 38 independent
inspections from 16 regulatory authorities.
We reviewed observations from these
inspections, together with the outcomes
of internal audits, and, where necessary,
implemented improvement actions.
Our strategy reflects our commitment 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 EFPIA and PhRMA.
Our continuous improvement programme
allows us to upgrade our systems and
minimise environmental impact. By applying
Lean methodology to our manufacturing
plants and supply chain, we have been
successful in reducing waste and inventory
costs. We have also improved efficiency,
quality, lead times, equipment effectiveness
and overall customer responsiveness.
We are continuing to establish more
efficient processes, with global supply
chain experts providing support throughout
the organisation.
Regulation and compliance
Manufacturing facilities and processes are
subject to rigorous regulatory standards.
These continuously evolve and are not
harmonised globally. They are also 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.
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, which consists of four steps
and applies to all our suppliers, downstream
supply chain partners and local business
development partners, 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
risk-mitigation process we seek to better
understand the partner’s risk approach and
ensure the partner understands and can
meet our standards. We conducted a total
of 11,236 assessments in 2015, taking our
total number of assessments to 13,845. Of
these 4,613 were in the Asia Pacific region,
followed by 4,115 in Europe and 3,538 in the
Americas. The remaining 1,579 assessments
relate to global suppliers and those based in
the Middle East and Africa.
In addition, we conducted 49 audits on
direct materials suppliers to ensure they
employ appropriate quality, health and
safety practices. 35% of suppliers met our
expectations and 65% implemented
improvements to address minor instances
of non-compliance. During our due diligence
process, we identified and rejected 326
suppliers, including 65 for reputational
related concerns.
† For further information on AstraZeneca’s approach
to doing business sustainably please refer to
In the wider world from page 55 and on our website,
www.astrazeneca.com.
AstraZeneca Annual Report and Form 20-F Information 2015
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Strategic Report Strategic Report Business Review
Sales and Marketing
Our return to growth strategy is built on maximising the
potential of our strong portfolio of primary care and
specialty care medicines by leveraging our global
commercial presence, particularly in Emerging Markets.
We are also investing in our Growth Platforms.
Overview
> Our Sales and Marketing teams operate in more than 100 countries
> Sales increased by 15% in China, which is now our second largest market
> In the US, declines in revenue from Nexium, Crestor and Synagis were offset by strong
performance of our Growth Platforms
> Despite an austere macroeconomic climate, we continued to launch innovative
medicines in Europe
> Japan continues as one of our Growth Platforms with revenue growth of 4% in 2015
> We worked closely with payers and providers to help deliver cost-effective medicines
> We increased access to healthcare through programmes in Emerging Markets,
serving some 3.5 million people
> We reaffirmed our commitment to ethical sales and marketing activity through
employee training, monitoring, corrective actions and reporting
100
Active in more than
100 countries
3.5m
Patient access programmes in
Emerging Markets reached
3.5 million people by the end
of 2015
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AstraZeneca Annual Report and Form 20-F Information 2015
Organisation and approach
To improve health and bring benefits to
patients around the world, we need to
ensure the right medicines are available and
that patients have access to them. To that
end, our Sales and Marketing teams, which
comprised around 34,800 employees at the
end of 2015, 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.
We market our products largely to
primary care and specialty care physicians.
We aim to meet their needs by having
highly accountable local leaders who
understand their customers and focus
on business growth.
We group our Sales and Marketing function
into Japan, one of our Growth Platforms,
and three Commercial Regions: North
America (US and Canada); Europe; and
International (Emerging Markets, Australia
and New Zealand). Underpinning all our
efforts is a commitment to operate
responsibly and conduct sales and
marketing activity in accordance with
applicable laws and our Values.
For more information on Product Sales in our
markets, please see Geographical Review from
page 227
US
As the sixth largest prescription-based
pharmaceutical company in the US,
we have a 4.5% market share of US
pharmaceuticals by sales value.
In 2015, sales in the US decreased by 6%
to $9,474 million (2014: $10,120 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’ rights to Tudorza and Daliresp
in the US.
The Affordable Care Act (ACA) has had,
and is expected to continue to have, a
significant impact on our US sales and the
US healthcare industry. In 2015, the overall
reduction in our profit before tax for the
year, due to discounts on branded
pharmaceutical sales to Medicare Part D
beneficiaries and an industry-wide excise
fee, was $786 million (2014: $714 million).
For more information on pricing pressure and
the ACA, please see Marketplace from page 12
and Geographical Review from page 227
While there is no direct governmental price
control for commercial prescription drug
sales in the US, some publicly funded
programmes, such as Medicaid and
TRICARE (Department of Veterans Affairs),
have statutorily mandated rebates and
discounts. These effectively serve as price
controls for such programmes. Other
challenges include continuing pressure
on pricing, and the availability and use of
prescription drugs for commercial and public
payers continues to increase. This is due to,
among other things, an increased focus on
generic alternatives. Increased generics use
is also due to rising patient co-insurance or
co-payments for branded pharmaceuticals
and budgetary policies of healthcare
systems and providers, including policies
about the use of ‘generics only’ formularies.
In 2015, 84.0% of prescriptions dispensed in
the US were generic compared with 83.4%
in 2014. While the adoption of a broad
national price-control scheme in the near
future is unlikely, increased focus on
pharmaceutical prices and their impact
on healthcare costs is likely to continue.
Europe
The total European pharmaceutical
market was worth $194 billion in 2015.
We are the twelfth largest prescription-
based pharmaceutical company in Europe
with a 2.5% market share of prescription
sales by value. Europe comprises countries
as defined in Market definitions on page 247.
In 2015, our sales in Europe decreased by
6% to $5,323 million (2014: $6,638 million).
Key drivers of the decline were continued
competition from Symbicort analogues,
ongoing volume erosion of Atacand and
Seroquel XR following loss of exclusivity,
pricing and volume pressure for Crestor
and Nexium, and lower net pricing on
Synagis. 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.
Established Rest of World (ROW)*:
opportunities and challenges
In 2015, sales in Japan increased by 4% to
$2,020 million (2014: $2,227 million). Strong
performance of Nexium and Crestor, and
the Diabetes franchise helped to drive this,
offsetting the headwinds from generic
competition. In Japan, we hold ninth
position in the ranking of pharmaceutical
companies by sales of medicines. Despite
biannual 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. The higher EGFR
prevalence in Asian markets makes Japan
a key market for the launch of Tagrisso
expected in 2016.
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 (CADTH), 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 66% funded by private payers and 34%
with public plans.
Our sales in Australia and New Zealand
declined by 19% in 2015. This was primarily
due to the continued erosion of Crestor and
Atacand by generic medicines. Nexium lost
exclusivity in Australia in 2014 and generic
medicines were launched.
* Established ROW comprises Australia, Canada,
New Zealand and Japan.
Emerging Markets: expansion and
collaboration
Emerging Markets, as defined in Market
definitions on page 247, comprises
various countries with dynamic, growing
economies. As outlined in Marketplace from
page 12, 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 $5,822 million,
AstraZeneca was the eighth largest, as
measured by prescription sales, and the
fourth fastest-growing top 10 multinational
pharmaceutical company in Emerging
Markets in 2015.
In China, AstraZeneca is the second
largest pharmaceutical company, as
measured by sales. We are driving
sustainable growth through strategic brands
investment, expanded hospitals coverage
and systematic organisational capability
improvements. Sales in China in 2015
increased by 15% to $2,530 million (2014:
$2,242 million). We delivered sales growth
at above the growth rate of the market, and
initiated several long-term market expansion
programmes in therapy areas. The industry
growth rate is expected to be moderated to
high single digits, impacted by increased
price pressure, hospital cost containment
and delays in new product registration.
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 our Diabetes, Respiratory,
Oncology, CV and Gastrointestinal
portfolios. To educate 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.
AstraZeneca Annual Report and Form 20-F Information 2015
49
Strategic Report Strategic Report Business Review
Sales and Marketing continued
Innovative collaborations are giving us
access to novel science, technology and
medicines. These complement and
strengthen our portfolio. One example is
our collaboration with FibroGen in China to
develop and commercialise roxadustat, a
potential first-in-class oral compound for
treating anaemia in patients with CKD.
Increasing access to healthcare†
We have made significant progress in
broadening the access to our products by
making medicines more affordable and we
are working towards greatly increasing
access, particularly in low income countries,
through our patient access programmes.
Our efforts to improve affordability are
particularly focused on ability to pay based
on disposable household income. We
continue to grow our capabilities and build
on the experience of wellbeing initiatives and
patient access programmes which provide
discounts on our medicines and other
patient services, for example FazBem in
Brazil, Disfruto Mi Salud in Central America
and the Caribbean, MAZ Salud in Mexico
and Karta Zdorovia in Russia. We have
significantly expanded these initiatives
across Latin America, the Middle East and
Africa, and Asia Pacific, and the number of
patient access programmes in Emerging
Markets has more than doubled since 2013,
reaching 3.5 million patients in total by the
end of 2015.
Improved access is bringing down
healthcare barriers, particularly in developing
countries. In 2015, we expanded our
efforts in Africa to enable greater access to
hypertension medication and other essential
services for patients who are otherwise
unable to access medication or other forms
of treatment.
For more information, please see the Healthy
Heart Africa case study over
Pricing and delivering value
Our global pricing policy helps to ensure
appropriate patient access while optimising
the sustained profitability of our products.
When setting the price of a medicine, we
consider its full value to patients, payers and
society generally. We also pursue a flexible
pricing approach. For example, we support
the concept of differential pricing, provided
that appropriate safeguards are in place to
help ensure lower-priced products reach
the patients who need them and are
not diverted for sale and use in more
affluent markets.
Our medicines help treat unmet medical
need, improve health and create economic
and therapeutic benefits. Effective
treatments can lower healthcare costs by
reducing the need for more expensive care,
preventing more serious and costly diseases
and increasing productivity by reducing or
preventing days lost to illness. Nevertheless,
pricing pressure remains, as outlined in
Marketplace on page 12. We are acutely
aware of the economic challenges faced by
payers and remain committed to delivering
value to payers and patients alike. We work
closely with payers and providers to
understand their priorities and requirements.
We also conduct real-world evidence
studies to demonstrate how our products
improve health outcomes, offer value and
support cost-effective healthcare.
Sales and marketing ethics†
We are committed to employing high ethical
standards of sales and marketing practice
worldwide. This is consistent with our Global
Policy on Ethical Interactions. We report
publicly on the number of
> confirmed breaches of external sales
and marketing codes
> breaches of our Code of Conduct or
supporting policies by employees and
contractors in our Commercial Regions,
and associated corrective actions.
During 2015, we continued to train
employees on the global standards that
govern the way we operate. We have
comprehensive processes as well as
dedicated compliance professionals who
monitor adherence to our Code of Conduct
and Global Policies. These professionals
also support our line managers locally
in supervising their staff. A network of
nominated signatories review our
promotional materials against applicable
requirements. In 2015, audit professionals
also conducted compliance audits on
selected marketing companies.
There were 1,749 instances, most of them
minor, of non-compliance with our Code of
Conduct, Global Policies or related control
standards in our Commercial Regions,
including instances by contract staff and
other third parties (2014: 1,847).
We removed 339 employees or contractors
from their roles as a result of these breaches
(a single breach may involve more than one
person). We also formally warned 490
others and provided further guidance or
coaching on our policies to 1,476 more.
The most serious breaches were raised
with the Audit Committee.
US Corporate Integrity Agreement and
The Physician Payments Sunshine Act
reporting
In April 2010, AstraZeneca signed an
agreement with the DOJ to settle an
investigation relating to the sales and
marketing of Seroquel IR. The requirements
of the associated Corporate Integrity
Agreement (CIA) between AstraZeneca and
the Office of the Inspector General of the US
Department of Health and Human Services
(OIG) included a number of monitoring and
self-reporting obligations that differ from the
self-reporting required by authorities in the
rest of the world. To meet these obligations,
AstraZeneca provided notices to the OIG
describing the outcomes of particular
investigations potentially relating to violations
of certain laws. We also submitted an
annual report to the OIG, summarising
monitoring and investigation outcomes
relevant to the CIA requirements. Under
the CIA, AstraZeneca also disclosed, on a
publicly available website, certain payments
to US physicians and institutions. The
CIA was for a period of five years and
successfully concluded on 30 April 2015.
AstraZeneca continues to maintain a
robust compliance framework to ensure
compliance with all applicable laws and
regulations, and that the business is
operating with high ethical standards.
AstraZeneca also continues to report to
the US government, detailed information
relating to payments to physicians and
teaching hospitals in the US, as required
by The Physician Payments Sunshine Act.
We identified 11 confirmed breaches of
external sales and marketing regulations
or codes in 2015 (2014: six).
† For further information on AstraZeneca’s approach
to doing business sustainably please refer to
In the wider world from page 55 and on our website,
www.astrazeneca.com.
50
AstraZeneca Annual Report and Form 20-F Information 2015
Healthy Heart Africa
Healthy Heart Africa (HHA) is our innovative programme
to support African governments in reducing the burden
of heart disease and, specifically, hypertension. This
challenge is huge. According to WHO, Africa is home to
the highest prevalence of adults living with hypertension
and an estimated 46% have high blood pressure.
The programme was launched in October
2014 in collaboration with the Kenyan
Ministry of Health and a portfolio of
well-respected implementing partners.
Addressing non-communicable diseases
such as hypertension in middle- and
low-income populations in a healthcare
system that, historically, has prioritised
communicable diseases and infections,
remains a challenge. However, in a short
space of time, the programme has achieved
remarkable progress which will enable
HHA to expand operations to other
geographies in order to achieve our
ambition of reaching 10 million hypertensive
patients across sub-Saharan Africa by
2025 – in line with WHO’s goal of a 25%
reduction in the prevalence of raised blood
pressure by that date.
By the end of 2015, we had:
> Screened one million patients in Kenya.
> Trained over 2,600 healthcare workers,
including doctors, nurses, community
health volunteers and pharmacists to
provide education and awareness,
screening and treatment services for
hypertension.
> Equipped at least 250 health facilities –
ranging from small dispensaries staffed
by a handful of people to large-scale
facilities – to provide hypertension
services, including the establishment
of secure supply chains for low-cost,
high-quality antihypertensive medicines.
> Worked with the Ministry of Health and
key scientific societies to develop a
hypertension treatment protocol.
> Created training materials for healthcare
providers and community health workers
on hypertension prevention, screening,
diagnosis and treatment. In many cases,
these community healthcare workers
had never received training about
hypertension before.
S
t
r
a
t
e
g
i
c
R
e
p
o
r
t
To reach our objectives, HHA has adopted
an innovative model:
> Raising awareness by leveraging
community health worker networks.
> Training providers and driving care to
lower levels in the healthcare system.
> Ensuring access to and availability of
treatment by ensuring that healthcare
workers are equipped to provide
screening and have a consistent supply
of appropriate medicines.
We especially
appreciate AstraZeneca’s
approach to partnership
in order to design and
implement a leading
programme that is
integrated into healthcare
platforms.”
Dr Joseph Kibachio, Head of Division
of Non-Communicable Diseases, Ministry
of Health, Kenya
1m
Screened one million patients in Kenya for
hypertension in 2015
Watch the video at www.astrazeneca.com
AstraZeneca Annual Report and Form 20-F Information 2015
51
Strategic Report Resources Review
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 11,700 permanent employees to help us achieve our strategic priorities
> Continued to offer customised leadership programmes through MIT
> Established a global personal development campaign and defined associated targets
> Increased the diversity of our leadership
> Continued the STAR programme to teach emerging talent about enterprise leadership
> Continued to simplify our organisational structure
Gender diversity
Board of Directors
of the Company 12
Male
Female
67%
33%
Directors of the
Company’s
subsidiaries* 360
Male
Female
72.1%
27.9%
SET* 13
AstraZeneca
employees 61,500
Male
Female
69%
31%
Male
Female
50.2%
49.8%
* 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.
52
AstraZeneca Annual Report and Form 20-F Information 2015
We value the talents and skills of our
61,500 employees in more than 100
countries. Our people strategy, which
supports our strategic priority of being a
great place to work, is 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.
Build and develop organisations
and capabilities
During 2015, we hired 11,700 permanent
employees. Additional employees joined
us through acquisitions, most notably the
transition of 560 BMS employees at our
Mount Vernon, Indiana US manufacturing
site. 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.
A global business
61,500
employees by geographical area
14,400
employees in
North America
(23%)
20,100
employees in Europe
(excluding Russia)
(33%)
1,400
employees in
Russia
(2%)
3,000
employees
in Japan
(5%)
11,000
employees
in China
(18%)
6,500
employees in
Asia Pacific
(excluding China,
Japan and Russia)
(10%)
Co-locating around three strategic R&D centres
> Cambridge, UK (1,600 employees)
> Gaithersburg, Maryland US (2,900 employees)
> Gothenburg, Sweden (2,200 employees)
3,400
employees in
Central and
South America
(6%)
1,700
employees in
Middle East
and Africa
(3%)
Hiring over recent years means that
employees with less than two years’ service
now represent 36% 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 below, which
shows an increasing concentration in
Emerging Markets.
Voluntary employee turnover increased
marginally to 9.2% in 2015 from 8.8% in
2014. However, the voluntary employee
turnover rate among our high performers in
2015 reduced to 4.0% from 6.8% in 2014.
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 2015, we reviewed our talent
management and succession planning
processes, and implemented a revised
approach which is focused on ensuring we
have robust succession plans in place for
our most business critical roles. Embedded
in this new approach is a focus on both
external sourcing and the development of
our people to ensure that we have the right
capabilities and leaders in place to deliver
our strategy.
As shown in the gender diversity figure
on the previous page, women comprise
49.8% of our global workforce. There are
currently four women on our Board (33%).
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 42.0% in 2015, which
exceeded our Scorecard target of 41%
for this measure. We continue to hire
high-quality leaders: 13% of the
approximately 130 leadership roles that
report to our senior leadership team joined
AstraZeneca in 2015. 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 2015, 15.6% 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), which exceeded our Scorecard target
of 13% for this measure.
To maximise our employees’ potential, we
use leadership programmes, both online
and instructor-led, to help build the right
capabilities and culture. In 2015, we
continued our programme for emerging
leaders with the Massachusetts Institute
of Technology (MIT). These programmes
aim to foster openness, inclusivity and
innovation and are a part of a wider effort
Sales and Marketing
workforce
composition (%)
Emerging
Markets
Established
Markets
56%
44%
to offer leaders at all levels of the
organisation appropriate, globally consistent
leadership development opportunities.
In 2015, a further 270 people participated
in our various talent development
programmes. We continued to offer the
STAR programme which teaches our
emerging talent about enterprise leadership
and provides an opportunity to discuss
AstraZeneca case studies and interact with
senior leaders. We also continued our
Insight Exchange programme to help foster
diversity and inclusion, and strengthen our
pool of emerging talent.
Our efforts received external recognition
in 2015. AstraZeneca was ranked second
among 400 businesses in Bloomberg’s
inaugural survey of ‘The best place to work
in corporate Britain’, while the National
Association for Female Executives ranked
us as one of its 50 leading companies for
the seventh year running. We also featured
among Working Mother Magazine’s 100
Best Companies.
Drive a vibrant, high-performing
culture
Continuing our emphasis on high
performance, in 2015 we implemented
a single global performance management
framework and approach. We require every
employee to have been set 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.
AstraZeneca Annual Report and Form 20-F Information 2015
53
Strategic Report Strategic Report Resources Review
Employees continued
We continue to track our progress with
these initiatives through our sample
employee survey which shows an eight
percentage point increase in the view that
AstraZeneca has been successful at
eliminating obstacles to efficiency when
compared to FOCUS 2014.
Generate a passion for people
development
We endeavour to ensure that all our
employees use their talents and abilities to
the full and are provided opportunities for
development. In addition to simplification,
another area of improvement highlighted by
our FOCUS 2014 employee survey was
career development. As a result, we are
strengthening our efforts in this area.
In 2015, for example, we conducted over
70 Development Week events covering
almost all our sites globally.
We encourage employees to take
ownership of their own development and
encourage leaders to spend time discussing
their employees’ development.
The ability of managers and leaders to
develop their employees is critical, and is
measured through our sample employee
surveys. The scores for the survey questions
pertaining to people development now
contribute to our global Scorecard objective
of being a great place to work.
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 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 2015, we completed a human rights
labour review in all countries where we have
a presence. The review focused on ILO core
themes, including freedom of association
and collective bargaining, child labour,
discrimination, working hours and wages.
In this second survey we added questions
on the living wage, data management and
recruitment and the results have remained
positive. Where a gap to ILO minimum
standards was identified, we are putting
in place local plans to close those gaps.
As well as measuring living wage progress
internally, we also conducted an
independent external review so that we can
assess developments in this area to inform
our approach better. As a first step we are
seeking accreditation from 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
As outlined in Strategic priorities on page 16
and 17, in 2013, we announced plans to
invest in three strategic R&D centres which
are shown on the map on the previous
page. This affected employees in the US
and the UK. We encouraged and supported
employees to relocate and have made good
progress. For example, 1,600 employees
now work in Cambridge and, of these
employees, 500 have relocated from other
sites in the UK. In addition to the 410
employees hired in 2015, over the next two
years we expect to hire approximately a
further 600 new employees to Cambridge.
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 our restructuring
programme, please see Financial Review from
page 68
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.
† For further information on AstraZeneca’s approach to doing
business sustainably please refer to In the wider world from
page 55 and on our website, www.astrazeneca.com.
Values in action:
We are entrepreneurial
People development is a key global priority.
In order to encourage a growth mindset
and connect individual development to
achievement of our strategic ambitions,
we held People Development Week
events in 2015. AstraZeneca employees
participated in more than 70 face-to-face
events held in more than 50 countries.
Engagement by staff was demonstrated
by 6,600 comments on people development
in our sample employee surveys.
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 26 to the
Financial Statements, from page 182.
We regularly conduct employee surveys
and an area of improvement highlighted
by our FOCUS 2014 employee survey was
the need to further simplify our organisation,
and we use the scores for survey questions
relating to simplification as a measure of
our success towards achieving our
Scorecard objective.
Across the Group, individuals, teams and
departments are encouraged to identify
opportunities for simplification by removing
obstacles to efficiency and improving the
way in which they work. In 2015, these
efforts were highlighted and shared in a
virtual ‘Simplification Week’ using our new
global intranet, Nucleus, and our global
social platform, Chatter.
To support our drive for simplification further,
we continue to widen the average span of
control (7.2 employees reporting to each
manager in 2015, up from 6.3 in 2012) and
limit the number of reporting layers in the
organisation. We believe this will increase
the speed of decision making, drive
accountability and improve communication.
54
AstraZeneca Annual Report and Form 20-F Information 2015
In the wider world
Our employees are critical to achieving our strategic
priorities. To realise our full potential, however, we also
depend on a wider set of stakeholders and are committed
to operating our business in a sustainable manner – that
is, in a way that delivers real value for our company, our
planet and society as a whole.
Overview
> Over 240 major or strategically important business development transactions over
the past three years
> Created external Sustainability Advisory Board to help confirm our sustainability
priorities and shape our strategy
> Undertaking a materiality assessment to identify the most significant sustainability
issues for AstraZeneca
> Met our aggressive 2010 to 2015 carbon footprint reduction target
> Surpassed our 2015 reduction targets for lost time injury and illness rate and vehicle
collision rate
> Finalised, with SET and Board approval, a new 2016 to 2025 Safety, Health and
Environment Strategy
> Community investment strategy focuses on healthcare in the community and
science education
> Young Health Programme has reached over 1.4 million young people
240
1.4m
More than 240 major or strategically
important business development
transactions over the past three years
Young Health Programme
has reached over 1.4 million
young people
Our stakeholders include the patients
and physicians for whom we provide
medicines for some of the most serious
diseases, and the universities and institutes
that collaborate with our scientists.
Governments, regulators, payers, suppliers,
other commercial organisations and the
communities in which we operate are
among our other stakeholders. We outline
our stakeholder relationships throughout
our Business Review, including Research
and Development from page 42 and
Sales and Marketing from page 48. In
Manufacturing and Supply from page
46, we examine our relationships with
suppliers and our commitment to working
only with those that embrace standards of
ethical behaviour consistent with our own.
This commitment extends to joint venture
and co-promotion partners, and research
and licensing partners.
Partnering
As outlined in Strategic priorities on
page 16 and 17, business development,
specifically partnering, is an important
element of our business. It supplements
and strengthens our pipeline and our
efforts to achieve scientific leadership.
As noted in Research and Development
from page 42, we strive to access
leading science from within and outside
our laboratories. Our partners include
academia, governments, industry, scientific
organisations and patient groups.
We pursue strategically aligned value-
enhancing business development
opportunities and focus on
> increasing early-stage research
transactions and academic alliances
> exploring value-creating peer
collaborations
AstraZeneca Annual Report and Form 20-F Information 2015
55
Strategic Report Strategic Report Resources Review
In the wider world continued
Vehicle collisions
Year
2015
2014
Collisions
per million km
4.15
4.66
Lost time injury/illness
Year
2015
2014
Lost time injury/illness rate
per million hours worked
1.37
1.59
Target
5.60
6.10
Target
1.91
2.10
> pursuing partnering, in-licensing and
acquisitions to strengthen our therapy
area portfolios.
Our business model also encompasses
externalisation as a component of our
portfolio management strategy. This
includes strategic collaborations to broaden
and accelerate the development of key
pipeline assets in our three therapy areas.
We also leverage opportunities in other
areas where we retain an interest in the
future development of projects. Our
collaborations with Lilly and Celgene are
examples of this approach. For more
information on these externalisation
partnerships, see Business model on
pages 8 and 9, and Financial Review from
page 62. We also divest medicines that
can be deployed better by a partner with
a primary focus in the relevant area.
Over the past three years we have
completed more than 240 major or
strategically important business
development transactions, including
some 122 in 2015. Of these transactions,
24 were related to clinical stage assets
or programmes, 48 to pre-clinical assets
or programmes and 11 to PHC and
biomarkers. Thirty-nine transactions
helped expand our biologics capabilities.
Approximately 30 agreements related to
our expanding commitment to Open
Innovation. Acquisitions completed in the
year included the acquisition of Actavis’
respiratory franchise in the US and the
acquisition of ZS Pharma. Agreements
regarding the acquisition of Takeda’s
respiratory portfolio and the acquisition
of a controlling equity position in Acerta
Pharma were signed in 2015. These were
not, however, included in the 2015 data as
the Takeda transaction is due to complete
Sustainability framework
A sustainability framework is embedded in the way we operate:
Sustainability
Advisory Board
Established in 2015 and
will meet 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 will also help
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 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 will focus 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
The Working Group of SET function representatives supports the Council.
The Working Group reviews issues with the potential to impact
AstraZeneca’s sustainability agenda. As appropriate, it prepares proposals
for the Council’s consideration.
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AstraZeneca Annual Report and Form 20-F Information 2015
Stakeholders
Regular engagement
with 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.
in the first half of 2016 and the transaction
with Acerta Pharma completed in February
2016. In addition, four transactions that
contribute to Externalisation Revenue
were completed in 2015 with a further 10
divestments or out-licences also completed.
For more information on our partnering activity
in 2015, please see Therapy Area Review from
page 24, Research and Development from page 42,
Financial Review from page 62 and Note 24 to the
Financial Statements from page 173
Sustainability
We want to be valued and trusted by our
stakeholders as a source of great medicines
over the long term. That means operating
in a way that recognises the interconnection
between business growth, the needs of
society, and the limitations of our planet.
Our sustainability efforts are aligned to,
and support the delivery of, our business
strategy in five core areas that are most
relevant to our business
> Increasing access to healthcare (see page
50 and Healthy Heart Africa on page 51)
> Natural resource efficiency (below)
> Responsible research (from page 44)
> Ethical business practices (see Working
with suppliers, Sales and marketing ethics
and Community investment on pages 47,
50 and 58 respectively)
> Being a great place to work (see Develop
a strong and diverse pipeline of leaders,
Human rights and Safety, health and
wellbeing on pages 53, 54 and 57
respectively).
Further information about our sustainability
agenda is available on the Sustainability pages
on our website, www.astrazeneca.com
During 2015, we commissioned an
independent think-tank to review our current
focus areas, examine our areas of strength
and weakness, and help identify our
priorities going forward. An internal focus
group meeting took place to refine and
calibrate the high-level findings. This
involved assessing risks and opportunities,
as well as the current level of integration,
for each issue. This assessment is
continuing and, will become the foundation
for the priorities and improvement targets
that define the next stage of our journey.
Our goal is to ensure that sustainability is
effectively aligned to our business strategy
and truly embedded into the way in which
we operate and define success.
For more information on our approach to
sustainability, benchmarking and assurance, see
Sustainability: supplementary information from
page 234 and the Sustainability pages on our
website, www.astrazeneca.com
Safety, health and wellbeing
We work to promote a safe, healthy and
energising work environment in which our
employees and partners are able to express
their talents, drive innovation and improve
business performance. Our five-year target
period ended in 2015. The targets for 2015
included
> no fatalities
> lost time injury/illness rate per million
hours worked of no more than 1.91
(a 25% reduction from the 2010 baseline)
> no more than 5.6 collisions per million
kilometres driven (40% reduction from
2008 baseline)
> at least 80% of sites and marketing
companies to offer six essential health
activities.
Our highest priority remains driver safety,
particularly among our sales force who form
the largest group of employees driving on
AstraZeneca business. We monitor
performance centrally to assess progress
and identify areas for improvement. In 2015,
we delivered our five-year target for reducing
collisions per million kilometres driven,
achieving a 55% reduction from baseline.
We regret, however, that one employee was
killed in a traffic accident while driving on
AstraZeneca business. We carried out a
detailed investigation into this accident and
developed an action plan to address the
findings. Actions were monitored and what
was learnt from the incident was shared
widely across the business. Having already
achieved our 2015 lost time injury/illness rate
target two years early, we achieved a further
reduction in 2015. This equates to a 46%
overall reduction from the 2010 baseline.
The 2015 health and wellbeing target was
missed, with 60% of sites offering six
essential health activities, compared to the
80% target. Although this is disappointing,
84% of sites now offer at least five activities,
compared to only 28% in 2011.
Natural resource efficiency
Our 2015 targets1 included reducing
> operational greenhouse gas footprint
to 714,375 tonnes CO2
Operational greenhouse gas footprint
emissions (tonnes CO2)
2015
2014
2013
Waste production (tonnes)
2015
2014
2013
Water use (m3)
2015
2014
2013
704,073
735,218
704,273
38,452
35,797
32,750
3,932,598
3,786,963
3,714,674
Note: Significant site purchases in 2014 and 2015 have
been absorbed into the annual data without historical
rebasing of data.
> hazardous waste to 0.633 tonnes/$m
sales and non-hazardous waste to
0.473 tonnes per employee
> water use to 3.4 million m3.
We are working to reduce our greenhouse
gas emissions by, among other things,
improving energy and fuel efficiency and
pursuing lower-carbon alternatives to fossil
fuels. During 2015, our air and road travel
and freight transport emissions decreased
due to greater achievement in switching
freighting of goods from air to sea and
reducing business air travel significantly.
Procurement of energy from certified
renewable sources increased to represent
6.1% of total consumption.
Our pMDI inhaler therapy relies on
hydrofluoroalkane (HFA) propellants which
affects our carbon 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 greenhouse gases. Excluding
emissions from patient use of our inhaler
therapy, our aim by 2015 was to reduce our
operational greenhouse gas footprint by
20% from our 2010 level. We achieved this,
with our operational greenhouse gas footprint
totalling 704,073 metric tonnes in 2015, a
reduction of 21.2% from our 2010 baseline.
For more information on carbon reporting,
please see Sustainability: supplementary
information from page 234
AstraZeneca Annual Report and Form 20-F Information 2015
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Strategic Report Strategic Report Resources Review
In the wider world continued
Values in action: Do the right thing
Michael Baldinger, CEO of RobecoSAM,
said: “As one of the top-scoring companies
in the pharmaceutical industry, AstraZeneca
PLC has qualified for inclusion in the 2016
Sustainability Yearbook and has received
the Silver Class distinction for its excellent
sustainability performance.”
Waste management is another key
aspect of our commitment to minimise
environmental impact. We aimed to reduce
our hazardous and non-hazardous waste
by 15% from our 2010 levels, indexed
appropriately. While waste prevention is
an essential goal, we seek to maximise
treatment by material recycling and avoiding
landfill disposal when prevention is
impractical. In 2015, our total waste was
38,452 metric tonnes with a tonnes/$m
index of 1.56. We have reduced hazardous
waste by 22% since 2010, due principally
to changing production patterns and major
investment at a UK manufacturing site in
2012 to enable recycling and reuse of
solvent wastes. Hazardous waste generation
indexed to $m revenues increased 5%,
missing our 2015 target. We reduced
non-hazardous waste by 14% since 2010,
but when indexed against staff numbers
the metric has not improved due to staff
reductions since the baseline was set.
We recognise the need to use water
responsibly and, where possible, to
minimise water use in our facilities. To
reach our 2015 water use reduction target
of 25% from 2010 levels, we initiated water
conservation plans at our largest sites.
In 2015, our water use was 3.9 million m3,
a reduction of 14% from our 2010 baseline.
This fell some distance short of achieving
our very ambitious five-year target. Water
use indexed to revenues was 159 m3/$m
(+16% from 2010 baseline).
We are also working on measuring and
reporting the environmental impact of
our external manufacturing activity and
encourage setting of appropriate
environmental targets with our suppliers.
We believe we have captured 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 Safety, Health and
Environment (SHE) improvement efforts
going forward.
We continue to integrate environmental
considerations across a medicine’s entire
life-cycle, from discovery, research
and development to manufacturing,
commercialisation and disposal. We follow
a progressive compliance programme to
ensure that our manufacturing emissions
of APIs do not exceed our internal standards
for safe discharges at our manufacturing
sites and we periodically conduct
compliance assessments. We also follow
a progressive approach to ensure
ecopharmacovigilance. This involves
regularly reviewing emerging science and
literature for new information that might
impact the environmental risk management
plans for our products.
Further information, including environmental
risk assessment data for our medicines, is
available on our website, www.astrazeneca.com
New Safety, Health and Environment
Strategy
In 2015, we finalised a new 2016 to 2025
SHE Strategy to build on our 2010 to 2015
performance and ensure that we are
protecting the health and safety of our
people and doing our ‘fair share’ to protect
the planet. As an output of this strategic
initiative, we have established a set of
targets aimed at keeping AstraZeneca
among the sector leaders in SHE
performance. Our targets for 2025
are shown over.
Achieving these targets during a period
of expected strong business growth will
require significant business engagement
and investment in resource efficiency.
In light of this challenge, and in recognition
that we narrowly missed our 2010 to
2015 water and waste efficiency targets,
we have established a dedicated fund for
capital projects that can drive substantial
improvement in natural resource efficiency.
We disclose our carbon and water
performance and targets to external
indices including the Carbon Disclosure
Project (CDP). In the build up to COP 21,
the 2015 Paris Climate Conference, we
signed up to the CDP commitments for
science-based targets and public disclosure
of information associated with climate
change performance.
Community investment
Our global community investment strategy
focuses on healthcare in the community
and science education. We are committed
to operating responsibly, which means
supporting our community and maximising
the benefit of our investment for all
stakeholders. For example, 2015 was the
fifth year of our partnership with the UK
educational charity Career Ready to support
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AstraZeneca Annual Report and Form 20-F Information 2015
increased participation by 16 to 19 year-olds
in science, technology, engineering and
maths subjects.
In 2015, we spent a total of approximately
$680 million (2014: approximately
$880 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. Through our three patient assistance
programmes4 in the US we donated
products valued at an average wholesale
price of over $617 million (2014: over
$800 million). We also donated products
worth over $17 million, valued at
average wholesale price, to charitable
organisation AmeriCares.
Young Health Programme
We continued to develop the three strands
of our Young Health Programme (YHP):
advocacy; research; and evidence
generation. These on-the-ground
programmes focus on the primary
prevention of non-communicable diseases
(NCDs) and associated adolescent risk
behaviours. With over 1.4 million young
people in communities across five
continents directly provided with the skills
and information they need to improve their
health, we have well exceeded our Clinton
Global Initiative Commitment to Action of
reaching 250,000 young people directly
by the end of 2015. Over 14,600 of these
young people have been trained to share
this health information with their peers and
New Safety, Health and Environment Strategy targets,
2016 to 2025
Eliminate workplace accidents
and illnesses
Protect natural resources
Accidents:
Carbon:
75%
75% reduction in total injury rate
from 2015 baseline
Health and wellbeing:
80%
80% of sites/marketing companies have
all four ‘Essential Health Activities’2
Driver safety:
55%
55% reduction in collisions per million
kilometres driven
30%
Compared to a 2015 baseline,
operational carbon at the same level and
reduce overall carbon intensity by 30%3
Waste:
10%
10% absolute reduction from 2015
baseline
Water:
Cap usage from 2015 baseline
90%
90% of API syntheses meet resource
efficiency targets at launch and establish
equivalent targets for biologics
Ensure the environmental safety of our products
Ensure effective environmental management of our products from pre-launch
through to product end-of-life
the community. The programmes have also
trained more than 12,000 frontline health
workers in adolescent health.
We continue to support research evidencing
the importance of adolescence in future
health, and undertake advocacy activities to
ensure adolescent health and the prevention
of NCDs are global and local priorities. The
engagement and involvement of youth is
at the core of the YHP. Activities in 2015
included commissioning research on NCD
risk behaviours and participation in the
development of an NCD prevention chapter
for UNICEF Facts for Life book. We also
funded YHP side meetings at WHO Geneva
(May 2015) and United Nations General
Assembly in September 2015.
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 April 2015 we donated
£50,000 via British Red Cross to the Nepal
Earthquake Appeal, $200,000 in July to
fund the replenishment of the Kuala Lumpur
Emergency Response Unit and £50,000 in
September to Europe Refugee Crisis
Appeal. In December, and as part of wider
AstraZeneca support for those affected by
the floods in Chennai, where over 1,000
AstraZeneca employees are based, we
donated $30,000 to SEWA International.
1 Figures have been revised from those previously published
to incorporate our biologics capabilities into our targets.
Our targets for 2011 to 2015 were set in 2010.
2 Healthy Eating & Drinking, Tobacco Cessation, Physical
Activity, Workplace Pressure Management.
3 Carbon target follows the science and uses the Science-
Based Target Setting tool developed by the World Resources
Institute. Operational footprint = energy and process
emissions, business travel, waste incineration, freight/
logistics, 1st tier supply chain energy and patient use of
inhalers. Carbon intensity = CO2 tonnes/$m sales.
4 For 2015 we have revised our reporting to reflect what was
shipped from AstraZeneca for use in our Patient Assistance
Programs as opposed to what was actually dispensed to
patients, and have also moved to reporting the wholesale
acquisition cost as opposed to average wholesale price.
As a result, the 2015 numbers reported are lower than
reported in 2014.
AstraZeneca Annual Report and Form 20-F Information 2015
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Strategic Report Strategic Report Resources Review
Intellectual Property
Discovering and developing medicines requires a significant 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 27 to the Financial
Statements from page 186. For more
information on the risks relating to patent
litigation and early loss and expiry of
patents, please see Risk from page 212.
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 210 and 211 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
pending patent protection. RDP generally
expires prior to patent expiry in all major
markets. 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.
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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.
Under the Generating Antibiotics Incentives
Now Act, the FDA may grant Qualified
Infectious Disease Product (QIDP) status.
An antibiotic achieving QIDP status is
granted five years’ exclusivity while QIDPs
that are also NCEs are entitled to 10 years’
exclusivity, extending to 12 years’ if the
disease state is an orphan. The period of
exclusivity granted to a product with QIDP
status runs concurrently with any pending
or granted patent protection.
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.
Infrastructure
The Group owns and operates R&D and production facilities and conducts sales
and marketing activities around the world. Significant information technology and
information services resources support these activities.
R&D resources
We have approximately 8,900 employees
in our R&D organisation, working in various
sites around the world. Our small molecule
sites are located in the UK (Alderley Park,
Cambridge and Macclesfield), Sweden
(Gothenburg), the US (Gaithersburg,
Maryland and Waltham, Massachusetts),
Japan (Osaka) and China (Shanghai).
Our biologics sites are located in the UK
(Cambridge) and in the US (Gaithersburg,
Maryland and Mountain View, 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.
Our strategic expansion in Emerging
Markets continues and includes the
ongoing growth of our R&D facility
in China (Shanghai).
R&D spend analysis
2015
2014
2013
Discovery
and early-stage
development
Late-stage
development
Core R&D
expenditure1
39%
47%
55%
61%
53%
45%
$5,603m $4,941m $4,269m
1 Reported R&D expenditure was $6.0 billion
(2014: $5.6 billion; 2013: $4.8 billion).
In 2015, Core R&D expenditure was
$5.6 billion in our R&D organisation (2014:
$4.9 billion; 2013: $4.3 billion). In addition,
we spent $1,341 million on acquiring
product rights (such as in-licensing) (2014:
$907 million; 2013: $635 million). We also
invested $258 million on the implementation
of our R&D restructuring strategy (2014:
$497 million; 2013: $490 million). The
allocations of spend by early-stage and
late-stage development are presented in
the R&D spend analysis table above.
Manufacturing and supply resources
Our principal small molecule manufacturing
facilities are in the UK (Avlon and
Macclesfield), Sweden (Gärtuna and
Södertälje), the US (Newark, Delaware;
Westborough, Massachusetts; West
Chester, Ohio; Mount Vernon, Indiana
and Coppell, Texas), China (Wuxi and
Taizhou), Russia (Vorsino), France (Reims
and Dunkerque), Japan (Maihara),
Australia (North Ryde), Indonesia (Jakarta),
Egypt (Cairo), India (Bangalore), Puerto
Rico (Canóvanas), Germany (Wedel),
Mexico (Lomas Verdes), Brazil (Cotia) and
Argentina (Buenos Aires). Our Taizhou
supply site won the 2015 Facility of the
Year award in the category of Project
Execution by the International Society
for Pharmaceutical Engineering.
We operate sites for the manufacture of
APIs in the UK and Sweden, complemented
by the efficient use of external sourcing. Our
principal tablet and capsule formulation sites
are in the UK, Sweden, Puerto Rico and the
US. We also have major formulation sites
for the global supply of parenteral and/or
inhalation products in Sweden, France,
Australia and the UK.
For biologics, our principal commercial
manufacturing facilities are in the US
(Frederick, Maryland, Greater Philadelphia,
Pennsylvania and Boulder, 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.
At the end of 2015, approximately 12,500
people at 29 sites in 17 countries were
working on the manufacture and supply
of our products.
Information technology and
information services resources
At the end of 2015, our IT organisation
comprised approximately 2,800 people
across our sites in the UK (Alderley Park
and Macclesfield), Sweden (Södertälje and
Gothenburg), the US (Wilmington, Delaware
and Gaithersburg, Maryland), and our
new technology centre in India (Chennai).
A further 250 IT people worked in our
R&D and operations sites and key
marketing companies.
In the beginning of 2014, we launched a
wide-ranging IT Transformation Programme
to better support our business priorities.
Since then, we have made various
changes to our operating model and
organisational structure to improve
efficiency, responsiveness and innovation.
Our IT vision is to deliver world-class
performance in terms of speed, quality,
cost and innovation. At the same time, we
are relying on IT to enable simplification of
our business processes. To achieve this we
need to improve our current performance
significantly while reducing our overall
spend. We will measure our success by
tracking customer satisfaction and recording
the number and severity of incidents with
business impacts as well as the speed with
which we respond to and mitigate such
incidents. We will also take into account
project delivery and cost (absolute and
as a percentage of revenue) as compared
to industry benchmarks.
Protecting our IT systems, IP and
confidential information against cyberattacks
is a key concern. Our IT organisation is
constantly 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 are equally vigilant in
monitoring our systems and data with
sophisticated technology. This includes
educating our employees about cybercrime,
internet use and best practices to mitigate
the risk of attack.
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Financial Review
Core Other Operating Income was $1.5
billion in the year and included $380 million
to divest US and $215 million for Rest of
World rights to Entocort. Core Operating
Profit increased by 6% to $6.9 billion and
Core Earnings per Share increased by 7%
to $4.26. Reported Operating Profit, at
$4.1 billion, included fair value adjustments
to contingent consideration, which reduced
SG&A costs by $432 million, primarily in
relation to the acquisition of BMS’s share
of the Global Diabetes Alliance.
We generated a cash inflow from operating
activities of $3.3 billion in the year with a
continued improvement in working capital
investment. We maintained a strong,
investment-grade credit rating and, in
November, issued a total of $6 billion of
bonds to fund corporate and business
development activity, repay certain
outstanding commercial paper obligations
and for general corporate purposes. We
ended the year with net debt of $7.8 billion.
As we look to the future, we expect a low to
mid single-digit percentage decline in Total
Revenue at CER in 2016. A low to mid
single-digit percentage decline in Core EPS
at CER is also expected. This guidance
incorporates the dilutive effects arising from
the Acerta Pharma and ZS Pharma
transactions announced in 2015. The
guidance also assumes the loss of exclusivity
for Crestor in the US from May 2016.
Externalisation Revenue is expected to be
ahead of that in 2015, including an increasing
element of recurring income arising from prior
agreements. This is in line with our long-term
business model. Core R&D costs are
expected to be at a similar level to 2015 while
we are committed to materially reducing Core
SG&A costs in 2016. The weakness of key
trading currencies against the US dollar has
continued. Based on average exchange rates
in January 2016 and our published currency
sensitivities, an adverse impact of around 3%
from currency movements on Total Revenue
and Core EPS in 2016 would be anticipated.
Marc Dunoyer
Chief Financial Officer
In 2015, a double-digit increase in our Growth Platforms
helped our top-line to remain resilient, despite headwinds
that included the loss of exclusivity of Nexium in the US.
This, combined with a strong gross margin and disciplined cost management, allowed
us to continue to make important long-term investment in our three main therapy areas,
while delivering a 7% growth in Core earnings.
In 2015, our financial performance reflected
continued progress from our Growth
Platforms, which grew by 11% in the year
and now contribute 57% of Total Revenue,
which increased by 1% to $24.7 billion in the
year. Our Respiratory franchise grew by 7%
during 2015, driven by a strengthening
portfolio, our Emerging Markets business
and the availability of new products in the
US and EU. Brilinta/Brilique grew by 44%
in the year, with particular strength in the
US and Emerging Markets, led by China,
and Diabetes delivered an impressive
performance, with encouraging growth
driven by Farxiga/Forxiga and the Bydureon
Pen. Strong growth in Emerging Markets
continued throughout the year with China,
Brazil and Russia all delivering double-digit
increases and our Japan business
maintained solid growth, with Symbicort,
Crestor and Nexium all maintaining leading
market share positions in a competitive
market environment. For the first time, New
Oncology, which includes the launches of
Lynparza, Iressa (US) and Tagrisso, was
included as a Growth Platform, given our
belief in its long-term importance for our
future growth.
The performance of the Growth Platforms
was supplemented by over $1 billion of
Externalisation Revenue arising from
entering into collaborations including the
strategic collaboration in haematology
with Celgene Corporation and the
co-development and co-commercialisation
arrangement with Daiichi Sankyo for
Movantik in the US. These offset the
headwinds from ongoing patent expiries,
including that of Nexium in the US in
February 2015, as well as the adverse
impacts from Synagis guideline changes
in the second half of 2014.
Excluding the impact of Externalisation
Revenue, the Core Gross Profit margin
increased by one percentage point,
helped by the mix of Product Sales and
manufacturing efficiencies, and Core SG&A
costs declined by 2% to $9.3 billion. We
have progressed a number of ongoing
programmes designed to address Core
SG&A costs including targeting sales,
marketing and medical cost effectiveness,
improving efficiencies across support
functions and IT, and optimising the
global footprint.
This allowed us to continue to focus on our
pipeline and Core R&D costs were up 21%
in the year to $5.6 billion as Oncology
attracted over 40% of total Core R&D
expenditure in the year, reflecting a number
of active trials.
62
AstraZeneca Annual Report and Form 20-F Information 2015
Our financial
performance in 2015
reflected continued
progress from our Growth
Platforms, which grew
11% in the year and
now contribute 57%
of Total Revenue.”
Contents
Introduction
Business background and results overview
Measuring performance
Results of operations – summary analysis of year to 31 December 2015
Cash flow and liquidity
Financial position
Capitalisation and shareholder return
Future prospects
Financial risk management
Critical accounting policies and estimates
Sarbanes-Oxley Act Section 404
62
63
64
65
69
71
75
76
76
77
81
The purpose of this Financial Review is to
provide a balanced and comprehensive
analysis of the financial performance of the
business during 2015, 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.
All growth rates in this Financial Review are
expressed at CER unless noted otherwise.
Business background and results
overview
The business background is covered in
the Marketplace section from page 12, the
Therapy Area Review from page 24 and
the Geographical Review from page 227,
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 the Patent expiries section
on page 60.
> 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 are
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 2015 are
> Total Revenue up 1% at CER to $24,708
million (Actual: down 7%).
– Respiratory up 7% at CER ahead of
the proposed acquisition of Takeda’s
respiratory business
– Brilinta/Brilique up 44% at CER,
underpinned by a recently-extended
US label and positive CHMP opinion
– Diabetes up 26% at CER, including
76% in Emerging Markets and global
Farxiga/Forxiga growth of 137%
– Emerging Markets up 12% at CER,
including China and Latin America
– each growing by 15% at CER
– Japan up 4% at CER, including 8%
in the fourth quarter
– New Oncology $119 million, comprising
Lynparza, Iressa (US) and Tagrisso.
> Core operating profit was up 6% at
CER (Actual: down 1%) to $6,902 million.
The increase reflected a reduction in our
Core SG&A costs and an increase in
Externalisation Revenue and Core other
operating income. We are continuing to
invest in our pipeline and Growth
Platforms.
> Reported operating profit was up 100%
at CER (Actual: 93%) to $4,114 million.
Total restructuring costs associated with
the global programme to reshape the
cost base of our business were $1,034
million in 2015.
> Our Core operating margin of 27.9% of
Total Revenue was up 1.3 percentage
points (Actual: 1.8 percentage points).
Reported operating margin was 16.7%
of Total Revenue.
> Core EPS for the full year was $4.26, up
7% at CER (Actual: flat). Reported EPS
was up 137% at CER (Actual: 128%)
to $2.23.
> Revenues of our Growth Platforms
> Dividends paid amounted to $3,486
increased 11% at CER and constituted
57% of our Total Revenue, with
million (2014: $3,521 million).
AstraZeneca Annual Report and Form 20-F Information 2015
63
Strategic Report
Strategic Report
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, principally 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
will include 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
2015 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 2015
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.
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 following costs that
the Core measures exclude:
– Amortisation of intangible assets
which generally arise from business
combinations and individual licence
acquisitions. 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.
Our Core financial measures do not
include such costs but 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 2015 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.
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. The adjustments made to
our Reported financial information in order
to show Core financial measures illustrate
clearly, on a year-on-year or period-by-
period basis, the impact on our
Management presents these results
externally to meet investors’ requirements
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
64
AstraZeneca Annual Report and Form 20-F Information 2015
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 2015 Reported
operating profit table below, our
reconciliation of Core financial measures
to Reported financial information in the
Reconciliation of Reported results to Core
results table below, and to the Results of
operations – summary analysis of year
ended 31 December 2014 section from
page 236 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.
Results of operations – summary analysis of year ended 31 December 2015
2015 Reported operating profit
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
Profit before tax
Taxation
Profit for the period
Basic earnings per share ($)
Reported
$m
CER
growth
$m
2015
Growth
due to
exchange
effects
$m
(387)
(2,067)
631
244
700
944
(56)
(850)
1,008
1,189
2,235
(16)
(2,083)
496
(1,587)
41
432
880
(24)
(258)
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
2014 Percentage of Total Revenue
2015 compared with 2014
Reported
2015
%
Reported
2014
Restated1
%
CER
growth2
%
Actual
growth
%
(1)
140
1
(12)
5
17
15
(8)
355
100
(9)
136
(7)
(20)
(3)
5
7
(15)
348
93
(18.8)
81.2
(1.4)
(24.3)
(44.9)
6.1
16.7
(22.0)
78.0
(1.2)
(21.0)
(49.0)
1.2
8.0
Reported
Restated1
$m
26,095
452
26,547
(5,842)
20,705
(324)
(5,579)
(13,000)
335
2,137
(885)
(6)
1,246
(11)
1,235
0.98
1 2014 comparatives have been restated to reflect the reclassification of Externalisation Revenue from other operating income and expense as detailed in Group Accounting Policies from page 144.
2 As detailed on page 64, CER growth is calculated using prior year actual results adjusted for certain exchange effects including hedging.
2015 Reconciliation of Reported results to Core results
Gross profit
Product Sales gross margin %2
Total Revenue gross margin %
Distribution costs
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Operating profit
Operating margin as a % of Total Revenue
Net finance expense
Taxation
Basic earnings per share ($)
2015
Reported
$m
Restructuring
costs
$m
Intangible
amortisation
and
impairments
$m
BMS’s share
of diabetes
alliance
$m
Legal
provisions
and other
$m
20,062
80.3%
81.2%
(339)
(5,997)
(11,112)
1,500
4,114
16.7%
(1,029)
(243)
2.23
158
369
–
258
618
–
–
136
921
178
1,034
1,604
–
–
–
54
–
54
–
(217)
0.65
–
(344)
1.00
409
(152)
0.24
–
–
–
254
(158)
96
115
(34)
0.14
2015
Core1
$m
20,589
82.6%
83.3%
(339)
(5,603)
(9,265)
1,520
6,902
27.9%
(505)
(990)
4.26
CER
growth
%
2
Core1 2015
Actual
growth
%
(5)
17
21
(2)
104
6
5
13
(9)
100
(1)
1 Each of the measures in the Core column in the above table are non-GAAP measures.
2 Gross margin as a % of Product Sales reflects gross profit derived from Product Sales, divided by Product Sales.
AstraZeneca Annual Report and Form 20-F Information 2015
65
Strategic Report Strategic Report
Financial Review continued
As detailed above, all growth rates in
this section are expressed at CER unless
noted otherwise.
Total Revenue
Total Revenue for the year was up 1% at
CER to $24,708 million, comprising Product
Sales of $23,641 million (down 1%) and
Externalisation Revenue of $1,067 million
(up 140%). Based on actual exchange rates,
Total Revenue declined by 7% in the year
reflecting the particular weakness of key
trading currencies against the US dollar.
Product Sales
The decline in Product Sales was driven
by the US market entry of Nexium generic
products from February 2015 as well as
an adverse impact from Synagis guideline
changes in 2014 and the change in
accounting for the US Branded
Pharmaceutical Fee, following issuance
of final regulations in 2014. Further details
of the effect of these regulations are
contained in the Financials (Prior year)
section of the Annual Report from
page 236.
US Product Sales were down 6% to $9,474
million, with Europe down 6% at $5,323
million. Established Markets were flat at
$3,022 million and Emerging Markets were
up 12% to $5,822 million, mainly driven by
growth in China of 15% to $2,530 million.
Further details of our product performance
are contained in the Geographical Review
from page 227.
Our Growth Platforms, which include New
Oncology, grew by 11%, representing 59%
of total Product Sales.
Product Sales of Respiratory medicines
were up 7% ahead of the proposed
acquisition of Takeda’s respiratory business
(as detailed on page 28). Sales of Brilinta/
Brilique in the year were $619 million, an
increase of 44%. The FDA approved Brilinta
tablets at a new 60mg dose to be used by
patients with a history of heart attack
beyond the first year of treatment in 2015.
Our Diabetes Product Sales were 26%
higher than in 2014, which included growth
of 137% on Farxiga/Forxiga with global
sales of $492 million and several successful
launches in the year in a number of
international markets. Product Sales in
Emerging Markets increased by 12% to
$5,822 million in 2015 as we continued to
focus on delivering innovative medicines to
these markets in the year, with a particular
focus on China and other leading markets
such as Russia and Brazil. Product Sales
in Japan increased by 4% to $2,020 million,
with Crestor continuing to grow strongly
in the year, up 8% to $468 million. Global
Product Sales of Crestor declined in the
year by 3% to $5,017 million, which primarily
reflected ongoing competition from generic
statins. Symbicort global Product Sales
declined by 3% to $3,394 million, with sales
in Europe down 14% to $1,076 million, with
a modest volume decline and a significant
price decline reflecting increased competition
from recently-launched analogue medicines.
Global Product Sales of Seroquel XR
declined by 12% to $1,025 million, as a
result of generic product competition.
Externalisation Revenue
The Group updated its revenue accounting
policy with effect from 1 January 2015. As
detailed earlier in the Annual Report, the
Group’s business model now includes an
increasing level of externalisation activity to
broaden and accelerate the development
and commercialisation of, as well as
maximising patient access to, key pipeline
assets in our three main therapy areas.
Historically, our Reported revenue reflected
only Product Sales, with Externalisation
Revenue forming part of other operating
income presented below gross profit.
Reflecting the increased level of
externalisation activity, Externalisation
Revenue, alongside Product Sales, is now
included in Total Revenue. Externalisation
Revenue includes development,
commercialisation and collaboration
Growth Platforms
Respiratory
Brilinta/Brilique
Diabetes
Emerging Markets
Japan
New Oncology
Total Growth Platform Product Sales1
2015
Product Sales
$m
2014
Product Sales
$m
CER growth
%
4,987
619
2,224
5,822
2,020
119
5,063
476
1,870
5,827
2,227
–
14,003
13,928
7
44
26
12
4
n/m
11
2014
$m
–
–
–
–
250
80
69
399
53
452
1 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
Durvalumab (Celgene)
Movantik (Daiichi Sankyo)
Brodalumab (Valeant Pharmaceuticals)
Nexium (Daiichi Sankyo)
Nexium OTC (Pfizer)
Forxiga (Ono Pharmaceuticals)
Others
Total milestones
Royalties
Total Externalisation Revenue
66
AstraZeneca Annual Report and Form 20-F Information 2015
2015
$m
450
200
100
123
–
–
107
980
87
1,067
revenue, such as royalties and milestone
receipts. Income is recorded as
Externalisation Revenue when the Group
has 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 the Group does not retain an interest,
continue to be recorded in other operating
income. The updated financial presentation
was adopted to reflect the Group’s
expanded entrepreneurial approach and is
considered to provide a clearer picture of
this important additional revenue stream.
The updated revenue accounting policy
results in a presentational change to the
results of operations only, and has no
impact on the Group’s net results or net
assets. Prior year comparatives have been
restated to reflect this change, resulting in
$452 million of income being reclassified
from other operating income to
Externalisation Revenue for 2014.
Further details of the arrangements giving
rise to the above revenues are included in
the Investments, divestments and capital
expenditure section of this Financial Review
from page 72.
Gross margin, operating margin and
earnings per share
Core gross margin as a percentage of
Product Sales was 82.6% in the year, 0.8
percentage points higher than last year at
CER due to the mix of Product Sales and
manufacturing efficiencies.
Core R&D expense in the year was up 21%
to $5,603 million, as the Group continued
its focused investment in the pipeline.
Oncology attracted over 40% of total Core
R&D expenditure in the year, reflecting a
number of active trials.
Core SG&A costs declined by 2% to
$9,265 million. Core SG&A costs declined
in the year by 1.1 percentage points as a
proportion of Total Revenue. A number of
ongoing programmes to reduce SG&A
costs are progressing. These initiatives are
centred on: sales, marketing and medical
cost effectiveness; centralisation
of selected functions and process
improvements; reduced third party spend;
additional efficiencies gained across
support functions; and IT and continued
footprint optimisation, including presence
in the UK and US. Resources are being
deployed more selectively to meet changing
customer needs and the evolving portfolio,
while driving top-line growth more efficiently.
Core other operating income in the year was
up 104% at $1,520 million which, in addition
to royalty income of $322 million, includes
$380 million of income on the disposal of
the US rights to Entocort, $215 million on the
disposal of Rest of World rights to Entocort,
$193 million on the disposal of Myalept and
$165 million on the disposal of Caprelsa. As
these elements of our income arose from
product divestments, where AstraZeneca
no longer retains 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.
Core operating profit increased by 6%
to $6,902 million in the year. The Core
operating margin increased by 1.3
percentage points to 27.9% of Total Revenue.
The increase reflected the reduction in
Core SG&A costs and the increase in
Externalisation Revenue and Core other
operating income, while we continued to
invest in our pipeline and Growth Platforms.
Core EPS was $4.26, up 7% compared
with last year (Actual: flat).
Pre-tax adjustments to arrive at Core profit
before tax amounted to $3,312 million in
2015 (2014: $5,192 million), comprising
$2,788 million adjustments to operating
profits (2014: $4,800 million) and $524
million to net finance expenses (2014: $392
million). Excluded from Core results were:
> Restructuring costs totalling $1,034 million
(2014: $1,558 million), incurred as the
Group continued the fourth phase of
restructuring announced in March 2013
and subsequently expanded.
> Amortisation totalling $1,460 million (2014:
$1,784 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). The decrease was driven
by reduced amortisation charges arising
from our Merck exit arrangements (which
commenced in 1998) as certain
associated intangible assets became fully
amortised. Further information on our
intangible assets is contained in Note 9 to
the Financial Statements from page 158.
> Intangible impairment charges of $143
million (2014: $99 million) excluding those
related to IT. Further details relating to
intangible asset impairments are included
in Note 9 to the Financial Statements from
page 158.
> Net cost associated with our acquisition
of BMS’s share of our Global Diabetes
Alliance in February 2014 amounting to
$463 million (2014: $1,423 million).
Included within this are $432 million of
amortisation charges and $409 million
of interest charges relating to a discount
unwind on contingent consideration
arising on the acquisition in 2014, offset
by a contingent consideration fair value
decrease of $378 million reflecting lower
expected Diabetes portfolio revenues in
line with latest forecasts.
> Net legal provisions and other charges of
$211 million (2014: $328 million), including
$115 million discount unwind charges,
offset by $54 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 $211 million
also included legal charges relating to
patent proceedings in the US for
Pulmicort Respules, charges relating to
the unsuccessful defence of the validity of
Crestor-related patents in Australia, and
damages paid to AbbVie following a
contract dispute over Synagis. Further
details of legal proceedings the Group is
currently involved in are contained within
Note 27 to the Financial Statements from
page 186.
Reported operating profit of $4,114 million
was $1,977 million higher than in 2014.
Fair value adjustments to contingent
consideration reduced SG&A costs and
increased Reported operating profit by
$432 million in the current year (2014:
fair value adjustments to contingent
consideration reduced Reported operating
profit by $512 million). These fair value
movements reflected estimates for future
liabilities that can change materially over
time. In addition, restructuring costs of
$1,034 million in 2015 were significantly
lower than restructuring costs of $1,558
million in 2014.
Reported net finance expense was $1,029
million (2014: $885 million). The increase
of $144 million was driven by increased
charges related to the discount unwind
AstraZeneca Annual Report and Form 20-F Information 2015
67
Strategic Report Strategic Report
Financial Review continued
on contingent consideration arising on
business combinations driven by underlying
increases in the contingent consideration
value held on the balance sheet in 2014
(including a full year’s discount unwind on
the contingent consideration arising from
our acquisition of BMS’s share of our Global
Diabetes Alliance).
The Reported taxation charge for the year of
$243 million (2014: $11 million) consisted of
a current tax charge of $633 million (2014:
$872 million) and a credit arising from
movements on deferred tax of $390 million
(2014: $861 million). The current tax charge
included a prior period current tax credit of
$404 million (2014: $109 million).
