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Mirati TherapeuticsANNUAL
REPORT
2014
About Sirtex
Sirtex is now supplying SIR-Spheres
microspheres in more than 30
countries, actively working to
improve the outcomes for people
with liver cancer. Together with the
assistance of medical practitioners,
we are challenging established
practices and developing innovative
new therapies that promise to
improve lives.
Our ongoing success is based
on a commitment to serving our
customers, professionalism,
continuous improvement
and innovation.
Our vision is to help make liver
cancer a chronic disease that
patients can successfully live with.
We produce a life enhancing
therapy with the potential to
improve the quality of life for tens
of thousands of people worldwide
every year.
Our business revolves around
helping medical professionals
use our product to improve the
clinical outcomes and quality of
life for people with liver cancer
and bringing a number of new
treatments and innovations to
market that will also improve
the quality of life and standard
of care for cancer patients.
All our activities are focused on
these goals and supporting the
medical professionals who treat
people with liver cancer. Our head
office is in Australia and we have
substantial manufacturing and
operations in the US, Germany
and Singapore.
TABLE OF CONTENTS
3 Product Evolution
5 2014 Financial Summary
7 Regional Markets
9 Clinical Investment
9 Research and Development
10 Our People
11 In the Community
13 Chairman’s Report
15 Chief Executive Officer’s Report
19 Key Management Personnel
20 Corporate Governance Statement
24 Financial Report
Sirtex 2014 AR 1
BOSTON, USA
REGIONAL MARKETS
MANUFACTURING FACILITIES
REGIONAL HEADQUARTERS
2001
2002
2003
2004
2005
2014 DOSE SALES
17.3%
BONN, GERMANY
FRANKFURT, GERMANY
8,561
DOSES
SOLD
SYDNEY, AUSTRALIA
HEAD OFFICE
9,000
8,000
7,000
6,000
5,000
4,000
3,000
2,000
1,000
SINGAPORE
2006
2007
2008
2009
2010
2011
2012
2013
2014
2014 REVENUE
2014 NET PROFIT AFTER TAX
33.7%
30.6%
Sirtex 2014 AR 2
PRODUCT EVOLUTION
Sirtex’s bold vision is that one day liver cancer will no longer be a
terminal disease that patients frequently die from but a chronic
condition that patients can successfully live with.
Expanding
uses for
our unique
therapy.
Delivering on this ambitious goal
will require extensive engagement
and collaboration with other
leaders and experts around the
world today and into the future.
Our approach to achieving our goal is
both pragmatic and realistic. We know
we won’t achieve this goal on our own.
We do know we can make significant
progress by collaborating and sharing
our knowledge with the many others
who also share our vision for healthcare
and humanity.
We are encouraged by the numerous
medical advances over recent decades
that have turned once terminal diseases
into tolerable chronic conditions.
Advances in treating HIV, diabetes and
ischemic heart disease illustrate what
can be achieved. Sirtex envisions similar
advances occurring in the treatment of
cancer.
Over the past four years Sirtex has
invested significantly in clinical programs
aimed at expanding the use of our
current SIR-Spheres microspheres
product. Our focus has been on
obtaining the clinical data that will help
healthcare professionals deliver better
outcomes for patients with metastatic
colorectal cancer and hepatocellular
carcinoma.
As we draw closer to realising this goal,
our attention is also shifting to how we
can further unlock the full potential of our
unique technology platform and expertise
in interventional oncology to help medical
professionals treat an even wider range
of cancers.
Interventional oncology innovations like
SIR-Spheres microspheres are a part
of the unrelenting advances in medicine
towards more cost-effective, less
invasive and more effective therapies
and treatments. The rapid evolution
and adoption of minimally invasive
procedures in cardiothoracic and
orthopaedic surgery are good examples.
Sirtex actively collaborates with leading
universities, researchers and other
medical and technology innovators on
a range of programs aimed at unlocking
and expanding the uses for our core
expertise in microsphere technology to
establish a range of new therapies aimed
at delivering better clinical outcomes for
cancer patients.
We expect these collaborations will
continue to expand as our core business
grows stronger internationally, providing
us with a solid foundation of revenue
and customers.
An example during the reporting period
was our three year commitment to
support researchers at The Australian
National University to look at ways
to treat solid tumours through the
application of nano-particle technology.
Another milestone was our collaboration
with Guerbet to examine ways SIR-
Spheres microspheres can be combined
with Guerbet’s widely used imaging agent
Lipiodol to address the unmet clinical
needs in patients with hepatocellular
carcinoma, metastatic colorectal cancer
and metastatic neuroendocrine tumours.
Our collaboration with Guerbet is just
one of many ways Sirtex is working to
expand the potential of SIR-Spheres
microspheres and our expertise
in delivering real solutions to help
medical professionals change cancer
from a terminal desease that patients
unfortunately often die from, to a chronic
condition that many patients can
successfully live with, or be cured of.
Sirtex 2014 AR 3
Elizabeth Deylen is one of the many people worldwide whose
liver cancer has been successfully treated with SIR-Spheres
microspheres.
”I would die
within months
if nothing was
done.”
Making plans: Elizabeth Deylen (right) with her sister Andrea in Melbourne, Australia. Together they
are planning a holiday and living life to the fullest after Elizabeth’s treatment with SIR-Spheres
microspheres in 2012.
“In June 2012 I was told I had stage
four bowel cancer with metastatic
liver cancer. I was 47 years old.
The metastases in my liver were so
all encompassing and inoperable.
I was terminal and would die within
months if nothing was done.
Within weeks of diagnosis, I was
given scans, surgery and started
chemotherapy in preparation for the
one thing that has ensured my survival
for the last two years, SIRT (selective
internal radiation therapy).
I consider myself one of the lucky few
because my oncologist, Associate
Professor Peter Gibbs, was aware of
SIR-Spheres microspheres and had more
than a decade of experience treating
patients with SIRT. It was one of those
happy coincidences, a moment
of synchronicity, where the patient
and the doctor meet at the right time.
I just happened to be suitable for SIRT
treatment according to Professor Gibbs.
I am convinced, without a shadow of
a doubt, I am still here today because
of the SIRT treatment. I came from a
scenario of being dead within months to
having my life extended so that I could
get my affairs in order, tell all the people
I care about that I love them and shorten
my bucket list considerably.
Last year I travelled to Europe with
my gorgeous sister Andrea and loving
husband Michael to visit our relatives
and see some of the great cities of the
world. I bought an S-Type Jaguar for
those country drives around Victoria,
I get to spend more time talking with my
son Max, who is a chemical engineer
in Sydney, and I am busy raising two
mischievous puppies that make me
smile every day.
SIRT has eradicated the metastases in
my liver to the point there is no longer
any cancer there. Since my SIRT
treatment in 2012, I have had 90 per
cent of my large intestine removed,
my appendix removed, a separate and
unrelated thyroid cancer removed and
I am currently having a second run of
12 sessions of chemotherapy because
the bowel cancer has now moved to my
lungs. The good news is the tumours in
my lungs are shrinking.
I have no unrealistic expectations for the
final outcome, however, for the last two
years I have lived a life full of happiness,
love, laughter, travel and good times.
I will always be grateful to Professor
Gibbs and his wonderful team who have
given me the time to end my life well and
I know that if I had not been treated with
SIR-Spheres in August of 2012, I would
not be here today planning my 50th
birthday in August 2014.”
Sirtex 2014 AR 4
2014 FINANCIAL SUMMARY
FIVE YEAR SUMMARY
Dose sales (units)
’000
Sales revenue
R&D investment
Clinical investment
Profit before income tax
Net profit
Capital investment
Total assets at 30 June
Total equity at 30 June
Net tangible assets at 30 June
Earnings per share (cents)
2010
4,171
64,333
3,062
8,867
19,103
16,080
1,384
66,660
51,543
50,155
28.8
2011
4,977
70,686
5,632
10,402
14,354
11,479
3,785
76,785
60,142
52,357
20.6
2012
6,141
82,627
5,723
12,243
22,118
17,103
1,092
96,656
73,548
57,314
30.7
2013
7,299
96,774
6,615
15,872
24,507
18,270
3,685
117,766
87,684
59,762
32.8
2014
8,561
129,363
7,981
22,168
31,110
23,868
6,187
148,710
107,583
60,219
42.5
PROFIT AFTER TAX
$’000
OPERATING CASH FLOW
$’000
EARNINGS PER SHARE
CENTS
0
8
0
,
6
1
9
7
4
,
1
1
3
0
1
,
7
1
0
7
2
,
8
1
8
6
8
,
3
2
2010
2011
2012
2013
2014
1
3
2
,
0
2
6
8
2
,
5
1
7
8
9
,
9
1
7
2
3
,
4
2
1
7
1
,
2
3
8
.
8
2
6
.
0
2
7
.
0
3
8
.
2
3
5
.
2
4
2010
2011
2012
2013
2014
2010
2011
2012
2013
2014
DIVIDENDS PER SHARE
CENTS
SHARE PRICE
$ (AT 30 JUNE EACH YEAR)
CASH ON HAND
$’000 (AT 30 JUNE EACH YEAR)
$16.88
$11.98
7
7
7
0
1
2
1
6.09
4.90
4.90
3.35
1
2
4
,
1
4
5
1
9
,
2
4
7
4
4
,
9
4
4
9
0
,
2
5
5
9
4
,
2
5
2009
2010
2011
2012
2013
2009
2010
2011
2012
2013
2014
2010
2011
2012
2013
2014
Sirtex 2014 AR 5
40
consecutive
quarters of
growth
25%
annual growth
of $1 invested
in Sirtex in
2004
17.3%
growth in
sales in
2014
30.9%
annual growth
in sales since
2004
DOSE SALES GROWTH
UNITS
SALES REVENUE
$’000
8,561
129,363
7,299
6,141
4,977
4,171
3,658
96,774
82,627
65,559
64,333
70,686
2010
2011
2012
2013
2014
2010
2011
2012
2013
2014
8,561
2014 Dose Sales
THE AMERICAS
5,836
EUROPE,
MIDDLE EAST
& AFRICA
1,916
ASIA PACIFIC
809
ASIA PACIFIC
EUROPE, MIDDLE EAST & AFRICA
THE AMERICAS
Sirtex 2014 AR 6
REGIONAL MARKETS
Another year of achievement
Sirtex’s strong business performance this year was underpinned by
our SIR-Spheres microspheres business, expansion in current markets
and entry to new markets, manufacturing capacity expansion and our
global clinical, research and development activities.
THE
AMERICAS
EUROPE, MIDDLE
EAST, AFRICA
PERFORMANCE
Revenue grew 37.4 per cent
to $96.0 million.
Dose sales grew 22.5 per cent
to 5,836.
MARKET GROWTH
INITIATIVES
We currently have over 400 active
treating centres in the US and this
year the team has been focused on
a number of market development
initiatives including:
Implementation and execution
of regional strategies focused on
treating and referring physician
communities.
Investment in the business,
including increasing the number
of customer-facing staff and
programs targeted at raising
awareness amongst the Medical,
Surgical, and Radiation Oncology
communities.
Expansion of treatment centres
and treatment adoption within the
Interventional Radiology community.
Moving treatment from a specialised
‘Centres of Excellence’ type model
to a mainstream treatment offered
by academic and community
medical centres.
Early stages of acceptance of
Y90 by the Medical, Surgical, and
Radiation Oncology communities
as an option for their mCRC
patients, driven by education
from our market development
and marketing team activity and
programs.
Digital marketing strategies to raise
awareness amongst patients and
advocacy groups.
Hiring and training of a full team
of Oncology Market Development
Managers who have partnered with
their Radiology counterparts to
bring together all relative disciplines
for discussions on optimal
patient care.
We initiated local, regional, and
national training programs for
oncologists and are working with
our regional partners to assess
and plan for SIRFLOX data release
in 2015.
A major focus is preparing for
increased volumes and working to
prepare our treatment centres for
success as well as making sure
reimbursement is organised and the
appropriate hospital resources are
dedicated to treating patients with
SIR-Spheres microspheres.
PERFORMANCE
Revenue grew 24.6 per cent to
$27.7 million.
Dose sales grew 5.6 per cent to
1,916 on the back of improved
reimbursement and funding in a
number of European Union markets
and the opening of 30 new
treatment sites across EMEA.
MARKET GROWTH
INITIATIVES
A major focus is the reimbursement
and funding environment in key
markets.
