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Sirtex Medical Limited (ASX:SRX)Macquarie Australia Conference
SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd
Mr Gilman Wong, CEO
Dr David Cade, CMO
Sydney, 8th May 2014
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Understanding Sirtex
SIR-Spheres microspheres deliver radiation therapy to inoperable liver cancers…‘from the inside out’
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• 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
Sirtex is a somewhat unique biotechnology company…
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Sirtex continues to grow SIR-Spheres microspheres dose sales...
Sales revenue$ thousands
Dose salesNumber of units
4
65,559 64,33370,686
82,627
96,774
4,171
4,977
6,141
7,299
3,658
…which has been reflected in Sirtex’s share price performance and dividend distribution
Share price$ per share
DividendsCents per share
5
$3.35$4.90 $4.90
7c 7c 7c
12c
10c
• 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
Financial year 2015 will be another exciting year for Sirtex with…
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Sirtex 2020Vision:2014 – 2020
SIR-Spheres microspheres currently possess three of the four fundamentals for broad commercial adoption
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1. Clinical development
• SIR-Spheres microspheres were developed during the 1990s
2. Regulatory approval
• SIR-Spheres microspheres have broad regulatory approval
− Australian TGA 1998
− US FDA 2002
− EU CE Mark 2002
3. Reimbursement by payers
• SIR-Spheres microspheres have broad reimbursement coverage
− USA Medicare, MedicaidPrivate carriers
− EMEA Broad reimbursementDiffers by country
− APAC More fragmented reimbursementDiffers by country
4. Level 1 evidence of effectiveness
• 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
• Level 1 evidence to further strengthen Reimbursement
Sirtex’s $60M investment in
clinical studies program
Sirtex’s is investing $60 million in clinical studies designed to deliver the Level 1 evidence of effectiveness
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Type of liver cancerSize
FOXFIREFOXFIRE Global 2010 mCRC490
StartStudy name (1)
SIRFLOX 2006 mCRC (3)532
SORAMIC 2010 HCC (4)375
SIRveNIB 2011 HCC360
Total 2,143
SARAH 2012 HCC400
Percentcompletion (2)
100%
83%
59%
68%
85%
Primary endpoint
OS (6)
PFS (5)
OS
OS
OS
(1) Each of the five studies is a randomized controlled trial (RCT)(2) Percent completion of patient recruitment as at end April 2014.(3) mCRC = metastatic colorectal cancer.(4) HCC = hepatocellular carcinoma.(5) PFS = progression-free survival(6) OS = overall survival
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Sirtex 2020Vision:Key near-term events
SIRFLOX completed patient recruitment in Q1 2013 and results will be available in Q1 2015
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Met
asta
tic c
olor
ecta
l can
cer (
mC
RC
)
2013 2014 2015 2016 2017
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
SIRFLOX
Completion of patient
recruitment (532 patients)
Primary endpoint available
Detailed presentation of results at
ASCO(1)
annual scientific meeting
Calendar year
(1) ASCO = American Society of Clinical Oncology
H1 H2
Cur
rent
H1 H2
FOXFIRE will complete patient recruitment in Q1 2015 and results are expected in H1 2017
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Met
asta
tic c
olor
ecta
l can
cer (
mC
RC
)
2013 2014 2015 2016 2017
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
FOXFIREFOXFIRE Global
Completion of patient
recruitment (490 patients)
Calendar year
Primary endpoint available
H1 H2H1 H2
Cur
rent
• Sirtex does not know nor have access to preliminary clinical study data results
• All of Sirtex’s clinical studies are in 1st 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
What impact will the results of Sirtex’s clinical studies have?
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In metastatic colorectal cancer the addressable market for SIR-Spheres microspheres is circa 279,000 patients
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(1) International Agency for Research on Cancer, World Health Organization, GLOBOCAN 2008, Cancer Incidence, Mortality and Prevalence Worldwide in 2008.
(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.
Colorectal Cancer
Global annual incidence (1) 1,235,000
Annual incidence in Sirtex’s markets (2) 965,000
Disease universe
Disease population in Sirtex’s markets
Patients with mCRC eligible for SIR-Spheres (3,4) 279,000
Addressable patient population in Sirtex’s markets
See Appendix for detailed breakdown of treatment cascade
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In mCRC positive Level 1 evidence should elevate SIRT from “salvage” to an earlier “line” of treatment
(1) NICE Technology Appraisal TA 93: Irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer. Aug 2005. ScHARR. The use of irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer: systematic review and economic evaluation. January 2005.