The Reported tax rate for the year was 8%.
This Reported tax rate was impacted by
a one-off benefit of $186 million following
agreement of US federal tax liabilities of
open years up to 2008, other net reductions
in provisions for tax contingencies partially
offset by the impact of internal transfers of
intellectual property resulting in a net credit
of $181 million and non-Core revaluations of
contingent consideration arising on business
combinations (credit of $432 million with
related tax charge of $39 million). Excluding
these effects, the Reported tax rate for the
year would have been 22%. The Core tax
rate for the year was 16%. Excluding the
benefit following agreement of US federal
tax liabilities of open years up to 2008 and
other net reductions in provisions for tax
contingencies partially offset by the impact
of internal transfers of intellectual property,
the Core tax rate would have been 21%.
The tax paid for the year was $1,354 million
(44% of Reported profit and 21% of Core
profit). The cash tax paid for the year was
$1,111 million higher than the tax charge for
the year as a result of certain items with no
cash impact including the benefit of $186
million following agreement of US federal tax
liabilities of open years up to 2008, other net
reductions in provisions for tax contingencies
of $259 million, $390 million of deferred tax
credits, cash payments made in respect of
audit settlements of $240 million and other
cash tax timing differences.
Reported post-tax profit for the year was
$2,826 million, an increase of 137%.
Reported earnings per share was up 137%
to $2.23.
Total comprehensive income increased by
$2,759 million from the prior year, resulting in
a net income of $2,488 million for 2015. This
was driven by the increase in profit for the
year of $1,591 million and an increase of
$1,168 million in other comprehensive
income. The increase in other comprehensive
income arose principally from gains recorded
on the remeasurement of our defined
benefit pension liability of $652 million
(2014: losses of $766 million) due to an
increase in the discount rate applied to our
pension liabilities reflecting an increase in
corporate bond yields and other reference
interest rate instruments.
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.
Further to the announcement in 2012
of a third phase of the programme, we
announced another restructuring
programme in 2013, which was combined
with the third phase to create a combined
Phase 4 programme. This combined
programme initially entailed an estimated
global headcount reduction of about 5,050
over the 2013 to 2016 period. The combined
programme of changes is estimated to
incur $2.5 billion in one-time restructuring
charges, of which $1.7 billion were expected
to be cash costs, and deliver $800 million of
annualised benefits by the end of 2016.
The Phase 4 programme was expanded in
2013 to include additional activities such as
a transformation of our IT organisation and
infrastructure, the exit of R&D activities in
Bangalore, India, and the exit from branded
generics in certain Emerging Markets to
further reduce costs and increase flexibility.
When completed, the expanded restructuring
programme is expected to deliver a further
$300 million in annual benefits by the end of
2016, bringing total anticipated annualised
benefits of the Phase 4 programme to $1.1
billion, and to affect a further approximately
550 positions, bringing the total global
headcount reduction under the Phase 4
programme to around 5,600 over the
2013 to 2016 period. Total incremental
programme costs from these new initiatives,
together with revisions to cost estimates for
the original programme, are estimated to be
$700 million, of which $600 million is cash,
bringing the total anticipated cost of our
Phase 4 programme to $3.2 billion by the
end of 2016.
In addition to this programme, we
announced an additional $600 million of
restructuring costs which are estimated to
be incurred by the end of 2016 (of which
$494 million were incurred by the end of
2015), associated with previously-announced
site exits (including Avlon in the UK) and the
integration of the Diabetes and Respiratory
businesses acquired from BMS and Almirall,
respectively. We anticipate that, once
completed, the total annualised benefits of
these additional actions will be $200 million.
During the latter part of 2015, the Company
implemented further targeted restructuring
of our commercial business, principally in
Venezuela (in response to challenging
economic conditions) and Europe. This
resulted in $102 million of restructuring costs
and is expected to deliver $30 million of
annualised benefit in 2016. Furthermore, as
part of the Company’s ongoing commitment
to improve productivity, we are initiating
multi-year transformation programmes
within our G&A functions (principally Finance
and HR) with anticipated costs by the end of
2018 of $270 million. Once complete, we
expect these transformation programmes to
deliver annualised benefits of $100 million by
the end of 2018.
The aggregate restructuring charges
incurred in 2015 across all our restructuring
programmes was $1,034 million, as we
continued to make progress in
implementing our restructuring plans.
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.
Earnings before interest, tax, depreciation,
amortisation and impairments includes
adjustments for amortisation and
depreciation charges of $2,676 million (2014:
$3,160 million) and interest of $1,029 million
(2014: $885 million) including $570 million
(2014: $453 million) for discount unwinds.
68
AstraZeneca Annual Report and Form 20-F Information 2015
Cash flow and liquidity – 2015
All data in this section is on a Reported basis.
Summary cash flows
Net (debt)/funds brought forward at 1 January
Earnings before interest, tax, depreciation, amortisation and impairment (EBITDA)
Movement in working capital and short-term provisions
Tax paid
Interest paid
Gains on disposal of intangible assets
Non-cash and other movements
Net cash available from operating activities
Purchase of intangibles (net)
Upfront payments on business acquisition
Payment of contingent consideration on business acquisitions
Other capital expenditure (net)
Investments
Dividends
Share proceeds
Distributions
Other movements
Net (debt)/funds carried forward at 31 December
Net debt/funds reconciliation
Cash and cash equivalents
Short-term investments
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)/funds
2015
$m
(3,223)
6,966
(49)
(1,354)
(496)
(961)
(782)
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
5,419
2,508
(1,201)
(533)
–
865
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)
2013
$m
(1,369)
8,295
166
(844)
(475)
–
258
7,400
(1,281)
(1,158)
–
(673)
(3,112)
(3,461)
482
(2,979)
99
39
2013
$m
9,217
796
402
10,415
(992)
(102)
(766)
(8,516)
(10,376)
39
Net cash generated from operating activities
was $3,324 million in the year ended 31
December 2015, compared with $7,058
million in 2014. Working capital increased by
$49 million in the year. This compared to a
decline of $2,508 million in 2014 which was
driven by a significantly higher level of rebate
accruals in the US, the phasing of costs
increasing accruals in the fourth quarter of
2014 and the accrual of an additional year’s
US Branded Pharmaceutical Drug Fee
following the change of regulations in 2014.
In the current year, the liabilities in relation
to these items normalised and, in addition,
rebate accruals were further reduced
following the loss of exclusivity for Nexium.
Gains on disposal of intangible assets
of $961 million includes $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. Non-cash and other
movements decreased operating
cash by $782 million and included
$432 million relating to fair value
adjustments on contingent consideration
arising on business combinations
(2014: increased operating cash by
$865 million including $512 million
increase on contingent consideration
arising on business combinations).
Investment cash outflows of $4,681 million
(2014: $7,125 million) included $2,446 million
relating to the acquisition of ZS Pharma.
This compared to cash payments relating
to business acquisitions in 2014 of $4,461
million, primarily related to the BMS diabetes
alliance and Almirall acquisitions. Further
details of business combination acquisitions
and their impact on our cash flows and
balance sheet are given in the table on page
72. Investment cash outflows also include
$579 million (2014: $657 million) of payments
against contingent consideration arising on
business combinations and $1,460 million
(2014: $1,740 million) for the purchase of
other intangible assets, which included
$684 million on the acquisition of the rights
to Actavis’ branded respiratory portfolio
in the US and Canada. The comparative
AstraZeneca Annual Report and Form 20-F Information 2015
69
Strategic Report Strategic Report
Financial Review continued
Bonds issued in 2015
Floating rate notes
1.750% Callable bond
2.375% Callable bond
3.375% Callable bond
4.375% Callable bond
Total
Repayment
dates
Face value
of bond
$m
Net book value
of bond at
31 December
2015
$m
2018
2018
2020
2025
2045
400
1,000
1,600
2,000
1,000
6,000
399
997
1,586
1,971
976
5,929
period of 2014 included a $409 million
payment to Merck on the consummation
of our Second Option and $310 million on
the settlement of pre-existing launch and
sales-related milestones with BMS.
Investment cash inflows include $1,130
million (2014: $nil) from the sale of intangible
assets, including 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. Further details of
the divestments giving rise to our investment
cash inflows are included in the Investments,
divestments and capital expenditure section
of this Financial Review from page 72.
Net cash distributions to shareholders
were $3,443 million (2014: $3,242 million)
including dividends of $3,486 million (2014:
$3,521 million). Proceeds from the issue
of shares on the exercise of share options
amounted to $43 million (2014: $279 million).
In November 2015, the Group 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.
Off-balance sheet transactions and
commitments
We have no off-balance sheet arrangements
and our derivative activities are non-
speculative. The table below sets out our
minimum contractual obligations at the
year end.
In 2015, the Group repaid a 5.125%
non-callable euro bond which had a
31 December 2014 carrying value of
$912 million.
At 31 December 2015, outstanding gross
debt (interest-bearing loans and borrowings)
was $15,053 million (2014: $10,843 million).
Of the gross debt outstanding at 31
December 2015, $916 million is due within
one year (2014: $2,446 million). Net debt at
31 December 2015 was $7,762 million,
compared to $3,223 million at the beginning
of the year, as a result of the net cash
outflow as described above.
In 2015, net assets decreased by $1,137
million to $18,509 million. The decrease in
net assets is broadly as a result of dividends
of $3,537 million and adverse movements
on exchange taken to reserves of $861
million, partially offset by the Group profit
of $2,826 million.
Business combinations
In 2015, we completed the acquisition of
ZS Pharma. In 2014, we completed the
acquisition of BMS’s share of our Global
Diabetes Alliance, the acquisition of the
rights to Almirall’s respiratory franchise and
the acquisition of the Definiens Group.
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
1,419
4,183
3,469
66
95
518
63
148
–
12
97
–
Over
5 years
$m
14,192
–
69
–
2015
Total
$m
2014
Total
$m
23,263
17,261
141
409
518
130
438
438
2,098
4,394
3,578
14,261
24,331
18,267
1 Bank loans and other borrowings include interest charges payable in the period, as detailed in Note 25 to the Financial Statements on page 177.
70
AstraZeneca Annual Report and Form 20-F Information 2015
Financial position – 31 December 2015
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
Investment in joint ventures
Net (debt)/funds
Net assets
2015
$m
Movement
$m
6,413
34,514
2,143
7,529
(19,120)
(1,242)
(1,096)
(1,439)
403
1,983
183
(815)
757
(135)
929
(862)
2014
$m
6,010
32,531
1,960
8,344
(19,877)
(1,107)
(2,025)
(577)
Movement
$m
192
6,503
51
(1,402)
(7,163)
282
557
1,045
2013
$m
5,818
26,028
1,909
9,746
(12,714)
(1,389)
(2,582)
(1,622)
(1,974)
977
(2,951)
(690)
(2,261)
458
85
(44)
26
502
59
221
59
(7,762)
(4,539)
(3,223)
(3,262)
281
–
39
18,509
(1,137)
19,646
(3,607)
23,253
Further information on our business
combinations can be found in the
Investments, divestments and capital
expenditure section of the Financial Review
from page 72.
Property, plant and equipment
Property, plant and equipment increased
by $403 million to $6,413 million. Additions
of $1,422 million (2014: $1,607 million),
including $21 million (2014: $515 million)
arising from business combinations, were
offset by depreciation of $677 million (2014:
$776 million), impairments of $28 million
(2014: $nil) and disposals of $70 million
(2014: $582 million).
Goodwill and intangible assets
The Group’s goodwill of $11,868 million
(2014: $11,550 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 $456 million arising on the
acquisition of ZS Pharma was capitalised
in 2015.
Intangible assets amounted to $22,646
million at 31 December 2015 (2014: $20,981
million). Intangible asset additions were
$4,640 million in 2015 (2014: $8,548 million),
including product rights acquired in the
acquisition of ZS Pharma of $3,162 million
(2014: $7,501 million on 2014 business
combinations). Amortisation in the year
was $1,999 million (2014: $2,384 million).
Impairment charges in the year amounted
to $148 million (2014: $122 million), including
$64 million for AMP-110 and $35 million
for Ardelyx. Disposals of intangible assets
totalled $169 million in the year (2014: $nil)
including $123 million on the sale of global
rights to Myalept.
Further details of our additions to intangible
assets, and impairments recorded, are
included in Note 9 to the Financial
Statements from page 158.
Receivables, payables and provisions
Trade and other receivables decreased
by $815 million with trade receivables
reduced by $129 million to $4,633 million
and prepayments and accrued income
increasing by $20 million. Non-current other
receivables decreased by $205 million to
$907 million driven by a reduction in the
Shionogi Crestor royalty prepayment as
detailed in Note 13 to the Financial
Statements on page 162.
Trade and other payables decreased by
$757 million in 2015 to $19,120 million,
including $223 million lower rebates and
chargebacks, and $571 million in other
non-current payables. Non-current payables
includes the long-term element of
contingent consideration, which as
indicated above, included an adjustment
of $432 million to the total fair value in 2015,
and the accrual for our minimum committed
Shionogi Crestor royalty payments.
The increase in provisions of $135 million
in 2015 included $706 million of additional
charges recorded in the year, partially offset
by $557 million of cash payments. Included
within the $706 million of charges for the
year were $338 million for our global
restructuring initiatives and $313 million in
respect of legal charges. Cash payments
included $408 million for our global
restructuring programmes. Further details
of the charges made against provisions
are contained in Notes 19 and 27 to the
Financial Statements on page 165, and 186
to 192, respectively.
Tax payable and receivable
Net income tax payable has decreased by
$929 million to $1,096 million, principally
due to a $186 million adjustment following
agreement of US federal tax liabilities of
open years up to 2008, other net reductions
in provisions for tax contingencies ($259
million), cash payments made in respect of
audit settlements ($240 million) and foreign
exchange ($194 million). The tax receivable
balance of $387 million (2014: $329 million)
AstraZeneca Annual Report and Form 20-F Information 2015
71
Strategic Report Strategic Report
Financial Review continued
comprises tax owing to AstraZeneca from
certain governments expected to be
received on settlements of transfer pricing
audits and disputes ($192 million) (see Note
27 to the Financial Statements from page
186) and cash tax timing differences ($195
million). Net deferred tax liabilities increased
by $862 million in the year mainly due to
deferred tax liabilities arising from the
acquisition of ZS Pharma. Additional
information on the movement in deferred tax
balances is contained in Note 4 to the
Financial Statements from page 151.
Retirement benefit obligations
Net retirement benefit obligations decreased
by $977 million in 2015 (2014: increase of
$690 million). Employer contributions to
the pension scheme of $402 million, net
remeasurement adjustments of $652 million
driven by an increase in the discount rate
applied to our pension liabilities under IAS
19 and beneficial exchange movements of
$182 million were offset by service cost
charges of $167 million and net financing
costs of $77 million. Benefits paid amounted
to $580 million (2014: $571 million).
Approximately 97% of the Group’s
obligations are concentrated in the UK, the
US, Sweden and Germany. In recent years,
the Group has undertaken several initiatives
to reduce its net pension obligation
exposure. For the UK defined benefit
pension scheme, which is AstraZeneca’s
largest defined benefit scheme, these
initiatives have included agreeing funding
Business combinations
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. In
addition to the cash contributions to be paid
into the UK pension scheme, AstraZeneca
makes contributions to an escrow account
which is held outside the pension scheme.
The escrow account assets are payable
to the fund in agreed circumstances, for
example, in the event of AstraZeneca and
the pension fund trustee agreeing a change
to the current long-term investment strategy.
the Financial Statements from page 186.
As detailed in Note 27 to the Financial
Statements, 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,
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.
Further details of the Group’s pension
schemes are included in Note 20 to the
Financial Statements from page 166.
Commitments and contingencies
The Group has 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 144. The Group also has taxation
contingencies. These are described in the
Taxation section in the Critical accounting
policies and estimates section on page 81
and in Note 27 to the Financial Statements
from page 186.
Investments, divestments and capital
expenditure
The Group has completed over 240 major
or strategically important business
development transactions over the past
three years, eight of which were accounted
for as business acquisitions under IFRS 3
‘Business Combinations’, being 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 2014; and Pearl Therapeutics,
Omthera, Amplimmune and Spirogen in
2013, and all others being in-licences,
strategic alliances and collaborations.
Research and development collaboration
payments
Details of future potential R&D collaboration
payments are also included in Note 27 to
Fair values of assets and liabilities acquired,
and consideration for the acquisitions in
2015 and 2014, as at the acquisition date,
are summarised below.
Assets acquired:
Non-current assets
Property, plant and equipment
Goodwill
Intangible assets
Current assets
Current liabilities
Non-current liabilities
Total assets
Consideration:
Upfront consideration
Contingent consideration
Total consideration
72
AstraZeneca Annual Report and Form 20-F Information 2015
2015
2014
BMS’s share of
diabetes
alliance
$m
ZS Pharma
$m
Rights to
Almirall’s
respiratory
franchise
$m
Definiens
Group
$m
21
456
3,162
169
(50)
(1,058)
2,700
2,700
–
2,700
478
1,530
5,746
480
(278)
(84)
7,872
2,703
5,169
7,872
37
311
1,400
24
(2)
(11)
1,759
878
881
1,759
–
–
355
–
–
(117)
238
150
88
238
2014
total
$m
515
1,841
7,501
504
(280)
(212)
9,869
3,731
6,138
9,869
Contingent consideration arising on business combinations
At 1 January
Acquisitions
Settlements
Fair value adjustments
Discount unwind
Foreign exchange
At 31 December
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
acquisition of ZS Pharma in the year 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 $1.2 billion for future
development, launch, and sales-related
milestones and various other sales-related
payments. 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’.
2015
2014
Acquisition of
BMS’s share
of diabetes
alliance
$m
Other
business
combinations
$m
5,386
–
(325)
(378)
409
–
1,513
–
(254)
(54)
115
(1)
Acquisition of
BMS’s share of
diabetes
alliance
$m
Other
business
combinations
$m
–
5,169
(657)
529
345
–
514
969
–
(17)
46
1
Total
2015
$m
6,899
–
(579)
(432)
524
(1)
Total
2014
$m
514
6,138
(657)
512
391
1
5,092
1,319
6,411
5,386
1,513
6,899
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 2015, we recorded
an interest charge of $524 million on
the discount unwind on contingent
consideration arising on our business
combinations, and a net fair value decrease
on contingent consideration of $432 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. At 31 December
2015, our contingent consideration balance
held on the balance sheet amounted to
$6,411 million (2014: $6,899 million) with
the movements of the balance detailed
in the table above.
Further details of our business acquisitions
in the past three years are contained in
Note 24 to the Financial Statements from
page 173. Details of our significant business
development transactions are given below:
> In September 2015, AstraZeneca
announced that it had entered into a
collaboration agreement with Valeant
under which it 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 Inc.
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 AstraZeneca 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, AstraZeneca
and Valeant will share profits.
> In April 2015, AstraZeneca entered into
two oncology agreements with Innate
Pharma S.A (Innate), firstly, a licence
which provides AstraZeneca 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. Currently in
Phase II development, IPH2201 is a
potential first-in-class humanised IgG4
antibody. Under the terms of the
combination licence, AstraZeneca
assumed exclusive Global rights to
research, develop, and commercialise
IPH2201 in combination with durvalumab.
AstraZeneca and Innate jointly fund
Phase II studies and AstraZeneca leads
the execution of these studies. Under the
terms of the agreements, AstraZeneca
made an initial payment to Innate 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. AstraZeneca
records all sales and will pay Innate
double-digit royalties on net sales. The
arrangement includes the right for Innate
to co-promote in Europe for a 50% profit
share in the territory.
> In April 2015, AstraZeneca signed a
Collaboration and License Agreement
with Celgene Corporation, a global leader
AstraZeneca Annual Report and Form 20-F Information 2015
73
Strategic Report Strategic Report
Financial Review continued
in haematological cancers, to develop
and commercialise durvalumab across
a range of blood cancers including
non-Hodgkin lymphoma, myelodysplastic
syndromes and multiple myeloma.
Durvalumab is an investigational immune
checkpoint inhibitor, directed against
programmed cell death ligand 1 (PD-L1).
Signals from PD-L1 help tumours avoid
detection by the immune system.
Durvalumab blocks these signals,
countering the tumour’s immune-evading
tactics. Under the terms of the
agreement, Celgene made an upfront
payment of $450 million to AstraZeneca in
relation to durvalumab, which is recorded
within Externalisation Revenue. Celgene
will lead on development across all clinical
trials within the collaboration and have
taken on all research and development
costs until the end of 2016, after which
they will take on 75% of these costs.
Celgene will also be responsible for
global commercialisation of approved
treatments. AstraZeneca 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, AstraZeneca announced
a co-commercialisation agreement with
Daiichi Sankyo, Inc. for Movantik in the
US. Movantik is a first-in-class once-daily
oral peripherally-acting mu-opioid
receptor antagonist (PAMORA) for
opioid-induced constipation (OIC). Opioids
play an important role in chronic pain relief
and work by binding to mu-receptors in
the central nervous system, but they also
bind to mu-receptors in the gastrointestinal
tract, which can result in patients suffering
from OIC. The drug was launched on
31 March 2015. Under the terms of the
agreement, Daiichi Sankyo Inc. 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. AstraZeneca will be responsible for
manufacturing, will record all sales and
will make sales-related commission
payments to Daiichi Sankyo, Inc. Both
companies will be jointly responsible
for commercial activities.
> In March 2015, AstraZeneca completed
the acquisition of the rights to Actavis Plc’s
branded respiratory business in the US
and Canada. The deal gave AstraZeneca
the ownership of the development
and commercial rights in the US and
Canada to Tudorza Pressair (aclidinium
bromide inhalation powder), a twice-daily
long-acting muscarinic antagonist (LAMA)
for COPD, and to Daliresp (roflumilast),
the only once-daily oral PDE4 inhibitor
currently on the market for COPD,
in the US. AstraZeneca also owns the
development rights in the US and Canada
for LAS40464, a combination of a fixed
dose of aclidinium with formoterol
long-acting beta-agonist (LAMA/LABA)
in a dry powder inhaler, which is approved
in the EU under the brand name Duaklir
Genuair. On completion of the acquisition,
AstraZeneca paid Actavis $600 million
and agreed to pay low single-digit
royalties above a certain revenue threshold.
> In September 2014, AstraZeneca and
Lilly entered into an agreement 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. AZD3293 is an oral, potent and
selective small molecule inhibitor of
BACE that has been shown in Phase I
studies to significantly and dose-
dependently reduce levels of amyloid
beta in the cerebro-spinal fluid of
Alzheimer’s patients and healthy
volunteers. Under the terms of the
agreement, Lilly will pay AstraZeneca
up to $500 million in development
and regulatory milestone payments.
AstraZeneca received the first milestone
payment of $50 million in 2015.
The companies will equally share
all future costs for the development
and commercialisation of AZD3293,
as well as net global revenues
post-launch. Lilly will lead clinical
development, working with researchers
from AstraZeneca’s Innovative Medicines
Unit for neuroscience, while AstraZeneca
will be responsible for manufacturing.
The companies will take joint responsibility
for commercialisation of AZD3293.
> In July 2013, AstraZeneca 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 CKD and ESRD. This broad
collaboration focuses on the US, China
and all major markets excluding Japan,
Europe, the CIS, the Middle East and
74
AstraZeneca Annual Report and Form 20-F Information 2015
South Africa, which are covered by an
existing agreement between FibroGen
and Astellas. The AstraZeneca-FibroGen
joint effort will be focused on the
development of roxadustat to treat
anaemia in CKD and ESRD, and may be
extended to other anaemia indications.
AstraZeneca and FibroGen plan to
undertake an extensive roxadustat Phase
III development programme for the US,
and to initiate Phase III trials in China, with
anticipated regulatory filings in China in
2016 and in the US in 2018. Under the
arrangement, AstraZeneca 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.
AstraZeneca 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
AstraZeneca will oversee promotional
activities and commercial distribution.
> In March 2013, AstraZeneca signed an
exclusive agreement with Moderna
Therapeutics 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, AstraZeneca
made an upfront payment of $240 million.
AstraZeneca will have exclusive access
to select any target of its 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
Therapeutics is entitled to an additional
$180 million for the achievement of
three technical milestones. Through this
agreement, AstraZeneca has the option
to select up to 40 drug products for
clinical development and Moderna
Therapeutics will be entitled to
development and commercial milestone
payments as well as royalties on drug
sales. AstraZeneca will lead the
pre-clinical, clinical development and
commercialisation of therapeutics
resulting from the agreement and
Moderna Therapeutics will be responsible
for designing and manufacturing the
messenger RNA Therapeutics against
selected targets. AstraZeneca is 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.
The Group determines 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.
In aggregate, payments capitalised under
the Group’s externalisation arrangements,
other than those detailed above, amounted
to $1,401 million in 2015 (2014: $201 million),
including $684 million on the acquisition of
the Actavis branded respiratory portfolio in
the US and Canada.
Details of our significant divestments are
given below:
> In November 2015, AstraZeneca signed
an agreement with Elan Pharma
International Limited, part of the Perrigo
Group (Perrigo), for the divestment of
rights to the Entocort business in US. The
Entocort business in the US consisted of
a branded product marketed by
AstraZeneca (Entocort EC) and an
authorised generic marketed by PAR
Pharmaceuticals under an exclusive
distribution agreement. Under the terms
of the agreement, Perrigo paid
AstraZeneca $380 million upon
completion of the transaction to acquire
the rights to sell Entocort capsules and
the authorised generic Entocort capsules
marketed by Par Pharmaceuticals. The
transaction involved the full divestment of
US rights in Entocort, including relevant
clinical data, regulatory documentation
and contracts, and inventory of finished
pack Entocort EC and authorised generic
capsules. The transaction did not include
the transfer of any AstraZeneca
employees or facilities.
> In September 2015, AstraZeneca
completed an agreement with Genzyme
Corporation (Genzyme), part of Sanofi
S.A., for the divestment of Caprelsa,
a rare-disease medicine. Caprelsa was
granted Orphan Drug Designation by
the US FDA in 2005 and is currently
available in 28 countries for the treatment
of aggressive and symptomatic medullary
thyroid carcinoma. Under the terms of the
agreement, Genzyme paid an upfront
payment of $165 million to acquire the
global rights to sell and develop Caprelsa,
and further development and sales
milestone payments of up to $135 million.
The transaction did not include the
transfer of any AstraZeneca employees
or facilities.
> In July 2015, AstraZeneca signed an
agreement with Tillotts Pharma AG for the
divestment of global rights, outside the
US, to Entocort (budesonide). Entocort is
a gastroenterology medicine for patients
with mild to moderate Crohn’s disease
and ulcerative colitis. Entocort is currently
available in over 40 countries, with total
Product Sales of $53 million outside the
US in 2014. Under the terms of the
agreement, Tillotts paid AstraZeneca
$215 million upon completion of the
transaction to acquire the rights to sell
and develop Entocort capsules and
enema formulations outside the US. The
transaction did not include the transfer of
any AstraZeneca employees or facilities.
> In January 2015, AstraZeneca completed
an agreement with Aegerion
Pharmaceuticals, to divest Myalept
(metreleptin for injection). Myalept was
originally developed by Amylin and
acquired by BMS in collaboration
with AstraZeneca in July 2012 and
subsequently acquired in whole by
AstraZeneca in February 2014. Aegerion
paid AstraZeneca $325 million, in a single
upfront payment, to acquire the global
rights to develop, manufacture and
commercialise Myalept, subject to an
existing distributor licence with Shionogi
covering Japan, South Korea, and
Taiwan. On completion, the Myalept
intangible was $123 million, which was
derecognised along with inventory of
$9 million, resulting in a gain on disposal
of $193 million being recognised as
other operating income.
Capitalisation
The total number of shares in issue at
31 December 2015 was 1,264 million (2014:
1,263 million). One million Ordinary Shares
were issued in consideration of share
option exercises for a total of $43 million.
Shareholders’ equity decreased by $1,137
million to $18,490 million at the year end.
Non-controlling interests were $19 million
(2014: $19 million).
Dividend and share repurchases
The Board has recommended a second
interim dividend of $1.90 (131.0 pence,
16.26 SEK) to be paid on 21 March 2016.
This brings the full year dividend to $2.80
(188.5 pence, 23.97 SEK). Based on a
measure of Core earnings per share against
Core operating profit, the Group has a
dividend cover ratio of 1.5 with respect to
2015 (2014: 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.
AstraZeneca Annual Report and Form 20-F Information 2015
75
Strategic Report Strategic Report
Financial Review continued
Capitalisation and shareholder return
Dividends for 2015
First interim dividend
Second interim dividend
Total
Summary of shareholder distributions
$
0.90
1.90
2.80
Pence
57.5
131.0
188.5
SEK
Payment date
7.71 14 September 2015
16.26
23.97
21 March 2016
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Total
Shares
repurchased
(million)
9.4
23.5
28.3
27.2
50.1
67.7
72.2
79.9
13.6
–
53.7
127.4
57.8
–
–
–
Cost
$m
352
1,080
1,190
1,154
2,212
3,001
4,147
4,170
610
–
2,604
6,015
2,635
–
–
–
Dividend per
share
$
Dividend
cost
$m
Shareholder
distributions
$m
0.70
0.70
0.70
0.795
0.94
1.30
1.72
1.87
2.05
2.30
2.55
2.80
2.80
2.80
2.80
2.80
1,236
1,225
1,206
1,350
1,555
2,068
2,649
2,740
2,971
3,339
3,604
3,653
3,496
3,522
3,537
3,5391
41,690
1,588
2,305
2,396
2,504
3,767
5,069
6,796
6,910
3,581
3,339
6,208
9,668
6,131
3,522
3,537
3,539
70,860
610.8
29,170
29.625
1 Total dividend cost estimated based upon number of shares in issue at 31 December 2015.
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.
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, and to
achieve $45 billion Total Revenue by 2023
(based on constant exchange rates).
We expect 2016 Total Revenue to decline by
low to mid single-digit percent at CER
compared to 2015. Core R&D costs as a
percentage of Total Revenue are expected
to be broadly in line with 2015. We are also
committed to reducing Core SG&A costs in
2016 versus 2015. Core earnings per share
is expected to decrease in 2016 by low to
mid single-digit percent at CER. This
guidance incorporates the dilutive effects
arising from recent transactions.
Financial risk management
Financial risk management policies
Insurance
Our risk management processes are
described in Risk overview from page 21.
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 the Group has not purchased in
the market product liability insurance since
February 2006.
Taxation
Tax risk management forms an integrated
part of the Group’s risk management
processes. Our tax strategy is to manage
tax risks and tax costs in a manner
consistent with shareholders’ best long-term
interests, taking into account both economic
and reputational factors. We draw a
distinction between tax planning using
artificial structures and optimising tax
treatment of business transactions, and we
engage only in the latter.
76
AstraZeneca Annual Report and Form 20-F Information 2015
Treasury
The principal financial risks to which the
Group is exposed are those arising from
liquidity, interest rate, foreign currency and
credit. The Group has 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, the Group’s 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 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 25 to the Financial Statements
from page 177 and in Risk overview from
page 21.
Sensitivity analysis of the Group’s exposure
to exchange rate and interest rate
movements is also detailed in Note 25 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 144. 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
> 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. Income from royalties and from
disposals of IP, brands and product lines
is included in other operating income.
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. Chargebacks are paid directly
to the wholesalers.
> Regulatory, including Medicaid and other
federal and state programmes, where we
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 $13,993
million in 2015 (2014: $13,181 million) with
increases in adjustments for regulatory and
chargebacks, and sales initiatives recorded
within other, driving the movement.
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 2015
77
Strategic Report Strategic Report
Financial Review continued
Gross to net Product Sales – US pharmaceuticals
Gross Product Sales
Chargebacks
Regulatory – US government and state programmes
Contractual – Managed-care and group purchasing organisation rebates
Cash and other discounts
Customer returns
Other
Net Product Sales
Movement in provisions – US pharmaceuticals
Chargebacks
Regulatory – US government and state programmes
Contractual – Managed-care and group purchasing organisation rebates
Cash and other discounts
Customer returns
Other
Total
Chargebacks
Regulatory – US government and state programmes
Contractual – Managed-care and group purchasing organisation rebates
Cash and other discounts
Customer returns
Other
Total
Chargebacks
Regulatory – US government and state programmes
Contractual – Managed-care and group purchasing organisation rebates
Cash and other discounts
Customer returns
Other
Total
78
AstraZeneca Annual Report and Form 20-F Information 2015
2015
$m
2014
$m
2013
$m
23,467
23,301
21,345
(2,985)
(1,714)
(7,543)
(472)
(333)
(946)
(2,794)
(1,389)
(7,730)
(436)
(295)
(537)
(2,449)
(1,435)
(6,918)
(399)
(112)
(341)
9,474
10,120
9,691
Brought
forward at
1 January
2015
$m
Provision for
current year
$m
Adjustment in
respect of
prior years
$m
Returns and
payments
$m
Carried
forward at
31 December
2015
$m
457
707
2,366
33
318
163
3,019
1,809
7,666
464
349
947
(34)
(95)
(123)
8
(16)
(1)
(3,118)
(1,644)
(7,703)
(461)
(184)
(923)
324
777
2,206
44
467
186
4,044
14,254
(261)
(14,033)
4,004
Brought
forward at
1 January
2014
$m
355
784
1,714
32
222
74
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
537
(155)
27
–
–
–
(1,466)
(7,078)
(435)
(199)
(448)
707
2,366
33
318
163
3,181
13,353
(172)
(12,318)
4,044
Brought
forward at
1 January
2013
$m
313
825
1,348
33
211
45
Provision for
current year
$m
2,439
Adjustment in
respect of
prior years
$m
10
Returns and
payments
$m
(2,407)
Carried
forward at
31 December
2013
$m
355
1,447
6,951
399
99
341
(12)
(33)
–
13
–
(1,476)
(6,552)
(400)
(101)
(312)
784
1,714
32
222
74
2,775
11,676
(22)
(11,248)
3,181
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 2015 net US pharmaceuticals
revenue by 2.8% (2014: 1.7%; 2013: 0.2%).
However, taking into account the
adjustments affecting both the current and
the prior year, 2014 revenue would have
been increased by 0.9% and 2013 revenue
would have been increased by 1.5%, by
adjustments between years.
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 66, the Group’s
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 is underpinned by our
marketed products and development
portfolio. The R&D expenditure on internal
activities to generate these products is
generally charged to profit in the year
that it is incurred. Purchases of IP and
product rights to supplement our R&D
portfolio are capitalised as intangible
assets. Further details of this policy are
included in the Group Accounting Policies
section of our Financial Statements from
page 144. Such intangible assets are
amortised from the launch of the underlying
products and are tested for impairment
both before and after launch. This policy
is in line with practice adopted by major
pharmaceutical companies.
Impairment testing of goodwill and
intangible assets
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 157. 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 AstraZeneca’s 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
AstraZeneca Annual Report and Form 20-F Information 2015
79
Strategic Report Strategic Report
Financial Review continued
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 24 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 2015 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 158.
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 27 to the Financial Statements from
page 186.
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 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, 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. 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 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
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 166.
80
AstraZeneca Annual Report and Form 20-F Information 2015
Strategic Report
The Strategic Report, which has been
prepared in accordance with the
requirements of the Companies Act
2006, comprises the following sections
> AstraZeneca at a glance
> Chief Executive Officer’s Review
> Strategy
> 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
4 February 2016
treasury operations and taxation, 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 2015 and
the assessment is set out in the Directors’
Responsibilities for, and Report on, Internal
Control over Financial Reporting on
page 135. KPMG LLP has audited the
effectiveness of our internal control over
financial reporting at 31 December 2015
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 136, their report is unqualified.
Taxation
Accruals for tax contingencies require
management to make judgements and
estimates in relation to tax audit issues and
exposures. Amounts accrued are based on
management’s interpretation of country-
specific tax law and the likelihood of
settlement. Tax benefits are not recognised
unless the tax positions are probable of
being sustained. 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. Any recorded exposure
to interest on tax liabilities is provided for
in the tax charge.
AstraZeneca faces a number of transfer
pricing audits in jurisdictions around the
world and, in some cases, is in dispute
with the tax authorities. These disputes
usually result in taxable profits being
increased in one territory and
correspondingly decreased in another.
Our balance sheet positions for these
matters reflect appropriate corresponding
relief in the territories affected.
Further details of the estimates and
assumptions we make in determining our
recorded liability for transfer pricing audits
and other tax contingencies are included in
the Tax section of Note 27 to the Financial
Statements on page 192.
Sarbanes-Oxley Act Section 404
As a consequence of our NYSE listing,
AstraZeneca is 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, such
as financial consolidation and reporting,
AstraZeneca Annual Report and Form 20-F Information 2015
81
Strategic Report Chairman’s Statement
…we are integrating
sustainability into how we
measure the success with
which we are delivering our
strategic priorities.”
The Board of Directors has sought to ensure that
AstraZeneca’s achievements in 2015 were underpinned
by strong corporate governance. Our efforts were also
focused on ensuring that the Group’s future success
is supported by corporate governance best practice.
Governance in support of our strategy
In his introduction to the Strategic Report,
our Chief Executive Officer, Pascal Soriot,
outlined a successful year for AstraZeneca
in implementing our strategy. The chart
overleaf summarises the governance
structure we have in place to ensure that
the Board is able properly to discharge
its responsibilities in setting that strategy,
as well as monitoring and reviewing its
progress, and ensuring that we manage our
risks and carry out business responsibly.
I would like to thank Graham Chipchase
for assuming the role of Chairman of the
Remuneration Committee after John Varley
stood down at last year’s AGM, having
spent nine years as a Non-Executive
Director. The Directors’ Remuneration
Report can be found from page 103 and
Graham’s Committee plays an essential role
in ensuring that the interests of the Executive
Directors and other senior leaders are
aligned with the interests of shareholders
over the short, medium and longer term.
Another important part of our work
is listening to the views of external
stakeholders, whether they are medical
practitioners and clinical researchers, or
representatives of investors and financial
institutions. We also maintain an active
dialogue with shareholders about executive
remuneration. Looking ahead, we will be
spending more time considering succession
planning to ensure we have the leaders
we need to deliver our goal of sustainable
growth over the longer term.
Committees of the Board
The Board’s work is supported by four
principal Committees and I am grateful
to their members, and especially their
Chairmen, for the role they play in the
robust governance of AstraZeneca.
Thanks are also due to Bruce Burlington
who became Chairman of the Science
Committee during the year, in succession
to Nancy Rothwell, who also stood down at
last year’s AGM, having spent nine years as
a Board member. This Committee provides
assurance to the Board on the quality,
competitiveness and integrity of our science.
Both of these Committees were
strengthened further during the year when
Shriti Vadera and Cori Bargmann (who was
elected for the first time as a Non-Executive
Director at our AGM in 2015) became
members respectively of the Remuneration
Committee and the Science Committee.
John Varley had also undertaken the
important role of Senior independent
Non-Executive Director. I am grateful to
Rudy Markham for taking on this role.
Transparent reporting
Rudy also chairs the Audit Committee which
has a crucial role in reviewing our financial
reporting, risk management and financial
controls. We aim to be as transparent as we
can in our reporting and, with that in mind,
in preparing our viability statement which is
on page 21 of this Annual Report, we also
reviewed our principal risks, how we
describe them and the information we
provide about them. I am grateful to the
members of the Audit Committee for
their thorough work in undertaking a
competitive tender process for our external
audit services in line with best practice.
As a result of this, the Board will be
recommending the appointment of
PricewaterhouseCoopers LLP at our
AGM in 2017.
A sustainable business
Geneviève Berger is another valued
member of the Board and the Science
Committee. She also performs a vital role
in overseeing AstraZeneca’s sustainability
framework and reporting to the Board.
For AstraZeneca, sustainability means
implementing our strategy and delivering
the targets we have set ourselves in a way
that promotes the long-term health of
AstraZeneca, the societies in which we
work, and the planet. Employees and
external stakeholders expect it and
AstraZeneca’s future ability to get new
medicines to patients in the most efficient
82
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance 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.
way depends on it. Moreover, it helps
attract and retain talented employees and
enhances trust in our business and our
reputation. In acting in this way, we not
only protect our licence to operate but also
deliver value to those who benefit from our
medicines, our shareholders, society and
the environment.
Achievements recognised
AstraZeneca has been working for over
a decade to achieve business success
in a responsible manner. For example,
we have delivered safety, health and
environment improvements and created a
diverse workforce; we have promoted the
development of our products in an ethical
way; and taken steps to broaden access
to our medicines. I am also pleased to
report that, in 2015, we met all our
obligations under our five-year Corporate
Integrity Agreement in the US, which has
now come to an end. Maintaining high
ethical standards in the way we conduct
our business remains a priority.
Our achievements were once again
recognised in 2015 with an improved score
of 84% (79% in 2014) in the Dow Jones
Sustainability Index. Our score contributed
to the ‘Silver Class’ rating awarded to us
for our sustainability performance by
RobecoSAM, the respected sustainability
investment specialist.
Looking ahead, if we are to be among the
best performers, there is more we need to
do. We have refreshed and strengthened
our governance arrangements, as outlined
in the section, In the wider world from page
55, and we are integrating sustainability into
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.co.uk
how we measure the success with which
we are delivering our strategic priorities.
We need to build on that by focusing
our work and ensuring that sustainability
thinking is part of our culture and embedded
into the way we do business.
A challenging business environment
In his Financial Review on page 62, our
Chief Financial Officer, Marc Dunoyer,
reported on the accelerating performance
of our Growth Platforms. He also reported
on the continued impact of the loss of
exclusivity as medicines such as Nexium
and Crestor continue to lose exclusivity in
key markets, including the US and Europe.
Such a loss of exclusivity is a normal part of
an innovative medicine’s life-cycle. It is
expected and we plan for it.
Even as we plan for loss of exclusivity,
we continue to face challenging market
conditions. The world pharmaceutical market
is growing and underlying demographic
trends remain favourable. Nonetheless, many
of the drivers of demand and supply in the
sector are under pressure. On the demand
side, we face increased competition from
generic drugs. In addition, securing an
appropriate level of reward for our medicines
is becoming more difficult in the face of
pricing pressures. On the supply side, the
industry faces an ongoing R&D productivity
challenge. Costs have risen and, although
in 2015 the FDA approved the highest
number of new medicines since 1996,
we still need to improve the probability
of success of our projects.
Return to shareholders
Consistent with our progressive dividend
policy, the Board has recommended a
second interim dividend of $1.90 per
Ordinary Share. This brings the dividend
for the full year to $2.80 per Ordinary Share.
The Board’s aim is to continue to strike
a balance between the interests of the
business, financial creditors and our
shareholders. After providing for investment
in the business, supporting the progressive
dividend policy and maintaining a strong
investment-grade credit rating, the Board
will keep under review investment in
earnings-accretive opportunities.
Appreciation
Before closing, and on behalf of the Board, I
want to thank the employees of AstraZeneca.
Their outstanding efforts helped make 2015
a great year for science and patients. In
particular, I want to express my appreciation
to Pascal and all the members of the Senior
Executive Team for their leadership in
delivering a successful year.
Leif Johansson
Chairman
AstraZeneca Annual Report and Form 20-F Information 2015
83
Corporate Governance Corporate Governance Overview
How our governance supports the delivery of our strategy.
Board
Audit Committee
Remuneration Committee
Chairman: Leif Johansson
Senior independent Non-Executive Director: Rudy Markham
Chairman: Rudy Markham
Chairman: Graham Chipchase
All Directors are collectively responsible for the success of the Group.
The Non-Executive Directors exercise independent, objective judgement
in respect of Board decisions, and scrutinise and challenge management.
They also have various responsibilities concerning the integrity of
financial information, internal controls and risk management.
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 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.
The Audit Committee provides
assurance to the Board in the
following areas: the integrity
of our financial reporting and
internal controls over financial
matters; our internal controls over
non-financial matters; compliance
with laws and our Code of
Conduct; the quality of the
Company’s relationship with
its external auditor; the role,
resources and effectiveness of
the Company’s internal audit
function; and the effectiveness of
the Company’s risk management
framework, in each case with the
ultimate aim of protecting our
shareholders’ interests.
The Remuneration Committee
considers and sets, on behalf
of the Board, the remuneration
(including pension rights and
compensation payments) of
Executive Directors and other
senior executives. No Director
is involved in deciding his or
her own remuneration.
Corporate Governance Report from page 90
Audit Committee Report from
Directors’ Remuneration
page 98
Report from page 103
Board Committee membership
Name
Cori Bargmann2
Geneviève Berger
Bruce Burlington
Ann Cairns
Graham Chipchase
Jean-Philippe Courtois
Marc Dunoyer
Leif Johansson
Rudy Markham
Nancy Rothwell7
Pascal Soriot
Shriti Vadera
John Varley9
Marcus Wallenberg
Audit
Remuneration
Nomination
and
Governance
✓ 3
✓ 3
Chairman5
✓
✓
✓ 7
Chairman
✓
✓ 7
✓
✓
✓
Chairman
✓
✓ 8
Chairman5
✓ 9
Science
✓ 2
✓
Chairman4
Chairman4
✓
Independent1
✓
✓
✓
✓
✓
✓
n/a
n/a6
✓
✓
n/a
✓
✓
1 As determined by the Board for the purposes of the UK Corporate Governance Code.
2 Cori Bargmann was elected as a Non-Executive Director and became a member of the Science Committee with effect from 24 April 2015.
3 Bruce Burlington and Graham Chipchase became members of the Nomination and Governance Committee with effect from 24 April 2015.
4 Bruce Burlington succeeded Nancy Rothwell as Chairman of the Science Committee with effect from 24 April 2015.
5 Graham Chipchase succeeded John Varley as Chairman of the Remuneration Committee with effect from 24 April 2015.
6 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.
7 Nancy Rothwell retired from the Board with effect from 24 April 2015.
8 Shriti Vadera became a member of the Remuneration Committee with effect from 17 February 2015.
9 John Varley retired from the Board with effect from 24 April 2015.
84
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Science Committee
Senior Executive Team
Key governance roles
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 advises the Board
on significant developments in
corporate governance.
Chairman: Bruce Burlington
The Science Committee
provides assurance to the
Board regarding the Group’s
R&D activities by reviewing
and assessing our approaches
in our chosen therapy areas; the
scientific technology and R&D
capabilities we deploy; the quality
and development of our scientists;
and our decision making.
Chairman
Leadership, operation and
governance of the Board, ensuring
Board effectiveness
CEO
Responsible to the Board for the
management, development and
performance of the business
Senior independent
Non-Executive Director
Acts as a sounding board for the
Chairman and an intermediary for
other Directors and shareholders
when necessary
The members of the SET are
> CEO
> CFO
> Nine Executive Vice-
Presidents (EVPs) from across
the organisation, representing
the three science units, the
four commercial units
(including GPPS), Operations
& IT and HR
> General Counsel
> Chief Compliance Officer
The Senior Executive Team (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.
The biographies of SET
members are shown on pages
88 and 89
Nomination and Governance
Science Committee on
Committee from page 93
page 94
Gender split of Directors
Length of tenure of Non-Executive Directors
Male
Female
8
4
Directors’ nationalities
American
British
French
Swedish
2
4
4
2
Under 3 years
Cori Bargmann
Ann Cairns
3–6 years
Leif Johansson
Geneviève Berger
Bruce Burlington
Graham Chipchase
Shriti Vadera
6–9 years
Jean-Philippe Courtois
Rudy Markham
9+ years
Marcus Wallenberg
2
5
2
1
AstraZeneca Annual Report and Form 20-F Information 2015
85
Corporate Governance Board of Directors
as at 31 December 2015
1
4
7
2
5
8
3
6
9
10
11
12
2 Pascal Soriot (56)
Executive Director and CEO (October 2012)
3 Marc Dunoyer (63)
Executive Director and CFO (November 2013)
Skills and experience Pascal brings 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.
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.
1 Leif Johansson (64)
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 Svenska Cellulosa
Aktiebolaget SCA 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.
86
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance 4 Rudy Markham (69)
Senior independent Non-Executive Director
(April 2015. Member of the Board since
September 2008)
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.
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.
Other appointments Rudy is Chairman and a
Non-Executive Director of Moorfields Eye Hospital
NHS Foundation Trust and 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. He served
as a Non-Executive Director of the UK Financial
Reporting Council from 2007 to 2012.
7 Bruce Burlington (67)
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.
8 Ann Cairns (58)
Non-Executive Director (April 2014)
5 Dr Cornelia Bargmann (54)
Non-Executive Director (April 2015)
Committee membership Member of the Audit
Committee
Committee membership Member of the Science
Committee
Skills and experience Cornelia (Cori) is the Torsten
N. Wiesel Professor and head of the Lulu and
Anthony Wang Laboratory of Neural Circuits and
Behavior at The Rockefeller University, New York.
She has held this position since 2004. Cori holds
a degree in biochemistry from the University of
Georgia and a PhD from the Massachusetts Institute
of Technology (MIT). She pursued a postdoctoral
fellowship with H. Robert Horvitz at MIT until 1991,
when she accepted a faculty position in the
Department of Anatomy at the University of
California, San Francisco, spending 13 years there,
before moving to Rockefeller. She has been a
Howard Hughes Medical Institute investigator since
1995. Cori was awarded the Benjamin Franklin
Medal in Life Science in 2015.
6 Geneviève Berger (60)
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.
Skills and experience Ann has more than
20 years’ in-depth financial and international
business experience and currently serves as
President, International Markets, for MasterCard.
Before joining MasterCard in 2011, Ann oversaw the
European liquidation of Lehman Brothers Holdings
International and was the Chief Executive,
Transaction Banking at ABN AMRO. At the start
of her career, Ann was an award-winning research
engineer, culminating as the head of Offshore
Engineer-Planning for British Gas. She holds a BSc
in pure mathematics from Sheffield University and
an MSc with research into medical statistics from
Newcastle University in the UK.
9 Graham Chipchase (52)
Non-Executive Director (April 2012)
Committee membership Chairman of the
Remuneration Committee and member of the
Nomination and Governance Committee
Skills and experience Graham has served as
Chief Executive Officer of global consumer
packaging company, Rexam PLC since 2010
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.
10 Jean-Philippe Courtois (55)
Non-Executive Director (February 2008)
Committee membership Member of the Audit
Committee
Skills and experience Jean-Philippe has more
than 30 years’ experience in the global technology
industry. He is President of Microsoft International
and previously served as Chief Executive Officer
and President of Microsoft EMEA. Jean-Philippe
has also served as Co-Chairman of the World
Economic Forum’s Global Digital Divide Initiative
Task Force and on the European Commission
Information and Communication Technology Task
Force. In 2009, he served as an EU Ambassador
for the Year of Creativity and Innovation and, in 2011,
was named one of ‘Tech’s Top 25’ by The Wall
Street Journal Europe.
Other appointments Jean-Philippe is a board
member of PlaNet Finance, a leading international
microfinance organisation.
11 Shriti Vadera (53)
Non-Executive Director (January 2011)
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.
12 Marcus Wallenberg (59)
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.
AstraZeneca Annual Report and Form 20-F Information 2015
87
Corporate Governance Senior Executive Team
as at 31 December 2015
1
4
7
10
13
2
5
8
3
6
9
11
1 Pascal Soriot
CEO
See page 86.
12
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. He joined AstraZeneca from
Genentech, where he 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.
88
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance
5 Pam Cheng
Executive Vice-President, Operations
and Information Technology
8 Paul Hudson
President, AstraZeneca, US and Executive
Vice-President, North America
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.
Paul was appointed Executive Vice-President,
North America in January 2013 and is accountable
for driving growth and maximising the contribution
of the commercial operations in North America
to AstraZeneca’s global business. Paul joined
AstraZeneca in 2006 as Vice-President and Primary
Care Director, UK and was later appointed President
of AstraZeneca’s subsidiary companies in Japan
and Spain. He has served as a Standing Board
Member of the Japan Pharmaceuticals
Manufacturers Association and EFPIA in Japan.
Before joining AstraZeneca, Paul worked for
Schering-Plough, where he held senior global
marketing roles. He received a degree in economics
from Manchester Metropolitan University and a
DipM from the UK’s Chartered Institute of Marketing.
6 Fiona Cicconi
Executive Vice-President, Human Resources
9 Dr Bahija Jallal
Executive Vice-President, MedImmune
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, 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 build one culture between
Roche and Genentech and identify and develop a
sustainable supply of leadership and talent from
within the organisation.
7 Dr Ruud Dobber
Executive Vice-President, Europe
Ruud was appointed Executive Vice-President,
Europe in January 2013 and is responsible for sales,
marketing and commercial operations across
AstraZeneca’s businesses in the 28 EU member
states. In addition to his European accountabilities,
Ruud is responsible for the development of our
late-stage, small molecule antibiotic pipeline as
well as its global commercialisation. Ruud joined
AstraZeneca in 1997 and has held various senior
commercial and leadership roles, including 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. Since 2012, Ruud has been
an Executive Committee Member of the European
Federation of Pharmaceutical Industries and
Associations (EFPIA) and was earlier 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.
Bahija was appointed Executive Vice-President,
MedImmune in January 2013 and is responsible
for biologics research activities. Bahija is tasked
with advancing the biologic pipeline of drugs. 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 post-doctoral research
at the Max-Planck Institute of Biochemistry in
Martinsried, Germany. She is a member of the
American Association of Science and the
Pharmacogenomics Working Group and is on the
Board of Directors of the Association of Women
in Science. She is also on the Board of Trustees
of the Johns Hopkins University.
10 Mark Mallon
Executive Vice-President, International
Mark was appointed Executive Vice-President,
International in January 2013 and is responsible
for the growth and performance of AstraZeneca’s
commercial businesses in various regions, including
Asia Pacific, Russia, Latin America, the Middle East
and Africa. Since joining AstraZeneca in 1994,
Mark has held multiple 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.
11 Luke Miels
Executive Vice-President, Global Product and
Portfolio Strategy, Global Medical Affairs and
Corporate Affairs
Luke was appointed Executive Vice-President,
Global Product and Portfolio Strategy (GPPS) in
May 2014, leading AstraZeneca’s global marketing,
business development and commercial portfolio
strategy operations. AstraZeneca’s Global Medical
Affairs and Global Corporate Affairs functions also
report to him. Luke joined AstraZeneca from Roche,
where he was Regional Vice-President Asia Pacific
for the Pharmaceuticals Division, and before that
Head of Metabolism for Global Marketing. Before
then, he was at Aventis where he held roles of
increasing seniority, including Country Manager
positions in Asia Pacific, Head of US Analytics and
Commercial Effectiveness, and US Vice-President
of Sales for Metabolism. He also led the US
integration of Sanofi and Aventis while he was there.
Luke began his career in 1995 with AstraZeneca in
Australia as a Sales Representative and Product
Manager. Luke holds a BSc in biology from Flinders
University in Adelaide and an MBA from the
Macquarie University, Sydney.
12 Dr Menelas Pangalos
Executive Vice-President, Innovative Medicines
and Early 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. 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 of the Royal
Society of Biology. In the UK, Mene serves on the
Medical Research Council, is on the Board of the
National Centre for Universities and Business
(NCUB), and a Non-Executive Director of the
UK Precision Medicine Catapult.
13 Jeff Pott
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.
AstraZeneca Annual Report and Form 20-F Information 2015
89
Corporate Governance Corporate Governance Report
Board composition
The membership of the Board at
31 December 2015 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.co.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.
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 six meetings in 2015,
including its usual annual strategy review.
Five took place in London, UK and one was
held at the offices of AstraZeneca’s French
marketing company in Rueil-Malmaison,
near Paris. The Board is currently scheduled
to meet six times in 2016, 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.
Board effectiveness
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 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, 40% of the
Company’s Non-Executive Directors are
women and women make up 33% 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
90
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Company and its shareholders. Information
about our approach to diversity in the
organisation below Board level can be found
in Employees from page 52.
The following changes to the composition
of the Board and its Committees have
occurred during the period covered by
this Annual Report:
> Shriti Vadera became a member of the
Remuneration Committee with effect from
17 February 2015.
> John Varley and Nancy Rothwell, both
Non-Executive Directors, retired from the
Board on 24 April 2015, each having
served as a Board member for nine years.
> With effect from 24 April 2015:
– Cori Bargmann was elected for the first
time as a Non-Executive Director and
became a member of the Science
Committee.
– Rudy Markham became Senior
independent Non-Executive Director.
– Graham Chipchase became Chairman
of the Remuneration Committee and
a member of the Nomination and
Governance Committee.
– Bruce Burlington became Chairman of
the Science Committee and a member
of the Nomination and Governance
Committee.
– Geneviève Berger was nominated to
oversee sustainability matters on behalf
of the Board.
Independence of the Non-Executive
Directors
During 2015, 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 4 February 2016.
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.
Appointments to the Board
The Nomination and Governance
Committee section from page 93 provides
information about the appointment process
for new Directors.
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.
The Company maintained Directors’ and
Officers’ Liability Insurance cover throughout
2015. The Directors are also able to obtain
independent legal advice at the expense
of the Company, as necessary, in their
capacity as Directors.
Newly appointed Directors are provided
comprehensive information about the Group
and their role as Non-Executive Directors.
They also typically attend 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
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
AstraZeneca Annual Report and Form 20-F Information 2015
91
Corporate Governance Corporate Governance Report continued
Board and Board Committee meeting attendance in 2015
Name
Cori Bargmann1
Geneviève Berger
Bruce Burlington2
Ann Cairns
Graham Chipchase3
Jean-Philippe Courtois
Marc Dunoyer
Leif Johansson
Rudy Markham
Nancy Rothwell4
Pascal Soriot
Shriti Vadera5
John Varley6
Marcus Wallenberg
Board meetings
Board Committee meetings
Audit Remuneration
Nomination
and
Governance
–
–
5(5)
5(5)
–
5(5)
–
–
5(5)
–
–
5(5)
–
–
–
–
–
–
7(7)
–
–
6(7)
7(7)
3(3)
–
6(6)
3(3)
–
–
–
1(1)
–
1(1)
–
–
2(2)
2(2)
1(1)
–
–
1(1)
–
Science
4(4)
3(6)
6(6)
–
–
–
–
–
–
2(2)
–
–
–
5(6)
4(4)
5(6)
6(6)
5(6)
6(6)
6(6)
6(6)
6(6)
6(6)
2(2)
6(6)
6(6)
2(2)
6(6)
Note: number in brackets denotes number of meetings during the year that Board members were entitled to attend.
1 Cori Bargmann was elected as a Non-Executive Director
3 Graham Chipchase became a member of the Nomination
5 Shriti Vadera became a member of the Remuneration
and became a member of the Science Committee with effect
from 24 April 2015.
and Governance Committee with effect from 24 April 2015.
Committee with effect from 17 February 2015.
4 Nancy Rothwell retired from the Board with effect from
6 John Varley retired from the Board with effect from
2 Bruce Burlington became a member of the Nomination and
24 April 2015.
Governance Committee with effect from 24 April 2015.
24 April 2015.
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 2015 evaluation involved each
Board member responding to a web-based
questionnaire 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.
In respect of the 2015 evaluation, overall
it was concluded that the Board continues
to operate effectively and in an open
manner and no significant problems
were raised. The main themes arising
from the responses to the questionnaire
were discussed between the Chairman
and individual Directors, and collectively
at the Board meeting in December 2015.
These included:
> Board members’ wish to spend more
time as a full Board considering
succession planning for the key senior
Board and executive roles in the
Company – Chairman, CEO and CFO
– in addition to the work done on CEO
and CFO succession planning during
2014 and 2015 by the Nomination and
Governance Committee.
> Increasing the opportunities for Board
members to meet executives immediately
below SET-level, primarily to facilitate the
Board’s assessment of high-potential
people and their capabilities, and for
succession planning purposes.
> The importance of the continuing
dialogue with shareholders about
executive remuneration, particularly that
of the Executive Directors and SET
members, its link to individual and
Company performance and the scope
for simplification.
> Board members’ wish to continue to hear
from external stakeholders (during 2015,
the Board met and received presentations
from, for example, medical practitioners
and clinical researchers in the oncology
field, representatives of major institutional
shareholders and financial analysts
covering the Company and the
pharmaceutical sector).
> Board members’ suggestions for areas
for further review by the Board during
2016, such as the supply chain for
biologics and the Company’s productivity
and efficiency programmes.
> Various practical matters, such as the
format and content of Board papers and
whether more than one Board meeting
each year should be held outside the UK.
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. Each Director continues to
perform effectively and to demonstrate
commitment to his or her role. In addition,
led by the Senior independent Non-
Executive Director, the other Directors
(absent the Chairman) evaluated the
performance of the Chairman. 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 2016.
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
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AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance effectiveness. During 2015, 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 2015 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 21 and Risk from page 212.
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,
including in 2015, 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 2015, the Chairman of the
Nomination and Governance Committee
was Leif Johansson. The members of the
Nomination and Governance Committee
were Rudy Markham; Nancy Rothwell
and John Varley until their retirement from
the Board on 24 April 2015; and Bruce
Burlington and Graham Chipchase with
effect from the same date. 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.
The Nomination and Governance
Committee considers both planned and
unplanned (unanticipated) succession
AstraZeneca Annual Report and Form 20-F Information 2015
93
Corporate Governance Corporate Governance Report continued
scenarios and met twice in 2015, spending
the majority of its time on routine succession
planning (internal and external) for the roles
of CEO and CFO, with the assistance
respectively of the search firms, Spencer
Stuart and Hoggett Bowers, both of whom
periodically undertake executive search
assignments for the Company. In addition,
the Committee concluded the search that
commenced in 2014 by recommending to
the Board that Cori Bargmann be proposed
for election by shareholders as a new
Non-Executive Director at the AGM in 2015.
The Zygos Partnership, a search firm that
has no other connection to the Company,
assisted the Committee with this work. The
Committee also considered and made a
number of recommendations to the Board
concerning the membership of Board
Committees to reflect the changes in Board
membership that occurred during the year.
The attendance record of the Nomination
and Governance Committee’s members is
set out on page 92.
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
> 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 2015, the members of the Science
Committee, all of whom have a knowledge
of, or an interest in, life sciences, were
Nancy Rothwell (Chairman of the Science
Committee) until her retirement from the
Board on 24 April 2015, Bruce Burlington
(Chairman of the Science Committee with
effect from 24 April 2015), Cori Bargmann
with effect from 24 April 2015, 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
2015. The Vice-President, IMED Operations
acts as secretary to the Science Committee.
The Science Committee met twice in
person in 2015, in London, UK and
Cambridge, UK and held four other
meetings, all of which were by telephone,
to review specific business development
or acquisition proposals.
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 opposite.
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 135.
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.
Business organisation
Early Stage Product Committees (ESPCs)
and Late Stage Product Committee
(LSPC)
The ESPCs and the LSPC were established
in 2013.
Early Stage Product Committees
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
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
The LSPC is also a senior level governance
body, accountable for the quality of the
portfolio post-Phase III investment decision.
It was formed in early 2013, replacing three
committees, in a move to streamline
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AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance development project governance. 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.
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 2015 were:
the CFO, who chaired the Disclosure
Committee; the EVP, GMD (who is also
the Company’s Chief Medical Officer); the
EVP, GPPS; the General Counsel; the
Vice-President, Corporate Affairs; the
Vice-President, Investor Relations; and the
Vice-President Finance, Group Controller.
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 our planned
disclosures, such as our quarterly results
announcements and scheduled investor
relations events.
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.
