Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Corporate Update (December 2021)
29 slides from Avita Medical's corporate update, Dec 15, 2021
Slide 1: Company Update
Company Update Dr. Michael Perry December 14, 2021 Exhibit 99.1
Slide 2: Forward-looking statements
Certain statements in this presentation and the accompanying oral commentary are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including statements rega
Slide 3: Key Accomplishments Since Last Shareholder Meeting
Fiscal 2022 RECELL® total net revenue growth of 105% vs prior year Cumulative U.S. commercial sales since September 2018 FDA approval exceeding $46M Soft Tissue Pivotal Trial: 94% Enrolled Vitiligo Pivotal Trial: 83% enrolled and the remaining 17% scheduled before year-end Transitional Pass-Through
Slide 4: AVITA Leadership Team
AVITA Leadership Team Dr. Michael S. Perry CEO >30 years experience Affiliations: Michael Holder CFO >30 years experience Affiliations: Donna Shiroma General Counsel >20 years experience Affiliations: Andrew Quick CTO >25 years experience Affiliations: Kathy McGee COO >25 years experience Affiliatio
Slide 5: One Platform. Endless Possibilities.
One Platform. Endless Possibilities. In the U.S., RECELL is approved for acute thermal burns. Use of RECELL in other indications is either (1) limited by United States law to investigational use; or (2) otherwise prohibited. RECELL enables regeneration of healthy skin Patch of healthy skin removed f
Slide 6: Development Pipeline and Growth Potential
Development Pipeline and Growth Potential
Slide 7: Focused Pipeline with Strong Growth Potential
Innovation New Device: Improved Ease of Use New Device: Fully Automated INDICATION DISCOVERY FEASIBILITY PIVOTAL APPROVAL Regenerative Therapeutics – Wounds & Dermatology (Current Platform) Acute Thermal Burns (U.S.) RECELL® Japan Vitiligo (U.S.) Soft Tissue Reconstruction (U.S.) Early-Stage Researc
Slide 8: Market Opportunity of Pipeline Exceeds $22 Billion
EXISTING PLATFORM NEW PLATFORMS: CELL BASED GENE THERAPY > $22 Billion in Combined TOTAL ADDRESSABLE MARKET Market Opportunity of Pipeline Exceeds $22 Billion Skin cells are genetically modified ~$6.8B Opportunity ~$15.8B Opportunity Burns Soft Tissue Vitiligo Epidermolysis Bullosa $ $ $ $ $
Slide 9: Current Platform: Efficacy is Well Demonstrated
Current Platform: Efficacy is Well Demonstrated Highly De-risked Pipeline with >15,000 Patients Treated Globally In the U.S., RECELL is approved for acute thermal burns. Use of RECELL in other indications is either (1) limited by United States law to investigational use; or (2) otherwise prohibited.
Slide 10: > $46 Million in U.S. RECELL Revenue Since Approval
> $46 Million in U.S. RECELL Revenue Since Approval 78% Burn Sites Activated 87% Burn Surgeons Certified Accomplishments Since Approval Continued Strong Adoption Despite COVID Headwinds *Data is compiled based on information voluntarily provided by our customers and is subject to change. Procedures*
Slide 11: Broad commercial payer acceptance before full commercial launch
AVITA will ensure broad commercial payer acceptance & coverage before pursuing a full commercial launch This is a Medicare specific code, which we estimate covers ~ 15% of patient lives C1832: Autograft suspension, including cell processing and application, and all system components Code provides ad
Slide 12: New Ease of Use Device Submitted for FDA Approval
New Ease of Use Device Submitted for FDA Approval * Market Research March 2020 HCPs N=15 Only 1 Set of Hands Required in the Sterile Field; Steps Reduced By 1/3rd Reduced number of steps New Device Simplified Process Improved Usability 94% of users of the RECELL System believe it will reduce their w
Slide 13: FDA Approval in Pediatric Full-Thickness & Larger Burns
FDA Approval in Pediatric Full-Thickness & Larger Burns ~25% of all burns occur in children Instructions for Use. RECELL® Autologous Cell Harvesting Device NBR – National Burns Repository * N = 41, “will significantly or somewhat impact RECELL usage” 80% of RECELL Customers Stated that these New Lab
Slide 14: Japan – PMDA Review in the Final Phases
Furue M, Yamazaki S, Jimbow K, Tsuchida T, Amagai M, Tanaka T et al. Prevalence of dermatological disorders in Japan: a nationwide, cross-sectional, seasonal, multi-center, hospital-based study. J Dermatol. 2011 April; 38(4):310-20, Japan Health System Review, 2018. Additional estimates based on dat
Slide 15: Vitiligo: Unmet Need, No FDA-Approved Products
