26
Page 1 of 9 EVENT: CEO’s Address Sirtex 2014 AGM DATE: Tuesday 28 th October 2014 START SLIDE: TITLE PAGE Good morning ladies and gentlemen thank you for taking the time to attend this meeting. SLIDE: FOCUSED ON PERFORMANCE AND GROWTH The 2014 financial year was a highly productive period for Sirtex as we recorded our 40 th consecutive quarter of growth in sales of SIR-Spheres microspheres. We are proud of our growth record and I am pleased to say this trend is continuing and at close of business yesterday YTD dose sales were up 28.7 per cent on the same period last year. Our goal now is to launch our business higher into new levels of growth. As I will outline for you today, we are making excellent progress in securing Sirtex’s sustainable long-term growth and success as a world leader in the rapidly evolving global market for interventional oncology. SLIDE: SALES REVENUE AND DOSE SALES I will start with a brief recap of our financial year results which again saw the delivery of record dose sales and revenues. Total revenue for the 2014 financial year was up 33.7 per cent to $129 million. Dose sales were up 17.3 per cent to 8,561. Net profit after tax was up 30.6 per cent to $23.8 million. What these positive numbers mean is that more and more medical professionals around the world are beginning to realise the enormous potential of our targeted liver cancer therapy to treat a wide range of patients and are hence making the decision to use SIR-Spheres microspheres. For personal use only

DATE: Tuesday 28th For personal use only · customers and grow our business globally. SLIDE: OPTIMISING VALUE AND SUSTAINABLE LONG-TERM GROWTH Our 2020Vision encompasses three distinct

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1 of 9

EVENT: CEO’s Address Sirtex 2014 AGM

DATE: Tuesday 28th October 2014

START SLIDE: TITLE PAGE Good morning ladies and gentlemen thank you for taking the time to attend this meeting. SLIDE: FOCUSED ON PERFORMANCE AND GROWTH The 2014 financial year was a highly productive period for Sirtex as we recorded our 40th consecutive quarter of growth in sales of SIR-Spheres microspheres. We are proud of our growth record and I am pleased to say this trend is continuing and at close of business yesterday YTD dose sales were up 28.7 per cent on the same period last year. Our goal now is to launch our business higher into new levels of growth. As I will outline for you today, we are making excellent progress in securing Sirtex’s sustainable long-term growth and success as a world leader in the rapidly evolving global market for interventional oncology. SLIDE: SALES REVENUE AND DOSE SALES I will start with a brief recap of our financial year results which again saw the delivery of record dose sales and revenues. Total revenue for the 2014 financial year was up 33.7 per cent to $129 million. Dose sales were up 17.3 per cent to 8,561. Net profit after tax was up 30.6 per cent to $23.8 million. What these positive numbers mean is that more and more medical professionals around the world are beginning to realise the enormous potential of our targeted liver cancer therapy to treat a wide range of patients and are hence making the decision to use SIR-Spheres microspheres. F

or p

erso

nal u

se o

nly

Page 2 of 9

SLIDE: FY2014 SALES BY REGION If we look at sales in each region, you can see The Americas remains the key driver of revenues with dose sales up 22 per cent. Revenue from The Americas grew by 37.4 per cent to $96 million. The majority of our sales are from the USA and whilst we continue to build this market we are also pushing into new markets in South America like Brazil and Argentina. Our business in Europe, the Middle East and Africa saw a modest 5.6 per cent dose sales growth and a revenue increase of 24.3 per cent to $27.7 million. Growth was slow in the first half of the year but improved in the second half on the back of improved reimbursement and funding in several European Union markets and the opening of 30 new treatment sites. It is worth noting the news announced a few weeks ago that ESMO, the European Society for Medical Oncology, has identified SIR-Spheres Y90 resin microspheres as an appropriate treatment for patients with colorectal liver metastases that have failed to respond to chemotherapy. We believe the new ESMO clinical guidelines will have a positive effect on improving patient access to SIR-Spheres microspheres across Europe. Sirtex’s business in the Asia Pacific is still very much in its infancy but has enormous potential and we continue to create a foothold in new markets. Asia Pacific revenues were up 20.9 per cent to $5.7 million with dose sales up 12.4 per cent as awareness and interest grows. SLIDE: DIVIDENDS AND SHARE PRICE Throughout the year Sirtex continued to make significant investments in our sales and marketing capabilities, global clinical programs, manufacturing capacity and information technology infrastructure. These investments are creating the structures to ensure the long term growth of our business, help more people benefit from our unique therapy and drive shareholder value for many years to come. The confidence we have in the business enabled us to increase our dividend to 14 cents this year. The payment amounts to $7.9 million returned to our shareholders. Sirtex has now returned $31.9 million in the past 6 years. This reflects Sirtex’s solid financial position and careful management of our financial resources. You will have also noticed our strong share price performance during the year as more and more investors begin to comprehend the long term potential for Sirtex. Since our AGM last year the Sirtex share price has increased 98.5 per cent. F