During 2016, Global Compliance will
continue 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;
monitoring compliance with our policies;
and ensuring that employees can raise any
concerns. Through the Group Compliance
Council, Global Compliance and IA work
with various specialist compliance functions
throughout our organisation to co-ordinate
compliance activities.
When a potential compliance breach is
identified, an internal investigation is
undertaken by staff from our Global
Compliance, HR and/or Legal teams. When
appropriate, external advisers are engaged
to conduct and/or advise on investigations.
Should an investigation conclude that 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 212
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
> consistency of operations or programmes
with established objectives and goals and
effective performance
> effectiveness and efficiency of operations
and employment of resources
> 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 worldwide
to all full-time and part-time Directors,
officers, employees and temporary staff, in
all companies within our Group. 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 over
40 languages and provides clear direction
as to how our commitment to honesty
and integrity is to be realised in consistent
actions across all areas of the business.
AstraZeneca Annual Report and Form 20-F Information 2015
95
Corporate Governance Corporate Governance Report continued
Compliance with the Code is mandatory
and every employee receives annual training
on it. The Code is reviewed periodically and
updated to take account of changing legal
and regulatory obligations. Our Global
Policies supplement the Code and provide
clear guidance in key risk areas.
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 e-mail and postal
addresses described in the Code. Anyone
who raises a potential breach in good faith is
fully supported by management. 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.
In 2015, 326 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 2014 there
were 247 reports. The majority of cases
come to our attention through management
and self-reporting, which can be seen as
an indication that employees are more
comfortable in raising their concerns
with line managers, local HR, Legal or
Compliance, as recommended in the Code
and reinforced in the 2015 Code training.
Other matters
Corporate governance statement under
the UK Disclosure 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 240 and
Corporate Information on page 245
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 194.
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
> AstraZeneca UK Limited: Algeria (scientific
office), Angola, Belarus, Bulgaria, Chile,
Costa Rica, Croatia, Cuba, Dubai (branch
office), Georgia, Ghana (scientific office),
Jordan, Kazakhstan, Nigeria, Romania,
Russia, Saudi Arabia (scientific office),
Serbia and Montenegro, Slovenia (branch
office), Syria and Ukraine
> AstraZeneca AB: Egypt (scientific office)
and Slovakia (branch office)
> AstraZeneca Singapore Pte Limited:
Vietnam.
Distributions to shareholders – dividends
for 2015
Details of our distribution policy are set out
in the Financial Review on page 178 and
Notes 22 and 23 to the Financial Statements
on page 172.
The Company’s dividend for 2015 of $2.80
(188.5 pence, SEK 23.97) per Ordinary
Share amount to, in aggregate, a total
dividend payment to shareholders of
$3,539 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 2015 AGM authorising the Company to
purchase its own shares. The Company
did not repurchase any of its own shares in
2015. On 31 December 2015, 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 24) and the Directors’
Report. Information on patent expiry dates
for key marketed products is included
in Patent Expiries from page 210. 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 25
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 163.
The Group has considerable financial
resources available. As at 31 December
2015 the Group has $8.3 billion in financial
resources (cash balances of $6.2 billion and
undrawn committed bank facilities of $3.0
billion which are available until April 2020,
with only $0.9 billion of debt due within one
year). Although no liability was recognised
at 31 December 2015, the Group has entered
into an agreement to invest in a majority
equity stake in Acerta Pharma for an upfront
payment of $2.5 billion that was paid on
2 February 2016 and a further unconditional
payment of $1.5 billion to 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 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.
96
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Changes in share capital
Changes in the Company’s Ordinary
Share capital during 2015, 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.
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 2015, 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 page 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 2015 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 2016 AGM, similar to
that passed at the 2015 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 2015, the
Group’s US legal entities made contributions
amounting in aggregate to $1,224,550
(2014: $1,650,200) 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/
responsibility/transparency. The annual
corporate contributions budget is reviewed
and approved by the Deputy General
Counsel, North America, 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 25 from page 177,
include further information on our use
of financial instruments.
Annual General Meeting
The Company’s AGM will be held on
29 April 2016. 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 29 April 2016 for the reappointment of
KPMG LLP as auditor of the Company.
The external auditor has undertaken various
non-audit work for us during 2015. More
information about this work and the audit
and non-audit fees that we have paid are set
out in Note 29 to the Financial Statements
on page 192. The external auditor is not
engaged by us 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 2015.
On 23 December 2015, we
announced a proposal to appoint
PricewaterhouseCoopers LLP (PwC)
as our external auditor for the financial
year ending 31 December 2017. The
proposed change of auditor follows a
recommendation by the Audit Committee
to the Board based on a formal tender in
line with best practice. More information
about the tender process is set out in the
Audit Committee Report from page 98.
A resolution to approve the appointment
of PwC will be put to shareholders at the
Company’s AGM in 2017.
Directors’ Report
The Directors’ Report, which has been
prepared in accordance with the
requirements of the Companies Act 2006,
comprises the following sections
> Business Review: Research and
Development
> Resources Review: Employees
> 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 signed on behalf of the Board.
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
4 February 2016
AstraZeneca Annual Report and Form 20-F Information 2015
97
Corporate Governance Audit Committee Report
The quality of
AstraZeneca’s financial
reporting is underpinned
by well-designed internal
controls, appropriate
accounting practices
and policies, and good
judgement.”
completed, and in December, on the
recommendation of the Committee,
the Board announced its decision to
recommend the appointment of
PricewaterhouseCoopers LLP (PwC) to
shareholders at the Company’s 2017 AGM.
The Committee were advised that the Public
Company Accounting Oversight Board
(PCAOB) and the Financial Reporting
Council (FRC) had both undertaken a review
of certain aspects of KPMG LLP’s audit of
AstraZeneca PLC’s financial statements for
the year ended 31 December 2014. We
have discussed the review and its findings
with KPMG and are satisfied with the
responses to be implemented by KPMG.
The PCAOB Report is not yet available.
Risk management
During the year the Committee reviewed
the Company’s approach to risk
management, its risk reporting framework,
and the focus of the Group Risk Team.
These discussions also provided the context
for the Committee’s consideration of the
development of the form and content of
the Directors’ viability statement and the
analysis that underpins the assurance
provided by that statement. Further
information on the Company’s Principal
Risks and the Directors’ viability statement
are on pages 21 to 23.
Compliance with the Code of Conduct
Compliance with our Code of Conduct
in Emerging Markets continued to be an
area of focus for the Committee, which
considered reports on matters in China,
Russia, the Middle East and Africa, and
India for example. In October, members
of the Committee visited the Company’s
commercial and IT operations in Bangalore
and Chennai respectively. We talked to
Dear shareholder
In this Report, we describe the work of the Audit
Committee during the year and the significant issues
considered. In 2015, our priorities were to receive
assurance on sound financial reporting, effective risk
management and compliance with the AstraZeneca
Code of Conduct.
The principal duties of the Audit Committee
(the Committee) are to provide assurance
to the Board, as part of the Board’s
stewardship and protection of our
shareholders’ interests, ensuring
> the integrity of our financial reporting,
internal controls of financial matters and
financial disclosures
> the effectiveness of our internal controls
over non-financial matters, and
compliance with laws and the
AstraZeneca Code of Conduct
> the quality of the Company’s relationship
with its external auditor and the
effectiveness of the external audit
> the role, resources and effectiveness of
the Company’s internal audit function
> the effectiveness of the Company’s risk
management framework.
Financial reporting
The quality of AstraZeneca’s financial
reporting is underpinned by well-designed
internal controls, appropriate accounting
practices and policies, and good
judgement. The Committee reviews, at
least quarterly, the Company’s significant
accounting matters and, where appropriate,
challenges management’s decisions before
approving the accounting policies applied.
During 2015, the Committee has looked
at the changes to AstraZeneca’s
revenue accounting policy to include
Externalisation Revenue in its Statement
of Comprehensive Income. For more
information on Externalisation Revenue,
please refer to the Financial Review from
page 62. This change in accounting policy
increases the transparency of the income
generated by the Company’s externalisation
activities and reflects changes over the past
two years to the Company’s strategy and
business model to realise the full value of
assets and technology and provide for
optimal investment in R&D.
We also looked closely at intangible asset
impairment reviews; restructuring, legal
provisions and other related charges,
to ensure that items are appropriately
accounted for in ‘Reported’ and ‘Core’
results. We also scrutinised revenue
recognition together with the associated
selling and marketing investments.
During 2015 the Committee oversaw
a competitive tender of the Company’s
external audit services. A thorough selection
process in line with best practice was
98
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance
Audit Committee membership
and attendance
The Audit Committee members are Rudy
Markham (Committee Chairman), Bruce
Burlington, Ann Cairns, Jean-Philippe
Courtois and Shriti Vadera – all Non-
Executive Directors. The Board considers
each member to be independent under the
UK Corporate Governance Code and under
the general guidance and specific criteria
of the Listing Standards concerning the
composition of audit committees applicable
to non-US companies listed on the NYSE.
In April 2015, we submitted the required
annual written affirmation to the NYSE
confirming our full compliance with those
standards. For the purposes of the UK
Corporate Governance Code, the Board
remains satisfied that at least one member
of the Audit Committee has recent and
relevant financial experience. At its meeting
in December 2015, the Board determined
that Rudy Markham and Ann Cairns are
Audit Committee financial experts for the
purposes of the Sarbanes-Oxley Act. For
more information regarding the experience
of the Audit Committee members, see the
Board of Directors’ biographies on pages
86 and 87. The Deputy Company Secretary
acts as secretary to the Audit Committee.
Meetings of the Audit Committee are
routinely attended by the CFO; the General
Counsel; the Chief Compliance Officer;
the Vice-President, IA; the Vice-President
Finance, Group Controller; and our external
auditor. The CEO attends on an agenda-
driven basis. In line with its normal practice,
the Audit Committee also held a number
of private meetings, without management
present, with the Chief Compliance Officer;
the General Counsel; the Vice-President,
IA; and the Company’s external auditor.
These meetings were held between Audit
Committee members and those individuals,
separately from the main sessions of the
Audit Committee.
Number of meetings and attendance
The Audit Committee held five scheduled
meetings in 2015. The attendance record
of the Audit Committee members is set out
in the Board and Board Committee meeting
attendance in 2015 table on page 92.
Following each Audit Committee meeting,
the Committee Chairman reported to the
Board on the principal matters covered at
the meeting and minutes of the meetings
were circulated to all Board members.
In addition, the Chairman of the Audit
Committee held regular scheduled calls
between Audit Committee meetings with
each of the CFO; the Chief Compliance
Officer; the Vice-President, IA; and the lead
partner of the external auditor.
The Audit Committee is currently scheduled
to meet five times in 2016 and will meet at
such other times as may be required.
Terms of reference
The terms of reference of the Audit
Committee, which are available on our
website, www.astrazeneca.com, include
reviewing and reporting to the Board on:
> Matters relating to the audit plans of the
external auditor and IA as well as
oversight of the work of the Global
Compliance function.
> The effectiveness of our overall framework
for internal control over financial reporting
and for other internal controls and
processes.
> Our overall framework for risk
management.
> The appropriateness of our accounting
policies and practices.
> Our annual and quarterly financial
reporting, including the critical estimates
and judgements contained in our
reporting.
> Our internal control over financial
reporting.
> Our Code of Conduct and whistleblower
procedures.
The Audit Committee is responsible for
notifying the Board of any significant
concerns of the external auditor or the
Vice-President, IA arising from their audit
work; any matters that may materially
affect or impair the independence of the
external auditor; any significant deficiencies
or material weaknesses in the design
or operation of our internal control over
financial reporting or other internal controls;
any serious issues of non-compliance; and
how the Audit Committee has discharged
its responsibilities. It oversees the
establishment, implementation and
maintenance of our Code of Conduct and
other related policies. It monitors the
Company’s response to letters requesting
information and investigations initiated by
regulatory and governmental authorities
such as the SEC, the DOJ and the FRC
pertaining to matters within the remit of the
AstraZeneca Annual Report and Form 20-F Information 2015
99
members of local and regional management
including our compliance officers about
AstraZeneca’s performance and its
approach to diversity, risk management,
business resilience and operating ethically,
within the law and in accordance with our
Code of Conduct.
I am pleased to report that 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. Naturally, maintaining
compliance with the Company’s Code of
Conduct and high ethical standards in all
countries where we conduct business or
have interactions will continue to be a
priority for the Committee.
Engagement with senior leaders
The Committee considers it important to
extend its interactions with members of
management below the SET. In addition
to the meetings with local and regional
management in India, the Committee met
informally with members of Internal Audit
Services (IA), Compliance, IS/IT and Finance
teams. In July 2015, the Chairman of the
Committee participated in a conference
with the Finance team on the subject of
‘Finance as Leaders’. We take a special
interest in the strength and depth of the
finance organisation and talent development
within that function.
We value dialogue with our shareholders
and welcome your feedback on this report.
Yours sincerely
Rudy Markham
Chairman of the Audit Committee
Corporate Governance Audit Committee Report continued
Audit Committee’s work. It has established
procedures for the receipt and handling
of complaints concerning accounting or
audit matters. It recommends to the Board
the appointment of the external auditor,
subject to the approval of the Company’s
shareholders at a general meeting.
Shareholders authorise the Directors to fix
the remuneration of the external auditor
at a general meeting. The Audit Committee
reviews and approves the appointment and
dismissal of the Vice-President, IA.
Activities of the Audit Committee
in 2015
The Audit Committee has an annual
calendar of topics, developed from its terms
of reference, with standing items which it
considers in accordance with its schedule
at each quarterly meeting or, in some
cases, annually.
During 2015 and in February 2016, the Audit
Committee considered and discussed the
following standing items:
> The key elements of the Financial
Statements, and the estimates and
judgements contained in our financial
disclosures. Various accounting matters
were considered. These 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 and;
goodwill and intangible asset impairment)
from page 77 and other important
matters such as considering and
approving a change to revenue
accounting to include Externalisation
Revenue in the Company’s Statement of
Consolidated Income, and subsequently
monitoring the application of the same.
Discussion of these matters was
supported by papers prepared by
management and the external auditor.
> The reports received from the external
auditor concerning its audit of the
Financial Statements of the Group
and 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. The Audit
Committee also reviewed quarterly
activity reports of audit work carried out
by IA and the status of follow-up actions
with management, as well as reports from
Global Compliance.
> Risk management review and update
of the Company’s risk management
approach, its risk reporting framework
and the focus of the Group Risk Team.
> Compliance with the 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 Audit Committee remained
focused on IT controls in the context
of the changes to the Group’s IT
environment, described below. More
information about this is set out in the
Sarbanes-Oxley Act Section 404 section
of the Financial Review on page 81.
> Data about 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 inquiries into
those matters.
> Reports from Global Compliance
confirming compliance with and the
successful completion of the Company’s
obligations under the Corporate Integrity
Agreement that had been in place for five
years in the US.
> 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.
> Going concern assessment and adoption
of the going concern basis in preparing
this Annual Report and the Financial
Statements.
> Other reports, on a quarterly basis,
concerning IA, Global Compliance and
Finance, including the internal audit plan
and progress and plans of Global
Compliance.
> Quarterly reports from the General
Counsel on the status of certain litigation
matters and governmental investigations.
> The amount of audit and non-audit fees of
the external auditor throughout 2015. The
Audit Committee was satisfied throughout
the year that the objectivity and
independence of the external auditor
were not in any way impaired by the
nature of the non-audit work undertaken
by the external auditor during the year, the
level of non-audit fees charged for such
work or any other facts or circumstances.
Further information about the audit and
non-audit fees for 2015 is disclosed in
Note 29 to the Financial Statements on
page 192.
> A review and assessment of the Audit
Committee’s performance.
Matters considered by the Audit Committee
in addition to its usual business as
described above included:
> Receiving regular updates from the
IT team in connection with the
transformation of AstraZeneca’s IT
infrastructure, with particular attention
to cybersecurity, business continuity
and transitioning into new payroll
software. The Audit Committee also
reviewed the performance of the Chennai
IT Centre which included a site visit in
October 2015.
> Considering the opportunity for
AstraZeneca in the Indian pharmaceutical
market which included a site visit to
Bangalore in October 2015, noting in
particular local management’s focus on
driving a strong compliance culture.
> Considering and reviewing compliance in
China, noting in particular improvements
in policy and controls and the importance
of training for new employees.
> Considering the execution and outcomes
of significant capital expenditure on the
construction of a plant in Russia.
> Post-investment reviews of a recent major
business development transaction,
a capital expenditure project, and the
integration of the BMS diabetes business
acquired at the start of 2014.
> Reviewing the preparation of the
Directors’ proposed viability statement
and the adequacy of the analysis
supporting the assurance provided by
that statement.
> Reviewing the operation and effectiveness
of the Company’s third party risk
management framework which supports
the management of key risks important
to AstraZeneca’s integrity and reputation
such as bribery and corruption, data
privacy, employment principles and
product security.
100
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance > The FRC’s review of certain aspects of
KPMG LLP’s audit of AstraZeneca PLC’s
financial statements for the year ended
31 December 2014. The Audit Committee
discussed the review and its findings
with KPMG. The Audit Committee was
satisfied with the responses to be
implemented by KPMG.
> Considering the external quality
assessment review of IA conducted by
Ernst & Young LLP during 2015.
In the course of carrying out its work, the
Audit Committee has taken the opportunity
to meet individual or groups of managers
to discuss and gain a deeper insight into
relevant areas of interest.
Significant financial reporting issues
considered by the Audit Committee
in 2015
The Audit Committee determined that the
significant matters considered during the
year were
> revenue recognition
> impairment of intangible assets
> litigation and contingent liabilities
> tax accounting
> post-retirement benefits
> allocation of Core and non-Core revenues
> Externalisation Revenue accounting.
Revenue recognition
The US is our largest single market and
sales accounted for 40.1% of our Product
Sales in 2015. 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.
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, a
significant development milestone such as
the publication of clinical trial results which
could significantly alter management’s
forecasts for the product.
considered the key tax developments at
OECD and in key jurisdictions, including
proposed requirements for country-by-
country reporting. The Audit Committee
was informed that the Company was on
track to meet such additional requirements.
Post-retirement benefits
Pension accounting continues to be
a significant area of focus. The Audit
Committee considered the investment
performance and financing of significant
pension plans.
In 2015, there were no significant
impairments of intangible assets.
Litigation and contingent liabilities
Litigation, particularly that relating to the
enforcement and defence of IP rights
protecting medicines, is a significant feature
of the pharmaceutical industry. In addition
to IP litigation, the Group is involved in a
number of government investigations and
is a defendant in certain product liability
actions. The Audit Committee receives
regular updates from the General Counsel,
and is informed by commentary from the
external auditor, on the status of those
litigation matters that might result in fines or
damages against the Company, to assess
whether provisions should be taken and,
if so, when and in what amounts. Of the
matters the Audit Committee considered in
2015 the Pulmicort Respules patent litigation
and Nexium anti-trust litigation, both in the
US, were among the most significant. The
Company took a reserve in the Pulmicort
Respules case after the US Court of
Appeals for the Federal Circuit affirmed
certain claims in the Pulmicort Respules
sterility patent were invalid and lifted the
preliminary injunction. Notwithstanding the
Company’s success defending the claims
in the Nexium anti-trust case, the plaintiffs
continue to seek opportunities to assert
their claims. Further information about the
Company’s litigation and contingent liabilities
is set out in Note 27 to the Financial
Statements from page 186.
Tax accounting
The Audit Committee considered the overall
tax affairs of the Group in 2015, noting that
the exposure associated with significant tax
contingencies has continued to reduce but
remains significant. The Audit Committee
Internal controls
At each quarterly meeting, the Audit
Committee receives a report of the matters
considered by the Disclosure Committee
during the quarter. At the February 2016
meeting, the CFO presented to the Audit
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 2015. Based
on their evaluation, the CEO and the CFO
concluded that, as at that date, we maintain
an effective system of disclosure controls
and procedures.
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 and safeguards
on non-audit services
We noted in our 2012 Annual Report that,
having reviewed the changes to the UK
Corporate Governance Code with regard
to putting the external audit contract out
to tender at least every 10 years, and
cognisant of the fact that the lead audit
partner at KPMG rotated in 2013, the Audit
Committee determined that the audit would
be put out to tender by 2018 in accordance
with the transitional 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.
The six largest audit firms were invited to
participate in the process, three of which
AstraZeneca Annual Report and Form 20-F Information 2015
101
Corporate Governance Audit Committee Report continued
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 2015, non-audit services provided to
the Company by KPMG included tax
compliance services and audit services in
relation to employee benefit funds, within
the scope of the pre-approved services
set out in the Non-Audit Services Policy.
All such services were presented to the
Audit Committee for pre-approval.
Fees paid to the auditor for audit,
audit-related and other services are
analysed in Note 29 to the Financial
Statements on page 192. Fees for non-audit
services amounted to 30% of the fees paid
to KPMG for audit, audit-related and other
services in 2015.
Assessing external audit effectiveness
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, the Audit
Committee recommended to the Board that
a resolution for the reappointment of KPMG
as the Company’s external auditor for the
year ending 31 December 2016 be
proposed to shareholders at the AGM in
April 2016.
Consistent with current market practice,
KPMG’s services to the Company are
provided pursuant to terms of engagement,
which are reviewed by the Audit Committee.
Neither these terms of engagement nor any
other agreement include any contractual
obligations under which the Board would be
prevented from appointing a different audit
firm were they to consider this to be in the
best interests of the Group.
declined. We agreed with KPMG that
given they would be prohibited from
being our auditor post 2020 they would
not participate. No contractual obligations
restricted the Audit Committee’s choice
of external auditor.
Having concluded a competitive tender
process in December the Audit Committee
recommended to the Board that PwC be
appointed as the Group’s statutory auditor
for the 2017 financial year. 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 2015.
Non-audit services
The Audit Committee maintains a policy (the
Non-Audit Services Policy) and procedures
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 policies and procedures cover 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 CFO (supported by the
Vice-President Finance, Group Controller),
monitors the status of all services being
provided by the external auditor. The
procedures also deal with placing non-audit
work out for tender, where appropriate.
Authority to approve work in excess of the
pre-agreed fee limits is delegated to the
102
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Directors’ Remuneration Report
Dear shareholder
As Chairman of the Remuneration Committee
(the Committee), I am pleased to present AstraZeneca’s
2015 Directors’ Remuneration Report incorporating
our Annual Report on Remuneration for 2015
(the Implementation Report). Our Remuneration
Policy, approved by shareholders at the 2014 AGM,
is reproduced from page 122.
Contents
Annual Statement from the Chairman of the Remuneration Committee
At a glance summary
Annual Report on Remuneration
> What did we pay our Directors?
> Share interests awarded in 2015
> Payments to former Directors
> Payments for loss of office
> Remuneration context and our past performance
> Directors’ interests in shares
> Governance
Implementation of Remuneration Policy in 2016
Additional information: Executive Directors’ share plans
Remuneration Policy Report (reproduced)
> Remuneration Policy for Executive Directors
> Remuneration scenarios for Executive Directors
> Approach to recruitment remuneration for Executive Directors
> Service contracts for Executive Directors
> Principles of payment for loss of office for Executive Directors
> Remuneration Policy for Non-Executive Directors
103
106
107
107
110
112
112
112
114
115
117
119
122
123
129
129
131
132
134
In 2015, I succeeded John Varley as
Chairman of the Committee. I would like
to offer thanks from the Committee to
John Varley and Nancy Rothwell, both of
whom retired following the 2015 AGM, for
their leadership and valued contribution to
the Committee.
Although the Committee is not proposing
material changes to remuneration within
policy this year, we have evolved the format
of this report by including an At a glance
section on page 106, as well as a brief table
of contents below. We hope shareholders
will find these improvements helpful.
2015 performance
The Company delivered a strong pipeline
and financial performance in 2015 as we
continued to implement our strategy to
achieve scientific leadership, return to
growth, and achieve 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.
This year our continued focus on our three
main therapy areas delivered further R&D
progress, supported by key agreements
with Acerta Pharma and Celgene in
Oncology, and ZS Pharma in CVMD.
We continued to make strong progress
towards achieving scientific leadership and
our ability to deliver innovation to the market
with a number of opportunities accelerated
and our pipeline progressed significantly
above expectations. To highlight two
achievements, the FDA’s accelerated
approval of Tagrisso provided an important
AstraZeneca Annual Report and Form 20-F Information 2015
103
Corporate Governance Directors’ Remuneration Report continued
new treatment option for lung cancer
patients, as did the FDA’s approval of
the expanded indication for Brilinta for
patients with a history of heart attack
beyond the first year.
In addition, we completed a number
of strategic business development
transactions this year, such as the
agreement with Takeda in Respiratory,
the Movantik collaboration and the Entocort
and Caprelsa divestments, which have
enabled the business to realise the full value
of assets and technology to reinvest in
support of our accelerated pipeline and
Growth Platforms.
The Committee noted that two acquisitions
were made close to the year end and the
Committee will take into account any dilutive
effect attributable to the transactions on the
Company’s LTIs in due course.
In terms of financial performance, our six
Growth Platforms delivered an 11% rise
in sales representing 57% of our Total
Revenue demonstrating continued delivery
of our return to growth strategy. Overall, the
performance of our Growth Platforms was
strong, particularly Brilinta/Brilique; Farxiga/
Forxiga in Diabetes; and Emerging Markets.
Despite the market slowdown in China,
sales growth was 15%, with Oncology and
Respiratory performing particularly well.
Although our Product Sales declined by
1% in 2015, reflecting the impact of the entry
of Nexium generic products in the US, the
performance of our Growth Platforms
demonstrates the impact that our return to
growth strategy is having on the business,
complementing our established products.
AstraZeneca
remains focused on
the delivery of our
strategy and aligns
reward to the creation
of sustained value
for our shareholders.”
Overall, our financial performance during
2015 continues to reflect the life-cycle
challenges which we have faced and the
substantial investment and progress which
we have made in developing our pipeline
over recent years. As a result of the actions
taken by our leadership team during this
phase in our strategy, our Core EPS has
risen by 7% during 2015 to $4.26 at actual
rate of exchange. In addition, Total Revenue
increased by 1% during the year to $24.7
billion. At actual exchange rates, Total
Revenue declined by 7% in the year
reflecting the particular weakness of key
trading currencies against the US dollar.
2015 remuneration outcomes
Performance measures are closely
aligned with Company strategy, ensuring the
Executive Directors only receive significant
reward for delivery of appropriately balanced
financial, non-financial and individual
performance. In evaluating reward the
Committee has ensured that the outcomes
reflect the actual performance of the
business and shareholder experience.
Valuable additional insight is provided by
the two members of the Committee who
are also members of the Audit Committee.
As I have outlined above, the Company
performed well against the components
of the global Scorecard (see page 107
for further information). When assessing
business performance the Committee noted
that some achievements were enabled by
additional investment which was not
originally budgeted when the Scorecard
targets were set. As a consequence, the
Committee has taken care to ensure
that Scorecard performance has been
appropriately evaluated by reference
to the original budgeted investment.
When considering business performance
together with the Executive Directors’
performance against their individual
objectives, annual bonus awards of 175%
and 149.3% of base salary were awarded
to Mr Soriot and Mr Dunoyer respectively.
In line with commitments made last year,
we have provided the targets and outcomes
under the achieve Group financial targets
performance measure. We continue to
provide appropriate disclosure of the other
measures, return to growth and achieve
scientific leadership, while being mindful
that the target ranges themselves remain
commercially sensitive at this time. As
highlighted last year, we will disclose the
targets when they are deemed no longer to
be sensitive, which we currently envisage
being in two years’ time. Consistent with
this approach, this year’s report includes
disclosure of the targets that were used for
the 2013 annual bonus.
The 2013 PSP award was tested for
performance following the end of 2015.
In the return to growth measure, the
Diabetes performance targets were set prior
to the acquisition of the remaining 50%
interest in the Global Diabetes Alliance
Assets and therefore the Committee
has evaluated performance consistently
against the original targets. As a result of
our performance over the last three years,
the timeframe of which coincides with
implementation of the new strategy which
Mr Soriot set out for AstraZeneca, the 2013
PSP award vested at 78% of maximum.
Disclosure of the 2013 PSP targets and
outcome can be found on page 109.
Remuneration in 2016
As set out in more detail on page 117,
we are not proposing to make material
changes to our remuneration arrangements
for 2016. Executive Directors will receive
salary increases of 2%, effective from
1 January 2016, in line with those for the
wider employee population. There are no
changes proposed to their benefit or
pension provision.
Target incentive opportunity levels attached
to the 2016 annual bonus and 2016 PSP
and AZIP awards will also remain
unchanged. The performance measures
under these plans will also remain
unchanged, albeit with the introduction of
a simplified approach to how we measure
performance under the return to growth
measure in our PSP, further details of which
are provided opposite.
104
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance
Directors’ Remuneration Report continued
Shareholder engagement
The Committee was pleased to note
that shareholders’ approval of our 2014
Implementation Report increased
significantly from 2013. Nevertheless,
the outcome was still lower than we would
like it to be. As such, over the course of
2015, on behalf of the Committee, I have
spoken with a number of our major
shareholders and I would like to take this
opportunity to thank them for the input
and feedback they provided.
I would like to address three key areas
raised by shareholders.
Simplifying our LTI arrangements
While it was recognised that our
arrangements are wholly aligned with
our strategy, some shareholders felt that
there may be an opportunity to simplify
the framework. During 2016, we intend
to continue discussions with our major
shareholders on this area, with a view
to ensuring that Executive Director reward
at AstraZeneca remains focused on the
delivery of our strategy and aligns reward
to the creation of sustained value for
our shareholders.
In addition, for 2016, we have decided to
simplify one of the elements of our PSP
by changing the return to growth measures
to one single measure consolidating the
existing six Growth Platforms in aggregate.
This change allows us to disclose the
aggregate target for this measure at the
start of the performance period, in contrast
to the individual targets for each Growth
Platform which remain commercially
sensitive, and assists in striking the right
balance between transparency in our
reporting on executive pay and protecting
our commercially sensitive information.
In addition, in relation to our LTIs, we are
aware that at times some shareholders
may have found our use of expected values
unclear. As such, while we continue to use
expected values internally to allow us to
allocate awards between the PSP and AZIP,
from 2016 onwards we will disclose the
value of LTI awards in terms of their face
value only.
Mr Soriot has received ‘above-target’
awards in recent years due to the
outstanding contribution he has made
to the business since his appointment.
The Committee values the ability to
recognise this progress.
More transparent link between the
financial targets communicated in May
2014 and executive pay
Some shareholders questioned whether
there could be a more transparent link
between the financial targets which we
communicated in May 2014 and executive
pay, and in particular whether a target
based on the 2023 revenue figure
($45 billion at 2013 exchange rates) could
be incorporated within our incentive plans.
This has some attraction, although there
is a clear balance to be struck given the
need to ensure that our arrangements are
simple, practicable and aligned to our
business. Ultimately, following discussions,
the Committee’s view is that the best way
to achieve line of sight to the 2023 revenue
target is by ensuring that the financial and
operational measures under the PSP are
directly linked to the long-term business
plan. However, the Committee will continue
to consider ways in which a more
transparent link between the 2023 revenue
target and executive pay may be achieved.
Above-target LTI awards
The use of ‘above-target’ awards at
AstraZeneca has been noted by some
shareholders. While we are aware that
the use of ‘target’ awards may be less
common in the wider market, at
AstraZeneca we find that operating a
‘target’ award level, with the flexibility to go
above or below this level, can be helpful in
setting and communicating award levels
internally, allowing the Committee to
differentiate performance appropriately.
In considering Mr Soriot’s remuneration,
we reference practice within UK quoted
companies, but we also remain mindful
of the fact that our peers are mainly US or
Swiss-based companies. Individuals with
the capability which Mr Soriot brings to the
CEO role are extremely valuable and he is
undoubtedly a sought-after individual
within our sector, particularly given the
re-invigoration of the Company which he
has led over the last three years.
In this context, the Committee aims to
ensure that Mr Soriot is appropriately
rewarded within our Remuneration Policy.
Next steps
We remain committed to ensuring that
our remuneration arrangements support
our strategy and the delivery of value to our
shareholders. As such, I hope that you find
this report clear, helpful and informative.
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
4 February 2016
AstraZeneca Annual Report and Form 20-F Information 2015
105
Corporate Governance Directors’ Remuneration Report continued
At a glance summary
Looking ahead to 2016 – our remuneration framework
Element
Salary
Pension
Annual bonus
Structure
Base salary, paid monthly
Opportunity
CEO – £1,190,000
CFO – £707,000
Salary supplement in lieu of pension
participation
CEO – 30% of salary
CFO – 24% of salary
Assessed by performance against one-year
financial, non-financial and individual
performance targets, with one-third of any
award deferred into Ordinary Shares or
ADSs, which will vest after three years
CEO – maximum 180% of salary
CFO – maximum 150% of salary
Change from 2015
2% increase
2% increase
No change
No change
No change
No change
Performance Share Plan
(PSP)
Assessed on three-year performance
against four equally-weighted measures:
CEO – 427.7% of salary
CFO – 300% of salary
No change
4.76% decrease
> Relative TSR
> Cash flow
> Return to growth
> Achieve scientific leadership (5
individual measures)
Additional two-year holding period
AstraZeneca Investment
Plan (AZIP)
Assessed on four-year performance
against two measures:
CEO – 71.3% of salary
CFO – 50% of salary
No change
4.76% decrease
> Dividend level
> Dividend cover
Additional four-year holding period
Our variable remuneration – 2015
2015 Annual bonus (see page 107 for further details)
Measure
Target (one-year)
Weighting
Performance
Level of award
Achieve Group financial targets
Cash flow
Core EPS
Revenue
Achieve scientific leadership
5 measures
Return to growth
6 measures
10%
20%
10%
6% each
5% each
Met target
Exceeded target
Exceeded target
Exceeded target
Exceeded target
CEO – 97.2% of maximum (175% of
salary)
CFO – 99.5% of maximum (149.3%
of salary)
2013-2015 PSP (see page 109 for further details)
Target (three-year)
Weighting
Performance
Level of award
TSR performance relative to peer group
Cumulative free cash flow
25% each
58% of maximum
100% of maximum
100% of maximum
55% of maximum
78% of maximum
Measure
Relative TSR
Cash flow
Achieve scientific leadership
5 key measures
Return to growth
5 measures
106
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Directors’ Remuneration Report continued
Annual Report on Remuneration
(the Implementation Report)
What did we pay our Directors?
Executive Directors’ single total figure remuneration (Audited)
Pascal Soriot
Marc Dunoyer
Total
2015
Base
salary
£’000
1,167
694
2014
Base
salary
£’000
1,133
680
1,861
1,813
2015
Taxable
benefits
£’000
115
65
180
2014
Taxable
benefits
£’000
108
62
170
2015
Annual
bonus
£’000
2,042
1,036
3,078
2014
Annual
bonus
£’000
1,926
1,016
2,942
2015
Long-term
incentives
vesting
£’000
4,723
2014
Long-term
incentives
vesting
£’000
–
2015
Pension
allowance
£’000
350
2014
Pension
allowance
£’000
340
3,993
8,716
–
–
167
517
163
503
2015
Total
£’000
8,397
5,955
14,352
2014
Total
£’000
3,507
1,921
5,428
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 2015, the Executive Directors principally took the allowance in cash (£96,000 in respect
of Mr Soriot, and £49,000 in respect of Mr Dunoyer) and selected other benefits including healthcare insurance, death-in-service provision
and advice in relation to tax.
Annual bonus – 2015
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 global Scorecard. As with 2014, we have set out below the targets for 2015 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 measures. 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 when we no longer consider the
targets to be commercially sensitive, which we currently anticipate to be two years after the end of the performance period (as we have
done for the 2013 annual bonus targets which are set out on page 114).
When assessing business performance the Remuneration Committee noted that some achievements were enabled by additional
investment which was not originally budgeted when the Scorecard targets were set. As a consequence, the Remuneration Committee
has taken care to ensure that Scorecard performance has been appropriately evaluated by reference to the original budgeted investment.
The global Scorecard outcome was 160% and the Remuneration Committee determined that Mr Soriot’s annual bonus should amount to
175% of base salary, representing 97.2% of his potential maximum, and that Mr Dunoyer’s bonus should amount to 149.3% of base salary,
representing 99.5% of his potential maximum. This includes the application of the Scorecard outcome and a further performance uplift to
reflect the Remuneration Committee’s view of Mr Soriot’s and Mr Dunoyer’s individual contributions beyond the achievements underpinning
the Scorecard outcome.
1. Achieve Group financial targets
These targets are based on the Company’s key financial measures. The annual bonus outcomes reflect the strong revenue and Core EPS
performance delivered in 2015, exceeding the targets set at the beginning of the year. Cash flow performance was also on target.
Performance measures for 2015
Achieve cash flow from operating activities target
Achieve Core EPS target
Achieve overall revenue target
Pascal Soriot level of award
Marc Dunoyer level of award
Weighting
10%
20%
10%
Target
$3.4bn1
$4.412
$24.8bn2
Outcome
$3.6bn1
Performance
Met target
$4.672
Exceeded target
$26.2bn2
Exceeded target
£852,000 (representing 41.7% of total annual bonus outcome)
£456,000 (representing 44% of total annual bonus outcome)
Pascal
Soriot
level of
award
13%
40%
20%
Marc
Dunoyer
level of
award
11.7%
36%
18%
1 The cash flow target, and the performance against that target, is evaluated by reference to net cash flow before distributions and other adjustments required by the performance conditions.
2 The Core EPS and revenue targets, and the performance against those targets, are evaluated by reference to budget exchange rates such that beneficial or adverse movements in currency, which
are outside the Company’s control, do not impact reward outcomes.
AstraZeneca Annual Report and Form 20-F Information 2015
107
Corporate Governance Annual Report on Remuneration
(the Implementation Report) continued
2. Achieve scientific leadership
These measures reflect the Company’s ability to deliver innovation to the market. In 2015, we continued to make significant progress
towards achieving scientific leadership and exceeded two out of five of our pipeline targets.
The AstraZeneca pipeline now includes 146 projects, of which 125 are in the clinical phase of development. There are 15 NME projects
currently in late-stage development, either in Phase III/pivotal Phase II studies or under regulatory review. During 2015, across the portfolio,
56 projects successfully progressed to their next phase. This includes three first launches and three first approvals in a major market, and
18 NME progressions. In addition, 18 projects have entered Phase I and 20 projects have been discontinued.
Performance measures for 2015
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
Weighting
Target
Outcome
Performance
6% per
measure
Commercially
sensitive
until March
2018
11
6
12
5
10
Met target
Met target
Met target
Exceeded target
Exceeded target
Pascal Soriot level of award
Marc Dunoyer level of award
£490,000 (representing 24% of total annual bonus outcome)
£262,000 (representing 25.3% of total annual bonus outcome)
Pascal
Soriot
aggregate
level of
award
Marc
Dunoyer
aggregate
level of
award
42%
37.8%
3. Return to growth1
These measures are based on quantitative sales targets for 2015 relating to the Company’s Growth Platforms: Brilinta/Brilique, Diabetes,
Respiratory, New Oncology, Emerging Markets, and Japan. In 2015, we met or exceeded all of our return to growth targets. Our Growth
Platforms contributed 57% of Total Revenue, an increase of 11% from 2014.
Performance measures for 2015
Deliver Brilinta/Brilique target
Build Diabetes franchise
Deliver Respiratory goals
Deliver New Oncology growth target
Deliver sales growth in Emerging Markets
Deliver Japan target
Pascal Soriot level of award
Marc Dunoyer level of award
Weighting
Target
5% per
measure
Commercially
sensitive
until March
2018
Outcome
$668m
$2,323m
Performance
Met target
Met target
$5,014m
Exceeded target
$123m
Exceeded target
$6,314m
$2,191m
Met target
Met target
£525,000 (representing 25.7% of total annual bonus outcome)
£281,000 (representing 27.1% of total annual bonus outcome)
Pascal
Soriot
aggregate
level of
award
Marc
Dunoyer
aggregate
level of
award
45%
40.5%
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 global Scorecard drive prima facie bonus outcomes, the Remuneration Committee also applies
judgement to assess the Executive Director’s individual performance.
For 2015, the Remuneration Committee has determined that following the application of the Scorecard outcome, Mr Soriot’s bonus will be
increased by £175,000 from 160% of base salary to 175% and, in respect of Mr Dunoyer, by £37,000 from 144% of base salary to 149.3%.
The Remuneration Committee awarded an individual performance uplift of 15% to Mr Soriot’s award, which recognises his leadership
qualities in driving the Company through a period of transitional change as we continue to return the Company to growth. The
Remuneration Committee in particular wished to recognise his continued focus on the Company’s longer-term strategy by unlocking the
value of non-core assets and technology to support our accelerated pipeline and Growth Platforms in the near term, and the acquisitions
of ZS Pharma and Acerta Pharma and business development deals which have the potential to generate sustainable returns for our
shareholders. In addition, under Mr Soriot’s leadership we have achieved excellent three-year TSR performance against our peers and
the Company was ranked as second best employer in the UK in an independent survey commissioned by Bloomberg.
The Remuneration Committee awarded an individual performance uplift of 5.3% to Mr Dunoyer’s award, which recognises in particular his
role in delivering financial performance in line with guidance despite significant foreign currency headwinds, the successful $6 billion bond
issue and the execution of the Company’s business development activities.
108
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance
Long-term incentives: 2013 Performance Share Plan (PSP)
The vesting of the PSP awards is contingent on continued employment and performance against four equally-weighted performance
measures over the three-year performance period. 78% of the PSP awards granted to Mr Soriot and Mr Dunoyer in 2013 in respect of the
2013-2015 performance period will vest in 2016. This is the first vesting of LTIs for Mr Soriot and Mr Dunoyer since joining the Company.
Pascal Soriot
Marc Dunoyer
Number of shares awarded
Number of shares vesting
125,113
90,853
97,588
70,865
1 Based on average closing share price over the three-month period to 31 December 2015 plus accrued dividends over the vesting period.
Value of shares vesting1
£’000
4,723
3,993
The TSR and cash flow targets were disclosed at the time of the award. The Remuneration Committee has determined that the 2013
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 2015 section from page 110.
1. Relative TSR
Performance measure for 2013–2015
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
Remuneration
Committee)
Outcome
4th
Vesting (% of
maximum)
58%
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 measure for 2013–2015
Adjusted cumulative cash flow1
Weighting
25%
Threshold target:
25% vesting
$9bn
Maximum target:
100% vesting
$13bn
Outcome
$14.1bn
Vesting (% of
maximum)
100%
1 The cash flow target, and the performance against that target, is evaluated by reference to net cash flow before distributions and other adjustments required by the performance conditions.
3. Achieve scientific leadership
Performance measures for 2013–2015
Weighting
Threshold target:
25% vesting
Maximum target:
100% vesting
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
4. Return to growth1
Performance measures for 2013–2015
Deliver Brilinta/Brilique target
Build Diabetes franchise2
Deliver Respiratory goals
Deliver sales growth in Emerging Markets
Deliver Japan target
5% per
measure
2
3
7
$1bn
9
4
5
10
$3bn
12
Weighting
Threshold target:
25% vesting
Maximum target:
100% vesting
5% per
measure
$1bn
$1.3bn
$3.2bn
$5bn
$2.4bn
$1.4bn
$1.9bn
$4.6bn
$7.1bn
$3.4bn
Outcome
6
5
14
$5.6bn
34
Outcome
$0.7bn
$1.1bn
$5.6bn
$6.6bn
$3.2bn
Vesting (% of
maximum)
100%
100%
100%
100%
100%
Vesting (% of
maximum)
0%
0%
100%
88%
88%
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.
2 The Diabetes performance targets were set prior to the acquisition of the remaining 50% interest in the Global Diabetes Alliance Assets and therefore the Remuneration Committee has evaluated
performance consistently against the original targets.
AstraZeneca Annual Report and Form 20-F Information 2015
109
Corporate Governance Annual Report on Remuneration
(the Implementation Report) 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
Cori Bargmann
Geneviève Berger
Bruce Burlington
Ann Cairns
Graham Chipchase
Jean-Philippe Courtois
Rudy Markham
Shriti Vadera
Marcus Wallenberg
Former Non-Executive Directors
Nancy Rothwell
John Varley
Total
2015
Fees
£’000
609
2014
Fees
£’000
572
2015
Taxable
benefits
£’000
–
2014
Taxable
benefits
£’000
–
2015
Annual
bonus
£’000
–
2014
Annual
bonus
£’000
–
2015
Long-term
incentives
vesting
£’000
–
2014
Long-term
incentives
vesting
£’000
–
2015
Pension
allowance
£’000
–
2014
Pension
allowance
£’000
–
2015
Total
£’000
609
2014
Total
£’000
572
59
87
114
95
107
95
156
108
87
35
46
–
85
105
65
92
95
130
95
85
107
140
1,598
1,571
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
59
87
114
95
107
95
156
108
87
35
46
–
85
105
65
92
95
130
95
85
107
140
1,598
1,571
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 £34,000 for 2015, and £34,500 for 2014. Further information on the
Non-Executive Directors’ fees can be found in the Summary of Non-Executive Directors’ remuneration for 2016 section on page 119.
Board changes
Cori Bargmann was elected as a Director, and Nancy Rothwell and John Varley retired as Directors, at the Company’s AGM on 24 April 2015.
Share interests awarded in 2015 (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
Pascal Soriot
Marc Dunoyer
13,482 Ordinary Shares awarded on 27 March 2015 at a
grant price of 4762 pence per share.
7,111 Ordinary Shares awarded on 27 March 2015 at a
grant price of 4762 pence per share.
Award over shares equal to one-third of the pre-tax annual bonus based on the prevailing market share price on the
award date.
Automatic deferral of one-third of annual bonus into Ordinary Shares or ADSs.
£642,000
£339,000
100%
27 March 2018
Summary of performance measures and targets
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 2015
Corporate Governance Performance Share Plan (PSP)
Interest awarded
Description of interest
Pascal Soriot
Marc Dunoyer
104,764 Ordinary Shares awarded on 27 March 2015
at a grant price of 4762 pence per share.
45,880 Ordinary Shares awarded on 27 March 2015
at a grant price of 4762 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
427.5% of base salary.
£4,989,000
315% of base salary.
£2,185,000
Vesting level at threshold performance
End of performance period
End of holding period
Summary of performance measures and targets
25%
31 December 2017
27 March 2020
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 2015
% 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 Remuneration 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 2015 is net cash flow before distributions and other adjustments
required by the performance conditions (subject to any further adjustments the Remuneration 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 2015
% of award under cash flow performance measure that vests
Less than $9 billion
$9 billion
Between $9 billion and $11 billion
$11 billion
Between $11 billion and $13 billion
$13 billion and above
0%
25%
Pro rata
75%
Pro rata
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.
Twenty-five percent of the award is based on return to growth measures based on quantitative sales targets
relating to the Company’s six Growth Platforms: Brilinta/Brilique, Diabetes, Respiratory, New Oncology, Emerging
Markets, and Japan.
As the PSP performance measures related to achieve scientific leadership and return to growth 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 126 of the Remuneration Policy Report.
AstraZeneca Annual Report and Form 20-F Information 2015
111
Corporate Governance Annual Report on Remuneration
(the Implementation Report) continued
AstraZeneca Investment Plan (AZIP)
Interest awarded
Description of interest
Pascal Soriot
Marc Dunoyer
17,460 Ordinary Shares awarded on 27 March 2015
at a grant price of 4762 pence per share.
7,646 Ordinary Shares awarded on 27 March 2015
at a grant price of 4762 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
Vesting level at threshold performance
End of performance period
End of holding period
71.25% of base salary.
£831,000
52.5% of base salary.
£364,000
100%
31 December 2018
31 December 2022
Summary of performance measures and targets
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.
Both performance hurdles must be achieved in each year of the performance period for the award to vest.
More information about the AZIP’s performance hurdles is set out on page 127 of the Remuneration Policy Report.
AstraZeneca 2012 Savings Related Share Option Scheme (SAYE)
Marc Dunoyer
Interest
Description of interest
Basis of award
Face value of award
An option granted over 544 Ordinary Shares on 28 September 2015 at a grant price of 3307 pence per share. The grant price
is set at 80% of the average market value of an Ordinary Share over the three consecutive trading days immediately preceding
the offer date.
The SAYE provides for the grant of options over Ordinary Shares.
£500 monthly payroll deductions over three years.
£18,000
Vesting level at threshold performance1
100%
End of performance period2
1 December 2018
Summary of performance measures and
targets
No performance conditions apply, but vesting is ordinarily subject to continued employment.
More information about the SAYE is set out on page 128 of the Remuneration Policy Report.
1 No performance conditions apply under the SAYE, other than continued employment.
2 As no performance conditions apply, this date represents the first date on which the option may normally be exercised.
Payments to former Directors (Audited)
No payments were made during 2015 to former Directors.
Payments for loss of office (Audited)
No payments were made for loss of office during 2015.
Remuneration context and our past performance
Statement of change in remuneration of CEO compared to other employees
Salary
Taxable benefits
Annual bonus
3%
6.5%
6%
3.6%
3.6%
9.4%
Percentage change of CEO against 2014
Average percentage change for employees against 2014
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 2014 and 2015 group.
112
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance CEO total remuneration table
Year
2015
2014
2013
2012
2012
2012
2011
2010
2009
CEO
Pascal Soriot
Pascal Soriot
Pascal Soriot
Pascal Soriot2
Simon Lowth4
David Brennan6
David Brennan
David Brennan
David Brennan
CEO single total figure
remuneration
£’000
Annual bonus
£’000
Annual bonus payout
against maximum
opportunity
%
8,397
3,507
3,344
3,6933
3,289
4,1477
7,863
9,690
5,767
2,042
1,926
1,870
335
1,034
–
1,326
1,583
1,751
97
94
94
68
86
–8
74
90
100
Value of LTIs
at vest
£’000
4,7231
–
–
–
1,3015
2,538
5,386
6,937
2,795
LTI vesting rates
against maximum
opportunity
%
78
–
–
–
385
38
62
100
62
1 Based on average closing share price over the three-month period to 31 December 2015 plus accrued dividends over the vesting period.
2 Mr Soriot was appointed CEO with effect from 1 October 2012.
3 This figure includes £991,000 paid to compensate Mr Soriot in respect of his forfeited bonus opportunity for 2012 and an award of £2,000,000 to compensate him for his loss of LTI awards,
both in respect of his previous employment.
4 Mr Lowth acted as Interim CEO from June to September 2012 inclusive.
5 Mr Lowth’s LTI awards which vested during 2012 were not awarded or received in respect of his performance as Interim CEO.
6 Mr Brennan ceased to be a Director on 1 June 2012.
7 This figure includes Mr Brennan’s pay in lieu of notice of £914,000.
8 Mr Brennan informed the Remuneration 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 Remuneration Committee
determined that no such bonus would be awarded and also that there should be no bonus award relating to his contractual notice period.
Total shareholder return (TSR)
The graph below compares the TSR performance of the Company over the past seven 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 2013, 2014 and 2015, 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 2015.
TSR over a seven-year period
AstraZeneca TSR vs comparator group
1 January 2015 – 31 December 2015 (%)
250
225
200
175
150
125
100
Jan
09
Jan
10
Jan
11
Jan
12
Jan
13
Jan
14
Jan
15
Jan
16
AstraZeneca
Pharmaceutical peers average
FTSE100
30
20
10
0
-10
LLY
BMS
PFI
SA
NOV
GSK
AZ
J&J
RH
AV
MRK
AstraZeneca TSR vs comparator group
1 January 2014 – 31 December 2015 (%)
AstraZeneca TSR vs comparator group
1 January 2013 – 31 December 2015 (%)
80
70
60
50
40
30
20
10
0
-10
LLY
AZ
BMS
NOV
AV
SA
MRK
PFI
J&J
RH
GSK
120
100
80
60
40
20
0
BMS
LLY
AV
AZ
NOV
RH
PFI
J&J
SA
MRK
GSK
Key:
AZ AstraZeneca, AV AbbVie, BMS Bristol-Myers Squibb, GSK GlaxoSmithKline, J&J Johnson & Johnson, LLY Eli Lilly, MRK Merck, NOV Novartis, PFI Pfizer, RH Roche Holding,
SA Sanofi-Aventis
AstraZeneca Annual Report and Form 20-F Information 2015
113
Corporate Governance Annual Report on Remuneration
(the Implementation Report) continued
Relative importance of spend on remuneration
The table below shows the overall spend on employee remuneration 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 140, or its Consolidated Statement of Cash Flows on page 143. Further
information on the Group’s Accounting Policies can be found from page 144.
Total employee remuneration1
Distributions to shareholders:
– Dividends paid
2015
$m
6,128
3,486
2014
$m
6,279
3,521
Difference in spend
between years
$m
Difference in spend
between years
%
(151)
(35)
(2.4)
(0.99)
1 This figure includes the remuneration paid to all employees in the Group, including the Executive Directors but excluding the Non-Executive Directors, who are not employees.
Disclosure of historic performance targets
2013 Annual bonus
In accordance with the Remuneration Committee’s commitment to disclosure as set out in the 2014 Directors’ Remuneration Report,
the Remuneration Committee has determined that the 2013 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 last year’s report. Mr Soriot’s 2013 annual bonus award was 170% of base salary, and Mr Dunoyer’s award was 129%.
The level of award for the Executive Directors in respect of the achieve scientific leadership performance measures was 44% of the total
bonus outcome, with the return to growth measures contributing 12%. These figures reflect the outcome of the global Scorecard and the
Executive Directors’ individual performance against it.
1. Achieve scientific leadership
Performance measures for 2013
Positive Phase III investment decisions
NME major submissions
External licensing opportunities in Phase I/II
Late-stage external opportunities
Phase II starts
2. Return to growth1
Performance measures for 2013
Deliver Brilinta/Brilique target
Build Diabetes franchise2
Deliver sales growth in Emerging Markets
Deliver Respiratory goals
Deliver Japan growth target
Target
Outcome
Performance
2
2
2
1
8
Target
$380m
$979m
$5,624m
$4,597m
$3,221m
3
3
4
3
11
Exceeded target
Exceeded target
Exceeded target
Exceeded target
Exceeded target
Outcome
$280m
$788m
$5,396m
$4,716m
$3,158m
Performance
Below target
Below target
Below 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.
2 The Diabetes performance targets were set prior to the acquisition of the remaining 50% interest in the Global Diabetes Alliance Assets and therefore the Remuneration Committee has evaluated
performance consistently against the original targets.
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. In the period since his appointment
on 1 October 2012, Mr Soriot has acquired 250,100 Ordinary Shares using his own resources which he gifted to family members for nil
consideration on 31 December 2015. As at 31 December 2015, Mr Soriot beneficially held Ordinary Shares amounting to 237% of his 2015
base salary, and it is anticipated that Mr Soriot will reach or exceed the minimum shareholding requirement within the time limit imposed by
the Board. Mr Dunoyer has fulfilled his requirement. All other SET members are required to build a shareholding over time and hold 125% of
base salary as shares while in office.
114
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance 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 2015.
The tables below show the interests of the Directors (including the interests of their Connected Persons, as such term is defined in the
Financial Services and Markets Act 2000) in Ordinary Shares as at 31 December 2015, 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 2015 and 4 February 2016, there was no change in the interests in Ordinary Shares shown in the tables below.
Executive Directors
Executive Director
Pascal Soriot
Marc Dunoyer
Value of shares
held beneficially
as percentage
of base salary
Shareholding
requirement
(to be built up within
5 years of date of
appointment)
237%
381%
300%
200%
Beneficially
held
59,951
57,304
Shares held
Options held
Subject to
performance
conditions
482,040
228,448
Subject to
deferral
33,247
9,790
Unvested
Vested but
unexercised
Exercised
during the year
–
544
–
–
–
–
Total
575,238
296,086
The value of shares is based on the London Stock Exchange closing price of 4616.5 pence per Ordinary Share on 31 December 2015.
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.
Non-Executive Directors
Leif Johansson
Cori Bargmann
Geneviève Berger
Bruce Burlington
Ann Cairns
Graham Chipchase
Jean-Philippe Courtois
Rudy Markham
Shriti Vadera
Marcus Wallenberg
Former Directors
Nancy Rothwell
John Varley
Beneficial interest in
Ordinary Shares at
31 December 2014 or
(if later) appointment date
Change to beneficial interest
Beneficial interest in
Ordinary Shares at
31 December 2015 or
(if earlier) date of retirement
39,009
–
2,090
2,749
1,225
1,900
2,635
2,452
6,500
63,646
2,643
13,000
–
1,959
–
600
1,100
1,100
3,400
–
3,500
–
–
–
39,009
1,959
2,090
3,349
2,325
3,000
6,035
2,452
10,000
63,646
2,643
13,000
Governance
Remuneration Committee membership
The Remuneration Committee members are Graham Chipchase (Chairman of the Remuneration Committee), Leif Johansson, Rudy
Markham and Shriti Vadera. Nancy Rothwell and John Varley were members of the Remuneration Committee until their retirement at the
Company’s AGM held on 24 April 2015. Shriti Vadera became a member of the Remuneration Committee with effect from 17 February
2015. The Deputy Company Secretary acts as the secretary to the Remuneration Committee.
How did the Remuneration Committee spend its time during 2015?
The Remuneration Committee met seven times in 2015. The individual attendance record of Remuneration Committee members is set
out on page 92. At the invitation of the Remuneration Committee, except where their own remuneration was being discussed, the CEO; the
EVP, Human Resources; the Vice-President, People Practices and Services; the Human Resources Vice-President, Centre of Excellence;
the Executive Compensation Director; and the Company Secretary attended one or more Remuneration Committee meetings in 2015 and
provided services that materially assisted the Remuneration Committee. In addition, all meetings of the Remuneration Committee were
attended by Nicki Demby, representing Deloitte LLP (Deloitte), the Remuneration Committee’s independent adviser.
AstraZeneca Annual Report and Form 20-F Information 2015
115
Corporate Governance Annual Report on Remuneration
(the Implementation Report) continued
The Remuneration Committee focused on the following principal matters at its meetings held in 2015 and in February 2016:
> The terms of senior executives’ 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
2014 and to set executive bonus targets during 2015 and LTI awards to be granted during 2015.
> The assessment of performance against targets to determine the level of vesting in 2015 under the PSP and AZIP, and the setting of PSP
and AZIP performance thresholds for awards made in 2015.
> 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 2013 and 2014 (including dialogue with major shareholders).
> Consultation with major shareholders and shareholder representative bodies regarding proposals to adjust CEO remuneration during
2015 and the potential simplification of future 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 2015 and for 2016.
> The assessment and setting of executive bonus targets during 2016 and LTI awards to be granted in 2016.
> The annual review of the performance of the Remuneration Committee.
> The review of the terms of reference of the Remuneration Committee.
> The preparation, review and approval of this Directors’ Remuneration Report.
Independent Adviser to the Remuneration Committee
The Remuneration 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 Remuneration Committee. Deloitte’s service to the
Remuneration Committee was provided on a time-spent basis at a cost to the Company of £176,000 (excluding VAT). During the year,
Deloitte also provided taxation advice and other specific non-audit advisory services to the Group. The Remuneration 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 2015, the resolution to approve the Annual Report on Remuneration for the year ended 31 December
2014 (the 2014 Implementation Report) was passed.
Resolution text
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 2014
739,049,685
84.11 139,601,566
15.89 878,651,251
69.54
12,522,725
% of Issued Share
The Remuneration Committee has carefully considered shareholders’ comments about the 2013 and 2014 Directors’ Remuneration
Reports. Before and after the 2015 AGM, John Varley and Graham Chipchase, each of whom has been the Remuneration Committee
Chairman during 2015, met and/or spoke with the Company’s major shareholders, the Investment Association and Institutional Shareholder
Services to clearly understand their views. Key areas arising from these discussions were the desire to see a clearer link between executive
pay and the achievement of the Company’s 2023 $45 billion revenue target (based on 2013 exchange rates), and the desire for greater
simplicity and transparency in the design of executive remuneration, particularly with respect to the Company’s LTI plans.
This year we have 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. This will reflect performance across our Growth Platforms as a whole. Further we have disclosed the
target for this measure now, at the start of the performance period. This is in line with our aim to strike the right balance between
transparency in our reporting on executive pay and protecting our commercially sensitive information.
We gave careful consideration to whether there could be a more transparent link between the financial targets which we communicated
in May 2014 and executive pay. This has some attraction, although there is a clear balance to be struck given the need to ensure that our
arrangements are simple, practicable and aligned to our business. Ultimately, following discussions, the Remuneration Committee’s view is that
the best way to achieve line of sight to the 2023 revenue target is by ensuring that the financial and operational measures under the PSP are
directly linked to the long-term business plan (including the 2023 $45 billion revenue target, which we announced in May 2014). However, the
Remuneration Committee will continue to consider ways in which a more transparent link between the 2023 revenue target and executive pay
may be achieved.
We intend to continue to consult with our major shareholders and shareholder representative bodies during the course of 2016 on
proposals to further simplify our LTI plans for the future.
116
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Service contracts
The notice periods and unexpired terms of Executive Directors’ service contracts at 31 December 2015 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
Unexpired term at 31 December 2015
27 August 2012
15 March 2013
12 months
12 months
Notice period
12 months
12 months
Terms of reference
A copy of the Remuneration Committee’s terms of reference is available on our website, www.astrazeneca.com. The Remuneration
Committee conducted a review of its terms of reference during 2015 but no changes were recommended to the Board as the terms
of reference were considered to remain appropriate.
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, a resolution to approve the Implementation Report of this Directors’ Remuneration
Report will be proposed at the AGM on 29 April 2016.
Implementation of Remuneration Policy in 2016
This section sets out how the Remuneration Committee intends to implement our Remuneration Policy during 2016.
Effective from 1 January 2016, Mr Soriot’s base salary was increased, in line with increases in the UK employee population, by 2% to
£1,190,000. Mr Soriot’s target annual bonus opportunity will remain unchanged at 100% of salary and his LTI plan target will remain
unchanged at 437.5% of base salary. However, the Remuneration Committee has granted an above-target LTI award for 2016 of 499%
of base salary.
Effective from 1 January 2016, Mr Dunoyer’s base salary was increased, in line with increases in the UK employee population, by 2% to
£707,000. Mr Dunoyer’s target annual bonus opportunity will remain unchanged at 90% of base salary and his LTI plan target award will
remain unchanged at 350% of base salary.
The annual bonus measures and weightings for 2016 are set out in the table overleaf and are consistent with those applicable in 2015.
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.
The performance measures and weightings for 2016 in respect of the LTI plans (AZIP and PSP) are set out in the tables overleaf and
are broadly consistent with those applicable in 2015. However, for 2016 we have decided to simplify one of the elements of the PSP
by changing the return to growth measure from six key individual measures to one aggregate measure. This will reflect performance
across our Growth Platforms as a whole. Furthermore, this change allows us to disclose the aggregate target for this measure at the
start of the performance period, in contrast to the individual targets for each Growth Platform which remain commercially sensitive.
This is in line with our aim to strike the right balance between transparency in our reporting on executive pay and protecting our
commercially sensitive information.
