Sirtex Medical Limited (ASX:SRX)
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1 Sirtex Medical Limited (ASX:SRX) Macquarie Australia Conference Mr Gilman Wong, CEO Dr David Cade, CMO Sydney, 8 th May 2014 SIR-Spheres is a registered trademark of Sirtex SIR-Spheres Pty Ltd
2 1 Understanding Sirtex
3 SIR-Spheres microspheres deliver radiation therapy to inoperable liver cancers from the inside out 2
4 Sirtex is a somewhat unique biotechnology company Sirtex has a successfully commercialised product Sirtex continues to grow year on year Sirtex is profitable Sirtex has positive operational cashflow and healthy cash reserves Sirtex has no debt Sirtex pays dividends But Sirtex also has the potential for significant growth 3
5 Sirtex continues to grow SIR-Spheres microspheres dose sales... Sales revenue $ thousands Dose sales Number of units 7,299 65,559 64,333 70,686 82,627 96,774 3,658 4,171 4,977 6,141 4
6 which has been reflected in Sirtex s share price performance and dividend distribution Share price $ per share Dividends Cents per share 12c 10c 7c 7c 7c $3.35 $4.90 $4.90 5
7 Financial year 2015 will be another exciting year for Sirtex with Continued SIR-Spheres microspheres dose and revenue growth Commissioning of the expanded manufacturing facility in Wilmington, USA and of the new manufacturing facility in Frankfurt, Germany Completion of recruitment of patients into the SARAH and FOXFIRE clinical studies Release of SIRFLOX results Primary endpoint available Q1 C15 Detailed presentation of results at ASCO June 2015 Increased investment of up to $10M in order to prepare the business for the release of the SIRFLOX clinical results Continued progress on other 2020Vision growth strategies 6
8 Sirtex 2020Vision:
9 SIR-Spheres microspheres currently possess three of the four fundamentals for broad commercial adoption 1. Clinical development 2. Regulatory approval 3. Reimbursement by payers 4. Level 1 evidence of effectiveness Sirtex s $60M investment in clinical studies program SIR-Spheres microspheres were developed during the 1990s SIR-Spheres microspheres have broad regulatory approval Australian TGA 1998 US FDA 2002 EU CE Mark 2002 SIR-Spheres microspheres have broad reimbursement coverage USA EMEA APAC Medicare, Medicaid Private carriers Broad reimbursement Differs by country More fragmented reimbursement Differs by country 5 large RCTs SIRFLOX FOXFIRE + FOXFIREGlobal SARAH SIRveNIB SORAMIC Level 1 evidence to support referrals by Medical Oncologists Level 1 evidence to support inclusion in Consensus Practice Guidelines 8 Level 1 evidence to further strengthen Reimbursement
10 Sirtex s is investing $60 million in clinical studies designed to deliver the Level 1 evidence of effectiveness Study name (1) Start Size Percent completion (2) Type of liver cancer Primary endpoint SIRFLOX % mcrc (3) PFS (5) FOXFIRE FOXFIRE Global % mcrc OS (6) SORAMIC % HCC (4) SIRveNIB % HCC SARAH % HCC OS OS OS Total 2,143 9 (1) Each of the five studies is a randomized controlled trial (RCT) (2) Percent completion of patient recruitment as at end April (3) mcrc = metastatic colorectal cancer. (4) HCC = hepatocellular carcinoma. (5) PFS = progression-free survival (6) OS = overall survival
11 Sirtex 2020Vision: Key near-term events 10
12 SIRFLOX completed patient recruitment in Q and results will be available in Q Metastatic colorectal cancer (mcrc) SIRFLOX Completion of patient recruitment (532 patients) Primary endpoint available Detailed presentation of results at ASCO (1) annual scientific meeting Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 H1 H2 H1 H2 Current Calendar year 11 (1) ASCO = American Society of Clinical Oncology
13 FOXFIRE will complete patient recruitment in Q and results are expected in H Metastatic colorectal cancer (mcrc) FOXFIRE FOXFIRE Global Completion of patient recruitment (490 patients) Primary endpoint available Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 H1 H2 H1 H2 Current Calendar year 12