A key achievement was helping
increase National Health Services
(NHS) patient access to SIR-
Spheres microspheres in the United
Kingdom.
We have increased the promotion
of SIR-Spheres microspheres to
referring oncologists, liver surgeons
and hepatologists through the sales
team and at national and European
congresses.
We expanded the sales and
marketing team to further improve
sales coverage and increase our
marketing activities in 2015.
In 2014, the EMEA office organised
10 satellite symposia promoting the
use of SIR-Spheres microspheres
at national and European
congresses throughout the year.
New promotional materials, including
an iPad sales aid, will further support
the sales team in their efforts.
Sirtex 2014 AR 7
ASIA
PACIFIC
PERFORMANCE
Revenue grew 20.9 per cent
to $5.7million.
Dose sales grew 12.4 per cent
to 809 on the back of new regional
markets and growing awareness
and acceptance of the treatment
in various countries.
MARKET GROWTH
INITIATIVES
The regional office and
manufacturing facility in Singapore
continues to grow with a key
focus on business expansion and
the appointment of experienced
oncology staff in the commercial
and business support functions.
Focus on a direct sales business
model to increase presence in the
region. Started business in Hanoi
and will be expanding to other cities
in Vietnam in 2014.
Sirtex organised the second Asia
Pacific Symposium in Singapore on
Liver-directed Y90 Microspheres
Therapy in November 2013.
We have adopted and are applying
health economic models for
reimbursement of SIR-Spheres
microspheres in key Asia markets.
Sirtex sponsored the Fifth European
Multidisciplinary Symposium on
Liver Directed Cancer Therapies
using Y90 Microspheres in Rome in
February 2014. This event attracted
more than 500 delegates.
During the reporting period we
executed a program of key opinion
leader developments to engage
with top oncologists ahead of the
release of the SIRFLOX results.
Sales and marketing are working
with new centres to drive
appropriate patient referrals from
clinicians inside and outside the
centre through face-to-face contact
and educational meetings.
Plans to open a further 25 new
centres in 2015 are on schedule
An extensive series of advisory
board meetings to engage and
prepare key opinion leaders from
different specialties ahead of the
SIRFLOX results in 2015.
Developed a cost-effectiveness
model to support national Health
Technology Assessments once the
SIRFLOX results are published.
We plan to organise more satellite
symposia in 2015 to promote the
use of SIR-Spheres microspheres
and improve awareness of the
SIRFLOX data amongst referring
clinicians.
Further plans in 2015 to improve the
environment for reimbursement and
funding and prepare payers for the
publication of the SIRFLOX results.
Recruitment into the 360 patient
SIRveNIB study continues to gather
pace and is progressing well across
12 countries.
The team initiated six new sites in
Korea, Taiwan and Singapore for
FOXFIRE Global study.
We opened nine new treatment
centres in Australia, India, Vietnam
and Thailand during the reporting
period.
Continual development of
KOLs in multi-disciplinary teams
including Medical Oncologists and
Gastroenterologists to strengthen
the business.
Sirtex 2014 AR 8
CLINICAL INVESTMENT
We believe our investment in
clinical studies will unlock the
full potential of SIR-Spheres
microspheres and expand its use
as a first line treatment.
During the reporting period, investment
in clinical programs reached a record
of $22 million. This is a direct reflection
of accelerating patient recruitment
rates driven by growing interest
among the medical community in
our programs.
With the data from SIRFLOX due to
be presented in 2015, attention is also
focused on the pending completion of
recruitment in the FOXFIRE, FOXFIRE
Global and SARAH studies.
In addition to our five major randomised
studies here, we are also preparing
to activate new clinical programs to
examine the efficacy of our SIR-Spheres
microspheres platform in the treatment
of a range of other cancers. All of these
efforts are part of our goal to support the
work of the medical profession worldwide
and to change cancer from a terminal
disease that patients frequently die from,
to a chronic disease that patients can
successfully live with.
METASTATIC COLORECTAL CANCER (mCRC)
SIRFLOX 532 Patients
FOXFIRE / FOXFIRE GLOBAL 490 Patients
HEPATOCELLULAR CARCINOMA (HCC)
SARAH
400 Patients
SORAMIC 375 Patients
SIR NIB 360 Patients
ve
H2
2013
H1
2014
H2
H1
2015
H2
H1
2016
H2
H1
2017
H2
Completion of patient recruitment
Detailed presentation of results at ASCO1 annual scientific meeting
Primary endpoint available
1ASCO = American Society of Clinical Oncology
RESEARCH AND DEVELOPMENT
Sirtex continues to make investing
in R&D a priority. Expanding
and enhancing the commercial
application of our platform
technology, collaboration with our
expert partners and protecting
our intellectual property in major
markets are key functions of our
R&D investment.
Over the past five years we have invested
$29 million in R&D. During the reporting
period, Sirtex’s investment reached a
record high of $8.0 million, reflecting
a growing portfolio of potential new
products and therapies progressing
towards commercialisation.
Sirtex’s global R&D activities are directed
at supporting our current market
leadership and the development of
promising new therapies that support
our technical and commercial capabilities
in interventional oncology and radiation
medicine.
Sirtex 2014 AR 9
progress in the development of a
protocol that will allow quantitative
imaging of SIR-Spheres microspheres
using PET scanning. Our goal is to give
medical professionals greater ability to
customise patient doses to support
better clinical outcomes.
INVESTMENT IN R&D
$’000
During the year, we achieved a number of
important milestones including the filing
of patents in major jurisdictions relating
to enhancements and administration and
the use of SIR-Spheres microspheres.
Collaboration is a key driver of innovation
and during the reporting period we
formalised our established relationship
with The Australian National University
with a three-year professorial chair. The
investment will focus on new applications
of carbon cage nanoparticle technology
to provide new targeted and localised
therapeutic options for cancer patients.
A similar collaboration in Singapore
is advancing.
Significant progress was made on the
SIR-Spheres Evolution Program which is
approaching market trials and regulatory
applications in multiple markets.
We continued to build on our world
leading position in radioactive
microsphere technologies for the
treatment of cancer and made excellent
2005
2
6
0
,
3
2
3
6
,
5
3
2
7
,
5
5
1
6
,
6
1
8
9
,
7
2010
2011
2012
2013
2014
OUR PEOPLE
With a growing and diverse customer base Sirtex respects
and acknowledges the value and benefit a diverse workforce
contributes to the community it serves.
Members of the global finance
support team.
Total staff
213
Women in
management
39%
WORKFORCE PROFILE AND NUMBERS
79
84
50
• AMERICAS
• EMEA
• ASIA PACIFIC
94
73
28
25
12
7
26
• RESEARCH & DEVELOPMENT
• ADMINISTRATION
• OPERATIONS
• RA & QA
• MEDICAL
• CLINICAL
• SALES & MARKETING
• TRAINING & DEVELOPMENT
At the end of the reporting
period, Sirtex had increased the
number of employees globally
by 20 per cent from the previous
year. Responsibly managing our
employees across 20 countries
is critical to the ongoing success
of our business.
We are fortunate to have a dedicated and
passionate group of people from around
the world who continue to view Sirtex as
a great place to both begin and sustain
their careers. Sirtex’s high participation
rate is evident with 21 per cent of our
global workforce celebrating five years’
service with the company.
The quality and breadth of our business
worldwide is a direct by-product of our
recruitment strategy and our ability to
attract and retain high calibre, talented
professionals. We intend to expand our
workforce at the same rate over the next
financial year.
GROWTH IN EMPLOYEE
NUMBERS GLOBALLY
SINCE 2006
It is incumbent upon us to ensure we
are always adapting to the realities of the
workplace. We offer challenging work
and competitive remuneration packages
and benefits that reward excellence,
quality of service and innovation.
Providing a flexible and inclusive
workforce is another key enabler to
providing a high level of support to
each other and our valued clients in
the medical profession. Almost 40 per
cent of the Sirtex team work from a
home office or enjoy a flexible working
arrangement.
Our highly regarded, quarterly
internal magazine – InnerSphere is a
communication vehicle to inform our
global team of the company strategy,
events and news. Our challenge for the
coming year is to further develop our
communication tools and programs
to support our growing and diverse
employee base.
Sirtex promotes health, safety and
well-being in the workplace. Sirtex has
been fortunate to experience very few
work-related injuries and will continue
to strive for an injury-free workplace.
In 2013, we partnered with DuPont to
develop a global program to review
our safety procedures and identify any
areas for improvement in our practices
globally. Since working with our teams
in Europe, the Americas, Singapore
and Australia, the exercise has led to a
number of new preventative measures
and reviews, as well as developing
emergency preparedness strategies and
looking in more detail at how we share
safety information about issues across
the business.
5
2
0
4
8
5
6
6
3
8
6
0
1
4
4
1
8
7
1
3
1
2
2005
2006
2007 2008
2009
2010
2011
2012
2013
2014
Sirtex 2014 AR 10
IN THE COMMUNITY
Sirtex is a committed and active member in the
medical, scientific, patient and research communities
we work with around the world.
Our goal is to create the
foundations for a long term
sustainable business which
is respected, supported and
welcomed wherever we operate.
Engaging with key stakeholder
groups helps Sirtex build trust and
gain further insights into the real
challenges faced by the medical
community and patients.
MEASURING OUR PERFORMANCE
In 2014 Sirtex contributed significantly
towards supporting patient, medical and
research communities and stakeholders
worldwide.
Patient Communities
Sirtex is a proud long term sponsor
of the US-based international patient
advocacy group YES! Beat Liver Tumors,
through educational grants and support
at national industry conferences. In
Europe we work with a number of local
and national patient advocacy groups
such as Bowel Cancer UK and the
European Cancer Patients Association
to develop awareness of the treatment
options available. Sirtex is mindful of the
independence of all these groups and
we seek to conduct all our efforts in a
transparent and open manner.
Medical Communities
Medical professionals provide valuable
input into several areas of our business
including research and development,
clinical programs, and patient treatment
guidelines. Our engagement with
the international medical community
includes hosting professional education
and development programs, gathering
product performance information,
developing treatment protocols and
educating patients and care givers.
In the US this year Sirtex invited 100
Interventional Radiologists to participate
in a three-day peer-to-peer advanced
training program in New York.
Sirtex has an ongoing proctoring
program to educate physicians on the
safe and effective use of SIR-Spheres
microspheres and during the year we
provided training for over 100 physicians.
Sirtex is a major supporter of the Society
of Interventional Radiology Foundation
through annual research grants, an
international residents scholarship,
training programs, the annual meeting
and a fellowship program. During the
reporting period we also provided surgical
training grants to the Americas Hepato-
Pancreatic Biliary Association and World
Congress of Interventional Oncology.
In Europe we supported a number
of professional organisations and
conferences including the annual
European Society for Medical Oncology
meeting and the Cardiovascular and
Interventional Radiology Society
of Europe.
Sirtex’s EMEA office also supports
structured training programs through a
formal proctorship program.
Research Communities
As a business founded on successful
research and development, Sirtex is
committed to supporting initiatives which
create career pathways for promising
researchers.
We seek to recognise excellence in
medical research aimed at making
cancer a chronic disease. To this end
in August 2013 we sponsored the
Excellence in Translational Cancer
Research at the NSW Premier’s Awards
for Outstanding Research.
Sirtex also supports a large number of
medical professionals and investigator
led studies that help enhance the
knowledge of our product and its
ability to help treat a range of cancers.
Our support and collaboration with
research hospitals and universities is
an essential part of the work we do to
develop new products and improve
current treatments.
Our efforts in this area are focused
on supporting research that explores
additional uses of our product platform.
A broad mixture of insights, opinions
and views is an essential component of
supporting our future product pipeline.
Our engagement encompasses working
directly on R&D projects, supporting
awards and research grants, along with
sharing insights and knowledge.
During the reporting period we provided
numerous educational grants to
multidisciplinary groups such as the
World Conference of Interventional
Oncology Global Embolization
Symposium and Technologies as
well as to focused research groups such
as the Americas Hepato-Pancreatic-
Biliary Association.
A research grant to North Carolina
State University will help expand our
knowledge and understanding of Yttrium
90 and its clinical use.
During the reporting period, the
EMEA office supported a number of
investigator initiated studies with a range
of partners including the University of
Oxford, Cancer Research UK and the
University of Magdeburg in Germany.
We helped several young researchers
attend important international medical
conferences.