Summary of Executive Directors’ remuneration for 2016
Executive Directors’ remuneration opportunity
Base salary
Pension provision
Annual bonus target
LTI plan award
1 LTI plan target remains at 437.5% of base salary.
Pascal Soriot
£1,190,000
30% of base salary
Marc Dunoyer
£707,000
24% of base salary
100% of base salary (normal range 0%-180%)
90% of base salary (normal range 0%-150%)
499% of base salary1
350% of base salary
AstraZeneca Annual Report and Form 20-F Information 2015
117
Corporate Governance Annual Report on Remuneration
(the Implementation Report) continued
Annual bonus
Return to growth
performance measures
Weighting
Achieve scientific leadership
performance measures
Weighting
Achieve Group financial targets
performance measures
Deliver Brilinta/Brilique target
NME Phase II starts
Achieve cash flow from
operating activities target
Achieve Core EPS target
NME and major life-cycle management
Phase III investment decisions
5% per
measure
NME and major life-cycle management
regional submissions
6% per
measure
Achieve overall revenue target
NME and major life-cycle management
regional approvals
Acquisition, licensing and divestment
opportunities
Weighting
10%
20%
10%
Deliver CVMD target
Deliver sales growth in
Emerging Markets
Deliver Respiratory goals
Deliver Japan growth target
Deliver New Oncology growth target
LTI plans
PSP
TSR ranking of the Company – 25% weighting
% 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 Remuneration Committee’s discretion
Adjusted cumulative cash flow – 25% weighting
% of award under cash flow performance measure that vests
Less than $9 billion
$9 billion
Between $9 billion and $11 billion
$11 billion
Between $11 billion and $13.5 billion
$13.5 billion and above
Achieve scientific leadership – 25% weighting
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
Return to growth1 – 25% weighting
Growth Platform revenue
0%
25%
Pro rata
75%
Pro rata
100%
Weighting
5% per
measure
Threshold target 25% vesting
Maximum target 100% vesting
$17bn
$20bn
1 In respect of the return to growth measure 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.
AZIP
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.
Both performance hurdles must be achieved, in each year of the performance period, for the award to vest.
118
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Summary of Non-Executive Directors’ remuneration for 2016
Board and Committee fees for the Non-Executive Directors, including the Chairman, were not reviewed in 2015 and, accordingly, there are
no changes to the level of fees proposed for 2016 at the date of this report. The fees will be reviewed during 2016 and, should any changes
be considered appropriate, changes may become effective during the 2016 financial year. The Non-Executive Director fees as at 4 February
2016 (together with those for 2015) are set out below. Further information on the Non-Executive Directors’ Board and Committee fees can
be found on page 134 of the Remuneration Policy Report.
Non-Executive Director fees in 2015 and as at 4 February 2016
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.
At 4 February
2016
£
2015
£
575,000
575,000
75,000
30,000
20,000
15,000
25,000
12,000
10,000
75,000
30,000
20,000
15,000
25,000
12,000
10,000
Additional information: Executive Directors’ share plans
Deferred Bonus Plan
The interests of Directors at 31 December 2015 in Ordinary Shares that are the subject of awards under the deferred bonus plan are
shown below.
Pascal Soriot
Award in respect of 2012 performance period
Award in respect of 2013 performance period
Total at 1 January 2015
Award in respect of 2014 performance period
Total at 31 December 2015
Marc Dunoyer
Award in respect of 2013 performance period
Total at 1 January 2015
Award in respect of 2014 performance period
Total at 31 December 2015
1 UK date convention applies.
Number of
shares
Award price
(pence)
Grant date1
Vesting date1
3,799
15,966
19,765
13,482
33,247
2,679
2,679
7,111
9,790
2939
3904
25.02.13
28.03.14
25.02.16
28.03.17
4762
27.03.15
27.03.18
3904
28.03.14
28.03.17
4762
27.03.15
27.03.18
Performance Share Plan (PSP)
The interests of Directors at 31 December 2015 in Ordinary Shares that are the subject of awards under the PSP are shown below.
Pascal Soriot
2013 award
2014 award
Total at 1 January 2015
2015 award
Total at 31 December 2015
Marc Dunoyer
2013 award
2014 award
Total at 1 January 2015
2015 award
Total at 31 December 2015
1 UK date convention applies.
Number of
shares
Award price
(pence)
Grant date1
Vesting date1
Performance period1
125,113
124,066
249,179
104,764
353,943
90,853
52,254
143,107
45,880
188,987
3297
3904
11.06.13
28.03.14
11.06.16
28.03.17
01.01.13 – 31.12.15
01.01.14 – 31.12.16
4762
27.03.15
27.03.20
01.01.15 – 31.12.17
3302
3904
01.08.13
28.03.14
01.08.16
28.03.17
01.01.13 – 31.12.15
01.01.14 – 31.12.16
4762
27.03.15
27.03.20
01.01.15 – 31.12.17
AstraZeneca Annual Report and Form 20-F Information 2015
119
Corporate Governance Annual Report on Remuneration
(the Implementation Report) continued
AstraZeneca Investment Plan (AZIP)
The interests of Directors at 31 December 2015 in Ordinary Shares that are the subject of awards under the AZIP are shown below.
Pascal Soriot
2013 award2
2014 award
Total at 1 January 2015
2015 award
Total at 31 December 2015
Marc Dunoyer
2013 award
2014 award
Total at 1 January 2015
2015 award
Total at 31 December 2015
Number of
shares
Award price
(pence)
Grant date1
Vesting date1
Performance period1
89,960
20,677
110,637
17,460
128,097
8,176
8,709
16,885
7,646
24,531
3297
3904
11.06.13
28.03.14
01.01.21
01.01.22
01.01.13 – 31.12.16
01.01.14 – 31.12.17
4762
27.03.15
01.01.23
01.01.15 – 31.12.18
3302
3904
01.08.13
28.03.14
01.01.21
01.01.22
01.01.13 – 31.12.16
01.01.14 – 31.12.17
4762
27.03.15
01.01.23
01.01.15 – 31.12.18
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.
Restricted share award
On 26 October 2012, Mr Soriot was granted an award of 69,108 restricted shares at an award price of 2894 pence per share. When
Mr Soriot joined AstraZeneca, he forfeited awards made to him by his previous employer. The Remuneration 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
> 27,644 vested on 31 October 2013
> 20,732 vested on 1 October 2014
> 20,732 vested on 1 October 2015.
The interests of Mr Soriot at 31 December 2015 in Ordinary Shares that are the subject of awards under this arrangement are shown below.
Pascal Soriot
Total at 1 January 2015
Final vesting of 2012 award
Total at 31 December 2015
Price on
vesting
date
(pence)
4181.5
Number of
shares
20,732
(20,732)1
–
1 Following certain mandatory tax deductions, Mr Soriot became beneficially interested in a net number of 17,985 Ordinary Shares.
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 Remuneration 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, or will vest, as follows
> 9,103 shares vested on 15 June 2014
> 41,472 shares vested on 15 June 2015
> 14,930 shares will vest on 1 August 2016.
120
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance The interests of Mr Dunoyer at 31 December 2015 in Ordinary Shares that are the subject of awards under this arrangement are shown below.
Marc Dunoyer
Total at 1 January 2015
Partial vesting of 2013 award
Total at 31 December 2015
Price on
vesting
date
(pence)
4211
Number of
shares
56,402
(41,472)1
14,930
1 Following certain mandatory tax deductions, Mr Dunoyer became beneficially interested in a net number of 21,980 Ordinary Shares.
AstraZeneca 2012 Savings Related Share Option Scheme (SAYE)
The interests of Mr Dunoyer at 31 December 2015 in options to subscribe for Ordinary Shares that are the subject of awards under the
SAYE are shown below.
Marc Dunoyer
Total at 1 January 2015
2015 award
Total at 31 December 2015
1 UK date convention applies.
Number of
shares under
option
–
544
544
Exercise price
(pence)
Grant date1
First date
exercisable1
Last date
exercisable1
3307
28.09.15
01.12.18
31.05.19
AstraZeneca Annual Report and Form 20-F Information 2015
121
Corporate Governance Remuneration Policy Report
This section sets out the Remuneration Policy (the Policy) that was approved by shareholders at the Company’s AGM in April 2014. It is
intended that the Policy shall remain in effect for a period of three years from 1 January 2015.
The Policy set out below has not been amended since its approval by shareholders in April 2014, other than to show changes to individual
remuneration in 2016 in the Remuneration scenarios for Executive Directors section on page 129 and the notes to those scenarios, which
remain within Policy. However, mindful of shareholder commentary on the Policy since its approval, the Remuneration Committee sought to
clarify certain aspects of the Policy in relation to its approach to recruitment remuneration for Executive Directors and, in 2014, it adopted
‘Operating guidelines’ with effect from 1 January 2015 identified on page 130, which do not form part of the Company’s Policy as approved
by shareholders. These clarifications are marked in bold in this Policy Report.
Setting the Company’s Policy
The Remuneration 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. All roles within the organisation are benchmarked
against 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 arrangements are benchmarked against a global pharmaceutical peer group and the FTSE30. Each year
the Company actively engages with its employees, either on a Group-wide basis or in the context of smaller focus groups, in order to solicit
feedback generally and on a wide range of specified issues, including pay.
While the Remuneration Committee did not consult with employees when determining the Executive Directors’ remuneration policy, it does
annually review Group remuneration data including ratios of average pay to senior executive pay; bonus data; gender and geographical
data in relation to base salaries and variable compensation; and aggregate data about the shareholding levels of senior managers. Many
employees are also shareholders in the Company and therefore had the opportunity to vote at the 2014 AGM on this Remuneration Policy
Report. In reviewing the base salaries of Executive Directors, the Remuneration 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 Remuneration 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 largest investors on general and
specific remuneration matters and provides an annual opportunity for representatives of those investors to meet the Chairman of the
Remuneration Committee and other Remuneration Committee and Board members. It is the Company’s policy to seek input from major
shareholders on an ad hoc basis where significant changes to remuneration arrangements are proposed. The Company’s shareholders
are encouraged to attend the Company’s AGM and any views expressed will be considered by the Remuneration Committee’s members.
The Remuneration 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, managing risk, and the pursuit of the Company’s
business objectives.
Legacy arrangements
The Remuneration Committee may approve remuneration payments and payments for loss of office where the terms of the payment were
agreed before the Policy came into effect, or at a time when the relevant individual was not a Director of the Company (provided that, in the
opinion of the Remuneration Committee, the agreement was not in consideration for the individual becoming a Director of the Company).
This includes the exercise of any discretion available to the Remuneration Committee in connection with such payments.
For these purposes, payments include the Remuneration Committee satisfying awards of variable remuneration including awards over
shares, on the basis of the terms agreed at the time the award is granted.
Minor amendments
The Remuneration Committee may make minor amendments to the arrangements for the Directors as described in this Remuneration
Policy Report (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 2015
Corporate Governance Remuneration Policy for Executive Directors
Fixed elements of remuneration: base salary, benefits and pension
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 Directors) in the context of their
local market.
Base salary
Purpose and link to strategy
Base salary is intended to
be sufficient (but no more
than necessary) to attract,
retain and develop
high-calibre individuals
in order to deliver the
Company’s strategy.
Benefits
Operation
Maximum opportunity
The Remuneration Committee determines base salary based on a number
of factors, including (but not limited to):
The current base salaries can be found on page 107 of the
Implementation Report.
> Recognition of the value of an individual’s sustained personal
performance and contribution to the business
> The individual’s skills and experience
> Internal relativities
> Conditions in the relevant external market.
Base salaries are normally reviewed annually to ensure they remain
competitive, with any change usually taking effect from 1 January.
There are no contractual provisions for clawback or malus of base salary.
While there is no formal maximum, annual base salary increases,
if any, for the Executive Directors 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 Remuneration Committee
in its discretion considers it appropriate. For example, this may
include:
> Increase in the scope and/or responsibility of the individual’s role
> Development of the individual within the role.
Purpose and link to strategy
Operation
Maximum opportunity
To provide market
competitive benefits.
Non-cash benefits are
designed to be sufficient
(but no more generous
than necessary) to attract,
retain and develop
high-calibre individuals
in order to deliver the
Company’s strategy.
.
UK-based Executive Directors are provided with a fund under the UK
Flexible Benefits Programme. The fund value is based on a range of
benefits including:
> 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 Remuneration 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. They can elect to take the fund as cash or elect one or more of
these benefits and take the balance as cash.
At its discretion, for Executive Directors on an international assignment or
relocating to take up other Company duties, the Remuneration Committee
may consider support towards the reasonable costs of relocation.
At its discretion, the Remuneration Committee may 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.
The Company also provides Directors’ and Officers’ Liability Insurance and
an indemnity to the fullest extent permitted by the law and the Company’s
Articles.
There are no contractual provisions for clawback or malus of benefits.
The current value of benefits available can be found on page 107
of the Implementation Report.
The maximum value of the fund available under the UK Flexible
Benefits Programme will be equivalent to the cost to the Company
of the suite of benefits at the time.
The maximum value of the suite of benefits for non-UK-based
Executive Directors will be equivalent to the cost of the suite of
benefits at the time.
The value of the support towards the costs of relocation will be
the reasonable costs associated with the Executive Director’s
particular circumstances.
The value of the support towards the costs of 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 Remuneration Committee has not set an overall level of
benefit provision, the Remuneration Committee keeps the benefit
policy and benefit levels under review.
Pension
Purpose and link to strategy
Operation
Maximum opportunity
Provision of retirement
benefits to attract, retain
and develop high-calibre
individuals in order to
deliver the Company’s
strategy.
Company allocations for Executive Directors’ pensions will be a proportion
of the individual’s base salary and is in line with local market practice.
As part of the UK Flexible Benefits Programme, the Company provides an
allocation consisting of a percentage of the UK-based Executive Director’s
base salary, which the Executive Director can elect to pay into a pension
scheme or take as cash. The Company will allocate an amount
benchmarked to the local market.
There are no contractual provisions for clawback or malus of pension.
Currently the CEO and CFO receive an allocation equivalent to
30% and 24% of their base salaries respectively as a contribution
towards the cost of their pension provisions.
The maximum annual allocation that may be provided to
UK-based Executive Directors is 35% of base salary.
Non-UK-based Executive Directors will receive a fund for the
purpose of providing retirement benefits in line with the local
market practice. The maximum value of that fund will be a sum
equivalent to local market practice. The Executive Director may
elect to take some or all of the fund as cash.
AstraZeneca Annual Report and Form 20-F Information 2015
123
Corporate Governance Remuneration Policy for Executive Directors continued
Variable elements of remuneration
Annual bonus
All employee bonuses are determined by reference to the Group scorecard and an assessment of individual performance. The Group scorecard is designed to reflect
the Company’s strategy and the focus of its business activity and priorities in the performance year. The performance measures are recommended by the CEO and
determined by the Remuneration Committee at the beginning of each year. They are designed to ensure that all eligible employees receive an element of reward based
on the Group’s overall financial and non-financial performance. A scorecard approach ensures that all employees across functions and geographies are focused on
the activities critical to delivering the business strategy. The performance measures and weightings underlying the annual bonus plan will be disclosed in advance.
The outcomes against targets, for reasons of commercial sensitivity, will be disclosed in arrears. The Implementation Report will identify, in arrears, the performance
versus the objectives and the consequent levels of remuneration deemed appropriate by the Remuneration Committee.
For Executive Directors, one-third of their pre-tax annual bonus is delivered in shares, which are deferred for three years, under the Deferred Bonus Plan. Employees
below SET level receive a bonus in cash and are not required to defer a proportion in shares.
Annual bonus: cash
Purpose and link to strategy
The annual cash bonus
rewards short-term
performance against
specific annual Group
and individual objectives.
These objectives are
designed to facilitate the
delivery of the Company’s
short-term strategy and
thereby create value
for our shareholders
over time.
Operation and framework used to assess performance
Maximum opportunity
The annual cash bonus is based on Group and individual performance in the relevant
performance year.
The maximum annual amount payable to an Executive
Director is 250% of base salary.
If the Remuneration Committee ever felt that it
would be in the interests of shareholders to grant 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.
Scorecard measures and targets are set annually by the Remuneration Committee
based on the key strategic objectives for the year. Payout levels are determined by the
Remuneration Committee after the year end, based on performance against targets.
The performance period is one year.
The performance measures form a Group scorecard which is closely aligned to
business strategy, and rewards scientific, commercial and financial success.
While we expect the performance measures to be largely unchanged each year,
the Remuneration Committee believes it is inadvisable to commit to a fixed set of
measures in advance in order to retain flexibility to align incentives with the focus
of corporate strategy in the relevant year.
The greatest weighting is typically placed on the achievement of financial targets, with
an equal weighting between the scientific and commercial growth metrics reflecting
the importance of both sales and R&D success. The actual annual weighting will
depend on the strategic priorities for the performance year.
The Group scorecard is made up of a number of separate metrics within each
performance measure. Each metric has a payout range associated with it (including
a target which is intended to be stretching). In relation to each metric, a threshold level
of performance is specified. If performance falls below this level there will be no payout
for that proportion of the award. Each metric has a different weighting. If none of the
metrics attributable to a performance measure is met then a bonus payout will not be
made in respect of that performance measure. If none of the metrics is met in any of the
performance measures, then no bonus payout will be made.
The Board will consider Company performance against the Group scorecard objectives
as well as the Executive Director’s individual performance in order to determine the
value of the bonus award. Individual performance will be assessed by the Remuneration
Committee on the basis of objective criteria established by the Chairman in the case of
the CEO, and by the CEO in the case of the CFO. The Remuneration Committee has the
discretion to move the theoretical award up or down subject to the annual bonus award
being no greater than the maximum percentage of base salary applicable to that award
in the year in question.
The Remuneration Committee will 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 its shareholders.
Two-thirds of the annual bonus is delivered in cash and one-third is delivered in shares,
which are deferred for three years as explained opposite.
The annual bonus, including the deferred share element, payable for target
performance for the CEO is currently 100% of base salary and for the CFO is currently
90% of base salary.
For bonuses awarded in respect of 2015 and subsequent years, the Remuneration
Committee will have 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 Remuneration Committee may only exercise its discretion for up to two years from
the payment date.
124
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Maximum opportunity
The maximum deferred bonus for Executive Directors is one-third
of the maximum pre-tax bonus as detailed in the Annual bonus:
cash section on page 124.
Annual bonus: Deferred Bonus Plan
Purpose and link to strategy
Operation and framework used to assess performance
The deferred share
element of the annual
cash bonus under the
Deferred Bonus Plan
is designed to align
Executive Directors’
interests with those
of shareholders.
Executive Directors are required to defer one-third of their pre-tax annual
cash bonus into shares.
On vesting, the cash value equivalent to dividends that would have been
paid during the three-year holding period will be paid subject to continued
employment.
Directors must normally remain in employment for three years from grant
for deferred shares to vest.
Once performance measures have been applied to determine the value
of the total bonus, no further performance measures apply to the deferred
share element.
For deferred share elements relating to bonuses awarded in respect of
2015 and subsequent years, the Remuneration Committee has discretion:
> to reduce or cancel any portion of an unvested deferred bonus 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 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 Remuneration Committee
may only exercise its discretion for up to two years from the vesting date.
Long Term Incentives (LTIs)
Overview: An Executive Director’s target LTI award is considered annually and set at a level which takes account of market analysis. The Remuneration Committee
has discretion to grant awards above or below target based on individual performance and potential. The CEO’s current LTI target is 250% of base salary on an
expected value basis, and the CFO’s current LTI target is 200% of base salary on an expected value basis. An illustration of the expected value basis can be found
in the Remuneration scenarios for Executive Directors section on page 129.
The Company’s variable long-term arrangements for Executive Directors currently comprise two LTI plans: the PSP and the AZIP. Under each of these plans the
maximum market value of shares that may be awarded is 500% of a participant’s base salary. If the Remuneration Committee ever felt that it would be in the interests
of shareholders to grant annual variable awards to an Executive Director with values exceeding the historical range of up to 500% in aggregate under the LTI plans,
it would consult major shareholders in advance. Currently when LTI awards are granted to Executive Directors, the split between the two plans is weighted in the
proportion: 75% PSP and 25% AZIP.
When granting LTI awards the Remuneration Committee applies a target as a percentage of base salary on an expected value basis. For the AZIP, the expected value
on vesting is 100% of the value of the award at grant. For the PSP, the expected value on vesting is 50% of the value of the award at grant.
The table overleaf explains the operation, minimums and maximums payable under each of these LTI plans.
Performance measures: Performance measures are recommended by the CEO and determined by the Remuneration Committee. The performance measures in
respect of the PSP are designed to drive long-term performance against the Company’s strategic objectives, in terms of commercial, scientific and financial success.
In respect of the AZIP, dividend-based performance hurdles motivate the generation of returns for shareholders on a sustainable basis over an extended period of
time, and will be set by the Remuneration Committee at a level it considers appropriate at the start of the performance period. The combined eight-year performance
and holding period is designed to reflect the development cycle of a medicine and therefore to align executive reward with successful product development.
When setting the performance measures at the start of the performance period, the Remuneration Committee will also determine an appropriate payout curve (if any),
for each measure. The Remuneration Committee will assess performance against the performance measures to determine the level of payout. The Remuneration
Committee may exercise its discretion to increase or decrease the payout should it consider it appropriate, subject to the maximum percentage of base salary
applicable in the year in question. The intention of the Remuneration Committee is to exercise judgement appropriately, in particular so that the experience of
shareholders over time is taken into account. As a matter of good practice, certain major shareholders would be consulted before any material change to the
performance measures for the PSP or AZIP are implemented.
The Remuneration Committee seeks to ensure that, on the one hand, reward outcomes are not purely mechanistic; but on the other, that in exercising its discretion,
that exercise is not seen by employees to be arbitrary or unfair. The Remuneration Committee’s objective is to use reward arrangements to drive performance by
employees which supports the creation of value for shareholders.
Cessation of employment and other circumstances: The LTI plans are governed by plan rules, which define how individual awards should be treated upon
termination of an Executive Director’s employment (see Principles of payment for loss of office for Executive Directors section on page 132). Provision is also made
for the treatment of awards in respect of corporate activity including rights issues, sale of a business outside the Group and a change of control. The treatment of
awards in these circumstances is also subject to Remuneration Committee discretion. In the event of a change of control an award will vest pro rata to the time elapsed
between the date of grant of the award and the date of the event to the extent that the performance measures have been met up to the date of the event, subject to the
Remuneration Committee’s discretion to make an alternative determination.
Other employees: Other employees at mid to senior levels globally are eligible for LTI awards in the form of 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 directly to influence the delivery
of the Company’s strategic goals. Awards under the AZIP are currently granted to SET members only (including the Executive Directors).
AstraZeneca Annual Report and Form 20-F Information 2015
125
Corporate Governance Remuneration Policy for Executive Directors continued
AstraZeneca Performance Share Plan (PSP)
Purpose and link to strategy
Operation and framework used to assess performance
Maximum opportunity
The PSP is an LTI plan
designed to align the
variable pay of our
Executive Directors
directly to the delivery
of our medium-term
business strategy.
The PSP provides for the grant of awards over Ordinary Shares or ADSs.
Vesting is dependent on the achievement of stretching three-year performance targets
and continued employment.
Performance measures and targets under the PSP are determined by the Remuneration
Committee at the start of the relevant three-year performance period and consist of a
range of measures designed to incentivise performance in furtherance of the Company’s
business strategy. The performance measures (currently a combination of four
measures: TSR; cumulative cash flow; sales of medicines in key therapy areas and
territories; and innovation metrics) are closely aligned to business strategy, and reward
commercial, scientific and financial success.
Currently each of the four measures has an equal weighting. When setting the
performance measures at the start of the performance period, the Remuneration
Committee will allocate weightings to those measures as it considers appropriate,
taking into account strategic and business priorities.
Under the PSP plan rules, the maximum market value
of shares that may be awarded at the date of grant in
respect of any year is 500% of a participant’s annual
base salary.
If each aspect of all of the performance measures is
met and exceeded, the Remuneration Committee
currently has the discretion to pay out a maximum of
125% of the value of the original award. However, the
Remuneration Committee has determined that it will
not exercise this discretion in relation to outstanding
or future awards.
This feature has therefore been removed from the
new PSP rules which are being put to shareholders
for approval at the AGM in 2014.
The three-year performance period commences on 1 January in the year of the
award. The vesting date is the third anniversary of the date on which the award is
granted. A two-year holding period commencing three years from the date of grant
for Executive Directors will be included in the new PSP rules which are being put to
shareholders for approval at the AGM in 2014 and, if approved, will be effective for
awards made after the AGM. These awards will vest at the end of the holding period.
During the holding period, no further performance measures will apply as performance
has already been assessed.
All the performance measures have a payout curve. The payout curves are structured
in different ways depending on the overall objective they are intended to measure.
Typically, performance measures are structured such that 25% of the award will vest
for threshold level of performance. The relationship between threshold, target and
out-performance will be determined by the Remuneration Committee at each grant of
the PSP and is dependent on whether the performance measure is science, commercial
or finance based. An award will typically vest at 100% if the target (usually set at upper
quartile performance) is achieved and threshold level of performance associated with
any metric will be at or above a median level. There will be other vesting points between
the threshold and maximum of 100% vesting, typically on a straight-line basis where the
performance measures permit.
The Remuneration 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.
Payouts can range from 0% to 100% of the original award.
On vesting, the cash value equivalent to dividends accrued during the vesting period
will be paid.
Subject to shareholder approval of the renewal of the PSP at the 2014 AGM, for awards
granted under the PSP after the AGM and in subsequent years, the Remuneration
Committee will have 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 Remuneration Committee may only exercise its discretion for up to two years from
the third anniversary of the date of grant.
126
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance AstraZeneca Investment Plan (AZIP)
Purpose and link to strategy
Operation and framework used to assess performance
The combined eight-year
performance and holding
periods of the AZIP are
influenced by the Group’s
medicine development
cycle, reflecting the long-
term investment horizons
that are a feature of the
pharmaceutical industry.
The AZIP provides for the grant of awards over Ordinary Shares or ADSs.
Vesting is dependent on achievement of two performance measures
over a four-year performance period. The award is then subject to a
further four-year holding period. Payout of the award is subject to
continued employment.
Performance measures and targets under the AZIP are determined by
the Remuneration Committee at the start of the relevant four-year
performance period.
Maximum opportunity
Under the AZIP plan rules the maximum market value of shares
that may be awarded at the date of grant in respect of any year
is 500% of a participant’s annual base salary.
Currently, two performance measures apply: dividend level and dividend
cover. Both measures must be achieved for the award to vest.
If an event occurs which causes the Remuneration Committee (acting fairly
and reasonably) to consider that a performance measure is no longer
appropriate it may adjust that measure.
The AZIP is operated over a four-year performance period, with a
subsequent four-year holding period. Performance periods commence on
1 January in the year of the award. Holding periods run for a period of four
years starting from the end of the performance period, and end on the
eighth anniversary of the start of the performance period. During the
holding period, no further performance measures apply as performance
has already been assessed.
If both measures are achieved in each year of the performance period, the
award will vest in full at the end of the holding period. If either or both of the
measures are not achieved, the award will lapse.
On vesting, the cash value equivalent to dividends paid during the
performance and holding periods will be paid.
For awards granted under the AZIP prior to the AGM in 2014, the
Company may reduce or cancel some or all of the shares that are the
subject of a participant’s award at any time during the performance or
the holding period if, in the opinion of the Remuneration Committee
(acting fairly and reasonably), this is warranted by the underlying
performance of the Company, the occurrence of an event that causes,
or is very likely to cause, reputational damage to the Company, or serious
misconduct by the participant.
In order to ensure consistency between our LTI plans, for awards granted
under the AZIP on or after the AGM and in subsequent years, the
Remuneration Committee will have 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
Remuneration Committee may only exercise its discretion for up to
two years from the end of the performance period.
AstraZeneca Annual Report and Form 20-F Information 2015
127
Corporate Governance Remuneration Policy for Executive Directors continued
Restricted shares
In certain circumstances, as part of the recruitment arrangements, an Executive Director may be awarded restricted shares. There are no performance measures
attached to awards of restricted shares because typically they will be awarded for the purpose of compensating newly recruited Executive Directors for loss of
entitlements on leaving a previous employment. However, the Remuneration Committee will consider whether the lost incentives were subject to performance
measures and their likely vesting. If foregone awards were subject to performance testing, then the compensatory AstraZeneca award will normally be granted
under the PSP and/or AZIP in order to align the performance conditions attaching to the award to the delivery of the Company’s strategy. Restricted share awards
will generally be used only when the foregone compensation was not subject to performance testing.
The Remuneration Committee may divide an award of restricted shares into tranches vesting 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 period will be defined at grant.
In most instances, there are no performance conditions attached to these awards. They will therefore vest in full if the individual remains in office on the vesting date.
On vesting, the cash value equivalent to dividends accrued during the vesting period will be paid.
There are no contractual provisions for clawback or malus of awards of restricted shares.
Restricted shares may be used for the same purpose on the recruitment of other employees.
AstraZeneca also operates another restricted share plan (the AstraZeneca Global Restricted Stock Plan) to provide LTI awards to eligible employees globally.
Currently Executive Directors and other senior executives are not eligible to participate in this plan.
Award of restricted shares
Purpose and link to strategy
Operation and framework used to assess performance
See above.
In certain circumstances,
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.
Restricted Share Plan (RSP)
Maximum opportunity
There is no maximum value of an award which may
be granted.
The Remuneration Committee will determine the value
of the award at grant, as it considers appropriate in all
the circumstances.
Purpose and link to strategy
Operation and framework used to assess performance
Maximum opportunity
The RSP is a LTI plan
designed to align the
variable pay of our key
employees, excluding
Executive Directors,
directly to the delivery
of our business strategy.
The RSP provides for the granting of restricted share awards to key employees,
excluding Executive Directors.
Mr Dunoyer, who was appointed as an Executive Director subsequent to his
appointment as EVP, GPPS, was granted an award of restricted shares to compensate
for loss of entitlements as a result of leaving his previous employment.
Under the RSP plan rules the maximum market value
of shares that may be awarded at the date of grant in
respect of any year is 500% of a participant’s annual
base salary.
The Remuneration Committee will determine the value
of the award at grant, as it considers appropriate in all
the circumstances.
In the case of Mr Dunoyer, the maximum payable is
100% of the shares awarded (65,505 shares).
UK employee share plans
All UK-based employees, including the Executive Directors, are eligible to participate in the SAYE Option Scheme and Share Incentive Plan, which are HM Revenue
& Customs (HMRC) approved plans.
Share Incentive Plan (SIP)
Purpose and link to strategy
Operation and framework used to assess performance
Maximum opportunity
Encouraging share
ownership
The Company operates an HMRC-approved SIP whereby UK employees, including
Executive Directors, may save a regular amount over one year with which to purchase
Partnership shares and for which, currently, a Matching share is granted for every four
shares purchased.
Partnership shares up to £125 per month from pre-tax
pay or such other maximum amount as determined
by the Company within the parameters of applicable
legislation.
SAYE Option Scheme (SAYE)
Purpose and link to strategy
Operation and framework used to assess performance
Maximum opportunity
Encouraging share
ownership
The Company operates an HMRC-approved save as you earn option scheme whereby
UK employees, including Executive Directors, may save a regular amount over three or
five years with which to purchase shares. Currently, shares are acquired at a 10%
discount to the market price prevailing at the date of the commencement of the
scheme. A maximum discount of 20% may be made available under the scheme.
Up to £250 per month from post-tax pay or such
other maximum amount as determined by the
Company within the parameters of applicable
legislation.
128
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Remuneration scenarios for Executive Directors
The charts below illustrate how much the current Executive Directors could receive under different performance scenarios in 2016,
assuming a constant share price. In order to compile the charts, the following assumptions have been made:
Minimum
remuneration
Consists of the fixed elements of remuneration only: base salary, taxable benefits and pension
> base salary is that applicable in 2016
> taxable benefits are taken from the corresponding figure in the Executive Directors’ single total figure
remuneration table for 2015 as set out on page 107
> pension measured as a cash payment equivalent to 30% of base salary in the case of the CEO and 24%
of base salary in the case of the CFO.
Pascal Soriot
Marc Dunoyer
Base salary
£’000
1,190
707
Taxable benefits
£’000
115
70
Pension
£’000
357
170
Total
£’000
1,662
947
Remuneration for
on-plan performance
(target)
Remuneration for
outperformance
(above target/
maximum)
Based on what the Executive Director would receive if performance were in line with the Company’s expectations
> on-target annual bonus payout of 100% of base salary for the CEO, and 90% for the CFO
> LTI shares, which vest at an on-target expected value of 250% of base salary for the CEO, and 200% in the
case of the CFO.
Based on what the Executive Director would receive at stretch performance and maximum vesting of the
performance shares
> an annual bonus payout of 180% of base salary for the CEO, and 150% for the CFO
> maximum vesting of the awards made under the Company’s LTI plans (representing 100% of the face value of the
PSP and AZIP awards where the PSP has an expected value of 50% and the AZIP an expected value of 100%).
Pascal Soriot
Marc Dunoyer
Minimum
100%
£1.7m
Minimum
100%
On plan
27% 19%
54%
£6.2m
On plan
32% 21%
47%
Outperformance
17%
22%
61%
£9.7m
Outperformance
21%
24%
55%
£m
0
1
2
3
4
5
6
7
8
9
10
£m
0
1
2
3
4
5
£0.9m
£3.0m
£4.5m
Fixed (base pay, pension and benefits)
Annual Variable
Long Term Incentives
When granting LTI awards the Remuneration Committee applies a target as a percentage of base salary weighted 25% in favour of the
AZIP and 75% in favour of the PSP.
The face value of the AZIP and PSP awards for the CEO at target is 437.5% of base salary. For 2015, the Remuneration Committee
awarded an above-target award at a face value of 499% which is taken into account in the figures provided in the outperformance row
of the chart above.
The face value of the AZIP and PSP awards for the CFO at target is 350% of base salary.
Approach to recruitment remuneration for Executive Directors
The Company seeks to pay no more than necessary to recruit the best candidate available for a role as an Executive Director. On the
recruitment of a new Executive Director, the Company seeks to put in place a remuneration package which is broadly in line with the
remuneration package applicable to relevant incumbent Executive Directors. However, in order to offer a competitive package to the most
capable candidate, the Company may consider providing remuneration arrangements that exceed those of existing Executive Directors.
The Remuneration Committee may also agree to pay allowances to expatriates in line with the Company’s international assignment policy
which provides for support towards housing, schooling and other relocation or assignment related costs.
The remuneration package offered to new recruits may include any element listed in the policy table above, or any other element which
the Remuneration Committee considers is appropriate given the particular circumstances, with due respect to the interests of the
Company’s shareholders.
AstraZeneca Annual Report and Form 20-F Information 2015
129
Corporate Governance
Remuneration Policy for Executive Directors continued
Operating guidelines: The Remuneration Committee is aware that the pharmaceutical industry is global and that future
Executive Directors might come from organisations with very different pay structures and practices. The Remuneration
Committee believes that it is in the interests of shareholders to retain an element of flexibility in the recruitment policy
to enable it to recruit the best candidates. However, this flexibility is limited. As described below, our intention is to use
buy-out awards on recruitment only to compensate a new recruit for awards which are forfeited at the previous employer.
All other aspects of the compensation opportunity of a new recruit will be subject to the maxima contained in the Policy.
In considering which elements to include, and in determining the approach for all relevant elements, the Remuneration Committee will take
into account a number of different factors, including typical market practice, existing arrangements for the other Executive Directors and
internal relativities and market positioning.
The Company may reimburse the costs of financial planning and tax advice to Executive Directors. The Company also provides
Directors’ and Officers’ Liability Insurance and an indemnity to the fullest extent permitted by the law and the Company’s Articles
to all Executive Directors.
The Company may find it necessary to compensate a new recruit for forfeiture of entitlements from a previous employer. The value of such
compensation cannot be anticipated and will depend upon a range of factors including the circumstances of the individual in question.
In such circumstances, the Company will seek to offer a package weighted towards equity in the Company. However, the precise nature
of the compensation package will depend on the type of entitlement that the recruit is foregoing and which the Company will generally seek
to compensate in kind; the buyout might therefore comprise cash and/or restricted shares and/or LTI. The Remuneration Committee will
obtain and take into account independent valuations of the entitlements to determine the appropriate level of compensation.
Shares which could be offered to the new recruit would be granted under LTI plans available at the time or under a plan specific to that
individual as permitted under the Financial Conduct Authority’s Listing Rules. Performance measures may apply to such share awards.
The Company’s policy seeks to link the performance of the Executive Director to the performance of the Company in any given period.
The precise targets and measures will depend on the objectives of the Company and the individual at that time and will be determined
by the Remuneration Committee.
The Company will not offer cash or shares to newly recruited Executive Directors as a bonus, or ‘golden hello’ on joining other than to
compensate for the loss of a previous remuneration opportunity. Where compensation is offered to a new recruit on his or her hire, the
Company will explain the reasons for this to shareholders in a timely manner, and will provide details of the payments.
Operating guidelines: The Remuneration Committee will not grant cash or share awards as a ‘golden hello’. As described
above, cash or share awards granted on joining the Company will be to compensate a new recruit for loss of previous
remuneration awards only.
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 and up to 500% of base salary under the AZIP. If the Remuneration 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
range of 0 – 680% of base salary (comprising up to 180% under the annual bonus and up to 500% in aggregate under the LTI plans), it
would consult major shareholders in advance.
The Company intends to honour all remuneration arrangements previously entered into in the case of Group employees who are promoted
to the position of an Executive Director.
130
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance 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, and to the Executive Directors only.
Notice period
The Company may terminate the employment of an Executive Director by giving not less than 12 months’ written
notice. The Company may agree, on the appointment of a new Executive Director, 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. The Company agreed to such a provision in the case of Mr Dunoyer.
An Executive Director may terminate his employment on 12 months’ written notice.
Payment in
lieu of notice
The Company may terminate an Executive Director’s contract at any time with immediate effect and pay him a
sum in lieu of notice. This sum will consist of (i) the base salary that the relevant Executive Director would have
been entitled to receive during the notice period and (ii) the cost to the Company of funding the Executive
Director’s flexible benefit arrangements for this period, including the Company’s contribution in respect of pension.
Garden leave
Summary
termination
Payments in
lieu of holiday
The payment in lieu of notice may be paid as a lump sum or the Company may decide to pay the first six months
of the payment in lieu in equal monthly instalments, with the balance paid within 30 days of the final instalment
being paid.
If an Executive Director has given or been given notice of termination, the Company has the right to place the
Executive Director on ‘garden leave’.
The Company may terminate an Executive Director’s employment summarily, in particular defined circumstances
such as gross misconduct, with no further payment.
If, on termination, the relevant Executive Director has exceeded his 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 Remuneration 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 the law and the
Company’s Articles is provided to the Executive Directors for the duration of their employment and for a minimum
of five years following termination.
Deemed
treatment
under AZIP
and restricted
share award
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
Remuneration Committee determines otherwise. If Mr Soriot’s employment is terminated by the Company (other
than in the event of prescribed misconduct events), his restricted share award will continue to subsist.
AstraZeneca Annual Report and Form 20-F Information 2015
131
Corporate Governance Remuneration Policy for Executive Directors continued
Principles of payment for loss of office for Executive Directors
The Company does not make additional payments for loss of office, other than, as appropriate, payments in lieu of notice as described
above 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 Remuneration 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. Provision is also made for the treatment of awards in respect of corporate activity including sale of a business outside the
Group. The treatment of awards in these circumstances may also be subject to Remuneration 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 incentive plan rules:
> Annual bonus
An Executive Director may receive a bonus for the performance year in which he leaves the Company. Typically this sum will reflect
an on-target bonus pro-rated for the part of the year in which he worked. This is at the discretion of the Remuneration Committee and
will depend on the circumstances, including an assessment of the Executive Director’s performance in the relevant period and the
circumstances of his departure. 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 Remuneration 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 his departure
and/or in accordance with the vesting schedule as the case may be. The Remuneration 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 rules of the LTI plans envisage circumstances under which some, all or none of an Executive Director’s shares held under LTI plans
will vest in connection with his departure. The exact timing and number of shares vesting will depend on the circumstances, including the
Executive Director’s reason for leaving (as set out in the table opposite) and may be subject to Remuneration Committee discretion,
depending on what it considers to be fair and reasonable in the circumstances.
> Restricted share awards and awards under the RSP
The treatment on termination will depend upon the terms of the individual Executive Director’s awards on recruitment. The Remuneration
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 131.
> Payments in relation to statutory rights
The amount considered reasonable to pay by the Remuneration Committee in respect of statutory rights may be included in the overall
termination payment.
> Payments required by law
The Company may pay damages, awards, fines or other compensation awarded to or in respect of an Executive Director by any
competent court or tribunal or other payments required to be made on termination of employment by any applicable law, regulator or
collective labour agreement.
> Mitigation
The departing Executive Director will be required to mitigate his loss by using reasonable efforts to secure new employment.
> Professional fees
The Company may pay an amount considered reasonable by the Remuneration Committee in respect of fees for legal and tax advice,
and outplacement support for the departing Executive Director.
132
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Treatment of LTI and Deferred Bonus Plan awards on cessation of employment
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 Remuneration
Committee decides otherwise.
Plan
Deferred Bonus Plan
(Annual Bonus Plan)
Other leaver scenarios
Ordinarily awards will lapse unless the
Remuneration Committee exercises its discretion to
apply the treatment for leavers by mutual agreement.
PSP
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.
Ordinarily awards will lapse unless the
Remuneration 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.
Ordinarily awards will lapse unless the
Remuneration Committee exercises its discretion
to apply the default treatment for leavers by reason
of redundancy or retirement described in this table.
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 Remuneration 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 Remuneration Committee, been satisfied from the date of
grant to the date of cessation of employment.
However, if the Remuneration Committee believes that exceptional circumstances
warrant this, it may exercise its discretion to vest the award on another basis.
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 Remuneration 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
Remuneration 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 Remuneration Committee has discretion to vest
the award or part of the award on a different basis.
Restricted shares and
awards under the RSP
Awards will lapse unless the Remuneration 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 Remuneration Committee decides not to pro-rate or
to pro-rate on some other basis.
Ordinarily awards will lapse unless the
Remuneration Committee exercises its discretion
to preserve all or part of an award.
AstraZeneca Annual Report and Form 20-F Information 2015
133
Corporate Governance Remuneration Policy for Non-Executive Directors
Non-Executive Directors, including the Chairman, receive annual Board fees. Additional fees are also payable for membership and
chairmanship of a Board Committee. 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 during
2013 are set out below. Fees applicable in future years will be set out in the corresponding year’s Implementation Report. The remuneration
of Non-Executive Directors is determined by the Chairman and the Executive Directors. The remuneration of the Chairman is determined by
the other members of the Remuneration Committee and the Senior independent Non-Executive Director.
No Director is involved in any decision relating to his or her own remuneration.
Annual Board and Committee fees
Purpose and link to strategy Operation
The annual fees are
intended to be sufficient
(but no more than
necessary) to attract,
retain and develop
high-calibre individuals.
Non-Executive Directors, including the Chairman, receive annual Board fees and additional fees for
membership and chairmanship of a Board Committee.
The individual fees paid to a Non-Executive Director 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. While Non-Executive Directors currently receive their fees in cash,
the Company reserves the right to award part, or all, of their fees in shares.
Maximum opportunity
The maximum fees payable in
aggregate to the Non-Executive
Directors may not exceed
£2,250,000 per year under the
Company’s Articles, as approved
by the Company’s shareholders.
There are no contractual provisions for clawback or malus of fees.
Non-Executive Director fees in 2013:
Chairman’s fee
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 Committee1
Membership of the Science Committee
Chairman of the Science Committee1
1 This fee is in addition to the fee for membership of the relevant Committee.
£
500,000
75,000
30,000
20,000
15,000
20,000
10,000
7,000
Benefits
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 the 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
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
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 2013, this amounted to £40,000. The amount of office costs to be reimbursed each year will be
determined at the discretion of the Remuneration Committee, based on an assessment of the
reasonable requirements of the Chairman. The Remuneration 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 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.
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 clawback or malus of other costs and expenses.
Letters of appointment
None of the Non-Executive Directors has a service contract but all have letters of appointment. In accordance with the Articles, following
their appointment, all Directors must retire at each AGM and may present themselves for election or re-election. The Company is mindful
of the independence provisions of the UK Corporate Governance Code and, in this regard, it is anticipated that Non-Executive Directors’
overall tenure will not normally exceed nine years. The Chairman may terminate his appointment at any time, with three months’ notice.
None of the Non-Executive Directors has a notice period or any provision in his or her letter of appointment giving him, or her, a right to
compensation payable upon early termination of appointment.
On behalf of the Board
A C N Kemp
Company Secretary
4 February 2016
134
AstraZeneca Annual Report and Form 20-F Information 2015
Corporate Governance Preparation of the Financial Statements
and Directors’ Responsibilities
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.
> 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
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
> 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.
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
4 February 2016
Pascal Soriot
Director
Directors’ Responsibilities for, and Report on,
Internal Control over Financial Reporting
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 2015 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
2015, 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 2015 and,
as explained on page 136, has issued an
unqualified report thereon.
135
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements Auditor’s Reports on the Financial Statements
and on Internal Control over Financial Reporting
(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 2015
(Sarbanes-Oxley Act Section 404). The
Directors’ statement on internal control over
financial reporting is set out on page 135.
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 196.
Independent Auditor’s Report to the Members
of AstraZeneca PLC only
Opinions and conclusions
arising from our audit
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 2015 set out on pages
140 to 195. In our opinion the Group Financial
Statements:
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, discounts, allowances and
returns in the US ($3,307m)
Refer to page 101 (Audit Committee Report),
page 145 (accounting policy) and page 77
(financial risk management).
> give a true and fair view of the state of the
Group’s affairs as at 31 December 2015
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 140 to 195, 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, 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 the result of
procedures undertaken in the context of and
solely for the purpose of our statutory audit
opinion on the Group Financial Statements as
The risk
Rebates, chargebacks and returns under
contractual and regulatory requirements in
the United States of America (‘US’), which
are deducted in arriving at revenue, are
complex and require significant judgement
and estimation by management in
establishing an appropriate accrual.
Our response
Our principal audit procedures included:
testing the Group’s controls surrounding
the deductions made to revenue for rebates,
chargebacks and returns 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 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, chargebacks
and returns policy, the judgement involved
and other related disclosures.
Our findings
In determining the appropriateness of the
rebates, chargebacks and returns deductions
in accordance with contractual and regulatory
requirements, there is room for judgement
and we found that within that, the Group’s
judgement was balanced (2014: balanced).
We found the assumptions used and the
resulting estimates to be balanced (2014:
balanced). We also found no errors in the
year-end rebate accrual calculations.
We found the disclosures on rebates,
chargebacks and returns to be proportionate.
Carrying value of intangible assets
($22,646m)
Refer to page 101 (Audit Committee Report),
page 147 (accounting policy), page 158
(financial disclosures) and page 79 (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
In this area 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 useful economic
lives. We also performed sensitivity analysis
over individual intangible asset models, where
we considered there to be a higher risk of
136
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 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 comparison to industry
practice and consideration of trial readouts,
regulatory announcements and the Group’s
internal governance and approval process.
We also interviewed a range of key Research,
Development and Commercial personnel to
corroborate these assumptions. For launched
products we discussed key assumptions
including the size of the therapeutic area
market, the product’s projected share of this
and expected pricing and associated costs.
Our procedures also included challenging
internally generated evidence by reviewing
analyst commentaries, consensus 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
(2014: balanced). We found that the disclosures
proportionately describe the inherent degree
of subjectivity in the estimates and the
potential impact on future periods of revisions
to these estimates.
Litigation and contingent liabilities
(provisions of $357m)
Refer to page 101 (Audit Committee Report),
page 147 (accounting policy), page 186
(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 logs and 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 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
(2014: 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 (2014: balanced). We found that
the Group gives extensive disclosure 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.
Tax provisioning ($1,734m)
Refer to page 101 (Audit Committee Report),
page 146 (accounting policy), page 192
(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 tax issues
and exposures.
Our response
In this area our principal audit procedures
included: testing the Group’s controls
surrounding tax provisioning, assessment
of correspondence with the relevant tax
authorities and the use of our own local
and international tax specialists to analyse
and challenge the assumptions used by
management to determine tax provisions,
based on our knowledge and experiences
of the application of the relevant legislation
by authorities and courts. We also assessed
the adequacy of the Group’s disclosures in
respect of tax and uncertain tax positions.
Our findings
We found the Group’s estimate of the
amounts to be recognised as tax liabilities
to be conservative (2014: conservative) and
that the disclosures provide a proportionate
description of the current status of uncertain
tax positions.
Post-retirement benefits ($1,974m)
Refer to page 101 (Audit Committee Report),
page 145 (accounting policy), page 166
(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
post-retirement defined benefit plans valuations
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 support of our own actuarial
specialists. This involved a comparison of
these key assumptions used against our own
internal benchmarks and externally derived
data. We obtained and assessed third party
assurance reports on controls over the
valuation of pension assets held by key
custodians and compared asset values to third
party confirmations. Additionally, we 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 (2014: balanced).
The third party assurance reports did not
identify significant deviations in the operation
of controls over the valuation of assets which
caused us to change the scope or extent
of our procedures and we found no errors in
our comparison of asset values to third party
confirmations. We found the disclosures
in respect of post-retirement benefits to
be 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 use
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 $140m
(2014: $94m), determined with reference to
a benchmark of Group profit before taxation,
normalised to exclude this year’s asset
impairments and fair value movement on
contingent consideration as disclosed in
Notes 9 and 18, which are specifically
audited, of which it represents 5.0%
(2014: 5.0%).
137
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements We report to the Audit Committee any
corrected or uncorrected identified
misstatements exceeding $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 trading entities, each of which is
determined to be a reporting component,
located in 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 nine components and specified
risk-focused audit procedures at two
standalone components as well as at 33
components serviced by the Group’s shared
service centres. The latter 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 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
neighbouring 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 $4m to $100m,
having regard to the mix of size and risk
profile of the Group across the components.
Materiality for the Group Financial Statements
Profit before tax plus
impairments and contingent
consideration revaluations
Materiality
$2,813m
$140m Whole financial
statements materiality
$7m
Misstatements reported
to the Audit Committee
Scoping and coverage
Group revenue (%)
Audits for
group reporting
purposes
Specified risk-
focused audit
procedures
73
22
Components’ absolute
profits/(losses) (%)
Audits for
group reporting
purposes
Specified risk-
focused audit
procedures
69
18
Group total assets (%)
Audits for
group reporting
purposes
Specified risk-
focused audit
procedures
85
4
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 five component
locations, during the year, in the UK, Sweden,
Japan, France and Germany to discuss and
challenge key risks and audit strategy. Video
or telephone conference meetings were also
held with all group reporting component
auditors throughout the audit and the majority
of the other component and shared service
centre auditors that were not physically
visited. 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.
5. Our opinion on the other matter prescribed
by the Companies Act 2006 is unmodified
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.
6. We have nothing to report on the
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
from page 21, 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 2018; or
> the disclosures in the Group Accounting
Policies concerning the use of the going
concern basis of accounting.
138
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements Scope and responsibilities
As explained more fully in the Directors’
Responsibilities Statement set out on page
135, 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
4 February 2016
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.
Under the Companies Act 2006 we are
required to report to you if, in our opinion:
> 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.
Under the Listing Rules we are required
to review:
> the Directors’ statements, set out on pages
96 and 21, in relation to going concern
and longer-term viability respectively; and
> the part of the Corporate Governance
Report on pages 82 to 97 relating to the
Group’s compliance with the eleven
provisions of the 2014 UK Corporate
Governance Code specified for our review.
We have nothing to report in respect of the
above responsibilities.
8. Other matter – we have reported
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 2015 and on the information
in the Directors’ Remuneration Report that
is described as having been audited.
139
AstraZeneca Annual Report and Form 20-F Information 2015Financial 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 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 derivatives designated in net investment hedges
Amortisation of loss on cash flow hedge
Net available for sale (losses)/gains 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
5
5
5
5
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
Restated*
$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
2013
Restated*
$m
25,711
95
25,806
(5,261)
20,545
(306)
(4,821)
(12,206)
500
3,712
50
(495)
–
3,267
(696)
2,571
8
(82)
(74)
(166)
(58)
111
1
69
4
(39)
(113)
2,458
2,556
15
2,470
(12)
$2.04
$2.04
1,252
1,254
Dividends declared and paid in the period
23
3,537
3,532
3,499
* 2013 and 2014 comparatives have been restated to reflect the reclassification of Externalisation Revenue from other operating income and expense as detailed in Group Accounting Policies.
All activities were in respect of continuing operations.
$m means millions of US dollars.
140
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements Consolidated Statement of Financial Position
at 31 December
Notes
2015
$m
2014
$m
2013
$m
Assets
Non-current assets
Property, plant and equipment
Goodwill
Intangible assets
Investments in 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
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
6,413
11,868
22,646
85
458
446
907
1,294
44,117
2,143
6,622
613
2
387
6,240
16,007
60,124
(916)
(11,663)
(9)
(798)
(1,483)
(14,869)
(14,137)
(1)
(2,733)
(1,974)
(444)
(7,457)
(26,746)
(41,615)
18,509
316
4,304
153
448
1,435
11,834
18,490
19
18,509
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
The Financial Statements from page 140 to 195 were approved by the Board on 4 February 2016 and were signed on its behalf by
Pascal Soriot
Director
Marc Dunoyer
Director
5,818
9,981
16,047
–
281
365
1,867
1,205
35,564
1,909
7,879
796
40
494
9,217
20,335
55,899
(1,788)
(10,362)
(2)
(823)
(3,076)
(16,051)
(8,588)
(1)
(2,827)
(2,261)
(566)
(2,352)
(16,595)
(32,646)
23,253
315
3,983
153
433
1,380
16,960
23,224
29
23,253
141
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements
Consolidated Statement of Changes in Equity
for the year ended 31 December
Share
capital
$m
312
Share
premium
account
$m
3,504
Capital
redemption
reserve
$m
153
Merger
reserve
$m
433
Other
reserves
$m
1,374
At 1 January 2013
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
Dividend paid by subsidiary to non-controlling interests
Net acquisition of non-controlling interests2
Net movement
At 31 December 2013
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
–
–
–
–
3
–
–
–
–
3
315
–
–
–
–
1
–
–
–
1
316
–
–
–
–
–
–
–
–
–
–
–
479
–
–
–
–
479
3,983
–
–
–
–
278
–
–
–
278
4,261
–
–
–
–
43
–
43
Retained
earnings
$m
17,955
2,556
(86)
(6)
Total
attributable
to owners
$m
23,731
2,556
(86)
–
(3,499)
(3,499)
–
(57)
–
–
97
482
(57)
–
–
97
(995)
(507)
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
6
–
–
–
–
–
–
6
153
433
1,380
16,960
23,224
–
–
–
–
–
–
–
–
–
153
–
–
–
–
–
–
–
–
–
–
–
–
–
–
15
15
448
–
–
–
–
–
–
–
–
–
40
–
–
–
–
–
40
1,420
–
–
15
–
–
–
1,233
(1,499)
(40)
1,233
(1,499)
–
(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)
43
(131)
15
(1,195)
(1,137)
Non-
controlling
interests
$m
215
15
(27)
–
–
–
–
(6)
(3)
(165)
(186)
29
2
(7)
–
–
–
–
(5)
–
(10)
19
1
(1)
–
–
–
–
–
Total
equity
$m
23,946
2,571
(113)
–
(3,499)
482
(57)
(6)
(3)
(68)
(693)
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)
316
4,304
153
448
1,435
11,834
18,490
19
18,509
1 Amounts charged or credited to other reserves relate to exchange adjustments arising on goodwill.
2 Net acquisition of non-controlling interests in 2013 includes acquisitions with cash payments of $110m due in 2014 and disposals with cash of $42m received in 2013.
142
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements Consolidated Statement of Cash Flows
for the year ended 31 December
Notes
3
10
2
24
18
10
Cash flows from operating activities
Profit before tax
Finance income and expense
Share of after tax losses of joint ventures
Depreciation, amortisation and impairment
Decrease/(increase) in trade and other receivables
(Increase)/decrease in inventories
Increase in trade and other payables and provisions
Gains on disposal of intangible assets
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 acquisitions
Payment of contingent consideration on business acquisitions
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
Payments received by subsidiaries from non-controlling interests
Net cash outflow from investing activities
Net cash (outflow)/inflow 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 interest
Movement in short-term borrowings
Net cash inflow/(outflow) from financing activities
Net (decrease)/increase 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
2015
$m
3,069
1,029
16
2,852
152
(315)
114
(961)
(782)
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
–
865
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)
2013
$m
3,267
445
–
4,583
(383)
135
414
–
258
8,719
(475)
(844)
7,400
(1,158)
–
(742)
69
(1,316)
35
(91)
38
130
–
114
(10)
42
(2,889)
4,511
482
(27)
–
–
(3,521)
(3,461)
(14)
(102)
520
(2,705)
(2,679)
8,995
(152)
6,164
(36)
–
(5)
(3,047)
1,464
7,596
(65)
8,995
143
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements Group Accounting Policies
Basis of accounting and preparation
of financial information
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).
The Group updated its revenue accounting
policy with effect from 1 January 2015.
Historically, reported revenue reflected only
Product Sales, with Externalisation Revenue
forming part of other operating income
presented below gross profit. From 1 January
2015, Externalisation Revenue, alongside
Product Sales, is included in Total Revenue.
Externalisation Revenue includes
development, commercialisation and
collaboration revenue, such as royalties and
milestone receipts, together with income
from services or repeatable licences. Income
is recorded as Externalisation Revenue when
the Group has 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 the Group does not retain an interest,
will continue to be recorded in other operating
income. The updated revenue accounting
policy results in a presentational change to the
Statement of Comprehensive Income only,
and has no impact on the Group’s net results
or net assets. The prior periods included in
the Group’s Consolidated Statement of
Comprehensive Income have been restated
accordingly, resulting in $452m of income
being reclassified from other operating
income to Externalisation Revenue for 2014
and $95m of income being reclassified from
other operating income to Externalisation
Revenue in 2013.
During the year, the Group has adopted the
amendments to IAS 19 ‘Employee Benefits’,
issued by the IASB in November 2013 and
effective for periods beginning on or after
1 July 2014. 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 197 to 201
and the Accounting Policies in respect of
Company information are set out on page 199.
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 25 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 2015, the Group
has $8.3bn in financial resources (cash
balances of $6.2bn and undrawn committed
bank facilities of $3.0bn that are available
until April 2020, with only $0.9bn of debt due
within one year). Although no liability was
recognised at 31 December 2015, the Group
had entered into an agreement to invest in
a majority equity stake in Acerta with an
upfront payment of $2.5bn which was paid
on 2 February 2016 (see Note 30 to the
Financial Statements). 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, 24 and 27 to
the Financial Statements. Financial risk
management policies are detailed in Note 25.
Revenue
Revenues comprise Product Sales and
Externalisation Revenue.
Revenues exclude inter-company revenues
and value-added taxes.
144
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 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.
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
will be recognised over the duration of those
services. Milestones and sales royalties
are recognised when 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 2015,
no amounts have met recognition criteria.
Payments to in-licence 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 zero).
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.
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
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, 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’ issued
in 2011. 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.
145
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 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.
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.
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. Any liability to interest on tax
liabilities is provided for in the tax charge.
See Note 27 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
remeasured to amortised cost using the
effective interest rate method at each reporting
date. Changes in carrying value are recognised
in profit.
146
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 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.
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. 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
bonds), 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).
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 remeasured to
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 the income
statement. 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.
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 zero.
147
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements In addition, the following amendments have
been issued:
> Amendments to IFRS 11 Accounting for
Acquisitions of Interests in Joint Operations,
effective for periods beginning on or after
1 January 2016.
> Amendments to IAS 16 ‘Property, Plant and
Equipment’ and IAS 38 ‘Intangible Assets’
Clarification of Acceptable Methods of
Depreciation and Amortisation, effective for
periods beginning on or after 1 January 2016.
> Amendments to IFRS 10 ‘Consolidated
Financial Statements’ and IAS 28
‘Investments in Associates and Joint
Ventures (2011)’ Sale or Contribution of
Assets between an Investor and its
Associate or Joint Venture. The IASB has
deferred those amendments until a date
to be determined by the IASB, although
early application is permitted.
> Amendments to IAS 1 (Disclosure Initiative),
effective for periods beginning on or after
1 January 2016.
The above amendments are not expected
to have a significant impact on the Group’s
net results, net assets or disclosures. The
amendments to IFRS 11 were endorsed by the
EU on 24 November 2015, the amendments
to IAS 16 and IAS 38 were endorsed by the
EU on 2 December 2015 and the amendments
to IAS 1 were endorsed by the EU on
18 December 2015. The amendments to
IFRS 10 and IAS 28 have yet to be endorsed
by the EU.
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 has not yet
been endorsed by the EU. 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.
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 has yet to be endorsed by the
EU. The Group is continuing to assess the
impact of IFRS 15 on the results of the Group
and including, but not limited to, the impact
on 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.
148
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements Notes to the Group Financial Statements
1 Revenue
Product Sales
Respiratory, Inflammation and Autoimmunity:
Symbicort
Pulmicort
Tudorza/Eklira
Daliresp
Duaklir
Others
Cardiovascular and Metabolic Diseases:
Onglyza
Brilinta/Brilique
Bydureon
Farxiga/Forxiga
Byetta
Legacy:
Crestor
Seloken/Toprol-XL
Atacand
Plendil
Others
Oncology:
Iressa
Lynparza
Tagrisso
Legacy:
Zoladex
Faslodex
Casodex
Arimidex
Others
Infection, Neuroscience and Gastrointestinal:
Nexium
Seroquel XR
Synagis
Local Anaesthetics
Losec/Prilosec
FluMist/Fluenz
Seroquel IR
Merrem
Diprivan
Movantik/Moventig
Others
Product Sales
Externalisation Revenue
Externalisation Revenue in 2015 was $1,067m (2014: $452m; 2013: $95m).
In 2015, Externalisation Revenue incudes $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 $87m (2014: $53m; 2013: $60m) is included in Externalisation Revenue.
2015
$m
3,394
1,014
190
104
27
258
4,987
786
619
580
492
316
2014
$m
3,801
946
13
–
–
303
5,063
820
476
440
225
327
2013
$m
3,483
867
–
–
–
327
4,677
378
283
151
10
206
5,017
5,512
5,622
710
358
234
377
758
501
249
494
750
611
260
559
9,489
9,802
8,830
543
94
19
816
704
267
250
132
623
–
–
924
720
320
298
142
647
–
–
996
681
376
351
142
2,825
3,027
3,193
2,496
1,025
662
404
340
288
250
241
200
29
405
3,655
1,224
900
488
422
295
178
253
252
–
536
6,340
23,641
8,203
26,095
3,872
1,337
1,060
510
486
245
345
293
265
–
598
9,011
25,711
149
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 2 Operating profit
Operating profit includes the following significant items:
Research and development expense
In 2013, research and development included a reversal of the intangible asset impairment charge of $285m, booked in 2011 for Lynparza (olaparib).
Selling, general and administrative costs
In 2015, selling, general and administrative costs includes a 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 2015, selling, general and administrative costs also include a total of $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.
In 2013, selling, general and administrative costs included an intangible asset impairment charge of $1,620m against Bydureon following
revised estimates for future sales performance.
Further details of impairment charges and reversals for 2015, 2014 and 2013 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
2015
$m
322
(114)
(64)
961
85
310
–
1,500
2014
Restated*
$m
2013
Restated*
$m
533
(212)
(18)
–
(235)
267
–
335
561
(157)
–
–
13
105
(22)
500
* 2013 and 2014 comparatives have been restated to reflect the reclassification of Externalisation Revenue from other operating income and expense as detailed in Group Accounting Policies.
