Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Investor Presentation (November 2021)
29 slides from Avita Medical's investor presentation, Nov 9, 2021
Slide 1: AVITA Medical Corporate Presentation November 2021
For personal use only November 2021 NASDAQ: RCEL ASX: AVH ©Copyright 2021 AVITA Medical. All Rights Reserved.
Slide 2: Legal Disclaimers
For personal use only Legal Disclaimers 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
Slide 3: AVITA Leadership Team
For personal use only AVITA Leadership Team Dr. Michael S. Perry Michael Holder Erin Liberto Andrew Quick Kathy McGee Donna Shiroma CEO CFO CCO CTO COO General Counsel >30 years experience >30 years experience >20 years experience >25 years experience >25 years experience >20 years experience Affili
Slide 4: Value Creation
For personal use only Value Creation Recent Key Accomplishments Projected Key Milestones • Soft Tissue Pivotal Trial: 89% Enrolled • Vitiligo Pivotal Trial Last Patient Enrolled / Q4 21 / • Vitiligo Pivotal Trial: Enrollment 70% Completed or Vitiligo Commercial launch H2 23 Scheduled • Last patient
Slide 5: One Platform. Endless Possibilities.
For personal use only One Platform. Endless Possibilities. RECELL enables Vitiligo RECELL delivers healthy skin cells regeneration of healthy skin Trauma Autologous skin cells are sprayed on patient Burns / Scalds Chronic Wounds Scar Revision Healthy skin processed using the RECELL System Infectious
Slide 6: Development Pipeline and Growth Potential
For personal use only Development Pipeline and Growth Potential
Slide 7: Focused Pipeline with Strong Growth Potential
For personal use only Focused Pipeline with Strong Growth Potential 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 Research Pr
Slide 8: Current Platform Enables Access to a Large Serviceable Addressable Market (SAM)
Current Platform Enables Access to a Large For personal use only Serviceable Addressable Market (SAM) FUTURE MARKETS ~$1.5B Efficacy Well Demonstrated Patients Publications & (in studies) Presentations ~$450M BURNS 1,690 181 DEFECTS/ ~$750M VITILIGO 453 57 CURRENT ACUTE INDICATION WOUNDS 82 25 ~$260
Slide 9: Thermal Burns: U.S. Target Market Expanded to Include Small Burns and Outpatient
Thermal Burns: U.S. Target Market Expanded to For personal use only Include Small Burns and Outpatient Patient Funnel and Addressable Market U.S. RECELL Commercial Sales Since Approval 8,000 ~486K Total Annual Burns in the U.S. PATIENTS 7,000 6,000 >$600 Million TAM ~80K Severe Burns (as defined as
Slide 10: Strong Adoption of the RECELL System
For personal use only Strong Adoption of the RECELL System 700 300 Accomplishments Since Approval 600 250 500 87% Burn 200 Surgeons Procedures* Certified Sites/Surgeons 400 150 300 78% 100 Burn Sites 200 Activated 50 100 0 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 >4,500 CY18 CY19 CY19 CY19 CY19 CY20 CY
Slide 11: Now Approved in Pediatric Full-Thickness Burns & Larger TBSAs
For personal use only Now Approved in Pediatric Full-Thickness Burns & Larger TBSAs Fewer procedures required for definitive closure vs conventional autograft1 5.9 3.6 Control 2.4 1.6 RECELL Pediatric Patients Adults with >50% TBSA 56% fewer mean 60% fewer mean procedures with procedures with RECELL
Slide 12: Japan Is an Attractive Opportunity for AVITA Medical
For personal use only Japan Is an Attractive Opportunity for AVITA Medical Background • March 3, 2019, AVITA Medical and COSMOTEC Company, Ltd, an M3 Group company, Patient Funnel and Addressable Market announced agreement to market and distribute the RECELL System. ~250,000 Incidence of Burns Needi
Slide 13: Vitiligo: Unmet Need, No FDA-Approved Products
For personal use only Vitiligo: Unmet Need, No FDA-Approved Products SIGNIFICANT UNMENT NEED LIMITED TREATMENT OPTIONS Up to 2% of the Phototherapy population affected (~6.5M in the US) • • 2-3 treatments / week for a few months to over a year Typically combined with a topical drug • Not Durable No
Slide 14: New Vitiligo Study Design Shortens Pathway to Completion
For personal use only New Vitiligo Study Design Shortens Pathway to Completion Blinded, Randomized, Study Evaluating RECELL for Repigmentation of Stable Vitiligo in 23 Patients Patient from a Prior Study at 6 MONTHS RECELL-treated area was 100% re-pigmented RECELL® Vitiligo Study 25 N=23 20 Number o
Slide 15: RECELL Case Study: Repigmentation of the Nipple-Areola Complex after Breast Treatment