Local Communities
Sirtex seeks to be a responsible and
positive force in our local communities
worldwide. Employees are encouraged
to participate in community projects
where they believe Sirtex can make
a meaningful difference through
volunteering or fundraising.
In the US our employees are active
members of their local Oncology Nursing
Societies. Members of the team joined
a run to support victims of the Boston
Marathon bombings.
In Europe, our head office participated in
a number of community running events
and is an active member of the Bonn
Business Ambassadors Group.
In Australia, a team from Sydney will
complete a 200 km charity ride to raise
money for cancer research.
Sirtex 2014 AR 11
Sirtex employees in the
US run to raise money
for Boston Marathon
bomb victims and their
families
Sydney employees
join the 200km ride to
Conquer Cancer
LOCAL
COMMUNITIES
Study grants support
the next generation
of interventional
oncologists
We support medical
leaders working to
advance knowledge of
interventional oncology
therapies
MEDICAL
COMMUNITIES
Staff from the Sirtex US office take
part in a fun run to raise money
for local families.
American actress Carolyn Hennesy with
Beat Liver Tumors co-founder Suzanne
Lindley at an event in Los Angeles, California.
While our
decisions are made
locally, our energies
and contributions
are united and
directed towards
four distinct
areas:
Dr David Boshall of St Vincent’s
Hospital in Sydney talks with Sirtex’s
Medhat Dawoud.
We support the next generation of
medical and research professionals.
PATIENT
COMMUNITIES
Sirtex supports YES!
Beat Liver Tumors and
its support for patients
and their families
We work to expand
awareness and access
to SIR-Spheres
microspheres
RESEARCH
COMMUNITIES
Sirtex sponsors the
NSW Premier’s Cancer
Research Awards
We seek to support
the next generation
of researchers and
interventional oncology
experts
Sirtex 2014 AR 12
CHAIRMAN’S REPORT
Sirtex’s record dose sales, revenues and share price
performance detailed in this 2014 Annual Report round
out a decade of continuous sales growth.
DIVIDENDS PER SHARE
CENTS
7
7
7
0
1
2
1
2009
2010
2011
2012
2013
Chairman
Richard Hill
This year’s many achievements,
as in the past, are the result
of careful and prudent long
term planning, investment and
commitment to our 2020Vision
strategy and meeting the needs
of our customers worldwide.
SHARE PRICE
$ (AT 30 JUNE EACH YEAR)
$16.88
$11.98
6.09
4.90
4.90
3.35
2009
2010
2011
2012
2013
2014
Sirtex 2014 AR 13
These achievements demonstrate that
great results take time and that Sirtex
is focused on creating long-term value
for its shareholders. This is the context
through which investors should always
view our business.
Our goal to change liver cancer from a
terminal disease to a chronic disease is
ambitious and will take time. We know
the potential rewards for the thousands
of medical professionals, patients and
their families and our shareholders will
be profound.
We believe Sirtex’s growth has only
just begun and that our 2020Vision
strategy is appropriate to ensure the long
term sustainability and growth of the
organisation for investors.
2014 FINANCIAL RESULTS
We achieved record dose sales of 8,561,
an improvement of 17.3 per cent on the
previous year. Total product revenue
for 2014 was $129.4 million, up 33.7
per cent. Net profit after tax was $23.9
million, up 30.6 per cent on last year.
Profit before tax was up 26.9 per cent to
$31.1 million.
Cash from operations was $32.2 million,
up 32.2 per cent on the previous year
and the company increased its cash
holdings from $52.1 million to $52.5
million at the end of the reporting period.
These solid results give us great
confidence in Sirtex’s long-term growth
potential and the soundness of our
2020Vision strategy. The company’s
activities and financial results are
discussed in detail in the Directors’
Report.
DIVIDENDS
Our strong financial position and positive
future outlook has also permitted
the company to pay a dividend to
shareholders over the last five years,
including a total of $6.7 million in October
2013. Sirtex has now paid shareholders
a total of $24 million in dividends since
2010. The Board continues to monitor
cash flow, ongoing capital requirements
and our committments as we make
future dividend decisions.
MULTIPLE GROWTH INITIATIVES
Our commitment to creating long-term
value and growth has seen the business
invest in the necessary infrastructure,
capabilities and support needed for a
company with sales many times larger
than what they are today.
Our focus for the coming financial year is
to prepare the business for a significant
uplift in sales and demand including
marketing and the training of new
employees.
I am pleased to report our expanded
facility in the US will become operational
within the next few months and our
new manufacturing facility in Frankfurt,
Germany will be operational early in
calendar year 2015.
Another major capital investment has
been our commitment to enhance our
internal systems and resource planning
capabilities.
Sirtex plans to invest approximately
$3 million in a new integrated software
application to bring greater efficiencies
to our collection, storage and use of
business information to empower our
manufacturing, clinical and marketing
teams, streamline our administrative
procedures and further improve our
competitiveness.
Together these investments put our
business in a solid position ahead of
the release of data from our global
SIRFLOX study in 2015.
CLINICAL INVESTMENT TO
DELIVER OUTCOMES
Our largest investment to date has been
in our extensive global clinical program.
Our medical customers want better
outcomes for their patients and we work
with them to achieve this.
We are hopeful of positive outcomes
from the SIRFLOX study and the
expansion of our clinical programs into
new therapeutic areas.
The fact that all of our clinical studies
are recruiting strongly is a positive
sign. Delivery of the results will be
a tremendous achievement and
contribution towards helping medical
professionals improve outcomes for
people with liver cancer.
All of us at Sirtex are excited about
the potential our technology platform
holds to help treat a wide range of other
common and hard to treat cancers and
bring hope to more people.
RESEARCH & DEVELOPMENT
Our clinical programs are not only
focused on expanding the use of our
product. They also play a valuable
role in developing treatment protocols
and insights that create significant
competitive advantages for Sirtex and
major benefits for medical professionals
and their patients.
Sirtex’s ability to continue to innovate
is crucial to our success over the
coming decade.
Investment in R&D remains an important
driver for future growth and we have
an exciting portfolio of product
enhancements and new product
technologies in our pipeline at various
stages of development.
During the reporting period we invested
6.2 per cent of revenue back into R&D
and development of new product
technologies. Our customers can see
we are a long term partner in their efforts
to lighten the burden of cancer.
DIRECTOR AND BOARD ACTIVITIES
There were no changes to the Board
membership during the reporting period.
The Sirtex Board has worked cohesively
and productively for several years now.
It remains focused and committed
to ensuring the global management
team has the necessary resources and
expertise required to continue to expand
the business internationally.
Our management team has successfully
and consistently worked well together
under the leadership of our Chief
Executive Officer, Gilman Wong. Staff
and management stability is a key asset
and one of the reasons we are able to
maintain solid performance.
OUR DEDICATED EMPLOYEES
WORLDWIDE
Our business enjoys significant loyalty
with 80 per cent of the staff we employed
five years ago still with us today. They are
a great team and I am always energised
to meet many of the new members
and hear why they have joined our
organisation.
Sirtex employees are talented and
united in their focus to execute and
deliver on our strategy to create market
leadership through solving the problems
faced by our medical customers. They
are also committed to deploying our
resources wisely and delivering financial
performance to create long term
shareholder value.
The Board appreciates that our success
is built on the hard work and commitment
of our dedicated management and staff
who represent Sirtex and contribute
to our good reputation among our
customers in more than 30 countries
around the world each day.
A RESPONSIBLE COMMUNITY
MEMBER
Sirtex is committed to conducting
business ethically and contributing to
the social, environmental and economic
wellbeing of the many communities in
which we operate.
Our report this year details our
commitment and support for a range
of stakeholders in the medical, patient
research and local communities
worldwide.
OUTLOOK
The business fundamentals for minimally
invasive interventional oncology solutions
like SIR-Spheres microspheres remain
strong and the Board believes the right
settings are in place for our continued
growth over the coming decade.
Targeted cost-effective treatments
like SIR-Spheres microspheres are
increasingly contributing towards
improving outcomes and saving
resources in the healthcare sector, while
playing an important role in overcoming
many of today’s global healthcare
challenges.
The Board is pleased with the progress
made on all fronts and the performance
of the Sirtex team. By all measures 2015
is shaping up to be another year of
growth and prosperity for Sirtex as we
pursue our goal of making a meaningful
difference in the lives of people
with cancer.
RICHARD HILL
CHAIRMAN
Sirtex 2014 AR 14
CHIEF EXECUTIVE OFFICER’S REPORT
Chief Executive Officer
Mr Gilman Wong
FY14
Dose Sales
8,561
Revenue
growth up
33.7%
Dose sales
growth up
17.3%
ANOTHER YEAR OF PROGRESS
AND GROWTH
Financial year 2014 saw the
achievement of a significant
milestone for Sirtex – 10 years
of consistent quarterly dose
sales growth.
This achievement, plus continued
progress in the growth of Sirtex
revenue, profitability, cash
generation and shareholder value
is an impressive achievement of
which we at Sirtex are all proud.
Yet it is not the end of the story,
it is just the beginning. Sirtex’s
2020Vision aims to deliver
accelerated growth in the
medium to longer term.
Each day around the world, a growing
number of medical professionals are
witnessing the powerful potential of our
unique therapy to help them in their
efforts to improve the outcomes for their
patients facing the challenge of liver
cancer.
Together with the medical community,
we share a common vision of a future
where liver cancer is no longer a terminal
disease. Unfortunately it is unlikely that a
cure for liver cancer will be found in the
foreseeable future. However we at Sirtex
envisage a future in which liver cancer will
become a chronic condition people can
successfully live with.
The excellent results detailed in this
report, and our performance over the
past decade, combine to give Sirtex a
very solid foundation on which to build a
truly great global business.
We want to further unlock the potential
of our unique technology, loyal customer
base and world-leading expertise in
interventional oncology solutions.
Over the last few years, many of us at
Sirtex have been fortunate to personally
meet a number of patients who have
had their liver cancer treated with SIR-
Spheres microspheres.
“Together with the
medical community,
Sirtex shares a vision
where liver cancer is no
longer a terminal disease
but a chronic condition
people can successfully
live with.”
Sirtex 2014 AR 15
Sirtex has structured the business
for sustainable long-term growth
based on three core foundations
1. SIR-Spheres microspheres
2. Research & Development
SIR-Spheres Evolution
New Technology
3. Mergers & Acquisitions
It is based on three core growth pillars
with the first focused on fully exploiting
the SIR-Spheres microspheres
technology platform not just in its
traditional application for liver cancer,
but also in cancers outside the liver
such as kidney cancer and cancers
involving other organs.
The second pillar supporting and guiding
our decisions is aimed at evolving the
current SIR-Spheres microspheres
platform and related technologies, which
include developments in carbon cage
nanoparticles, coated nanoparticles
and radioprotector technologies.
“Our vision is pragmatic
and realistic.”
The third pillar is focused on potential
future merger and acquisition activities.
This is not an area where we have been
active but will potentially become more
active in coming years as our business
continues to expand globally.
As with the other pillars, our approach is
methodical and practical. Sirtex will only
be interested in acquiring new products
or partnering with any businesses that
add significant value and enhance the
level of service and support we provide
worldwide.
Our business is a long-term one and
our valued customers in the medical
profession are all long-term partners in
helping deliver successful outcomes for
their patients. It is important that we all
continue to manage Sirtex’s operations
and growth in this context.
CLINICAL PROGRAM
Under the first pillar of our growth
strategy, our clinical investment is
designed to significantly expand the
use of our current SIR-Spheres
microspheres product.
With our SIRFLOX study data currently
being collected and verified, recruitment
for our other large randomised controlled
studies is progressing well.
The SARAH study is on track to
complete recruitment by the 2014
calendar year end and the FOXFIRE
study is due to complete recruitment
shortly afterwards.
Our $60 million investment in clinical studies is set to deliver
STUDY NAME
START
TOTAL
PATIENTS
%
RECRUITMENT
AT 30 JUNE
2013
%
RECRUITMENT
AT 30 JUNE
2014
TYPE OF
LIVER
CANCER
SIRFLOX
FOXFIRE
FOXFIRE GLOBAL
SORAMIC
SIRveNIB
SARAH
2006
2010
2010
2011
2012
532
490
375
360
400
100%
100%
mCRC
46%
41%
53%
44%
94%
mCRC
63%
69%
92%
HCC
HCC
HCC
Sirtex 2014 AR 16
It is these deeply moving personal stories
and outcomes that inspire and motivate
our important work each and every day.