Vitiligo: Unmet Need, No FDA-Approved Products Advances in Vitiligo: An Update on Medical and Surgical Treatments. A. Dillon, et al. J Clin Aesth Derm. 2017. Willingness-to-Pay and Quality of Life in Patients with Vitiligo. Radtke, et al. BJD. 2009. SIGNIFICANT UNMENT NEED Up to 2% of the population
Slide 16: Vitiligo Study is Close to Completion
Blinded, Randomized, Study Evaluating RECELL for Repigmentation of Stable Vitiligo in 23 Patients Vitiligo Study is Close to Completion In the United States, RECELL is not approved for treatment of vitiligo. Patient from a Prior Study at 6 MONTHS RECELL-treated area was 100% re-pigmented RECELL trea
Slide 17: Early Completion of Soft Tissue Reconstruction Trial
Early Completion of Soft Tissue Reconstruction Trial Clinical trial demonstrates use of less donor skin without compromising healing outcomes relative to conventional autografting In the U.S., RECELL is approved for acute thermal burns. Use of RECELL in other indications is either (1) limited by Uni
Slide 18: Soft Tissue Synergies with Current Commercial Burn Focus
Soft Tissue Synergies with Current Commercial Burn Focus In the U.S., RECELL is approved for acute thermal burns. Use of RECELL in other indications is either (1) limited by United States law to investigational use; or (2) otherwise prohibited. In the United States, RECELL is not approved for use in
Slide 19: RECELL in Genetic Skin Defects and Rejuvenation
RECELL in Genetic Skin Defects and Rejuvenation CURRENT PLATFORM FUTURE PLATFORM Treatment using RECELL for harvesting and direct reintroduction of the patient’s own healthy skin cells RECELL as a platform for treatment using the patient’s corrected skin cells Patch of healthy skin removed from pati
Slide 20: Cell Based Gene Therapy Development Activity
Cell Based Gene Therapy Development Activity Study Objectives: Develop a ‘Spray-on’ suspension delivery system of modified cells and establish proof-of-concept Target IND-enablement by establishing preclinical evidence of safety and dosing Proof of Concept FDA Interaction IND-enabling Studies First-
Slide 21: Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa
Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa In the U.S., RECELL is approved for acute thermal burns. Use of RECELL in other indications is either (1) limited by United States law to investigational use; or (2) otherwise prohibited. THE CHALLENGE THE OPPORTUNITY DEBILITATING Skin frag
Slide 22: Exploring Novel RNA-Based Approach for Rejuvenation
Patented RNA technology for delivery of telomerase enzyme to aged cells Demonstrated reversal of aging and return of functionality in cells of progeria patients (human model of accelerated aging) Patented and proprietary Spray-On Skin Cells technology and device (RECELL) Expertise in skin regenerati
Slide 23: Corporate
Corporate
Slide 24: Financial Overview
12 Months Ended June 30 (USD in $000s) 2018 2019 2020 2021 Commercial Sales 929 5,474 14,263 21,483 BARDA Sales - - - 7,749 Total Revenue 929 5,474 14,263 29,232 Gross Profit 383 4,203 11,290 23,283 BARDA Income 7,734 5,921 3,926 2,055 Cash 10,986 20,174 73,639 110,746 $12.45 Share Price1 Financial
Slide 25: A Global Total of Granted Patents & Pending Applications
A Global Total of 56 Granted Patents & 26 Pending Applications Note: AVITA Medical owns granted patents in Austria, Australia, Belgium, Brazil, France, Germany, Hong Kong, Italy, Japan, Netherlands, Portugal, Spain, Sweden, Turkey, United Kingdom and USA. AVITA Medical owns pending patent applicatio
Slide 26: Value Creation Events: Looking Forward
Quarters referenced in calendar year. As of January 1, 2022 Avita Medical will report on a calendar year basis. Value Creation Events: Looking Forward Projected Key Milestones Vitiligo Pivotal Trial Last Patient Enrolled / Vitiligo Commercial launch Last patient enrolled in Soft Tissue Trial / Soft
Slide 27: Risk factors
There are numerous risk factors involved with the Company’s business. Some of these risks can be mitigated by the use of safeguards and appropriate systems and controls, but some are outside the control of the Company and cannot be mitigated. Accordingly, an investment in the Company carries no guar
Slide 28: Indications for Use
INDICATIONS FOR USE: The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous RES® Regenerative Epidermal Suspension f
Slide 29: Revolutionary treatment using a patient’s own skin for life-changing outcomes In the U.S., RECELL
Revolutionary treatment using a patient’s own skin for life-changing outcomes In the U.S., RECELL is approved for acute thermal burns. Use of RECELL in other indications is either (1) limited by United States law to investigational use; or (2) otherwise prohibited.