Download FACT SHEET

FACT SHEET
FIRST HALF 2016 FINANCIAL YEAR SUMMARY
SIRTEX MEDICAL LIMITED (ASX: SRX)
February 2016
www.sirtex.com
An emerging global leader in cancer therapies
Sirtex Medical Limited is an Australian-based global healthcare business working to
improve outcomes for people with cancer. Our current lead product is a targeted
radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres.
Approximately 61,000 doses have been supplied to treat patients with liver
cancer at more than 950 medical centres in over 40 countries. Our manufacturing
and logistics operations in the US, Germany and Singapore supply a growing
number of customers daily. Our ongoing success is based on our commitment
to serving the needs of our medical customers, high levels of professionalism and
continuous improvement and innovation. Our business is positioned for significant
long-term growth with our current sales representing a small per cent of the total
addressable primary and secondary liver cancer markets.
Our current lead product SIR-Spheres® Y-90 resin
microspheres
SIR-Spheres microspheres are used to deliver targeted internal radiation therapy
directly to liver tumours via the hepatic artery. The therapy is called Selective
Internal Radiation Therapy (SIRT) and is performed using minimally invasive
112595.991296
techniques by interventional radiologists. SIR-Spheres microspheres are currently
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used in primary liver cancer (hepatocellular
carcinoma) and secondary liver
cancer (metastatic liver cancer), where the liver tumour has originated from
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cancer in another part of the body. All available clinical evidence suggests SIR78817.193907
Spheres microspheres have the
potential to double the rate of tumour shrinkage
and tumour remission. Clinical data also suggests SIR-spheres microspheres
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are capable of improving the life expectancy of patients by 35 to 100 per cent
compared to other treatments.
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ASX Code:SRX
Market capitalisation: $2.0 billion
Shares on issue: 57.2 million
52 Week High/Low:
$41.33 – $14.80
Date listed on ASX:
24 August 2000
Market sector: Healthcare
First Half Sales Revenue Growth over Five Years
$ thousands
$112,596
APAC – $4,088
EMEA – $19,073
THE AMERICAS – $89,435
80,452
58,581
46,042
45038.396518
SIR-Spheres microspheres are tiny radioactive
polymer spheres that emit pure beta radiation.
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Each is about the size of four red blood cells ®or
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one-third the diameter of a human hair. They
microspheres
lodge in the small blood vessels of the tumour
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where they destroy it from inside over a short
period while sparing the surrounding healthy
0.000000
tissue.
®
2020Vision
SNAPSHOT
36,800
1H
FY12
1H
FY13
1H
FY14
1H
FY15
1H
FY16
microspheres
Strategy creating long-term sustainable growth and value®
Sirtex’s vision is that cancer will no longer be a terminal disease but
a chronic
microspheres
condition patients can successfully live with or be cured from. To achieve this
ambitious goal, Sirtex is guided by its 2020Vision strategy based on:
Board of Directors
Richard Hill
John Eady
Grant Boyce
Katherine Woodthorpe
Gilman Wong
1. Expanding the use of SIR-Spheres microspheres for liver and other cancers
2. Commercialising multiple innovations and new technologies based around
our core technology platform
3. Reviewing growth opportunities through partnerships and acquisitions of
commercial-ready complementary technologies to enhance shareholder
value through the use of our internal capabilities and distribution infrastructure.
To deliver on this vision, Sirtex continues to invest in all areas of its business
to build the capacity and capabilities that will support current and future
growth. The company is building manufacturing and logistics capacity, sales
and marketing teams, clinical infrastructure, information technology capabilities
and administrative support. These investments will ensure Sirtex is positioned
to realise the full potential of its unique therapy to help medical professionals
everywhere improve outcomes for people with cancer.
Chairman – Non-Executive
Director – Non-Executive
Director – Non-Executive
Director – Non-Executive
Managing Director –
Chief Executive Officer
Senior Management
Gilman Wong
Darren Smith
David Cade
Michael Mangano
Nigel Lange
Robert Hardie
Managing Director –
Chief Executive Officer
Chief Financial Officer –
Company Secretary
Chief Medical Officer
President US
CEO Europe & APAC
Global Head of Operations
1H FY16 DOSE SALES
NUMBER OF UNITS
1H FY16 GEOGRAPHIC SPLIT OF SALE
NUMBER OF UNITS
5,728
APAC
EMEA
THE AMERICAS
4,950
THE AMERICAS
+18.8%
3,919
4,028
5,728
3,522
1H FY16
Dose Sales
2,698
EUROPE,
MIDDLE EAST
& AFRICA
+8.8%
+9.3%
1H
FY12
1H
FY13
1H
FY14
1H
FY15
1,219
ASIA PACIFIC
481
1H
FY16
Dose sales
5,728, up 15.7%
Revenue
$112.6 million, up 40.0%
Profit before tax
$33.2 million, up 38.6%
R&D investment
$5.4 million, up 32.0%
Clinical investment
$10.8 million, down 9.6%
Net profit after tax
$25.9 million, up 46.9%
Cash
$73.7 million
Earnings per share
45.4 cents
Dividend
20 cents per share, up 42.9%
NOTE: All amounts are Australian dollars.
