The Ventracor Opportunity

Transcription

The Ventracor Opportunity
6 November 2008
Peter Crosby – Chief Executive Officer
Graeme Fallet – Chief Financial officer
Forward Looking Statements
This presentation contains forward looking statements included in these materials which involve subjective judgment and
analysis and are subject to significant uncertainties, risks, and contingencies, many of which are outside the control of, and are
unknown to Ventracor Limited (“Ventracor”) and any of its subsidiary companies. In particular, they speak only as of the date of
these materials, they assume the success of Ventracor’s business strategies, and are subject to significant
regulatory, business, competitive and economic uncertainties and risks. No representation, warranty or assurance (express or
implied) is given or made in relation to any forward looking statement by any person (including Ventracor and ABN AMRO
Morgans Corporate Limited). In particular, no representation, warranty or assurance (express or implied) is given in relation to
any underlying assumption or that any forward looking statement will be achieved. Actual future events may vary materially from
the forward looking statements and the assumptions on which the forward looking statements are based. Given these
uncertainties, readers are cautioned to not place undue reliance on such forward looking statements. Subject to any continuing
obligations under applicable law or any relevant listing rules of the ASX, Ventracor disclaim any obligation or undertaking to
disseminate any updates or revisions to any forward looking statements in these materials to reflect any change in expectations
in relation to any forward looking statements or any change in events, conditions or circumstances on which any such statement
is based. Nothing in these materials shall under any circumstances create an implication that there has been no change in the
affairs of Ventracor since the date of these materials.
CAUTION: Investigational Device in US. Limited by US law to Investigational Use Only.
6 November 2008
Page 2
Copyright © Ventracor 2008
Summary
The Ventracor VentrAssist® Left Ventricular Assist Device
(LVAD) is long term therapy for end stage heart failure.
The VentrAssist LVAD has outstanding clinical results from
several trials, and shows advantages over existing devices.
Well on the way to commercialisation of the VentrAssist
LVAD, with growing revenues, and a global organization
Now number 2 in a large potential market, and positioned to
claim major market share.
US clinical trials tracking well, and likely to be first with US
market approval of a third generation LVAD.
Seeking to raise ~$10M after costs through a
Share Purchase Plan (SPP) and placement of up to 15% of
the Company’s shares
6 November 2008
Page 3
Ventracor – a growing company
Global organization: ~150 employees worldwide
Headquarters – Sydney, Australia, Operations in US & Europe
VentrAssist® LVAD – a third generation centrifugal pump
50 hospitals in 12 countries ready to implant the VentrAssist LVAD
Longest implant duration >4 years
Regulatory approval to market in Europe & Australia
Well along US regulatory pathway (2 US clinical trials under way)
On the way to a profitable business
Rapidly growing revenues
>370 cumulative patients implanted; >50 worldwide sites
189 VentrAssist LVADs sold in FY2008 (254% increase over FY2007)
80 implants in first 4 months of FY2009
6 November 2008
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Growing Revenues
FY08
Sales up 254% to $17.3M
166 patients implanted
189 devices sold
Growth in all regions
US up $7.3M to $9.3M
Europe up $4.2M to $5.9M
Australasia up $0.9 M to $2.1M
6 November 2008
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Large Potential Market
Growing Rapidly
6 November 2008
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Large potential market for LVADs
End stage heart failure is a growing clinical problem
>50,000 new patients each year in US; One year mortality ∼50%
Not enough donor hearts for transplant ⇒ large unmet clinical need
LVAD is the only therapy if heart transplant not an option
Bridge to Transplant (BTT)
Support native heart while waiting for a donor – well accepted indication
Market today ~1000 pa, estimated to grow to ~3000* pa
Destination Therapy (DT)
Long term use, when heart transplant not an option; potential ~50,000* pa
VentrAssist LVAD addresses limitations of first generation devices
Rapid US sales growth after release of Thoratec Heartmate II
First of new generation rotary pumps designed for long term use
BTT use growing rapidly. Expect DT in the next couple of years.
Builds the market ready for Ventracor’s Pre-Market Approval in the US
* Independent market estimates
6 November 2008
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Ventracor a fast follower
VentrAssist LVAD 3G centrifugal pump
Clinical results better than HM II 2G axial pump PMA data
Designed to have significant advantages over existing products
Likely to be first 3G centrifugal pump to market in US
Good clinical results published from multiple trials
Takes advantage of prepared ground
US reimbursement in place. All devices sold in US clinical trials
Substantial time advantage over followers
Growing clinical experience worldwide
6 November 2008
Already in 27 of 74 US DT sites
>370 patients implanted
>50 worldwide sites
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Competitive Positioning – US
Company
Device
Enrolling in US Trials
Worldwide
Technology CE Mark
Expected US PMA