or p

erso

nal u

se o

nly

Page 3 of 9

SLIDE: SIRFLOX EXPANDING THE USE OF SIR-SPHERES The release of data from our SIRFLOX study will be a defining point for Sirtex. SIRFLOX is a metastatic colorectal cancer study in 1st Line patients and is the largest interventional oncology study ever conducted, representing an investment to date of approximately $24 million. Preliminary data from our SIRFLOX study is currently expected to be available for release during March next year with detailed results expected to be presented at the American Society of Clinical Oncology in June 2015. Sirtex believes the SIRFLOX result should be positive. This is an evidence based view, founded on the results of six previously completed, albeit smaller clinical studies and the results of two large scale retrospective analyses which were all positive. Indeed, to date there has not been a failed study of SIR-Spheres microspheres. It is also important to note that Sirtex does not know nor have access to interim clinical study results and as soon as we receive definitive data we will appropriately inform the market. What if the results are not positive? The SIRFLOX study is in 1st Line therapy whereas SIR-Spheres microspheres are currently primarily used as “salvage” or last line therapy so a not positive result would mean that dose sales growth could be expected to continue in line with our historical annual growth. A positive result however, should see an acceleration in dose sales growth rates, and potentially a step change in growth in terms of multiples of our current dose sales. Growth is not expected to be instantaneous but rather a ramp up over ensuing years. In FY2015 we are rolling out a number of initiatives aimed at preparing the market for the release of the SIRFLOX data and have for that purpose committed $10 million over and above our normal expenditure. This is primarily in the sales and marketing area to educate and inform key members of the medical community and facilitate their understanding and practical application of the results. SLIDE: INVESTOR “LUNCH AND LEARN” Understanding clinical studies, their design, conduct, results and interpretation is complex, especially for those without a specialist science or medical background. To ensure the investment community is able to fully appreciate and interpret the SIRFLOX data, Sirtex is hosting investor Lunch & Learn presentations on the subject of interpreting cancer clinical studies. These will be held in December and presented by Professor Eric Van Cutsem, an internationally recognised Key Opinion Leader in gastrointestinal oncology. F

or p

erso

nal u

se o

nly

Page 4 of 9

Professor Van Cutsem will present an independent expert overview of clinical studies in general and discuss how he and his peers may interpret not only Sirtex’s studies but oncology studies in general. We believe his independent insights and experience will be of great value to the wider investor community and help investors and analysts accurately interpret and understand our SIRFLOX data and the data from other oncology studies. SLIDE: 2020VISION While Sirtex has delivered excellent growth over the past 10 years, the challenge and opportunity for us is to launch our business to an even higher level of performance and growth on a global scale. Guiding our dedicated staff to new heights is our 2020Vision strategy. 2020Vision is creating the settings for long term sustainable growth and value. It brings strong focus to a range of specific initiatives designed to build on our core strengths, enhance our current product and technology platforms, improve the way we help and serve our customers and grow our business globally. SLIDE: OPTIMISING VALUE AND SUSTAINABLE LONG-TERM GROWTH Our 2020Vision encompasses three distinct pillars. The first pillar is focused on expanding the use of our core product, SIR-Spheres microspheres. The second pillar is development of new or future generation technology. The third pillar relates to potential future acquisitions. With respect to the first pillar of our 2020Vision, sales and marketing has been our major focus over the past few years as we continue to grow the use of SIR-Spheres microspheres in the “salvage” market. At the same time we have invested significantly in clinical programs. SLIDE: CLINICAL PROGRAMS ARE DRIVING EXPANDED USE The goal being to significantly expand the use of SIR-Spheres microspheres by providing the medical community with the Level 1 evidence they need to make informed treatment decisions. Several years ago we initiated a clinical study strategy involving five major studies. Unlike many companies that rely on one study, Sirtex has covered many bases and the results of each of our studies can provide significant impact. Our clinical program is well advanced with patient recruitment and on track as previously advised.