The growing number of liver cancer
patients successfully living with their
disease, and the insights of the
dedicated medical professionals who
treat them, illuminates a bright and
hopeful path forward for Sirtex and the
wider international medical community.
Together they are showing us what is
possible and reinforcing our commitment
to making liver cancer a disease we hope
many more people can successfully live
with or overcome altogether.
These insights drive our collective efforts
guided by our 2020Vision.
2020VISION STRATEGY
Implementation of our 2020Vision
continues to shape and guide both short
and long-term decision making across
the business.
Sirtex’s 2020Vision focuses on a range of
initiatives around our current product and
its evolution, research and development,
expansion of our capabilities, ability to
serve our customers and deliver on
our goals.
Cancer is notoriously difficult to treat
and so our vision to maintain and drive
long-term growth for our business and to
expand our product portfolio is pragmatic
and realistic.
Our 2020Vision provides a robust
structure for the business to enable
sustainable long-term growth while
delivering on our goals and vision.
CHIEF EXECUTIVE OFFICER’S REPORT
Clinical study results are complex and
may be a challenge to interpret. Therefore
we are planning to initiate a series of
information sessions for investors to
help them better understand clinical
study results. These will be presented
by independent experts and conducted
well in advance of the SIRFLOX study
data release.
new therapies that align with our core
technical and commercial capabilities
and skills in interventional oncology,
targeted radiation therapies and
innovative new approaches to treating
cancer.
We know our goal to help make liver
cancer a chronic disease is ambitious
and won’t be achieved on our own.
We are also investing heavily in our
sales and marketing and stakeholder
education programs to facilitate the
market’s understanding of the final
results when they are released.
We anticipate the SIRFLOX study
results will be positive and we are
planning for success. A positive outcome
could lead to a step change in growth
and acceptance of SIR-Spheres
microspheres, moving our therapy
further up the treatment chain to be used
as a first line treatment for metastatic
colorectal cancer (mCRC). However,
it is important to remember a study result
which is not positive will have little or
no impact on our current sales growth
and demand for our product. This is
because our clinical studies are in first
line therapy, whereas our current sales
are in the salvage therapy market and we
will continue to be able to serve a patient
population that has few options.
As our large studies progress towards
completion, we are directing our
resources and skills towards providing
therapies for a range of other potential
indications.
Our RESIRT kidney cancer study is
progressing well and we envisage moving
our research into a pivotal global clinical
study during the 2015 calendar year.
RESEARCH, DEVELOPMENT &
COLLABORATION
The second pillar of our vision is our
investment in R&D. Sirtex continues
to invest in innovation to ensure the
advancement of our product offering
is a priority.
During the reporting period our R&D
investment was $8.0 million or 6.2 per
cent of total revenue.
Our global R&D activities are aimed at
supporting our current product and
the parallel development of multiple
It is a goal greater than one person or
company and a goal that makes Sirtex a
key part of the wider international efforts
underway by other leaders in the field.
The innovation required highlights the
need for extensive collaboration. During
the reporting period Sirtex continued
to foster strong links with several other
leaders in interventional oncology and
related fields.
Our research in association with The
Australian National University, University
of New South Wales, Peter MacCallum
Institute, and the National Cancer Centre
Singapore is progressing well.
A key achievement this year was the
start of our collaboration with Guerbet,
a pioneer in the field of contrast agents
with more than 80 years of experience.
Guerbet is the only global pharmaceutical
group dedicated to medical imaging
and has a complete offering of
contrast products for X-Ray, MRI and
interventional radiology. It also has a
range of injectors and related medical
equipment to provide improved diagnosis
and treatment of patients.
To promote the discovery of new
products and assure future growth,
Guerbet annually devotes significant
resources (about 10 per cent of sales)
to research and development. The
company employs more than 1,400
people worldwide and is listed on NYSE
and Euronext Paris. In 2013 it reported
sales of €387 million (AU$560 million).
Our research collaborations with all of
these organisations help enhance and
expedite our product development while
reducing many of the risks and costs
associated with undertaking such world
leading work on our own.
Together these collaborations will move
us closer towards the ground-breaking
innovation we seek in order to lead and
transform the market.
ANOTHER EXCEPTIONAL YEAR
OF ACHIEVEMENT
Growing global demand for our SIR-
Spheres microspheres liver cancer
therapy is directly reflected in our strong
operating results and another year of
record sales growth.
We continued the positive growth trend
of the past decade with dose sales up
17.3 per cent to achieve a total of $129.4
million in revenue, up 33.7 per cent on
the previous year.
Importantly for the future, we continue
to make good progress with efforts to
enhance and expand the use of our
current product and develop our product
pipeline and exciting new technologies.
Some of the key milestones achieved
by the Sirtex team during the reporting
period include:
Record revenues of $129.4 million,
up 33.7 per cent on 2013
Record dose sales of 8,561, up
17.3 per cent on 2013
Net profit after tax of $23.9 million,
up 30.6 per cent on the previous year
Earnings per share of 42.5 cents,
up 29.8 per cent
Cash balance of $52.5 million and
no debt
Successful follow-up of patients in
the SIRFLOX study with SARAH
and FOXFIRE studies scheduled to
complete recruitment by late 2014
and early 2015
Opening of our new regional office in
Bonn, Germany
Our new European manufacturing
facility in Frankfurt, Germany set to
begin shipping customer orders in
calendar year 2015
Installation of the new manufacturing
equipment in Wilmington, USA, ready
for commissioning
A new global collaboration agreement
with Guerbet
Winning Frost & Sullivan’s Australian
Life Sciences Company of the
Year Award
Awarded the NSW Premier’s Export
Award for Health & Biotechnology
Presentation of the inaugural Sirtex
Award for Excellence in Translational
Sirtex 2014 AR 17
greater cost efficiencies and medical
professionals continue to seek effective
and innovative new treatments like ours
to help them improve patient outcomes
and address the burden of cancer in their
communities.
We believe 2015 and beyond will
bring about the positive results of the
recent years of effort and investment in
manufacturing, sales and marketing and
clinical programs.
We acknowledge we operate in an
increasingly competitive marketplace and
that our success may inspire imitators
and competitors.
We believe we have one of the best
therapies available on the market and all
of us at Sirtex are deeply committed to
achieving long-term growth while at the
same time helping positively change the
outcomes for people with liver cancer.
The operational excellence of our global
business is built on a working culture
of cooperation and mutual respect to
ensure our talented staff are able to meet
our ongoing commitment to the medical
professionals and their patients who
depend on our product for their quality
of life.
In summary, our continued operational
performance, the delivery of our
2020Vision and the three pillar growth
strategy will ensure long-term growth,
improve patient outcomes and
shareholder value for many years
to come.
GILMAN E WONG
CHIEF EXECUTIVE OFFICER
Medicine at the New South Wales
Premier’s Award for Outstanding
Cancer Research
any potential issues and ensuring all our
occupational health and safety practices
are at world class standards.
• Strong interest from the Australian
investment community in technical
medical presentations by some of our
global key opinion leaders.
SALES & MARKETING
A major focus during the year has been
to ensure readiness for the release of
the SIRFLOX data in 2015, including the
expansion of manufacturing, logistics,
sales and marketing and the training of
our customers, suppliers and employees.
A number of market growth initiatives
were developed in the context of our
strategy and will continue to be rolled
out globally in FY2015.
A good example was the high interest
and attendance at the fifth European
Multidisciplinary Symposium on Liver-
Directed Cancer Therapy in Rome.
Six years ago a handful of specialists
attended. This year there were more than
500 from around the world.
It is the growing interest from the medical
community like this which gives us great
confidence in our strategy and ability to
continue to drive shareholder value in the
coming years.
OUR PEOPLE
Sirtex now has a global team of over
200 people in 20 countries. The diversity
of expertise and experience from this
global network is part of our competitive
advantage.
We make a significant effort to attract
and hire the best people by providing all
employees with a working environment
that inspires and supports them to
perform at their best. In 2014 we
increased by 35 new permanent
employees.
During the reporting period we initiated
internal career development programs
aimed at developing a strong internal
talent pipeline in each of our key
geographic markets. This ultimately
benefits our customers and their patients.
Sirtex is committed to providing a healthy
and safe workplace for all employees and
during the reporting period we initiated
a global program aimed at identifying
MANUFACTURING AND
SUPPLY CHAIN
Sirtex operates a highly efficient global
supply chain to ensure its products
are delivered on time to hundreds of
customers in approximately 30 countries.
The robust structure and operation of
our supply chain plays an important
role in our growth and ability to serve
our growing customers base. It is a
significant and valuable asset that will
allow us to introduce new products
and services for our valued customers.
It is also a key element in our ability to
maintain our costs.
Our capable team has been busy this
year working towards the expansion
of our US facility in Wilmington and the
commissioning of our new German
manufacturing plant. Our strategy is
to ensure our worldwide logistics and
production capacity is sufficient to meet
the anticipated sales growth demands,
not only for our current market but the
increased demand potential following
the release of potential positive
SIRFLOX results.
To ensure we manage our business and
it’s global growth, we have undertaken
a comprehensive review of our internal
global technology platform. Our current
system has met our requirements.
However as we expect significant growth
in coming years, we must ensure Sirtex
has in place a robust platform to support
our expansion.
During the coming year we are looking
to invest $3 million in a major upgrade
to our information technology systems
and other process improvements which
will be essential for our connected
global supply chain, sales and customer
management systems as we grow.
LOOKING AHEAD
The unmet needs for minimally invasive
medical solutions and innovative
interventional oncology solutions globally
remain very strong.
We believe the next few years will
begin to see a consolidation in this area
as both payers and regulators seek
Sirtex 2014 AR 18
OTHER KEY MANAGEMENT PERSONNEL*
Darren Smith – Chief Financial Officer
and Company Secretary
Experience and Expertise
Mr Smith was appointed Company
Secretary in July 2008 and Chief
Financial Officer in February 2009.
Mr Smith previously held CFO and
senior executive finance and general
management positions in a number of
international, Australian listed and private
companies. Mr Smith holds an MBA
from the Australian Graduate School
of Management (AGSM), the University
of New South Wales, a Bachelor of
Business from the University of Western
Sydney, is a Fellow of CPA Australia
having been a member for over 20
years and is a member of the Australian
Institute of Company Directors.
Responsibilities
Mr Smith has overall responsibility
for the Finance, IT and Human Resources
function of the Group.
Dr Burwood Chew – CEO Asia Pacific
Experience and Expertise
Dr Chew joined Sirtex in January 2011 as
Head of the Asia Pacific region. Dr Chew
has extensive experience in oncology and
for many years has held senior regional
positions with Bayer Healthcare, Sanofi-
Aventis, and with Wellcome (now GSK).
Dr Chew is a medical graduate from the
University of New South Wales.
Responsibilities
Dr Chew is based in our regional office
in Singapore with responsibility for the
development and execution of the
strategic direction of Sales and Marketing
in Australia, New Zealand and Asia
Pacific. This large region comprises
heterogeneous markets with direct sales,
distributors and licensing partners.
Michael Mangano – President US
Dr David N Cade – Chief Medical Officer
Experience and Expertise
Mr Mangano joined Sirtex in January
2010, after 15 years of experience in
the medical device industry with Boston
Scientific where he had numerous
management positions both within
the US and internationally.
Responsibilities
Mr Mangano is based in our regional
office in the greater Boston area and
responsible for the development
and execution of the strategic direction
of Sales and Marketing in North,
Central and Latin America.
Nigel Lange – CEO Europe
Experience and Expertise
Mr Lange joined Sirtex US in 2002,
then set up Sirtex operations in Europe.
Before joining Sirtex, Mr Lange held
senior roles at Nordion Inc (NYSE:NDZ)
and has over 20 years of experience in
the healthcare industry.
Responsibilities
Mr Lange is based in our regional office
in Bonn, Germany, where he is
responsible for the development and
execution of the strategic direction of
Sales and Marketing in Europe as well
as the Middle East and Africa, a region
which for Sirtex comprises a total of
20 countries with direct sales and
distributor sales models.
Experience and Expertise
Dr Cade joined Sirtex in 2003 and
has served as the Chief Medical Officer
since 2007. He previously held the
positions of US Medical Director based
in New York, USA, from 2005 to 2007,
and European Medical Director based in
Bonn, Germany, from 2003 to 2005.