Implants
BTT
DT
HeartMate I
>10,000
1G pulsatile
1995
-
-
2002
Heartmate II
>1800
2G axial
Nov 2005
-
√
April 2008 for BTT
Ventracor
VentrAssist
>370
3G centrifugal
Dec 2006
>87% done
√
CY2010 for BTT
Jarvik
Jarvik 2000*
~320
2G axial
May 2005
Feasibility
Terumo
Duraheart
~65
3G centrifugal
Feb 2007
IDE
~6 patients
Heartware
HVAD
47
3G centrifugal
Submitted
IDE
1st patient
2
3G centrifugal
-
-
Thoratec
World Heart Levacor
* Jarvik 2000 is a low output (5 l/min) device, so may not be comparable
Management estimates of Worldwide implants based on published data
Ventracor likely to be 1st to US market with a 3G LVAD
More devices implanted in US than all other third
generation or centrifugal LVADs, combined.
6 November 2008
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Claiming Market Share
Clinical & Regulatory
Operations
6 November 2008
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Outstanding Clinical Results
Results from several clinical trials published
CE Mark Bridge Trial1
33 patients, 6 centers Australia & Europe
82% success to end point heart transplant or eligible at 154 days
85% survival
Average support 210 days (4-795d)
US Feasibility Trial (BTT)2
28 patients, 4 US centers
82% success to end point HtX or listed UNOS 1A or 1B at 180 days
86% survival (one patient voluntarily not listed)
Average support 195 days
End points & survival statistics better than HMII PMA data
1
2
Esmore D, et al “VentrAssist Left Ventricular Assist Device, Clinical Trial Results and Clinical Development Plan Update”
Eur J CardThor Surg 2007;32:735-744
Boyle A et al “The VentrAssist LVAD as a Bridge to Cardiac Transplantation: Results of the US Feasibility Trial”
Presented at ISHLT Annual Scientific Meeting, Boston, April 2008
6 November 2008
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US Clinical Trials Recruiting Now
Bridge to Transplant (BTT)
Tests the VentrAssist in patients waiting for donor heart
End point: >75% survival to heart transplant or listed 180 days
140 patients - with “early look” built in after 70% complete
Continued Access Protocol (CAP) approved for 95 patients
Destination Therapy (DT) – EVERLAST
Module A: Does implanting the VentrAssist in “less sick” patients give
better results than continuing with drugs and waiting?
180 patients, 2 year follow up
Module B: Is the VentrAssist at least as good as the Heartmate XVE?
6 November 2008
192 patients max, 2 year follow up
Successful outcome is device failure free, stroke free survival
Page 12
US Clinical Trials Status
BTT Trial
Feasibility Trial complete – 28 patients
First patient in pivotal trial 6 June 2007
122 patients implanted: >87% complete (5 Nov 2008)
Expect to complete enrollment around the new year
75 patient outcomes to date (98 needed for interim analysis)
Results to date tracking feasibility trial
EVERLAST DT Trial
6 November 2008
First patient enrolled 5 September 2007
54 patients enrolled (including control arm and small patient group)
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Projected US Regulatory Timing
Today
Feasibility Trial
BTT Pivotal
Continued Access Protocol until PMA approval
Follow up and File PMA
FDA
Review
DT Enrollment
Continued Access Protocol until PMA approval
Follow up & File
PMA
Future Estimates
Calendar Years
2005
2006
FDA
Review
2007
2008
2009
2010
2011
2012
Clinical trial partner – InCHOIR did REMATCH DT Trial
Assumes PMA Panel meeting needed for both trials
FDA will likely require Post Approval Study after PMA
6 November 2008
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2013
BTT Enrolment Tracking Well
VentrAssist BTT Trial enrolment as fast as Thoratec Heartmate II BTT Trial
140
120
Number of Implants
100
Cumulative VentrAssist BTT Enrolment
HMII BTT Cumulative enrolment from start
80
60
40
20
4 HMII BTT Implants by 27 April 2005
0
28/Apr/07
06/Aug/07
14/Nov/07
22/Feb/08
01/Jun/08
09/Sep/08
Date in VentrAssist BTT Trial Enrolment
Historical Thoratec data from Thoratec press releases and investment analyst reports
6 November 2008
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18/Dec/08
Rest of World Business
European business growing
FY2008 product revenue $5.9M, 57 VentrAssist LVADs sold
Celebrating 100th patient implanted, end October 2008
Direct sales force in Germany, UK, France & Benelux
Distributors established in Scandinavia, Italy & Greece
European market development
Germany the biggest market (>50% of sales)
Large differences between countries
Limited or no reimbursement in some countries (eg: France)
Reimbursement recently obtained for Belgium
Asia Pacific
6 November 2008
FY2008 product Revenue $2.1M
6 hospitals in the region have done at least one implant
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Share Purchase Plan
And Placement
6 November 2008
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2009 Financial Update
October a record month: $2.8m revenue, 27 implants
Revenue for the 4 months to 31 October was $8.6m
Implant run rate for first 4 months >20 per month
Balance Sheet cash at 31 October was $11.4m
Reduction in operating costs
Deferral of R&D on advanced product development projects
Reduction of some marketing activities
Careful monitoring of manufacturing ramp up and reduction of
finished goods stock and work-in-progress
Further deferral of some capital equipment expenditure
Re-forecast cash requirements to ~$10M needed to
get to 30 June 2009
6 November 2008
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Ventracor Seeks to Raise $10M
Share Purchase Plan (SPP) up to $5000 per
