Australia (ASX: AVH) U.S. (OTCQX: AVMXY)
Annual General Meeting22 November 2013Perth, Australia
Galatéa de las esferas Salvador Dalí, 1952
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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 forward‐looking 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. For
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I. OpenII. Chairman’s AddressIII. Chief Executive Officer’s PresentationIV. Formal Business of AGMV. QuestionsVI. Close
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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.
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How turn the novel, disruptive technology embodied in ReCell into shareholder value?
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Condition Annual number of procedures potentially appropriate for ReCell application
Chronic wounds (lower limb ulcers)
15,000,000 Approximately 1.5% of general population of OECD countries (3.2%>70 year olds) (1)
Aesthetics 2,100,000 Treatment sought from cosmetic surgeons for skin discoloration, acne, skin defects, stretch marks; 650,000 US alone (3)
Plastic / Dermatology / Reconstructive
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 20053 American Society for Aesthetic Plastic Surgery 20044 Forschner et al. Current state of vitiligo therapy. J Dtsch Dermatol Ges 5(6):467‐75 2007
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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 YearsFor
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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
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ROW
ROW
ROW
ROW
ROW
ROW
EMEA
EMEA
EMEA
EMEA
EMEA
EMEA
USA
USA
USA
USA
USA
USA
Scars
Vitiligo
Aesthetics
Chronic Wounds
Acute Burns/
Trauma
Indications Preclinical PII/Feasibility PIII/Pivotal Post‐MarketStudies
OpportunitiesAdditional 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.
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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
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• Number of usages (excluding clinical studies)• Number of publications
1 Jan – 8 Nov 2013
0
200
400
600
800
1000
2007 2008 2009 2010 2011 2012 2013
ReCell Uses by Year
0
5
10
15
20
25
30
35
2007 2008 2009 2010 2011 2012 2013
ReCell Publications by Year
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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 revenuesF
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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
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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 peer‐review 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 venuesF
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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
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Program Target Date Complete dyspigmentation Randomised Control Trials
Submit FDA IDE for pivotal 1Q 20142Q 2014
Complete enrolment Chronic Wound RCT Submit FDA IDE for pivotal
3Q 20141Q 2015
Continue ‘clinical‐marketing’ studies on high value indications Aesthetics, burns, reconstructive, dermatology
On‐going
Convert marketing studies into publications – peer‐reviewed, white papers, conference presentations
On‐going
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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.
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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
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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
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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
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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.
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• 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%
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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 brakesF
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