Dr Cade is a medical graduate of Monash
University, and holds an MBA from the
Melbourne Business School and the
ESADE Business School in Barcelona,
Spain. Prior to joining Sirtex, Dr Cade
worked at Booz Allen Hamilton, a global
management consultancy.
Responsibilities
Dr Cade has responsibility for all medical
affairs of the group, and is based in the
Sydney head office.
Robert Hardie – Global Head of
Operations
Experience and Expertise
Mr Hardie joined Sirtex in June 2006
and was appointed Global Head of
Operations in October 2006. Mr Hardie
previously held senior engineering and
management positions in various industry
sectors, and has a strong engineering,
manufacturing, production planning and
logistics background.
Responsibilities
Mr Hardie has overall responsibility
for global operations including
manufacturing, supply chain management
and logistics. Mr Hardie is based in the
Sydney head office.
*Excluding Board of Directors. Please refer to the Directors’ Report.
Sirtex 2014 AR 19
CORPORATE GOVERNANCE STATEMENT
The Board is committed to
achieving and demonstrating the
highest standards of corporate
governance. As such, Sirtex
Medical Limited and its controlled
entities (the ‘Group’) have adopted
a corporate governance framework
and practices to ensure they meet
the interests of shareholders.
The Group complies with the
Australian Securities Exchange
Corporate Governance Council’s
Corporate Governance Principles
and Recommendations 2nd
Edition (the ‘ASX Principles’).
This statement incorporates the
disclosures required by the ASX
Principles under the headings of
the eight core principles. All of
these practices, unless otherwise
stated, were in place for the full
reporting period.
Further information on the Group’s
corporate governance policies and
practices can be found on Sirtex
Medical Limited’s website at
http://www.sirtex.com/au/
investors/investor-resources/
corporate-governance-and-policies/
PRINCIPLE 1:
LAY SOLID FOUNDATION FOR
MANAGEMENT AND OVERSIGHT
Functions of the Board and
Management
The Board of Directors is responsible
for the corporate governance of the
Group and operates in accordance with
the principles set out in its Charter. To
ensure that the Board is well equipped
to discharge its responsibilities, it has
established guidelines for the nomination
and selection of Directors and for
the operation of the Board. These
responsibilities include:
Setting the strategy for the Group,
including operational and financial
objectives and ensuring that there are
sufficient resources for this strategy
to be achieved
Appointing the Chief Executive
Officer (‘CEO’), approving other key
executive appointments and planning
for executive succession
Overseeing and evaluating the
performance of the CEO and the
executive team through a formal
performance appraisal process
having regard to the Group’s
business strategies and objectives
Monitoring compliance with legal,
regulatory and occupational health
and safety requirements and
standards
Overseeing the identification of
key risks for the Group and the
implementation of an appropriate
internal control framework to ensure
those risks are managed to an
acceptable level
Approving the Group’s budgets and
significant acquisitions, expenditures,
and divestitures
Approval of the annual and half-yearly
financial reports
Ensuring the market and
shareholders are fully informed of
material developments.
The Board has delegated responsibilities
for the management of operations and
administration of the Company to the
CEO and the executive management
team. The Board ensures that the CEO
and the executive management team are
appropriately qualified and experienced
to discharge their responsibilities and
has in place procedures to monitor and
assess their performance.
To ensure that the responsibilities of the
Board are upheld and executed to the
highest level, the Board has established
the following committees:
Remuneration Committee
Audit & Risk Committee
The roles and responsibilities of these
committees are discussed later in this
statement. Each of these committees
have established Charters and operating
procedures in place, which are reviewed
on a regular basis.
The Board does not have a Nomination
Committee. The Board believes that
as it is not large (four Directors), a
formal Nomination Committee would
not provide any marked efficiencies
or enhancements. The charter of
the nomination committee has been
included into the Board Charter and as
such the Board considers all matters
that would be relevant regarding Board
appointments.
Senior Executive performance
evaluation
The Board reviews the performance of
the CEO and the executive team on a
yearly basis. Performance is measured
against a set of key performance
indicators which have been established
with reference to the Group’s strategy
and the individual’s responsibilities.
The Remuneration Committee annually
reviews and determines the remuneration
arrangements for the CEO and the
executive team, submitting their
recommendations to the Board for
approval.
PRINCIPLE 2:
STRUCTURE OF THE BOARD
TO ADD VALUE
Board composition
The names of the members of the
Board as at the date of this report are
as follows:
Richard Hill (Chairman) – Independent
Non-Executive Director
John Eady (Deputy Chairman) –
Independent Non-Executive Director
Grant Boyce – Independent Non-
Executive Director
Gilman Wong – Managing Director
and CEO
The Board’s composition is determined
with regard to the following criteria:
A majority of Independent Non-
Executive Directors and a Non-
Executive Director as chairman
Re-election of Directors at least every
three years (except for the Managing
Director)
The size of the Board is appropriate
to facilitate effective discussion and
efficient decision making.
With regard to Director Independence,
the Board has adopted specific principles
which state that an Independent Director
must not be a member of management
and must comply with the following
criteria:
Not, within the last three years,
have been employed in an executive
position of the Group
Not be a substantial shareholder
or be associated with a substantial
shareholder
Sirtex 2014 AR 20
CORPORATE GOVERNANCE STATEMENT
Not, within the last three years,
acted as a professional advisor to
the Group either as a principal or
material consultant
Have no material contractual
relationship with any entity within
the Group other than in the capacity
as a Director.
At the commencement of this reporting
period, the Board comprised of
four Directors, three of whom were
Independent Non-Executive directors.
The Board can therefore be considered
to be independent.
Role of the Chairman
The Board Charter provides that the
Chairman should be an Independent
Non-Executive Director. The Chairman
is responsible for the leadership of the
Board. This includes taking responsibility
for ensuring that the Board functions
effectively and that they comply with the
continuous disclosure requirements of
the ASX. The Chairman’s responsibilities
are set out in the Board Charter and
include:
Setting the agenda for Board
meetings
Managing the conduct, frequency
and length of Board meetings to
ensure that all Directors have had the
opportunity to establish a detailed
understanding of the issues affecting
the Group
Facilitating the Board meetings to
ensure effective communication
between the Directors and that all
directors have contributed to the
decision making process thereby
leading to a considered decision
being made in the best interest
of the Group and its shareholders.
Remuneration Committee
A Remuneration Committee has
been established by the Board. The
Committee’s role and operations are
documented in a Charter which is
approved by the Board. This Charter is
available on the Group’s website under
http://www.sirtex.com/media/59780/
remuneration_committee_charter_
march_2013.pdf
The Committee’s Charter provides
that all members of the Remuneration
Committee must be Independent Non-
Executive Directors. Members of the
Committee throughout the period and
at the date of this report are John Eady
(Chair), Grant Boyce, and Richard Hill,
all of whom are Independent Non-
Executive Directors.
The number of meetings held and
attended by each member throughout
the period is set out in the Directors’
Report.
Directors’ performance evaluation
The Board undertakes an assessment
of its collective performance, the
performance of the Board committees
and the Chairman on an annual basis.
These performance evaluations were
carried out during the reporting period
and were compliant with the Group’s
established practices.
Independent professional advice
and access to information
Each Director has the right of access
to all relevant information in the Group
in addition to access to the Group’s
executives. Each Director also has the
right to seek independent professional
advice subject to prior consultation with,
and approval from, the Chairman. This
advice will be provided at the Group’s
expense and will be made available to all
members of the Board.
Insurance
The Group has in place a Directors and
Officers liability insurance policy providing
cover for current and former Directors
and executive officers of the Group
against liabilities incurred whilst acting in
their respective capacity.
PRINCIPLE 3:
PROMOTE ETHICAL AND
RESPONSIBLE DECISION MAKING
Code of Conduct
The Group recognises the importance
of establishing and maintaining
high ethical standards and decision
making in conducting business and is
committed to increasing shareholder
value in conjunction with fulfilling its
responsibilities as a good corporate
citizen. All Directors, managers and
employees are expected to act with the
utmost integrity, honesty and objectivity.
The Group has established a Corporate
Code of Conduct and a Director’s
Code of Conduct, copies of which
are available on the Sirtex website
under www.sirtex.com/media/59823/
corporatecodeofconduct.pdf and
www.sirtex.com/media/59826/
directorscodeofconduct.pdf. New
employees are introduced to the
Corporate Code of Conduct as part
of their induction training.
Unethical practices, including fraud, legal
and regulatory breaches, and policy
breaches are required to be reported on
a timely basis to management. Reporting
parties are able to do so without fear
of reprisal or retribution as their identity
and report are kept in the strictest
confidence. External third party reporting
procedures are available to employees
to provide them with the assurance that
their identity will be kept confidential at
all times.
Securities Trading Policy
The Group has established a Securities
Trading Policy which governs the trading
in the Group’s shares and applies to all
Directors and employees of the Group.
A copy of this policy is available on the
Group’s website under www.sirtex.com/
media/59635/cpol011_-_securities_
trading_policy.pdf
Under this policy, an executive, employee
or Director must not trade in any
securities of the Group at any time when
they are in possession of unpublished,
price sensitive information in relation to
those securities, or during Black Out
periods. There are three scheduled Black
Out periods each year set out as follows:
The period of four weeks prior to
the release of the full-year results
to the market
The period of four weeks prior to
the release of the half-year results
to the market
The period of four weeks prior to
the Annual General Meeting.
Trading in securities of the Group is only
allowed outside the Black Out periods.
As required by the ASX listing rules, the
Group notifies the ASX of any transaction
conducted by Directors in securities of
the Group.
Diversity Policy
Diversity includes, but is not limited
to, gender, age, ethnicity and cultural
background. The Group is committed
to diversity and recognises the benefits
arising from employee and Board
Sirtex 2014 AR 21
diversity and the importance of benefiting
from all available talent. The Group
has implemented a Diversity and Equal
Employment Opportunity policy. A copy
of this policy is available on the Group’s
website under www.sirtex.com.au/
media/64744/cpol014_-_sirtex_diversity_
policy.pdf.
The Group recognises that promoting
the role of women at all levels within the
organisation, as well as facilitating other
diversity initiatives, is important. Several
programs have been developed and
implemented to promote the diversity
of the workforce within the Group.
Over time, these programs will improve
diversity of the workforce.
As at 30 June 2014, the percentage of
females working within the Group was
as follows:
All
Staff Female
%
Female
All roles
213
Management
Executives
Board
68
12
4
90
26
1
–
42%
39%
8%
0%
PRINCIPLE 4:
SAFEGUARD INTEGRITY IN
FINANCIAL REPORTING
Audit and Risk Committee
An Audit and Risk Committee has
been established by the Board. The
Committee’s role and operations are
documented in a Charter which is
approved by the Board. This Charter
is available on the Group’s website
under www.sirtex.com/media/59777/
auditcommitteecharter.pdf.
The Committee’s Charter provides
that all members of the Audit and Risk
Committee must be Independent Non-
Executive Directors and that the Chair
cannot be the Chairman of the Board.
Members of the Committee throughout
the period and at the date of this report
are Grant Boyce (Chair), John Eady and
Richard Hill, all of whom are Independent
Non-Executive Directors.
The purpose of the Committee is to:
Ensure the integrity of the Group’s
internal and external financial
reporting including compliance with
applicable laws and regulations
Ensure that financial information
provided to the Board is of a
sufficiently high quality to allow the
Board to make informed decisions
Ensure that appropriate and effective
internal systems and controls are
in place to manage the Group’s
exposure to risk
Oversee the appointment,
compensation and retention of
the external auditor, and review
of any non-audit services provided
by the external auditor
Regular performance review of the
external auditor regarding quality,
costs and independence.
The number of meetings held and
attended by each member throughout
the period is set out in the Directors’
Report.
PRINCIPLE 5:
MAKE TIMELY AND BALANCED
DISCLOSURE
Sirtex Medical Limited has established
policies and procedures to ensure timely
and balanced disclosure of all material
matters concerning the Group, and
ensure that all investors have access
to information on the Group’s financial
performance. This ensures that the
Group complies with the information
disclosure requirements under the
ASX Listing rules.
These policies and procedures include
a comprehensive Disclosure Policy that
includes identification of matters that
may have a material impact on the share
price of Sirtex, notifying them to the
ASX, posting relevant information on the
Group’s website under www.sirtex.com/
media/59638/cpol004_-_corporate_
communications_and_disclosure_
policy.pdf.
