1H FY13 Investor Presentation

Sirtex Medical Limited (ASX:SRX)
Results for the half year ending 31st December 2012
Mr Gilman Wong, CEO
Mr Darren Smith, CFO
Dr David Cade, CMO
March 2013
SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd
Today’s briefing covers three key areas
•
Understanding Sirtex
– The current position
– A closer look at the Clinical Development Strategy
– The targeted potential market
•
A brief overview of half year results
•
The 2020Vision and key milestones
1
Understanding Sirtex
2
SIR-Spheres microspheres are a highly effective
treatment option for inoperable liver cancer
3
Sirtex is a somewhat unique biotechnology company…
•
Sirtex has a 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
...so it is easy to view Sirtex like a good industrial stock
4
...but Sirtex has great potential to grow significantly
•
Sirtex has now supplied over 30,000 doses of SIR-Spheres microspheres
for patient treatment
•
Numerous smaller clinical studies have been published all of which were
positive
•
In calendar 2012 there were over 160 peer reviewed medical publications
referencing SIR-Spheres microspheres
•
Sirtex is investing in large clinical studies to deliver level 1 clinical data to
support the widespread adoption of its product by the medical community
•
Positive level 1 clinical evidence will drive a significant step-change in
demand for SIR-Spheres microspheres
...whilst Sirtex will continue to grow in the short term, it is the longer term
potential that is the real opportunity
5
The broad commercial adoption of a cancer therapy
requires four fundamentals to be in place
1. Clinical development
Need to discover
or invent
something!
•
Drugs
−
−
−
•
6
Pilot clinical study
Pivotal clinical study
•
3. Reimbursement by
payers
Need to be
allowed to sell it!
Someone needs
to pay for it!
•
Drugs
−
−
−
Phase 1 clinical trial
Phase 2 clinical trial
Phase 3 clinical trial
Medical Devices
−
−
•
2. Regulatory approval
USA
EU
Australia
FDA approval
EMA approval
TGA approval
Drugs & Medical Devices
USA
EU
Australia
FDA approval
CE Mark
TGA approval
Need to convince
physicians to use it!
•
Drugs & Medical Devices
−
USA
Medicare, Medicaid
Private carriers
−
Level 1 evidence is generated in a
randomised controlled trial (RCT)
−
EU
Highly fragmented
Differs by country
−
Test the new treatment against the
existing standard of care
−
Australia
Medicare
Private insurers
−
Demonstrate to Medial Oncologist
referrers (the patient’s ‘air traffic
controller’) that it works
−
Incorporate the treatment into medical
consensus guidelines (the ‘recipe
book’ of medical practice)
Medical Devices
−
−
−
4. Level 1 evidence of
effectiveness
SIR-Spheres microspheres currently possess three of
the four fundamentals for broad commercial adoption
1. Clinical development
3. Reimbursement by
payers
2. Regulatory approval
4. Level 1 evidence of
effectiveness
Sirtex’s clinical
studies program
•
SIR-Spheres microspheres
were developed during the
1990s at the University of
Western Australia
7
•
SIR-Spheres microspheres have
broad regulatory approval
−
US FDA
2002
−
EU CE Mark
2002
−
Australian TGA
1998
−
Multiple other regulatory
approvals in Americas, EMEA
and APAC markets
•
SIR-Spheres microspheres have
broad reimbursement coverage
−
USA
•
Medicare, Medicaid
Private carriers
−
EMEA
Broad reimbursement
Differs by country
−
APAC
More fragmented
reimbursement
Differs by country
Sirtex’s clinical studies are
unique as they are NOT needed
to support
…regulatory approvals
…reimbursement
•
They are needed to support
widespread adoption of SIRSpheres microspheres by the
Medical Oncology community
Sirtex’s $60 million investment in clinical studies is
designed to deliver the level 1 clinical evidence
Percent
Type of
Primary
completion (2) liver cancer endpoint
Study name (1)
Start
Size
SIRFLOX
2006
518
94%
mCRC (3)
PFS (5)
FOXFIRE
FOXFIRE Global
2010
490
35%
mCRC
OS (6)
SORAMIC
2010
375
30%
HCC (4)
OS
SIRveNIB
2011
360
43%
HCC
OS
SARAH
2012
400
20%
HCC
OS
Total
8
2,143
(1)
(2)
(3)
(4)
(5)
(6)
Each of the five studies is a randomised controlled trial (RCT)
Percent completion of patient recruitment as at end December 2012.
mCRC = metastatic colorectal cancer.