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 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
2015
$m
158
258
618
–
2014
$m
107
497
662
292
2013
$m
126
490
805
–
1,034
1,558
1,421
2015
$m
298
81
34
–
621
1,034
2014
$m
246
153
209
292
658
1,558
2013
$m
632
399
–
–
390
1,421
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.
150
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 2 Operating profit continued
Financial instruments
Included within operating profit are the following net gains and losses on financial instruments:
(Losses)/gains on forward foreign exchange contracts
Losses on receivables and payables
Gains and losses on available for sale current investments
Total
2015
$m
(22)
(36)
74
16
2014
$m
(98)
(64)
31
(131)
2013
$m
102
(136)
13
(21)
Gains and losses on available for sale current investments includes gains of $43m (2014: gains of $9m; 2013: gains of $19m) 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
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 on business combinations (Note 18)
Discount unwind on other long-term liabilities
Total
Net finance expense
2015
$m
8
28
10
–
46
(361)
(31)
(77)
(36)
(524)
(46)
(1,075)
(1,029)
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
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)
2013
$m
9
23
18
–
50
(388)
(25)
(79)
(3)
–
–
(495)
(445)
2013
$m
(4)
5
42
(406)
Fair value losses of $30m (2014: $29m fair value losses; 2013: $43m fair value losses) on interest rate fair value hedging instruments and $30m
fair value gains (2014: $29m fair value gains; 2013: $42m 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 $5m (2014: $4m fair value losses; 2013: $77m fair value losses) on derivatives related to debt instruments designated at fair
value through profit or loss and $15m fair value gains (2014: $3m fair value gains; 2013: $82m 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 (2014: $nil; 2013: $nil).
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
Deferred tax expense
Origination and reversal of temporary differences
Adjustment to prior years
Taxation recognised in the profit for the period
2015
$m
1,037
(404)
633
(482)
92
(390)
243
2014
$m
981
(109)
872
(833)
(28)
(861)
11
2013
$m
1,352
46
1,398
(699)
(3)
(702)
696
151
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 4 Taxation continued
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 Sweden and UK tax rates
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 losses/(gains) recognised in other comprehensive income
Other
Total
Taxation relating to components of other comprehensive income
2015
$m
(133)
(58)
(8)
(199)
(8)
80
14
1
87
(112)
2014
$m
2013
$m
182
–
34
216
(39)
150
(64)
3
50
266
(7)
(92)
17
(82)
19
–
(16)
1
4
(78)
The reported tax rate of 8% for the year ended 31 December 2015 benefited from a $186m adjustment following agreement of US federal tax
liabilities of open years up to 2008, other net reductions in provisions for tax contingencies partially offset by the impact of internal transfers of
intellectual property resulting in a net credit of $181m and revaluations of contingent consideration arising on business combinations (credit of
$432m with related tax charge of $39m). Excluding these effects, the reported tax rate for the year was 22%.
The cash tax paid for the year was $1,354m which was 44% of profit before tax.
Taxation has been provided at current rates on the profits earned for the periods covered by the Group Financial Statements. 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 2013 prior period current tax adjustment
relates mainly to an increase in provisions for tax contingencies partially offset by tax accrual to tax return adjustments.
The 2015, 2014 and 2013 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 $6,957m at 31 December 2015
(2014: $6,128m; 2013: $6,196m).
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 2015, the UK Government
substantively enacted legislation to reduce the main rate of UK Statutory Corporation Tax to 18% by 2020. Details of material tax exposures
and items currently under audit and negotiation are set out in Note 27.
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 20.25% (2014: 21.5%; 2013: 23.25%)
Differences in effective overseas tax rates
Deferred tax (credit)/charge relating to reduction in UK and other tax rates1
Unrecognised deferred tax asset
Items not deductible for tax purposes
Items not chargeable for tax purposes
Other items2
Adjustments in respect of prior periods3
Total tax charge for the year
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
2013
$m
3,267
760
(29)
(59)
(20)
11
(10)
–
43
696
1 The 2015 item relates to the reduction in the UK Statutory Corporation Tax rate from 20% to 18% effective from 1 April 2020. The 2014 and 2013 items relate to the reduction in the UK Statutory
Corporation Tax rate from 23% to the rate of tax of 20% effective from 1 April 2015.
2 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 statute of limitations (tax credits of $297m).
3 Further detail explaining the adjustments in respect of prior periods is set out above.
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.
152
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 4 Taxation continued
Deferred tax
The movements in the net deferred tax balance during the year are as follows:
Intangibles,
property, plant
& equipment1
$m
Pension and
post-retirement
benefits
$m
Intercompany
inventory
transfers
$m
Net deferred tax balance at 1 January 2013
(2,688)
Taxation expense
Other comprehensive income
Additions through business combinations4
Exchange
441
–
(812)
(5)
Net deferred tax balance at 31 December 2013
(3,064)
Taxation expense
Other comprehensive income
Additions through business combinations5
Exchange
Net deferred tax balance at 31 December 2014
Taxation expense
Other comprehensive income
Additions through business combinations6
Exchange
Net deferred tax balance at 31 December 20157
543
150
(147)
40
(2,478)
355
80
(1,206)
(12)
(3,261)
553
26
(90)
–
21
510
(4)
215
–
(93)
628
30
(198)
–
(33)
427
921
(154)
–
–
(31)
736
(6)
–
(35)
(65)
630
156
–
–
(48)
738
Untaxed
reserves2
$m
(1,284)
183
–
–
(13)
(1,114)
368
–
–
168
(578)
(156)
–
–
42
(692)
Losses and
tax credits
carried forward3
$m
Accrued
expenses
and other
$m
411
81
–
81
–
573
(44)
–
–
(4)
525
58
–
161
(8)
736
622
125
(7)
5
(8)
737
4
(35)
37
(47)
696
(53)
(9)
–
(21)
613
Total
$m
(1,465)
702
(97)
(726)
(36)
(1,622)
861
330
(145)
(1)
(577)
390
(127)
(1,045)
(80)
(1,439)
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 13 to 20 years.
4 The deferred tax liability of $726m relates to the acquisition of Pearl Therapeutics ($319m), Omthera ($198m), Amplimmune ($205m) and Spirogen ($4m) as detailed in Note 24.
5 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).
6 The deferred tax liability of $1,045m relates to the acquisition of ZS Pharma.
7 The UK had a net deferred tax asset of $273m as at 31 December 2015, mainly in respect of the pension and post-retirement benefits, which has been recognised on the basis of sufficient
forecast future taxable profits against which the deductible temporary differences can be utilised.
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 2013
Deferred tax liabilities at 31 December 2013
Net deferred tax balance at 31 December 2013
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
Deferred tax liabilities at 31 December 2015
Net deferred tax balance at 31 December 2015
347
(3,411)
(3,064)
1,212
(3,690)
(2,478)
1,055
(4,316)
(3,261)
518
(8)
510
631
(3)
628
430
(3)
427
775
(39)
736
657
(27)
630
780
(42)
738
–
(1,114)
(1,114)
–
(578)
(578)
–
(692)
(692)
Analysed in the statement of financial position, after offset of balances within countries, as:
Deferred tax assets
Deferred tax liabilities
Net deferred tax balance
573
–
573
525
–
525
736
–
736
2015
$m
1,294
(2,733)
(1,439)
855
(118)
737
838
(142)
696
732
(119)
613
2014
$m
1,219
(1,796)
(577)
Total
$m
3,068
(4,690)
(1,622)
3,863
(4,440)
(577)
3,733
(5,172)
(1,439)
2013
$m
1,205
(2,827)
(1,622)
Unrecognised deferred tax assets
Deferred tax assets of $414m have not been recognised in respect of deductible temporary differences (2014: $216m; 2013: $214m) 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.
2015
2,825
$2.23
$2.23
1,264
1
1,265
2014
1,233
$0.98
$0.98
1,262
2
1,264
2013
2,556
$2.04
$2.04
1,252
2
1,254
153
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 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
nine Executive Vice-Presidents representing IMED, MedImmune, Global Medicines Development, North America, Europe, International, GPPS,
Operations & Information Services, 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.
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
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
13,664
435
2,548
1,985
1,205
46
6,219
37,586
(12,878)
24,708
2014
Restated*
$m
Total Revenue
2013
Restated*
$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
1,854
5,041
6,895
265
1,303
624
729
497
464
1,830
4,930
10,642
607
10,198
1,177
2,005
13,987
811
1,836
2,403
1,208
52
6,310
37,834
(12,028)
25,806
* 2013 and 2014 comparatives have been restated to reflect the reclassification of Externalisation Revenue from other operating income and expense as detailed in Group Accounting Policies.
154
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 6 Segment information continued
Export sales from the UK totalled $6,851m for the year ended 31 December 2015 (2014: $5,709m; 2013: $6,192m). Intra-Group pricing is
determined on an arm’s length basis.
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
2015
$m
(743)
3,412
1,101
344
4,114
2015
$m
6,251
8,690
26,499
937
42,377
2015
$m
1,478
653
4,215
172
6,518
Operating (loss)/profit
(Loss)/profit before tax
2014
$m
(851)
1,780
818
390
2,137
2014
$m
5,826
8,764
24,750
874
40,214
2014
$m
2,703
6,362
2,732
199
11,996
2013
$m
(171)
3,055
591
237
3,712
2015
$m
(1,113)
3,023
821
338
3,069
2014
$m
(1,174)
1,477
549
394
1,246
2013
$m
(467)
3,016
477
241
3,267
Non-current assets1
Total assets
2013
$m
4,525
4,102
24,535
832
33,994
2015
$m
14,712
10,636
31,604
3,172
60,124
2014
$m
14,926
11,184
29,324
3,161
58,595
2013
$m
16,199
6,924
29,146
3,630
55,899
Assets acquired2
Net operating assets3
2013
$m
637
747
2,490
236
4,110
2015
$m
3,713
3,704
22,334
1,458
31,209
2014
$m
3,002
4,110
20,190
1,570
28,872
2013
$m
2,400
4,168
21,583
2,002
30,153
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 and payables.
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
2015
$m
1,024
1,023
2,986
1,380
6,413
2015
$m
588
5,180
11,031
6,842
23,641
Property, plant and equipment
2014
$m
824
971
2,830
1,385
6,010
2014
$m
773
6,394
11,892
7,036
26,095
2013
$m
1,226
1,158
2,048
1,386
5,818
2013
$m
685
6,521
11,515
6,990
25,711
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 two wholesalers (2014: two; 2013: one) individually represented greater than
10% of Product Sales. The value of these transactions recorded as Product Sales were $3,458m and $2,757m (2014: $3,261m and $2,674m; 2013:
$3,166m).
155
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements
7 Property, plant and equipment
Cost
At 1 January 2013
Capital expenditure
Additions through business combinations (Note 24)
Transfer of assets into use
Disposals and other movements
Exchange adjustments
At 31 December 2013
Capital expenditure
Additions through business combinations (Note 24)
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 24)
Transfer of assets into use
Disposals and other movements
Exchange adjustments
At 31 December 2015
Depreciation
At 1 January 2013
Charge for year
Impairment
Disposals and other movements
Exchange adjustments
At 31 December 2013
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
Net book value
At 31 December 2013
At 31 December 2014
At 31 December 2015
Land and
buildings
$m
Plant and
equipment
$m
Assets in course
of construction
$m
Total property,
plant and
equipment
$m
5,850
8,645
21
1
67
(275)
19
5,683
34
213
156
136
(976)
(334)
4,912
23
21
269
(239)
(174)
4,812
2,668
331
7
(73)
19
2,952
252
(639)
(214)
2,351
198
9
(203)
(102)
2,253
2,731
2,561
2,559
222
3
295
(773)
61
8,453
184
206
124
405
(962)
(698)
7,712
223
–
359
(442)
(384)
576
565
4
(362)
(7)
(5)
771
874
96
70
(541)
(27)
(123)
1,120
1,155
–
(628)
(3)
(76)
15,071
808
8
–
(1,055)
75
14,907
1,092
515
350
–
(1,965)
(1,155)
13,744
1,401
21
–
(684)
(634)
7,468
1,568
13,848
6,314
575
94
(900)
54
6,137
524
(744)
(534)
5,383
479
19
(411)
(288)
5,182
2,316
2,329
2,286
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
771
1,120
1,568
8,982
906
101
(973)
73
9,089
776
(1,383)
(748)
7,734
677
28
(614)
(390)
7,435
5,818
6,010
6,413
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.
Impairment charges in 2013 were attributable to strategy changes affecting manufacturing operations in China and the impact of restructuring
our site footprint in the US. These charges were recognised in cost of sales.
The net book value of land and buildings comprised:
Freeholds
Leaseholds
2015
$m
2,432
127
2014
$m
2,489
72
2013
$m
2,656
75
Included within plant and equipment are Information Technology assets held under finance leases with a net book value of $70m (2014: $74m;
2013: $86m).
156
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 8 Goodwill
Cost
At 1 January
Additions through business combinations (Note 24)
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
2015
$m
11,868
456
(143)
12,181
318
(5)
313
2014
$m
10,307
1,841
(280)
11,868
326
(8)
318
11,868
11,550
2013
$m
10,223
77
7
10,307
325
1
326
9,981
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 2015, 2014 and 2013) 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% (2014: 10%; 2013: 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 2015 (and 31 December 2014 and 31 December 2013).
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.
157
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 9 Intangible assets
Cost
At 1 January 2013
Additions through business combinations (Note 24)
Additions – separately acquired
Disposals
Exchange and other adjustments
At 31 December 2013
Additions through business combinations (Note 24)
Additions – separately acquired
Disposals
Exchange and other adjustments
At 31 December 2014
Additions through business combinations (Note 24)
Additions – separately acquired
Disposals
Exchange and other adjustments
At 31 December 2015
Amortisation and impairment losses
At 1 January 2013
Amortisation for year
Impairment
Impairment reversals
Disposals
Exchange and other adjustments
At 31 December 2013
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
Net book value
At 31 December 2013
At 31 December 2014
At 31 December 2015
Product,
marketing and
distribution rights
$m
Other
intangibles
$m
Software
development
costs
$m
22,862
2,045
635
(46)
57
25,553
6,926
907
(23)
(1,464)
31,899
3,162
1,341
(198)
(886)
35,318
7,659
1,498
2,025
(285)
(11)
58
10,944
2,008
81
(23)
(465)
12,545
1,718
143
(31)
(271)
2,135
371
–
–
(7)
2,499
575
25
–
(287)
2,812
–
60
(4)
(73)
1,905
–
166
–
19
2,090
–
115
(41)
(138)
2,026
–
77
(14)
(70)
2,795
2,019
1,578
93
–
–
–
11
1,682
193
18
–
(240)
1,653
174
–
(2)
(52)
1,217
188
57
–
–
7
1,469
183
23
(41)
(76)
1,558
107
5
(14)
(47)
Total
$m
26,902
2,416
801
(46)
69
30,142
7,501
1,047
(64)
(1,889)
36,737
3,162
1,478
(216)
(1,029)
40,132
10,454
1,779
2,082
(285)
(11)
76
14,095
2,384
122
(64)
(781)
15,756
1,999
148
(47)
(370)
14,104
1,773
1,609
17,486
14,609
19,354
21,214
817
1,159
1,022
621
468
410
16,047
20,981
22,646
Other intangibles consist mainly of licensing and rights to contractual income streams.
158
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 9 Intangible assets continued
Amortisation charges are recognised in profit as follows:
Year ended 31 December 2013
Cost of sales
Research and development expense
Selling, general and administrative costs
Other operating income and expense
Total
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
Impairment charges are recognised in profit as follows:
Year ended 31 December 2013
Research and development expense
Selling, general and administrative costs
Total
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
Product,
marketing and
distribution rights
$m
Other
intangibles
$m
Software
development
costs
$m
502
–
898
98
1,498
701
–
1,203
104
2,008
369
–
1,321
28
1,718
–
30
4
59
93
–
60
25
108
193
–
57
31
86
174
–
–
188
–
188
–
–
183
–
183
–
–
107
–
107
Product,
marketing and
distribution rights
$m
Other
intangibles
$m
Software
development
costs
$m
335
1,690
2,025
81
–
–
81
79
–
64
143
–
–
–
–
–
18
18
–
–
–
–
–
57
57
–
23
–
23
–
5
–
5
Total
$m
502
30
1,090
157
1,779
701
60
1,411
212
2,384
369
57
1,459
114
1,999
Total
$m
335
1,747
2,082
81
23
18
122
79
5
64
148
The impairment reversal of $285m booked in 2013 was recorded in research and development expense.
Impairment charges and reversals
In 2015 and 2014, impairment charges relate to the termination, or reassessment of the likelihood of success, of several individual projects,
none of which had significant capitalised values.
In 2013, AstraZeneca commenced enrolment of the first patient in the first of several Phase III clinical programmes for Lynparza (olaparib). As a
result of the initiation of this programme, an impairment charge of $285m, taken in 2011, was reversed and the full historic carrying value of the
asset restored to the balance sheet. There are several indications currently under development for Lynparza (olaparib) and, at the date of the
reversal of the impairment, the recoverable value of the intangible asset relating to Lynparza (olaparib) determined using value in use calculations
as detailed below, was estimated to be at least $650m above its carrying value. The 2013 impairment charge of product, marketing and distribution
rights included a charge of $1,758m against the intangible asset for Bydureon, acquired as part of the 2012 collaboration with BMS on Amylin
products, following revised estimates for future sales performance that were below AstraZeneca’s commercial expectations at that time of
entering into the collaboration. Impairment charges also included $136m following AstraZeneca’s decision not to proceed with regulatory filings
for fostamatinib.
159
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 9 Intangible assets continued
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 2015, 2014 and 2013) 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%
(2014: 13%; 2013: 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 2015, the Group held intangible assets for
products in development of $8,732m (2014: $6,598m; 2013: $5,457m), for which the most sensitive assumption is the probability of technical
success, and intangible assets for launched products of $13,504m (2014: $13,915m; 2013: $9,969m), for which the most sensitive assumptions
are the projected market share of the therapeutic area and expected pricing. In addition, we consider the sensitivity of our 2015 impairment
conclusions to possible changes to the post tax discount rate and noted that a change of 1% would have no effect on the level of impairment
recorded in 2015. 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.
Significant assets
Description
Carrying value
$m
Remaining amortisation
period
Intangible assets arising from the restructuring of a joint venture with Merck
Product, marketing and distribution rights
RSV franchise assets arising from the acquisition of MedImmune
Product, marketing and distribution rights
FluMist intangible assets arising from the acquisition of MedImmune
Product, marketing and distribution rights
Onglyza intangible assets acquired from BMS
Forxiga/Farxiga intangible assets acquired from BMS
Bydureon intangible assets acquired from BMS
Other diabetes intangible assets acquired from BMS
Product, marketing and distribution rights
Product, marketing and distribution rights
Product, marketing and distribution rights
Product, marketing and distribution rights
Movantik/Moventig asset acquired from Nektar Therapeutics
Product, marketing and distribution rights
Intangible assets acquired from Almirall and Actavis
Product, marketing and distribution rights
Intangible assets arising from the acquisition of Definiens
Research technology rights
Intangible assets arising from the acquisition of Ardea1
Product, marketing and distribution rights
Intangible assets arising from the acquisition of Pearl Therapeutics1
Product, marketing and distribution rights
Intangible assets arising from the acquisition of Omthera1
Product, marketing and distribution rights
Intangible assets arising from the acquisition of Amplimmune1
Product, marketing and distribution rights
Intangible assets arising from the acquisition of ZS Pharma1
Product, marketing and distribution rights
1 Assets in development are not amortised but are tested annually for impairment.
10 Investments in joint ventures
At 1 January
Additions
Share of after tax losses
Exchange adjustments
At 31 December
1,858
2,781
445
1,308
1,718
1,248
1,420
395
1,778
302
1,434
951
533
470
3,162
1-15 years
10 years
16 years
8 years
12 years
15 years
7-18 years
16 years
4-23 years
14 years
Not amortised
Not amortised
Not amortised
Not amortised
Not amortised
2015
$m
59
45
(16)
(3)
85
2014
$m
–
70
(6)
(5)
59
2013
$m
–
–
–
–
–
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.
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.
Both investments are accounted for using the equity method.
Aggregated summarised financial information for the 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 joint ventures
160
AstraZeneca Annual Report and Form 20-F Information 2015
2015
$m
123
75
(11)
187
93
(8)
85
2014
$m
76
58
(6)
128
64
(5)
59
2013
$m
–
–
–
–
–
–
–
Financial Statements 11 Other investments
Non-current investments
Equity securities available for sale
Total
Current investments
Equity securities and bonds available for sale
Equity securities held for trading
Fixed deposits
Total
2015
$m
458
458
548
–
65
613
2014
$m
502
502
775
–
20
795
2013
$m
281
281
735
46
15
796
The equity securities and bonds available for sale in current investments include $467m (2014: $775m; 2013: $735m) held in a custody account.
Further details of this custody account are included in Note 20.
Impairment charges of $17m in respect of available for sale securities are included in other operating income and expense (2014: $23m; 2013: $22m).
Equity securities and bonds available for sale, and equity securities held for trading, 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 financial instruments, 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).
2013
Equity securities and bonds available for sale
Equity securities held for trading
Total
2014
Equity securities and bonds available for sale
Total
2015
Equity securities and bonds available for sale
Total
Level 1
$m
Level 2
$m
Level 3
$m
807
46
853
927
927
654
654
–
–
–
–
–
–
–
209
–
209
350
350
352
352
Total
$m
1,016
46
1,062
1,277
1,277
1,006
1,006
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, 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
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.
2013
$m
138
70
–
–
(8)
9
209
161
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements
12 Derivative financial instruments
Derivative financial instruments consist of interest rate swaps (included in instruments designated at fair value if related to debt designated at fair
value, or instruments in a fair value hedge relationship if formally designated as in a fair value hedge relationship), cross-currency swaps (included in
instruments designated in net investment hedges), currency options and forward foreign exchange contracts (included below in other derivatives).
Designated in a fair value hedge
Related to instruments designated at fair value through profit or loss
Designated as a net investment hedge
Other derivatives
31 December 2013
Designated in a fair value hedge
Related to instruments designated at fair value through profit or loss
Designated as a net investment hedge
Other derivatives
31 December 2014
Designated in a fair value hedge
Related to instruments designated at fair value through profit or loss
Designated as a net investment hedge
Other derivatives
31 December 2015
Non-current
assets
$m
Current
assets
$m
Current
liabilities
$m
Non-current
liabilities
$m
108
69
188
–
365
–
16
–
24
40
–
–
–
(2)
(2)
–
–
(1)
–
(1)
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)
Total
$m
108
85
187
22
402
Total
$m
79
82
304
–
465
Total
$m
49
77
320
(8)
438
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
2015
2014
2013
1.2% to 2.1% 1.2% to 2.3% 0.3% to 3.2%
13 Non-current other receivables
Non-current other receivables of $907m (2014: $1,112m; 2013: $1,867m) include a prepayment of $617m (2014: $906m; 2013: $1,276m) 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 Company recognising liabilities, and corresponding prepayments, for the discounted value of total minimum
payments. The current portion of the prepayment is $260m (2014: $323m; 2013: $350m) and is reported in amounts due within one year (see
Note 15). Non-current other receivables also include prepayments in relation to our research collaboration with Moderna Therapeutics.
14 Inventories
Raw materials and consumables
Inventories in process
Finished goods and goods for resale
Inventories
2015
$m
960
545
638
2,143
2014
$m
663
501
796
2013
$m
570
659
680
1,960
1,909
The Group recognised $2,942m (2014: $3,214m; 2013: $2,981m) of inventories as an expense within cost of sales during the year.
Inventory write-offs in the year amounted to $112m (2014: $126m; 2013: $91m).
162
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 15 Current trade and other receivables
Amounts due within one year
Trade receivables
Less: Amounts provided for doubtful debts (Note 25)
Other receivables
Prepayments and accrued income
Amounts due after more than one year
Other receivables
Prepayments and accrued income
Trade and other receivables
2015
$m
4,685
(52)
4,633
543
1,268
6,444
28
150
178
6,622
2014
$m
4,816
(54)
4,762
1,050
1,262
7,074
22
136
158
7,232
2013
$m
5,578
(64)
5,514
684
1,420
7,618
110
151
261
7,879
All financial assets included within current trade and other receivables are held on the consolidated statement of financial position 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
2015
$m
1,250
4,990
6,240
(189)
6,051
2014
$m
1,009
5,351
6,360
(196)
6,164
2013
$m
1,094
8,123
9,217
(222)
8,995
The Group holds $110m (2014: $114m; 2013: $119m) 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 on the consolidated statement of financial position at amortised cost. Fair value approximates to carrying value.
17 Interest-bearing loans and borrowings
Current liabilities
Bank overdrafts
Finance leases
5.4% Callable bond
5.125% Non-callable bond
Other loans (Commercial paper)
Total
Non-current liabilities
Finance leases
5.125% Non-callable bond
5.9% Callable bond
Floating rate notes
1.75% Callable bond
1.95% Callable bond
2.375% Callable bond
0.875% Non-callable bond
7% Guaranteed debentures
3.375% Callable bond
5.75% Non-callable bond
6.45% Callable bond
4% Callable bond
4.375% Callable bond
Total
Repayment
dates
On demand
2014
2015
Within one year
2015
2017
2018
2018
2019
2020
2021
2023
2025
2031
2037
2042
2045
2015
$m
189
67
–
–
660
916
28
–
1,796
399
997
997
1,586
812
355
1,971
515
2,719
986
976
14,137
2014
$m
196
48
–
912
1,290
2,446
60
–
1,825
–
–
996
–
902
370
–
540
2,718
986
–
8,397
2013
$m
222
30
766
–
770
1,788
72
1,035
1,854
–
–
996
–
–
356
–
573
2,717
985
–
8,588
US dollars
euros
euros
US dollars
US dollars
US dollars
US dollars
US dollars
euros
US dollars
US dollars
pounds sterling
US dollars
US dollars
US dollars
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).
163
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 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.
2013
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 2013
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
Instruments in a
fair value hedge
relationship1
$m
Instruments
designated
at fair value2
$m
Amortised
cost3
$m
Total
carrying
value
$m
–
–
–
–
856
856
–
–
–
–
828
828
–
–
–
–
1,398
1,398
–
–
–
766
356
1,122
–
–
–
–
370
370
–
–
–
–
355
355
222
30
72
770
7,304
8,398
196
48
60
2,202
7,139
9,645
189
67
28
660
12,356
13,300
222
30
72
1,536
8,516
10,376
196
48
60
2,202
8,337
10,843
189
67
28
660
14,109
15,053
Fair
value
$m
222
30
72
1,536
9,296
11,156
196
48
60
2,202
9,662
12,168
189
67
28
660
15,132
16,076
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, and a
portion of the US dollar 1.75% callable bond repayable in 2018.
2 Instruments designated at fair value through profit or loss include the US dollar 7% guaranteed debentures repayable in 2023.
3 Included within borrowings held at amortised cost are amounts designated as hedges of net investments in foreign operations of $1,327m (2014: $1,453m; 2013: $1,608m) held at amortised cost.
The fair value of these borrowings was $1,516m at 31 December 2015 (2014: $1,641m; 2013: $1,769m).
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 gain of $10m was made during the year on the fair value of bonds designated at fair value through profit or loss, due to increased credit risk.
A gain of $48m 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.
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
18 Trade and other payables
Current liabilities
Trade payables
Value added and payroll taxes and social security
Rebates and chargebacks
Accruals
Other payables
Total
Non-current liabilities
Accruals
Other payables
Total
164
AstraZeneca Annual Report and Form 20-F Information 2015
2015
2014
2013
1.2% to 2.1% 1.2% to 2.3% 0.3% to 3.2%
2015
$m
3,469
207
3,307
2,983
1,697
2014
$m
3,492
201
3,530
3,231
1,432
2013
$m
2,499
207
2,853
3,606
1,197
11,663
11,886
10,362
256
7,201
7,457
219
7,772
7,991
126
2,226
2,352
Financial Statements 18 Trade and other payables continued
With the exception of contingent consideration payables of $6,411m (2014: $6,899m; 2013: $514m) held within other payables, that arose on
business combinations (see Note 24), 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 24)
Settlements
Revaluations
Discount unwind
Foreign exchange
At 31 December
2015
$m
6,899
–
(579)
(432)
524
(1)
6,411
2014
$m
514
6,138
(657)
512
391
1
6,899
2013
$m
–
532
–
(18)
–
–
514
As detailed in Note 24, 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 $378m in 2015
(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.
Further details of the potential future payments on our business combinations, including details of the possible ranges of payments, are included
in Note 24. 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.
19 Provisions
At 1 January 2013
Charge for year
Cash paid
Reversals
Exchange and other movements
At 31 December 2013
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
Due within one year
Due after more than one year
Total
Severance
$m
Environmental
$m
Employee
benefits
$m
637
652
(532)
(20)
34
771
39
254
(472)
(21)
(45)
526
–
338
(408)
(40)
(13)
403
88
27
(28)
–
–
87
–
15
(17)
–
(1)
84
–
8
(25)
–
–
67
148
20
(19)
–
3
152
–
8
(16)
–
19
163
–
7
(12)
–
–
158
Legal
$m
100
23
(78)
(5)
19
59
–
91
(71)
(4)
(1)
74
–
313
(69)
–
39
357
2015
$m
798
444
1,242
Other
provisions
$m
371
49
(24)
(78)
2
320
–
66
(57)
(39)
(30)
260
10
40
(43)
(12)
2
257
2014
$m
623
484
1,107
Total
$m
1,344
771
(681)
(103)
58
1,389
39
434
(633)
(64)
(58)
1,107
10
706
(557)
(52)
28
1,242
2013
$m
823
566
1,389
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.
Details of the environmental and legal provisions are provided in Note 27.
Employee benefit provisions include the Deferred Bonus Plan. Further details are included in Note 26.
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.
165
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 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, Sweden and Germany, are ‘defined benefit’, where benefits are based on employees’ length
of service and average final salary (typically averaged over one, three or five years). 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 funds. 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
specifically with reference to AstraZeneca’s credit rating, market capitalisation, cash flows and the solvency of the relevant pension scheme.
Financing Principles
97% of the Group’s defined benefit obligations at 31 December 2015 are in schemes within the UK, the US, Sweden or Germany. In these
countries, the pension obligations are funded with reference to the following financing principles:
> The Group has a fundamental belief in funding the benefits it promises to employees.
> The Group 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 Group’s core business. The Group believes in taking some rewarded risks with the investments
underlying the funding, subject to a medium to long-term plan to reduce those risks if opportunities arise.
> The Group recognises that deciding to hold certain investments may cause volatility in the funding position. The Group 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.
> In the event that local regulations require an additional level of financing, the Group would consider the use of alternative methods of providing
this that do not require immediate cash funding but help mitigate exposure of the pension arrangement to the credit risk of the Group.
These principles are appropriate to AstraZeneca’s business at the present date; should circumstances change they may require review.
AstraZeneca has developed a funding framework to implement these principles. This determines the cash contributions payable to the pension
funds, but does not affect the IAS 19 liabilities. To reduce the risk of committing excess capital to pension funds, liability valuations are based on
the expected return on the actual pension assets, rather than a corporate bond yield. At present, this puts a different, lower value on the liabilities
than IAS 19.
UK
With regard to the Group’s UK defined benefit 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 managed by a corporate Trustee which is legally separate from the Company. The Trustee Directors are composed 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 plus 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 funding valuation of the AstraZeneca Pension Fund was carried out by a qualified actuary as at 31 March
2013. An updated funding valuation is due as at 31 March 2016.
In addition, AstraZeneca makes contributions to a separate account which is held outside the UK Pension Fund. The assets held in this account
will be payable to the AstraZeneca Pension Fund in agreed circumstances, for example, in the event of AstraZeneca and the Pension Fund
Trustee agreeing on a change to the current long-term investment strategy. At 31 December 2015, £315m ($467m) of assets held in this
separate account are included within other investments (see Note 11). The structure of this separate account is a custody account held by
AstraZeneca with HSBC. There is a charge in favour of the Pension Fund Trustee over the assets held in this custody account.
Under the current funding plan, a lump sum contribution of £196m ($305m) was made towards the deficit in January 2015, with a further
contribution of £51m ($76m) due before 31 March 2016. Contributions are made by transferring assets from the custody account described
above. The Company and the UK Pension Fund are currently exploring revised funding plans and extended target dates for full funding.
Under the agreed funding principles 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 ($7,241m) compared to a market value of assets at 31 March 2013 of £4,394m ($6,510m).
166
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 20 Post-retirement benefits continued
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’.
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 as at 31 December 2015 are shown below for each of the other countries with significant defined benefit plans. These plans
account for 90% of the Group’s defined benefit obligations outside the UK. The US and Sweden pension funds are managed by fiduciary bodies
with responsibility for the investment policies of those funds. These plans are funded in line with the financing principles and contributions paid as
prescribed by the funding framework.
> The US defined benefits programme was actuarially revalued at 31 December 2015, when plan obligations were $1,794m and plan assets
were $1,566m. 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 2015, when plan obligations were estimated to amount
to $1,423m and plan assets were $1,045m.
> The German defined benefits programme was actuarially revalued at 31 December 2015. In accordance with practice in Germany, the plan
has a low level of funding; plan obligations amounted to $345m and plan assets were $19m.
On current bases, it is expected that contributions (excluding those in respect of past service deficit contributions) during the year ending
31 December 2016 for the four main countries will be $173m.
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 2015, some 3,433 retired employees and covered dependants currently benefit
from these provisions and some 10,582 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 2015 was $23m (2014: $20m; 2013: $16m). Plan assets were $293m
and plan obligations were $318m at 31 December 2015. 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 2015. 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 Pensionable pay frozen at 30 June 2010 levels following UK fund changes.
2015
2014
UK
Rest of Group
UK
Rest of Group
3.0%
–1
3.0%
3.8%
2.1%
3.0%
0.8%
3.8%
3.1%
–1
3.0%
3.5%
2.0%
3.2%
0.8%
3.0%
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 2015 and members expected to retire in 2035
(2014: 2014 and 2034 respectively).
Country
UK
US
Sweden
Germany
Life expectancy assumption for a male member retiring at age 65
2015
23.2
22.9
20.5
18.7
2035
24.5
24.4
22.4
21.5
2014
23.7
23.1
20.5
18.7
2034
25.3
24.7
22.4
21.5
The UK life expectancy has fallen over the year due to a higher-than-expected number of pensioner-age deaths in the UK over 2014/15, compared
to the prior year assumptions. This has created the expectation of a less rapid rate of longevity improvement in future years, which has been
reflected by the Company by adopting the CMI 2015 Mortality Projections Model with a 1% long-term improvement rate in 2015.
167
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 20 Post-retirement benefits continued
Risks associated with the Company’s defined benefit pensions
The UK defined benefit plan accounts for 65% 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 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 (over 40%) in growth
assets. The largest allocation within the growth asset
portfolio is held in equities (approximately 23%). 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.
The Company and Trustee have put in place an equity option
hedging strategy for the UK Pension Fund to reduce the
volatility of equity investment returns. This strategy covers
over 60% of the equity exposure.
In addition, changes to the investment strategy have been
adopted over the course of the year which further diversify
the growth portfolio and which are expected to reduce
investment risk and increase expected returns.
The investment strategy will continue to evolve to further
improve the expected risk/return profile over 2016.
The Company and Trustee have 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,
although this will be partially offset by an increase in the
value of the UK Pension Fund’s bond holdings.
The UK Pension Fund holds a significant proportion of its
assets (around 35%) in corporate bonds, which provide a
hedge against falling bond yields (falling yields which increase
the DBO will also increase the value of the bond assets).
This interest rate hedge is further extended by investments in
gilts and the use of interest rate derivatives, so that overall the
UK Pension Fund liabilities are approximately 45% hedged
against falling interest rates on an economic value basis.
Note that there are some differences in the credit quality
of bonds held by the UK Pension Fund and the bonds
analysed to decide the DBO discount rate, such that there
remains some risk should yields on different quality bond/
swap assets diverge.
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%).
The UK Pension Fund holds some inflation-linked assets
which provide a hedge against higher-than-expected inflation
increases on the DBO. This is augmented by inflation swaps,
such that overall the UK Pension Fund assets hedge
approximately 50% of the liability exposure to changes in
expected inflation on an economic value basis.
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 UK Pension Fund entered into a longevity swap during
2013 which provides hedging against the longevity risk of
increasing life expectancy over the next 78 years for around
10,000 of the Pension Fund’s current pensioners and covers
$3.4bn of the Pension Fund’s liabilities. A one year increase
in life expectancy will result in $207m 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 through new legislation).
168
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 20 Post-retirement benefits continued
Post-retirement scheme deficit
The assets and obligations of the defined benefit schemes operated by the Group at 31 December 2015, 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.
UK
$m
Rest of Group
$m
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: Hedge funds (no quoted market price)
Cash and cash equivalents
Others
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
Total fair value of scheme assets1
6,467
2,954
9,421
UK
$m
Rest of Group
$m
1,005
21
255
63
1,563
9
78
–
30
–
(26)
–
–
38
111
–
76
12
1,700
320
1,373
74
3,112
106
33
–
(94)
(63)
(14)
16
–
–
335
1
302
110
7,311
(1,168)
(2,474)
(5,200)
(8,842)
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 statement of
financial position
1 Included in scheme assets is $nil (2014: $nil) of the Company’s own assets.
Fair value of scheme assets
At beginning of year
Interest income on scheme assets
Expenses
Actuarial (losses)/gains
Exchange adjustments
Employer contributions
Participant contributions
Settlements
Benefits paid
Scheme assets’ fair value at end of year
(1,094)
(1,862)
(4,495)
(7,451)
(1,420)
(986)
(1,538)
(3,944)
(2,514)
(2,848)
(6,033)
(11,395)
(984)
(990)
(1,974)
(1,531)
(1,420)
(2,951)
3,235
10,546
(1,763)
(1,125)
(1,767)
(4,655)
(2,931)
(3,599)
(6,967)
(13,497)
UK
$m
Rest of Group
$m
7,311
257
(5)
(375)
(311)
360
5
(447)
(328)
6,467
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
UK
$m
7,021
307
(5)
670
(426)
88
6
–
(350)
7,311
Rest of Group
$m
3,248
133
(4)
274
(291)
96
–
–
(221)
3,235
The actual return on the plan assets was a loss of $82m (2014: gain of $1,384m).
2014
Total
$m
2,705
341
1,628
137
4,675
115
111
–
(64)
(63)
(40)
16
–
38
446
1
378
122
2014
Total
$m
10,269
440
(9)
944
(717)
184
6
–
(571)
10,546
169
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 20 Post-retirement benefits continued
Movement in post-retirement scheme obligations
UK
$m
Rest of Group
$m
2015
Total
$m
UK
$m
Rest of Group
$m
2014
Total
$m
Present value of obligation in scheme at beginning of year
(8,842)
Current service cost
Past service cost
Participant contributions
Benefits paid
Interest expense on post-retirement scheme obligations
Actuarial gains/(losses)
Obligations arising on acquisitions
Settlements
Exchange adjustments
(34)
(44)
(5)
328
(301)
613
–
447
387
Present value of obligations in scheme at end of year
(7,451)
The obligations arise from the following plans:
(4,655)
(105)
16
–
252
(133)
478
–
–
203
(3,944)
UK
$m
Rest of Group
$m
(13,497)
(8,403)
(4,127)
(12,530)
(139)
(28)
(5)
580
(434)
1,091
–
447
590
(11,395)
2015
Total
$m
(33)
(63)
(6)
350
(369)
(841)
(4)
–
527
(8,842)
(103)
(22)
–
221
(163)
(869)
(50)
–
458
(136)
(85)
(6)
571
(532)
(1,710)
(54)
–
985
(4,655)
(13,497)
UK
$m
Rest of Group
$m
2014
Total
$m
Funded – pension schemes
Funded – post-retirement healthcare
Unfunded – pension schemes
Unfunded – post-retirement healthcare
Total
(7,429)
(3,142)
(10,571)
(8,815)
(3,694)
(12,509)
–
–
(22)
(7,451)
(281)
(506)
(15)
(281)
(506)
(37)
(3,944)
(11,395)
–
–
(27)
(8,842)
(360)
(586)
(15)
(360)
(586)
(42)
(4,655)
(13,497)
The weighted average duration of the post-retirement scheme obligations in the UK is 16 years and 14 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 2015, are set out below.
Operating profit
Current service cost
Past service 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
(34)
(44)
(5)
(83)
257
(301)
(44)
(127)
(105)
16
(10)
(99)
100
(133)
(33)
(132)
2015
Total
$m
(139)
(28)
(15)
(182)
357
(434)
(77)
(259)
(375)
(64)
(439)
3
370
240
238
56
386
36
414
59
756
276
652
UK
$m
Rest of Group
$m
(33)
(63)
(5)
(101)
307
(369)
(62)
(163)
670
(8)
(848)
15
(171)
(103)
(22)
(4)
(129)
133
(163)
(30)
(159)
274
(13)
(725)
(131)
(595)
2014
Total
$m
(136)
(85)
(9)
(230)
440
(532)
(92)
(322)
944
(21)
(1,573)
(116)
(766)
Included in total assets and obligations for the UK is $nil (2014: $473m) in respect of the Investment Account (defined contribution) section of the
UK Pension Fund. In 2015, AstraZeneca decided to no longer convert assets held in the Investment Account section into the defined benefit
section, as members reached retirement. As a result, settlements within the year include $447m relating to the Investment Account being
removed from both the UK assets and liabilities with a net impact of $nil on the overall deficit.
Past service cost in 2015 includes a credit to operating income of $21m arising from the reduction of the pre-65 maximum annual cost of
medical coverage in the US retiree health plans.
Group costs in respect of defined contribution schemes during the year were $302m (2014: $238m). Past service cost relates predominantly to
enhanced pensions on early retirement in the UK and Sweden.
170
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 20 Post-retirement benefits continued
Rate sensitivities
The following table shows the US dollar effect of a change in the significant actuarial assumptions used to determine the retirement benefits
obligations in our four main defined benefit pension obligation countries.
Discount rate
UK ($m)
US ($m)
Sweden ($m)
Germany ($m)
Total ($m)
Inflation rate1
UK ($m)
US ($m)
Sweden ($m)
Germany ($m)
Total ($m)
Rate of increase in salaries
UK ($m)
US ($m)
Sweden ($m)
Germany ($m)
Total ($m)
Mortality rate
UK ($m)
US ($m)
Sweden ($m)
Germany ($m)
Total ($m)
+0.5%
530
111
143
32
816
+0.5%
(525)
(14)
(159)
(21)
(719)
+0.5%
–
(12)
(66)
(1)
(79)
+1 year
(313)2
(24)
(63)
(13)
(413)
2015
-0.5%
(600)
(118)
(164)
(37)
(919)
2015
-0.5%
517
15
140
19
691
2015
-0.5%
–
12
58
1
71
2015
-1 year
3143
25
62
13
414
+0.5%
622
119
201
39
981
+0.5%
(457)
(19)
(229)
(25)
(730)
+0.5%
–
(15)
(82)
(1)
(98)
+1 year
(318)
(25)
(105)
(15)
(463)
2014
-0.5%
(676)
(125)
(232)
(45)
(1,078)
2014
-0.5%
520
19
200
23
762
2014
-0.5%
–
15
72
1
88
2014
-1 year
324
26
105
15
470
1 Rate of increase in pensions in payment follows inflation.
2 Of the $313m increase, $207m is covered by the longevity swap.
3 Of the $314m decrease, $214m 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.
171
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 21 Reserves
Retained earnings
The cumulative amount of goodwill written off directly to reserves resulting from acquisitions, net of disposals, amounted to $624m (2014: $639m;
2013: $679m) using year end rates of exchange. At 31 December 2015, 49,105 shares, at a cost of $4m, have been deducted from retained
earnings (2014: 168,388 shares, at a cost of $10m; 2013: 99,341 shares, at a cost of $2m).
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
Balance at beginning of year
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
Balance at end of year
2015
$m
490
(528)
(15)
(333)
14
(862)
(372)
2014
$m
1,782
(823)
(40)
(529)
100
(1,292)
490
2013
$m
1,901
(166)
(6)
(58)
111
(119)
1,782
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
2015
$m
316
–
316
Allotted, called-up and fully paid
2014
$m
316
–
316
2013
$m
315
–
315
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
At 31 December
No. of shares
2015
2014
2013
1,263,143,338
1,257,170,087
1,246,779,548
979,332
5,973,251
10,390,539
1,264,122,670
1,263,143,338
1,257,170,087
Share repurchases
No Ordinary Shares were repurchased by the Company in 2015 (2014: nil; 2013: nil).
Share option schemes
A total of 1.0m Ordinary Shares were issued during the year in respect of share option schemes (2014: 6.0m Ordinary Shares; 2013: 10.4m
Ordinary Shares). Details of Directors’ interests in shares are shown in the Directors’ Remuneration Report from page 103.
Shares held by subsidiaries
No shares in the Company were held by subsidiaries in any year.
23 Dividends to shareholders
Final
Interim
Total
2015
Per share
$1.90
$0.90
$2.80
2014
Per share
$1.90
$0.90
$2.80
2013
Per share
$1.90
$0.90
$2.80
2015
$m
2,400
1,137
3,537
2014
$m
2,395
1,137
3,532
2013
$m
2,372
1,127
3,499
The second interim dividend, to be confirmed as final, is $1.90 per Ordinary Share and $2,402m in total. This will be payable on 21 March 2016.
On payment of the dividends, exchange gains of $2m (2014: losses of $3m; 2013: gains of $1m) arose. These exchange gains are included in
Note 3.
172
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 24 Acquisitions of business operations
2015 Acquisitions
ZS Pharma
On 17 December, 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,
which is under regulatory review by the US Food and Drug Administration with a Prescription Drug User Fee Act goal date of 26 May 2016.
A submission for European Marketing Application Authorisation was made late in 2015.
ZS Pharma represents a strong fit with AstraZeneca’s pipeline and portfolio in Cardiovascular and 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 has 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 knowhow 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 Financial Statements were approved, the finalisation of the accounting
entries for this transaction has yet to be completed. Our provisional assessment of the fair values of the assets and liabilities acquired is detailed
below. Our assessment will be completed in 2016.
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)
(1,045)
(13)
(1,058)
2,244
456
2,700
(73)
(181)
2,446
173
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 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.
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.
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.
174
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 24 Acquisitions of business operations continued
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 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.
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.
175
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 24 Acquisitions of business operations continued
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
Almirall
$m
Definiens
$m
5,746
478
6,224
480
(278)
(84)
6,342
1,530
7,872
(5,169)
2,703
–
2,703
1,400
37
1,437
24
(2)
(11)
1,448
311
1,759
(881)
878
(2)
876
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.
2013 acquisitions
Pearl Therapeutics
On 27 June 2013, AstraZeneca completed the acquisition of Pearl Therapeutics. Pearl Therapeutics is based in Redwood City, California, and
is focused on the development of inhaled small molecule therapeutics for respiratory disease. AstraZeneca acquired 100% of Pearl Therapeutics’
shares for an upfront consideration of $569m. In addition, consideration of up to $450m is payable if specified development and regulatory
milestones in respect of any triple combination therapies and selected future products that AstraZeneca develops using Pearl Therapeutics’
technology platform are achieved. Sales-related payments of up to a further $140m are payable if pre-agreed cumulative sales thresholds are
exceeded. Contingent consideration was fair valued using decision-tree analysis, with key inputs including the probability of success and
consideration of potential delays.
Goodwill of $44m was recorded for the acquisition and is underpinned by a number of elements, which individually cannot be quantified. Most
significant among these is the synergistic benefit generated by acquiring Pearl Therapeutics’ workforce, whose skills and knowhow are critical
to the best and most efficient completion of the ongoing development programmes.
Pearl Therapeutics’ results were consolidated into the Group’s results from 27 June 2013. For the period from acquisition to 31 December 2013,
Pearl Therapeutics’ revenues were immaterial, in the context of the Group’s revenue, and its loss after tax was $49m.
Omthera Pharmaceuticals
On 18 July 2013, AstraZeneca completed the acquisition of Omthera Pharmaceuticals, Inc. Omthera is a specialty pharmaceutical company
based in Princeton, New Jersey, focused on the development and commercialisation of new therapies for abnormal levels of lipids in the blood,
referred to as dyslipidaemia.
AstraZeneca acquired 100% of Omthera’s shares for an upfront consideration of $323m with up to $120m in future development and approval
milestones. Contingent consideration was fair valued using decision-tree analysis, with key inputs including the probability of success and
consideration of potential delays.
Omthera’s results were consolidated into the Group’s results from 18 July 2013. For the period from acquisition to 31 December 2013, Omthera’s
revenues were immaterial, in the context of the Group’s revenue, and its loss after tax was $10m.
Amplimmune
On 4 October 2013, AstraZeneca completed the acquisition of Amplimmune, a privately-held, Maryland, US-based biologics company focused
on developing novel therapeutics in cancer immunology. Under the terms of the agreement, AstraZeneca acquired 100% of Amplimmune’s
shares for an initial consideration of $225m and deferred consideration of up to $275m based on reaching 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.
The acquisition bolsters AstraZeneca’s Oncology pipeline by obtaining multiple early-stage assets for its immune-mediated cancer therapy
(IMT-C) portfolio, including AMP-514, an anti-programmed cell death 1 (PD-1) monoclonal antibody (MAb). Other Amplimmune assets include
multiple preclinical molecules targeting the B7 pathways.
Goodwill of $33m arising on the acquisition is underpinned by a number of elements, which individually cannot be quantified, but include
Amplimmune’s very early programmes of potential interest for oncology, immunology and infectious diseases, as well as research tools and
animal models.
Amplimmune’s results were consolidated into the Group’s results from 4 October 2013. For the period from acquisition to 31 December 2013,
Amplimmune’s revenues were immaterial, in the context of the Group’s revenue, and its loss after tax was $5m.
176
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 24 Acquisitions of business operations continued
Spirogen
On 15 October 2013, AstraZeneca completed the acquisition of Spirogen, a privately-held biotech company focused on antibody drug conjugate
technology for use in oncology. AstraZeneca acquired 100% of Spirogen’s shares for an initial consideration of $200m and deferred consideration
of up to $240m based on reaching predetermined development milestones. Existing out-licensing agreements and associated revenue streams
were excluded from this acquisition. Contingent consideration was fair valued using decision-tree analysis, with key inputs including the probability
of success and consideration of potential delays.
AstraZeneca also entered into a collaboration agreement with ADC Therapeutics to jointly develop two of ADC Therapeutics’ antibody-drug
conjugate programmes in preclinical development. AstraZeneca also made an equity investment in ADC Therapeutics, which has an existing
licensing agreement with Spirogen.
Spirogen’s results were consolidated into the Group’s results from 15 October 2013. For the period from acquisition to 31 December 2013,
Spirogen’s revenues were immaterial, in the context of the Group’s revenue, and its loss after tax was immaterial.
The fair values assigned to the business combinations completed in 2013 were:
2013 acquisitions
Non-current assets
Intangible assets (Note 9)
Property, plant and equipment (Note 7)
Deferred tax assets
Current assets
Current liabilities
Non-current liabilities
Deferred tax 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
Less: deferred upfront consideration
Net cash outflow
Pearl Therapeutics
$m
Omthera
$m
Amplimmune
$m
Spirogen
$m
985
–
60
1,045
12
(4)
(379)
674
44
718
(149)
569
(4)
–
565
526
–
18
544
67
(10)
(216)
385
–
385
(62)
323
(63)
–
260
534
7
14
555
17
(8)
(219)
345
33
378
(153)
225
(17)
(75)
133
371
1
–
372
–
–
(4)
368
–
368
(168)
200
–
–
200
Total
$m
2,416
8
92
2,516
96
(22)
(818)
1,772
77
1,849
(532)
1,317
(84)
(75)
1,158
Acquisition costs arising on acquisitions in 2013 were immaterial.
If the 2013 acquisitions had taken effect at the beginning of the reporting period in which the acquisitions occurred (1 January 2013), on a
pro forma basis, the revenue of the combined Group for 2013 would have been unchanged and the profit after tax would have been $2,458m.
This pro forma information has been prepared taking into account any amortisation, interest costs and related tax effects but does not purport
to represent the results of the combined Group that actually would have occurred had the acquisition taken place on 1 January 2013 and should
not be taken to be representative of future results.
25 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 either
fair value 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:
> 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.
177
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 25 Financial risk management objectives and policies continued
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 $3,223m at the beginning of the year to a net debt position of $7,762m at 31 December 2015, primarily
as a result of increased outflows from investing activities, including acquisitions.
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 $6,240m, fixed deposits of $65m, less overdrafts of $189m at 31 December 2015, the Group has
committed bank facilities of $3bn available to manage liquidity. At 31 December 2015, the Group has issued $1,327m under a Euro Medium
Term Note programme and $12,782m 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 2020 and were undrawn at 31 December 2015.
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 2013
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
Bank
overdrafts
and other
loans
$m
993
–
–
–
–
–
993
(1)
–
992
Bank
overdrafts
and other
loans
$m
1,488
–
–
–
–
–
1,488
(2)
–
1,486
Bonds
$m
1,217
1,482
393
2,143
290
10,497
16,022
(6,872)
132
9,282
Bonds
$m
1,490
401
2,151
298
1,298
10,135
15,773
(6,461)
(63)
9,249
Trade
and other
payables
$m
10,370
1,044
660
285
230
1,010
13,599
–
(885)
12,714
Trade
and other
payables
$m
11,909
1,720
936
924
1,323
7,002
23,814
–
(3,937)
19,877
Total
non-derivative
financial
instruments
$m
Interest
rate swaps
$m
Cross-
currency
swaps
$m
Total
derivative
financial
instruments
$m
12,614
2,559
1,084
2,446
523
11,507
30,733
(6,890)
(753)
23,090
(70)
(70)
(51)
(51)
(51)
(77)
(370)
370
(193)
(193)
(16)
(16)
(16)
(16)
(15)
(229)
(308)
97
24
(187)
(86)
(86)
(67)
(67)
(66)
(306)
(678)
467
(169)
(380)
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)
Finance
leases
$m
34
33
31
18
3
–
119
(17)
–
102
Finance
leases
$m
45
45
31
8
1
–
130
(22)
–
108
Total
$m
12,528
2,473
1,017
2,379
457
11,201
30,055
(6,423)
(922)
22,710
Total
$m
14,864
2,098
3,050
1,195
2,281
17,075
40,563
(6,152)
(4,156)
30,255
178
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 25 Financial risk management objectives and policies continued
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
Bank
overdrafts
and other
loans
$m
851
–
–
–
–
–
851
(2)
–
849
Trade
and other
payables
$m
Total
non-derivative
financial
instruments
$m
11,701
13,186
1,522
1,110
1,277
2,187
5,313
23,110
–
(3,990)
19,120
3,881
2,997
2,731
4,214
19,505
46,514
(8,242)
(4,099)
34,173
Finance
leases
$m
66
41
22
10
2
–
141
(46)
–
95
Interest
rate swaps
$m
Cross-
currency
swaps
$m
Total
derivative
financial
instruments
$m
(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)
Bonds
$m
568
2,318
1,865
1,444
2,025
14,192
22,412
(8,194)
(109)
14,109
Total
$m
13,115
3,810
2,952
2,386
4,199
19,461
45,923
(7,974)
(4,222)
33,727
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 $6,411m of contingent consideration held within other payables at fair value (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 long-term debt entered into in 2007 in order to finance the acquisition of MedImmune and entered into in 2015 in
order to finance the acquisition of ZS Pharma has been held at fixed rates of interest. The Group uses interest rate swaps and forward rate
agreements to manage this mix.
At 31 December 2015, 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. The interest rate swap on the 2018 bond was entered into in 2015. No new interest rate swaps were entered
into during 2014 or 2013. At 31 December 2015, 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 144. 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, as at 31 December 2015, 31 December 2014 and 31 December
2013, 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
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
Fixed rate
$m
Floating rate
$m
30
7,376
7,406
–
–
–
1,758
1,212
2,970
15
9,217
9,232
2013
Total
$m
1,788
8,588
10,376
15
9,217
9,232
In addition to the financial assets above, there are $6,494m (2014: $7,576m; 2013: $7,772m) of other current and non-current asset investments
and other financial assets on which no interest is received.
179
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 25 Financial risk management objectives and policies continued
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 60% of Group external sales in 2015 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.
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. As at 31 December 2015, 3.4% of interest-bearing loans and borrowings were denominated in pound sterling and 5.4% of interest-
bearing loans and borrowings were denominated in euros. 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. Exchange
differences on foreign currency borrowings not designated in a hedge relationship are taken to profit.
During 2013, the Group entered into a cross-currency swap to convert the remaining un-hedged $250m of the 1.95% 2019 maturing bond into
fixed Japanese yen debt. This instrument was designated in a net investment hedge against the foreign currency risk of the Group’s Japanese
yen net assets. In 2014, $125m of the Japanese yen cross-currency swap was de-designated from the net investment hedge in order to maintain
hedge effectiveness.
Also in 2013, the Group entered into a cross-currency swap to convert $151m into fixed Chinese renminbi debt maturing in 2018. This instrument
was designated in a net investment hedge against the foreign currency risk of the Group’s Chinese 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 would be taken to profit.
Foreign currency risk arises where 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 $98m equivalent of local currency
cash, on which there have been delays in obtaining approval for remittance outside the country.
The official exchange rate for essential goods and services is VEF 6.3/$ as published by CENCOEX (the National Foreign Trade Center). However,
alternative exchange rates exist and these include the SICAD (Supplementary Foreign Currency Administration System) rate and the SIMADI
(Sistema Marginal de Divisas) rate, which was introduced in 2015. At 31 December 2015, the SICAD rate was VEF 13.5/$ (31 December 2014:
VEF 12.0/$) and the SIMADI rate was VEF 199.7/$.
For the period to 31 December 2015, the Group used the SICAD rate for the consolidation of the financial statements of the Venezuelan subsidiaries.
The Group believes that the SICAD rate represents the most appropriate rate for consolidation as it reflects their best expectation of the rate at
which profits will be remitted. Factors such as future uncertainty and significant delays experienced in remitting cash at the CENCOEX rate, as
well as management actions in dealing with the government to settle a portion of the overdue receivables at the SICAD rate were taken into account.
If the Group were to use 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 $163m on its total intercompany balances with the subsidiaries in Venezuela and
the local currency cash would be reduced to $7m 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
2015, with all other variables held constant. Based on the composition of our long-term debt portfolio as at 31 December 2015, a 1% increase
in interest rates would result in an additional $30m in interest expense being incurred per year. The exchange rate sensitivity analysis assumes
an instantaneous 10% change in foreign currency exchange rates from their levels at 31 December 2015, with all other variables held constant.
The +10% case assumes a 10% strengthening of the US dollar against all other currencies and the -10% case assumes a 10% weakening of
the US dollar.
180
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 25 Financial risk management objectives and policies continued
Each incremental 10% movement in foreign currency exchange rates would have approximately the same effect as the initial 10% detailed in the
table below and each 1% change in interest rates would have approximately the same effect as the 1% detailed in the table below.
31 December 2013
Increase/(decrease) in fair value of financial instruments ($m)
Impact on profit: (loss)/gain ($m)
Impact on equity: gain/(loss) ($m)
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)
Interest rates
Exchange rates
-1%
(839)
–
–
+10%
(12)
(274)
262
-10%
12
274
(262)
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)
+1%
669
–
–
+1%
844
–
–
+1%
997
–
–
There has been no change in the methods and assumptions used in preparing the above sensitivity analysis over the three-year period.
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 84% of US sales (2014: three wholesalers accounted for approximately 75%;
2013: three wholesalers accounted for approximately 77%).
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
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
2013
$m
5,059
330
78
47
5,514
2013
$m
64
(5)
5
64
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.
181
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 25 Financial risk management objectives and policies continued
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 and short-term bank deposits.
The most significant concentration of financial credit risk at 31 December 2015 was $4,389m 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.
At 31 December 2015, the Group had investments of $1,050m (2014: $300m; 2013: $nil) 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 2015 was $1,098m (2014: $316m; 2013: $nil).
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 2015 was $451m
(2014: $457m; 2013: $326m).
26 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
2015
2014
2013
7,100
14,800
17,500
20,700
60,100
7,200
13,800
16,800
18,100
55,900
7,200
14,000
14,600
15,800
51,600
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 2015 was 61,500 (2014: 57,500; 2013: 51,500).
The costs incurred during the year in respect of these employees were:
Salaries
Social security costs
Pension costs
Other employment costs
2015
$m
4,603
567
484
474
6,128
2014
$m
4,657
664
459
499
6,279
2013
$m
3,833
622
445
376
5,276
Severance costs of $338m are not included above (2014: $254m; 2013: $652m).
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.
182
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 26 Employee costs and share plans for employees continued
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 Company also 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 in respect of Partnership Shares, the first award of which was made in 2011. 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 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.
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 93 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.
Share plans
The charge for share-based payments in respect of share plans is $211m (2014: $178m; 2013: $156m). The plans are equity settled.
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 close
period of the Company. The first grant of awards was made in June 2005. 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. There were no grants of awards under this plan in 2015. The plan has been replaced by the AstraZeneca 2014 Performance
Share Plan. Further details of this plan can be found in the Directors’ Remuneration Report from page 103.
Shares awarded in June 2013
Shares awarded in August 2013
Shares awarded in November 2013
Shares awarded in February 2014
Shares awarded in March 2014
1 Weighted average fair value.
Shares
’000
2,867
197
30
37
2,368
WAFV1
pence
1649
1649
1649
n/a
1952
WAFV1
$
25.73
25.12
26.38
30.55
32.34
183
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 26 Employee costs and share plans for employees continued
The AstraZeneca 2014 Performance Share Plan
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 close 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 to all participants in 2015, 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 2015 under the plan was in March with further grants in June, August, September and November.
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
‘000
12
141
40
2
2,223
36
152
8
7
WAFV
pence
2133
2156
2250
n/a
2381
2087
2123
n/a
2178
WAFV
$
35.75
35.79
n/a
36.62
35.29
33.05
33.21
32.32
33.31
The AstraZeneca Investment Plan
This plan was introduced in 2010 and approved by shareholders at the 2010 AGM. The main grant of awards in 2015 under the plan was in
March, with a further, smaller grant in August. 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 2015, 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 June 2013
Shares awarded in August 2013
Shares awarded in March 2014
Shares awarded in September 2014
Shares awarded in March 2015
Shares awarded in August 2015
Shares
’000
157
8
67
7
64
4
WAFV
pence
3297
3302
3904
4499
4762
n/a
WAFV
$
51.45
n/a
64.68
n/a
70.58
66.42
The AstraZeneca Global Restricted Stock Plan
This plan was introduced in 2010. The main grant of awards in 2015 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 2013
Shares awarded in June 2013
Shares awarded in August 2013
Shares awarded in March 2014
Shares awarded in August 2014
Shares awarded in March 2015
Shares awarded in August 2015
Shares
’000
1,417
986
13
2,076
25
1,966
17
WAFV
pence
3254
3297
3206
3904
4312
4762
4245
WAFV
$
49.42
51.45
50.23
64.68
71.57
70.58
66.42
184
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 26 Employee costs and share plans for employees continued
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 five times in 2015 to make awards to 365 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 2013
Shares awarded in March 2013
Shares awarded in June 2013
Shares awarded in August 2013
Shares awarded in September 2013
Shares awarded in November 2013
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
’000
2
144
25
119
85
739
115
155
134
72
64
9
164
69
31
41
41
WAFV
pence
3125
n/a
n/a
3302
n/a
3297
4042
n/a
4265
4312
4499
4672
4762
4174
4245
4199
4355
WAFV
$
n/a
49.23
51.45
50.23
49.21
52.76
61.10
64.68
71.50
71.57
74.05
73.23
70.58
66.09
66.42
64.64
66.62
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.
