Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Q1 2022 Earnings Presentation
41 slides from Avita Medical's earnings presentation, May 17, 2022
Slide 1: One Platform.
One Platform. May 2022 NASDAQ: RCEL ASX: AVH
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: Transforming Lives with Skin Regeneration
RECELL® System: FDA approved for the treatment of acute thermal burns Proprietary Spray-On SkinTM offers life changing benefits Point of care technology that is safe & effective Published health economic model demonstrating hospital cost savings Deep scientific and clinical pedigree 2 randomized con
Slide 4: 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 5: Value Creation: Key Accomplishments and Milestones
First Quarter 2022 Revenue Growth of +61% YoY FDA Approval of New “Ease of Use” RECELL Device Vitiligo Pivotal Trial: Enrollment Complete Soft Tissue Pivotal Trial: Enrollment Completed TPT Payment Created by CMS for Hospital Outpatient Setting PMDA Approval of Burns in Japan Initial Proof of Concep
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 LAUNCH Regenerative Therapeutics – Wounds & Dermatology (Current Platform) Acute Thermal Burns (U.S.) RECELL® Japan Vitiligo (U.S.) Soft Tissue Reconstruction (U.S.) Early-Stage
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: Thermal Burns: U.S. Target Market Expanded
Thermal Burns: U.S. Target Market Expanded to Include Small Burns and Outpatient Outpatient Pass Through 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) Targe
Slide 11: New C-Code Provides Additional Payment in Outpatient Setting
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 Now FDA Approved
New Ease of Use Device Now FDA Approved * Market Research March 2020 HCPs Only 1 Set of Hands Required in the Sterile Field; Steps Reduced By 33% Reduced number of steps New Device Simplified Process Improved Usability 94% of surveyed users of the RECELL System believe it will reduce their workload/
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: Approval of Burns Received in Japan
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: High Unmet Need, No FDA-Approved Products
Vitiligo: High 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 UNMET NEED Up to 2% of the popula
Slide 16: Vitiligo Study Enrollment Complete
Blinded, Randomized, Study Evaluating RECELL for Repigmentation of Stable Vitiligo Vitiligo Study Enrollment Complete 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 Contr
Slide 17: RECELL Case: Repigmentation of the Nipple-Areola Complex
RECELL Case: 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 In the United States, RECELL is not approved for use with patients suffering vitiligo. Established Track Record
Slide 18: Soft Tissue Repair Will Expand the Burns Business
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 19: 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 20: 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 21: 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 22: Cell and Gene Therapy Development Activity
Cell and Gene Therapy Development Activity Program Objective: Optimize Spray-On Skin™ Cells with modified skin cells and establish IND-readiness Proof of Concept FDA Interaction IND-enabling Studies First-in-human (IND) Four key steps
Slide 23: Sizeable Market Opportunity Estimated in EB
1. Has et al, “Consensus reclassification of inherited epidermolysis bullosa and other disorders with skin fragility.” Br J of Dermatology. 2020. Range 1,100-2,500. 2. DEB prevalence estimated as 6/million. RDEB estimated to be approximately half of DEB prevalence = 3/million. Range: 1.35- 8/million
Slide 24: Skin Regeneration from Corrected Autologous Skin Cell Suspension
100 µm Skin Regeneration from Corrected Autologous Skin Cell Suspension Immunocompromised mouse model Full-thickness injury created Recapitulated human dermis Application of corrected cells Correction of RDEB Single-Site Mutation In Vivo Evaluation of Gene-corrected Skin Cells New, healthy skin rege
Slide 25: 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 26: Reverse Aging of Skin Cells Derived using the RECELL Device
Reverse Aging of Skin Cells Derived using the RECELL Device 2 hrs 24 hrs Successful delivery of mRNA-hTERT & expression in Skin Cells Derived from RECELL Skin cells harvested from RECELL Device Telomerase Point-of-Care hTERT modification Immunocompromised mouse model Full-thickness injury created Re
Slide 27: 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 regenerat
Slide 28: Corporate
avita Corporate
Slide 29: Financial Overview
Financial Overview 1. RCEL as 2/25/2022 NASDAQ ticker symbol: RCEL ASX ticker symbol: AVH Analysts Matt O'Brien, Piper (U.S.) Josh Jennings, Cowen (U.S.) Ryan Zimmerman, BTIG (U.S.) Chris Kallos, MST (AUS) John Hester, Bell Potter (AUS) Shane Storey, Wilsons (AUS) Brooks O’Neil, Lake Street (U.S.) L
Slide 30: A Global Total of Granted Patents & Pending Applications
A Global Total of 19 Granted Patents & 23 Pending Applications AVITA Medical owns granted patents in USA, China, Japan, Australia, France, Germany, Italy, Spain, United Kingdom, Brazil and Hong Kong, as well as pending patent applications in USA, China, Canada, EPO, Brazil, and Hong Kong. ROBUST PRO
Slide 31: 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 32: Value Creation: Key Accomplishments and Milestones
First Quarter 2022 Revenue Growth of +61% YoY FDA Approval of New “Ease of Use” RECELL Device Vitiligo Pivotal Trial: Enrollment Complete Soft Tissue Pivotal Trial: Enrollment Completed TPT Payment Created by CMS for Hospital Outpatient Settings PMDA Approval of Burns in Japan Initial Proof of Conce
Slide 33: 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 34: Indications for Use and Contraindications
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 35: 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.
Slide 36: RECELL Process for Autologous Cell Harvesting and Application
1 HARVEST INCUBATE RINSE DISAGGREGATE FILTER APPLY RECELL Process For Autologous Cell Harvesting and Application 2 3 4 5 6
Slide 37: RECELL Spray-On Skin Treats 80cm2 from 1cm2 Biopsy
RECELL Spray-On SkinTM Treats 80cm2 of Skin from a 1cm2 Biopsy Cell Harvesting Device that delivers Spray-On Skin Cells within 30 minutes at the point of care AUTOLOGOUS RECELL DONOR SITE SPLIT-THICKNESS SKIN GRAFT DONOR SITE Fresh (non-cultured cells) with the “free edge healing cascade” ACTIVATED
Slide 38: Pivotal Trial Results in Second- and Third-Degree Burns
Published in JBCR and Presented at ABA Published in Burns and Presented at ABA Pivotal Trial #1 (101 Patients) RECELL (alone) versus SoC (STSG) in Second-Degree Burns Pivotal Trial #2 (31 Patients) RECELL (with widely expanded graft) versus STSG in Third-Degree Burns Significant Drop in Donor Skin R
Slide 39: RECELL Free Edge Advantage
RECELL “Free Edge” Advantage Healing Process without RECELL Free edge limits signaling to wound boundary (i.e. outside → in) Healing Process with RECELL Spray-On Skin Cells signal from within the wound (i.e. inside → out)
Slide 40: Skin Injury Framework
Skin Injury Framework Wound Depth Superficial Wound Superficial Partial Thickness Wound Full Thickness Wound Deep Partial Thickness Wound 1st degree 2nd degree 2nd degree 3rd degree TARGET INJURY Wound Size 0-9.9%* 10-19.9% 20-29.9% 30-39.9% 40%+ Total Body Surface Area (TBSA) Affected Small / Parti
Slide 41: Transforming Care
Transforming Care Can reduce costs and accelerate recovery by decreasing the number of painful procedures and length of stay in hospital 30% Reduction in Length of Stay (LOS)¹ 35% Fewer Procedures² 30% Cost Savings² Fewer procedures and faster healing times get patients home more quickly Reduced don