For

per

sona

l use

onl

y

Page 5 of 9

SLIDE: NEW INDICATIONS WILL ALSO EXPAND USE As our large global studies in metastatic colorectal cancer and hepatocellular carcinoma progress towards completion, we are broadening our focus beyond the liver towards the potential use of SIR-Spheres microspheres to treat cancers in other organs. Leading this program is our RESIRT study investigating the use of SIR-Spheres microspheres in kidney cancer patients. RESIRT aims to evaluate the technical feasibility, safety and maximum dose that patients can tolerate when using SIR-Spheres microspheres to treat cancer in the kidney. As recently announced, the originally planned maximum dose did not cause any toxicity therefore Sirtex has extended the study to recruit additional patients at higher dose levels. These early results are extremely encouraging and we anticipate moving into a pivotal global clinical study in 2015. Other studies are planned and we will be providing details once these are confirmed. SLIDE: THREE GLOBAL MANUFACTURING HUBS In addition to our investment in clinical studies, another key element to the successful expansion of our SIR-Spheres microspheres is our ability to consistently manufacture and deliver on time our product to hundreds of customers in more than 40 countries. The efficient operation of our manufacturing and supply chain is an invaluable asset and will continue to play an important role in our expansion and growth. The logistics systems and processes we have built will allow us to introduce any number of new products and services for our customers. Its efficient operation is also a key element in our ability to control and maintain our costs. During the year two new hot cells have been installed in our expanded US facility in Wilmington and the fit-out of our new German manufacturing plant in Frankfurt is on time and on budget. We are well prepared to meet the anticipated sales growth in our current market and new markets. SLIDE: COLLABORATION DRIVING MULTIPLE INNOVATIONS Our research & development is broadly divided into two areas, firstly SIR-Spheres evolution aiming at further improving the method of administration of our core product, which is progressing to plan. F

or p

erso

nal u

se o

nly

Page 6 of 9

Our second focus is new technology. Looking to the future we are working on some highly promising technologies. Research, particularly in our industry, takes considerable time and resources and there certainly is no guarantee of success. The Sirtex model is to outsource our research activities by seeking out appropriate collaborating research partners in universities and other high quality research institutions. The R&D team at Sirtex essentially manages these relationships and the associated projects, ensuring we continue heading towards a commercial outcome for Sirtex as soon as possible. Some of the key institutions we are currently working with include the Australian National University, University of Sydney, the Peter MacCallum Cancer Centre, and the National Cancer Centre of Singapore. Broadly, our major research programs constitute development of a range of different platform technologies, each with the potential to underpin a range of exciting new products. A good example is the Carbon Cage Nanotechnology that we are developing with the Australian National University. Carbon Cage Nanoparticles can carry a high internal payload of radioactive material which is encapsulated in an outer carbon shell. This carbon shell is chemically inert and possesses ideal properties for the attachment of coatings for a variety of purposes, for example to target specific cancers or to impart stealth-like properties thereby enhancing their ability to evade detection by the immune system. Carbon Cage Technology could be used in a range of new diagnostic or therapeutic agents with unique characteristics compared to the current state of the art. Our collaboration with the National Cancer Centre of Singapore is to investigate the application of the Carbon Cage Nanotechnology to prevent spread of metastasis after surgery to treat ovarian cancer. With the Peter MacCallum Cancer Centre we are working on a novel radioprotector compound to protect normal tissue against the effects of ionising radiation. The compound is a DNA binding anti-oxidant that is able to repair within nanoseconds damage caused to DNA by exposure to x-rays. Our immediate goal is to develop this compound for use in preventing the onset of painful and potentially treatment limiting oral mucositis in cancer patients receiving external beam radiotherapy for head and neck cancer. However, it is clear that there are many more scenarios where such a drug could be used to minimise the deleterious side effects of radiotherapy. In addition, we believe there are also several other important applications involving protection of civilian populations and military personnel in certain wartime situations. Indeed, there has already been some interest shown in this work by the US Department of Defence. Another platform technology we are working on again concerns nanoparticles, this time RAFT polymer coated magnetic nanoparticles. RAFT polymerisation technology was discovered by the CSIRO in 1998. It enables the synthesis of polymer chains with an unprecedented level of control of the molecular weight and with a high degree of functional versatility. What this means is that we are able to produce coatings on our nanoparticles that are much thinner than can be produced otherwise and also have nanoparticles that do not clump or aggregate once administered into the bloodstream.

