Sirtex Medical Ltd Results for the full year ending June 2011 Gilman Wong CEO Darren Smith CFO October 2011 SIR-Spheres is a registered trademark of Sirtex SIR-Spheres Pty Ltd.
Our lead product A highly effective treatment for inoperable liver cancer Selective Internal Radiation Therapy (SIRT) targets a high radiation dose to cancer tumours in the liver while maintaining low radiation dose to normal tissue. 1
2011 Operational Highlights Record dose sales in all markets ( 19%) • Accelerated clinical study recruitment ( 140%) • • SIR ve NIB study commenced in Asia • Additional independent peer review clinical evidence published Added 102 new treatment centres to global distribution network • Increase ( 29%) in clinical and marketing staff worldwide • R&D investment up ( 84%) • • Singapore Regional office and manufacturing facility operational • Declared third shareholder dividend of 7 cents in October 2
Dose Sales Continue to Grow 510 hospitals and treatment centres worldwide Dose US Europe Asia Pacific sales 19% 25% 3% Europe, Africa, Treatment US Middle East Asia Pacific centres 265 167 78 3
Regional Dose Sales 2011 Number of units • Continued strategy of building infrastructure in Sales and Marketing to support future growth • Recruitment of staff in key areas and positions • Asia Pacific expanding clinical and support teams and entering new markets US Europe Asia Pacific 2,969 2,490 2,298 1,805 1,603 1,444 1,288 1,077 985 454 405 332 332 375 393 332 182 140 FY06 FY07 FY08 FY09 FY10 FY11 FY06 FY07 FY08 FY09 FY10 FY11 FY06 FY07 FY08 FY09 FY10 FY11 4
Achieving Clinical Study Recruitment Milestones Study Recruitment Study Start FY06-09 FY10 FY11 Total size (30/ 6/ 11) SIRFLOX 2006 89 55 107 251 450 56% FOXFIRE 2010 39 45 9% 6 490 SORAMIC 2010 12 12 3% 360 SIR ve NIB 2011 53 53 360 15% 5
Investment in all areas of the business $ millions Providing a platform for future growth Sales & marketing Clinical study support Research & development 2007 2008 2009 2010 2011 6
2011 Financial Year Highlights 4,977 Product dose sales 4,171 + 19% Number of units 70,286 Product revenue 64,333 + 9% $ millions 17 15 Profit before tax* + 13% $ millions 16.1 11.5 Net profit after tax -29% $ millions 42.9 Cash on hand 41.4 $ millions + 4% Full franked dividend 7c 7c Cents per share 2010 2011 * Excluding FX and UWA 7
2011 NPAT Reconciliation $ thousands 4,446 * 16,080 739 9,280 -3,030 -1,666 -568 11,479 -1,059 -1.071 -434 -8,563 2,909 -5,575 Clinical R&D NPAT FX Dr.Gray/ Sales Volume Interest COGS Sales & Admin Singa- Reg/QA NPAT FY’10 UWA price income studies price marketing pore & other FY’11 increase settle- increase increase setup ment (ARI) * In FY2011 certain Clinical and R&D activities have been classified as internally generated intangible assets in accordance with AASB 138 Intangible Assets 8
Constant Growth in Revenues and Sales Sales revenues Dose sales $ thousands Number of units 70,290 65,559 4,977 64,333 4,171 3,658 Europe Europe 38,125 33,334 2,581 2,108 22,559 1,329 US US Asia Asia FY06 FY07 FY08 FY09 FY10 FY11 FY06 FY07 FY08 FY09 FY10 FY11 9
Earnings and Assets Earnings per share Net tangible assets Cents $ thousands Earnings per share Net tangible assets Net tangible assets per share Total equity 93.9 60,142 89.9 52,357 51,543 50,155 67.4 39,179 37,562 38.9 23,287 21,694 35.8 21,764 19,991 19,077 32.7 30.7 17,123 28.8 21.2 3.2 2.8 2.2 FY06 FY07 FY08 FY09 FY10 FY11 FY06 FY07 FY08 FY09 FY10 FY11 10
Investment in Clinical Evidence and Innovation SI R-Spheres microsphere Pre-clinical First in Human Pre-market Post -market Current product is approved m CR CRC C / HCC* CC* 1st st Line e m CRC SI RFLOX (n = 450) 1st st Line e m CRC FOXFI RE (n = 490) SI R ve ve NI B (n = 360) 1st st Line e HCC vs s so sorafen enib SORAMI C (n = 375) 1st Line HCC CC + / - so sorafen enib Renal Ca Cance cer RESI RT (n = 15 - 24) New technologies Radioprotector Microspheres evolution I m aging g and Delivery * HCC – hepatocellular carcinoma; mCRC – metastatic colorectal liver cancer Note: Current @ September 2011 11