RECELL Case Study: Repigmentation of the Nipple-Areola For personal use only Complex after Breast Treatment Before RECELL® 12 months After RECELL® • 23 year old female with vitiligo. • Donor skin was harvested from adjacent unaffected areas. • Dermabrasion of the vitiligo patches was performed to th
Slide 16: Significant Market Opportunity in Repigmenting Stable Vitiligo
For personal use only Significant Market Opportunity in Repigmenting Stable Vitiligo OPPORTUNITY ESTIMATION MARKET TAILWINDS Payers with coverage for vitiligo treatments TOTAL MARKET (e.g., phototherapy) 4.5M Prevalence of Vitiligo in the United States Growing (range 3-6.5 million) reimbursement (up
Slide 17: Soft Tissue Reconstruction Trial Enrollment is Gaining Momentum
Soft Tissue Reconstruction Trial Enrollment is For personal use only Gaining Momentum Clinical trial demonstrates use of less donor skin without compromising healing Patient treated for necrotizing fasciitis. outcomes relative to conventional autografting TREATMENT DAY RECELL® Soft Tissue Study 20 N
Slide 18: Soft Tissue Efforts are Synergistic with Current Commercial Burn Focus
For personal use only Soft Tissue Efforts are Synergistic with Current Commercial Burn Focus 136 Burn Centers ~50% of Burn Centers are (Current Target) Expanded Acute Wounds also Level 1 / Level 2 Sales Team Will Target a Trauma Accounts Total of 366 Centers +230 High Volume Trauma Centers (Future E
Slide 19: Soft Tissue Repair Will Expand the Burns Business to Encompass All Acute Wounds
Soft Tissue Repair Will Expand the Burns Business For personal use only to Encompass All Acute Wounds Female, pregnant 28 year old who suffered from a de-gloving Injury OPPORTUNITY ESTIMATION Post Debridement of Injury TOTAL MARKET Open wounds >4.5M presented at the Emergency patients Department 6 M
Slide 20: RECELL in Genetic Skin Defects and Rejuvenation
For personal use only RECELL in Genetic Skin Defects and Rejuvenation CURRENT PLATFORM FUTURE PLATFORM Treatment using RECELL for harvesting and direct reintroduction of the RECELL as a platform for treatment using the patient’s patient’s own healthy skin cells corrected skin cells Autologous skin c
Slide 21: Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa
For personal use only Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa Preclinical research partnership underway with Gates Center for Regenerative Medicine (University of Colorado), exploring the combination of a novel gene correction approach with AVITA Medical’s Spray-On SkinTM Cells t
Slide 22: Exploring Novel RNA-Based Approach for Rejuvenation
Exploring Novel RNA-Based Approach For personal use only for Rejuvenation Multi-Billion Dollar Market Presents a Sizeable Opportunity • >$16.5B spent in aesthetic procedures per year (US)* • >3M aesthetic procedures per year (US) aimed to improve skin tightness, texture & evenness in skin tone* • Co
Slide 23: Corporate
For personal use only Corporate
Slide 24: Financial Overview
For personal use only Financial Overview 12 Months Ended June 30 $19.66 (USD in $000s) 2018 2019 2020 2021 Share Price1 Commercial Sales 929 5,474 14,263 21,483 BARDA Sales - - - 7,749 $480 Million Total Revenue 929 5,474 14,263 29,232 Market Capitalization1 Gross Profit 383 4,203 11,290 23,283 BARD
Slide 25: A Global Total of Granted Patents & Pending Applications
For personal use only A Global Total of 56 Granted Patents & 26 Pending Applications EXPANDING PORTFOLIO TO SUPPORT CURRENT AND ROBUST PROTECTION ACROSS PATENT FAMILIES FUTURE INDICATIONS Cell Suspension Commercial RECELL device, composition of Next Generation RECELL devices to improve ease of Prepa
Slide 26: Value Creation
For personal use only Value Creation Recent Key Accomplishments Projected Key Milestones • Soft Tissue Pivotal Trial: 89% Enrolled • Vitiligo Pivotal Trial Last Patient Enrolled / Q4 21 / • Vitiligo Pivotal Trial: Enrollment 70% Completed or Vitiligo Commercial launch H2 23 Scheduled • Last patient
Slide 27: Risk Factors and Disclosures
For personal use only Risk Factors and Disclosures • 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. Acco
Slide 28: Important Safety Information
For personal use only Important 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 prepar
Slide 29: For personal use only
For personal use only Revolutionary treatment using a patient’s own skin for life-changing outcomes Zed, treated with the RECELL® System NASDAQ CM: RCEL ASX: AVH © 2020 . All rights reserved. In the U.S., RECELL is approved for acute thermal burns. Use of RECELL in other indications is either (1) li
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