For personal use only · 2013-02-26 · Andrew Thelwell UK, Managing Director, Commercial...
Transcript of For personal use only · 2013-02-26 · Andrew Thelwell UK, Managing Director, Commercial...
Investor Presentation
VitroGro® ECM: Think Different
Dr Steven Mercer (CEO) [email protected]
February 2013
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Tissue Therapies Limited
Tissue Therapies: Introduction
! An Australian biomedical company developing advanced technologies for more cost effective wound healing, tissue repair, cell culture and other global applications
! Worldwide exclusive rights to commercialise VitroGro® technology – VitroGro® ECM will be the first product launched for difficult to heal wounds
! Patents granted in the USA, Europe, China, Hong Kong, South Korea, Japan, South Africa, Australia and New Zealand – pending applications in Canada & India
! CE Mark (EU) approval expected 2nd half CY2013 – then immediate sales launch in UK, Germany, Switzerland, Austria, Benelux and Nordic countries – sales launch expected 1st half CY2014 in Poland, Czech Republic, Hungary, Russia ,Turkey, UAE, Saudi
Arabia, Bahrain – global rollout to follow
! Approved EU claim is for treatment of difficult to heal wounds – broad on-label use
! Partnerships with Quintiles (hiring & support services) and Movianto (logistics) – minimises operational risk, restrain costs and optimise revenue
! Attractive margin product – more convenient, consistent and cost effective than existing wound care treatments
! USA FDA approval for 2 pivotal clinical trials expected 4th quarter CY2013
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Capital Raising
Placement ! Placement raising approximately A$8.7 million gross proceeds
– Approximately 41.5 million New Shares to be issued – Represents 24.1% of pre-raising issued capital
Entitlement Offer ! Fully Underwritten 1 for 10 pro-rata non-renounceable entitlement offer to raise
approximately A$4.5 million gross proceeds – Approximately 21.4 million New Shares to be issued – New Shares issued will rank equally with existing shares on issue
Offer Price ! A$0.21 per New Share
– 24.8% discount to TIS 15 day VWAP¹ – 25.0% discount to TIS closing price on Wednesday 20th February, 2013 of A$0.28
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¹ 15 day VWAP is calculated as A$0.279 as at 20th February, 2013
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Capital Raising
Key Strategic Objectives: ! Maximise Company value by accelerating sales launches in:
– Additional EU countries – Countries outside EU that use CE Mark as important part of approval for sale which include:
Russia, Turkey, Middle East, South Africa, Latin America, Canada, Australia
! Achieve profitability and be cash flow positive 2nd half CY2014
Methods to Achieve Strategic Objectives: ! Sales, marketing and logistics preparation and execution for accelerated sales launch in EU
and internationally
! 2 health economic / reimbursement studies with UK and German Government data – valid throughout EU and internationally – maximum market access
! Final preparation and submission of USA FDA applications for 2 pivotal clinical trials – using VitroGro® ECM to heal venous ulcers and diabetic ulcers
! Further manufacturing validation required for USA FDA approval for sale
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Capital Raising
Use of Funds:
! To achieve the key objectives, the specific use of funds are expected to be:
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VitroGro® ECM
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What is VitroGro® ECM
VitroGro® ECM is a synthe2c, extra-‐cellular matrix (ECM) protein crea2ng a physical structure (a scaffold) that binds to the wound bed:
! Restores aDachment sites in skin & guides cells during wound healing
! Diabe2c foot ulcer (DFU), venous leg ulcer (VLU) & pressure ulcers are primary markets
! Addressing a significant un-‐met need in providing a convenient, cost effec2ve treatment – improved healing, only 1 applica2on per week for 10 weeks – correc2on of wound 2ssue pathology by delivery of biologically appropriate matrix
! Scale up manufacturing complete – VitroGro® ECM in warehouses ready to ship
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Global Market
Global venous, diabetic and pressure ulcer market in 2008
Global market is growing rapidly:
! Market size estimated to be US$30 – US$40 billion – minimum 15% compound per annum
! No definitive treatments – In 2012 in the UK, only 9% of venous ulcers were healed
! Growth driven by an aging population, increasing incidence of venous disease & diabetes as well as expanding affordability of health care, primarily in developing countries.