shareholder in Australia and NZ
Issue price $0.081 per share
20% discount to 5 day VWAP 28 October
40% discount to 30 day VWAP
Minimum subscription is $500
Placement of up to 15% of shares around the time of
SPP close
Continuing to explore strategic partners, strategic
investors, and debt facilities
6 November 2008
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Use of Proceeds
Complete enrolment in the US BTT clinical trial
Conduct an interim analysis of the data which may
lead to an early conclusion to the BTT trial
Present BTT results at the key International Society of
Heart and Lung Transplant congress in April 2009
Preparation for filing of a Pre-Market Approval
Application for the VentrAssist LVAD with the US FDA
Continuation of enrolment in the US Destination
Therapy (DT) EVERLAST™ clinical trial
Continuation of commercialisation of the VentrAssist
LVAD in Europe & Australia
6 November 2008
Page 20
Summary
The Ventracor VentrAssist® Left Ventricular Assist Device
(LVAD) is long term therapy for end stage heart failure.
The VentrAssist LVAD has outstanding clinical results from
several trials, and shows advantages over existing devices.
Well on the way to commercialisation of the VentrAssist
LVAD, with growing revenues, and a global organization
Now number 2 in a large potential market, and positioned to
claim major market share.
US clinical trials tracking well, and likely to be first with US
market approval of a third generation LVAD.
Seeking to raise ~$10M after costs through a
Share Purchase Plan (SPP) and placement of up to 15% of
the Company’s shares
6 November 2008
Page 21
Key risk factors
Funding Risk
The Company may be unable to secure on acceptable terms, or at all, the future funding it requires
to commercialise the VentrAssist LVAD, particularly given the current uncertain and volatile
economic climate and equity markets. Failure to secure further funding will have a material
adverse impact on investments in Ventracor.
Investment Risk
An investment in Ventracor should be considered speculative and is subject to risks associated
with general share market conditions, economic conditions, inflation, currency fluctuation, interest
rates, supply and demand and changes to legislation and other such commercial factors. The
share price of Ventracor may move up or down.
Product Risk
There is a risk that the VentrAssist LVAD may not meet the performance objectives necessary for
regulatory approval, or may be subject to design or manufacturing issues which could result in a
recall or suspension of sales.
Competition
Competition from other medical device companies or other technology which may provide a
substitute for Ventracor’s product(s) may affect the viability of Ventracor as a business.
Risk that Market for LVADs does not develop
The anticipated market for LVADs may not grow to a size whereby Ventracor can achieve a
commercial return from funds provided by its shareholders.
6 November 2008
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Key risk factors
Clinical Risk
The conduct of a clinical trial requires the engagement of many hospitals, and clinicians at those
hospitals, and good patient selection, all which are out of Ventracor's control. Adverse events with a
patient in a clinical trial may also be incorrectly ascribed to Ventracor's products. Failure of a
physician to follow the instructions for use of Ventracor's products may also result in adverse clinical
outcomes.
A number of clinical trial and regulatory steps to be taken are outside of the direct control of the
Company and may ultimately follow a course which is different from historical precedents upon which
the chart is based. In addition, unforeseen circumstances might impact upon envisaged timeframes
for both the clinical trials and the regulatory approval processes.
Module A of the EVERLAST DT Trial is the first clinical trial of an LVAD in the US on a “less sick”
patient population. As such, the Company is breaking new clinical and regulatory ground, with
unknown results. The Company is at an early stage of enrolment in the EVERLAST Trial, and it is
possible that enrolment may not be as fast as planned or anticipated.
Regulatory Risk
There is no guarantee that the necessary regulatory approvals will be obtained or that there will not
be a delay in obtaining such approvals. Delays could arise from increased competition for clinical trial
sites and patients which inhibits the recruitment rate in the Ventracor’s trials. Delay in FDA regulatory
approval will adversely affect the Company’s ability to generate significant revenues in the future.
6 November 2008
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Thank you and Questions
Contact Details
Peter Crosby
Chief Executive Officer
Ventracor Limited
126 Greville Street, Chatswood NSW 2067
Sydney Australia
T: +61 2 9406 3088 F: +61 2 9406 3124
Graeme Fallet
Chief Financial Officer
Ventracor Limited
126 Greville Street, Chatswood NSW 2067
Sydney Australia
T: +61 2 9406 3066 F: +61 2 9406 3101
VENTRACOR, VENTRASSIST, and the circle device are trademarks of Ventrassist Pty Ltd, registered in several jurisdictions and used under license by Ventracor
Limited. The VENTRASSIST® LVAD includes technology protected by US Patents 6227797, 6250880, 6609883, 6638011, 6820057, 6866625, 6966748, 7156802 and
other granted patents, registered designs and/or pending applications in the USA and other jurisdictions.
6 November 2008
Page 25

The Ventracor Opportunity

Transcription

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