Sirtex Medical Ltd Results for the full year ending June 2011 - - PowerPoint PPT Presentation

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Sirtex Medical Ltd Results for the full year ending June 2011 - - PowerPoint PPT Presentation

Nov 25, 2023 332 likes •551 views

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

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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.

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SLIDE 2

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.

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SLIDE 3

2011 Operational Highlights

  • Record dose sales in all markets (19%)
  • Accelerated clinical study recruitment (140%)
  • SIRveNIB 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

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SLIDE 4

Dose Sales Continue to Grow

510 hospitals and treatment centres worldwide

Dose sales US

19%

Europe

25%

Asia Pacific

3%

Treatment centres US

265

Europe, Africa, Middle East

167

Asia Pacific

78

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SLIDE 5

Regional Dose Sales 2011

  • 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

FY06 FY08 FY07 FY09 FY10 FY11 1,077 1,805 1,444 2,298 2,490 2,969

Number of units

FY06 FY08 FY07 FY09 FY10 FY11 140 454 332 985 1,288 1,603 FY06 FY08 FY07 FY09 FY10 FY11 182 332 332 375 393 405

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SLIDE 6

Achieving Clinical Study Recruitment Milestones

SIRFLOX FOXFIRE SIRveNIB SORAMIC 56% 9% 15% 3%

Recruitment (30/ 6/ 11)

2006 2010 2011 2010

Start FY06-09 Study

450 490 360 360

Study size FY10 FY11 Total

89 55 107 251 12 12 53 53 6 39 45

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Investment in all areas of the business

Providing a platform for future growth

Sales & marketing Clinical study support Research & development

2008 2007 2009 2010 2011

$ millions

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2011 Financial Year Highlights

Product dose sales Number of units Product revenue $ millions

4,171 4,977 64,333 70,286 + 19% + 9%

* Excluding FX and UWA

Profit before tax* $ millions

15 17 + 13%

Net profit after tax $ millions

16.1 11.5

  • 29%

Cash on hand $ millions

41.4 42.9

Full franked dividend Cents per share

7c 7c

2010 2011

7

+ 4%

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SLIDE 9

2011 NPAT Reconciliation

$ thousands

Dr.Gray/ UWA settle- ment 16,080

  • 8,563
  • 5,575

2,909 9,280 739 4,446*

  • 3,030
  • 568
  • 1,059

11,479 NPAT FY’10 NPAT FY’11 FX Sales price increase Volume increase Interest income Clinical studies COGS price increase (ARI) Sales & marketing Admin Singa- pore setup Reg/QA & other

  • 1.071
  • 434
  • 1,666

R&D

* In FY2011 certain Clinical and R&D activities have been classified as internally generated intangible assets in

accordance with AASB 138 Intangible Assets

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Constant Growth in Revenues and Sales

Sales revenues $ thousands

FY06 FY08 FY07 FY09 FY10 FY11 22,559 38,125 33,334 65,559 64,333 70,290 Europe Asia US

Dose sales Number of units

FY06 FY08 FY07 FY09 FY10 FY11 1,329 2,581 2,108 3,658 4,171 4,977 Europe Asia US

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Earnings and Assets

Earnings per share Cents

FY06 FY08 FY07 FY09 FY10 FY11

Net tangible assets $ thousands

FY06 FY08 FY07 FY09 FY10 FY11

Net tangible assets per share Earnings per share Net tangible assets Total equity 30.7 38.9 67.4 89.9 35.8 3.2 2.2 32.7 28.8 2.8 93.9 21.2 17,123 19,077 19,991 21,764 21,694 23,287 37,562 39,179 50,155 51,543 52,357 60,142

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Investment in Clinical Evidence and Innovation

SORAMI C (n = 375) SI RFLOX (n = 450) Current product is approved SI Rve

veNI B (n = 360)

FOXFI RE (n = 490) RESI RT (n = 15 - 24)

* HCC – hepatocellular carcinoma; mCRC – metastatic colorectal liver cancer Note: Current @ September 2011

m CR CRC C / HCC* CC* 1st st Line e m CRC 1st Line HCC CC + / - so sorafen enib 1st st Line e HCC vs s so sorafen enib 1st st Line e m CRC Renal Ca Cance cer

Microspheres evolution

I m aging g and Delivery

Radioprotector SI R-Spheres microsphere New technologies Pre-clinical First in Human Pre-market Post -market

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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 SIRveNIB expected to complete recruitment in

2013/2014

  • Positive data from our major clinical studies will support significant

growth in demand for SIR-Spheres microspheres

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SIRFLOX FOXFIRE

  • 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

more effective than just standard chemotherapy in patients diagnosed with colorectal cancer that has spread to the liver.

  • Number of patients: 490 (UK)

Two large studies aimed at expanding treatment for patients with metastatic Colorectal Cancer (mCRC)

Investing for Long Term Growth – Clinical Evidence

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Investing for Long Term Growth - Clinical Evidence

SORAMIC SIRveNIB

  • 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)
  • 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)

Two large studies aimed at Hepatocellular Carcinoma (HCC) or primary liver cancer

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  • 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

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

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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

Investment in Innovation – New Products

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First Quarter Dose Sales 2012

Dose sales US

19%

Europe

  • 7%

Asia Pacific

19%

Dose sales up an average of 11 %

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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.

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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
  • f 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

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Thank you

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