Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Investor Presentation (June 2012)
38 slides from Avita Medical's investor presentation, June 2012
Slide 1: Investor Presentation June 2012
Investor Presentation June 2012 Australian (ASX: AVH) U.S. (OTCQX: AVMXY)
Slide 2: Forward-looking statements
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 o
Slide 3: Avita Medical overview
3 Avita Medical develops and distributes regenerative, tissue‐engineered products for treating wounds, burns, scars and skin defects. Avita's treatment utilizes the patients' own skin to regenerate and expedite wound healing. • Lead product, ReCell® is on the market & generating revenues. • Regu
Slide 4: Frontier of medical technology
4 Frontier of Novel, patented regenerative medicine technology, with vast market potential for treating unmet therapeutic needs, including burns, reconstructive/ plastic applications, chronic wounds, medical vitiligo and aesthetics technology ReCell® Spray‐on‐Skin® is rapid, low cost, minimizes scar
Slide 5: Revenues, loss and gross profit
5 REVENUES 5.00 Revenues of $4.54 million (year $ Millions 2.50 ending 30 June 2011) Gross Profit of $3.5 Million 0.00 2008 2009 2010 2011 Overall Gross Margins of 73% LOSS FROM OPERATIONS 15.00 Losses due to Continuing Operations $ Millions 7.50 $1.95 Million Cash on Balance Sheet $10.9 M
Slide 6: Goal: Regrow, replace, restore function of tissues
6 Goal: Regrow, replace, restore function of tissues, organs or limbs damaged, lost or non‐functional (e.g. trauma, disease, senescence) All tissues and organs – in theory – have capability to regenerate Fundamental change to practice of medicine Key Product: ReCell® Spray‐On Skin®
Slide 7: ReCell Spray-On Skin
7 Initial product ReCell® Spray‐On Skin® point‐of‐care stem‐cell treatment for wide range of wounds and dermal defects: • Chronic Wounds • Burns • Plastic and Reconstructive Surgery • Aesthetic/Cosmetic Procedure Currently on the market & generating revenue • Regulatory clearance in Europe (CE M
Slide 8: Avita's regenerative technology
8 Avita’s regenerative technology Harnesses body’s intrinsic ability to heal itself and packages it into an easy‐to‐use bedside kit for the clinician Addresses needs of all stakeholders: • Patients: Provides improved outcomes • Surgeon/Clinician: Easy, fast and effective with reduced morbidity;
Slide 9: ReCell procedure steps
9 Thin, split thickness skin Cells rinsed in ‘buffer sample (20x20x0.2mm) cocktail’ of similar skin Biopsy incubated in proprietary enzyme Suspension filtered ‘cocktail’ approx. 20 min Suspension sprayed on Biopsy removed from wound, covered with incubator, mechanically dressing. Remove agitated to
Slide 10: Intellectual property portfolio
10 Broad intellectual property portfolio • 9 patents granted (U.S., PCT, Australia, Japan and EU) Registered trademark ‘Spray‐ • 7 applications pending On Skin’ reinforces Key technology and associated IP relates to: the company’s global branding as • Dissociation of epithelial tissue ReCell inc
Slide 11: ReCell counters normal healing
11 ReCell counters, cancels and redirects “normal” healing, leading to accelerated regeneration NORMAL HEALING ReCell HEALING Healing by secondary intention Accelerated regeneration Cells gradually detach from the ECM Wound bed ‘seeded’ with activated cells and slowly migrate inward from the leading
Slide 12: Result: normal, healthy, new skin
12 Activated progenitor Cell signalling ReCell® encourages and Disaggregated cells undergo period of suspension directs cells migrate high mitotic activity sprayed onto proliferation, over wound area with rapid proliferation wound surface vascularisation and and differentiation innervation Result: ‘
Slide 13: Applications
13 Applications Chronic wounds such as diabetic, venous, arterial or pressure ulcers Burns, scalds and donor sites associated with grafts Scar revisions to improve colour, texture & function Pigmentation disorders such as Vitiligo Epidermal defects such as naevi, acne, discolouration Pro
Slide 14: Day 1, Week 3, Month 10 results
14 Day 1 Week 3 Month 10 Prep and debridement post‐ReCell post‐ReCell
Slide 15: Neck pre-treatment 12 months post-ReCell
15 Neck pre‐treatment 12 months post‐ReCell®
Slide 16: Neck pre-treatment 10 month post-ReCell
16 Neck pre‐treatment 10 month post‐ReCell
Slide 17: Before treatment, 2 months post treatment
17 Before treatment 2 months post treatment
Slide 18: Pre-ReCell, 12 month post-ReCell
18 Pre‐ReCell 12 month post‐ReCell
Slide 19: Lower limb ulcers burden
19 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 • Failu
Slide 20: Pre-op analysis using 3D VideoCap scanner
20 Pre‐op analysis Planar Arear: 830 mm2 Real Area: 954 mm2 using a Scanner Perimeter: 109 mm 3D VideoCap® Missing Volume: 589 mm3
Slide 21: Ulcer healing time course
21 T1 @ 7 T2 @ 14 T3 @ 21 T4 @ 28 T5 @ 35 T0 days days days days days
Slide 22: Wound area measurements T1-T5