For

per

sona

l use

onl

y

Page 7 of 9

The group we are working with at the University of Sydney are world leaders in the application of RAFT technology. The University of Sydney group have developed and refined their expertise in this area over several years of working with us to the point where we are beginning to identify several promising applications of the coated particles for biomedical applications including use as a MRI contrast agent and possibly to enhance the use of external beam radiotherapy. However, because of the uniqueness of our coated nanoparticles interest has also been generated for non-medical applications. For example, we are currently also working with a collaborator in the US who is developing novel propulsion systems based on our polymer coated magnetic nanoparticles for small satellites. We believe that each of our platform technologies holds considerable potential for a number of commercial applications. Our approach is to seek out appropriate clinical experts to advise us and work with us in helping to identify those applications to take forward to the next stage of development. By working as we do with external collaborators we ensure we are working with the best people in each particular field while simultaneously reducing the risk and cost of undertaking such ambitious work on our own. All of our research programs have the potential to equal or exceed the market potential for SIR-Spheres microspheres. The third pillar of our business relates to potential future acquisitions. One of the key areas that businesses struggle with in the medical market is how to effectively commercialise their technology. Sirtex has demonstrated an ability to successfully commercialise a somewhat complex medical device, this is one of our core strengths. We are on the look-out for commercial ready businesses or technology that we could potentially acquire to add value and enhance our long term growth prospects. This would make Sirtex a more robust business and add to shareholder value. SLIDE: OUR VISION IS TO MAKE CANCER A CHRONIC DISEASE We all know cancer is a notoriously difficult condition to treat so our goals need to be realistic and pragmatic. Together with our customers and collaborators in the medical community, Sirtex shares a common vision where cancer is a treatable chronic condition that patients can successfully live with or be cured from. F

or p

erso

nal u

se o

nly

Page 8 of 9

It is an ambitious goal but one for which there are many precedents. Diseases like HIV, diabetes and heart disease were all considered terminal conditions a few decades ago. Advances in medicine have seen these conditions become chronic conditions people can successfully live with. With liver cancer, we are witnessing a growing body of independent medical evidence that indicates an increasing number of patients are now able to live with their disease. These good outcomes are due to a number of medical innovations which includes SIR-Spheres microspheres. SILDE: ELIZABETH DEYLEN Working at Sirtex we often hear from clinicians about different patients and their unique stories. To date we have supplied more than 45,000 doses of SIR-Spheres microspheres globally. One of the people to have been treated with SIR-Spheres microspheres is a woman in Melbourne, Elizabeth Deylen pictured here on the right with her sister Andrea. In 2012, Elizabeth was told she had stage four bowel cancer with metastases to her liver and that she had only a few months to live. She was treated with SIR-Spheres microspheres prescribed by medical oncologist Professor Peter Gibbs and his team at the Royal Melbourne Hospital. Two years on and Elizabeth no longer has signs of cancer in her liver and she recently celebrated her 50th birthday in Bali with her family. While every case is different and this is just one example, it does show us what is possible and reinforces our commitment to making liver cancer a chronic condition that patients can successfully live with or be cured from. It is stories of people like Elizabeth Deylen, and the work of dedicated medical professionals like Professor Peter Gibbs which inspire and drive our collective efforts at Sirtex and our commitment to our 2020Vision. CONCLUSION To conclude, 2014 has been another important year in building and preparing Sirtex for continued growth into the future. A key focus is on ensuring our readiness for the release of the SIRFLOX clinical study data in 2015 and preparing to meet the response from our customers in the global medical community. We have strong confidence in our future as demand for minimally invasive medical solutions remain very strong and medical professionals continue to seek effective and innovative new treatments like ours to improve patient outcomes.

