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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 101336.392167 used in primary liver cancer (hepatocellular carcinoma) and secondary liver cancer (metastatic liver cancer), where the liver tumour has originated from 90076.793037 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 67557.594778 are capable of improving the life expectancy of patients by 35 to 100 per cent compared to other treatments. 56297.995648 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. 33778.797389 Each is about the size of four red blood cells ®or 22519.198259 one-third the diameter of a human hair. They microspheres lodge in the small blood vessels of the tumour 11259.599130 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]