14 What impact will the results of Sirtex s clinical studies have? Sirtex does not know nor have access to preliminary clinical study data results All of Sirtex s clinical studies are in 1 st line therapy, currently majority of Sirtex s dose sales are in salvage therapy If the results of the clinical studies were not positive, SIR-Spheres microspheres would remain a salvage therapy and dose sales growth could be expected to continue in line with our historical annual growth rates Sirtex remains confident that our clinical studies will be positive and this should result in an acceleration in dose sales growth Positive Level 1 data should elevate SIR-Spheres microspheres up the treatment chain resulting in a much larger addressable market as demonstrated on the following slides 13
15 In metastatic colorectal cancer the addressable market for SIR-Spheres microspheres is circa 279,000 patients Colorectal Cancer Global annual incidence (1) 1,235,000 Disease universe Annual incidence in Sirtex s markets (2) 965,000 Disease population in Sirtex s markets See Appendix for detailed breakdown of treatment cascade Patients with mcrc eligible for SIR-Spheres (3,4) 279,000 Addressable patient population in Sirtex s markets 14 (1) International Agency for Research on Cancer, World Health Organization, GLOBOCAN 2008, Cancer Incidence, Mortality and Prevalence Worldwide in (2) Sirtex markets = APAC: Australia, China, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand. EMEA: Austria, Belgium, Egypt, Estonia, Finland, France, Germany, Greece, Israel, Italy, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, The Netherlands, Turkey, United Kingdom. Americas: Argentina, Brazil, Canada, Mexico, USA. (3) SIR-Spheres microspheres (4) Sirtex data & analysis. See Appendix 1: Contestable Market Analysis.
16 In mcrc positive Level 1 evidence should elevate SIRT from salvage to an earlier line of treatment Example: Colorectal Cancer ,000 patients eligible for SIR- Spheres microspheres With positive Level 1 data: SIRT elevated to a 1 st -line or post 1 st - line therapy 100 patients with inoperable mcrc 85% 85 receive 1 st -line chemotx (1) 75% 64 receive 2 nd -line chemotx 25% 75% 25% 15% Receive no further palliative treatment Today SIRT confined to last-line salvage therapy Small number of patients eligible for SIRT, due to attrition 16 receive 3 rd -line chemotx ~25% ~4 8 receive salvage therapies ~75% 15 (1) NICE Technology Appraisal TA 93: Irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer. Aug ScHARR. The use of irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer: systematic review and economic evaluation. January 2005.
17 SARAH will complete patient recruitment in Q and results are expected in H Hepatocellular carcinoma (HCC) SARAH Completion of patient recruitment (400 patients) Primary endpoint available Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 H1 H2 H1 H2 Current Calendar year 16
18 In hepatocellular carcinoma the addressable market for SIR-Spheres microspheres is circa 209,000 patients Hepatocellular Carcinoma Global annual incidence (1) 750,000 Disease universe Annual incidence in Sirtex s markets (2) 616,000 Disease population in Sirtex s markets See Appendix for detailed breakdown of treatment cascade Patients with HCC eligible for SIR-Spheres (3,4) 209,000 Addressable patient population in Sirtex s markets 17 (1) International Agency for Research on Cancer, World Health Organization, GLOBOCAN 2008, Cancer Incidence, Mortality and Prevalence Worldwide in (2) Sirtex markets = APAC: Australia, China, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand. EMEA: Austria, Belgium, Egypt, Estonia, Finland, France, Germany, Greece, Israel, Italy, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, The Netherlands, Turkey, United Kingdom. Americas: Argentina, Brazil, Canada, Mexico, USA. (3) SIR-Spheres microspheres (4) Sirtex data & analysis. See Appendix 1: Contestable Market Analysis.