22 T1 T2 T3 T4 T5 954 mm2 676 mm2 456 mm2 134 mm2
Slide 23: Chronic ulcer study preliminary results
23 Subjects treated: • 20 Patients treated (data through 8 weeks) • Age: 58 ‐ 79 years • Open ulcer >6 months, non‐responsive to standard treatment (compression, grafts) • Wound depth: mixed, mid‐partial to full thickness Preliminary treatment results: • > 60% healed within 5 weeks • Immediate (
Slide 24: Wound care, plastics and aesthetics uses
24 WOUND CARE PLASTICS AESTHETICS Burns Scar remodelling Cosmetic relief • ReCell® Alone • Pre‐existing • Acne scars • Combination with other • Burn, graft scars • Hyper or hypo‐ treatments (e.g., mesh • Surgical scars pigmentation grafts, dermal substitutes) • Biopsy • Liver spots • Mohs surg
Slide 25: Annual procedures potentially appropriate for ReCell
25 Condition Annual number of procedures potentially appropriate for ReCell application Chronic wounds (lower Approximately 1.5% of general population (3.2%>70 yo) of OECD 12,000,000 limb ulcers) countries (1) Burns 650,000 Burns requiring medical intervention (2) Plastic / Dermatology / 580,000 (US
Slide 26: Global distribution: direct, distributor, joint venture
26 Avita Medical Europe Cambridge, UK Avita Medical Americas Avita Medical Italia Los Angeles Milan, Italy Avita Medical MENA Kuwait Direct Avita Medical Asia Distributor Pacific Australia Joint Venture Regulatory Approval Pending
Slide 27: US burns trial study design
27 Study Design Randomized, within‐patient, controlled study comparing clinical performance of ReCell® device with STMSG for treatment of deep partial‐thickness burns. Patients must have injury patterns such that two, 100‐320 cm2 regions (not necessarily contiguous) of 2nd degree depth available
Slide 28: Management team
28 William F. Dolphin, Ph.D., CEO 29 years international executive experience; significant M&A experience Stella Sung, Ph.D., Business Development Officer 18 years senior management, business development and venture capital Andrew Quick, VP Research & Technology 20 years medical device experie
Slide 29: Upcoming milestones
29 FDA submission for ReCell in burns Mid 2013 Commencement of pilot study of ReCell in scar remodeling Q2 2012 IDE for pivotal study of ReCell in scar remodeling Q1 2013 Feasibility studies of ReCell in chronic wounds H2 2012
Slide 30: Investment summary
30 Novel, patented regenerative medicine technology—potential to change paradigm of wound healing Enormous market potential due to applicability in multiple indications Commercialized and generating revenues internationally Relatively near term significant value inflection point—FDA submissi
Slide 31: Company and investor relations contacts
31 COMPANY Stella M. Sung, Ph.D., Business Development Officer 9221 Corbin Ave, Suite 220 Northridge, CA 91324‐2494 Tel: +1‐818 356 9418 Email: SSung@avitamedical.com www.avitamedical.com Investor Relations Mark A. McPartland, Senior Vice President MZ Group Main: +1‐646‐593‐7140 Mobile: +1‐910‐297‐6
Slide 32: Supplemental Items
avita Supplemental tems
Slide 33: Avita and ReCell featured on Sky News
Avita And ReCell Featured On Skynews February 19, 2012
Slide 34: ReCell regenerative process regulation
34 With ReCell® the regenerative process is regulated and controlled by the presence of “Positively Stressed” keratinocytes (K) yielding enhanced release of key proteins (e.g.,HSP90), platelets (P), releasing PDGF, and Stem Cells (SC) (“intelligent bags of growth factors“ (proliferators, e.g., VEGF)
Slide 35: HSP90 and growth factor signaling
35 HSP90 blocks action of TGFb, disinhibiting response to VEGF (vascular endothelial growth factor) and PDGF (platelet‐derived growth factor) by endothelial cells and fibroblasts (Fb) resulting in proliferation and differentiation of key cell types accompanied by rapid development of blood vessels a
Slide 36: Normal skin regeneration through maturation and remodeling
36 ‘Normal’ skin regenerates through maturation and remodeling with appropriate stratification and mix of all cells types (stem cells, keratinocytes, fibroblasts, melanocytes, Langerhans cells, nervous tissue, blood vessels, etc. ) producing texture, pliability, sensitivity , pigmentation and colora
Slide 37: Procedure advantages and disadvantages
37 Procedure Advantages Disadvantages Skin graft • Standard of care • Scarring, cosmetic issues, skin • Extended hospitalization • Specific graft procedure ”quality” • Repeated operations inexpensive • Large, painful donor site • Rapid procedure • Infection, rejection Cultured epithelia • Large cove
Slide 38: Companies involved with burns/wound care products
38 Range of companies involved with burns/wound care products Procedure Companies • 3M Health Care • Hill‐Rom Company, Inc. • Baxter • Johnson & Johnson • Carrington Laboratories, Inc. • Kinetic Concepts, Inc. • ConvaTec, Ltd. • Medline Industries Skin graft/Wound care: • Covidien, Ltd. • Molnlycke