185
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 27 Commitments and contingent liabilities
2015
$m
2014
$m
2013
$m
Commitments
Contracts placed for future capital expenditure on property, plant and equipment and software development costs not
provided for in these accounts
518
438
481
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
8,818
4,754
Under 1 year
$m
Years 1 and 2
$m
Years 3 and 4
$m
428
3
1,464
279
1,952
1,270
Years 5
and greater
$m
4,974
3,202
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 2015.
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 212, 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.
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 2013, 2014 or 2015.
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 15 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 33 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 2015 in the aggregate of $67m (2014: $84m; 2013: $87m), 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 $71m and $119m (2014: $50m and $80m; 2013: $50m
and $90m), which relates mainly to the US.
186
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 27 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 27, 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 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 2015, 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 litigation
In September and October 2015,
AstraZeneca received Paragraph IV notices
challenging patents listed in the FDA Orange
Book with reference to Brilinta. AstraZeneca
has received notice from 15 companies that
each submitted an ANDA seeking to market
ticagrelor. In October and November 2015,
in the US District Court for the District of
Delaware, AstraZeneca filed patent
infringement lawsuits in response to these
Paragraph IV notices from the ANDA filers.
Litigation is at an early stage and no trial
dates have been set.
Byetta (exenatide)
US patent litigation
In December 2014, AstraZeneca commenced
patent litigation in response to a Paragraph IV
notice from Teva Pharmaceuticals USA, Inc.
(Teva). Trial is scheduled for December 2016
in the US District Court for the District of
Delaware (the District Court). In December
2015, AstraZeneca commenced patent
litigation in response to a Paragraph IV notice
from Amneal Pharmaceuticals LLC (Amneal)
in the District Court. The Amneal proceedings
are at an early stage and no trial date has
been set.
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 alleges invalidity of the patents.
In December 2015, AstraZeneca filed an
answer including counterclaims that Sanofi’s
proposed lixisenatide product would infringe
several AstraZeneca patents. Certain
patents-at-issue are listed in the FDA Orange
Book with reference to Byetta. Proceedings
are in the early stages in the US District Court
for the District of Delaware. No trial date has
been set in the proceedings against Sanofi.
Separately, in December 2015, Sanofi filed
petitions in the US Patent Trial and Appeals
Board for inter partes review of certain
patents that are also at issue in the above-
referenced District Court litigation against
Sanofi. Proceedings are at an early stage.
187
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 27 Commitments and contingent
liabilities continued
Crestor (rosuvastatin calcium)
US patent litigation
AstraZeneca is defending three patent
infringement lawsuits in the US District Court
for the District of South Carolina (the District
Court) which, among other things, claim
that AstraZeneca’s Crestor sales induce
infringement of the plaintiffs’ patents. The first
was filed in April 2011 by plaintiff Palmetto
Pharmaceuticals, LLC (Palmetto), and the other
two, which have been consolidated, were
filed in July and December 2013 by co-
plaintiffs Medical University of South Carolina
Foundation for Research Development and
Charleston Medical Therapeutics, Inc. In
December 2015, the District Court issued
an order dismissing the first of these cases,
filed by Palmetto, and entered judgment
in AstraZeneca’s favour. In January 2015,
Palmetto filed notice that it intends to appeal.
Patent proceedings outside the US
In Australia, in 2011 and 2012, AstraZeneca
instituted proceedings against Actavis
Australia Pty Ltd, Apotex Pty Ltd and Watson
Pharma Pty Ltd asserting infringement of
three formulation and method patents for
Crestor. AstraZeneca was unsuccessful in
defending the validity of these patents, at trial
and on appeal. This patent litigation concluded
in September 2015 when the High Court
of Australia dismissed an appeal filed by
AstraZeneca. Relevant parties could pursue
damages claims against AstraZeneca.
A provision has been taken in respect of
generic entities which were prevented by
court order from launching their products in
Australia before AstraZeneca’s patents were
subsequently found invalid.
In Japan, in 2014, Teva Pharma Japan Inc.
(Teva) filed a patent invalidation request with
the Japanese Patent Office (JPO) in relation to
the Crestor substance patent. In June 2015,
the JPO dismissed Teva’s request. Teva
appealed the decision but subsequently
withdrew the appeal. A second invalidation
action relating to the same patent has been
filed by an individual.
In the Netherlands, in 2014, AstraZeneca
received a letter from Resolution Chemicals
Ltd. (Resolution) indicating that it had sought
marketing authorisation for a rosuvastatin zinc
product. In April 2014, AstraZeneca received
a writ of summons from Resolution alleging
partial invalidity and non-infringement of the
supplementary protection certificate (SPC)
related to the Crestor substance patent. 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
product does not infringe the SPC. AstraZeneca
appealed and the appeal was heard in
November 2015. A decision is expected in
the first quarter of 2016.
In the UK, in October 2015, Resolution
Chemicals Ltd., commenced an action
alleging partial invalidity and non-infringement
of the supplementary protection certificate
related to the Crestor substance patent.
AstraZeneca has responded.
Daliresp (roflumilast)
US patent litigation
In April 2015, AstraZeneca received
Paragraph IV notices challenging patents
listed in the FDA Orange Book with reference
to Daliresp. AstraZeneca has received notice
from 11 companies that each submitted an
ANDA seeking to market roflumilast. In May
2015 and subsequently, in the US District
Court for the District of New Jersey,
AstraZeneca filed patent infringement lawsuits
in response to these Paragraph IV notices
from the ANDA filers. Litigation is at an early
stage and no trial dates have been set.
Faslodex (fulvestrant)
US patent litigation
In 2014, 2015 and 2016, AstraZeneca filed
patent infringement lawsuits in the US District
Court in New Jersey 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. The first trial is expected
to be scheduled for the second half of 2016.
In September 2015, AstraZeneca also filed
a patent infringement lawsuit relating to one
of the seven Paragraph IV notices in the
US District Court in West Virginia which is
currently stayed by the West Virginia court.
Patent proceedings outside the US
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.
In Germany, in July 2015, AstraZeneca was
served with a nullity complaint by Hexal AG
(Hexal), commencing invalidity proceedings
before the Federal Patent Court, and requesting
revocation of the German part of the Faslodex
formulation use patent, European Patent
No. 1,250,138 (the ‘138 patent). In September
2015, AstraZeneca filed a request for a
provisional injunction against Hexal in the
Regional Court of Düsseldorf after Hexal
threatened to launch a generic Faslodex
product in the fourth quarter of 2015. The
provisional injunction request was denied in
November 2015. AstraZeneca filed an appeal
against this decision in November 2015. In
December 2015, AstraZeneca filed an
infringement suit against Hexal in the Regional
Court of Mannheim referring to their threatened
launch of a generic Faslodex product.
In October 2015, Hexal filed a notice of
opposition against European Patent No.
2,266,573 (the ‘573 Patent) granted in
June 2015. The ‘573 Patent is related
to the ‘138 patent referred to above.
Losec/Prilosec (omeprazole)
US patent litigation
In 2008, Apotex Inc. (Apotex) was found
to infringe AstraZeneca’s US Patent Nos.
4,786,505 and 4,853,230. In 2013, the US
District Court for the Southern District of
New York (the District Court) ordered Apotex to
pay $76 million in damages with an additional
sum of $28 million in pre-judgment interest,
and an unspecified amount of post-judgment
interest. Apotex appealed. In April 2015, the
US Court of Appeals for the Federal Circuit
affirmed the bulk of the damages award, with
the exception of a small portion of the award
which related to sales post patent expiration
during a portion of the paediatric exclusivity
period. In July 2015, the District Court ordered
Apotex to pay approximately $99m to
AstraZeneca. The proceeding is now closed
and AstraZeneca has recognised the income.
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 Canadian Patent No.
1,292,693. Apotex has appealed.
Movantik/Moventig (naloxegol)
US patent litigation
In October 2015, Neptune Generics LLC, an
affiliate of Gerchen Keller Capital LLC, filed for
inter partes review (IPR) with the US Patent
Office challenging the validity of one of the six
patents listed in the FDA Orange Book with
reference to Movantik. The IPR relates to
US Patent No. 7,786,133, which is licensed
to AstraZeneca from Nektar Therapeutics.
AstraZeneca is considering its response.
Patent proceedings outside the US
In Europe, in October 2014, Generics UK Ltd.
(trading as Mylan) filed an opposition to the
grant of European Patent No. 1,694,363.
This matter is scheduled for oral proceedings
on 25 February 2016.
Nexium (esomeprazole magnesium)
US patent litigation
In September 2015, AstraZeneca received
a Paragraph IV notice from Zydus
Pharmaceuticals (USA) Inc. and Cadila
Healthcare Ltd. (together, Zydus) challenging
certain patents listed in the FDA Orange Book
with reference to Nexium oral suspension.
Zydus submitted an ANDA seeking to market
esomeprazole magnesium oral suspension.
In October 2015, in response to Zydus’ notice,
AstraZeneca filed a patent infringement
lawsuit against Zydus in the US District Court
for the District of New Jersey (the District
Court). The Nexium oral suspension litigation
188
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 27 Commitments and contingent
liabilities continued
is at an early stage and no trial date has been
set. Separately, several Nexium and Nexium
24HR (OTC) patent litigations are ongoing in
the District Court. Proceedings are at various
stages and no trial dates have been set.
Following the District Court’s denial of Mylan
Pharmaceuticals, Inc.’s (Mylan) motion to
dismiss for lack of jurisdiction in 2014, Mylan
was granted the right to appeal that decision
to the US Court of Appeals for the Federal
Circuit and argument was heard on that
appeal in January 2016.
Patent proceedings outside the US
In Canada, in July 2014, the Federal Court
found Canadian Patent No. 2,139,653 invalid
and not infringed by Apotex Inc. On 6 July
2015, AstraZeneca’s appeal was dismissed.
AstraZeneca has sought leave to appeal to
the Supreme Court of Canada.
In Canada, in July 2014, AstraZeneca
received a notice of allegation from Teva
Canada Limited (Teva) alleging either that
Teva’s esomeprazole magnesium product
would not infringe the patents listed on
the Canadian Patent Register in relation
to Nexium or, alternatively, that certain of
the patents were invalid. AstraZeneca
commenced a proceeding in 2014, but has
now discontinued its application pursuant
to a settlement agreement.
In Canada, in July 2015, Pharmascience Inc.
commenced an action for damages allegedly
suffered during the period while it was unable
to launch its esomeprazole product due to
ongoing proceedings under the Patented
Medicines (Notice of Compliance) Regulations.
AstraZeneca is defending the claim.
Onglyza (saxagliptin) and Kombiglyze XR
(saxagliptin and metformin)
US patent litigation
Beginning April 2014 and continuing into 2015,
a number of generics companies sent notices
that they had submitted ANDAs for saxagliptin
hydrochloride 2.5mg and 5mg tablets
containing a Paragraph IV Certification
alleging that US Patent Nos. 7,951,400
(the ‘400 Patent) and RE44,186 (the ‘186
Patent), listed in the FDA Orange Book with
reference to Onglyza, are invalid, unenforceable
and/or will not be infringed by the products as
described in the ANDAs. Several of these
companies also sent notices that they had
submitted ANDAs for saxagliptin hydrochloride
and metformin 2.5mg/1000mg, 5mg/1000mg,
and 5mg/500mg tablets containing a
Paragraph IV Certification alleging that US
Patent Nos. 8,628,799 (the ‘799 Patent) and/
or the ‘186 Patent listed in the FDA Orange
Book with reference to Kombiglyze XR, are
invalid, unenforceable and/or will not be
infringed by the products as described in
the ANDAs. AstraZeneca initiated patent
infringement proceedings asserting the ‘400
Patent, the ‘186 Patent and the ‘799 Patent
in the US District Court for the District of
Delaware (District Court) against all of the
above-referenced patent challenges. The
District Court dismissed without prejudice
all claims and counterclaims with respect to
the ‘799 Patent and the ‘400 Patent.
In June 2015, Mylan filed a petition for an inter
partes review (IPR) with the US Patent and
Trademark Office (USPTO) challenging the
validity of the ‘186 Patent. In December 2015,
the USPTO declined to institute the IPR
(the December Decision). In January 2016,
Mylan filed a Request for Rehearing with
the USPTO seeking reconsideration of the
December Decision.
Pulmicort Respules (budesonide
inhalation suspension)
US patent litigation
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)
US patent litigation
In February 2015, AstraZeneca settled patent
infringement litigation against Pharmadax, Inc.
and Pharmadax USA, Inc. (together,
Pharmadax) that was pending in the US District
Court for the District of New Jersey by granting
Pharmadax a licence to the Seroquel XR
product patent effective from 1 November
2016, or earlier in certain circumstances.
In February 2015, AstraZeneca filed a patent
infringement lawsuit against Macleods
Pharmaceuticals, Ltd., Macleods Pharma USA,
Inc. and AB Pharmaceuticals, LLC. (together,
Macleods) in the US District Court for the District
of New Jersey. In June 2015, AstraZeneca
settled the patent infringement litigation by
granting Macleods a licence to the Seroquel XR
product patent effective from 1 November
2016, or earlier in certain circumstances.
Patent proceedings outside the US
In Canada, in April 2015, AstraZeneca and
Teva Canada Limited (Teva) entered into a
settlement agreement ending the ongoing
patent litigation between the parties, as well
as a claim for section 8 damages, and
allowing Teva to continue selling generic
Seroquel XR in Canada.
In Italy, in June 2015, following a challenge to
the validity of the formulation patent covering
Seroquel XR by Sandoz S.p.A. and Sandoz
A/S, the Court of Turin found the Seroquel XR
formulation patent invalid.
In Germany, generic entities have claimed,
or could claim, damages relating to the
preliminary injunction issued in April 2012
that prevented generic Seroquel XR sales by
those entities until the injunction was lifted
following a November 2012 Federal Patent
Court decision that held that the Seroquel XR
patent was invalid. A provision has been taken.
In France, in April 2015, Mylan SAS (Mylan)
brought a patent invalidation action against
AstraZeneca’s French designation of the
Seroquel XR formulation patent, European
Patent No. 0,907,364 (the ‘364 Patent).
AstraZeneca is defending that action and has
brought a claim against Mylan for infringement
of the ‘364 Patent. In the third quarter of 2015,
Mylan launched its generic Seroquel XR
product at-risk. In November 2015, AstraZeneca
obtained a preliminary injunction against
Mylan, which was overturned on appeal in
December 2015. AstraZeneca had a similar
litigation pending against Accord Healthcare
France SAS and Accord Healthcare Limited
that was settled in January 2016.
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. (the licensee
and patent holder, respectively), commenced
proceedings in relation to Canadian Patent
No. 2,449,098.
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 approximately 2,500 claims of
physical injury from treatment with Byetta and/or
Bydureon. The lawsuits allege multiple types
of injuries including pancreatitis, pancreatic
cancer, thyroid cancer, and kidney cancer. A
multi-district litigation has been 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 co-ordinated proceeding has
been established in Los Angeles, California in
regard to the various lawsuits in California
state courts.
189
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 27 Commitments and contingent
liabilities continued
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. The plaintiffs have
appealed that ruling. A similar motion was
granted in favour of the defendants in the
California state co-ordinated proceeding,
and judgment has not yet been entered.
Onglyza (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
physical injury from treatment with Onglyza.
The lawsuits allege injuries including pancreatic
cancer. The lawsuit that was pending claiming
congestive heart failure from treatment with
Onglyza has been dismissed.
A single case pending in Alabama state court
has been set for trial on 21 June 2016.
A motion for summary judgment is pending.
Crestor (rosuvastatin calcium)
AstraZeneca is defending a number of
lawsuits 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 co-ordinated proceeding in Los Angeles,
California. The claims of approximately 600
additional plaintiffs are waiting to be added
to the co-ordination. In October 2014, the
co-ordination judge dismissed the claims
of the non-California plaintiffs whose claims
were in the co-ordinated proceeding. The
plaintiffs have appealed the October 2014
order dismissing the non-California plaintiffs
from the proceeding. There are now
approximately 700 plaintiffs remaining with
claims pending in California state court.
The claims that were pending in the Eastern
District of Kentucky have been dismissed,
and the two plaintiffs involved are seeking
to have their claims reinstated in California.
Farxiga (dapagliflozin)
AstraZeneca has been named as one of
multiple defendants in a lawsuit filed in the
US District Court for the Western District
of Kentucky involving one plaintiff claiming
physical injury, including diabetic ketoacidosis
and kidney failure, from treatment with Farxiga.
Nexium (esomeprazole magnesium)
AstraZeneca has been defending product
liability lawsuits brought in 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 have appealed
the dismissal of their claims to the US Court
of Appeals for the Ninth Circuit, and fewer
than 40 plaintiffs have appealed the dismissal
of their claims to the California Second
Appellate Division.
Seroquel IR (quetiapine fumarate)
With regard to the Seroquel product liability
litigation in the US, AstraZeneca is currently
defending one case in active litigation involving
a single plaintiff.
With regard to insurance coverage for the legal
defence costs and settlements that have been
incurred in connection with the Seroquel IR
product liability claims in the US related to
alleged diabetes and/or other related alleged
injuries, all disputes with insurers have now
been settled.
Commercial litigation
Crestor (rosuvastatin calcium)
Qui tam litigation
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 disposition or earlier
resolution of the Texas Attorney General
litigation involving Crestor disclosed below.
Texas Attorney General litigation
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 November 2012, a Motion to Certify a Claim
as a Class Action and Statement of Claim were
filed in Israel in the District Court in Tel Aviv,
Jaffa, 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 a Claim as a Class Action and
Statement of Claim containing similar
allegations to those in the first action were
filed in the same court against the same
defendants. The court has not yet ruled on
the Motion to Certify.
Nexium (esomeprazole magnesium)
Consumer litigation
AstraZeneca is a defendant in a class action
filed in Delaware State Court alleging that
AstraZeneca’s promotion, advertising and
pricing of Nexium to physicians, consumers
and third party payers was unfair, unlawful
and deceptive. This action is the last of a
number of similar, previously resolved lawsuits.
In July 2015, the court granted AstraZeneca’s
motion to dismiss and entered judgment
in AstraZeneca’s favour. The plaintiffs are
appealing to the Delaware Supreme Court.
Settlement anti-trust litigation
AstraZeneca is a defendant in a multi-district
litigation class action and individual lawsuit
alleging that AstraZeneca’s settlements of
certain patent litigation in the US relating to
Nexium violated US anti-trust 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.
Following the court’s denial of plaintiffs’
motion for a new trial and preliminary
injunction, the court entered judgment in
favour of AstraZeneca in September 2015.
The plaintiffs have appealed that judgment.
Nexium/Prilosec trademark litigation
AstraZeneca filed separate complaints in the
US District Court for the District of Delaware
(the Delaware District Court) against
Camber Pharmaceuticals, Inc. (Camber)
and Dr. Reddy’s Laboratories, Inc. (Dr. Reddy’s)
to enforce certain AstraZeneca trademark
rights related to Nexium and Prilosec.
Dr. Reddy’s has filed its own separate claims
against AstraZeneca in both the Delaware
District Court and the US District Court for
the District of New Jersey. The Delaware
District Court has issued preliminary injunctions
against Camber’s and Dr. Reddy’s sales of
generic esomeprazole magnesium in purple
capsules. Dr. Reddy’s has appealed the
decision of the Delaware District Court to the
US Court of Appeals for the Third Circuit, and
the appeal is pending. All cases related to this
matter have been stayed pending this appeal.
Seroquel IR (quetiapine fumarate) and
Seroquel XR (quetiapine fumarate)
In relation to the state law claims brought by
state Attorneys General generally alleging that
AstraZeneca made false and/or misleading
statements in marketing and promoting
Seroquel, AstraZeneca remains in litigation
with the Attorney General of Mississippi.
190
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 27 Commitments and contingent
liabilities continued
Qui tam litigation in New York
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 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 Seroquel
off-label and provided unlawful remuneration
to physicians in connection with the promotion
of Seroquel. The DOJ and all US states have
declined 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.
Texas Attorney General litigation
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.
Synagis (palivizumab)
In September 2011, MedImmune filed an
action against AbbVie, Inc. (AbbVie) (formerly
Abbott International, LLC) in the Circuit Court
of Montgomery County, Maryland, seeking
a declaratory judgment in a contract dispute.
AbbVie’s motion to dismiss was granted.
In September 2011, AbbVie filed a parallel action
against MedImmune in Illinois State Court
and trial began in August 2015. In September
2015, a jury returned a verdict in favour of
AbbVie and awarded AbbVie damages in
the amount of approximately $94 million.
In December 2015, MedImmune and AbbVie
reached a settlement of this matter bringing
this litigation to a conclusion.
Toprol-XL (metoprolol succinate)
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. The complaint is very
similar to prior class action complaints filed by
private parties against AstraZeneca relating to
Toprol-XL in 2006 and resolved by settlement
in 2012. The State seeks an unspecified amount
of trebled damages and pre-judgment interest.
Other commercial litigation
Average Manufacturer’s Price qui tam
litigation (Streck)
AstraZeneca was one of several manufacturers
named as a defendant in a lawsuit filed in
the US Federal Court in Philadelphia under
the qui tam (whistleblower) provisions of the
federal and certain state False Claims Acts
alleging inaccurate reporting of Average
Manufacturer’s prices to the Centers for
Medicare and Medicaid Services. The action
was initially filed in October 2008 but
remained under seal until May 2011. In July
2015, AstraZeneca agreed upon a negotiated
settlement to resolve the dispute. This matter
is now concluded.
Medco qui tam litigation (Schumann)
AstraZeneca had been named as a
defendant in a lawsuit filed in the Federal Court
in Philadelphia (the Federal Court) under
the qui tam (whistleblower) provisions of the
federal and certain state False Claims Acts
alleging overpayments by federal and state
governments resulting from alleged false
pricing information reported to the government
and alleged improper payments intended
to influence the formulary status of Prilosec
and Nexium to Medco and its customers.
In January 2013, the Federal Court granted
AstraZeneca’s motion and dismissed the
case with prejudice. The plaintiff appealed.
In October 2014, the US Court of Appeals
for the Third Circuit affirmed the Federal
Court’s decision to dismiss AstraZeneca
from the litigation with prejudice. The matter
is now concluded.
Ocimum Lawsuit
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.
Government investigations/proceedings
Crestor (rosuvastatin calcium)
The DOJ and all US states have declined
to intervene in the civil component of an
investigation regarding Crestor. Prior to
September 2015, one additional component of
the investigation remained. In September 2015,
AstraZeneca was informed that the additional
component of the investigation has been
closed, bringing this matter to a conclusion.
Synagis (palivizumab)
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 co-operating
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
co-ordinated with the Florida government to
provide the appropriate responses and
co-operate 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 inquiries from the State of New
York and DOJ (which are 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
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.
AstraZeneca is co-operating with these
inquiries. AstraZeneca’s investigation has
involved indications of inappropriate conduct in
certain countries, including China. Resolution
of these matters could involve the payment of
fines and/or other remedies.
Good Manufacturing Practices subpoena
In March 2013, AstraZeneca received a
subpoena duces tecum from the US Attorney’s
Office in Boston seeking documents and
information relating to products manufactured
or packaged at AstraZeneca’s Macclesfield
facility in the UK. AstraZeneca co-operated
with this inquiry which is now closed.
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.
191
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 27 Commitments and contingent
liabilities continued
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.
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 $361m,
a decrease of $234m compared to 2014
mainly due to releases following tax authority
agreement and exchange rate effects.
AstraZeneca faces a number of transfer
pricing 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. The international
tax environment presents increasingly
challenging dynamics for the resolution of
transfer pricing disputes. These disputes
usually result in taxable profits being increased
in one territory and correspondingly decreased
in another. Our balance sheet positions for
these matters reflect appropriate corresponding
relief in the territories affected. Management
considers that at present such corresponding
relief will be available, but given the challenges
in the international tax environment will keep
this aspect under careful review.
Management continues to believe that
AstraZeneca’s positions on all its transfer
pricing audits and disputes are robust and
that AstraZeneca is appropriately provided.
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 $1,373m relating
to a number of other tax contingencies,
a decrease of $307m mainly due to releases
following expiry of statute of limitations 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.
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
$357m (2014: $521m; 2013: $529m), however,
management believes that it is unlikely that
these additional losses will arise. It is possible
that some of these contingencies may reduce
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 $174m
(2014: $227m; 2013: $344m). Interest is
accrued as a tax expense.
28 Operating leases
Total rentals under operating leases charged to profit were as follows:
Operating leases
2015
$m
185
2014
$m
185
2013
$m
188
The future minimum lease payments under operating leases that have initial or remaining terms in excess of one year at 31 December 2015 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
29 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
Tax advisory services
Other assurance services
Corporate finance services
Fees payable to KPMG LLP in respect of the Group’s pension schemes:
The audit of subsidiaries’ pension schemes
1 2015 and 2014 fees payable to KPMG LLP (2013: Fees payable to KPMG Audit Plc).
2015
$m
95
245
69
409
2015
$m
3.2
5.4
2.5
0.1
–
0.5
–
0.6
12.31
2014
$m
100
247
91
438
2014
$m
2.5
5.0
2.5
0.3
–
0.5
–
0.5
11.31
2013
$m
92
248
110
450
2013
$m
2.2
5.0
2.6
0.6
–
0.6
0.5
0.4
11.91
Audit-related assurance services include fees of $1.8m (2014: $1.8m; 2013: $1.7m) in respect of section 404 of the Sarbanes-Oxley Act.
192
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements 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
Termination benefits
Share-based payments
2015
$’000
29,265
2,636
–
17,885
49,786
2014
$’000
30,252
2,265
–
20,253
52,770
2013
$’000
25,029
2,323
3,855
16,509
47,716
Total remuneration is included within employee costs (see Note 26). Further details of Directors’ emoluments are included in the Directors’
Remuneration Report from pages 103 to 134.
30 Subsequent events
On 2 February 2016, AstraZeneca completed an agreement to invest in a majority equity stake in Acerta Pharma B.V. (Acerta), 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.
Under the terms of the agreement, AstraZeneca has acquired 55% of the issued share capital of Acerta 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 shareholders
to sell, and AstraZeneca to buy, the remaining 45% of shares in Acerta. 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. Acerta has approximately 150 employees.
AstraZeneca’s 55% holding is a controlling interest and Acerta’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. Acerta’s results
and net assets will be consolidated into the Company’s results from 2 February 2016.
Given the close proximity of the completion of the transaction to the date the Financial Statements were approved, the accounting entries for this
transaction have not yet been determined. Our provisional assessment of the fair values of the assets and liabilities acquired will be completed
in 2016.
193
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements Group Subsidiaries and Holdings
In accordance with Section 409 of the Companies Act 2006 a full list of subsidiaries, partnerships, associates and joint ventures, the country of
incorporation and the effective percentage of equity owned as at 31 December 2015 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. Products are manufactured in 17 countries worldwide and
are sold in over 100 countries. The Group Financial Statements consolidate the Financial Statements of the Company and its subsidiaries at
31 December 2015.
At 31 December 2015
Wholly owned subsidiaries
Aktiebolaget Hässle
AlphaCore Pharma Limited
AlphaCore Pharma, LLC1
Amylin Ohio LLC1
Amylin Pharmaceuticals LLC1
Ardea Biosciences Limited
Ardea Biosciences, Inc.
Arrow Therapeutics Limited
Astra Alpha Produtos Farmaceuticos Lda
Astra Export & Trading Aktiebolag
Astra Läkemedel Aktiebolag
Country
Sweden
England
United States
United States
United States
England
United States
England
Portugal
Sweden
Sweden
Astra Pharmaceuticals (Pty) Limited
South Africa
Astra Pharmaceuticals Limited
Astra Tech International Aktiebolag
AstraPharm2
AstraZeneca A/S
AstraZeneca do Brasil Limitada
AstraZeneca (Thailand) Limited
AstraZeneca (Wuxi) Trading Co. Ltd
AstraZeneca AB
AstraZeneca AG
AstraZeneca AS
AstraZeneca Asia-Pacific Business
Services SDN BHD
AstraZeneca B.V.
AstraZeneca Biotech AB
AstraZeneca BioVentureHub AB
AstraZeneca Bulgaria EOOD
England
Sweden
England
Denmark
Brazil
Thailand
China
Sweden
Switzerland
Norway
Malaysia
Netherlands
Sweden
Sweden
Bulgaria
AstraZeneca CAMCAR Costa Rica, S.A.
Costa Rica
AstraZeneca CAMCAR, S.A.
AstraZeneca Canada Inc.3
AstraZeneca China UK Limited
Panama
Canada
England
AstraZeneca Collaboration Ventures LLC1
United States
AstraZeneca Colombia S.A.
AstraZeneca Continent B.V.
Colombia
Netherlands
AstraZeneca Czech Republic, s.r.o.
Czech Republic
AstraZeneca d.o.o.
Croatia
AstraZeneca Death In Service Trustee Limited
England
AstraZeneca Dunkerque Production SCS
AstraZeneca Eesti OÜ
AstraZeneca Egypt for
Pharmaceutical Industries JSC
AstraZeneca Egypt for Trading LLC
France
Estonia
Egypt
Egypt
AstraZeneca Employee Share Trust Limited
England
AstraZeneca Farmaceutica Chile Limitada
Chile
AstraZeneca Farmaceutica Holding Spain, S.A. Spain
AstraZeneca Farmaceutica Spain S.A.
Spain
AstraZeneca Finance Coöperatief WA
Netherlands
AstraZeneca Finance Limited
AstraZeneca Finance S.A.S.
AstraZeneca FZ-LLC
AstraZeneca Gamma B.V.
England
France
United Arab Emirates
Netherlands
194
AstraZeneca Annual Report and Form 20-F Information 2015
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
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
At 31 December 2015
AstraZeneca GmbH
AstraZeneca Health Care S.A. de C.V.
AstraZeneca Holding Aktiebolag4
AstraZeneca Holding France S.A.S.
AstraZeneca Holding GmbH
AstraZeneca Holdings B.V.
AstraZeneca Holdings Pty Limited
AstraZeneca Hong Kong Limited
Country
Germany
Mexico
Sweden
France
Germany
Netherlands
Australia
Hong Kong
AstraZeneca Ilac Sanayi ve Ticaret Limited Sirketi Turkey
AstraZeneca India Private Limited5
AstraZeneca Industries, LLC
AstraZeneca Insurance Company Limited
AstraZeneca Intermediate Holdings Limited4
India
Russia
England
England
AstraZeneca International Holdings Aktiebolag2 Sweden
AstraZeneca Investment (China) Co., Ltd
AstraZeneca Investments Limited
AstraZeneca Israel Ltd
AstraZeneca Japan Limited
AstraZeneca Jota B.V.
AstraZeneca K.K.
AstraZeneca Kft
AstraZeneca Korea Co. Ltd
AstraZeneca Latvija SIA
AstraZeneca Lietuva UAB
AstraZeneca Limited
AstraZeneca Luxembourg S.A.
AstraZeneca Maroc SARLAU
AstraZeneca Nigeria Limited
AstraZeneca Nominees Limited
AstraZeneca Nordic AB
AstraZeneca Österreich GmbH
AstraZeneca OY.
AstraZeneca Peru S.A.
AstraZeneca Pharma Poland Sp.z.o.o.
AstraZeneca Pharma S.R.L.
China
England
Israel
England
Netherlands
Japan
Hungary
Republic of Korea
Latvia
Lithuania
New Zealand
Luxembourg
Morocco
Nigeria
England
Sweden
Austria
Finland
Peru
Poland
Romania
AstraZeneca Pharmaceutical (China) Co. Ltd
China
AstraZeneca Pharmaceuticals (Phils.) Inc.
Philippines
AstraZeneca Pharmaceuticals (Pty) Limited
South Africa
AstraZeneca Pharmaceuticals Aktiebolag
Sweden
AstraZeneca Pharmaceuticals Co., Limited.
China
AstraZeneca Pharmaceuticals Ireland Limited
Ireland
AstraZeneca Pharmaceuticals Limited
AstraZeneca Pharmaceuticals, LLC
Kenya
Russia
AstraZeneca Pharmaceuticals
Pakistan (Private) Limited
AstraZeneca Pharmaceuticals, LP6
AstraZeneca Produtos Farmaceuticos Lda
AstraZeneca PTY Limited
AstraZeneca Quest Limited
AstraZeneca Reims S.A.S.
AstraZeneca Rho B.V.
AstraZeneca S.A.
AstraZeneca S.A.
Pakistan
United States
Portugal
Australia
England
France
Netherlands
Greece
Chile
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
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
Financial Statements At 31 December 2015
AstraZeneca S.A.
AstraZeneca S.A. / N.V.
AstraZeneca S.A.S.
AstraZeneca S.A.3
AstraZeneca Sdn Bhd
AstraZeneca Share Trust Limited
AstraZeneca Sigma B.V.
AstraZeneca Singapore Pte Limited
AstraZeneca Södertalje 1 AB
AstraZeneca Södertalje 2 AB
AstraZeneca SpA
AstraZeneca Sweden Investments Limited
AstraZeneca Taiwan Limited3
AstraZeneca Treasury Limited2
AstraZeneca Tunisie SaRL
AstraZeneca UK Limited
AstraZeneca Ukraina LLC
AstraZeneca US Investments Limited4
Country
Argentina
Belgium
France
Uruguay
Malaysia
England
Netherlands
Singapore
Sweden
Sweden
Italy
England
Taiwan
England
Tunisia
England
Ukraine
England
AstraZeneca Venezuela S.A.
AstraZeneca Zeta B.V.
AstraZeneca, LP6
AstraZeneca, S.A. de C.V.
Atkemix Nine Inc.
Atkemix Ten Inc.
Ayzee 1 Limited
AYZEE 2 Limited
AYZEE 3 Limited
AYZEE 4 Limited
AZ Reinsurance Limited
AZENCO2 Limited
AZLP Holdings LLC1
AZ-Mont Insurance Company
BMS Holdco Inc.
Bolivarian Republic
of Venezuela
Netherlands
United States
Mexico
United States
United States
England
England
England
England
Cayman Islands
England
United States
United States
United States
Cambridge Antibody Technology Group Limited England
Corpus Christi Holdings Inc.
Cresco Ti Systems GmbH
Definiens AG
Definiens Inc.
Drimex LLC
Entasis Therapeutics Inc.
Entasis Therapeutics Limited7
Gotland Pharma S.A.
IPR Pharmaceuticals, Inc.
KuDOS Horsham Limited
KuDOS Pharmaceuticals Limited
Laboratorio Beta, S.A.
Laboratorio Icaro S.A.
Laboratorio Lailan, S.A.
Laboratorio Odin, S.A.
Laboratorio Tau S.A.
MedImmune Biologics Inc.
MedImmune Limited
MedImmune Pharma B.V.
MedImmune U.K. Limited
MedImmune Ventures, Inc.
MedImmune, LLC1
Meronem Group Limited
United States
Germany
Germany
United States
Egypt
United States
England
Bolivarian Republic
of Venezuela
Puerto Rico
England
England
Spain
Spain
Spain
Spain
Spain
United States
England
Netherlands
England
United States
United States
England
Novastra Promoção e Comércio Farmacêutico LdaPortugal
Novastuart Produtos Farmaceuticos Lda
Portugal
Omthera Pharmaceuticals Inc.
Optein, Inc.
Pearl Therapeutics, Inc.
United States
United States
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
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
At 31 December 2015
Pharmaceutical Manufacturing
Company Pty Limited
Pharmaceutical Manufacturing
Division Pty Limited
Simesa SpA
Sofotec GmbH
Spirogen Sarl2
Country
Australia
Australia
Italy
Germany
Switzerland
Stauffer Management Company LLC1
United States
Stuart-Produtos Farmacêuticos Lda
Stuart Pharma Aktiebolag
Symbicom Aktiebolag2
Tika Läkemedel Aktiebolag
Zenco (No 8) Limited
Portugal
Sweden
Sweden
Sweden
England
Zeneca Epsilon – Produtos Farmacêuticos Lda Portugal
Zeneca Finance (Netherlands) Company
England
Zeneca Holdings Inc.
United States
Zeneca Ilac Sanayi Ve Ticaret Anonim Sirketi
Turkey
Zeneca Inc.
Zeneca Wilmington Inc.4
United States
United States
Zenecapharma Produtos Farmaceuticos Lda
Portugal
ZS Pharma Inc.
United States
Subsidiaries where the effective interest is less than 100%
AstraZeneca Pharma India Limited5
I.C. Insurance Holdings Limited
P.T. AstraZeneca Indonesia
SPA AstraZeneca Al Djazair8
Joint ventures
Archigen Biotech Limited8
Centus Biotherapeutics Limited8
India
England
Indonesia
Algeria
England
England
Montrose Chemical Corporation of California
United States
Significant holdings
Albireo Limited9
C.C.Global Chemicals Company
Other holdings
ADC Therapeutics Sàrl10
Adherium Limited
Affinita Biotech, Inc.11
Armaron Bio Pty Ltd12
BlinkBio Inc.12
Catabasis Pharmaceuticals, Inc.
Cerapedics, Inc.13
Elusys Therapeutics, Inc.14
Fibrogen, Inc.
G1 Therapeutics, Inc.15
Hydra Biosciences Inc.
Inotek Pharmaceuticals Corporation
Moderna Therapeutics Inc.16
PhaseBio Pharmaceuticals, Inc.13
Regulus Therapeutics Inc.
Silence Therapeutics PLC
VentiRx Pharmaceuticals, Inc.17
England
United States
Switzerland
New Zealand
United States
Australia
United States
United States
United States
United States
United States
United States
United States
United States
United States
United States
United States
England
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
75
51
95
65.77
50
50
50
23.5
37.5
8.84
5.6
16.22
17.43
18.49
10.7
8.61
7.2
1.8
18.03
4.27
7.3
7
14.5
6.7
0.17
12
1 Ownership held as membership interest.
2 Ownership held in class A and B shares.
3 Ownership held in ordinary and special shares.
4 Directly held by AstraZeneca PLC.
5 Accounting year end is 31 March.
6 Ownership held as partnership interest.
7 Ownership held in preference, deferred and ordinary shares.
8 Ownership held in class A shares.
9 Ownership held in class A voting preference shares, class A non-voting preference shares,
and class B voting preference shares.
10 Ownership held in class B ordinary shares and class C ordinary shares.
11 Ownership held in class A voting and class A non-voting shares.
12 Ownership held in class B preference shares.
13 Ownership held in class C preference shares.
14 Ownership held in class D preference shares.
15 Ownership held in class A preference shares and class B preference shares.
16 Ownership held in class D preference shares and class E preference shares.
17 Ownership held in class A preference shares.
195
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements Independent Auditor’s Report to the Members of
AstraZeneca PLC only
Opinions and conclusions arising
from our audit
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 2015 set
out on pages 197 to 201. 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 2015
> 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 2015.
Scope and responsibilities
As explained more fully in the Directors’
Responsibilities Statement set out on page
135, 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
4 February 2016
196
AstraZeneca Annual Report and Form 20-F Information 2015
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
2015
$m
2014
$m
1
30,047
27,426
2
3
3
3
4
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
15
7,303
7,318
(1,467)
(912)
(2,379)
4,939
32,365
(283)
(7,889)
(8,172)
24,193
316
4,261
153
2,754
16,709
24,193
The Company Financial Statements from page 197 to 201 were approved by the Board on 4 February 2016 and were signed on its behalf by
Pascal Soriot
Director
Marc Dunoyer
Director
Company’s registered number 2723534
197
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements
Statement of Changes in Equity
for the year ended 31 December
At 1 January 2014
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 2014
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
Share
capital
$m
315
Share
premium
account
$m
3,983
Capital
redemption
reserve
$m
153
Other
reserves
$m
2,847
Profit and
loss account
$m
17,656
–
–
–
–
–
1
1
316
–
–
–
–
–
–
–
–
–
–
–
–
278
278
4,261
–
–
–
–
–
43
43
–
–
–
–
–
–
–
–
–
–
–
(93)
–
(93)
153
2,754
–
–
–
–
–
–
–
–
–
–
–
(131)
–
(131)
2,623
316
4,304
153
Total
equity
$m
24,954
2,584
1
2,585
(3,532)
(93)
279
(3,346)
24,193
1,974
1
1,975
2,584
1
2,585
(3,532)
–
–
(3,532)
16,709
1,974
1
1,975
(3,537)
(3,537)
–
–
(3,537)
15,147
(131)
43
(3,625)
22,543
At 31 December 2015, $15,147m (31 December 2014: $16,709m) of the profit and loss account reserve was available for distribution. Included
in other reserves is a special reserve of $157m, arising on the redenomination of share capital in 1999.
Included within other reserves at 31 December 2015 is $782m (31 December 2014: $913m) in respect of cumulative share-based payment awards.
These amounts are not available for distribution.
198
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements Company Accounting Policies
Basis of presentation of
financial information
These financial statements were prepared in
accordance with FRS 101 ‘Reduced Disclosure
Framework’. The amendments to FRS 101
(2014/15 Cycle) issued in July 2015 and
effective immediately have been applied.
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 the transition to FRS 101, the Company has
applied IFRS 1 while ensuring that its assets
and liabilities are measured in compliance
with FRS 101. On transition to IFRS no GAAP
differences arose.
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 140 to 195) 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,
modified to include revaluation to fair value
of certain financial instruments as described
below, in accordance with the Companies
Act 2006. The Group Financial Statements
are presented on pages 140 to 195 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 144 to 148.
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.
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. 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.
199
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements Notes to the Company Financial Statements
1 Fixed asset investments
At 1 January 2015
Additions
Disposals
Capital reimbursement
Exchange
Amortisation
At 31 December 2015
A list of subsidiaries is included on pages 194 and 195.
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
5.125% Non-callable bond
Amounts due after more than one year
Amounts owed to subsidiaries
7.2% Loan
Interest-bearing loans and borrowings
5.9% Callable bond
Floating rate notes
1.75% Callable bond
1.95% Callable bond
2.375% Callable bond
0.875% Non-callable bond
3.375% Callable bond
5.75% Non-callable bond
6.45% Callable bond
4% Callable bond
4.375% Callable bond
All loans and borrowings are unsecured.
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
Shares
$m
16,186
–
–
(133)
–
–
Investments in subsidiaries
Loans
$m
11,240
5,934
(3,069)
–
(116)
5
Total
$m
27,426
5,934
(3,069)
(133)
(116)
5
16,053
13,994
30,047
Repayment
dates
euros
2015
US dollars
US dollars
US dollars
US dollars
US dollars
US dollars
euros
US dollars
pounds sterling
US dollars
US dollars
US dollars
2023
2017
2018
2018
2019
2020
2021
2025
2031
2037
2042
2045
2015
$m
679
128
7
814
2015
$m
–
–
283
1,747
399
997
997
1,586
812
1,971
515
2,719
986
976
13,705
2015
$m
8,262
3,979
1,747
–
13,988
2014
$m
1,309
150
8
1,467
2014
$m
912
912
283
1,747
–
–
996
–
902
–
540
2,718
986
–
7,889
2014
$m
5,429
2,743
–
912
9,084
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.
200
AstraZeneca Annual Report and Form 20-F Information 2015
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
Byetta and Farxiga product liability litigations, each of which are described more fully in Note 27 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. AstraZeneca is co-operating with these inquiries.
AstraZeneca’s investigation has involved indications of inappropriate conduct in certain countries, including China. Resolution of these matters
could involve the payment of fines and/or other remedies.
Other
The Company has guaranteed the external borrowing of a subsidiary in the amount of $288m.
6 Statutory and other information
The Directors were paid by another Group company in 2015 and 2014.
201
AstraZeneca Annual Report and Form 20-F Information 2015Financial Statements 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
Profit on disposal of subsidiary
Other operating income and expense
Operating profit
Finance income
Finance expense
Share of after tax losses of 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:
Equity holders of the Company
Non-controlling interests
Earnings per share
Earnings per $0.25 Ordinary Share (basic)
Earnings per $0.25 Ordinary Share (diluted)
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
For the year ended 31 December
Cash flows
Net cash inflow/(outflow) from:
Operating activities
Investing activities
Financing activities
2011
Restated*
$m
2012
Restated*
$m
2013
Restated*
$m
2014
Restated*
$m
26,095
452
(5,842)
(324)
(5,579)
25,711
95
(5,261)
(306)
(4,821)
(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
$m
40,927
1,896
1,294
16,007
60,124
(14,869)
(26,746)
18,509
316
18,174
19
18,509
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
2012
$m
2013
$m
2014
$m
2015
$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)
33,591
29
(6,026)
(346)
(5,523)
(11,161)
1,483
748
12,795
50
(562)
–
12,283
(2,333)
9,950
(480)
9,470
9,917
33
$7.29
$7.25
$2.70
38.1%
29.5
2011
$m
27,267
543
1,514
23,506
52,830
(15,752)
(13,612)
23,466
323
22,917
226
23,466
2011
$m
7,821
(2,022)
(9,321)
(3,522)
* Comparatives have been restated to reflect the reclassification of externalisation revenue from other operating income and expense as detailed in Group Accounting Policies.
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.
202
AstraZeneca Annual Report and Form 20-F Information 2015
Financial Statements Marketed Products
Respiratory, Inflammation
and Autoimmunity
> Accolate (zafirlukast) is an oral
leukotriene receptor antagonist for the
treatment of asthma.
> Bricanyl Respules (terbutaline) is a
short-acting beta2-agonist administered
via a nebuliser for acute treatment of
asthma and COPD in both children
and adults.
> Bricanyl Turbuhaler (terbutaline) is a
short-acting beta2-agonist for the acute
treatment of bronchial-obstructive
symptoms in asthma and COPD.
> Daliresp (roflumilast) is an oral PDE4
(phosphodiesterase-4) inhibitor for adults
with severe COPD to decrease their
number of exacerbations (US only).
> Duaklir Genuair (aclidinium/formoterol
in a dry powder inhaler) is 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.
> Eklira Genuair/Tudorza/Bretaris
(aclidinium in a dry powder inhaler) is a
LAMA for the maintenance treatment
of COPD.
> Oxis Turbuhaler (formoterol) is a fast
onset, long-acting beta2-agonist for the
treatment of bronchial-obstructive
symptoms in asthma and COPD.
> Pulmicort Turbuhaler/Pulmicort
Flexhaler (budesonide) is an inhaled
corticosteroid for maintenance treatment
of asthma.
> Pulmicort Respules (budesonide) is
a corticosteroid, administered via a
nebuliser, for the treatment of asthma
in both children and adults.
> Rhinocort (budesonide) is a nasal steroid
treatment for allergic rhinitis (hay fever),
perennial rhinitis and nasal polyps.
> Symbicort pMDI (budesonide/
formoterol in a pressurised metered-dose
inhaler) is a combination of an inhaled
corticosteroid and a fast onset, long-
acting beta2-agonist for maintenance
treatment of asthma and COPD, including
chronic bronchitis and emphysema in the
US, Australia and some other markets.
> Symbicort Turbuhaler (budesonide/
formoterol in a dry powder inhaler) is a
combination of an inhaled corticosteroid
and a fast onset, long-acting beta2-
agonist for the maintenance treatment of
asthma and COPD. In asthma, it is also
approved for Symbicort Maintenance And
Reliever Therapy (Symbicort SMART).
Symbicort Turbuhaler is approved in
Europe, Japan and many other countries
excluding the US.
Cardiovascular and
Metabolic diseases
Cardiovascular disease
> Atacand1/Atacand HCT/Atacand Plus
(candesartan cilexetil) is an angiotensin II
antagonist for the 1st line treatment
of hypertension and symptomatic
heart failure.
> Brilinta/Brilique (ticagrelor) is an
oral antiplatelet for acute coronary
syndromes (ACS).
> Crestor 2 (rosuvastatin calcium) is
a statin for dyslipidaemia and
hypercholesterolemia.
> Plendil (felodipine) is a calcium antagonist
for hypertension and angina.
> Seloken/Toprol-XL (metoprolol
succinate) is a beta-blocker once-daily
tablet for control of hypertension, heart
failure and angina.
> Tenormin3 (atenolol) is a beta-blocker for
hypertension, angina pectoris and other
CV disorders.
> Zestril4 (lisinopril dihydrate) is an
angiotensin converting enzyme inhibitor
for a wide range of CV diseases, including
hypertension.
Metabolic disease
> Bydureon (exenatide extended-release
for injectable suspension) is 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.
> Byetta (exenatide injection) is a twice-
daily injectable GLP-1 receptor agonist
indicated to improve glycaemic control in
adults with Type 2 diabetes.
> Farxiga/Forxiga (dapagliflozin) is 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.
> Kombiglyze XR (saxagliptin and
metformin hydrochloride extended
release) combines saxagliptin (Onglyza)
and extended release metformin
(metformin XR) in a once-daily tablet
for Type 2 diabetes.
> Komboglyze (saxagliptin and metformin
hydrochloride) combines saxagliptin
(Onglyza) and metformin immediate
release (metformin IR) in a twice-daily
tablet for Type 2 diabetes.
> Onglyza (saxagliptin) is an oral
dipeptidyl peptidase 4 (DPP-4) inhibitor
for Type 2 diabetes.
> Symlin (pramlintide acetate) is an injected
amylin analogue for Type 1 and Type 2
diabetes in patients with inadequate
glycaemic control.
> Xigduo (dapagliflozin and metformin
hydrochloride) 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.
> Xigduo XR (dapagliflozin and metformin
hydrochloride extended-release)
combines dapagliflozin (Farxiga/Forxiga),
an SGLT2 inhibitor, and metformin XR, in
a once-daily tablet to improve glycaemic
control in adult patients with Type 2
diabetes who are inadequately controlled
by metformin alone.
1 Licensed from Takeda Chemicals Industries Ltd.
2 Licensed from Shionogi. The extension of the global licence
agreement with Shionogi for Crestor and the modification of
the royalty structure became effective 1 January 2014.
3 Divested US rights to Tenormin to Alvogen Pharma US Inc.
effective 9 January 2015.
4 Licensed from Merck. Divested US rights to Zestril to
Alvogen Pharma US Inc. effective 9 January 2015.
AstraZeneca Annual Report and Form 20-F Information 2015
203
Additional Information Marketed Products continued
Oncology
Infection, Neuroscience
and Gastrointestinal
> Arimidex (anastrozole) is an aromatase
Infection
> Fluenz/FluMist (influenza vaccine
live, intra-nasal) is an intra-nasal, live,
attenuated, trivalent influenza vaccine.
> Fluenz Tetra/FluMist Quadrivalent1
(influenza vaccine live, intra-nasal) is an
intra-nasal, live, attenuated, quadrivalent
influenza vaccine.
> Merrem/Meronem2 (meropenem) is a
carbapenem anti-bacterial used to treat
serious infections in hospitalised patients.
> Synagis3 (palivizumab) is 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.
> Zinforo4 (ceftaroline fosamil) is a
novel injectable cephalosporin used
in community-acquired pneumonia
and complicated skin and soft
tissue infections.
1 Daiichi Sankyo holds rights to Fluenz Tetra/FluMist
Quadrivalent in Japan.
2 Licensed from Dainippon Sumitomo Pharmaceuticals Co.,
Limited.
3 US rights only. AbbVie holds rights to Synagis outside
the US.
4 Licensed from Forest (now a wholly-owned subsidiary of
Allergan). AstraZeneca holds global rights, excluding the
US, Canada and Japan.
Neuroscience
> Diprivan (propofol) is an intravenous
general anaesthetic used to induce and
maintain general anaesthesia, intensive
care sedation and conscious sedation for
surgical and diagnostic procedures.
> EMLA (lidocaine and prilocaine) is a
local anaesthetic for topical application
(cream and patch) to prevent pain
associated with injections and minor
surgical procedures, and to facilitate
cleansing/debridement of leg ulcers.
inhibitor used to treat breast cancer. It has
been shown to be significantly superior
to tamoxifen at preventing breast cancer
recurrence during and beyond the
five-year treatment course.
> Casodex, Cosudex (bicalutamide) is
an anti-androgen therapy used to treat
prostate cancer. A 50mg tablet is used
for advanced prostate cancer; a 150mg
tablet is used for locally advanced
prostate cancer.
> Faslodex (fulvestrant) is 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.
> Iressa (gefitinib) is 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).
> Lynparza (olaparib) is an oral poly
ADP-ribose polymerase (PARP) inhibitor.
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.
> Nolvadex (tamoxifen citrate) is a widely
used breast cancer treatment outside
the US.
> Tagrisso (osimertinib) is an EGFR-TKI
indicated for patients with metastatic
EGFR T790M mutation-positive NSCLC.
> Zoladex (goserelin acetate implant) in one
and three month subcutaneous or
intra-muscular injections, is a luteinising
hormone-releasing hormone (LHRH)
agonist used to treat prostate cancer,
breast cancer and certain benign
gynaecological disorders.
> Movantik/Moventig (naloxegol) is 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.
> Naropin (ropivacaine) is a long-acting
local anaesthetic for surgical anaesthesia
and acute pain management.
> Seroquel IR (an immediate release
formulation of quetiapine fumarate) is an
atypical anti-psychotic generally approved
for the treatment of schizophrenia and
bipolar disorder (mania, depression and
maintenance).
> Seroquel XR (an extended release
formulation of quetiapine fumarate)
is generally approved for the treatment
of schizophrenia, bipolar disorder,
major depressive disorder and, on
a more limited basis, for generalised
anxiety disorder.
> Vimovo1 (naproxen/esomeprazole
magnesium) is generally approved for
symptomatic relief in the treatment of
rheumatoid arthritis, osteoarthritis and
ankylosing spondylitis in patients at risk
of developing NSAID-associated gastric
and/or duodenal ulcers.
> Xylocaine (lidocaine) is a short-acting
local anaesthetic for topical and
regional anaesthesia.
> Zomig (zolmitriptan) is used for the acute
treatment of migraine, plus for the acute
treatment of cluster headache in the EU.
Zomig is available in three formulations:
oral tablet; orally dispersible tablet; and
nasal spray.
1 Licensed from Pozen. Divested US rights to Horizon Pharma
USA, Inc. effective 22 November 2013.
Gastrointestinal
> Losec/Prilosec (omeprazole) is a
proton pump inhibitor used to treat
acid-related diseases.
> Nexium (esomeprazole magnesium)
is a proton pump inhibitor used to treat
acid-related diseases.
204
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information N/A
N/A
2017
2017
2018
N/A
N/A
2017
2019
Development Pipeline
as at 31 December 2015
Includes AstraZeneca sponsored or directed studies only.
Phase III/Pivotal Phase II/Registration
NMEs and significant additional indications
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
Mechanism
Area Under Investigation
Respiratory, Inflammation and Autoimmunity
Date
Commenced
Phase
Estimated Regulatory Submission/Submission Acceptance†
US
EU
Japan
China
anifrolumab# TULIP
IFN-alphaR MAb
systemic lupus erythematosus
Q3 2015
2019
(Fast Track)
2019
2019
IL-5R MAb
severe asthma
Q4 2013
H2 2016
H2 2016
N/A
N/A
benralizumab# CALIMA
SIROCCO ZONDA
BISE BORA GREGALE
benralizumab#
TERRANOVA GALATHEA
brodalumab#
AMAGINE-1,2,3
Zurampic (lesinurad)
CLEAR 1,2 CRYSTAL
IL-5R MAb
IL-17R MAb
COPD
psoriasis
selective uric acid
reabsorption inhibitor
(URAT-1)
chronic treatment of
hyperuricemia in patients
with gout
Q3 2014
2018
2018
Q3 2012
Accepted1
Accepted
Q4 2011
Approved
Accepted2
PT003 GFF PINNACLE
LABA/LAMA
PT010
tralokinumab STRATOS 1,2
TROPOS MESOS
LABA/LAMA/ICS
IL-13 MAb
Cardiovascular and Metabolic diseases
COPD
COPD
severe asthma
Q2 2013
Q3 2015
Q3 2014
Accepted
H2 2016
2018
2018
2018
2018
Brilinta/Brilique3
Epanova#
Farxiga/Forxiga4
roxadustat# OLYMPUS
ROCKIES
ZS-9 (sodium zirconium
cyclosilicate)
Oncology
acalabrutinib#6
P2Y12 receptor antagonist
arterial thrombosis
Launched
Launched
Accepted
Launched
omega-3 carboxylic acids
severe hypertriglyceridemia
Approved
2018
2019
SGLT2 inhibitor
Type 2 diabetes
Launched
Launched
Launched
Accepted
hypoxia-inducible factor prolyl
hydroxylase inhibitor
anaemia in CKD/ESRD
Q3 2014
2018
N/A
N/A
H2 20165
potassium binder
hyperkalaemia
Accepted
Accepted
Bruton's tyrosine kinase (BTK)
inhibitor
B-cell blood cancers
H2 2016
cediranib ICON 6
VEGFR tyrosine kinase inhibitor PSR ovarian cancer
Q2 2007
Q2 2014
Q1 2015
Q4 2015
Q2 2015
durvalumab# PACIFIC
durvalumab# HAWK¶
PD-L1 MAb
PD-L1 MAb
stage III NSCLC
2nd line SCCHN (PD-L1 positive)
durvalumab#
+ tremelimumab ALPS¶
durvalumab# + tremelimumab
ARCTIC
durvalumab# + tremelimumab
CONDOR¶
durvalumab# + tremelimumab
DANUBE
durvalumab# + tremelimumab
EAGLE
durvalumab# + tremelimumab
KESTREL
durvalumab# + tremelimumab
MYSTIC
durvalumab# + tremelimumab
NEPTUNE
PD-L1 MAb + CTLA-4 MAb
metastatic pancreatic ductal
carcinoma
PD-L1 MAb + CTLA-4 MAb
3rd line NSCLC
PD-L1 MAb + CTLA-4 MAb
2nd line SCCHN (PD-L1 negative)
Q2 2015
PD-L1 MAb + CTLA-4 MAb
1st line bladder
PD-L1 MAb + CTLA-4 MAb
2nd line SCCHN
PD-L1 MAb + CTLA-4 MAb
1st line SCCHN
PD-L1 MAb + CTLA-4 MAb
1st line NSCLC
PD-L1 MAb + CTLA-4 MAb
1st line NSCLC
Q4 2015
Q4 2015
Q4 2015
Q3 2015
Q4 2015
moxetumomab pasudotox#
PLAIT
anti-CD22 recombinant
immunotoxin
hairy cell leukaemia
Q2 2013
2017
(Orphan Drug)
selumetinib# ASTRA
selumetinib# SELECT-1
Tagrisso (AZD9291) AURA,
AURA 2
MEK inhibitor
MEK inhibitor
EGFR tyrosine kinase inhibitor
differentiated thyroid cancer
2nd line KRASm NSCLC
≥2nd line advanced EGFRm
T790M NSCLC
Q3 2013
Q4 2013
Q2 2014
2018
2017
Launched
(Breakthrough
designation,
Priority Review,
Orphan Drug)
Accepted
(Orphan
Drug)
2020
2019
2020
2019
2017
2017
(Fast Track)
2017
2017
2017
2018
2019
2018
2017
2019
2017
2017
2017
2017
2019
2019
2018
2018
2019
2019
2018
2018
2017
2017
2019
2019
2018
2018
2017
Approved7
(Accelerated
assessment)
Accepted
(Priority
Review)
2017
AstraZeneca Annual Report and Form 20-F Information 2015
205
Additional Information
Development Pipeline continued
Compound
Mechanism
Area Under Investigation
Tagrisso (AZD9291) AURA 3
EGFR tyrosine kinase inhibitor
≥2nd line advanced EGFRm
T790M NSCLC
Date
Commenced
Phase
Q3 2014
Estimated Regulatory Submission/Submission Acceptance†
US
2017
EU
2017
Japan
2017
China
tremelimumab¶ DETERMINE
CTLA-4 MAb
mesothelioma
Q2 2014
H2 2016
H2 2016
H2 2016
(Orphan
Drug, Fast
Track)
Infection, Neuroscience and Gastrointestinal
CAZ AVI#
CAZ AVI#
MEDI-550
Zinforo#
cephalosporin/beta lactamase
inhibitor
serious infections, complicated
intra-abdominal infection,
complicated urinary tract infection
cephalosporin/beta lactamase
inhibitor
hospital-acquired pneumonia/
ventilator-associated pneumonia
Q1 2012
N/A
Accepted
Q2 2013
N/A
Accepted
2017
2017
pandemic influenza virus
vaccine
extended spectrum
cephalosporin with affinity to
penicillin-binding proteins
pandemic influenza prophylaxis
N/A
H1 20168
N/A
N/A
pneumonia/skin infections
N/A
Launched
N/A Submitted
† US and EU dates correspond to anticipated acceptance
of the regulatory submission.
# Partnered and/or in collaboration.
¶ Registrational Phase II/III trial.
1 US regulatory submission accepted in Q1 2016.
2 CHMP Positive Opinion received December 2015.
3 Brilinta in the US; Brilique in rest of world.
4 Farxiga in the US; Forxiga in rest of world.
5 Rolling NDA submission to be initiated in H2 2016.
6 Completion of the agreement with Acerta Pharma Q1 2016.
7 CHMP Positive Opinion received December 2015. Approval
received Q1 2016.
8 MAA submitted December 2015. Regulatory acceptance
anticipated H1 2016.