19 Understanding and interpreting cancer clinical studies Results of cancer clinical studies are complex, so Sirtex intends to facilitate information sessions to enable a better understanding and interpretation Anticipate conducting information session(s) in Q4 2014, well ahead of the results from the SIRFLOX study becoming available These session(s) will be conducted by Independent experts Content intended to be useful for interpretation of any cancer clinical study Similar format to Sirtex s recent Lunch & Learn investor days on 25 th and 26 th February 2014 (see Fact Sheets will also be prepared and made available 18
20 Sirtex 2020Vision: Beyond liver cancer 19
21 Cancer is notoriously difficult to treat, but Sirtex s vision is both pragmatic and realistic Sirtex s vision is that cancer will no longer be a terminal disease that patients die from but a chronic disease that patients can successfully live with 20
22 Sirtex has structured the business for sustainable longterm growth based on 3 growth pillars The 3 Growth Pillars SIR-Spheres microspheres Research & Development M&A SIR-Spheres evolution New technology Pillar 1 Pillar 2 Pillar 3 Fully exploit SIR-Spheres microspheres in Primary liver cancers (HCC etc.) Secondary liver cancers (mcrc etc.) Kidney cancer Cancers of other organs Continue to evolve SIR-Spheres microspheres Three additional platform technologies Carbon cage nanoparticles Coated nanoparticles Radioprotector 21
23 SIR-Spheres microspheres beyond the treatment of liver cancer Investigating the use of SIR-Spheres microspheres for the treatment of primary kidney cancer Sirtex also plans to investigate the use of SIR-Spheres microspheres for the treatment of cancers in other organs 22
24 Sirtex, the future outlook Continued growth and financial performance Achievement of significant milestones over the next 12 months SIRFLOX (mcrc) final results FOXFIRE (mcrc) completion of patient recruitment SARAH (HCC) completion of patient recruitment Commissioning of new and expanded manufacturing facilities Sirtex s 2020Vision strategic plan will drive solid growth into the next decade Primary focus on promoting and developing SIR-Spheres microspheres Accelerated growth could be expected with positive Level 1 evidence of effectiveness Strong position to take advantage of future opportunities 23
25 24 Thank You
26 Appendix 1: Contestable market analysis 25
27 Patients with liver metastases from colorectal cancer eligible for SIR-Spheres microspheres 965,000 Annual incidence of colorectal cancer in Sirtex s markets 483,000 (50% ) (1) Develop secondary liver metastases from primary colorectal cancer 483,000 (50%) (1) Do not develop secondary liver metastases from primary colorectal cancer 72,000 (15%) (1) Suitable for surgical resection 410,000 (85%) (1) Not suitable for surgical resection 62,000 (15%) (1) Receive no palliative treatment 349,000 (80%) (1) Receive palliative treatment: Chemotherapy Biologic agents SIR-Spheres microspheres 279,000 (80%) (2) Eligible for SIR-Spheres microspheres 26 (1) Hind D, Tappenden P, Tumur I et. al. The use of irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer: systematic review and economic evaluation. Technology assessment report commissioned by the HTA Programme on behalf of The National Institute for Clinical Excellence. 10 January (2) Sirtex data and analysis.
28 Patients with hepatocellular carcinoma eligible for SIR-Spheres microspheres 616,000 Annual incidence of hepatocellular carcinoma in Sirtex s markets 185,000 (30%) (1) Very early to early stage disease 308,000 (50%) (1) Intermediate to advanced stage disease 123,000 (20%) (1) Terminal stage disease Curative treatments: Surgical resection Liver transplantation Radio-frequency ablation Suitable for palliative treatments No treatment possible 46,000 (15%) Receive no palliative treatment 262,000 (85%) Receive palliative treatment: TACE Sorafenib SIR-Spheres microspheres 209,000 (80%) (2) Eligible for SIR-Spheres microspheres (1) Llovet et. al. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst (2) Sirtex data and analysis. 27
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