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

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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

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65,559 64,33370,686

82,627

96,774

4,171

4,977

6,141

7,299

3,658

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…which has been reflected in Sirtex’s share price performance and dividend distribution

Share price$ per share

DividendsCents per share

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$3.35$4.90 $4.90

7c 7c 7c

12c

10c

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• 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

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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

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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

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SIRFLOX completed patient recruitment in Q1 2013 and results will be available in Q1 2015

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Met

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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

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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

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• 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

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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

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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

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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

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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 organsFor

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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

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• 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

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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

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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 F

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