Matters involving potential market
sensitive information must first be
reported to the CEO. The CEO will
advise the other Directors if the issue
is important enough to warrant the
consideration of the full Board. In all
cases the appropriate action must
be determined and carried out in a
timely manner in order for the Group to
comply with the Information Disclosure
requirements of the ASX.
Once the appropriate course of
action has been agreed upon, the
CEO or the Company Secretary will
disclose the information to the relevant
authorities. Board approval is required
for market sensitive information such as
financial results, material transactions
or upgrading/downgrading financial
forecasts.
PRINCIPLE 6:
RESPECT THE RIGHTS OF
SHAREHOLDERS
Sirtex Medical Limited has established
a Shareholder Communication Policy
which describes the Group’s approach to
promoting effective communication with
shareholders which include:
The Annual Report, including relevant
information about the operations of
the Group during the period, key
financial information, changes in
the state of affairs and indications
of future developments. The Annual
Report can be accessed through the
ASX website or the Sirtex website
under www.sirtex.com/au/investors/
investor-resources/annual-reports/
The half-year and full year financial
results are announced to the ASX
and are available to shareholders
through the ASX website or the
Sirtex website
All announcements made to the
market and related information are
made available to all shareholders
through the Sirtex website under
www.sirtex.com/au/investors/
investor-resources/recent-
announcements/
Detailed notices of shareholder
meetings are sent to all shareholders
in advance of the meeting
Shareholding and dividend payment
details are available through the
Group’s share register, Boardroom
Pty Ltd.
The Board encourages full participation
by shareholders at the Annual General
Meeting to ensure a high level of
Director accountability to shareholders
and shareholders’ identification with
the Group’s strategy and goals. The
shareholders are requested to vote on
matters such as the adoption of the
Group’s remuneration report, the granting
of securities to Directors and changes to
the Constitution.
The external auditor attends the Annual
General Meeting to answer any questions
concerning the audit of the Group and
the contents of the Auditor’s Report.
Sirtex 2014 AR 22
CORPORATE GOVERNANCE STATEMENT
PRINCIPLE 7:
RECOGNISE AND MANAGE RISK
Risk management framework
Sirtex recognises that a robust risk
management framework is essential
for corporate stability, protecting the
interests of its stakeholders and for
sustaining its competitive market position
and long term performance.
The following objectives drive the Group’s
approach to risk management:
Having a culture that is risk aware
and supported by high standards of
accountability at all levels
Promoting and achieving an
integrated risk management
approach whereby risk management
forms a part of all key organisational
processes
Supporting more effective decision
making through better understanding
and consideration of risk exposures
Increasing shareholder value by
protecting and improving share price
and earnings per share in the short
to medium term while building a
sustainable business in the longer
term
Safeguarding the Group’s assets
Enabling the Board to fulfil its
governance and compliance
requirements
Supporting the sign off for ASX
Principles four and seven by the
Chief Executive Officer and the Chief
Financial Officer.
Audit and Risk Committee
Under its Charter, the Audit and
Risk Committee has been delegated
responsibility by the Board to oversee
the implementation and review of
risk management and related internal
compliance and control systems
throughout the Group.
The Committee reviews the
appropriateness and adequacy of internal
processes for determining, assessing
and monitoring risk areas including the
assessment of the effectiveness of the
Group’s internal compliance and controls
including:
The existence and adequacy of key
policies and procedures
The adequacy of disclosures and
processes for regular reporting of
information to the appropriate parties,
including the Board.
PRINCIPLE 8:
REMUNERATE FAIRLY AND
RESPONSIBLY
Remuneration Committee
The Committee is also responsible for
monitoring the Group’s compliance with
applicable laws and regulations including:
Ensuring that management is
reviewing developments and changes
in applicable laws and regulations
relating to the Group’s responsibilities
Reviewing management’s actions
and responses to ensure that the
Group’s practices are compliant with
all new developments
Reviewing material, actual and
suspected breaches of applicable
laws and regulations, and any
breaches of Group policies
Reviewing material litigation, legal
claims, contingencies or significant
risks relating to the Group
Reviewing Director and executive
management related party
transactions.
Major issues and findings that are
presented and discussed at the
Committee meetings are reported to the
Board by the Audit and Risk Committee.
Corporate reporting
The Board has required management
to design and implement a risk
management and internal control system
to manage the Group’s material business
risks and to report on whether those risks
are being effectively managed.
The Chief Executive Officer and the
Chief Financial Officer have reported and
declared in writing to the Board as to the
effectiveness of the Group’s management
of its material business risks, in
accordance with Recommendation
7.2 of the ASX Corporate Governance
Principles.
The Board has received the relevant
declaration from the Chief Executive
Officer and the Chief Financial Officer
in accordance with s295A of the
Corporations Act 2001 and the relevant
assurances under Recommendation
7.3 of the ASX Corporate Governance
Principles.
As previously stated in Principle 2, the
Board has established a Remuneration
Committee whose role is documented in a
Charter which is approved by the Board.
The objective of the Committee is to assist
the Board in determining appropriate
remuneration arrangements for the
Directors and executive management.
These objectives include:
Reviewing the adequacy and form
of remuneration of Independent Non-
Executive Directors and ensuring
their remuneration is reflective of the
responsibilities and the risks of being
a Director of the Group
Reviewing the contractual
arrangements of the Chief
Executive Officer and the executive
management team including their
remuneration
Comparing the remuneration of
the Chief Executive Officer and
the executive management team
with similar industries to ensure
that remuneration on offer can
attract, retain and properly reward
performance which will translate into
long term growth in shareholder value
Annually review key performance
indicators for the Chief Executive
Officer and the executive
management team to ensure that
they remain congruent with the
Group’s strategies and objectives
Reviewing incentive performance
arrangements when instructed by
the Board
Reviewing proposed remuneration
arrangements for new Directors or
executive appointments.
The Committee will submit their
recommendations to the Board, and the
Board will review these recommendations
before providing their approval. Details of
the Group’s remuneration structure and
details of senior executive’s remuneration
and incentives are set out in the
Remuneration Report contained within
the Directors’ Report. The Remuneration
Report also contains details on the
structure of Non-Executive Director
Remuneration.
Sirtex 2014 AR 23
FINANCIAL REPORT
for the year ended 30 June 2014
Sirtex Medical Limited
Consolidated Entity
ABN 35 078 166 122
TABLE OF CONTENTS
25 Directors’ Report
47 Auditor’s Independence Declaration
48 Directors’ Declaration
49 Independent Auditor’s Report
52 Consolidated Statement of Profit or Loss
and Other Comprehensive Income
53 Consolidated Statement of Financial Position
54 Statement of Changes in Equity
55 Statement of Cash Flows
56 Notes to the Financial Statements
84 Additional Stock Exchange Information
85 Company Information
Sirtex 2014 AR 24
DIRECTORS’ REPORT
for the year ended 30 June 2014
The Directors of Sirtex Medical Ltd present their report, together with the financial statements of the consolidated entity, being
Sirtex Medical Ltd and its controlled entities (‘the Group’) for the year ended 30 June 2014.
Directors
The Directors of Sirtex Medical Ltd during the financial year and until the date of this report are Mr R Hill, Dr J Eady, Mr G Boyce,
and Mr G Wong. Details of the Directors, including their skills, experience, and expertise, are set out below.
Richard Hill – Chairman
(Non-Executive)
BA, LLB (Sydney), LLM (London)
Experience and Expertise
Mr Hill was appointed a director in September 2004 and Chairman in August 2006. He
previously held senior executive positions with HSBC Investment Bank in Hong Kong and New
York and has extensive experience in international M&A and capital raising. He was a founding
partner of Hill Young & Associates, a corporate advisory firm. He is also an attorney of the
New York State Bar.
Directorships held in other listed entities during the last three years
Calliden Group Limited – Chairman
Biota Holdings Limited
BlackWall Property Funds – Chairman
Special Responsibilities
Member of the Audit Committee and the Remuneration Committee
Interest in Shares and Options
1,974 share rights
Experience and Expertise
Dr Eady was appointed a director in March 2005. He spent most of his career with CRA
Limited in a range of senior executive positions. He has broad Board experience including
that with the Australian Federal Government’s Industry, Research and Development Board.
Dr Eady is a Fellow of the Academy of Technological Sciences and Engineering, and consults
extensively on business improvement.
Directorships held in other listed entities during the last three years
Nil
Special Responsibilities
Chairman of the Remuneration Committee and Member of the Audit Committee
Interest in Shares and Options
5,000 ordinary shares in Sirtex Medical Limited
1,234 share rights
Experience and Expertise
Mr Boyce was appointed a director in December 2002. He is a Chartered Accountant and
the founder of Montrose Partners, a West Australian firm of chartered accountants. He was
a Partner with Ernst & Young and worked in their Perth and New York offices. He has also
served previously as Company Secretary for Sirtex.
Directorships held in other listed entities during the last three years
Nil
Special Responsibilities
Chairman of the Audit Committee and Member of the Remuneration Committee
Interest in Shares and Options
5,000 ordinary shares in Sirtex Medical Limited
987 share rights
Experience and Expertise
Mr Wong was appointed Chief Executive Officer in May 2005 and director in June 2005.
Mr Wong previously held CEO and senior executive positions in the commercial and industry
sector including 10 years with Email Limited. He has a strong planning and sales and
marketing background.
Directorships held in other listed entities during the last three years
Nil
Interest in Shares and Options
60,000 ordinary shares in Sirtex Medical Limited
347,000 Executive Performance Rights
Dr John Eady – Deputy Chairman
(Non-Executive)
BSc (Hons), PhD, FTSE
Grant Boyce – Director
(Non-Executive)
CA, BCom
Gilman Wong – Executive Director
and Chief Executive Officer
Sirtex 2014 AR 25
Company Secretary
Darren Smith – Company
Secretary and Chief
Financial Officer
MBA, BBus, FCPA
Experience and Expertise
Mr Smith was appointed company secretary in July 2008 and Chief Financial Officer in
February 2009. Mr Smith previously held CFO and senior executive finance and general
management positions in a number of international, Australian listed and private companies.
Mr Smith holds an MBA from the Australian Graduate School of Management (AGSM), The
University of New South Wales, a Bachelor of Business from the University of Western Sydney,
and is a Fellow of CPA Australia having been a member for over 20 years and is a member
of AICD.
Interest in Shares and Options
5,000 ordinary shares in Sirtex Medical Limited
111,000 Executive Performance Rights
Directors’ meetings
The number of Directors’ meetings (including meetings of committees of Directors) and number of meetings attended by each
of the Directors of the company during the financial year are:
Directors
Held
Attended
Held
Attended
Held
Attended
Board of Directors
Remuneration Committee
Audit Committee
R Hill (Chairman)
Dr J Eady
G Boyce
G Wong
11
11
11
11
Principal activities
11
11
11
11
6
6
6
–
6
6
6
–
3
3
3
–
3
3
3
–
Sirtex Medical Ltd and its controlled entities (the ‘Group’) form a medical device group whose primary objective is to manufacture
and to distribute effective liver cancer treatments utilising small particle technology to approved markets in Asia-Pacific, Europe and
Middle East and North and South America.
Review of operations and financial results
The Group’s main product, called SIR-Spheres microspheres, is a targeted radioactive treatment for liver cancer. This treatment
is called Selective Internal Radiation Therapy (SIRT) being a minimally invasive surgical procedure performed by an interventional
radiologist. The SIR-Spheres microspheres lodge in the small blood vessels of the tumour where they destroy it from the inside over
a short period while sparing the surrounding healthy tissue. During the year, the Group sold 8,561 doses worldwide representing
less than 2% of the addressable market.
Dose sales for the year increased by 17.3% over the previous financial year. The US market with 5,836 doses achieved growth
of 22.5%, the European and Middle East and Africa (EMEA) market with 1,916 doses achieved growth of 5.6%, and Asia Pacific
(APAC) recorded 809 dose sales representing growth of 12.3%. The doses have been sold through over 600 hospitals worldwide.
The largest individual customer, a hospital in the US, represented 1.3% of total dose sales during the year (2013: 1.6%).
Sirtex recorded sales revenue of $129,363,426 for the financial year ended 30 June 2014. This represents an increase of 33.7%
over last financial year ($96,773,847). The higher sales revenue growth compared to volume growth is a result of changes in
geographic revenue mix with stronger growth in the high margin US region, and of positive foreign currency fluctuations, as the
Australian Dollar depreciated against the US dollar and the Euro during the year.
