Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Investor Presentation (August 2021)
28 slides from Avita Medical's investor presentation, Aug 27, 2021
Slide 1: AVITA Medical Corporate Presentation August 2021
For personal use only August 2021 NASDAQ: RCEL ASX: AVH ©Copyright 2021 AVITA Medical. All Rights Reserved.
Slide 2: Legal Disclaimers
Legal Disclaimers For personal use only 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
AVITA Leadership Team For personal use only Dr. Michael S. Perry Michael Holder Erin Liberto Andrew Quick Kathy McGee Dona 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 Affiliatio
Slide 4: Value Creation
Value Creation For personal use only Key Accomplishments Projected Key Milestones • RECELL® commercial revenue growth of +45% • Japan PMDA Approval Q4 21 vs prior quarter • EB: Initial proof of concept for delivery of Q4 21 • Cumulative U.S. commercial sales since genetically modified cells in suspe
Slide 5: One Platform. Endless Possibilities.
One Platform. Endless Possibilities. For personal use only 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
Focused Pipeline with Strong Growth Potential For personal use only 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 Market
Current Platform Enables Access to a Large Serviceable Market For personal use only FUTURE MARKETS ~$1.5B Efficacy Well Demonstrated Patients Publications & (in studies) Presentations ~$450M BURNS 1,656 172 DEFECTS/ ~$750M VITILIGO 435 56 CURRENT ACUTE INDICATION WOUNDS 71 24 ~$260M Total Highly De-
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 For personal use only 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
Strong Adoption of the RECELL System Accomplishments Since For personal use only 700 300 Approval 600 250 500 85% Burn 200 Surgeons Procedures* Certified Sites/Surgeons 400 150 300 77% 100 Burn Sites 200 Activated 50 100 0 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 ~4,000 CY18 CY19 CY19 CY19 CY19 CY20 CY20
Slide 11: Now Approved in Pediatric Full-Thickness Burns & Larger TBSAs
Now Approved in Pediatric Full-Thicken Burns & Larger TBSAs For personal use only 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
Japan Is an Attractive Opportunity for AVITA Medical For personal use only KEY PATIENT POPULATIONS IN JAPAN Burn Vitiligo Trauma ~6,000 ~2 million ~22,000 Patients treated Patients Suffer RECELL Eligible Trauma Patients severe burns per year from Vitiligo • March 3, 2019, AVITA Medical and COSMOTEC
Slide 13: Vitiligo: Unmet Need, No FDA-Approved Products
Vitiligo: Unmet Need, No FDA-Approved Products For personal use only SIGNIFICANT UNMENT NEED LIMITED TREATMENT OPTIONS DRUGS AND PHOTOTHERAPY SURGICAL Up to 2% of the Medical Phototherapy Skin grafting management population affected For disease For disease For repigmentation of (~6.5M in the US) sta
Slide 14: New Vitiligo Study Design Shortens Pathway to Completion
New Vitiligo Study Design Shortens Pathway to Completion Blinded, Randomized, Study Evaluating RECELL for For personal use only AT 6 MONTHS Repigmentation of Stable Vitiligo in 23 Patients RECELL-treated area was 100% re-pigmented • New design focuses on 1:20 donor expansion, using less donor skin f
Slide 15: RECELL Case Study: Repigmentation of the Nipple-Areola Complex
RECELL Case Study: Repigmentation of the Nipple-Areola Complex after Breast Treatment For personal use only 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
Significant Market Opportunity in Repigmenting Stable Vitiligo For personal use only OPPORTUNITY ESTIMATION MARKET TAILWINDS Payers with coverage for vitiligo treatments (e.g., phototherapy) TOTAL MARKET Growing 4.5M Prevalence of Vitiligo in the United States reimbursement (range 3-6.5 million) (up
Slide 17: Soft Tissue Reconstruction Trial Enrollment is Gaining Momentum
Soft Tissue Reconstruction Trial Enrollment is Gaining Momentum Clinical trial demonstrates use of less donor skin without compromising healing Patient treated for necrotizing fasciitis. For personal use only outcomes relative to conventional autografting TREATMENT DAY RECELL® Soft Tissue Study 20 N
Slide 18: Soft Tissue Repair: Synergistic with Current Commercial Focus
Soft Tissue Repair: Synergistic with Current Commercial Focus For personal use only Same Unmet Needs as Same Treatment Reimbursement in Burns Protocol to Burns Place Future Target: 366 Total Centers Reduction of donor site Consistent treatment Able to leverage existing morbidity & donor site protoco
Slide 19: RECELL in Genetic Skin Defects and Rejuvenation
RECELL in Genetic Skin Defects and Rejuvenation For personal use only 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 20: Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa
Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa For personal use only THE CHALLENGE THE OPPORTUNITY Preclinical research partnership underway, exploring the combination of a novel gene correction approach with AVITA Medical’s Spray-On SkinTM Cells technology DEBILITATING AVITA AND GATES
Slide 21: Exploring Novel RNA-Based Approach for Rejuvenation
Exploring Novel RNA-Based Approach for Rejuvenation For personal use only 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 22: Corporate
For personal use only Corporate
Slide 23: Financial Overview
Financial Overview For personal use only 12 Months Ended June 30 $18.43 (USD in $000s) 2018 2019 2020 2021 Share Price1 Commercial Sales 929 5,474 14,263 21,483 BARDA Sales - - - 7,749 $459 Million Total Revenue 929 5,474 14,263 29,232 Market Capitalization1 Gross Profit 383 4,203 11,290 23,283 BARD
Slide 24: A Global Total of Granted Patents & Pending Applications
A Global Total of 56 Granted Patents & 26 Pending Applications EXPANDING PORTFOLIO TO SUPPORT CURRENT AND For personal use only ROBUST PROTECTION ACROSS PATENT FAMILIES FUTURE INDICATIONS Cell Suspension Commercial RECELL device, composition of Next Generation RECELL devices to improve ease of Prepa
Slide 25: Value Creation
Value Creation For personal use only Key Accomplishments Projected Key Milestones • RECELL® commercial revenue growth of +45% • Japan PMDA Approval Q4 21 vs prior quarter • EB: Initial proof of concept for delivery of Q4 21 • Cumulative U.S. commercial sales since genetically modified cells in suspe
Slide 26: For personal use only
Revolutionary For personal use only 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
Slide 27: Risk Factors and Disclosures
Risk Factors and Disclosures For personal use only • 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
Important Safety Information For personal use only • 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