Phases I and II
NMEs and significant additional indications
Compound
Mechanism
Area Under Investigation
Phase
Respiratory, Inflammation and Autoimmunity
abediterol (AZD0548)
anifrolumab#
AZD7594
AZD7624
AZD9412#
mavrilimumab#
MEDI-551#
MEDI2070#
abrilumab#
MEDI9929#
PT010
RDEA3170
tralokinumab
anifrolumab#
AZD1419#
AZD7986
AZD8871
AZD8999
AZD9567
lesinurad+allopurinol
MEDI4920
MEDI5872#
MEDI7836
Cardiovascular and Metabolic diseases
MEDI6012
AZD4076
MEDI0382
MEDI4166
MEDI8111
LABA
IFN-alphaR MAb
inhaled SGRM
inhaled P38 inhibitor
inhaled interferon beta
GM-CSFR MAb
CD19 MAb
IL-23 MAb
alpha(4)beta(7) MAb
TSLP MAb
LABA/LAMA/ICS
asthma/COPD
lupus nephritis
asthma/COPD
COPD
asthma/COPD
rheumatoid arthritis
neuromyelitis optica1
Crohn’s disease
Crohn’s disease/ulcerative colitis
asthma/atopic dermatitis
asthma
selective uric acid reabsorption inhibitor
(URAT-1)
chronic treatment of hyperuricemia in patients
with gout
IL-13 MAb
IFN-alphaR MAb
TLR9 agonist
DPP1
MABA
MABA
oral SGRM
atopic dermatitis
systemic lupus erythematosus (subcutaneous)
asthma
COPD
COPD
COPD
rheumatoid arthritis
selective uric acid reabsorption inhibitor
(URAT-1)+xanthine oxidase inhibitor
chronic treatment of hyperuricemia in patients
with gout
anti-CD40L-Tn3 fusion protein
B7RP1 MAb
IL-13 MAb-YTE
LCAT
primary Sjögren’s syndrome
systemic lupus erythematosus
asthma
ACS
anti-miR103/107 oligonucleotide
non-alcoholic fatty liver disease/non-alcoholic
steatohepatitis (NASH)
GLP-1/glucagon dual agonist
diabetes/obesity
PCSK9/GLP-1 MAb + peptide fusion
diabetes/cardiovascular
Rh-factor II
trauma/bleeding
II
II
II
II
II
II
II
II
II
II
II
II
II
I
I
I
I
I
I
I
I
I
I
II
I
I
I
I
Date
Commenced
Phase
Q4 2007
Q4 2015
Q3 2015
Q4 2014
Q3 2015
Q1 2010
Q1 2015
Q1 2013
Q4 2012
Q2 2014
Q2 2014
Q3 2013
Q1 2015
Q4 2015
Q3 2013
Q4 2014
Q4 2015
Q4 2013
Q4 2015
Q4 2015
Q2 2014
Q4 2008
Q1 2015
Q4 2015
Q4 2015
Q1 2015
Q4 2015
Q1 2014
206
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information Mechanism
Area Under Investigation
Phase
Date
Commenced
Phase
Compound
Oncology
AZD1775#
AZD2014
AZD3759 BLOOM
Tagrisso (AZD9291) BLOOM
AZD4547
AZD5069 + durvalumab#
AZD9150# + durvalumab#
AZD5363#
durvalumab#
WEE-1 inhibitor
mTOR serine/threonine kinase inhibitor
ovarian cancer
solid tumours
EGFR tyrosine kinase inhibitor
EGFR tyrosine kinase inhibitor
FGFR tyrosine kinase inhibitor
CXCR2 + PD-L1 MAb
STAT3 inhibitor + PD-L1 MAb
AKT kinase inhibitor
PD-L1 MAb
durvalumab# + tremelimumab
PD-L1 MAb + CTLA-4 MAb
MEDI-551#
MEDI-573#
savolitinib/volitinib#
selumetinib#
AZD0156
AZD2811
AZD5312#
AZD6738
AZD8186
AZD8835
AZD9150#
CD19 MAb
IGF MAb
MET tyrosine kinase inhibitor
MEK inhibitor
ATM serine/threonine kinase inhibitor
Aurora B kinase inhibitor
androgen receptor inhibitor
ATR serine/threonine kinase inhibitor
PI3 kinase beta inhibitor
PI3 kinase alpha inhibitor
STAT3 inhibitor
Tagrisso (AZD9291) + (durvalumab# or
selumetinib# or savolitinib#) TATTON
EGFR tyrosine kinase inhibitor + (PD-L1 MAb or
MEK inhibitor or MET tyrosine kinase inhibitor)
brain metastases in advanced
EGFRm NSCLC
solid tumours
SCCHN
breast cancer
solid tumours
gastric cancer
diffuse B-cell lymphoma
metastatic breast cancer
papillary renal cell carcinoma
2nd line KRAS wt NSCLC
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
haematological malignancies
advanced EGFRm NSCLC
AZD9496
durvalumab#
durvalumab# + MEDI0680
durvalumab# + MEDI6383#
selective oestrogen receptor downregulator
(SERD)
ER+ breast cancer
PD-L1 MAb
PD-L1 MAb + PD-1 MAb
OX40 agonist + PD-L1 MAb
solid tumours
solid tumours
solid tumours
durvalumab# + dabrafenib + trametinib2
PD-L1 MAb + BRAF inhibitor + MEK inhibitor
melanoma
durvalumab# + tremelimumab
PD-L1 MAb + CTLA-4 MAb
solid tumours
Iressa + durvalumab#
MEDI0562#
MEDI-551# + rituximab
MEDI-565#
MEDI0639#
MEDI0680
MEDI1873
MEDI3617#
MEDI4276
MEDI6383#
MEDI9197#
MEDI9447
PD-L1 MAb + EGFR tyrosine kinase inhibitor
NSCLC
humanised OX40 agonist
CD19 MAb + CD20 MAb
CEA BiTE MAb
DLL-4 MAb
PD-1 MAb
GITR agonist fusion protein
ANG-2 MAb
HER2 bispecific ADC MAb
OX40 agonist
TLR 7/8 agonist
CD73 MAb
solid tumours
haematological malignancies
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
solid tumours
Infection, Neuroscience and Gastrointestinal
AZD3241
AZD3293#
CXL#
MEDI7510
MEDI8852
MEDI8897#
MEDI4893
ATM AVI#
AZD8108
MEDI1814
MEDI3902
myeloperoxidase inhibitor
multiple system atrophy
beta-secretase inhibitor
Alzheimer’s disease
beta lactamase inhibitor/cephalosporin
methicillin-resistant S. aureus
RSV sF+GLA-SE
influenza A MAb
RSV MAb-YTE
prevention of RSV disease in older adults
influenza A treatment
passive RSV prophylaxis
MAb binding to S. aureus toxin
hospital-acquired pneumonia/serious S. aureus
infection
monobactam/beta lactamase inhibitor
targeted serious bacterial infections
NMDA antagonist
amyloid beta MAb
anti-Psl/PcrV
suicidal ideation
Alzheimer’s disease
prevention of nosocomial pseudomonas
pneumonia
II
II
II
II
II
II
II
II
II
II
II
II
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
I
I
I
I
Q4 2012
Q1 2013
Q4 2015
Q4 2011
Q3 2015
Q1 2014
Q3 2014
Q2 2015
Q1 2012
Q2 2012
Q2 2014
Q1 2013
Q4 2015
Q4 2015
Q2 2014
Q4 2013
Q2 2013
Q4 2014
Q1 2012
Q3 2014
Q4 2014
Q3 2014
Q2 2014
Q2 2015
Q1 2014
Q4 2013
Q2 2014
Q1 2015
Q2 2014
Q1 2011
Q2 2012
Q4 2013
Q4 2015
Q4 2010
Q4 2015
Q3 2014
Q4 2015
Q3 2015
Q2 2015
(Orphan Drug)
Q4 2014
Q4 2010
Q3 2015
Q4 2015
Q1 2015
(FDA Fast Track)
Q4 2014
(FDA Fast Track)
Q4 2012
Q4 2014
Q2 2014
Q3 2014
(FDA Fast Track)
# Partnered and/or in collaboration.
1 Neuromyelitis optica: Now lead indication. Multiple sclerosis trial completed in 2015.
2 MedImmune-sponsored trial in collaboration with Novartis AG.
AstraZeneca Annual Report and Form 20-F Information 2015
207
Additional Information Development Pipeline continued
Significant Life-Cycle Management
Compound
Mechanism
Area Under Investigation
Date
Commenced
Phase
Estimated Regulatory Submission Acceptance†
US
EU
Japan
China
Respiratory, Inflammation and Autoimmunity
Duaklir Genuair#
Symbicort SYGMA
Symbicort
LAMA/LABA
ICS/LABA
ICS/LABA
Cardiovascular and Metabolic diseases
Brilinta/Brilique1 EUCLID
P2Y12 receptor antagonist
Brilinta/Brilique1 HESTIA
P2Y12 receptor antagonist
Brilinta/Brilique1
PEGASUS-TIMI 54
P2Y12 receptor antagonist
Brilinta/Brilique1 SOCRATES
P2Y12 receptor antagonist
Brilinta/Brilique1 THEMIS
P2Y12 receptor antagonist
COPD
2018
Launched
2018
as-needed use in mild asthma
Q4 2014
breath actuated inhaler asthma/COPD
N/A
2018
2018
2018
2019
outcomes trial in patients with peripheral
artery disease
prevention of vaso-occlusive crises in
paediatric patients with sickle cell
disease
outcomes trial in patients with prior
myocardial infarction
outcomes trial in patients with stroke
or TIA
outcomes trial in patients with Type 2
diabetes and CAD, but without a
previous history of MI or stroke
Q4 2012
2017
2017
2017
2018
Q4 2014
2020
2020
Q4 2010
Launched
(Priority
Review)
Accepted2 Accepted
H2 2016
Q1 2014
H1 2016
H1 2016
H2 2016
2017
Q1 2014
2018
2018
2018
2019
Q2 2010
Q1 2013
Q4 2014
2018
2017
2020
2018
2017
2020
2018
2020
2020
Bydureon EXSCEL
GLP-1 receptor agonist
Type 2 diabetes outcomes trial
Bydureon weekly suspension GLP-1 receptor agonist
Type 2 diabetes
Epanova STRENGTH
omega-3 carboxylic acids
outcomes trial in statin-treated
patients at high CV risk, with persistent
hypertriglyceridemia plus low
HDL-cholesterol
Epanova/Farxiga/Forxiga3
omega-3 carboxylic acids/
SGLT2 inhibitor
non-alcoholic fatty liver disease/
non-alcoholic steatohepatitis (NASH)
Q1 2015
Farxiga/Forxiga3
DECLARE-TIMI 58
Farxiga/Forxiga3
SGLT2 inhibitor
Type 2 diabetes outcomes trial
Q2 2013
2020
2020
SGLT2 inhibitor
Type 1 diabetes
Q4 2014
2018
2017
2018
Kombiglyze XR/Komboglyze4 DPP-4 inhibitor/metformin
Type 2 diabetes
Launched
Launched
Submitted
FDC
Onglyza SAVOR-TIMI 53
DPP-4 inhibitor
Type 2 diabetes outcomes trial
saxagliptin/dapagliflozin FDC DPP-4 inhibitor/SGLT2
Type 2 diabetes
Q2 2010
Q2 2012
Accepted
Launched
Accepted6 Accepted
H2 20165
Xigduo XR/Xigduo7
Oncology
inhibitor FDC
SGLT2 inhibitor/metformin
FDC
Type 2 diabetes
Launched
Launched
Faslodex FALCON
oestrogen receptor antagonist 1st line hormone receptor +ve
Q4 2012
H2 2016
H2 2016
H2 2016
2020
advanced breast cancer
Lynparza (olaparib) SOLO-1
PARP inhibitor
1st line BRCAm ovarian cancer
Lynparza (olaparib) SOLO-2
PARP inhibitor
2nd line or greater BRCAm PSR ovarian
cancer, maintenance monotherapy
Lynparza (olaparib) SOLO-3
PARP inhibitor
gBRCA PSR ovarian cancer
Lynparza (olaparib) GOLD
PARP inhibitor
2nd line gastric cancer
Lynparza (olaparib) OlympiA
PARP inhibitor
gBRCA adjuvant breast cancer
Lynparza (olaparib) OlympiAD PARP inhibitor
gBRCA metastatic breast cancer
Lynparza (olaparib) POLO
PARP inhibitor
Lynparza (olaparib)
PARP inhibitor
pancreatic cancer
prostate cancer
Q3 2013
Q3 2013
Q1 2015
Q3 2013
Q2 2014
Q2 2014
Q1 2015
2017
H2 2016
2018
2020
H2 2016
2018
Q3 2014 (Breakthrough
Therapy
designation)8
2017
2017
2020
2017
2018
2017
2017
2017
2020
2017
2018
Tagrisso (AZD9291) ADAURA EGFR tyrosine kinase inhibitor adjuvant EGFRm NSCLC
Tagrisso (AZD9291) FLAURA EGFR tyrosine kinase inhibitor 1st line advanced EGFRm NSCLC
Tagrisso (AZD9291)
+ durvalumab# CAURAL9
EGFR tyrosine kinase inhibitor
+ PD-L1 MAb
≥2nd line advanced EGFRm T790M
NSCLC
Q4 2015
Q1 2015
Q3 2015
2022
2017
2022
2017
2017
2020
208
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information
Compound
Mechanism
Area Under Investigation
Infection, Neuroscience and Gastrointestinal
Date
Commenced
Phase
Estimated Regulatory Submission Acceptance†
US
EU
Japan
China
Diprivan#
linaclotide#
Nexium
Nexium
sedative and anaesthetic
conscious sedation
GC-C receptor peptide
agonist
irritable bowel syndrome with
constipation (IBS-C)
proton pump inhibitor
stress ulcer prophylaxis
N/A
N/A
Launched
Accepted Launched
N/A
N/A
Accepted10
H2 2016
proton pump inhibitor
paediatrics
Launched
Launched
H2 2016
Accepted
†
US and EU dates correspond to anticipated acceptance
of the regulatory submission.
# Partnered and/or in collaboration.
1 Brilinta in the US; Brilique in rest of world.
2 CHMP Positive Opinion received December 2015.
3 Farxiga in the US; Forxiga in rest of world.
4 Kombiglyze XR in the US; Komboglyze in the EU.
5
Timing of China submission dependent on US
regulatory approval.
6 CRL received October 2015.
7 Xigduo XR in the US; Xigduo in the EU.
8
Breakthrough Therapy designation granted for prostate
cancer patients with BRCA1/2 or ATM gene mutated
mCRPC who have received previous taxane-based
chemotherapy and one newer hormonal agent (abiraterone
or enzalutamide).
9 Temporarily closed to enrolment.
10 Submission accepted January 2016.
Terminations
NME/Line Extension
NME
NME
NME
NME
NME
NME
NME
NME
NME
NME
NME
NME
NME
NME
LCM
LCM
LCM
LCM
LCM
LCM
Compound
AZD2115#
AZD5213
AZD5847
AZD9977
durvalumab# ATLANTIC
durvalumab# + MEDI6469#
selumetinib# SUMIT
sifalimumab#
tenapanor (AZD1722)#
MEDI-551# + MEDI0680
MEDI-559
MEDI6469#
MEDI6469# + rituximab
MEDI6469# + tremelimumab
brodalumab#
durvalumab# after (Tagrisso (AZD9291) or Iressa
or (selumetinib# +docetaxel) or tremelimumab)
MEDI-551#
moxetumomab pasudotox#
Nexium
tralokinumab
# Partnered and/or in collaboration.
¹ SLE project stopped but molecule under evaluation for alternative indications.
Completed Projects/Divestitures
Reason for Discontinuation
Area Under Investigation
Strategic
Safety/efficacy
Safety/efficacy
Safety/efficacy
Strategic
Strategic
Safety/efficacy
Strategic
Safety/efficacy
Safety/efficacy
Safety/efficacy
Strategic
Strategic
Strategic
Lack of efficacy
Strategic
Safety/efficacy
Safety/efficacy
Regulatory
Safety/efficacy
COPD
Tourette’s syndrome/neuropathic pain
tuberculosis
diabetic kidney disease
3rd line NSCLC (PD-L1 positive)
solid tumours
uveal melanoma
systemic lupus erythematosus1
ESRD-Pi/CKD with T2DM
diffuse large B-cell lymphoma
passive RSV prophylaxis
solid tumours
solid tumours
solid tumours
asthma
NSCLC
chronic lymphocytic leukaemia
paediatric acute lymphoblastic leukaemia
refractory reflux oesphagitis (JP)
idiopathic pulmonary fibrosis
Compound
Myalept
Mechanism
leptin analogue
Area Under Investigation
lipodystrophy
Completed/
Divested
Estimated Regulatory Submission Acceptance†
US
EU
Japan
China
Completed
Launched
Lynparza (olaparib) capsule
PARP inhibitor
BRCAm PSR ovarian cancer
Completed
Launched
Launched
AZD0914
GyrAR
serious bacterial infections (Phase III)
Divested in
Phase II
Movantik/Moventig#1
oral peripherally-acting
mu-opioid receptor antagonist
opioid-induced constipation
Completed
Launched
Launched
Bydureon Dual Chamber Pen GLP-1 receptor agonist
brodalumab AMVISION-1,22
IL-17R MAb
Type 2 diabetes
psoriatic arthritis
Completed
Launched
Launched
Launched
Partnered
Caprelsa3
Caprelsa3
Entocort5
Iressa
AZD49017
VEGFR/EGFR tyrosine kinase
inhibitor with RET kinase activity
VEGFR/EGFR tyrosine kinase
inhibitor with RET kinase activity
medullary thyroid cancer
Divested
Launched
Launched Approved4
Accepted
differentiated thyroid cancer
Divested
glucocorticoid steroid
Crohn’s disease/ulcerative colitis
Completed/
Divested
Launched
Launched
Q4 2015
N/A
EGFR tyrosine kinase inhibitor
EGFRm NSCLC
Completed Launched6
Launched
Launched
Launched
NK3 receptor antagonist
polycystic ovarian syndrome
Divested in
Phase II
† US and EU dates correspond to anticipated acceptance
of the regulatory submission.
# Partnered and/or in collaboration.
¹ Movantik in the US; Moventig in EU.
² AstraZeneca has granted Valeant an exclusive licence
to develop and commercialise brodalumab.
³ Divested to Genzyme (deal completed October 2015).
4 Approved in Japan in September 2015.
5 Global rights, outside the US, divested to Tillotts Pharma
AG in July 2015. AstraZeneca continues to support the
Japanese regulatory submission.
6 Launched in US Q3 2015.
7 Divested to Millendo Therapeutics, Inc. Agreement
announced January 2016.
AstraZeneca Annual Report and Form 20-F Information 2015
209
Additional Information
Patent Expiries
Patent expiries for our key marketed products
AstraZeneca is exposed to third party challenges of its patents and products. 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 212. Many of
our products are subject to challenges by third parties. Details of material challenges by third parties can be found in Note 27 to the
Financial Statements from page 186. The expiry dates shown below do not include any granted SPC/PTE and/or Paediatric Exclusivity
periods unless asterisked; see key in footnotes. (In Europe, the exact SPC situation may vary by country as different Patent Offices may
grant SPC at different rates.) 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 227.
US
US patent expiry
US Product Sales ($m)
Key marketed products
New Chemical Entity patent(s) Expiry dates of other patents (such as the FDA Orange Book)
Atacand3
Brilinta
Bydureon
Byetta
Crestor 4
Daliresp
Faslodex
Farxiga
Iressa
Kombiglyze XR
Lynparza
Nexium
Onglyza
Pulmicort8
Seloken/Toprol-XL
Seroquel XR9
Symbicort
Synagis
Tudorza
Zoladex
2018, 2019
2021, 2030
20161, 2017, 2018, 2020, 2021, 2022, 2024, 2025, 2026, 2028
20161, 2
20201
2020
2017 (20225)
20231
2022, 2024
20231
20161, 2017, 2018, 2020
20182, 20212, 20222
2023, 2024
20212
2020, 2027, 2028, 2029, 2030
2025
2024, 2027, 2028, 2031
20162, 20182, 20192, 20202,7
2028
2018, 20192
2017
2017, 2018, 2021, 2023, 2024, 2026, 2028, 2029
2020
2023
2016, 2022, 2027
2021, 2022
2015
34
240
482
209
2014
44
146
374
199
2,844
2,918
2013
72
73
131
152
2,912
–
324
–
–
–6
–
–
340
122
–
–6
–
1,876
2,123
481
211
91
738
1,511
499
–
26
265
224
131
743
1,233
617
–
23
104
356
261
6
–6
70
902
420
200
89
716
1,520
285
103
28
China, EU and Japan
China, EU and Japan combined
Product Sales ($m)10
Key marketed products
Atacand
Patents
Brilique
NCE Patents
Non-NCE Patents
Bydureon
Non-NCE Patents
Byetta
Non-NCE Patents
Crestor
NCE Patent
Non-NCE Patents
Duaklir Genuair
NCE Patent
Non-NCE Patents
Eklira Genuair
NCE Patent
Non-NCE Patents
Faslodex
Non-NCE Patents
China patent expiry
EU patent expiry 11
Japan patent expiry
2015
2014
2013
12
2018, 2019
2021
Expired
2018, 20241
202113
12
2018, 2019
2021, 2027
2020, 202114, 202514
2017, 2020, 2021, 20211, 2022, 2024,
2026, 202715
2018, 2021, 2024, 2025, 2026,
2027, 2028
2020
2017, 2018, 2020, 20211,15
2018, 20201
2020, 2021
20171,2
2020
20171
2021, 20231
2020
2016, 2022, 2025, 2027
20251
2016, 2022, 2025, 2027, 2028, 2029
20251
2016, 2022, 2025, 2027, 2028
2020
2016, 2022, 2025, 2027
20251
2016, 2022, 2025, 2027, 2028, 2029
20251
2016, 2022, 2025, 2027, 2028
202116
2021
20261
91
255
82
84
151
232
59
105
200
155
17
46
1,585
1,877
1,864
21
61
–
12
–
–
259
295
272
210
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information Key marketed products
China patent expiry
EU patent expiry 11
Japan patent expiry
2023
2027, 2028
20271
2027, 2028
Forxiga
NCE Patent
Non-NCE Patents
Iressa
NCE Patent
Kombiglyze XR
NCE Patent
Non-NCE Patents
Komboglyze
NCE Patent
Non-NCE Patents
Lynparza
NCE Patent
Non-NCE Patents
Nexium
NCE Patent
Non-NCE Patents
Onglyza
NCE Patent
Non-NCE Patents
Pulmicort18
Non-NCE Patents
Seloken/Toprol-XL
Non-NCE Patents
Seroquel XR
Non-NCE Patents
Symbicort
Non-NCE Patents
Synagis
Non-NCE Patents
Zoladex
Non-NCE Patents
2016
2021
2025
2021
2025
2021, 2024
2024, 2027
Expired
2018, 2019
2021
2025
2018
Expired
2017
2018
–
2021
201917
20261
2025
20261
2025
2021, 20291
2024, 2027
Expired
2018
20241
2025
2018
Expired
2017
2023
20281, 2028
2018
–
–
–
–
2021, 2024
2024, 2027
20181
2018, 2019
–
–
2018
Expired
19
China, EU and Japan combined
Product Sales ($m)10
2015
134
2014
74
2013
10
389
459
489
–6
–6
23
–6
–6
–
–6
–6
–
950
966
828
168
164
62
653
428
176
564
428
306
481
400
381
1,310
1,666
1,634
377
468
401
526
443
581
2018, 2019
2017, 2019, 2020
2023
2021
2023
2021
1 Date represents expiry of granted PTE; or expiry of granted SPC where SPC has been granted in several or all countries.
2 Date includes Paediatric Exclusivity.
3 Atacand HCT.
4 A settlement agreement permits Watson Laboratories, Inc. and Actavis, Inc. (together, Watson) to begin selling its generic version of Crestor and its rosuvastatin zinc product beginning 2 May 2016.
5 Date in brackets reflects seven years’ Orphan Drug exclusivity to 13 July 2022.
6 Komboglyze/Kombiglyze XR Product Sales are included in the Onglyza Product Sales figure.
7 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.
8 A licence agreement with Teva permits their 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.
9 Licence agreements with various generics companies allow launches of generic versions of Seroquel XR in the US from 1 November 2016 or earlier upon certain circumstances, subject to
regulatory approval.
10 Aggregate revenue for China, the EU and Japan.
11 Expiry in major EU markets.
12 Takeda retained rights.
13 The patent was revoked during opposition proceedings at the European Patent Office. The patentee has appealed that decision.
14 Regulatory approval for the product is pending in China.
15 There is eight years’ data exclusivity and two years’ market exclusivity for Byetta and Bydureon to 2016.
16 Decision of the Patent Reexamination Board invalidating the patent suspended pending outcome of appeal process.
17 SPC expires 2 March 2019. There is eight years’ data exclusivity and two years’ market exclusivity for Iressa in the EU to 24 June 2019.
18 The 2018 expiry relates to the formulation in the Turbuhaler presentation and to a process useful for the Respules product.
19 Rights licensed to Astellas.
AstraZeneca Annual Report and Form 20-F Information 2015
211
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 21. 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
A succession of negative drug project results and a failure to reduce
development timelines effectively, or produce new products 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 priorities or
to meet targets or expectations on page 225.
Failure to meet development targets
The development of any pharmaceutical product candidate is a complex,
risky and lengthy process involving significant financial, R&D and other
resources, which may fail at any stage of the process due to various
factors. These include failure to obtain the required regulatory or marketing
approvals for the product candidate or its manufacturing facilities;
unfavourable clinical efficacy data; safety concerns; failure of R&D to
develop new product candidates; failure to demonstrate adequate
cost-effective benefits to regulatory authorities and/or payers; and the
emergence of competing products.
Because 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.
Production and release schedules for biologics may be more significantly
impacted by regulatory processes than other products. This is due to more
complex and stringent regulation on the manufacturing of biologics and
their supply chain.
Delay to new product launches
Our continued success depends on the development and successful
launch of innovative new drugs. 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.
Significant delays to anticipated launch dates of new products could
have a material adverse effect on our financial condition 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.
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.
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Additional Information Product pipeline and IP risks
Impact
Acquisitions and strategic alliances, including licensing and collaborations, may be unsuccessful
We seek licensing arrangements and strategic collaborations to expand
our product portfolio and geographical presence as part of our business
strategy. Such licensing arrangements and strategic collaborations are key,
enabling us to grow and strengthen the 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.
Also, under many of our licensing arrangements and strategic
collaborations, we make milestone payments well in advance of the
commercialisation of the products, with no assurance that we will recoup
these payments.
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.
Furthermore, we experience strong competition from other pharmaceutical
companies in respect of licensing arrangements, strategic collaborations,
and acquisition targets, and therefore, 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.
If we fail to complete these types of collaborative projects in a timely
manner, on a cost-effective basis, or at all, this may limit our ability to
access a greater portfolio of products, IP technology and shared expertise.
Additionally, disputes or difficulties in our relationship with our collaborators
or partners may arise, often due to conflicting priorities or conflicts of
interest between parties, which may erode or eliminate the benefits of
these alliances.
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.
Further, if liabilities are uncovered in an acquired business, an acquired
business fails to perform in line with expectations, or a strategic transaction
does not deliver the results we intended, then the Group or our shareholders
may suffer losses and may not have adequate remedies against the seller
or third parties. 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.
AstraZeneca Annual Report and Form 20-F Information 2015
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Additional Information Risk continued
Product pipeline and IP risks
Impact
Difficulties obtaining and maintaining regulatory approvals for new products
Delays in regulatory reviews and approvals impact patient and market
access. In addition, post-approval requirements result in increased
costs and may impact the labelling and approval status of currently
marketed products.
Limitations on the availability of patent protection or the use of compulsory
licensing in certain countries in which we operate could have a material
adverse effect on the pricing and sales of our products and, consequently,
could materially adversely affect our revenues from those products. 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 60,
the Effects of patent litigation in respect of IP rights risk on page 218 and
the Expiry or loss of, or limitations to, IP rights and consequential pressure
from generic competition risk on page 215.
We are subject to strict controls on the commercialisation processes for
our pharmaceutical products, including their development, manufacture,
distribution and marketing. Safety, efficacy and quality must be established
before a drug can be marketed for a given indication. The criteria for
establishing safety, efficacy and quality may vary by country or region and
the submission of an application to regulatory authorities may or may not
lead to the grant of marketing approval. Regulators can refuse to grant
approval or may require additional data before approval is given, even
though the medicine may already be launched in other countries. Approved
products are also subject to regulations, and a failure to comply can
potentially result in losing regulatory approval to market our products.
Regulations may require a company to conduct additional clinical trials after
a drug’s approval, which can result in increased costs, labelling challenges
or loss of regulatory approval.
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. Existing marketed products
are also subject to these same forces, and new data and meta-analyses
have the potential to drive changes in the approval status or labelling.
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.
Unanticipated and unpredictable policy making by governments and
regulators can adversely influence regulatory decision making, often
leading to severe delays in regulatory approval. The predictability of the
outcome and timing of review processes remains challenging due to
evolving regulatory science, competing regulatory priorities, unpredictable
policy making and limits placed on regulatory authority resources.
Failure to obtain and enforce effective IP protection
Our ability to obtain and enforce patents and other IP rights in relation to our
products is an important element in protecting our investment in R&D and
creating long-term value for the business. Some countries in which we
operate are still developing their IP laws, others are limiting the applicability
of their IP laws to certain pharmaceutical inventions. Certain countries may
seek to limit or deny effective IP protection for pharmaceuticals because of
adverse political perspectives around the desirability of appropriate IP
protection for pharmaceuticals.
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Additional Information Commercialisation risks
Impact
Expiry or loss of, or limitations to, IP rights and consequential pressure from generic competition
If challenges to our IP by generic drug manufacturers succeed and generic
products are launched, or generic products are launched ‘at risk’ on the
expectation that challenges to our IP will be successful, this may materially
adversely affect our revenues and financial condition. Furthermore, if
limitations on the availability, scope or enforceability of patent protection are
implemented in jurisdictions in which we operate, generic manufacturers in
these countries may be increasingly able to introduce competing products
to the market earlier than they would have been able to, had more robust
patent protection or Regulatory Data Protection been available.
A pharmaceutical product is protected from being copied for the limited
period of protection under patent rights and/or related IP rights such as
Regulatory Data Protection or Orphan Drug status. This period of
protection helps us recoup our overall R&D investment. Early loss of IP
rights may threaten our ability to recoup our investment in a patent product.
Expiry or loss of these rights can materially adversely affect our revenues
and financial condition due to the launch of generic copies of the product
in the country where the rights have expired or been lost (see the Patent
Expiries section on pages 210 and 211, which contains a table of certain
patent expiry dates for our key marketed products). Products protected by
our IP account for a significant proportion of our revenues. For example, in
2015, US Product Sales for Crestor and Seroquel XR were $2,844 million
(2014: $2,918 million) and $716 million (2014: $738 million), respectively.
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. Typically, products under patent protection or within the period of
Regulatory Data Protection generate significantly higher revenues than
those not protected by such rights.
A pharmaceutical product competes with other products marketed by
research-based pharmaceutical companies and approved for the same
condition, as well as with generic drugs for that condition marketed by
generic drug manufacturers. Generic versions of products 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.
The majority of our patented products, including Nexium, Crestor and
Seroquel XR, are subject to pricing pressures due to competition from
generic copies of these products and from generic forms of other drugs
in the same product class (for example, generic forms of Losec/Prilosec,
Lipitor and Seroquel IR). Additionally, generic manufacturers are often able
to invest more resources in the marketing of their products than we do, due
to their lack of R&D expenses.
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, as detailed in Note 27 to the
Financial Statements from page 186, we are currently facing challenges
from numerous generic drug manufacturers regarding our patents relating
to key products, including Brilinta, Faslodex, Seroquel XR, Byetta, Daliresp,
Onglyza and Crestor (which goes off-patent in the US in May 2016). Patent
challenges are also discussed in the Effects of patent litigation in respect of
IP rights risk on page 218. Generic manufacturers may also take advantage
of the failure of certain countries to properly enforce Regulatory Data
Protection and may launch generics during this protected period. This is
a particular risk in some Emerging Markets where appropriate patent
protection may be difficult to obtain or enforce.
AstraZeneca Annual Report and Form 20-F Information 2015
215
Additional Information Risk continued
Commercialisation risks
Impact
Abbreviated approval processes for biosimilars
While no application for a biosimilar has been made in relation to an
AstraZeneca biologic, various regulatory authorities are implementing or
considering abbreviated approval processes for biosimilars that would
compete with patented biologics.
The extent to which biosimilars would differ from patented biologics on
price is unclear. However, due to their complex nature, it is uncertain
whether biosimilars would have the same impact on patented biologics
that generic products have had on patented small molecule products.
For example, in 2010, the US enacted the Biologics Price Competition
and Innovation Act within the ACA, which contains general directives for
biosimilar applications. The FDA issued final guidance in April 2015 on
implementing an abbreviated biosimilar approval pathway. In March 2015,
the FDA approved the first biosimilar product submitted under the
abbreviated biosimilar pathway. However, significant questions remain,
including standards for designation of interchangeability and data collection
requirements to support extrapolation of indications. In addition, due to the
recent submissions and approvals of abbreviated biosimilar applications, a
number of legal challenges construing the requirements of the abbreviated
biosimilar pathway are under review. For example, in July 2015, the US
Court of Appeals for the Federal Circuit held that biosimilar applicants were
not required to provide copies of the biosimilar application or manufacturing
information but needed to provide 180-day commercial marketing notice
to the reference sponsor. Although this decision and other ongoing legal
challenges do not directly impact an AstraZeneca biologic, uncertainty
regarding the abbreviated biosimilar approval pathway may remain until
these initial legal challenges reach final conclusion.
In Europe, the EMA published final guidelines on similar biologics
containing MAbs and in May 2012, the first MAb biosimilar application was
submitted with recommendation for approval made by the EMA. Notably,
various jurisdictions have adopted either the EMA guidelines or those set
forth by WHO to enable biosimilars to enter the market after discrete
periods of data exclusivity.
Political and socio-economic conditions
We operate in over 100 countries around the world, some of which may be
subject to political and social instability. There may be disruption to our
business if there is instability in a particular geographic region, including as
a result of war, terrorism, riot, unstable governments, civil insurrection or
social unrest. For instance, our operational risks in Ukraine have increased
due to growing political and economic uncertainty in the region.
In addition, it is uncertain when any such abbreviated approval processes
may be fully realised, particularly for more complex protein molecules
such as MAbs. Such processes may materially and adversely affect the
future commercial prospects for patented biologics, such as the ones that
we produce.
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. Broader economic developments, such as potential
international sanctions and global oil price developments, could
exacerbate this effect in the Ukrainian and Russian markets.
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Additional Information Commercialisation risks
Impact
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.
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.
Developing our business in Emerging Markets
The development of our business in Emerging Markets is a critical factor
in determining our future ability to sustain or increase our global Product
Sales. This poses various challenges 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); inadequate infrastructure to address disease
outbreaks (such as the Ebola virus); the need to impose developed market
compliance standards; the need to meet a more diverse range of national
regulatory, clinical and manufacturing requirements; inadvertent breaches
of local and international law; not being able to recruit appropriately skilled
and experienced personnel; identification of the most effective sales and
marketing channels and route to market; and interventions by national
governments or regulators restricting market access and/or introducing
adverse price controls.
Challenges to achieving commercial success of new products
The successful launch of a new pharmaceutical product involves
substantial investment in sales and marketing activities, launch stocks and
other items. The commercial success of our new medicines is particularly
important to replace lost Product Sales following patent expiry. We may
ultimately be unable to achieve commercial success for any number of
reasons. These include 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.
As a result, we cannot be certain that compounds currently under
development will achieve success, and 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.
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.
Our products are subject to competition by other products approved for
the same or similar indication, and the approval of a competitive product
that is considered superior, or equivalent to, one of our products may result
in immediate and significant decreases in our revenues.
AstraZeneca Annual Report and Form 20-F Information 2015
217
Additional Information Risk continued
Commercialisation risks
Impact
Managing or litigating infringement disputes over so-called ‘freedom to
operate’ can be costly. We may be subject to injunctions against our
products or processes and be liable for damages or royalties. We may
need to obtain costly licences. These risks may be greater in relation to
biologics and vaccines, where patent infringement claims may relate to
discovery or research tools, and manufacturing methods and/or biological
materials. While we seek to manage such risks by, for example, acquiring
licences, forgoing certain activities or uses, or modifying processes to
avoid infringement claims and permit commercialisation of our products,
such steps can entail significant cost and there is no guarantee that they
will be successful.
If we are not successful in maintaining exclusive rights to market one or
more of our major products, particularly in the US where we achieve
our highest Product Sales, our revenue and margins could be materially
adversely affected.
Unfavourable resolution of such current and similar future patent litigation
matters could subject us to damages (including enhanced damages),
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.
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, as well as potential
legislation that expands the commercial importation of medicines into the
US, could materially adversely affect our business or results of operations.
We expect these pricing pressures will continue, and may increase.
Effects of patent litigation in respect of IP rights
Any of the IP rights protecting our products may be asserted or challenged
in IP litigation and/or patent office proceedings initiated against or 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 may not succeed in
protecting or enforcing our patents in such litigation or other challenges.
We bear the risk that courts may decide that third parties do not infringe
our asserted IP rights. This may result in AstraZeneca losing exclusivity
and/or erosion of revenues.
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 exclusively by third parties, including research-based and generic
pharmaceutical companies and individuals. Third parties may seek
damages for alleged patent infringement. In the US, they may also seek
enhanced (ie up to treble) damages for alleged wilful infringement of
their patents.
Details of material patent litigation matters can be found in Note 27 to the
Financial Statements from page 186.
Price controls and reductions
Most of our key markets have experienced the implementation of various
cost control or reimbursement mechanisms for pharmaceutical products.
For example, in the US, prices are being depressed through restrictive
reimbursement policies and cost control tools such as restricted lists
and formularies, which 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, payers are shifting a greater proportion of the
cost of branded medicines to the patient via out-of-pocket payments at the
pharmacy counter. The patient out-of-pocket spend is generally in the form
of a co-payment or, in some cases, a co-insurance, which is designed,
principally, to encourage patients to use generic medicines.
In Emerging Markets, governments are increasingly controlling pricing in the
self-pay sector and favouring locally manufactured drugs.
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 on page 14 and
overleaf in the following risk factor.
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Additional Information Commercialisation risks
Impact
Economic, regulatory and political pressures
We face continued economic, regulatory and political pressures to limit or
reduce the cost of our products.
In 2010, the US enacted the ACA, a comprehensive health reform law
that expands insurance coverage, implements delivery system reforms
and places a renewed focus on cost and quality. In terms of specific
provisions impacting our industry, the law mandates higher rebates and
discounts on branded drugs for certain Medicare and Medicaid patients
as well as an industry-wide excise fee. Implementation of several health
system delivery reforms included in the ACA has commenced and will
continue through 2018. The ACA expands the patient population eligible
for Medicaid and provides new insurance coverage for individuals through
state and federally operated health insurance exchanges. In general,
patients enrolled in the exchanges are subject to higher cost sharing
obligations and may not have as robust access to prescription drugs as
compared to patients enrolled in Medicare Part D or commercial plans.
Based, in part, on the impact of ACA to other healthcare sectors, there
is ongoing scrutiny of the US pharmaceutical industry that could result
in further government intervention and financial constraint. Many
stakeholders, including some in Congress and others in the broader
healthcare system, such as health plans, have dramatically increased their
criticism over the value of medicines in the US and have placed a stronger
emphasis on innovative therapies. Such criticism and focus on the value of
medicines has resulted in proposed policy and legislative changes at the
state and federal levels aimed at imposing price controls on medicines and
increasing price transparency. For more information, please see Regulatory
requirements and Pricing of medicines in the Marketplace section from
page 13 and page 14, respectively.
In the EU, efforts by the EC to reduce inconsistencies and improve
standards in the disparate national pricing and reimbursement systems met
with little immediate success as Member States guard their right to make
healthcare budget decisions. The industry continues to be exposed in
Europe 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. Recent controversy regarding the high price of a drug marketed by
one of our competitors for chronic hepatitis C may provoke further EU
collaboration and may eventually lead to a change in the overall pricing and
reimbursement landscape.
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.
Further information regarding these pressures is contained in Regulatory
requirements and Pricing of medicines in the Marketplace section from
page 13 and page 14, respectively.
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.
While new patients entering the US healthcare system due to the ACA
may lead to a slight increase in prescription drug utilisation, we expect
that our financial and other costs resulting from the ACA, many of which
we are unable to accurately estimate, will far outweigh any increase in
Product Sales.
The continued disparities in EU and US pricing systems could lead
to marked price differentials between markets, 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.
Increased transparency of net prices and strengthened collaboration by
governments may accelerate the development of further cost containment
policies (such as procurement or the comparison of net prices etc).
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 counterfeit and/or illegally diverted
products replace sales of genuine products; or genuine products are
recalled following discovery of counterfeit products; or products which
have been the subject of theft or illegal diversion are recalled; or illegally
diverted products replace sales of products which are approved/allowed
for sale in a market.
AstraZeneca Annual Report and Form 20-F Information 2015
219
Additional Information Risk continued
Commercialisation risks
Impact
Increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation
There is an increasing global focus on the implementation and enforcement
of anti-bribery and anti-corruption legislation.
For example, 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 and other
countries are also enforcing their own anti-bribery laws more aggressively
and/or adopting tougher new measures.
We are the subject of current anti-corruption investigations and there can
be no assurance that we will not, from time to time, continue to be subject
to informal inquiries 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 27 to the Financial
Statements from page 186.
Failure to adhere to applicable laws, rules and regulations
Any failure to comply with applicable laws, rules and regulations may result
in civil and/or criminal legal proceedings being filed against us, or in us
becoming subject to regulatory sanctions. Regulatory 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.
Failure of information technology 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 loss of clinical trial
records (patient names and treatments), personal information (employee
bank details, home address), intellectual property of 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 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.
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.
Failure to comply with applicable laws, including ongoing control and
regulation, could materially adversely affect our business or results of
operations. 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. For example, if regulatory issues concerning
compliance with 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 and our reputation.
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 have invested 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.
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.
The inability to effectively backup 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.
220
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information Commercialisation risks
Impact
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.
Failure of outsourcing
We have outsourced various business-critical operations to third party
providers. This includes certain R&D processes, IT systems, HR and
finance, tax and accounting services.
If inappropriately managed, the expected value of these initiatives could be
lost through low employee engagement and hence productivity, increased
absence and attrition levels, and industrial action.
Our failure to successfully implement these planned cost-reduction
measures, either through the successful conclusion 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.
The failure of outsource providers to deliver timely services, and to the
required level of quality, and the failure of outsource providers to co-operate
with each other, could materially adversely affect our financial condition or
results of operations. In addition, such failures could adversely impact our
ability to meet business targets, maintain a good reputation within the
industry and with stakeholders, and result in non-compliance with
applicable laws and regulations.
A failure to successfully manage and implement the integration of IT
infrastructure services provided by our outsource providers could create
disruption, which could materially adversely affect our business or results
of operations.
In addition, failure to manage outsourcing or insourcing transition
processes may disrupt our business. For instance, as we transition
services that previously were outsourced to our service centre in Chennai
(India), incumbent outsource providers may cease to continue to provide
the same level of resources and quality of service.
Failure to attract and retain key personnel and failure to successfully engage 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. For
example, the success of our science activities depends largely on our
ability to attract and retain sufficient numbers of high-quality researchers
and development specialists. 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.
Our ability to achieve high levels of employee engagement in the workforce,
and hence benefit from strong commitment and motivation, is key to the
successful delivery of our business objectives.
The inability to attract and retain highly skilled personnel, in particular those
in key scientific and leadership positions and those in our talent pools, 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 adversely
impact our business or results of operations.
While we are committed to working on improving drivers of engagement,
such as increasing our employees’ understanding of our strategy and our
ongoing efforts to reduce organisational complexity, our efforts may be
unsuccessful.
AstraZeneca Annual Report and Form 20-F Information 2015
221
Additional Information Risk continued
Supply chain and business execution risks
Impact
Difficulties and delays in the manufacturing, distribution and sale of our products
Manufacturing, forecasting, distribution and sales difficulties may result
in product shortages and significant delays, which may lead to lost Product
Sales and materially adversely affect our business, financial condition or
results of operations.
Third party supply failure could lead to significant delays and/or difficulties
in obtaining goods and services on commercially acceptable terms and/or
adversely affect AstraZeneca’s reputation. This may materially adversely
affect our business, financial condition or results of operations.
Loss of access to sufficient sources of key goods and biological materials
or services may interrupt or prevent planned research activities and/or
increase our costs. Further information is contained in Working with
suppliers in Manufacturing and Supply on page 47.
Slight variations in any part of the manufacturing process or
components may lead to a product that does not meet its stringent
design specifications. Failure to meet these specifications may lead to
recalls, spoilage, drug product shortages, regulatory action and/or
reputational harm.
We may experience difficulties and delays in manufacturing our products,
such as:
> Supply shortages associated with gaps between forecasted and actual
demand for products.
> 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 related to the construction of new facilities or the expansion of
existing facilities, including those intended to support future demand for
our products.
> 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.
Reliance on third party goods and services
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), 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.
Unexpected events and/or events beyond our control could result in the
failure of the supply of goods and services. For example, suppliers of key
goods may cease to trade or experience supply chain failures such as
those described under the risk above. In addition, we may experience
limited supply of biological materials, such as cells, animal products or
by-products. Furthermore, government regulations could result in restricted
access to, use or transport of such materials.
Manufacturing biologics
Manufacturing biologics, especially in large quantities, is complex and may
require the use of innovative technologies to handle living micro-organisms
and facilities specifically designed and validated for this purpose, with
sophisticated quality assurance and control procedures.
Final market release of a biologic depends on a number of in-process
manufacturing and supply chain parameters to ensure the product
conforms with its safety, identity and strength requirements and meets its
quality and purity characteristics.
Biologics production facilities, especially for drug substance manufacture,
are very specialised and can take years to develop and bring on line as
licensed facilities. Predicting demand for certain classes of biologics,
especially prior to launch, can be challenging. We expect that external
capacity for biologics drug substance production will remain constrained
for the next several years and, accordingly, may not be readily available for
supplementary production in the event that we experience unforeseen
need for such capacity.
222
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information 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 27 to the Financial Statements
from page 186 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 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 applicable laws, rules and regulations relating to anti-competitive behaviour
Any failure to comply with laws, rules and regulations relating to
anti-competitive behaviour may expose us to regulatory sanctions
and/or lawsuits from governmental authorities and private, non-
governmental entities.
Certain of our commercial arrangements with generics companies, which
have sought to settle patent challenges on terms acceptable to both
innovator and generics manufacturer, may be subject to challenge by
competition authorities.
Details of material litigation matters which raise allegations of anti-
competitive behaviour can be found in Note 27 to the Financial Statements
from page 186.
Where a government authority investigates our adherence to competition
laws, or we become subject to private party lawsuits, this may result in
inspections of our sites or requests for documents and other information.
Competition investigations or legal proceedings could be costly, divert
management attention or damage our reputation and demand for
our products.
Unfavourable resolution of such current and similar future proceedings
against us could subject us to fines and penalties, including enhanced
(ie up to treble) damages, require us to make significant provisions in our
accounts relating to legal proceedings and could materially adversely affect
our business results of operations, including, by requiring us to change
our commercial practice.
Substantial product liability claims
Any failure to comply with laws, rules and regulations relating to the
manufacturing, design, and provision of appropriate warnings concerning
the dangers and risks of our medicines that result in injuries allegedly
caused by the use of our medicines 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 27
to the Financial Statements from page 186.
Significant product liability claims can result in requests for documents
and other information. These legal proceedings 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 226.
AstraZeneca Annual Report and Form 20-F Information 2015
223
Additional Information Risk continued
Legal; regulatory and compliance risks
Impact
Failure to adhere to applicable laws, rules and regulations relating to environment, health and safety; environmental and
occupational health and safety liabilities
Any failure to comply with laws, rules and regulations relating to the
environment or occupational health or safety may expose us to regulatory
sanctions and/or lawsuits from governmental authorities and private,
non-governmental entities. Additionally, the failure to adequately anticipate
and proactively manage emerging policy and legal developments
associated with the environment, health and safety could adversely affect
our licence to operate and/or reputation.
We have environmental and/or occupational health and safety-related
liabilities at some currently and formerly owned, leased and third party
sites, the most significant of which are detailed in Note 27 to the Financial
Statements from page 186.
While we carefully manage compliance and any known liabilities, and
work to stay ahead of policy and legislative developments, if a significant
compliance issue, environmental, occupational health or safety incident
or legal requirement for which we are responsible were to arise, this could
result in us being responsible for fines and penalties, damages, and other
costs. In some circumstances, such liability could materially adversely
affect our business or results of operations. In addition, our financial
provisions for any obligations that we may have relating to environmental
or occupational health and safety liabilities may be insufficient if the
assumptions underlying the provisions, including for example our
assumptions regarding the portion of waste at a site for which we are
responsible, prove incorrect or if we are held responsible for additional
contamination or occupational health and safety-related claims.
Misuse of social media platforms and new technology
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 or 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.
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, for example, 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, as well as additional legal
obligations. Similarly, the involuntary public disclosure of commercially
sensitive information, such as trade secrets through external media
channels, or an information loss could adversely affect our business or
results of operations. In addition, negative posts or comments on social
media websites or other digital channels or new forms of technology about
us or, for example, the safety of our products, could harm our reputation.
224
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information Economic and financial risks
Impact
Failure to achieve strategic priorities or to meet targets or 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 risks and uncertainties that we are unaware of and/or that
are beyond our control.
Any failure to successfully implement our business strategy 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.
Adverse impact of a sustained economic downturn
A variety of significant risks may arise from a sustained global economic
downturn including for example the economic slowdown in China, our
second largest market. Additional pressure from governments and other
healthcare payers on medicine prices and volumes of sales in response to
recessionary pressures on budgets may cause a slowdown or a decline in
growth in some markets. In some cases, those governments 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.
In addition, our customers may cease to trade, which may result in
losses from writing off debts, or the sustained economic downturn
may unfavourably affect the spending patterns of the consumers of
our 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 95% of our cash investments are managed centrally and are
invested in collateralised bank deposits or 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 and financial institution default risk.
Fluctuations in exchange rates
As a global business, currency fluctuations can significantly affect our
results of operations, which are reported in US dollars. Approximately
40% of our global 2015 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, Australian dollar
and Canadian dollar. We have a growing exposure to Emerging Market
currencies, some of which are subject to exchange controls, and these
currencies, such as that of Venezuela, may be subject to material
devaluations against the US dollar. Major components of our cost base
are located in the UK and Sweden, where an aggregate of approximately
20% of our employees are based.
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.
While we have adopted cash management and treasury policies to
manage this risk (see the Financial risk management policies section of the
Financial Review on 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 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 Group 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 on page 76.
Movements in the exchange rates used to translate foreign currencies
into US dollars may materially adversely affect our financial condition or
results of operations. Additionally, 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 dates and the
settlement dates for these transactions. In addition, there are foreign
exchange differences arising on the translation of equity investments
in subsidiaries.
AstraZeneca Annual Report and Form 20-F Information 2015
225
Additional Information Risk continued
Economic and financial risks
Impact
Limited third party insurance coverage
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 in recent years, we have continued to adjust our coverage
profile, accepting a greater degree of uninsured exposure. The Group 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 27 to the
Financial Statements from page 186 for details.
Taxation
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.
AstraZeneca’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.
Pensions
Our pension obligations are largely backed by assets invested across the
broad investment market. Our most significant obligations relate to the UK
pension fund.
If we are found to have a financial liability 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, this could require us to
make significant provisions in our accounts relating to legal proceedings
and could materially adversely affect our business or results of operations.
For more information, please see the Substantial product liability claims
risk on page 223.
The resolution of these disputes 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 and EPS. Claims, regardless of
their merits or their outcome, are costly, divert management attention and
may adversely affect our reputation.
If any of these double tax treaties should be withdrawn or amended,
especially in a territory where a member of the 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
business or results of operations, as could a negative outcome of a tax
dispute or a failure by the 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 27 to the Financial Statements on page 186 for details of current
tax disputes.
Changes in tax regimes could result in a material impact on the Group’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 OECD, governments and tax authorities through
public consultations to ensure international institutions and governments
understand the business implications of law changes. Specific OECD
BEPS recommendations that we expect to impact the Group include
changes to patent box regimes, restrictions of interest deductibility and
revised transfer pricing guidelines.
Sustained falls in these asset values could reduce pension fund solvency
levels, which may result in requirements for additional cash, restricting the
cash available for business growth. Similarly, 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. See Note 20 to the Financial Statements from page 166 for
further details of the Group’s pension obligations.
226
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information Geographical Review
This section contains further information about the performance of our products within
the geographical areas in which our sales and marketing efforts are focused. Sales
relates to Product Sales.
Our financial performance – Product Sales
US
Europe
Established ROW
Emerging Markets
Total
Respiratory, Inflammation and Autoimmunity
Sales
$m
9,474
5,323
3,022
5,822
23,641
2015
Actual
growth
%
CER
growth
%
Sales
$m
10,120
6,638
3,510
5,827
(6)
(6)
–
12
(1)
26,095
(6)
(20)
(14)
–
(9)
2014
2013
Actual
growth
%
CER
growth
%
4
–
(12)
8
1
4
(1)
(4)
12
3
Sales
$m
9,691
6,658
3,973
5,389
25,711
Established ROW
Emerging Markets
Prior year
World
CER
growth
%
Actual
growth
%
US
Actual
growth
%
Sales
$m
(3)
1,520
Europe
CER
growth
%
Actual
growth
%
(26)
(28)
(14)
(13)
n/m
n/m
–
–
n/m
n/m
Sales
$m
404
88
9
–
1
Actual
growth
%
CER
growth
%
(12)
(9)
2
4
n/m
n/m
–
–
n/m
n/m
Sales
$m
394
609
2
–
–
Sales
$m
1,076
117
76
–
26
88
1
(5)
n/m
n/m
–
(31)
1,945
11
1,383
(20)
(21)
(6)
(7)
25
527
(7)
(9)
4
5
127
1,132
Actual
growth
%
CER
growth
%
6
28
22
35
n/m
n/m
–
–
(9)
15
–
–
(1)
25
World
sales
$m
3,801
946
13
–
–
303
5,063
2015
Symbicort
Pulmicort
Tudorza/Eklira
Daliresp
Duaklir
Others
Total
2014
Symbicort
Pulmicort
Tudorza/Eklira
Others
Total
Sales
$m
3,394
1,014
190
104
27
258
4,987
Sales
$m
3,801
946
13
303
5,063
(11)
7
n/m
n/m
n/m
(15)
(2)
200
103
104
–
18
15
n/m
n/m
n/m
(5)
7
World
CER
growth
%
10
11
Actual
growth
%
9
9
n/m
n/m
(7)
8
(6)
10
Sales
$m
1,511
211
–
26
1,748
US
Actual
growth
%
Sales
$m
Actual
growth
%
23
1,462
(6)
–
(55)
15
162
13
110
1,747
Europe
CER
growth
%
(4)
(6)
(3)
(5)
n/m
n/m
(4)
(2)
(5)
(4)
Established ROW
Actual
growth
%
CER
growth
%
8
(13)
–
(18)
2
17
(6)
–
(15)
11
Sales
$m
458
97
–
27
582
Emerging Markets
Prior year
Sales
$m
370
476
–
140
986
Actual
growth
%
CER
growth
%
14
32
–
16
22
22
35
–
19
27
World
sales
$m
3,483
867
–
327
4,677
AstraZeneca Annual Report and Form 20-F Information 2015
227
Additional Information Geographical Review continued
Cardiovascular and Metabolic diseases
World
CER
growth
%
Actual
growth
%
US
Actual
growth
%
Sales
$m
(3)
2,844
(3)
2
4
44
35
137
(15)
2
(2)
(15)
(14)
420
89
240
482
261
34
209
–
1
54
(13)
(2)
64
29
114
(23)
5
–
(88)
(21)
(9)
(4)
(6)
30
32
119
(29)
(3)
(6)
(27)
(22)
(3)
Sales
$m
916
141
97
230
81
126
105
62
13
37
93
Europe
CER
growth
%
Actual
growth
%
(24)
(9)
(22)
–
42
91
(38)
(23)
(32)
(23)
(30)
(17)
(9)
8
(6)
18
65
126
(26)
(11)
(16)
(8)
(17)
(1)
4
4,634
4
1,901
World
CER
growth
%
Actual
growth
%
US
Actual
growth
%
Sales
$m
Sales
$m
Actual
growth
%
Europe
CER
growth
%
(2)
(1)
2,918
–
1,200
(2)
(3)
117
1
68
191
n/m
(18)
59
(4)
(18)
(8)
11
119
4
70
191
n/m
(16)
59
(4)
(15)
(7)
12
481
91
146
374
122
44
199
–
8
68
4,451
Sales
$m
28
356
6
1
19
70
15
19
514
Sales
$m
26
340
–
5
15
25
411
82
(31)
100
185
100
(39)
31
–
(47)
36
17
US
Actual
growth
%
8
5
n/m
(80)
27
n/m
n/m
(24)
25
US
Actual
growth
%
13
5
–
–
150
–
7
155
124
231
57
66
169
81
19
48
133
2,283
Sales
$m
171
207
128
30
49
23
4
23
635
Sales
$m
226
245
166
42
76
33
788
177
(5)
42
235
n/m
(25)
125
(10)
(6)
(19)
9
175
(4)
40
235
n/m
(26)
119
(10)
(6)
(19)
8
Europe
CER
growth
%
Actual
growth
%
(24)
(15)
(22)
(29)
(36)
n/m
n/m
(30)
(19)
(12)
2
(8)
(14)
(24)
n/m
n/m
(18)
(4)
Europe
CER
growth
%
Actual
growth
%
(10)
11
(6)
(21)
(18)
14
(4)
(12)
10
(7)
(21)
(19)
14
(6)
66
12
37
8
32
26
22
7
40
13
834
Sales
$m
667
59
19
33
5
17
43
27
9
54
18
951
Established ROW
Emerging Markets
Prior year
Sales
$m
571
Actual
growth
%
CER
growth
%
(14)
(1)
Sales
$m
686
Actual
growth
%
CER
growth
%
(6)
27
(2)
70
2
41
9
91
125
n/m
150
n/m
(21)
15
(4)
(22)
(12)
–
(4)
30
–
(10)
(5)
11
World
sales
$m
5,512
820
758
476
440
225
501
327
249
161
333
9,802
12
(37)
12
60
88
(40)
(19)
(22)
(26)
(28)
(12)
27
(26)
33
80
124
(30)
(7)
(11)
(15)
(17)
159
512
112
9
73
193
23
213
40
100
1
2,120
Established ROW
Actual
growth
%
CER
growth
%
(17)
(10)
Emerging Markets
Prior year
Sales
$m
727
Actual
growth
%
CER
growth
%
7
11
World
sales
$m
5,622
195
(21)
94
n/m
n/m
(39)
145
(10)
(30)
(28)
(11)
210
(13)
106
n/m
n/m
(35)
164
(10)
(23)
(24)
(3)
125
524
66
4
20
245
20
221
51
114
2,117
238
13
120
100
n/m
1
186
(3)
(6)
(7)
13
251
17
133
100
n/m
5
200
(3)
(4)
(5)
17
378
750
283
151
10
611
206
260
197
362
8,830
Established ROW
Emerging Markets
Prior year
Sales
$m
Actual
growth
%
CER
growth
%
Sales
$m
Actual
growth
%
CER
growth
%
272
54
137
131
79
–
–
60
733
Sales
$m
322
59
177
169
108
48
883
(16)
(8)
(23)
(22)
(27)
–
–
25
(17)
(2)
5
(10)
(11)
(17)
–
–
44
(4)
Established ROW
Actual
growth
%
CER
growth
%
(13)
(5)
(12)
(25)
(30)
(20)
(18)
(6)
3
(4)
(18)
(24)
(13)
(11)
345
87
272
105
103
1
–
30
943
Sales
$m
350
76
280
104
99
36
945
World
sales
$m
924
720
623
320
298
–
–
142
3,027
(2)
14
(3)
1
4
n/m
–
(17)
–
27
49
4
9
16
n/m
–
–
18
Emerging Markets
Prior year
Actual
growth
%
CER
growth
%
–
3
4
12
1
29
4
4
14
6
14
5
36
8
World
sales
$m
996
681
647
376
351
142
3,193
2015
Crestor
Onglyza/Kombiglyze XR/
Komboglyze
Seloken/Toprol-XL
Brilinta/Brilique
Bydureon
Farxiga/Forxiga
Atacand
Byetta
Plendil
Tenormin
Others
Total
2014
Crestor
Onglyza/Kombiglyze XR/
Komboglyze
Seloken/Toprol-XL
Brilinta/Brilique
Bydureon
Farxiga/Forxiga
Atacand
Byetta
Plendil
Tenormin
Others
Total
Oncology
Sales
$m
5,017
786
710
619
580
492
358
316
233
118
260
9,489
Sales
$m
5,512
820
758
476
440
225
501
327
249
161
333
9,802
2015
Zoladex
Faslodex
Iressa
Casodex
Arimidex
Lynparza
Tagrisso
Others
Total
2014
Zoladex
Faslodex
Iressa
Casodex
Arimidex
Others
Total
Sales
$m
Actual
growth
%
World
CER
growth
%
816
704
543
267
250
94
19
132
2,825
Sales
$m
924
720
623
320
298
142
3,027
(12)
(2)
(13)
(17)
(16)
n/m
n/m
(7)
(7)
7
9
(2)
(6)
(5)
n/m
n/m
6
7
World
CER
growth
%
Actual
growth
%
(7)
6
(4)
(15)
(15)
–
(5)
(4)
7
(1)
(10)
(12)
4
(2)
228
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information Infection, Neuroscience and Gastrointestinal
Infection
2015
Synagis
FluMist/Fluenz
Merrem/Meronem
Others
Total
2014
Synagis
FluMist/Fluenz
Merrem/Meronem
Others
Total
Neuroscience
2015
Seroquel XR
Seroquel IR
Local Anaesthetics
Vimovo
Movantik/Moventig
Others
Total
2014
Seroquel XR
Seroquel IR
Local Anaesthetics
Vimovo
Others
Total
Gastrointestinal
2015
Nexium
Losec/Prilosec
Others
Total
2014
Nexium
Losec/Prilosec
Others
Total
World
CER
growth
%
Actual
growth
%
(26)
(26)
(2)
(5)
(24)
(18)
–
11
(17)
(15)
World
CER
growth
%
Actual
growth
%
(15)
20
(14)
(13)
(10)
(15)
20
(10)
(10)
(9)
World
CER
growth
%
Actual
growth
%
(16)
40
(20)
(13)
(12)
56
(6)
2
n/m
n/m
(21)
(12)
(10)
(3)
World
CER
growth
%
Actual
growth
%
(9)
(48)
(4)
5
(7)
(12)
(8)
(46)
–
9
(4)
(10)
World
CER
growth
%
Actual
growth
%
(32)
(19)
(27)
(30)
(26)
(10)
(24)
(24)
World
CER
growth
%
Actual
growth
%
(6)
(13)
(16)
(7)
(4)
(11)
(16)
(5)
Sales
$m
662
288
241
59
1,250
Sales
$m
900
295
253
78
1,526
Sales
$m
1,025
250
392
84
29
332
2,112
Sales
$m
1,224
178
488
96
420
2,406
Sales
$m
2,496
340
142
2,978
Sales
$m
3,655
422
194
4,271
US
Actual
growth
%
(43)
(6)
167
(41)
(30)
US
Actual
growth
%
(19)
10
(45)
(27)
(13)
US
Actual
growth
%
(3)
n/m
–
(90)
n/m
(12)
16
US
Actual
growth
%
(1)
n/m
–
(50)
(24)
(10)
US
Actual
growth
%
(52)
(32)
(17)
(49)
US
Actual
growth
%
(12)
(7)
(21)
(12)
Sales
$m
285
206
16
24
531
Sales
$m
499
218
6
41
764
Sales
$m
716
46
–
1
28
22
813
Sales
$m
738
(72)
–
10
25
701
Sales
$m
902
18
117
1,037
Sales
$m
1,876
28
141
2,045
202
63
136
35
1
84
521
Sales
$m
343
89
197
33
110
772
Sales
$m
284
97
19
400
Sales
$m
368
129
43
540
Europe
CER
growth
%
Actual
growth
%
(6)
9
(23)
(25)
(5)
(6)
16
(10)
(25)
(4)
Europe
CER
growth
%
Actual
growth
%
(9)
67
(35)
–
(6)
(9)
64
(35)
(20)
(6)
Sales
$m
377
76
24
6
483
Sales
$m
401
70
32
5
508
–
7
2
3
12
Sales
$m
–
7
4
9
20
25
34
142
24
–
65
290
Sales
$m
44
36
168
23
84
Europe
CER
growth
%
(30)
(18)
(17)
27
(41)
(29)
(31)
6
n/m
n/m
(24)
(32)
(10)
(20)
Europe
CER
growth
%
Actual
growth
%
(18)
(15)
(4)
3
(4)
(18)
(16)
(5)
3
(5)
(12)
(12)
355
Established ROW
Emerging Markets
Prior year
Sales
$m
Actual
growth
%
CER
growth
%
Sales
$m
Actual
growth
%
CER
growth
%
–
–
(50)
(67)
(40)
–
14
(50)
(22)
(15)
–
(1)
199
26
224
–
–
(100)
(100)
(6)
13
(4)
10
40
13
World
sales
$m
900
295
253
78
1,526
Established ROW
Actual
growth
%
CER
growth
%
–
75
(20)
(31)
(9)
–
100
(20)
(8)
9
Emerging Markets
Prior year
Sales
$m
–
–
211
23
234
Actual
growth
%
CER
growth
%
–
–
(7)
64
(4)
–
–
(3)
50
–
World
sales
$m
1,060
245
293
89
1,687
Established ROW
Emerging Markets
Prior year
(43)
(6)
(15)
4
–
(22)
(18)
(34)
8
(1)
22
–
(11)
(5)
Established ROW
Actual
growth
%
CER
growth
%
(39)
(66)
(8)
15
(14)
(26)
(35)
(63)
(1)
25
(7)
(20)
82
107
114
24
–
161
488
Sales
$m
99
125
123
30
201
578
World
sales
$m
1,224
178
488
96
–
420
2,406
(18)
(14)
(7)
(20)
–
(20)
(16)
(1)
(5)
6
(10)
–
(10)
(4)
Emerging Markets
Prior year
Actual
growth
%
CER
growth
%
(7)
(17)
1
58
(3)
(5)
–
(13)
9
63
1
1
World
sales
$m
1,337
345
510
91
452
2,735
Sales
$m
Actual
growth
%
Sales
$m
Actual
growth
%
CER
growth
%
Sales
$m
Actual
growth
%
CER
growth
%
Europe
CER
growth
%
Actual
growth
%
(23)
(25)
(56)
(26)
(7)
(10)
(47)
(11)
Europe
CER
growth
%
Actual
growth
%
2
(2)
–
1
2
(2)
–
1
Established ROW
Emerging Markets
Prior year
Sales
$m
549
74
3
626
Sales
$m
606
106
7
719
Actual
growth
%
CER
growth
%
(9)
(30)
(57)
(13)
5
(19)
(57)
1
Established ROW
Actual
growth
%
CER
growth
%
2
(36)
–
(7)
9
(30)
–
1
Sales
$m
761
151
3
915
Sales
$m
805
159
3
967
Actual
growth
%
CER
growth
%
(6)
(5)
–
(5)
3
(1)
33
2
World
sales
$m
3,655
422
194
4,271
Emerging Markets
Prior year
Actual
growth
%
CER
growth
%
2
(1)
–
1
5
1
33
5
World
sales
$m
3,872
486
231
4,589
AstraZeneca Annual Report and Form 20-F Information 2015
229
Additional Information Geographical Review continued
Growth rates in this Geographical
Review are expressed at CER unless
otherwise stated. All commentary in this
section relates to Product Sales.