Receiveno
further palliative treatment
85%
75%
25%
15%
25%
75%
100 patients with inoperable mCRC
85 receive 1st-line chemoTx (1)
64 receive 2nd-line chemoTx
16 receive 3rd-line chemoTx
~4 – 8 receive salvage therapies
~25%~75%
SIRT confined to last-line “salvage” therapy
279,000 patients eligible for SIR-Spheres microspheres
• With positive Level 1 data: SIRT elevated to a 1st-line or post 1st- line therapy
2015 – 2020
Example: Colorectal Cancer
• Small number of patients eligible for SIRT, due to attrition
Today
SARAH will complete patient recruitment in Q4 2014 and results are expected in H1 2016
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Hep
atoc
ellu
lar c
arci
nom
a (H
CC
)
2013 2014 2015 2016 2017
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
SARAH
Completion of patient
recruitment (400 patients)
Primary endpoint available
Calendar year
H1 H2H1 H2
Cur
rent
In hepatocellular carcinoma the addressable market for SIR-Spheres microspheres is circa 209,000 patients
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(1) International Agency for Research on Cancer, World Health Organization, GLOBOCAN 2008, Cancer Incidence, Mortality and Prevalence Worldwide in 2008.
(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.
Hepatocellular Carcinoma
Global annual incidence (1) 750,000
Annual incidence in Sirtex’s markets (2) 616,000
Disease universe
Disease population in Sirtex’s markets
Patients with HCC eligible for SIR-Spheres (3,4) 209,000
Addressable patient population in Sirtex’s markets
See Appendix for detailed breakdown of treatment cascade
Understanding and interpreting cancer clinical studies
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• 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 25th and 26th February 2014 (see http://www.sirtex.com/au/investors/)
• Fact Sheets will also be prepared and made available
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Sirtex 2020Vision:Beyond liver cancer
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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
Cancer is notoriously difficult to treat, but Sirtex’s vision is both pragmatic and realistic
Sirtex has structured the business for sustainable long-term growth based on 3 growth pillars
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SIR-Spheres microspheres
The 3 Growth Pillars
Research & Development
M&A
Pillar 1 Pillar 2 Pillar 3
SIR-Spheres evolution
New technology
• Continue to evolve SIR-Spheres microspheres
• Three additional platform technologies− Carbon cage nanoparticles− Coated nanoparticles− Radioprotector
• Fully exploit SIR-Spheres microspheres in − Primary liver cancers (HCC etc.)− Secondary liver cancers (mCRC
etc.)− Kidney cancer− Cancers of other organs
SIR-Spheres microspheres beyond the treatment of liver cancer…
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• 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
• 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
Sirtex, the future outlook…
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Thank You
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Appendix 1: Contestable market analysis
Patients with liver metastases from colorectal cancer eligible for SIR-Spheres microspheres
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(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 2005.
(2) Sirtex data and analysis.
965,000Annual incidence of colorectal
cancer in Sirtex’s markets
483,000 (50% ) (1)
Develop secondary liver metastases from primary
colorectal cancer
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
483,000 (50%) (1)
Do not develop secondary liver metastases from primary
colorectal cancer
279,000 (80%) (2)
Eligible forSIR-Spheres microspheres
72,000 (15%) (1)
Suitable for surgical resection
Patients with hepatocellular carcinoma eligible for SIR-Spheres microspheres
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(1) Llovet et. al. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst 2008.(2) Sirtex data and analysis.
616,000Annual incidence of hepatocellular
carcinoma in Sirtex’s markets
308,000 (50%) (1)
Intermediate to advanced stage disease
Suitable for palliative treatments
46,000 (15%) Receive no palliative treatment
262,000 (85%) Receive palliative treatment:
• TACE• Sorafenib• SIR-Spheres microspheres
185,000 (30%) (1)
Very early to early stage disease123,000 (20%) (1)
Terminal stage disease
No treatment possible
Curative treatments:• Surgical resection • Liver transplantation• Radio-frequency ablation
209,000 (80%) (2)
Eligible for SIR-Spheres microspheres