Expanding use of our current lead product
Expanding use in other cancers
The strategy to expand the use of our current lead product is focused
on providing the international medical community with the irrefutable level
one clinical evidence they need to make informed treatment decisions.
We continue to examine the potential of SIR-Spheres microspheres in
a number of other cancers. Leading this program is our RESIRT study
into the treatment of primary kidney cancer. Our pilot study results have
proven positive with limited side-effects at high doses. We anticipate
completing recruitment in early 2016. Planning is also underway to
investigate the use of SIR-Spheres microspheres for the treatment of
cancers in other organs.
Sirtex’s $60 million investment over five years into five major post
marketing randomised clinical trials (RCTs) is nearing completion. These
studies are the largest of their kind in the world and are designed to
demonstrate the efficacy of SIR-Spheres microspheres as a fist-line
treatment for liver cancer either in combination with, or against the
current standard of care chemotherapy.
The majority of our large clinical studies have now completed
recruitment
STUDY NAME
SIRFLOX
START
TOTAL % RECRUITMENT % RECRUITMENT TYPE OF
PATIENTS
AT 30 JUNE
AT 31 DEC
LIVER
2015
2015 CANCER
2006
530
100%
100%
mCRC
FOXFIRE
2010
FOXFIRE GLOBAL
573
100%
100%
mCRC
SARAH
2012
460
100%
100%
HCC
SORAMIC
2010
375
85%
97%
HCC
SIRveNIB
2011
360
85%
95%
HCC
Metastatic colorectal cancer (mCRC)
Sirtex reported the major findings of the SIRFLOX study at the ASCO
Annual Meeting in Chicago in May 2015. Patients treated with SIRSpheres microspheres saw an additional 7.9 months or 62.7%
improvement in Progression-Free Survival (PFS) in their livers versus
chemotherapy alone and a 31% reduction in the risk of progression,
which was highly significant and clinically meaningful. SIR-Spheres
microspheres tripled the complete response rate, where no evidence
of disease in the liver could be detected, to 6% of all patients. The data
supports first-line use in mCRC patients and Sirtex expects momentum
will now build over time. Overall Survival (OS) data from SIRFLOX will
be combined with OS data from the FOXFIRE and FOXFIRE Global
studies, representing over 1,100 patients, and will be available in 2017.
Hepatocellular carcinoma (HCC)
The SIRveNIB (Asia Pacific) and SARAH (France) studies are multicentre randomised controlled trials using SIR-Spheres microspheres
versus the approved drug sorafenib (Nexavar®) in locally advanced
HCC. In March 2015, the SARAH study completed recruitment.
SORAMIC (pan European) is a multicentre randomised controlled trial
using sorafenib versus SIR-Spheres microspheres in combination
with sorafenib. SORAMIC and SIRveNIB are expected to complete
recruitment in the 1H of calendar year 2016.
SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd. Sirtex Medical Limited makes
no warranties or representations regarding the accuracy or completeness of the information contained
in this investor fact sheet. Certain statements made may contain forward looking statements which
involve known and unknown risk, uncertainties and other factors, which may cause the actual results
or performance or achievements of the Company to be materially different from any future results,
performance or achievements expressed or implied by such forward looking statements.
Commercialising multiple new products
The second pillar of our growth strategy is focused on improving the
clinical administration of our SIR-Spheres microspheres product while
also commercialising a number of promising new platform technologies
in collaboration with a number of the world’s leading research
institutions and universities. Each of these platform technologies has
significant commercial potential if eventual products are developed.
Sirtex has demonstrated its ability to successfully commercialise a
sophisticated new medical technology globally. Under the third pillar of
our 2020Vision we have focussed on identifying new commercial-ready
businesses or medical technologies that would complement our current
business.
Global liver cancer market
• A large unmet medical need worldwide for better treatments
• Very low five year survival rate versus other cancers
Metastatic colorectal cancer
• Over 1.2 million people diagnosed annually worldwide
• Majority of patients will die due to the disease burden in the liver
Hepatocellular carcinoma
• Over 750,000 people diagnosed annually worldwide
• Sixth most common cancer
• Third leading cause of cancer-related deaths.
Contact Information
Head Office
Level 33, 101 Miller Street North Sydney NSW 2060 Australia Tel: +61 2 9964 8400
Fax:+61 2 9964 8410
Americas
300 Unicorn Park Drive
Woburn, MA 01801, United States
Tel: +1 888 474 7839
Fax:+1 978 229 9585
Europe, Middle East & Africa
Josef-Schumpeter-Allee 33 53227 Bonn, Germany
Tel: +49 228 1840 730
Fax:+49 228 1840 735
Asia Pacific
50 Science Park Road, #01-01 The Kendall Science Park II, Singapore 117406 Tel: +65 6308 8370
Fax:+65 6778 9424
Investor Relations
Investor Contact
Dr Tom Duthy
Global Investor Relations Manager
Sirtex Medical Limited
Tel: +61 2 9964 8427
Email: [email protected]