Gross margin increased to 84.3% for the year ended 30 June 2014, compared to 81.9% for last financial year. This was the result
of improved efficiencies due to higher manufacturing volumes, a full year without contract manufacturer, and a price increase in the
US region at the end of the financial year.
Profit before tax has improved 26.9% to $31,109,946 for the year ended 30 June 2014 (2013: $24,507,306), and Profit after tax
has increased by 30.6% to $23,867,803 (2013: $18,270,025).
Earnings per share for the year ended 30 June 2014 have increased to $0.425 (2013: $0.328). During the year, a final dividend
has been paid in respect of the previous financial year. The fully franked dividend was $0.12 per share, representing an increase
of 20.0% over the previous dividend paid.
Net assets for the Group increased by 22.5% to $107,582,178 (2013: $88,137,730), mainly due to the investment of $18,848,091
(2013: $12,500,888) in intangible assets and $6,189,143 (2013: 3,694,838) in plant and equipment.
A significant part of the Group’s clinical activities is focused on five major post-marketing clinical studies. Consistent with last year,
expenses for these studies have been capitalised as they continue to satisfy the recognition criteria for AASB 138 Intangible Assets.
Additions to capitalised costs incurred for these trials as well as for two smaller development projects during the financial year
ended 30 June 2014 represent a total of $18,848,091 compared to $12,500,888 for the previous financial year.
Sirtex 2014 AR 26
DIRECTORS’ REPORT
for the year ended 30 June 2014
Dividends
An ordinary dividend of 12 cents per share was declared for the financial year ended 30 June 2013 and paid during the financial
year ended 30 June 2014 (30 June 2013: 10 cents).
Significant changes in state of affairs
During the financial year there were no significant changes in the state of affairs of the Consolidated Entity other than that referred
to in the financial statements or notes thereto.
Future developments, prospects and business strategies
The Group’s strategy focuses on promoting and developing SIR-Spheres microspheres to become a worldwide standard of care
for patients with liver cancer, representing a market estimated at approximately 480,000 patients per year.
To achieve this objective, Sirtex is investing in five major randomised controlled studies that are collectively seeking to recruit in
excess of 2,100 patients from over 180 hospitals worldwide, with a total investment of approximately $60 million over 5 years.
Cumulatively, this clinical study dataset is approximately 10 times the size of the dataset that currently exists from previously
completed clinical studies of SIR-Spheres microspheres. With a Clinical Operations team comprising in excess of 20 employees
in the US, Europe, and Asia Pacific, together with contract research organisations and other service providers, the Group possesses
the project management and patient recruitment capabilities that are required to complete these large studies.
To prepare for future significant growth upon completion of the clinical studies, the Group has announced a significant
manufacturing expansion program that will increase the medium term capacity to manufacture SIR-Spheres microspheres from
currently two hot cells, one in the US and one in Singapore, to six hot cells, with three in the US, two in Germany, and one in
Singapore. This expansion is expected to be completed within 6 months. Longer term plans to expand beyond this program will
be put in place if and when required by market demand.
The Group has been successful in gaining regulatory approval for SIR-Spheres microspheres in key global markets. They include
US, Argentina, Brazil, the European Union, Israel and various Middle East and African markets, Australia, New Zealand, Singapore,
Hong Kong, Taiwan, South Korea and various other Asian markets. Sirtex is working towards gaining regulatory approvals in Japan,
China, Canada, and other markets for its SIR-Spheres microspheres product to continue its geographic growth.
The Group has also invested heavily and will continue to do so in its business processes, infrastructure and human resources.
Sirtex runs globally integrated enterprise resource planning systems to efficiently handle customer orders and manufacturing
requirement planning to ensure timely delivery of SIR-Spheres microspheres to the end customer. In addition, significant
investments have been made in human resources, with an increase in staff numbers from 58 in 2008 to 213 at the end of the
financial year.
Environmental regulations
The operations are not subject to significant environmental regulation under the law of any of the jurisdictions the Group is
operating in.
Unissued Shares
Executive Performance rights on issue at year end
As at 30 June 2014, the unissued shares of Sirtex Medical Limited under Executive Performance Rights are as follows:
Grant date
22 February 2011
23 August 2011
28 August 2012
26 November 2013
Date of Vesting
3 July 2013
7 July 2014
1 July 2015
1 July 2016
Exercise Price $
nil
nil
nil
nil
Number of Rights
33,000
456,000
687,000
448,850
Right holders do not have any rights to participate in any issue of shares or other interests in the company or any other entity.
For further details on rights issued as remuneration, refer to the Remuneration Report.
Directors’ rights on issue at year end
As at 30 June 2014, the unissued shares of Sirtex Medical Limited under Non-Executive Directors Rights are as follows:
Grant date
24 September 2013
Date of Vesting
24 September 2014
Exercise Price $
nil
Number of Rights
4,195
Share options on issue at year end or exercised during the year
During the year ended 30 June 2014, there were no ordinary shares of Sirtex Medical Ltd issued on the exercise of options.
No share options have been issued during the year, and no share options are outstanding at 30 June 2014.
Sirtex 2014 AR 27
Directors’ interests
The relevant interest of each Director in the share capital of the Company, as notified by the Directors to the ASX in accordance
with section 205G (1) of the Corporations Act 2001, as at 30 June 2014 is as follows:
R Hill
Dr J Eady
G Boyce
G Wong
2014
Ordinary Shares
–
5,000
5,000
60,000
2014
Rights
1,974
1,234
987
347,000
2013
Ordinary Shares
–
5,000
5,000
–
2013
Rights
–
–
–
322,188
Indemnification of officers and auditors
During or since the financial year, the Company has paid premiums to insure each of the Directors of the Group against liabilities
incurred by them arising out of their conduct while acting in the capacity of Director, subject to certain terms and conditions.
The insurance policy prohibits disclosure of the value of the premium.
During or since the financial year, the Company has also agreed to continue to indemnify the Directors of the Group against
certain liabilities incurred by them arising out of their conduct while acting in the capacity of Director, subject to certain terms
and conditions, and to the applicable requirements of the Corporations Act.
Events after reporting date
On 7 July 2014, a total of 456,000 Executive Performance Rights issued on 23 August 2011 fully vested, having exceeded the
performance target. As at 31 July 2014, a total of 387,000 of these performance rights have been exercised and issued as ordinary
shares of Sirtex Medical Limited.
On 22 July 2014, a total of 6,289 Non-Executive Directors Rights were granted. These rights will vest after one year with a dealing
restriction of up to a further 6 years.
No other matter or circumstance has arisen since the end of the financial year, that has significantly affected, or may significantly
affect, the operations of the Group, the results of those operations, or the state of affairs of the Group in future financial years.
Proceedings on behalf of the Company
No person has applied for leave of Court to bring proceedings on behalf of the Company or intervene in any proceedings to which
the company is a party for the purpose of taking responsibility on behalf of the Company for all or any part of those proceedings.
The company was not a party to any such proceedings during the year.
Non-audit services
The Board of Directors, in accordance with advice from the audit committee, is satisfied that the provision of non-audit services
during the year is compatible with the general standard of independence for auditors imposed by the Corporations Act 2001.
The directors are satisfied that their services disclosed below did not compromise the external auditor’s independence for the
following reasons:
• all non-audit services are reviewed and approved by the audit committee prior to commencement to ensure they do not adversely
affect the integrity and objectivity of the auditor; and
• the nature of the services provided do not compromise the general principles relating to auditor independence in accordance
with APES 110: Code of ethics for Professional Accountants set out by the Accounting Profession Ethical Standards Board.
The auditors have not provided any non-audit services to Sirtex Medical Limited (2013: $3,225).
A total of $155,000 has been paid as remuneration of the auditor of the parent entity and a total of $126,000 has been paid as
remuneration of the auditors of subsidiaries for audit and review of financial reports for the year.
Auditor’s independence declaration
The auditor’s independence declaration for the year ended 30 June 2014 has been received and can be found on page 47
of the financial report and forms part of the Directors’ report.
Rounding off of amounts
The company is an entity to which ASIC Class Order 98/100 applies and, accordingly, amounts in the financial statements and
Directors’ Report have been rounded to the nearest thousand dollars, unless otherwise indicated.
Sirtex 2014 AR 28
DIRECTORS’ REPORT
for the year ended 30 June 2014
Sirtex Limited 2014 Remuneration Report
1. Letter from the Chairman of the Remuneration Committee
Dear Shareholder,
I am pleased to present the remuneration report for the financial year ended 30 June 2014, outlining the nature and amount of
remuneration for Sirtex’s non-executive directors and other Key Management Personnel, as defined under section 300A of the
Corporations Act, 2001 and its associated regulations.
During the 2014 financial year Sirtex has continued to grow and develop, as carefully-planned strategies were implemented.
Marketing structures are becoming more sophisticated, leading to greater sales expertise and reach, while our manufacturing
capabilities have increased and the necessary logistics support has evolved to address complex challenges. At the same time,
our clinical programs are growing with several reaching critical stages, needing careful and comprehensive management. All of this
has been made possible by professional, capable staff, stepping up to the more complex roles with dedication – and of course to
executive leadership that has supported the team, providing them with the necessary direction, processes and training, and building
a sense of purpose and empowerment.
Sirtex’s continued success will depend on those committed leaders and staff being able to develop additional skills as the work
changes, and to be able to identify and address effectively threats and opportunities as they arise. For this reason, the Board
believes that our people are fundamental enablers of Company performance and has given high priority to remuneration structure
and policy. The Company must continue to attract and retain high calibre executives; the circumstances of the Company remain
dynamic and are rapidly evolving.
While shareholders have been supportive of the Board in making improvements to the remuneration policies and practices of
the Company, and we are grateful for this, the Remuneration Committee remains very much aware of the commitment made
to shareholders subsequent to the strike received in 2011, to remain engaged and diligent regarding remuneration governance
matters. Our work in 2014 has attempted to fulfil this ongoing commitment.
1.1 Context of Changes to Remuneration and Governance Made in 2014
Sirtex has delivered considerable shareholder value over the past three years. The growth involved and the work necessary
to implement strategic and operational plans for the future, however, bring with it additional complexity and impact. As a result,
a critical objective is for us to ensure that remuneration policies, structures and levels remain market competitive so that we can
attract and retain the necessary leadership and staff. Current remuneration policies and practices are, in the view of the Board,
appropriate in the context of:
• Growing global business in terms of value, market awareness and geographic presence. We are now selling to nearly
800 treatment centres in 39 countries.
• Continued growth in dose sales with 17.3% growth in the 2014 financial year.
• Net profit after tax (NPAT) has continued to grow, by 30.6% during 2014 alone.
• Earnings per share (EPS) grew 29.5% during 2014.
• Share price has also grown 40.9% in 2014.
• Over the last 5 years annualised TSR Alpha™ was 28.2%, and 42.1% over the last 3 years. This measure normalises for market
expectations where a TSR Alpha™ of 0 indicates that shareholder expectations, as at the beginning of the measurement period,
have been met and outcomes above 0, that they have been exceeded. Sirtex’s TSR Alpha™ figures indicate that expected
returns to shareholders have not only been delivered but significantly exceeded.
•
In the last 4 years Sirtex has delivered $17 million worth of dividends to shareholders.
During the 2014 financial year the Board has continued to develop and refine the Company’s remuneration policies and practices.
The focus of the Remuneration Committee in the 2014 financial year has been on:
• Reviewing local and international remuneration/market indicators relevant to Sirtex roles;
• Documenting and adopting formal, written policies and other documents that form part of the Remuneration Governance
Framework including:
– Executive KMP Remuneration Policy and Procedure,
– NED Remuneration Policy and Procedure,
– Short-term Incentive (STI) Policy and Procedure,
– Long-term Incentive (LTI) Policy and Procedure, and
– Clawback of Overpaid Executive Incentives Policy and Procedure.
• Making adjustments to Fixed Remuneration, incentive mixes and performance indicators to improve alignment with business
results.
Sirtex 2014 AR 29
Our work aimed to:
• Fulfil the Board’s commitment to shareholders to continue to improve remuneration governance and practices.
• Adhere to the relevant, adopted (best practice) policies and practices outlined as part of the Company’s Remuneration
Governance Framework.
• Obtain appropriate positioning relative to market benchmarks for both Fixed Remuneration and Total Targeted Remuneration
(inclusive of incentive opportunities for target performance).
• Build alignment between the evolving circumstances of the Company and the remuneration quantum and structure for senior
executives and for the Board.