HCC = hepatocellular carcinoma.
PFS = progression-free survival
OS = overall survival
Patient recruitment into Sirtex’s clinical studies has
accelerated with the first level 1 data due in late 2014
Global clinical study recruitment
Patients recruited
2009
9
2010
2011
2012
2013
•
$7.0 million investment in 1H 2013
( 13%) resulted in…
•
…recruitment for 1H 2013  43%
globally
•
SIRFLOX study will complete
recruitment by end of March 2013
as previously communicated
•
SIRFLOX study data due late
2014
Sirtex’s five main clinical studies are all randomised
controlled trials…i.e. the gold standard
Definitions are worth knowing (not just in relation to SRX!)
•
Randomised controlled trial (RCT) = a clinical trial in which patients are randomly assigned to
either the new treatment being tested or the current standard-of-care treatment
•
Sirtex’s five main studies are all RCTs
Example – Sirtex’s flagship SIRFLOX study is an RCT
518
10
Sirtex’s RCTs use either progression-free survival or
overall survival as the primary endpoint of the study
Definitions are worth knowing (cont.)
•
Primary endpoint = the treatment outcome that is measured to compare treatment A (the new
treatment being tested) to treatment B (usually the current standard-of-care)
Examples of primary endpoints
− How long do individuals ‘live’ if they receive treatment A versus treatment B? (overall survival)
− How long is the tumour in ‘remission’ with treatment A versus treatment B? (progression-free survival)
− How much does the tumour ‘shrink’ with treatment A versus treatment B? (tumour response rate)
•
Secondary endpoint = other treatment outcomes you might want to study…‘while you’re at it’
•
Overall survival (OS) = the time interval from randomisation until death
•
Progression-free survival (PFS) = the time interval from randomisation until tumour
progression
11
The statistical design and analysis of the SIRFLOX
study is led by an independent consultant biostatistician
•
Led by Prof. Val Gebski
•
Head of Biostatistics and Research Methodology, NHMRC Clinical Trials Centre, Sydney
•
Presented original SIR-Spheres microspheres data to US FDA in 2000
•
Group statistician for several national collaborative oncology clinical trials groups
•
Has ensured Sirtex’s SIRFLOX study is optimally designed
− Appropriate primary endpoint of progression-free survival
− Large enough sample size (statistical power)
•
NHMRC Clinical Trials Centre possibly one of the top three biostatistical units globally
− NHMRC CTC
− University of Oxford
− Duke University North Carolina
12
Although SIR-Spheres microspheres already has US,
EU and multiple other regulatory approvals…
Sirtex employs the US FDA Guidance for Industry: Clinical Trial Endpoints for the Approval
of Cancer Drugs and Biologics (1) in the design and conduct of its large clinical studies
Primary Endpoint
Trial Design
Advantages
Disadvantages
Overall survival
• Randomised controlled
trial
• Universally accepted direct
measure of clinical benefit
• Easily measured
• Precisely measure
• May involve larger studies
• May be affected by cross over
treatment
• May be affected by subsequent
treatments
• Includes non-cancer deaths
Progression free survival
• Randomised controlled
trial
• Smaller sample size and
shorter follow-up necessary
c.f. overall survival studies
• Not affected by cross over or
subsequent treatments
• Generally based on objective
and quantitative assessment
• Not statistically validated as a
surrogate for overall survival in
all settings
• Not as precisely measured
• Subject to assessment bias
esp. in open label studies
• Definitions vary among studies
• Require frequent CT scans /
MRI scans
13
(1) Reference: Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, U.S. Department of Health and Human Services
Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) 2007.
