Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Investor Presentation (September 2022)
22 slides from Avita Medical's investor presentation, Sep 20, 2022
Slide 1: Investor Webinar Briefing September 20, 2022
Investor Webinar Briefing September 20, 2022 (U.S.) / September 21, 2022 (AU) NASDAQ: RCEL ASX: AVH ©Copyright 2022 AVITA Medical. All Rights Reserved.
Slide 2: Legal Disclaimers
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 presentation, includi
Slide 3: Transforming Lives with Skin Restoration
Transforming Lives with Skin Restoration AVITA MEDICAL OVERVIEW Regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration Patented RECELL® technology, a new treatment paradigm for burn injuries Leverag
Slide 4: Why AVITA Medical?
Why AVITA Medical? Strong IP Estate World-Class Executive Team Total of 19 granted patents, 25 pending applications, Executive management team has 150+ years of and automated devices in development with 01 experience with proven track records across medical associated established IP protection devic
Slide 5: Year in Review: Continued Growth and Expansion
Year in Review: Continued Growth and Expansion Recent Accomplishments Strong U.S. RECELL Commercial Growth • Commercial Revenue Growth: 9,000 • Year-to-date 2022: +39% year-over-year 8,000 • Second Quarter 2022: +23% same quarter prior year 7,000 • New “Ease of Use” RECELL Device: 6,000 • FDA approv
Slide 6: Strong Adoption of RECELL Reflected in Key Leading Indicators
Strong Adoption of RECELL Reflected in Key Leading Indicators 800 300 Accomplishments Since Approval 700 250 600 93% Burn 200 Surgeons Procedures* 500 Certified Sites/Surgeons 400 150 300 100 84% Burn Sites 200 Activated 50 100 0 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 ~6,5000 CY18 CY19 CY19
Slide 7: New Ease of Use Device FDA Approved & Launched
New Ease of Use Device FDA Approved & Launched New Device Reduced Simplified Improved number of steps Process Usability 94% of surveyed users of the RECELL System believe it will reduce their workload/allow them to perform other duties* Steps Reduced By 33% * Market Research March 2020 HCPs 7
Slide 8: Approval of Burns and Favorable Reimbursement in Japan
Approval of Burns and Favorable Reimbursement in Japan BACKGROUND PATIENT FUNNEL - BURNS ADDRESSABLE MARKET * COMMERCIAL PARTNER: COSMOTEC, an M3 Company ~250,000 Incidence of Burns Needing Medical Treatment in Japan PATIENTS INDICATION: Burns Additional Indication(s) to Follow Based on U.S. Pivotal
Slide 9: Acute Traumatic Wound Opportunity
Acute Traumatic Wound Opportunity Female, pregnant 28-year-old who OPPORTUNITY ESTIMATION suffered from a de-gloving injury TOTAL MARKET >4.5M Open wounds presented at the Emergency patients Department POST DEBRIDEMENT OF INJURY TOTAL ADDRESSABLE MARKET TAM >140K RECELL eligible trauma procedures $1
Slide 10: Acute Traumatic Wounds Indication on Track for FDA Submission
Acute Traumatic Wounds Indication on Track for FDA Submission Patient treated for necrotizing fasciitis Effectiveness Data As seen with burns treatment with RECELL, the study confirms use of less donor skin relative to the standard of care control (conventional skin grafting) Safety Data TREATMENT D
Slide 11: Vitiligo Opportunity
Vitiligo Opportunity OPPORTUNITY ESTIMATION Patient from a prior study at 6 months RECELL-treated area was 100% re-pigmented TOTAL MARKET 4.5M Prevalence of Vitiligo in the United States (range 3-6.5 million) TOTAL ADDRESSABLE RECELL treated MARKET Prevalence of Stable TAM $5.2 Billion 1.3M Vitiligo
Slide 12: Vitiligo Indication on Track for FDA Submission
Vitiligo Indication on Track for FDA Submission Primary Endpoint Effectiveness Data Proportion of study sites achieving Study achieved its primary effectiveness ≥80% repigmentation for RECELL- treated sites vs Control at Week 24 endpoint of super-superiority A B Treatment Safety Data Laser ablation
Slide 13: New RECELL Device: Automated
New RECELL Device: Automated KEY UPDATES • New RECELL Automated Device in development for Vitiligo: • FDA Submission expected in H2 2023 • FDA Approval expected in H2 2024 • Protected by issued patents in the U.S. and certain other countries for automated device which provides a further barrier to e
Slide 14: Summary: Focused Pipeline with Strong Growth Potential
Summary: Focused Pipeline with Strong Growth Potential 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 Research Programs
Slide 15: Projected Key Milestones
Projected Key Milestones Platform Expansion and Automation Vitiligo: • FDA Submission H2 2022 • FDA Approval H2 2023 Soft Tissue: • FDA Submission H2 2022 • FDA Approval H2 2023 Automated Vitiligo Device: • FDA Submission H2 2023 • FDA Approval H2 2024 15
Slide 16: Current Platform Has Significant Market Opportunity
Current Platform Has Significant Market Opportunity $ 0.6B Burns $5.2B Vitiligo $1B Acute Traumatic ~$6.8B Opportunity Wounds ~ $7 Billion in Combined TOTAL ADDRESSABLE MARKET 16
Slide 17: Corporate
avita Corporate
Slide 18: Financial Overview
Financial Overview Unaudited 12 Months Unaudited 3 Months 12 Months Ended June 30 Ended December 31 Ended June 30 (USD in $000s) 2018 2019 2020 2021 2020 2021 2021 2022 Commercial Sales 929 5,474 14,263 21,483 17,918 25,091 6,699 8,242 BARDA Sales - - - 7,749 - 7,934 3,605 93 Total Revenue 929 5,474
Slide 19: AVITA Leadership Team
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 Affiliations: Affiliations:
Slide 20: Risk Factors and Disclosures
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. Accordingly, an investment
Slide 21: Important Safety Information
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 prepare autologous RES® Rege
Slide 22: Revolutionary treatment using a patient's own skin
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) limited by United States
AVITA Medical — Investor Presentation (September 2022) on 6ix