Investing for Long Term Growth – Clinical Evidence • Level 1 clinical data is required by the medical community to gain widespread acceptance of SIR-Spheres microspheres. • Investing $60 million in clinical studies over 5 years to underpin long term shareholder value by creating the foundation for significant business growth worldwide • 13 active studies (four major) recruiting globally • Collaborations with Bayer Pharmaceuticals and The University of Oxford • SIRFLOX and SIR ve NIB expected to complete recruitment in 2013/2014 • Positive data from our major clinical studies will support significant growth in demand for SIR-Spheres microspheres 12
Investing for Long Term Growth – Clinical Evidence Two large studies aimed at expanding treatment for patients with metastatic Colorectal Cancer (mCRC) SIRFLOX • Evaluate SIR-Spheres microspheres in combination with FOLFOX chemotherapy vs. FOLFOX chemotherapy alone for first-line treatment of inoperable liver-only or liver- predominant bowel cancer metastases • Number of patients: 450 (Globally) • Establish if chemotherapy and SIR-Spheres microspheres is FOXFIRE more effective than just standard chemotherapy in patients diagnosed with colorectal cancer that has spread to the liver. • Number of patients: 490 (UK) 13
Investing for Long Term Growth - Clinical Evidence Two large studies aimed at Hepatocellular Carcinoma (HCC) or primary liver cancer SORAMIC • Compare efficacy of current accepted standard of care chemotherapy drug sorafenib compared to sorafenib with SIR-Spheres microspheres in patients with inoperable liver cancer • Number of patients: 375 (Europe) SIR ve NIB • Compare efficacy of SIR-Spheres microspheres directly against current accepted standard of care chemotherapy drug sorafenib in patients with inoperable liver cancer • Number of patients: 360 (Asia Pacific) 14
Investment in Innovation – SIR-Spheres Evolution As more clinicians worldwide use our product, we want to make it simpler and more accurate to maximise potential positive clinical outcomes. Our SIR-Spheres Evolution program has made significant progress in the following areas • Improved delivery system will provide improved method of administering SIR-Spheres • Imageable diagnostic spheres will improve patient work up and post treatment data • Computer based patient treatment planning system will allow tailored approach for each case based on needs 15
Investment in Innovation – New Products Radioprotector technology • Protects healthy tissue from effects of radiation • Pre-clinical studies in Europe, US and Australia underway Nano particle developments • Will detect, target or treat a wider range of cancers • Pre-clinical studies currently underway Carbon Caged Nanoparticles • Exploits the novel properties of nanoscale carbon encapsulation • Will enable a variety of novel targeted therapeutic approaches 16
First Quarter Dose Sales 2012 Dose sales up an average of 11 % Dose US Europe Asia Pacific sales 19% - 7% 19% 17
First Quarter 2012 Update Excellent growth in US up 19% building on the initiatives put • in place Excellent growth in Asia Pacific up 19% showing early promise • from the structural changes made commencing calendar year 2011 • EU dose sales expected to rebound in second and subsequent quarters • Record dose sales achieved in September 2011 Clinical studies recruitment is up 132% in the first quarter • • Publication of the ENRY 325 patient retrospective analysis provides further clinical data supporting the use of SIR-Spheres microspheres • National Institute for Health and Clinical Excellence (NICE) released final guidance on how SIRT can be used in metastatic colorectal liver cancer (mCRC), a positive result. 18
Summary • Sirtex continues to perform with 29 consecutive quarters of dose sales growth • The long term strategy put in place over recent years to provide the foundations for substantial growth is progressing as planned • Significant improvement in clinical study patient recruitment with two of our major clinical studies set to complete recruitment (2013/2014) • Solid financial performance and position • Ongoing commitment to evolving current product and innovation with new technology • We are confident growth will continue and expect it to accelerate with the release of positive results from our major clinical studies 19
Thank you 20
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