With level 1 clinical evidence the addressable market
for SIR-Spheres microspheres is circa 480,000 patients
Global annual incidence (1)
Annual incidence in Sirtex’s
markets (2)
Colorectal
Cancer
Hepatocellular
Carcinoma
1,235,000
750,000
Disease
universe
616,000
Disease
population in
Sirtex’s markets
965,000
See Appendix for detailed breakdown of treatment cascade
Patients eligible for SIRSpheres microspheres (3)
14
279,000
209,000
Eligible patient
population in
Sirtex’s markets
(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) Sirtex data & analysis. See Appendix 1: Contestable Market Analysis.
A brief overview of Half
Year Results
15
The half year results demonstrate solid progress
Dose sales
Number sold
Product revenue
$ '000s
2,698
3,522
36,800
46,042
10,710
Profit before tax
$ '000s
Net profit after tax
$ '000s
6,097
Operating cash flow
$ '000s
5,680
Dividends paid (Fully Franked)
$ '000s
3,904
FY2012
16
7,780
13,186
5,577
FY2013
30%
25%
30%
28%
132%
43%
Growth delivers improved financial performance as
Sirtex invests for the future
$ '000s
10,108
2,657
3,394
729
590
159
Clinical
Regulatory
& QA
6,097
NPAT
1H
FY12
17
Sales
Volume
increase
FX
impact
Sales &
Marketing
Admin
7,810
866
Tax and
Other
NPAT
1H
FY13
Key drivers of revenue are doses and foreign
exchange
Revenue, $’000
• Revenue has more than
doubled over the last five
years
• The appreciation of the
Australian dollar in recent
years has slowed revenue
growth compared to doses
2H
Doses sold, #
1H
• Doses have almost tripled over
the last five years
• Each new half has exceeded
the proceeding half
• Strategies aimed at delivering
longer term growth…
• but, as in the past, there could
be some variation along the
way
18
Sirtex’s significant milestones over the last 6 months…
Company highlights – July 2012 to December 2012
•
•
•
•
•
•
•
•
•
19
34 consecutive quarters of growth
Standard and Poors added Sirtex to ASX 200
Continued profitability with a healthy cash flow
Payment of fourth annual dividend of 10 cents per share (7 cents prior)
Announced tripling US manufacturing capacity
Announced establishment of European manufacturing facility
Continued expansion of global operations and infrastructure
Further positive clinical data released
Collaboration with National Cancer Centre, Singapore
2020VISION
20
The 2020Vision is our strategy to achieve growth
Structuring for long term sustainable business expansion
•
Progressing our clinical studies program to provide the level 1 evidence
of the effectiveness of SIR-Spheres microspheres
•
Building manufacturing capacity to satisfy expected increased future
demand
•
Ensuring there is a sufficient number of treating hospitals that are
accessible and able to service the eligible patient population
•
Building our Sales & Marketing capability to effectively service a
significantly increased market
•
•
Ensuring support structures facilitate the growth of the business
21
SIR-Spheres evolution to further improve our therapy
Sirtex is evolving its core product and developing new
technologies
SIR-Spheres Evolution Program
•
•
•
New delivery system will simplify and improve method of administering
•
Development is based on customer needs and feedback from users in all
markets
Imageable SIR-Spheres to improve work-up and treatment monitoring
Computer-based patient treatment planning system to tailor administered
dose
New technology
•
•
22
R&D investment of $2.9m ( 9%) in 1H 2013
Program developing three new platform technologies (Carbon Cage
nano-technology, RAFT coated nano-technology, radioprotector)
Our plan for the future
•
Sirtex’s 2020Vision strategic plan will drive solid growth into the next
decade
•
Primary focus on promoting and developing SIR-Spheres microspheres
•
Continuing growth expected
•
Expect a step change in growth with positive level 1 clinical evidence
•
Longer term objective is to provide a wider choice of targeted and tailored
oncology treatment options for a wider range of patients
•
Strong position to take advantage of future opportunities
23
Thank You
24
Appendix 1:
contestable market analysis
25
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
72,000 (15%) (1)
Suitable for
surgical resection
483,000 (50%) (1)
Do not 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
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 2005.
(2) Sirtex data and analysis.
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
Suitable for
palliative treatments
No treatment possible
Curative treatments:
• Surgical resection
• Liver transplantation
• Radio-frequency ablation
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 2008.
(2) Sirtex data and analysis.
27