! Additional sales potential in consumer, retail and acute wound care products – currently not in sales projections
(Please see global market references at end of presentation) 7
42%
22%
36%
USA / Canada
UK / Europe
Rest of World
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VitroGro® ECM: Clinical Effectiveness
EU clinical trial : Venous Leg Ulcer (VLU) study In human trials, VitroGro® ECM has demonstrated consistent and convenient healing of venous, diabetic and pressure ulcers that had not responded to expert care
! Results:
– Trial patients were relatively old (average age 72 years) and had suffered venous ulcers that had not responded to expert care for an average of 36 months
– Strong results: 34% completely healed & 42% more than 90% healed within 12 weeks
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Wound area reduction in 45 patientstreated with VitroGro® ECM over 12 weeks*
Wound area reduction (%) * Prior to treatment, patients had no response to 4 weeks of standard care
>90% - 100% >70% - !90% >50% - !70% >20% - !50% Not improved
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Numb
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42%
11% 11%16%
20%
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VitroGro® ECM: Example of Economic Effectiveness
Preliminary UK economic modelling: ! Many ulcers do not heal promptly when
managed using current standard of care treatment – Up to 50% of venous ulcers may be present for
7 to 9 months and between 8% and 34% may be present for more than 5 years
– For this reason it is appropriate to show the cost comparison between using VitroGro® ECM and managing a non-healing ulcer with standard of care for a duration of one year
! 51% saving for the cost of treatment for a non healing ulcer with a duration of 1 year
! Planned UK & German reimbursement studies to expand this data for EU and international use
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VitroGro® ECM Standard of care non-healing ulcer for 1 year
* Cost savings in labour, hospitalisation, dressings, supplies and medications
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£ 2,000
£ 3,000
£ 4,000
£ 5,000
£ 6,000
£ 7,000
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Cost of VitroGro® ECM treatment compared to 1 year cost of managing a non-healing ulcer using standard of care in
the United Kingdom
£3,237
£7,165
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Difference is £3,928
which is a saving of 51%
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Commercialisation: TIS Partnerships in Place
Tissue Therapies has partnerships in place that minimise operational risk, restrain cost and optimise revenue while maintaining flexibility and control
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! Quintiles – Outsourced HR for dedicated VitroGro® ECM sales team – shared risk/reward – KPI based fee structure
! Movianto – Integrated Logistics, Multi-lingual Customer Support, Order
Entry, Supply, Accounts Receivable
! Eurogentec – Manufacture of VitroGro® ECM Protein
! Catalent – Fill, finish & release
! Queensland University of Technology (QUT) – Research & Development
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Tissue Therapies Board
! Roger Clarke (Chairman): Chairman of Board of Advice RBS Morgans Holdings, NextDC Ltd and Coalbank Ltd. Director of MTQ Insurance Ltd, Trojan Equity Ltd and Maverick Drilling & Exploration Ltd and former Chairman & Director of PIPE Networks Ltd
! Mel Bridges: past & present Chairman & Director of multiple listed and private biotech, healthcare and other technology companies including Alchemia Ltd, ImpediMed Ltd, Benitec Ltd, ALS Ltd, Genetic Technologies Ltd and Genera Biosystems Ltd
! Cherrell Hirst AO: past and present Chair and Director of multiple biotech and other companies including Peplin Ltd, ImpediMed Ltd, QBF, Medibank Private Ltd, Suncorp Metway Ltd and Avant Insurance Ltd
! Iain Ross: past & present senior commercial roles with Sandoz and Roche and as a Chairman, Director and CEO of multiple listed and private international biotech and diagnostic companies including Celltech plc, Phadia AB, Ark Therapeutics plc and Benitec Limited
! Steven Mercer: CEO Tissue Therapies, formerly Mercy Tissue Engineering, Smith & Nephew Surgical, IBM Health Industries. Extensive international experience in biotech clinical commercialisation
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Management Team
Name Title Location Experience
Management Steven Mercer Chief Executive Officer Australia Extensive experience in clinical
commercialisation of devices and biotech in large corporations and in start ups.
Nigel Johnson Chief Operations Director Australia
Operations, regulatory and quality management experience in range of biotech. including blood products, tissue implants and with TIS since 2004
Drummond McKenzie Chief Financial Officer Australia Experienced Chief Financial Officer and Company Secretary in multiple industries – with TIS since IPO in 2004.
Brian Ziegelaar International Product Manager Australia Experienced global international manager in sales and marketing for innovative clinical devices – PhD in tissue engineering.
Hedie Meka Regulatory & Intellectual Property Manager
Australia IP attorney experienced in commercialisation and regulatory affairs – PhD in protein chemistry.
Andrew Thelwell UK, Managing Director, Commercial Operations EU
UK Experienced EU regional senior sales & marketing executive in wound care.