2015 in brief
> AstraZeneca is the sixth largest
prescription-based pharmaceutical
company in the US, with a 4.5% market
share of US pharmaceuticals by
sales value.
> AstraZeneca is the twelfth largest
prescription-based pharmaceutical
company in Europe, with a 2.5% market
share of sales by value.
> In 2015, sales in the US decreased by 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 declined by 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 14% decline 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. Duaklir more
than doubled its first-half sales in the final
quarter and Lynparza was launched in
Europe in 2015.
> Sales in the Established Rest of World
(ROW) were stable in the year at
$3,022 million (2014: $3,510 million; 2013:
$3,973 million). Japan sales increased
4% at CER to $2,020 million (2014:
$2,227 million; 2013: $2,485 million)
driven by strong growth of Crestor and
Nexium, though there was a decline in
the sales of Symbicort. Canada sales
grew by 4% to $533 million at CER
(2014: $590 million; 2013: $637 million)
in the year driven by increased sales
of Onglyza and Symbicort.
> Emerging Markets sales in the year
increased by 12% to $5,822 million (2014:
$5,827 million; 2013: $5,389 million) with
contributions to 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 by 15%
to $2,530 million (2014: $2,242 million;
2013: $1,840 million), while Brazil sales
grew by 16% at CER to $381 million
(2014: $451 million; 2013: $447 million)
and Russia sales grew by 21% at CER
to $231 million (2014: $312 million; 2013:
$310 million).
2014 in brief
> AstraZeneca was the fourth largest
prescription-based pharmaceutical
company in the US, with a 5.2% market
share of US pharmaceuticals by
sales value.
> AstraZeneca was the tenth largest
prescription-based pharmaceutical
company in Europe, with a 2.8% market
share of sales by value.
> In the US, sales increased by 4% to
$10,120 million (2013: $9,691 million; 2012:
$10,655 million), driven by an increase in
Diabetes franchise sales, aided by the
acquisition of BMS’s 50% interest in the
diabetes alliance, as well as strong
performance across our Growth
Platforms, including Symbicort and
Brilinta, offset by declines in revenue from
Nexium, Seroquel IR and Synagis. Sales
from our Diabetes franchise increased by
$644 million or 109% to $1,234 million.
> Sales in Europe decreased by 1% to
$6,638 million (2013: $6,658 million; 2012:
$7,143 million). Key drivers of the decline
were the ongoing volume erosion on
Atacand and Seroquel XR following
generic entry and the negative price and
volume impacts primarily related to
government pricing interventions. Crestor
volumes declined 3% due to increased
pressure from generic statins in a number
of markets. Symbicort sales decreased to
$1,462 million (2013: $1,502 million; 2012:
$1,465 million) due to pricing pressure
and the impact of Symbicort analogues.
These challenges were partially offset by
our Growth Platforms, including Brilique
growth and the expansion of our Diabetes
portfolio following the acquisition of
BMS’s interest in the joint diabetes
alliance plus continued strong demand
for Fluenz (2014: $70 million; 2013:
$42 million; 2012: $3 million).
> Established Rest of World sales
decreased by 4% to $3,510 million (2013:
$3,973 million; 2012: $5,080 million).
Canada continued to be negatively
impacted by erosion of Crestor and
Nexium sales due to generic competition,
with total sales down 1%. Sales in
Australia were also lower due to generic
competition to Crestor and Atacand.
Sales growth in Japan declined by 3% to
$2,227 million (2013: $2,485 million; 2012:
$2,904 million), as a result of generic
pressure on oncology products, Casodex
and Arimidex, and the impact of the April
2014 mandated biennial price cut. Strong
demand in Japan continued for Nexium
and Crestor, with sales increasing to
$860 million (2013: $815 million; 2012:
$665 million).
> Emerging Markets sales increased by
12% to $5,827 million (2013: $5,389
million; 2012: $5,095 million), with sales
growth in China of 22%. Volume growth
on Brilinta, our Diabetes and Respiratory
franchises, Nexium and Crestor, was
partially offset by pricing pressure,
predominantly in China and Asia Pacific.
US
In 2015, sales in the US decreased by 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 from our
Diabetes franchise increased by $187 million
or 15% to $1,421 million (2014: $1,234
million; 2013: $590 million).
Brilinta sales of $240 million (2014: $146
million; 2013: $73 million) increased 64%
in 2015. Brilinta continued its strong
momentum with significant 2015 growth
in hospital units purchased volume
(+58% November 2015), new-to-brand
prescriptions (39%) and total prescriptions
(48%), supported with our expanded
indication to include long-term use in
patients with a history of heart attack. The
new label nearly doubles the number of
patients indicated for Brilinta in the US and is
highlighted with language that demonstrates
Brilinta’s superiority over Plavix. Brilinta grew
its US branded leadership in oral antiplatelet
(OAP) new-to-brand retail prescription share
which increased by 2.7 percentage points
over 2014 to 10.9% in 2015, and Brilinta also
achieved US branded market leadership in
share of all OAP new prescriptions for the
first time in 2015.
Crestor continued to demonstrate resilience
in the highly competitive statin market,
89.0% of which is generic. In 2015, Crestor
was the highest branded retail prescription
230
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information pill in the US and more than a million new
patients started therapy on Crestor in 2015.
Crestor achieved sales of $2,844 million
(2014: $2,918 million; 2013: $2,912 million)
and a total prescription share within the
statin market of 8.9% in December 2015.
Crestor sales in 2015 were 3% below 2014
sales, with a decrease in volume of 6%
partially offset by higher average net prices
(+3%). Crestor continued to maintain its
strong formulary access, with Commercial/
Medicare preferred access of 85% at the
end of 2015 (2014: 84%; 2013: 84%).
Symbicort pMDI sales at $1,520 million
were in line with 2014 (2014: $1,511 million;
2013: $1,233 million), with volume increases
of 10% and prescription growth of 14.0%
versus 2014 offset by pricing pressures.
Symbicort achieved a 34.0% total
prescription share in the month of
December 2015, up 1.08 percentage points
over the month of December 2014 in the
ICS/LABA market.
In March 2015, we completed our
acquisition of Daliresp and Tudorza from
Forest Laboratories Holdings Ltd (owned
by Actavis). The acquisition granted
AstraZeneca US rights for manufacturing
and commercialisation of these products.
Daliresp achieved sales of $104 million and
Tudorza achieved sales of $103 million for
the 10 months of ownership in 2015.
In February 2014, we completed our
acquisition of BMS’s 50% interest in our
joint diabetes alliance. The acquisition gave
us ownership of the IP and global rights for
the development, manufacturing and
commercialisation of the diabetes business,
which includes Onglyza, Komboglyze,
Kombiglyze XR, Farxiga/Forxiga, Xigduo,
Xigduo XR, Byetta, Bydureon and Symlin.
Onglyza/Kombiglyze XR sales in the US
declined by 13% to $420 million (2014: $481
million; 2013: $265 million) primarily driven
by lower average net price.
Bydureon sales in the US were $482 million
(2014: $374 million; 2013: $131 million).
Bydureon prescription market share
remained static in 2015, with a total
prescription market share of 19.4% of the
rapidly growing GLP-1 market in December
2015. Byetta achieved sales of $209 million
(2014: $199 million; 2013: $152 million).
Farxiga (launched February 2014) and
Xigduo XR (launched November 2014)
accelerated the overall growth of the SGLT2
class of medicines by 79% post-launch1 and
by the end of December 2015, over 407,000
patients were on Farxiga or Xigduo XR since
launch and the Farxiga family captured
nearly one in four new SGLT2 patient
treatment decisions. Our SGLT2 franchise
sales grew by 114% from 2014 to 2015.
Lynparza reached $70 million (2014: $nil)
following the launch of the medicine at the
end of 2014. Growth was driven by the pool
of eligible patients awaiting treatment as well
as patients newly tested for BRCA mutation.
Tagrisso, the only approved medicine
indicated for patients with metastatic EGFR
T790M mutation-positive NSCLC, had sales
of $15 million following the launch in
November 2015.
In 2015, sales of Synagis were down 43% to
$285 million (2014: $499 million; 2013: $617
million). A key driver of the decline was the
continued adoption of guidelines from the
American Academy of Pediatrics Committee
on Infectious Disease that restricted patients
eligible for preventive therapy with Synagis.
FluMist Quadrivalent launched in the US in
2013 as the first and only FDA-approved
nasal spray flu vaccine to help protect
against four strains of influenza. FluMist
revenues in the US were down 6% to
$206 million (2014: $218 million; 2013:
$199 million) driven by delays in supply.
Nexium was the seventh most prescribed
branded pharmaceutical in the US. Nexium
sales in the US declined 52% to $902 million
(2014: $1,876 million; 2013: $2,123 million)
due primarily to volume erosion, pricing
pressure, and recognition of an unfavourable
returns provision following loss of exclusivity.
Despite the entrance of multiple generic
competitors, Nexium remains the branded
market leader retaining significant
prescription market share and volume
within the proton pump inhibitor class, and
maintains greater than 65% share of the
esomeprozole molecule market.
Seroquel IR 2015 sales were $46 million
(2014: negative $72 million; 2013: negative
$17 million). The loss of exclusivity for
Seroquel IR in March 2012 and unfavourable
reserve adjustments for Medicaid liabilities
and provisions taken on channel inventories
resulted in negative sales in 2014 and 2013.
No further adjustments were required in
2015. The presence of generic competition
has also impacted the prescription volume
of Seroquel XR. Sales of Seroquel XR were
down 3% to $716 million (2014: $738 million;
2013: $743 million) driven by lower volume.
Movantik launched in March 2015 and
achieved US sales of $28 million. In
March 2015, the Company announced
a co-commercialisation agreement with
Daiichi Sankyo for Movantik in the US.
Movantik share among chronic opioid
patients starting a new branded Rx laxative
(NBRx) in the final quarter of 2015 was 29%.
The Affordable Care Act (ACA), which was
enacted in March 2010, has had, and is
expected to continue to have, a significant
impact on our US sales and the US
healthcare industry as a whole. In 2015, the
overall measurable reduction in our profit
before tax for the year due to discounts on
branded pharmaceutical sales to Medicare
Part D beneficiaries and an industry-wide
excise fee was $786 million (2014: $714
million; 2013: $557 million). This amount
reflects only those effects of the ACA that
we know have had or will have a direct
impact on our financial condition or results
of operations and which we are therefore
able to quantify based on known and
isolatable resulting changes in individual
financial items within our Financial
Statements. There are other potential
indirect or associated consequences of the
implementation of the ACA, which continue
to evolve and which cannot be estimated
but could have similar impacts. These
include broader changes in access to, or
eligibility for, coverage under Medicare,
Medicaid or similar government
programmes. These could indirectly impact
our pricing or sales of prescription products
within the private sector. By their nature and
the fact that these potentially numerous
consequences are not directly linked to a
corresponding and quantifiable impact on
our Financial Statements, it is not possible
to accurately estimate the financial impact
of these potential consequences of the ACA
or related legislative changes when taken
together with the number of other market;
and industry-related factors that can also
result in similar impacts. Further details on
the impact of the ACA are contained in
Pricing of medicines from page 14 and in
Risk from page 212.
Currently, there is no direct governmental
control of prices for commercial prescription
drug sales in the US. However, some
publicly funded programmes, such as
Medicaid and TRICARE (Department of
Defense), have statutorily mandated rebates
AstraZeneca Annual Report and Form 20-F Information 2015
231
Additional Information Geographical Review continued
and discounts that have the effect of price
controls for these programmes. Additionally,
pressure on pricing, availability and use of
prescription drugs for both commercial and
public payers continues to increase. This is
driven by, among other things, an increased
focus on generic alternatives. Budgetary
policies within healthcare systems and
providers, including the use of generics only
formularies, and increases in patient
co-insurance or co-payments, are the
primary drivers of increased generics use.
In 2015, 84.0% of prescriptions dispensed
in the US were generic. While widespread
adoption of a broad national price-control
scheme in the near future is unlikely,
increased focus on pharmaceutical prices
and their impact on healthcare costs is likely
to continue for the foreseeable future.
Rest of World
Sales of $14,167 million (2014: $15,975
million; 2013: $16,020 million) outside the
US in 2015 was up by 2% at CER but
negatively impacted on a Reported basis
by movements in underlying currencies.
Emerging Markets delivered a strong
performance, up 12% with sales of $5,822
million (2014: $5,827 million; 2013: $5,389
million), with Japan and Canada also
generating increased sales at CER. Europe
and Other Established ROW sales were
down at 6% and 19% respectively reflecting
the competition from generic products and
the continuing challenging economic
environment, partially offset by the
performance of Growth Platforms.
Europe
AstraZeneca is the twelfth largest
pharmaceutical company in Europe,
with a 2.5% market share of prescription
sales by value.
Despite a slight improvement in conditions,
the macroeconomic environment remains
challenging, with the ongoing impact of
austerity measures leading to increased
pressure on healthcare budgets. Many
governments in Europe intervene directly
to control the price, volume and
reimbursement of medicines. Several
governments have imposed price
reductions and increased the use of generic
medicines as part of healthcare expenditure
controls. A number of countries are applying
strict criteria for cost-effectiveness
evaluations of medicines, which contributes
to a difficult environment for branded
pharmaceuticals in Europe.
Total sales in Europe were down 6% to
$5,323 million (2014: $6,638 million; 2013:
$6,658 million). Volume erosion on Seroquel
XR and Atacand following generic entries
resulted in a decrease in sales of 29% to
$307 million (2014: $512 million; 2013: $641
million). Crestor sales declined 9%, with a
7% reduction in volumes and 2% reduction
in prices as a result of increased competition
from generic statins in a number of
countries, including France and Italy.
Government interventions continue to
impact both price and volume negatively.
Our Growth Platform sales partially offset
these trends. Brilique sales increased 18%
at CER to $230 million (2014: $231 million;
2013: $163 million). Our Diabetes franchise
generated sales of $410 million (2014: $359
million; 2013: $119 million). Respiratory
sales were negatively impacted by pricing
pressure on Symbicort and the impact of
Symbicort analogues, with sales declining
to $1,076 million (2014: $1,462 million; 2013:
$1,502 million), as volumes fell by 3% and
prices fell by 11%.
In Germany, sales increased by 4% to
$601 million (2014: $693 million; 2013:
$657 million), driven by strong growth
across the Diabetes portfolio and continued
growth with Brilique. Total Diabetes sales
reached $126 million in 2015 (2014: $108
million; 2013: $32 million). Overall growth
was partly offset by the ongoing impact
of pricing and generic versions of Atacand
and Seroquel XR.
In the UK and Ireland, sales decreased by
18% to $633 million (2014: $832 million;
2013: $766 million), driven by ongoing
volume erosion on Seroquel XR following
generic entries and a decline in Zoladex
sales to $58 million (2014: $83 million; 2013:
$94 million). Diabetes sales decreased to
$61 million in 2015 (2014: $68 million; 2013:
$27 million) and Brilique sales marginally
decreased to $28 million (2014: $30 million;
2013: $18 million).
Sales in France decreased by 9% to $922
million (2014: $1,213 million; 2013: $1,212
million), driven by price and volume erosion
on Atacand and Zoladex, following generic
entries and subsequent government pricing
interventions. Increased pressure from
generic statins has adversely affected
Crestor, with sales down 12% to
$298 million (2014: $404 million; 2013:
$428 million). At constant exchange rates,
France experienced growth of Brilique with
$29 million of sales (2014: $30 million; 2013:
$18 million) and Diabetes with $50 million of
sales (2014: $52 million; 2013: $20 million).
Sales in Italy decreased by 5% to
$544 million (2014: $688 million; 2013:
$737 million), mainly driven by generic
entries, pricing intervention and the
implementation of volume prescription
controls associated with existing and
new austerity measures.
Sales in Spain increased by 3% at CER
to $426 million (2014: $497 million; 2013:
$507 million), mainly driven by strong
growth across the Growth Platforms.
Established ROW2
Established ROW sales of $3,022 million
were flat at CER (2014: $3,510 million; 2013:
$3,973 million). The key products with sales
growth in Established ROW in 2015 were
Nexium, Symbicort, Brilinta, and Onglyza.
Japan
Sales in Japan were $2,020 million,
increasing by 4% at CER but negatively
impacted on a Reported basis by the
revaluation of the Japanese yen (2014:
$2,227 million; 2013: $2,485 million).
Nexium achieved sales of $405 million
(2014: $358 million; 2013: $278 million).
Crestor sales grew by 8% at CER to
$468 million (2014: $502 million; 2013:
$537 million), retaining its position as the
number one brand in the statin market in
Japan. Symbicort sales at $176 million
(2014: $207 million; 2013: $175 million)
decreased by 2%, achieving a market
share of 39.4%.
Sales were also negatively impacted by
generic competition for our non-promoted
oncology products.
Canada
Canada returned to growth in 2015 driven
by the strong performance of Symbicort
and the Diabetes portfolio (including the
launch of Forxiga in January 2015).
Canadian sales increased by 4% at CER
to $533 million (2014: $590 million; 2013:
$637 million).
232
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information the Russian Federation. The Russian market
grew by 12% during 2015. AstraZeneca’s
growth came from Iressa, Pulmicort and
Brilinta. We have 559 clinical trial sites in 46
cities. Our new production facility in Vorsino
is expected to commence commercial
production in early 2016.
The Latin American pharmaceutical market
continues to grow. However, in many
countries, growth is being predominantly
captured by generics, branded generics
and private label product offerings. Sales
were up 15% to $1,024 million (2014: $1,181
million; 2013: $1,188 million) driven principally
by Brazil, which grew by 16% to $381 million
(2014: $451 million; 2013: $447 million),
following successful launch of Forxiga and
continued strong uptake of Brilinta. Sales in
Argentina also grew rapidly by 37% driven
by strong growth in Diabetes, Brilinta and
Respiratory. The Mexico prescription drug
market continues to grow. Sales grew by
11% at CER to $195 million (2014: $210
million; 2013: $206 million), driven by the
Diabetes and Respiratory Growth Platforms.
In the Middle East and Africa, despite
political challenges arising from geopolitical
and broader political conflict, sales grew by
13%, driven by strong growth in Egypt,
Saudi Arabia, the Gulf States, and several
Emerging Markets in Africa as well as steady
growth in Turkey. Sales in South Africa were
flat and declined by 13% in Tunisia reflecting
local market conditions. Sales of $889
million in Asia were in line with 2014 at CER
(2014: $948 million; 2013: $900 million).
Double digit growth in Vietnam, Indonesia,
Malaysia and India were offset by sales
decreases due to price erosions incurred
by loss of exclusivity in Taiwan and Korea.
Launches in Emerging Markets in 2015
included: Forxiga in India, Colombia,
Ecuador, and Taiwan; Bydureon in Mexico;
and Zinforo in Mexico.
1 Growth based on Invokana trend pre Farxiga launch,
and the composition of Farxiga and Invokana to
18 December 2015 (excluding holidays) to derive the
impact on SGLT2 class.
2 Canada, Japan, Australia and New Zealand.
3 Australia and New Zealand.
4 Emerging Markets excluding China.
Other Established ROW3
Sales in Other Established ROW declined
by 19% to $469 million (2014: $693 million;
2013: $851 million). Sales in Australia
declined by 21% to $435 million (2014: $658
million; 2013: $817 million) due to continued
volume erosion on Crestor and Atacand
following generic entries in 2013 and pricing
pressure on other mature brands (Seroquel
and Arimidex). Nexium sales in Australia
declined following the loss of exclusivity
in Australia in August 2014.
Emerging Markets
In Emerging Markets, sales increased by
12% to $5,822 million (2014: $5,827 million;
2013: $5,389 million), which was principally
driven by growth in China, Russia, Brazil
and Argentina, and growth across a broad
range of markets in our strategic Growth
Platforms – Brilinta, and our Diabetes and
Respiratory franchises.
In many of the larger markets, such as Brazil
and Mexico, patients tend to pay directly for
prescription medicines and consequently,
these markets are at less risk of direct
government interventions on pricing and
reimbursement. In other markets, such as
South Korea, Taiwan and Turkey, where
governments pay for medicines, we are
seeing continued efforts to reduce the cost
of prescriptions in line with the efforts in
Europe, Canada and Australia.
China
Sales in China (excluding Hong Kong) grew
by 15% to $2,530 million (2014: $2,242
million; 2013: $1,840 million). AstraZeneca
remained the second largest multinational
pharmaceutical company in China during
2015. Despite the market slowdown, we
saw continued strong sales of Oncology
and Respiratory in particular, with sales
growth of 17% and 38% respectively. We
have continued to make strong progress
on the listing of Brilinta, Byetta and Onglyza
into key hospitals. Brilinta has reached
$38 million in sales. We continue to have
the largest sales force among multinational
pharmaceutical companies in China. The
number of hospitals covered grew by 34%.
Other Emerging Markets4
We continued to build our presence in
Russia, with sales growing by 21% to
$231 million (2014: $312 million; 2013:
$310 million) from strong performance
in the retail segment. To increase access
to our medicines, we established patient
affordability programmes in 50 regions of
AstraZeneca Annual Report and Form 20-F Information 2015
233
Additional Information Sustainability: supplementary information
Summary information about our
commitment and performance in key areas
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.
The Strategy section from page 8
describes how we create value across the
life-cycle of a medicine and highlights our
distinctive capabilities and our strategy.
Our commitment to operating responsibly
underpins all of these efforts. This helps
to ensure the future sustainability of the
Group in a way that adds value for
our stakeholders. The Sustainability
section from page 57 reviews our
sustainability governance and
commitments. These encompass:
> Environmental sustainability: managing
our impact on the environment, across all
our operations, with a particular focus on
carbon emissions, waste and water use
(see page 57).
> Access to healthcare: as we expand our
geographic footprint, exploring ways of
increasing access to healthcare for more
people, tailored locally to different patient
needs (see page 50).
> Responsible research: underpinning
our accelerated drive for innovation with
sound bioethics worldwide and
maintaining a strong focus on patient
safety in everything we do, minimising the
risks and maximising the benefits of all
our medicines throughout R&D, and after
launch (see page 44).
> Ethical business practices:
− Working to consistent global standards
of ethical sales and marketing practices
in all our markets as we work to restore
growth (see page 50).
− Working only with suppliers who have
standards consistent with our own as
we increase our outsourcing to drive
business efficiency (see page 47).
− Making a positive contribution to
our local communities around the
world, through community support
programmes consistent with improving
health and promoting science
(see page 58).
> Being a great place to work:
− Ensuring that diversity in its broadest
sense is reflected in our leadership
and people strategies (see pages 52
and 53).
− Continuing to develop and embed a
consistent approach to human rights
across our worldwide activities (see
page 54).
− Promoting the safety, health and
wellbeing of all our people worldwide
as we continue to drive a high-
performance culture and the
achievement of our business goals
(see page 57).
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
As expectations of stakeholders evolve,
we continue to engage with them and use
the feedback to inform the development
of our sustainability strategy and risk
management planning.
We also use the insights gained from
external surveys to develop our approach
in line with global best practice. A member
of the Dow Jones Sustainability Index (DJSI)
since 2001, we were once again listed in the
2015 World Index (the top 10% of the largest
2,500 companies). We also retained our
listing on the DJSI STOXX – European Index
(the top 20% of the 600 largest European
companies) for the eighth year running (one
of four pharmaceutical companies to do so
out of 14 assessed). We achieved a total
score of 84% (2014: 79%) compared with
a sector best score of 88% (2014: 87%).
We increased individual scores for 14 out
of 24 criteria for 2015 (compared to seven
out of 24 criteria in 2014). These included
corporate governance, code of conduct,
marketing practices, supply chain
management, customer relationship
management, innovation management,
environmental policy management system,
climate strategy, labour practice indicators
and human rights, human capital
development, talent attraction and retention,
occupational health and safety, bioethics
and health outcomes contribution. While
these scores are encouraging, we lost
ground in some areas, including risk and
crisis management, social reporting,
environmental reporting and operational
eco-efficiency, strategy to improve access
to drugs or products, and addressing cost
burden. To understand these lower scores
better, we commissioned an in-depth
external benchmark survey. We will use
the analysis to plan ways to improve in
these areas.
External assurance
Bureau Veritas has provided independent
external assurance to a limited level on the
following sustainability information contained
within this Annual Report
> Patient safety, page 44
> Clinical trials and transparency, page 45
> Research use of human biological
samples, page 45
> Animal research, page 45
> Increasing access to healthcare, page 50
> Healthy Heart Africa, page 51
> Sales and marketing ethics, page 50
> Working with suppliers, page 47
> Natural resource efficiency, page 57
> Develop a strong and diverse pipeline
of leaders, page 53
> Human rights, page 54
> Managing change, page 54
> Employee relations, page 54
> Safety, health and wellbeing, page 57
> Community investment, page 58
> Sustainability, page 57
> Sustainability framework, page 56.
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 us 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.
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.
234
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information Carbon reporting
Global greenhouse gas emissions data for the period 1 January 2015 to 31 December 2015
Emissions from:
Combustion of fuel and operation of facilities2
Electricity, heat, steam and cooling purchased for own use3
Company’s chosen intensity measurement:
Emissions reported above normalised to million US dollar revenue
Supplemental information:
Net electricity, heat, steam and cooling emissions, after write down due to voluntary purchase of electricity supplied
under certified low carbon supply contracts or carbon certificates4
Supply chain emissions:
Upstream emissions from personnel air travel, goods transport and waste incineration
Downstream emissions from HFA propellants released during patient use of our inhaled medicines
2015
2014
2013 1
2012
Tonnes of CO2e
324,300
273,500
328,700
290,300
318,600
274,400
318,700
277,100
24.2
23.7
23.1
21.3
223,700
238,600
238,200
250,800
156,000
508,800
167,900
448,900
155,400
352,000
169,800
299,600
1 Regular review of the data is carried out to ensure accuracy and consistency. This has led to slight changes in the data for previous years. None of the changes are statistically significant. The
data quoted in this Annual Report are generated from the revised data.
2 Included in this section are greenhouse gases from direct fuel combustion, process and engineering emissions at our sites and from fuel use in our vehicle fleet.
3 Greenhouse gases from electricity are calculated using a location-based approach as described in GHG Protocol Scope 2 Guidance (January 2015). Market instruments (US Renewable Energy
Certificates, UK Renewable Energy Guarantees of Origin) are then discounted. This approach is consistent with previous years. In future years Scope 2 emissions reporting will follow the dual
reporting approach.
4 Some electricity supplied to our UK sites has been provided under a green power contract and is backed up with an equivalent quantity of Renewable Energy Guarantees of Origin and some of
the electricity consumed at our US sites is covered by purchase of Renewable Energy Certificates.
The above table provides data on our global
greenhouse gas emissions for 2015.
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 and USEPA
eGRID 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 2015 GHG emissions
data. The assurance statement, including
scope, methodology, overall opinion, and
limitations and exclusions, is available
on our website, www.astrazeneca.com.
AstraZeneca Annual Report and Form 20-F Information 2015
235
Additional Information Financials (Prior year)
Results of operations – summary analysis of year ended 31 December 2014
2014 Reported operating profit – restated
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
Profit before tax
Taxation
Profit for the period
Basic earnings per share ($)
2014 Restated1
Restated1 Percentage of Total Revenue
20141 compared with 20131
2013
CER
growth
$m
833
354
1,187
(572)
615
(23)
(716)
(896)
(136)
(1,156)
Reported
$m
26,095
452
26,547
(5,842)
20,705
(324)
(5,579)
(13,000)
335
2,137
(885)
(6)
1,246
(11)
1,235
0.98
Growth
due to
exchange
effects
$m
Reported
$m
Reported
2014
%
Reported
2013
%
(22.0)
78.0
(1.2)
(21.0)
(49.0)
1.2
8.0
(20.4)
79.6
(1.2)
(18.7)
(47.3)
2.0
14.4
(449)
25,711
3
95
(446)
25,806
(9)
(5,261)
(455)
20,545
5
(42)
102
(29)
(419)
(306)
(4,821)
(12,206)
500
3,712
(445)
–
3,267
(696)
2,571
2.04
CER
growth2
%
3
375
5
11
3
7
15
7
(27)
(31)
Actual
growth
%
1
378
3
11
1
6
16
7
(33)
(42)
1 2014 and 2013 results have been restated to reflect the reclassification of Externalisation Revenue from other operating income and expense as detailed in Group Accounting Policies from page 144.
2 CER growth is calculated using prior year actual results adjusted for certain exchange effects including hedging.
2014 Reconciliation of Reported results to Core results
Gross profit
Product Sales gross margin %3
Total Revenue gross margin %
Distribution costs
Research and development
Selling, general and administrative costs
Other operating income and expense
Operating profit
Operating margin as a % of Total Revenue
Net finance expense
Taxation
Basic earnings per share ($)
2014
Reported
$m
Restructuring
costs
$m
Intangible
amortisation
and
impairments
$m
Acquisition of
BMS’s share
of diabetes
alliance
$m
Legal
provisions
and other
$m
20,705
77.6%
78.0%
(324)
(5,579)
(13,000)
335
2,137
8.0%
(885)
(11)
0.98
107
701
146
–
497
662
292
–
141
811
230
–
–
932
–
1,558
1,883
1,078
–
(255)
1.03
–
(376)
1.19
345
(356)
0.85
–
–
–
379
(98)
281
47
(42)
0.23
2014
Core2
$m
21,659
81.3%
81.6%
(324)
(4,941)
(10,216)
759
6,937
26.1%
(493)
(1,040)
4.28
Core2 20141
compared with 20131
CER
growth
%
4
Actual
growth
%
2
7
15
16
19
6
16
15
15
(13)
(17)
1 2014 and 2013 results have been restated to reflect the reclassification of Externalisation Revenue from other operating income and expense as detailed in Group Accounting Policies from page 144.
2 Each of the measures in the Core column in the above table is a non-GAAP measure.
3 Gross margin as a % of Product Sales reflects gross profit derived from Product Sales, divided by Product Sales.
236
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information All growth rates in this section are
expressed at CER unless otherwise stated.
2014 Product Sales increased 3%
compared with 2013. Accelerating
performance of the Group’s Growth
Platforms more than offset the impact of
volume erosion on mature brands including
Nexium in the US and pricing pressures in
Established Markets. 2014 Product Sales in
the US were up 4% with Europe down 1%.
Established ROW Product Sales were down
4%. Emerging Markets Product Sales were
up 12%, mainly driven by growth in China
of 22%. China became our second largest
market in 2014. Further details of our sales
performance are contained in the
Geographical Review from page 227.
Externalisation Revenue
As detailed in the Financial Review from
page 66, the Group has updated its revenue
accounting policy. Reflecting the increased
level of externalisation activity, Externalisation
Revenue, alongside Product Sales, are now
included in Total Revenue. 2014 and 2013
results have been restated to reflect this
change, resulting in $452 million of income
being reclassified from other operating
income to Externalisation Revenue in 2014
(2013: $95 million).
In mid-2014, the US Internal Revenue
Service issued final regulations that affected
how the annual US Branded Pharmaceutical
Fee, imposed by the health care reform
legislation in 2010, is recognised. Under the
new regulations, the fee is based on actual
sales in the current year which necessitated
an additional year’s charge to be recognised
in 2014. In line with other pharmaceutical
industry peers, we previously accrued for
this charge based on prior year’s sales and
recorded the charge as a cost in SG&A.
The final regulation had two impacts on
the Group’s results in 2014:
> As the fee is now calculated on actual
sales in the current year, AstraZeneca
considers it more appropriate to account
for the fee as a deduction from revenue
rather than a charge to SG&A. The new
legislation was effective from July 2014
and, therefore, AstraZeneca treated the
charge for the period since July 2014 as
a deduction from revenue rather than as
a cost in SG&A. In 2014 this had the
effect of reducing revenue by $113 million.
This presentational change to the income
statement had no impact on earnings
for 2014.
> We recorded a catch-up full annual
> Restructuring costs totalling $1,558 million
charge to SG&A, reflecting this new basis,
in 2014. The additional year’s charge was
excluded from Core financial measures
as detailed below.
Core gross margin as a percentage of
Product Sales in 2014 was 81.3%, 0.4
percentage points lower than 2013 at CER
as the effect of an unfavourable product
mix, including additional costs associated
with the Diabetes brands, more than offset
the benefit of a lower Crestor royalty.
Core R&D expense in 2014 was up
15% reflecting increased spend on our
late-stage pipeline.
Expenditures in core SG&A in 2014 were
16% higher than 2013, driven by
investments in sales and marketing
dedicated to the Group’s Growth Platforms.
The acquisitions of BMS’s share of the
diabetes alliance and the rights to Almirall’s
respiratory franchise in 2014 added
approximately 4,100 employees. The
selective investment in our Growth
Platforms was partially funded by a
decline in G&A costs during 2014.
Core other income in 2014 was up
19% which included royalty income of
$533 million.
The 2014 Core operating profit was
down 13%. Core operating margin in
2014 was 26.1% of Total Revenue, down
6.4 percentage points from 2013. The
decline in Core operating profit was greater
than the decline in Total Revenue primarily
due to expenditure associated with the
Group’s key Growth Platforms and
strengthened pipeline.
Core EPS was $4.28 in 2014, down 8%
compared with 2013. The smaller decline
in Core EPS compared with Core operating
profit was largely due to a lower tax rate.
This favourable tax effect was partially
offset by an increase in the number of
shares outstanding and a marginally higher
Core finance expense in 2014 compared
with 2013.
Pre-tax adjustments in 2014 to arrive at
Core profit before tax amounted to
$5,192 million in 2014 (2013: $4,678 million).
Excluded from Core results were:
(2013: $1,421 million), incurred as the
Group continued the fourth phase of
restructuring announced in March 2013.
Restructuring costs included in 2014
included a $292 million loss on disposal
of our Alderley Park site.
> Amortisation totalling $1,784 million
(2013: $1,591 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). The increase
was driven by amortisation charges in
connection with payments in respect
of our final Merck exit arrangements.
> Intangible impairment charges of
$99 million (2013: net $1,712 million,
including a $1,758 million impairment
relating to Bydureon). Further details
relating to intangible asset impairments
are included in Note 9 to the Financial
Statements from page 158.
> Costs associated with our acquisition
of BMS’s share of our Global Diabetes
Alliance amounting to $1,423 million.
Included within this are $407 million
of amortisation charges, a contingent
consideration fair value uplift charge of
$529 million reflecting higher expected
Diabetes portfolio revenues following
the successful integration of the newly
acquired elements, and $345 million of
interest charges relating to a discount
unwind on contingent consideration
arising on the acquisition (as detailed
in Note 18 to the Financial Statements
from page 164).
> Net legal provisions and other charges of
$328 million (2013: income of $46 million),
including a $201 million charge for the
additional year’s US Branded
Pharmaceutical Fee and $47 million
discount unwind charges relating to
contingent consideration arising on our
other business combinations as detailed
in Note 18 to the Financial Statements
from page 164).
2014 Reported operating profit was down
31% at CER to $2,137 million. The larger
declines compared with the respective
Core financial measures are mainly the
result of our enhanced business acquisition
activities including our acquisition of BMS’s
share of our Global Diabetes Alliance, offset
by reduced impairment charges in 2014.
AstraZeneca Annual Report and Form 20-F Information 2015
237
Additional Information Financials (Prior year) continued
Net finance expense in 2014 was
$885 million (2013: $445 million). The
increase was driven by $453 million
(2013: $nil) related to the discount unwind
on both contingent consideration arising
on business combinations ($391 million)
and other long-term liabilities ($62 million).
The 2014 Reported taxation charge of
$11 million (2013: $696 million), consisted
of a current tax charge of $872 million (2013:
$1,398 million) and a credit arising from
movements on deferred tax of $861 million
(2013: $702 million). The current tax charge
in 2014 included a prior period current
tax credit of $109 million (2013: charge
of $46 million).
The tax paid in 2014 was $1,201 million,
which was 96% of Reported profit and 19%
of Core profit.
The Reported tax rate for 2014 was 0.9%
compared with 21.3% for 2013. The
Reported tax rate of 0.9% was impacted
by a one-off benefit of $117 million in respect
of the inter-governmental agreement of a
transfer pricing matter, the non-Core impact
of the revaluation of the fair value of
contingent consideration arising on
business combinations (charge of $512
million with related tax credit of $157 million),
and the benefit of the UK Patent Box
legislation ($35 million). Excluding these
effects, the Reported tax rate for 2014
would have been 18.2%. The Core tax rate
for 2014 was 16.2%. Excluding the benefit
from the transfer pricing agreement and
Patent Box, the Core tax rate would have
been 18.5%. Further details relating to
movements in our taxation balances are
included in Note 4 to the Financial
Statements from page 151.
Reported post tax profit for 2014 was
$1,235 million, a decrease of 34%. Reported
EPS was down 34% to $0.98.
Total comprehensive income in 2014
decreased by $2,729 million from the prior
year, resulting in a loss of $271 million. This
was driven by the decrease in profit of
$1,336 million, and a decrease of $1,393
million in other comprehensive income
driven by movements in exchange rates in
our consolidated results of $1,352 million,
principally due to the strengthening of the
US dollar against sterling, the euro and
krona, and losses on the remeasurement
of our defined benefit pension liability
of $766 million in accordance with the
requirements of IAS 19 ‘Employee
Benefits’ (driven by a reduction in the
discount rate applied to our pension
liabilities partially offset by actuarial gains
on our scheme assets).
Cash flow and liquidity – 2014
All data in this section is on a Reported
basis.
Net cash generated from operating
activities was $7,058 million in the year
ended 31 December 2014, compared
with $7,400 million in 2013. Reductions in
working capital partially offset the lower
operating profit and higher tax payments.
Working capital movements in 2014 were
principally driven by general increases in
trade payables and accruals, as a result of
our increased R&D and SG&A spend, an
increase in the US Managed Markets
liabilities, an additional year’s Branded
Pharmaceutical levy and a reduction in trade
receivables principally in Japan and the US.
Non-cash and other movements included
$512 million relating to fair value adjustments
on contingent consideration arising on
business combinations.
Investment cash outflows in 2014 of $7,125
million (2013: $3,112 million) included $3,804
million (2013: $1,158 million) on completion
of business acquisitions, inclusive of BMS’s
share of our Global Diabetes Alliance ($2,703
million), the rights to Almirall’s respiratory
franchise ($876 million) and the acquisition
of Definiens ($150 million). The 2013
comparative period included payments on
the completion of the acquisitions of Pearl
Therapeutics, Omthera, Amplimmune and
Spirogen. Investment cash outflows in 2014
also include $657 million (2013: $nil) of
payments against contingent consideration
arising on business combinations and
$1,740 million (2013: $1,316 million) for the
purchase of other intangible assets, which
included a $409 million payment to Merck
on the consummation of our Second Option
and $310 million on the settlement of
pre-existing launch- and sales-related
milestones with BMS.
238
AstraZeneca Annual Report and Form 20-F Information 2015
Net cash distributions to shareholders in
2014 were $3,242 million (2013: $2,979
million), through dividends of $3,521 million
(2013: $3,461 million) partially offset by
proceeds from the issue of shares of
$279 million (2013: $482 million) due to
the exercise of share options.
At 31 December 2014, outstanding gross
debt (interest-bearing loans and borrowings)
was $10,843 million (2013: $10,376 million).
Of the gross debt outstanding at
31 December 2014, $2,446 million was
due within one year (2013: $1,788 million).
Net debt at 31 December 2014 was
$3,223 million, compared to a net funds
position of $39 million at the beginning of
2014, as a result of the net cash outflow as
described above.
Financial position – 2014
All data in this section is on a Reported basis.
In 2014, net assets decreased by $3,607
million to $19,646 million. The decrease in
net assets was broadly as a result of
dividends of $3,532 million and adverse
movements on exchange taken to reserves
of $1,352 million, partially offset by the 2014
Group profit of $1,235 million.
Property, plant and equipment
Property, plant and equipment increased
by $192 million to $6,010 million in
2014. Additions of $1,607 million (2013:
$816 million), including $515 million (2013:
$8 million) arising on business combinations,
were offset by depreciation of $776 million
(2013: $906 million) and disposals of
$582 million (2013: $82 million). Property,
plant and equipment also increased due
to the transfer of a prepayment balance
of $350 million, which related to amounts
paid to BMS for fixed assets under our
previous joint operation with BMS; with the
acquisition of BMS’s interest in the diabetes
franchise we acquired the underlying
property, plant and equipment to which
this prepayment related.
Additional Information reduction of one year’s Shionogi royalty
payments. The increase in trade payables
was driven by our increased in year R&D
and SG&A spend in the later part of 2014.
The rebates and chargebacks balance
includes an additional year’s US Branded
Pharmaceutical levy.
The decrease in provisions of $282 million
in 2014 included $633 million of cash
payments, partially offset by $434 million
of additional charges recorded in 2014.
Included within the $434 million of charges
for 2014 were $254 million for our global
restructuring initiative and $91 million in
respect of legal charges. Cash payments
in 2014 included $472 million for our global
restructuring programme.
Tax payable and receivable
Net income tax payable decreased by
$557 million in 2014 to $2,025 million,
principally due to cash tax timing
differences, foreign exchange and a
$117 million adjustment in respect of prior
periods following the settlement of the
inter-governmental agreement of a transfer
pricing matter. The 31 December 2014
tax receivable balance of $329 million
comprised tax owing to AstraZeneca
from certain governments expected to
be received on settlements of transfer
pricing audits and disputes and cash
tax timing differences. Net deferred tax
liabilities increased by $1,045 million in
2014, mainly due to a reversal of taxable
temporary differences.
Retirement benefit obligations
Net retirement benefit obligations decreased
by $690 million in 2014. Employer
contributions to the pension scheme of
$184 million and beneficial exchange
movements of $268 million were offset by
service cost charges of $221 million, net
financing costs of $92 million and net
remeasurement adjustments of $766 million.
Goodwill and intangible assets
The Group’s goodwill of $11,550 million as
at 31 December 2014 (2013: $9,981 million)
principally arose on the acquisition of
MedImmune in 2007 and the restructuring
of our US joint venture with Merck in 1998.
Goodwill of $1,841 million arising on our
acquisitions of BMS’s share of our Global
Diabetes Alliance ($1,530 million) and the
rights to Almirall’s respiratory franchise
($311 million) was capitalised in 2014.
Intangible assets amounted to $20,981
million at 31 December 2014 (2013: $16,047
million). Intangible asset additions were
$8,548 million in 2014 (2013: $3,217 million),
including product rights acquired in our
acquisitions of $7,501 million (2013: $2,416
million). Amortisation in 2014 was $2,384
million (2013: $1,779 million). Impairment
charges in the year amounted to
$122 million (2013: $2,082 million).
Further details of our additions to intangible
assets, and impairments recorded, are
included in Note 9 to the Financial
Statements from page 158.
Receivables, payables and provisions
Trade receivables decreased by $752 million
to $4,762 million principally in Japan and
the US.
In 2014, prepayments and accrued income
decreased by $928 million. As detailed in
our 2013 Annual Report, in 2013, we
modified the royalty structure under our
global licence agreement for Crestor, which
was amended to include fixed minimum
and maximum annual royalty payments
to Shionogi. These future royalties were
recognised within payables and as a
prepayment. The reduction in prepayments
in 2014 was driven by the payment of
one year’s royalties under this revised
agreement, along with a transfer of
$350 million from prepayments to property,
plant and equipment as detailed above.
Trade and other payables increased by
$7,163 million in 2014 to $19,877 million,
with increases of $993 million in trade
payables, $677 million of rebates and
chargebacks, and $5,781 million in other
payables, including $6,385 million in
contingent consideration offset by a
AstraZeneca Annual Report and Form 20-F Information 2015
239
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
2011
2012
2013
2014
2015
1,292
1,361
3194.0
2543.5
2975.0
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
2011
%
0.6
0.7
0.8
1.2
0.2
1.0
13.8
81.7
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
1 Includes Euroclear and ADR holdings.
At 31 December 2015, the Company had
97,260 registered holders of 1,264,122,670
Ordinary Shares. There were 104,150
holders of Ordinary Shares held under
the Euroclear Services Agreement,
representing 10.8% of the issued share
capital of the Company and approximately
172,000 holders of ADSs, representing
10.8% 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.
With effect from 6 February 2015, Citibank,
N.A. (Citibank) succeeded JPMorgan
Chase Bank (JPMorgan) 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 2014 and 2015, 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).
240
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information 2014
2015
– 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$)
4103.0
4823.5
4597.0
4780.0
4847.0
4863.0
4424.5
4627.5
4347.5
4424.5
4379.0
4247.5
4520.0
4627.5
3549.5
3723.0
4092.5
4169.5
4272.0
4019.0
3903.5
3947.0
4120.5
3903.5
4033.5
3947.0
4075.0
4285.5
446.3
532.5
536.0
558.5
625.0
638.0
603.0
597.5
584.5
603.0
567.0
548.0
597.5
597.0
380.5
409.7
467.3
484.5
538.0
522.5
508.5
509.0
538.0
508.5
523.5
509.0
538.0
550.5
68.38
81.09
76.31
75.38
72.22
73.35
34.541
34.77
67.891
34.54
34.37
32.39
34.11
34.77
58.51
62.45
68.49
67.15
64.44
63.71
30.281
30.47
64.331
30.28
30.69
30.47
30.85
32.80
1 With effect from 27 July 2015, the Company’s ADS ratio was changed to two ADSs per one Ordinary Share. The former ratio was one ADS per one Ordinary Share.
Major shareholdings
At 31 December 2015, the following 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 and Transparency Rules:
Shareholder
BlackRock, Inc.
Investor AB
The Capital Group Companies, Inc.
Number of
Ordinary Shares
Date of
disclosure to
Company1
Percentage of
issued share
capital
100,885,181 8 December 2009
51,587,810
2 February 2012
37,925,813
17 July 2015
7.98
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 decrease would have arisen unless the holding moved up or down through a whole number percentage level. The percentage level may increase (on the cancellation of shares following
a repurchase of shares under the Company’s share repurchase programme) or decrease (on the issue of new shares under any of the Company’s share plans).
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 2015 and 31 January 2016. Any changes
between 31 January 2016 and 29 February 2016 will be set out in the Notice of Annual General Meeting 2016 and Shareholders’ Circular.
Changes in the percentage ownership held 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
Legal & General Investment Management Limited
31 January
2016
31 January
2015
31 January
2014
2 February
2013
7.98
4.08
3.00
< 5.00
< 3.00
< 3.00
7.99
4.08
< 3.00
< 5.00
< 3.00
< 3.00
8.01
4.09
3.01
5.78
4.52
< 3.00
8.08
4.13
< 3.00
5.83
4.57
4.62
ADSs evidenced by ADRs issued by Citibank, as depositary, are listed on the NYSE. At 31 January 2016, the proportion of Ordinary Shares
represented by ADSs was 11.07% of the Ordinary Shares outstanding.
Number of registered holders of Ordinary Shares at 31 January 2016:
> In the US: 712
> Total: 97,256
Number of record holders of ADRs at 31 January 2016:
> In the US: 1,889
> Total: 1,912
AstraZeneca Annual Report and Form 20-F Information 2015
241
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 2015, payable on
21 March 2016, is 19 February 2016 and the
ex-dividend date is 18 February 2016. For
ADRs listed on the NYSE, the record date is
19 February 2016 and the ex-dividend date
is 17 February 2016.
At 31 January 2016, 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 2016, payable on 12 September 2016,
is 12 August 2016.
Title of class
Ordinary Shares
Amount
owned
Percentage
of class
500,191
0.04
Future dividends will normally be paid as
follows:
Related party transactions
During the period 1 January 2015 to
31 January 2016, 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 29 to the
Financial Statements from page 192).
Options to purchase securities from
registrant or subsidiaries
(a) At 31 January 2016, options outstanding
to subscribe for Ordinary Shares were:
Number of shares
3,725,301
Subscription
price (pence)
Normal
expiry date
1882 – 3599 2016 – 2021
The weighted average subscription price of
options outstanding at 31 January 2016 was
2713 pence. All options were granted under
Company employee share schemes.
(b) Included in paragraph (a) are options
granted to officers of the Company
as follows:
Number of shares
40,343
Subscription
price (pence)
Normal
expiry date
2280 – 3599 2017 – 2021
(c) At 31 January 2016, none of the Directors
of the Company held options to subscribe
for Ordinary Shares.
During the period 1 January 2015 to
31 January 2016, 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 Limited, 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.
242
AstraZeneca Annual Report and Form 20-F Information 2015
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 2016 will
be published on 29 April 2016 and results in
respect of the first six months of 2016 will be
published on 28 July 2016.
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
2 Kingdom Street, London W2 6BD.
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 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.
Additional Information 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.
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.
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
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 2015. 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 under proposed US Treasury
regulations, certain entities), 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
(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.
AstraZeneca Annual Report and Form 20-F Information 2015
243
Additional Information Shareholder Information continued
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
limitations affecting security holders
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)
2013
2014
2015
End of year spot rates (statement of financial position)
2013
2014
2015
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 26 of the Financial Statements and Directors’ Remuneration Report
Shareholder waiver of dividends
Page 96 in the Corporate Governance Report
SEK/US$
US$/GBP
6.5089
6.7901
8.395033
6.4233
7.7451
8.41140
1.5621
1.6532
1.53567
1.6502
1.5559
1.48165
244
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information 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
2 Kingdom Street, London W2 6BD
(telephone +44 (0)20 7604 8000). 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.
The Group’s corporate office is at
2 Kingdom Street, London W2 6BD.
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 $125,
which currently represents 500 shares.
Rights, preferences and restrictions
attaching to shares
As at 31 December 2015, the Company
had 1,264,122,670 Ordinary Shares and
50,000 Redeemable Preference Shares
in issue. The Ordinary Shares represent
99.98% and the Redeemable Preference
Shares represent 0.02% of the Company’s
total share capital (these percentages have
been calculated by reference to the closing
mid-point US$/GBP exchange rate
on 31 December 2015 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 an extraordinary resolution
passed at a general meeting of such
holders is required.
General meetings
AGMs and other general meetings, as
from time to time may be required, where
a special resolution is to be passed or a
Director is to be appointed, 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 156.
AstraZeneca Annual Report and Form 20-F Information 2015
245
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
Accolate
Arimidex
Atacand
Atacand HCT
Atacand Plus
Axanum
Bricanyl
Brilinta
Brilique
Bydureon
Byetta
Caprelsa
Casodex
Cosudex
Crestor
Diprivan
EMLA
Entocort
Farxiga
Faslodex
Fluenz
FluMist
Forxiga
Genuair
Iressa
Kombiglyze
Komboglyze
Losec
Lynparza
Meronem
Merrem
Movantik
Moventig
Myalept1
Naropin
Nexium
Symlin
Synagis2
Tagrisso
Tenormin3
Toprol-XL
Turbuhaler
Vimovo
Xigduo
Xylocaine
Zestril3
Zoladex
Zomig
Zurampic
Nolvadex
Onglyza
Oxis Turbuhaler
Plendil
Pressair
Prilosec
Pulmicort
Pulmicort Flexhaler
Pulmicort Respules
Pulmicort Turbuhaler
Respules
Rhinocort
Seloken
Seroquel
Seroquel XR
Symbicort
Symbicort SMART
Symbicort Turbuhaler
1 AstraZeneca assigned this trade mark to Aegerion effective 9 January 2015.
2 AstraZeneca owns this trade mark in the US only. AbbVie owns it in the rest of the world.
3 AstraZeneca assigned these trade marks in the US to Alvogen effective 9 January 2015.
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
Bretaris
Cubicin
Daliresp/Daxas
Duaklir
Eklira
Epanova
Tudorza
Zinforo
Zytiga1
Licensor or Owner
Almirall, S.A.
Cubist Pharmaceuticals, Inc.
Takeda GmbH
Almirall, S.A.
Almirall, S.A.
Chrysalis Pharma AG
Almirall, S.A.
Forest Laboratories Holdings Limited
Janssen Pharmaceutical K.K.
1 AstraZeneca has been licensed this trade mark for use in Japan only.
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
Plavix
Invokana
Lipitor
Owner
SANOFI S.A.
Johnson & Johnson Corporation
Pfizer Ireland Pharmaceuticals
messenger RNA Therapeutics
Moderna Therapeutics, Inc.
246
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information Glossary
Market definitions
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 2015 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 2015
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
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 2015
247
Additional Information Glossary continued
The following abbreviations and expressions
have the following meanings when used in this
Annual Report:
CEO – the Chief Executive Officer of the
Company.
CER – constant exchange rates.
Abbott – Abbott Laboratories.
AbbVie – AbbVie Inc.
ACA (Affordable Care Act) – the 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 Syndrome.
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.
AGM – an Annual General Meeting
of the Company.
Aegerion – Aegerion Pharmaceuticals, Inc.
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 2015.
API – active pharmaceutical ingredient.
Ardea – Ardea Biosciences, Inc.
Articles – the Articles of Association of the
Company.
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.
Celgene – Celgene International Sàrl.
CFDA – China Food and Drug Administration.
CFO – the Chief Financial Officer of the Company.
CHMP – the Committee for Medicinal Products
for Human Use.
CIS – Commonwealth of Independent States.
Code of Conduct – the Group’s Code
of Conduct.
Company or Parent Company – AstraZeneca
PLC (formerly Zeneca Group PLC (Zeneca)).
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.
GSK – GlaxoSmithKline plc.
Gulf – Bahrain, Kuwait, Oman, Pakistan, Qatar
and the United Arab Emirates.
Heptares – Heptares Ltd.
HHA – Healthy Heart Africa programme.
HR – human resources.
IA – the Group’s Internal Audit Services function.
COPD – chronic obstructive pulmonary disease.
IAS – International Accounting Standards.
Corporate Integrity Agreement (CIA) – the
agreement described in the US Corporate
Integrity Agreement reporting section on
page 50.
CROs – contract research organisations.
CVMD – Cardiovascular and Metabolic diseases.
CV – cardiovascular.
Daiichi Sankyo – Daiichi Sankyo, Inc.
Definiens – Definiens AG.
Director – a director of the Company.
DOJ – the United States Department of Justice.
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.
EC – European Commission.
EFPIA – European Federation of Pharmaceutical
Industries and Associations.
EGFR – epidermal growth factor receptor.
EMA – European Medicines Agency.
EPO – European Patent Office.
EVP – Executive Vice-President.
EU – the European Union.
FDC – fixed-dose combination.
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.
FibroGen – FibroGen, Inc.
Forest – Forest Laboratories Holdings Limited.
FRC – Financial Reporting Council.
GAAP – Generally Accepted Accounting
Principles.
GMD – Global Medicines Development.
GPPS – Global Product and Portfolio Strategy.
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.
IFRS – International Financial Reporting
Standards or International Financial Reporting
Standard, as the context requires.
IFRS 8 – IFRS 8 ‘Operating Segments’.
IMED – Innovative Medicines and Early
Development.
Immunocore – Immunocore Limited.
Innate Pharma – Innate Pharma S.A.
IP – intellectual property.
IS – information services.
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.
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.
Lilly – Eli Lilly and Company.
LTI – long-term incentive, in the context of share
plan remuneration arrangements.
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.
248
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information major market – US, EU, Japan and China.
MAT – moving annual total.
MedImmune – MedImmune, LLC (formerly
MedImmune, Inc.).
Merck – Merck Sharp & Dohme Corp.
(formerly Merck & Co., Inc.).
MI – myocardial infarction.
Moderna Therapeutics – Moderna
Therapeutics, Inc.
Myriad – Myriad Genetics, Inc.
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.
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.
pound sterling, £, GBP or pence – references
to the currency of the UK.
Omthera – Omthera Pharmaceuticals, Inc.
Pozen – POZEN, 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).
PD-L1 – an anti-programmed death-ligand 1.
Pearl Therapeutics – Pearl Therapeutics, Inc.
Pfizer – Pfizer, Inc.
PhRMA – Pharmaceutical Research and
Manufacturers of America.
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.
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 Manchester Limited.
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 60.
Regulatory Exclusivity – any of the IP rights
arising from generation of clinical data and
includes Regulatory Data Protection, Paediatric
Exclusivity and Orphan Drug status.
Roche – F. Hoffmann-La Roche AG.
RSV – respiratory syncytial virus.
Sanofi– SANOFI S.A.
Sarbanes-Oxley Act – the US Sarbanes-Oxley
Act of 2002.
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.
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.
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.
Ventana – Ventana Medical Systems, Inc.
WHO – World Health Organization, the United
Nations’ specialised agency for health.
YHP – Young Health Programme.
ZS Pharma – ZS Pharma, Inc.
AstraZeneca Annual Report and Form 20-F Information 2015
249
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 Information
Corporate Integrity Agreement
Corporate Governance
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
Ethics
Environmental impact
Finance income and expense
Financial instruments
Financial position 2014
Financial position 2015
Financial Review
Financial risk management
Financial Statements 2015
Financial summary
Financials 2014
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
Inflammation
144, 199
4, 56-57, 193
173-177
14, 49, 231
68-73, 160, 174-176, 237-239
45
82, 97, 245
245
2
84, 86-87, 98-102
98-102
44-45, 234
10, 13
70-73, 174
86-87
30-33
8-9
7, 42, 53-54
76
30-33
69, 146, 163
82
4
45
95-98
186-192
58-59
245
95
140-143
245
50
82-135
72, 175-176
25, 205-209
30-33
114-115
135
52-53, 90-91
76, 96, 172
153
182-185
52-54
50, 96
58
151
146, 151, 161-162
238-239
71
62-81
76-77, 177-182
135-202
2
236-239
52-53
227-233
12-13
247-249
202
194-195
7, 16-17
51
54
136-139
39-41
see Respiratory, Inflammation and
Autoimmunity
Information Technology
Infrastructure
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
Oncology
Operating profit
Operational overview
Other investments
PARTHENON programme
Patent Expiries
Patents
Patient safety
Personalised healthcare
Physician Payments Sunshine Act
Pipeline and Therapy Area Introduction
Political donations
Post-retirement benefits
Primary care
Product revenue information
Property, plant and equipment
Provisions
Regulatory requirements
Related party transactions
Relations with shareholders
Remuneration
Remuneration Policy
Research and Development
Reserves
Respiratory, Inflammation and Autoimmunity
Restructuring
Results of operations 2014
Results of operations 2015
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
Specialty care
Strategic priorities
Sustainability: supplementary information
Tagrisso
Takeda
Taxation
Taxation information for shareholders
Trade and other payables
Trade and other receivables
Trade marks
Values and purpose
Young Health Programme
ZS Pharma
22, 61, 220
61
71, 79-80, 101, 136, 145, 158-160, 239
60
163-164
18-20
146, 148, 192
10-11
22, 80-81, 101, 137, 147, 186-191, 199,
214-215, 218, 223
34-38
46
247
12-15
34-38
1, 62-67, 150-151, 236
2
147, 161
33
15
see Intellectual Property
22, 44-45
43-44
50
24-41
97
80, 101, 137, 166-171
10
227-233
71, 146, 156, 238
165
13-14
193, 242
93
107-116
117-134
42-45
172
26-29
68, 150
238
65
21, 212-226
48-50
227-233
24-41, 227-233
81
85, 94
154-155
88-89
172
75, 172
76, 96
240-244
10
16-17
234-235
4, 34, 36
5, 28
68, 76, 81, 146, 151-153, 199
242-244
71, 146, 164-165, 239
71, 146, 163, 181
246
8-9
59
4, 72, 173
250
AstraZeneca Annual Report and Form 20-F Information 2015
Additional Information 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,
Core financial measures and constant
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 2015
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 2015; 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. 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 97%
(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 212 of this Annual Report. Nothing in
this Annual Report should be construed as
a profit forecast.
AstraZeneca Annual Report and Form 20-F Information 2015
251
Additional Information Additional Information
Registered office and corporate
headquarters
AstraZeneca PLC
2 Kingdom Street
London W2 6BD
UK
Tel: +44 (0)20 7604 8000
Investor relations
UK: as above
US:
Investor Relations
AstraZeneca Pharmaceuticals LP
One MedImmune Way
Gaithersburg MD 20878
US
Tel: +1 (301) 398 0000
For more information please see
www.astrazeneca.com
Registrar
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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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SE-101 23 Stockholm
Sweden
Tel: +46 (0)8 402 9000
US Depositary
Citibank Shareholder Services
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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
252
AstraZeneca Annual Report and Form 20-F Information 2015
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