• Reward staff for pursuing and achieving important outcomes in an increasingly complex and global environment.
1.2 Conclusion
While in past years the Remuneration Committee focused on addressing specific issues that led to our ‘first strike’, more recently
we have been focussed on broader remuneration governance matters to ensure that there is a solid foundation for the future.
In many respects, the Remuneration Committee has been conservative in recommending material increases to Board and executive
packages, and remains so, but remuneration market levels change considerably as companies grow and staff roles become more
complex. Some necessary changes were made last financial year and more were necessary in FY14 in order to retain key talent and
position the Company’s remuneration structure and levels so that it is able to respond effectively to remuneration expectations as
we grow.
As Chair of the Remuneration Committee, I would like to thank shareholders for their support at the 2013 AGM, and to invite
feedback from shareholders regarding the changes made during 2014. I hope you will continue to support us by voting to adopt
this remuneration report at the upcoming AGM.
Regards,
Dr John Eady
Chair of the Remuneration Committee
2. Persons Covered by this Report
This report covers remuneration arrangements and outcomes for the following KMP.
Non-executive Directors
• Mr Richard Hill, Independent Non-executive Chairman,
• Dr John Eady, Independent Non-executive Director and Deputy Chairman,
– Chair of Remuneration Committee,
• Mr Grant Boyce, Independent Non-executive Director,
– Chair of the Audit Committee.
Executives
• Mr Gilman Wong, Managing Director & CEO,
• Mr Darren Smith, CFO and Company Secretary,
• Mr Michael Mangano, President The Americas,
• Mr Nigel Lange, Chief Executive EMEA,
• Dr Burwood Chew, Chief Executive Asia Pacific,
• Mr Robert Hardie, Global Head of Operations,
• Dr David Cade, Chief Medical Officer.
Sirtex 2014 AR 30
DIRECTORS’ REPORT
for the year ended 30 June 2014
3. Remuneration Governance Framework
During the 2014 financial year, the Remuneration Committee further developed and documented the Company’s Remuneration
Governance Framework.
The governance of Key Management Personnel (KMP) remuneration remains of key interest to stakeholders and observers and
Sirtex treats the issue with utmost diligence, seeking input from a wide range of sources:
• The Board;
• The Remuneration Committee members;
• External remuneration consultants (ERCs);
• Company management such as HR managers;
• Stakeholder groups and shareholders;
• Other experts and professionals such as tax advisors and lawyers; and
•
Individual KMP to understand roles and complexities.
Interactions between various parties on remuneration matters are overseen by the Remuneration Committee to ensure that there
is appropriate independence and controls in place. The Remuneration Committee uses the various contributions to determine its
view of the KMP remuneration structure, policies and levels appropriate to the Company’s specific circumstances.
3.1 Securities Trading Policy
The Securities Trading Policy of the Company specifies that Sirtex personnel are prevented from trading in the securities of the
Company when in possession of insider information or during specified blackout periods (also referred to as prohibited periods).
There are at least three scheduled blackout periods each year, which are:
• The four weeks prior to the date of the Company’s annual general meeting (AGM);
• The four weeks prior to the release by the Company of its half yearly results announcement to the ASX Limited (ASX);
• The four weeks prior to the release by the Company of its yearly results announcement to ASX.
Other blackout periods can be declared by the Board from time to time as may be appropriate. There are also provisions in
the policy to allow an individual to trade under exceptional circumstances, with the permission of the Board and after an assessment
of those circumstances. Acquisition of shares in relation to vested Rights under the LTI plan is excluded from the securities
trading policy.
3.2 Executive KMP Remuneration Policy and Procedure
The Executive KMP Remuneration Policy and Procedure applies to executives defined as:
• Managing Director – accountable to the Board for the Company’s performance and long-term planning;
• Stratum 2 Direct Reports to the Managing Director – roles that are business unit, functional, or expertise heads.
This policy outlines the Company’s intentions regarding executive remuneration, as well as how remuneration is intended to be
structured, benchmarked and adjusted in response to changes in the circumstances of the Company, and in line with good
governance.
Broadly the policy describes the following in relation to executives:
• Remuneration should be composed of:
– Fixed Remuneration (inclusive of superannuation, allowances, benefits and any applicable fringe benefits tax (FBT)),
– STI which provides a reward for performance against annual objectives and personal effectiveness,
– LTI which provides a securities-based reward for performance against indicators of shareholder benefit or value creation,
over a three year period.
•
•
In total, the sum of the three elements will constitute total targeted remuneration (TTR).
Internal relativities should be considered to recognise Sirtex’s particular organisation design, using ‘strata’ to map the
relationships between roles.
• External market factors should be considered and used to benchmark practices.
• TTR should be structured with reference to market practice.
• Fixed remuneration policy mid-points should be set with reference to P50 (the median or the middle) of the relevant market
practice.
• TTRPs (being the fixed remuneration plus at-risk awards intended to be paid for targeted levels of performance) should be set
with reference to P75 (the upper quartile; the point at which 75% of the sample lies below) of the relevant market practice so
as to attract, retain and reward those who achieve targeted objectives in both the short and long-term.
• Remuneration will be managed within a range so as to allow for the recognition of individual differences such as the calibre
of incumbents and the competency with which they fulfil roles.
Sirtex 2014 AR 31
• Exceptions will be managed separately such as when particular talent needs to be retained or there are individuals with unique
expertise that need to be acquired (‘Red circle’ exceptions).
• Termination benefits will generally be limited to the default amount allowed for under the Corporations Act (without shareholder
approval).
The document also describes how the various components of remuneration should be treated in the case of a termination.
The linkage between Senior Executive remuneration and Company performance is broadly:
Policy Area
Relationship to Company Performance
Fixed Remuneration
Fixed remuneration is linked to Company performance via the benchmarking which takes market
capitalisation (largely linked to share price) into consideration.
At-risk components
(STI and LTI)
The at-risk components reflect Company performance, being linked to business levers that drive
strategic initiatives or lagging indicators that measure shareholder experience.
The policies are designed to ensure that the measures and targets used are aligned to Company
strategy and the influence that individual, senior executives can make to Company performance.
While many influencing factors are quantitative, some are more subjective, aimed at assessing personal
effectiveness, in the context of the prevailing circumstances.
STI measures generally focus on internal perspectives, such as dose sales, that can be considered as
leading indicators for the external measures used for LTI awards.
In this way, the policies seek to link overall executive remuneration with longer-term strategies and
the experience of shareholders, it being higher when longer term issues are being addressed effectively
and the Company is doing well.
3.3 Non-executive Director Remuneration Policy
The Non-Executive Director Remuneration Policy applies to Non-Executive Directors (NEDs) of the Company in their capacity
as Directors and as members of committees. It may be summarised as follows:
• Remuneration may be composed of:
– Board fees,
– Committee fees,
– Superannuation, and
– Securities.
• Remuneration will be managed within the aggregate fee limit (AFL) or fee pool approved by shareholders of the Company.
• Guidelines indicate when the Board should seek adjustment to the AFL, such as in the case of the appointment of additional,
non-executive directors.
• Remuneration should be reviewed annually.
• Termination benefits will not be paid to NEDs.
• As with the senior executives, P75 market positioning for comparable ASX listed companies is applied to NEDs, as is the
policy of fixed remuneration being set by reference to the P50 of market practice.
• Equity grants to make up the P75– P50 gap reflect the senior executive policy and recognise that it is not appropriate to
provide performance-based incentives to NEDs. With these equity grants, NED remuneration is variable and will vary in line
with movements in shareholder value.
The document also outlines the market-based procedure undertaken to review NED remuneration and determine appropriate
changes.
3.4 Short-term Incentive Policy & Procedure
The Short-term Incentive Policy & Procedure may be summarised as follows:
• The Company operates a formal Short-term Incentive Plan (STI/STIP) as part of the remuneration offered to executives (as
defined in the policy) so at to:
– Create a strong link between performance and reward, and
– Share company success with the executives that contribute to it through their efforts.
• NEDs are excluded from participation.
• The measurement period for performance is the financial year of the Company.
• Where possible, there are threshold, target and stretch levels of objectives, with awards being scaled on a pro-rata
basis dependent on actual performance. This is intended to provide an opportunity to obtain a reward under a range
of circumstances, including outperformance above the target level of performance.
Sirtex 2014 AR 32
DIRECTORS’ REPORT
for the year ended 30 June 2014
•
In the case of a termination, the STI is pro-rated for the portion of the year worked, but not triggered or accelerated.
• The Board retains discretion to adjust actual awards so as to manage circumstances in which the calculated award may
be considered inappropriate.
• The Board has discretion to defer some part of an STI offer, and
• The Clawback policy applies to STI awards.
The document also outlines the process needed to implement the short-term incentive scheme.
3.5 Long-term Incentive Policy & Procedure
The Long-term Incentive Policy & Procedure may be summarised as follows:
• The Company operates a formal Long-term Incentive Plan (LTI/LTIP) as part of the remuneration offered to executives
(as defined in the policy) so as to:
– Create a strong link between performance and reward over the long-term; and
– Share long-term company success with the executives that contribute to it.
• NEDs are excluded from participation.
• The measurement period for performance includes three financial years.
• As well as formal LTI plan rules (currently the Executive Performance Rights Plan), explanatory material is provided to
participants to ensure clarity regarding its operation.
• Where possible, there are threshold, target and stretch levels of objectives, with vesting of LTI being scaled on a pro-rata basis
depending on actual performance.
• The Board retains discretion to adjust actual vesting so as to manage circumstances in which the calculated vesting may be
considered inappropriate.
• The Clawback Policy applies to the LTIP, and
• Executive Performance Rights may not be transferred or otherwise dealt with other than with prior approval of the Board.
The document also outlines the procedure to be undertaken in relation to the operation of the long-term incentive scheme.
3.6 Clawback Policy and Procedure
The Clawback Policy and Procedure was introduced to address the emerging expectation that Boards are able to clawback
overpayments of incentives to executives. This is only likely to arise in the case of a material mis-statement in the Company’s
accounts or an error in performance assessment linked to the payment of incentives to executives. The clawback policy relates to
the current and previous three financial years on a rolling basis. The policy states that in the case of an overpayment of incentives,
the following sources of funds will be prioritised as being subject to the clawback:
• Deferred STI awards, if any,
• Vested LTI grants that remain subject to dealing restrictions, if any,
•
•
Imminent STI awards that are earned but will be withheld, and
Imminent LTI vesting that has been earned but will be withheld.
Further recovery action, if any, will be determined by the Board, having regard to the amounts of overpayments remaining
outstanding, the cost of recovery, the potential impact on current and former executives and the potential impact on the Company.
Reduction of future (not imminent) STI award opportunities or LTI grants will not be used to recover overpaid remuneration.
Sirtex 2014 AR 33
3.7 Variable Remuneration – Executive Short-term Incentive (STI) Plan – Detail
Aspect
Plan Rules, Offers and Comments
Measurement Period
The Company’s financial year, i.e. from 1 July to the following 30 June.
Award Opportunities
FY14 Offer
The MD/CEO had a target STI award opportunity of 50% of Fixed Remuneration while the other
executives who are KMP had a target award opportunity of 35% of Fixed Remuneration.
Key Performance
Indicators (KPIs),
Weighting and
Performance Goals
FY14 Offer
KPIs and other influencing factors reflect the nature of specific roles, while creating shared objectives
where appropriate. A shared KPI for FY14 was Company earnings before interest, tax, depreciation
and amortisation, excluding exchange rate fluctuations, clinical studies, and Research & Development
expenditure (normalised EBITDA). Role-specific influencing indicators included such factors as dose
sales, expense control, delivery performance, cost-of-goods sold, audit compliance and to cover
project-style work, progress against milestones. These were judged by the Board as key levers for
Company success. While other factors have been considered, the Board believes that the number
of factors/measures used must be small so as not to reduce focus on those aspects deemed most
important.
In the case of qualitative factors, such as leadership development, actual performance is judged by
the Board based on a range of inputs, one of which is information from the MD/CEO in relation to his
Direct Reports.
Weightings are applied to the KPIs selected for each participant to reflect the relative importance
of each KPI.
The Board retains discretion to vary actual STI payments in the case that unforeseen circumstances
prevailed over the period.
The following outlines the award scale used in relation to the normalised Company EBITDA and dose
sales KPI.
Performance Level
Budget Achievement
Percentage of Target STI Payable
STI Performance Reward Scale
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