Eva-Lisa Heinrichs Global Medical Director UK Experienced Medical Director in clinical devices and biotech with postgraduate qualifications in wound care.
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Advisory Team
Name Title Location Experience
Advisors Prof. Zee Upton QUT; Chief Scientific Advisor Australia Professor and experienced biochemist with
extensive R&D and IP development achievements in biotech.
Geoffrey Morris USA; Global Commercialisation Consultant
USA Experienced international senior business development executive in pharma and wound care companies.
Ron Shannon Global Health Economic Projects, USA; Epidemiology, Sales Modelling & Health Economics
USA Expert and experienced health economist and epidemiologist – formerly worked for multiple international health and woundcare companies.
Prof. Keith Harding Cardiff University; Clinical Research Consultant
UK An internationally respected, expert wound care clinician and researcher.
Prof. Robert Baxter Kolling Institute, University of Sydney; Scientific Advisor
Australia Internationally respected expert and inventor in cell biology, physiology and clinical endocrinology with international commercialisation experience.
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VitroGro® ECM: CE Mark
! European Medicines Agency (EMA) review - final step – desk audit of manufacturing quality data only – maximum 210 calendar days from start date – approval expected 2nd half CY2013
! Already closed-out: - safety and efficacy - packaging - labeling - indications for Use, “Hard to heal wounds …” - instructions for use
! Benefits of EMA review – definitive regulatory approval for sale signed off by all EU member countries + 3 additional countries – optimal regulatory package for approval for sale in Turkey, Middle East, South Africa, Latin America,
Russia, Taiwan, Canada and Australia
! EMA review period is being used to: – prepare for earlier sales launches in Nordic, Czech Republic, Poland, Hungary, Middle East, Turkey, Latin
America & Russia – likely to bring revenue forward – finalise and lodge FDA applications for pivotal venous and diabetic ulcer trials
! All EMA device reviews have resulted in recommendation for sale
! EU sales will start immediately following CE Mark is granted
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VitroGro® ECM: Accelerated Sales Launch
4Q 2013 United Kingdom, Benelux, Austria Germany, Switzerland, Sweden* Denmark* Finland*, Norway*
1Q 2014 Hungary*, Czech Republic*, Poland*, Russia*, Turkey* ( plus UAE*, Saudi Arabia*, Bahrain*)
1Q 2015 France (clinical data from 1st FDA trial for reimbursement), Northern Italy
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(* Accelerated sales launch program from revised business plan.)
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Disclaimer
! This document has been prepared by Tissue Therapies Ltd (the Company) to provide existing and prospective investors in Tissue Therapies Ltd with an update on the Company and its operations
! The information contained in the presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares in any jurisdiction in which it is illegal for the Company to make such an offer.
! Subject to the law, no representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained in this document or opinions expressed in the course of this presentation.
! This presentation contains forward-looking statements which can be identified by the use of words such as “may”, “should”, “will”, “expect”, “anticipate”, “believe”, “estimate”, “intend”, “scheduled” or “continue” or similar expressions. Any forward-looking statements contained in this presentation are subject to significant risks, uncertainties, assumptions, contingencies and other factors (many of which are outside the control of, and unknown to, Tissue Therapies Ltd and its officers, employees, agents or associates), which may cause the actual results or performance to be materially different from any future result so performed, expressed or implied by such forward-looking statements.
! There can be no assurance or guarantee that actual outcomes will not differ materially from these statements.
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Market Size References
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! Sen C, Gordillo G, Roy S, Kirsner R, Lambert L, Hunt T, Gottrup F, Gurtner G, Longaker M. Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy. Wound Repair Regen. 2009; 17(6): 763–771.
! Drew P, Posnett J, Rusling L, on behalf of the Wound Care Audit Team. The cost of wound care for a local population in England. Int. Wound J 2007;4:149–155.
! Harding K, Queen D. Chronic Wounds and Their Management and Prevention is a Significant Public Health Issue. Editorial. Int. Wound J 2010; Vol 7; 3:125-126
! Madden, M. “Alienating evidence based medicine vs. innovative medical device marketing: A report on the evidence debate at a Wounds conference.” In press Social Science & Medicine xxx (2012) 1e7
! Purwins S, Herberger K, Debus ES, Rustenbach SJ, Pelzer P, Rabe E, Schafer E Stadler R, Augustin M. Cost-of-illness of chronic leg ulcers in Germany. Int. Wound J 2010; 7:97–102 Health economics attractive to Governments
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