For

per

sona

l use

onl

y

Page 9 of 9

Sirtex is committed to creating long term sustainable growth and value by working together with our partners in the medical community to make cancer a chronic condition and improve the lives of thousands of people. Our continued focus on the fundamentals, operational performance, and disciplined execution of our 2020Vision strategy will continue to create shareholder value for many years to come. The success of Sirtex is a team effort and I would like to thank all Sirtex staff for their dedication and commitment, our directors, the medical community and our shareholders. Together we are making a difference to the lives of those suffering from liver cancer and at the same time significantly growing the value of our business. Thank you. Gilman E Wong Chief Executive Officer Sirtex Medical Limited 28th October 2014

For

per

sona

l use

onl

y

2014 Annual General Meeting

Sydney Australia

Tuesday, 28th October 2014

SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd

For

per

sona

l use

onl

y

2014 Annual General Meeting

Mr Gilman Wong

Chief Executive Officer

6

For

per

sona

l use

onl

y

Focused on Performance and Growth

7

2001 2005 2010 2014

17.3%

30.6%

33.7%For

per

sona

l use

onl

y

Sales Revenue and Dose Sales

Sales revenue$ 000

Dose salesNumber of units

EMEAUSA

APAC

$129,363 8,561

8

FY14FY10 FY11 FY12 FY13 FY14FY10 FY11 FY12 FY13

64,33370,686

82,62796,774

4,1714,977

6,141

7,299

For

per

sona

l use

onl

y

FY 2014 Sales by Region

The Americas5,836 (+22%)

Europe, Middle East & Africa1,916 (+5.6%)

Asia Pacific809 (+12.4%)

9

8,561FY2014

dose sales

For

per

sona

l use

onl

y

14

Dividends and Share Price

DividendsCents per share

SRX share price $ at 30th June each year

10

2009 20122010 20142011 2013

$16.88

$3.35

12

10

77

2010 20132011 2014 2014

$4.90$4.90

$6.09

$11.98

For

per

sona

l use

onl

y

SIRFLOX study expanding the use of SIR-Spheres

532

• Completed patient recruitment in March 2013• Detailed results expected to be presented at ASCO meeting June 2015

11

For

per

sona

l use

onl

y

Investor “Lunch and Learn”

12

Understanding Cancer Clinical StudiesProfessor Eric Van Cutsem

INDEPENDENT EXPERT DISCUSSION

SYDNEY MELBOURNE

10th & 11th December 2014

For

per

sona

l use

onl

y

13

For

per

sona

l use

onl

y

Optimising value and sustainable long-term growth

14

1SIR-Spheres

microspheres

3Mergers &

Acquisitions

2Research &

Development

• SIR-Spheres Evolution Program

• New technologies including:− Carbon cage

nanoparticles− Coated

nanoparticles− Radioprotector.

• Fully exploit SIR-Spheres microspheres in:− Primary / secondary

liver cancer Kidney cancer and several other cancers.

Sirtex three pillars

• Commercial ready technology that will add value and grow the business

• Seeking to capitalise on our capabilities and infrastructure.F

or p

erso

nal u

se o

nly

Clinical programs are driving expanded use

15

Hepatocellular carcinoma (HCC)

SARAH Full recruitment

Primary endpoint available

2013 2014 2015 2016 2017

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 H1 H2H1 H2

Metastatic colorectal cancer (mCRC)

FOXFIREFOXFIRE Global Full recruitment

Primary endpoint available

Metastatic colorectal cancer (mCRC)

SIRFLOXFull recruitment Detailed results

Primary endpoint available

Major clinical programs

For

per

sona

l use

onl

y

New indications will also expand use

16

• RESIRT study investigating use of SIR-Spheres microspheres in treatment of primary kidney cancer

• Results to date are positive and justify expansion to define optimum dosage levels

• Plans to investigate use of SIR-Spheres microspheres for the treatment of cancers in other organs

For

per

sona

l use

onl

y

17

Three global manufacturing hubs

Boston, USA Frankfurt,

Germany

Singapore

For

per

sona

l use

onl

y

Collaboration driving multiple innovations

18

For

per

sona

l use

onl

y

“Sirtex's vision is that one day cancer will no longer be a terminal disease that patients unfortunately die from, but a

chronic disease that patients can successfully live with or be cured from.”

19

Our vision is to make cancer a chronic diseaseF

or p

erso

nal u

se o

nly

For

per

sona

l use

onl

y

2014 Annual General Meeting

SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd

For

per

sona

l use

onl

y