Australia (ASX: AVH) U.S. (OTCQX: AVMXY) Galatéa de las esferas Salvador Dalí, 1952 Annual General Meeting 22 November 2013 Perth, Australia
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.
3 I. Open II. Chairman s Address III. Chief Executive Officer s Presentation IV. Formal Business of AGM V. Questions VI. Close
4 Mr Dalton Gooding Chairman of Avita Medical Limited
5 Dr William Dolphin CEO of Avita Medical Limited
6 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.
7 How turn the novel, disruptive technology embodied in ReCell into shareholder value?
8 Condition Chronic wounds (lower limb ulcers) Aesthetics Plastic / Dermatology / Reconstructive Annual number of procedures potentially appropriate for ReCell application 15,000,000 Approximately 1.5% of general population of OECD countries (3.2%>70 year olds) (1) 2,100,000 Treatment sought from cosmetic surgeons for skin discoloration, acne, skin defects, stretch marks; 650,000 US alone (3) 1,500,000 Treatments sought from plastic surgeons for scar remodeling; 580,000 US alone (3) Vitiligo 1,200,000 Reported cases seeking treatment (prevalence: 2% of population ~ 12 million) (4) Burns 650,000 Burns requiring medical intervention (2) TOTAL 10 14 Million Potential annual procedures 1 Graham et al. Prevalence of lower limb ulceration. Adv Skin Wound Care 16(6):305 16 2003. 2 US Center for Disease Control (CDC); AM Burn Assoc National Burn Repository 2005 3 American Society for Aesthetic Plastic Surgery 2004 4 Forschner et al. Current state of vitiligo therapy. J Dtsch Dermatol Ges 5(6):467 75 2007
9 Lay the Foundation Team in place Develop KOLs & Champions Clinical studies (RCTs, high value indications) Reimbursement for key markets Regulatory clearance in major markets Build for the future Critical sales elements in place Product positioned in key markets Centres of Excellence and ReCell clinics Expanded product line 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
10 Demonstrate clinical effectiveness Unassailable clinical data through randomised control trials (RCT) High impact, high value indications addressing unmet clinical need Results published in peer review journals Demonstrate customers willing to use and buy Validative sales High profile, influential surgeons and clinicians using and purchasing Endorsement of Key Opinion Leaders (KOLs) Focus on select, high value markets Secure Intellectual Property Patents Broad, defendable claims covering core technology in major markets Manufacturing margins Scalable, low cost, high margin manufacture Quality control
11 Indications Preclinical PII/Feasibility PIII/Pivotal Post Market Studies Acute Burns/ Trauma USA EMEA ROW Scars USA EMEA ROW Aesthetics USA EMEA ROW Vitiligo USA EMEA ROW Chronic Wounds USA EMEA ROW Opportunities USA EMEA ROW Additional opportunities exist in treatment of periodontal disease, tracheal regeneration, diseases affecting the corneal epithelium, necrotizing fasciitis, epidermolysis bullosa, rhinophyma, single side mastectomy areola and other reconstruction.
12 Building the user base: Deep vs Broad Novel, disruptive technologies requires paradigm change Work closely with relatively few, select surgeons and centres High profile influential surgeons and centres willing and able to: Use and purchase ReCell Serve as training and reference sites Conduct clinical post market studies Present results in publications, congresses, case reports and white papers Support reimbursement applications Focus on select high value indications Focus on select high value geographic markets Mixed model: Direct, Distributors, Partners, Joint Ventures
13 Number of usages (excluding clinical studies) Number of publications 1000 ReCell Uses by Year 35 ReCell Publications by Year 800 30 25 1 Jan 8 Nov 2013 600 20 400 15 200 10 5 0 2007 2008 2009 2010 2011 2012 2013 0 2007 2008 2009 2010 2011 2012 2013
14 Dyspigmentation Lower Limb Ulcers Acute Burns Goal: Support applications for regulatory approval Provide clinical marketing data to support sales (not science experiments) Generate growing sales revenues
15 Large market: ~ 5 million potential patients Encompasses vitiligo, dyspigmented scars, (e.g., aesthetics, plastics, reconstructive, dermatology) Cleared for sale EU (CE mark), China (SFDA), Australia (TGA) Payors: mixed: Self, Public, Private Insurance Demonstrated clinical effectiveness Pilot case series: Completed: 150 patients (Australia, Germany, Italy, UK, Jordan); Data published in peer review journals and congress presentations Pilot Randomised Control Trials: Completed: Vitiligo (Netherlands); Dyspigmented scar (US FDA PII); Underway: Dyspigmented scar (Germany); completed 1Q 2014 US FDA Pivotal (PIII) IDE in preparation; submission 2Q 2014 Marketing strategy Target key clinicians ( Push ) through direct and media marketing Direct to consumer marketing ( Pull ) with targeted advertising, promotional campaigns, public press, print, electronic and social media venues Conduct & publicise focussed post market studies Approx 45% of FY2013 ReCell sales
16 Very large and growing market: ~ 15 million potential patients Encompasses Venous leg ulcers (VLU), Diabetic foot ulcers (DFU), Pressure (Decubitus) ulcers Cleared for sale EU (CE mark), China (SFDA) Payors: mixed: Self, Public, Private Insurance Demonstrated clinical effectiveness Pilot case series: Completed: 82 patients (Italy, UK); Data published in peerreview journals and congress presentations Pilot RCT studies: Underway: Multicentre randomised control trial; France, Germany, United Kingdom; complete enrolment 3Q 2014 US FDA Pivotal (PIII) IDE submission 2Q 2015 Marketing strategy Target key clinicians ( Push ) through direct and media marketing Direct to consumer marketing ( Pull ) with targeted advertising, promotional campaigns, public press, print, electronic and social media venues
