Annual General Meeting Perth, Western Australia 29 November 2012

Transcription

1 Australia (ASX: AVH) U.S. (OTCQX: AVMXY) Galatéa de las esferas Salvador Dalí, 1952 Annual General Meeting Perth, Western Australia 29 November 2012

2 This presentation may include forward looking statements. You can identify these statements by the fact that they use words such as anticipate, estimate, expect, project, intend, plan, believe, target, may, assume or similar expressions. These forward looking statements speak only as at the date of this presentation and are based on management s expectations and beliefs concerning future events. Forward looking statements are necessarily subject to risks, uncertainties and other factors, many of which are outside the control of Avita Medical that could cause actual results to differ materially from such statements. Avita Medical makes no undertaking to subsequently update or revise the forwardlooking statements made in this release to reflect events or circumstances after the date of this release. This presentation is intended to provide background information only and does not constitute or form part of an offer of securities or a solicitation or invitation to buy or apply for securities, nor may it or any part of it form the basis of, or be relied on in any connection with any contract or commitment whatsoever. 2

3 3 The Art of Beautiful Science Avita Medical develops and distributes regenerative, tissue engineered products for the treatment of wounds, burns, scars and skin defects. Australian Exchange (ASX:AVH); U.S. Exchange (OTCQX: AVMXY). Consolidated Market Valuation $42 M Cash on hand $16 million Lead product ReCell Spray On Skin point of care stem cell treatment for wide range of wounds and dermal defects Currently on the market & generating revenue Regulatory clearance in Europe (CE Marked), Australia (TGA), China (SFDA) US FDA trials underway (US DoD funded $4.4M )

4 4 To create a leading global healthcare company in the field of regenerative medicine. To provide, innovative, exceptional and cost effective solutions that exceed customer expectations and address the needs of patients, clinicians and healthcare systems. To deliver above average returns to shareholders while sustaining a challenging and rewarding work environment for our employees.

5 5 Avita s regenerative technology: Harnesses body s intrinsic ability to heal itself and packages it into an easy to use bedside kit Addresses needs of all stakeholders: Patients: Provides improved outcomes Surgeon/Clinician: Easy, fast and effective with reduced morbidity; revenue generator Healthcare System: Reduced patient care costs

6 6 Frontier of medical technology Technology addresses very large and growing markets Unique and patented product offering Proven technology; Generating early revenues; Significantly de risked Regenerative medicine and stem cell therapies is a rapidly emerging field with no dominant players Fundamentally changing practice of medicine Lead product ReCell Spray on Skin On market and generating revenue: 1 st mover advantage Vast market potential for treatment of unmet therapeutic needs including chronic wounds, burns, reconstructive/ plastic applications, vitiligo and aesthetics Addressable market in excess of $2.5B ReCell is rapid, low cost, point of care solution; improved outcomes, reduced morbidity, provides significant savings to healthcare system No similar harvesting, processing and delivery technology for autologous tissue commercially available ReCell regenerative technology is novel and patented Approximately 4,500 patients have been successfully treated with ReCell to date Commercialized and generating early revenues: CE marked (Europe); TGA (Australia); SFDA (China; pricing studies underway); FDA trials underway (US) ReCell has been embraced by key influential surgeons and Centers of Excellence in the UK, France and Germany; US$4.3M from US DoD for FDA trials Experienced board and management team with success in launching new clinical applications.

7 7 People Business Models Plan Product Processes Vision without action is a daydream; Action without a plan is a nightmare.

8 8 Lay the Foundation Team in place Develop KOLs & Champions Clinical studies Reimbursement for key markets Regulatory clearance in major markets Expanded product line Build for the future Critical sales elements in place Product positioned in key markets Centres of Excellence and ReCell clinics Distribution partnerships Grow sales Drive the Business; Recognise Value Grow sales Expand geographical markets Expand partnerships Develop follow on products Establish Avita as leader in regenerative medicine Now 2 Years Now 3 Years Now 5 Years

9 9 Obtain reimbursement for ReCell in key markets Establish ReCell as a core tool in the management of chronic wounds Expand ReCell product line offerings to differentiate specific markets Obtain FDA clearance for ReCell sales and marketing in the US Increase shareholder value and visibility among potential institutional investors

10 10 Healing Compromised healing Ulcers Failed grafts Co morbidities Elderly, paediatric, diabetic, etc Quality of outcome Burns (functional, sensation, appearance) Decreased morbidity (donor site, grafting, 2 o procedures, after care) Cosmesis Repigmentation Burns, surgery Vitiligo Dyspigmentation Cosmetic improvement Scar remodelling Acne scar Rejuvenation procedures Visible body areas Faces, hands ReCell boosts healing potential & delivers skin matching

11 11 ReCell suspension sprayed onto wound surface Result: normal, healthy, new skin with full complement of constituent cells types, including melanocytes, keratinocytes, fibroblasts and basal cells in proper proportion Disaggregated cells migrate over wound area Cell signalling encourages and directs proliferation, vascularisation and innervation Activated positively stressed progenitor cells undergo period of high mitotic activity with rapid proliferation and differentiation

