Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Investor Presentation (November 2021)
29 slides from Avita Medical's investor presentation, Nov 12, 2021
Slide 1: One Platform, Endless Possibilities
Exhibit 99.2 medical One Platform Endless Possibilities November 2021 NASDAQ: RCEL ASX: AVH I f j ; Se Cl
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: 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 4: Value Creation: Key Accomplishments and Projected Milestones
Quarters referenced in calendar year. As of January 1, 2022 Avita Medical will report on a calendar year basis. Value Creation Recent Key Accomplishments Projected Key Milestones Vitiligo Pivotal Trial Last Patient Enrolled / Vitiligo Commercial launch Last patient enrolled in Soft Tissue Trial / So
Slide 5: One Platform. Endless Possibilities.
One Platform. Endless Possibilities. RECELL enables regeneration of healthy skin Patch of healthy skin removed from patient Healthy skin processed using the RECELL System Autologous skin cells are sprayed on patient RECELL delivers healthy skin cells Free cells modulate and catalyze the healing proc
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: Current Platform Enables Access to a Large Serviceable Addressable Market
CURRENT INDICATION Total Potential Opportunity ~$1.5B Thermal Burns Trauma Vitiligo FUTURE MARKETS ~$750M ~$450M Current Platform Enables Access to a Large Serviceable Addressable Market (SAM) A common goal: Full skin restoration (Re-epithelialization and re-pigmentation) Highly De-risked Pipeline w
Slide 9: Thermal Burns: U.S. Target Market Expanded to Include Small Burns and Outpatient
Thermal Burns: U.S. Target Market Expanded to Include Small Burns and Outpatient Outpatient Pass Thru Code Opens Doors to Small Burns and Expands Serviceable Market Opportunity Total Annual Burns in the U.S. Severe Burns (as defined as burns > 5% Body Surface Area that may require grafting) Target:
Slide 10: Strong Adoption of the RECELL System
78% Burn Sites Activated 87% Burn Surgeons Certified Accomplishments Since Approval Strong Adoption of the RECELL System *Data is compiled based on information voluntarily provided by our customers and is subject to change. Procedures* Sites/Surgeons > $46 Million in U.S. RECELL Revenue Since Approv
Slide 11: Now Approved in Pediatric Full-Thickness Burns & Larger TBSAs
1. Instructions for Use. RECELL® Autologous Cell Harvesting Device * N = 41, “will significantly or somewhat impact RECELL usage” Fewer procedures required for definitive closure vs conventional autograft1 80% of RECELL Customers Stated that the New Label Enhancements Will Positively Impact Their Us
Slide 12: Japan Is an Attractive Opportunity for AVITA Medical
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 13: 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 14: New Vitiligo Study Design Shortens Pathway to Completion
New Vitiligo Study Design Shortens Pathway 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 treated Negative Control Komen L, Vrijman C, Tjin EP, Krebbers G, de Rie MA, Luiten
Slide 15: RECELL Case Study: Repigmentation of the Nipple-Areola Complex
Yu et al. Repigmentation of nipple-areola complex after RECELL® treatment on breast vitiligo. Journal of Cosmetic Dermatology, 2021 RECELL Case Study: Repigmentation of the Nipple-Areola Complex after Breast Treatment Established Track Record in Vitiligo: 1,000 patients treated internationally & 12
Slide 16: Significant Market Opportunity in Repigmenting Stable Vitiligo
Significant Market Opportunity in Repigmenting Stable Vitiligo OPPORTUNITY ESTIMATION MARKET TAILWINDS Concentrated HCP base: Estimating <1,000 procedural dermatologists and plastic surgeons with interest in treating vitiligo SAM $750 Million TAM $5.2 Billion 4.5M (range 3-6.5 million) TOTAL MARKET
Slide 17: Soft Tissue Reconstruction Trial Enrollment is Gaining Momentum
COVID19 IMPACT Soft Tissue Reconstruction Trial Enrollment is Gaining Momentum N=65 TREATMENT DAY Patient treated for necrotizing fasciitis. 1 YEAR POST-RECELL TREATMENT Clinical trial demonstrates use of less donor skin without compromising healing outcomes relative to conventional autografting In
Slide 18: Soft Tissue Efforts are Synergistic with Current Commercial Burn Focus
Soft Tissue Efforts are Synergistic 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 appro
Slide 19: Soft Tissue Repair Will Expand the Burns Business to All Acute Wounds
Soft Tissue Repair Will Expand the Burns Business to Encompass All Acute Wounds 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
Slide 20: 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 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 $19.66 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: Key Accomplishments and Projected Milestones
Quarters referenced in calendar year. As of January 1, 2022 Avita Medical will report on a calendar year basis. Value Creation Recent Key Accomplishments Projected Key Milestones Vitiligo Pivotal Trial Last Patient Enrolled / Vitiligo Commercial launch Last patient enrolled in Soft Tissue Trial / So
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 and Safety Information
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
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.
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