17 Smallest of market opportunities: ~ 650,000 potential patients p.a. Encompasses wide range of applications within burn treatment; disruptive Cleared for sale EU (CE mark), China (SFDA) Payors: Public (requires reimbursement) Demonstrated clinical effectiveness Numerous case series; Data published in peer review journals and congress presentations RCT studies: Underway: US FDA Pivotal (PIII) Multicentre randomised control trial; significant difficulty in recruitment; under review Marketing strategy In cleared markets target key clinicians ( Push ) through direct and media marketing Build credibility within the medical and scientific community (clinical data, study results, publications, presentations) Utilising influential users (KOLs) as advocates for ReCell through presentations at national and international congresses, symposia, and publications Obtain reimbursement with support and endorsement of KOLs Approx 45% of FY2013 ReCell sales
18 Program Complete dyspigmentation Randomised Control Trials Submit FDA IDE for pivotal Target Date 1Q 2014 2Q 2014 Complete enrolment Chronic Wound RCT Submit FDA IDE for pivotal 3Q 2014 1Q 2015 Continue clinical marketing studies on high value indications Aesthetics, burns, reconstructive, dermatology Convert marketing studies into publications peer reviewed, white papers, conference presentations On going On going
19 Coverage and reimbursement by healthcare payer, whether commercial, private or government (e.g., UK:NHS; Australia:Medicare) required to allow provider to be compensated by payer In the present cost constrained health care environment, payers need to be convinced that the new device/drug will provide both clinical and economic advantages over the "old" treatment.
20 UK: application submitted to NICE (National Institute for Health and Care Excellence); under review by Medical Technologies Advisory Committee (MTAC); Draft Scope available for comment Germany: supporting application submitted by 8 hospitals Multiple authorities involved: InEK: Institut für das Entgeltsystem im Krankenhaus (Institute for the Hospital Remuneration System) DIMDI: Deutsche Institut für Medizinische Dokumentation und Information (German Institute of Medical Documentation and Information) G DRG: Diagnosis Related Group; ICD 10 GM German Modification US, FR, IT : Process underway
21 With Foundation in place, drive sales to broader market Implementing marketing strategy based on combination of Push (top down: clinicians) and Pull (bottom up: patients) Influencing Key Medical Opinion ( Push ) Build credibility for ReCell within the medical and scientific community (clinical data, study results, publications, presentations). Targeting of identified potential high volume surgeons and clinicians through direct and media marketing Utilising influential ReCell users (KOLs) as advocates for ReCell through presentations of data at national and international congresses, symposia, and publications. Direct to consumer marketing ( Pull ) Targeted advertising, promotional campaigns to heighten visibility and create name recognition for ReCell and Avita Public press, print, electronic and social media venues
22 Product Information and Promotional Campaign High quality collateral marketing materials (e.g., tear sheets and product brochures), scientific publications and white papers, website content, social media, training and educational videos and other promotional material. Identifying, targeting and influencing potential high volume customers using direct contact, promotional material, the dissemination of scientific and technical publications, and attendance and presentations at international conference and exhibitions. Implementation of a well defined publication and advertisement strategy, addressing major medical and professional publications, as well public press, using print, electronic and social media venues Targeted advertising, promotional and direct mail campaigns to heighten visibility and create name recognition for the Company and its products, Exhibition at major trade shows, As appropriate, contracting with leading medical supply distributors and partnerships. In discussions regarding specialised ReCell clinics
23 Patents granted: Europe (PCT), Australia, Japan, Hong Kong, Latin America; Under examination in US. Broad claims covering core aspects of the technology embodied in ReCell. Granted trademark protection for use of the term ReCell and Spray On Skin (branding) 6 new patents submitted and under review covering key features of epithelial regenerative technology. Full ownership of all IP with transfer of previously licensed intellectual property from the McComb Foundation.
24 Complete overhaul of operations yielding increased efficiencies; Put in place formal continuous improvement model Revamp of Quality System Major modifications to the manufacturing process 2008 2013 Reduced operating losses by >50% Increased gross margins by >200% Reduced ReCell COGs by 60% Reduced Breath A Tech COGs by 35%
25 Foundation laid (Phase I) Clinical studies for major indications at or near completion Influential surgeons using and purchasing Reimbursement process well advanced IP secured High margin manufacture in place Building for the future (Phase II) Team in place ReCell positioned in high value indications, high value markets Growing commercial sales Partnering; Distributors Time to step on the accelerator, not the brakes
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