12 12 Condition Chronic wounds (lower limb ulcers) Annual number of procedures potentially appropriate for ReCell application 15,000,000 Approximately 1.5% of general population (3.2%>70 yo) of OECD countries (1) Burns 850,000 Burns requiring medical intervention (2) Plastic / Dermatology / Reconstructive 580,000 (US) Treatments sought from plastic surgeons for scar remodeling. (3) Vitiligo >200,000 Reported cases seeking treatment (prevalence: 2% of population ~ 12 million) (4) Aesthetics 600,000 (US) Treatment sought from cosmetic surgeons for skin discoloration, acne, skin defects, stretch marks (3) TOTAL Million Potential annual procedures 1 Graham et al. Prevalence of lower limb ulceration. Adv Skin Wound Care 16(6): US Center for Disease Control (CDC); AM Burn Assoc National Burn Repository American Society for Aesthetic Plastic Surgery Forschner et al. Current state of vitiligo therapy. J Dtsch Dermatol Ges 5(6):

13 13 Lower limb ulcers (venous, pressure and diabetic) are significant health problem and major healthcare burden in OECD countries Afflicts approximately 1.5% of general population; >3% of population over 70 y.o. Morbidity includes: Pain & Infection Impairment of mobility & function Failure to resolve contributor to loss of limb Standard of care ineffective Costly, includes salves and ointments, negative pressure therapy, frequent dressing changes, special compression bandages, medications (includes growth factors), skin grafts (auto or allo) Low success rate of treatment; approx. 50% of lower limb ulcers remain unresolved after 12 weeks of treatment

14 14 Subjects treated: 20 Patients treated Age: years Open ulcer >6 months (average 12.2 months), non responsive to standard treatment (compression, grafts) Preliminary treatment results: > 60% fully healed within 5 weeks Immediate (within 72 hr) reduction of pain reported

15 Data provided by B. De Angelis et al., Tor Vergata University, Rome, Italy. 15

16 % Re epithelialization ( )Trajectories of 15 VLUs (open avg of 18 months; min 12 weeks, max 374 weeks) treated with ReCell. 12 of 15 (80%) healed by week 12. Mean healing trajectories of 60% of patients (n=139) healed within 20 weeks (from Steed et al. 2006) Mean healing trajectories of 40% of patients (n=93) not healed within 20 weeks (from Steed et al. 2006) Healing trajectories from 232 patients with venous leg ulcers enrolled in 8 VLU RCTs at 2 independent centers Weeks (post treatment) Steed et al., Wound healing trajectories as outcome measures of venous stasis ulcer treatment. Int Wound J. 2006;3:40 47

17 Data based on recorded expenses in treatment of 26 burns patients at Pinderfields Hospital Burns Units United Kingdom during

18 18 ReCell addresses the needs of a wide range of indications; Diverse markets each have distinct requirements. Initiated major product development project: next generation of ReCell products addressing the specific needs of each market segment. The new products will: Provide differentiation of product to address needs of different markets Allow implementation of a range of business models and pricing flexibility reflecting the need of specific markets Significantly broaden addressable market base

19 19 Avita Medical Europe Cambridge, UK Avita Medical Americas Los Angeles Avita Medical Italia Milan, Italy Avita Medical MENA Kuwait Direct Distributor Joint Venture Avita Medical Asia Pacific Australia Regulatory Approval Pending

20 20 * * Mr Dalton Gooding; Chairman Mr Ian Macpherson; Deputy Chairman Dr William Dolphin; Managing Director Prof Fiona Wood; Non Executive Director Mr Jeremy Curnock Cook; Non Executive Director Mr Matt MacNamara; Non Executive Director Mr Gabriel Chiappini; Company Secretary

21 21 New Directors Mr Jeremy Curnock Cook:served on the boards of numerous international healthcare and biotechnology companies; former head of the life science private equity team at Rothschild Asset Management; responsible for the launch of the first dedicated biotechnology fund for the Australian market and the launch of a joint venture with Johnson & Johnson Development Corporation for the creation of Healthcare Ventures; responsible for the conception and launch of the International Biotechnology Trust (IBT). Mr Matt McNamara: Chief Investment Officer and Fund Manager of OctaPhillip Bioscience Managers; extensive experience in the biotech sector; decade of experience in sales & marketing and general management with Merck & Co. and Johnson and Johnson Medical Pty. Ltd.; CEO of a Life Sciences Venture Capital fund, SciCapital Pty. Ltd.

22 22 William F. Dolphin, Ph.D., CEO; 26 years international executive experience in biotech and technology sectors; significant M&A experience * * Timothy Rooney, COO/CFO; 23 years senior finance and operations management; pharmaceutical wholesale distribution & supply Debra Leeves, General Manager, EMEA; 20 years senior sales and marketing management in pharmaceutical and medical device sector Lorraine Glover, General Manager, Asia Pacific; 22 years experience in the commercial biotechnology and medical devices industry Stella Sung, Ph.D., Business Development Officer; 18 years senior management, business development and venture capital Andrew Quick, MS., VP Research & Technology; 21 years medical device experience; expertise in design, development and clinical research William Marshall, VP Operations; 31 years industry experience; expertise in lean manufacturing, quality and regulatory systems

23 23 Additions to Management Team Ms Debra Leeves, General Manager Europe, Middle East and North Africa (EMEA). Ms Leeves has an outstanding record in the healthcare and biotech sector. Previously, Ms Leeves was Marketing Manager EMEA for GE Healthcare and in various senior sales and marketing management roles with Pfizer/Wyeth and GlaxoSmithKline. Mr Timothy Rooney, Chief Operating Officer/Chief Financial Officer. Mr Rooney has 23 years experience in senior finance and operations. Most recently he was CFO/COO of a large pharmaceutical wholesale business, which under his guidance grew from an early stage start up to a US$450 million business.