Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — 39th Annual J.P. Morgan Healthcare Conference (January 2021)
50 slides from Avita Medical's conference presentation, Jan 12, 2021
Slide 1: 39th Annual J.P. Morgan Healthcare Conference
For personal use only 39th Annual J.P. Morgan Healthcare Conference January 12, 2020 NASDAQ: RCEL ASX: AVH ©Copyright 2021 AVITA Medical. All Rights Reserved.
Slide 2: Forward-Looking Statement
Forward-Looking Statement For personal use only This presentation is made available by AVITA Medical, Inc. (“AVITA”, “the Company”, or “we”). It is intended to provide background information only, and may not be reproduced or redistributed in whole or in part nor may its contents be disclosed to any
Slide 3: AVITA Medical: Investment Highlights
AVITA Medical: Investment Highlights RECELL System: FDA approved for the treatment of acute thermal burns For personal use only • Proprietary Spray-On SkinTM Cells offers life changing benefits Point of care technology that is safe & effective • Published health economic model demonstrates hospital
Slide 4: 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 5: First Indication: Thermal Burns
First Indication: Thermal Burns Current Standard of Care Is Suboptimal and Expensive SPLIT-THICKNESS SKIN GRAFTS (STSG) ARE THE STANDARD OF CARE (SoC) For personal use only Harvesting skin from donor site for Donor site wound created while Typical SoC donor site scar 52 weeks STSG harvesting skin fo
Slide 6: RECELL Spray-On Skin
RECELL Spray-On Skin Treats 80cm2 of Skin from a 1cm2 Biopsy For personal use only AUTOLOGOUS COMPLETE Cell Harvesting Device that delivers Full range of skin cell types with Spray-On Skin Cells within 30 re-pigmentation minutes at the point of care SPLIT-THICKNESS SKIN GRAFT DONOR SITE ACTIVATED SA
Slide 7: 1st Premarket Approval Treatment in Burns in Years
1st Premarket Approval Treatment in Burns in 20 Years Dual multi-center, randomized, controlled premarket approval studies For personal use only Pivotal Trial #1 (101 Patients) Pivotal Trial #2 (31 Patients) RECELL (alone) versus SoC (STSG) in RECELL (with widely expanded graft) versus STSG in Secon
Slide 8: RECELL "Free Edge" Advantage
RECELL “Free Edge” Advantage For personal use only Healing Process without RECELL Healing Process with RECELL Free edge limits signaling Spray-On Skin Cells signal to wound boundary from within the wound (i.e. outside → in) (i.e. inside → out) • The wound boundary acts as a “free edge” between injur
Slide 9: RECELL Delivers Life-Changing Outcomes
RECELL Delivers Life-Changing Outcomes Case series presented at 50th Annual ABA Meeting (2018) 1 Year For personal use only Treatment Day Day 7 Day 21 3 Months 1 Year • Compassionate Use case • Reintroduction of melanocytes resulted in an excellent cosmetic outcome • 12-year-old girl with 2nd-degree
Slide 10: Published Health Economic Model
Published Health Economic Model: Demonstrates Patient and Health Care System Benefits RECELL saves the hospital money in all in-patient scenarios where the burn is For personal use only 10% Total Body Surface Area (TBSA) or greater Transforming Care Reduces costs and accelerates recovery by decreasi
Slide 11: Development Pipeline and Growth Potential
For personal use only Development Pipeline and Growth Potential
Slide 12: 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 Adults (U.S.) Burns and Wounds (Japan) Vitiligo (U.S.) Soft Tissue Reconstruction (U.S.) Pedia
Slide 13: Current De-Risked Platform Enables Access to a Large Serviceable Market
Current De-Risked Platform Enables Access to a Large Serviceable Market For personal use only FUTURE MARKETS >$1.5B Efficacy Well Demonstrated ~$85M Patients Publications & (in studies) Presentations ~$450M BURNS 1,281 121 DEFECTS/ ~$750M VITILIGO 481 39 CURRENT ACUTE INDICATION WOUNDS 108 15 ~$260M
Slide 14: 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 Quarterly U.S. RECELL Patient Funnel and Addressable Market Sales Since Approval 6,000 ~486K Total Annual Burns in the U.S. PATIENTS 5,000 >$650 Million TAM ~80K Severe Burns (as defined as burns >
Slide 15: Strong Adoption of the RECELL System
Strong Adoption of the RECELL System Accomplishments Since For personal use only 600 250 Approval 500 200 ~75% Burn Surgeons 400 Certified Procedural Volumes 150 Sites/Surgeons 300 ~65% 100 Burn Sites 200 Activated 50 100 ~8% Procedural 0 Q4 CY18 Q1 CY19 Q2 CY19 Q3 CY19 Q4 CY19 Q1 CY20 Q2 CY20 Q3 CY
Slide 16: Pathway to the Outpatient Market
Pathway to the Outpatient Market For personal use only AVITA has applied for a STEP 1 The current indication Transitional Pass Thru Payment Pilot Launch to ensure private for RECELL is valid for Outpatient Medicare Patients, payers expand coverage using for all sites of service which represent ~15%
Slide 17: Skin Injury Framework
Skin Injury Framework TARGET INJURY For personal use only Superficial Wound Superficial Partial Deep Partial Full Thickness Thickness Wound Thickness Wound Wound Wound Depth 1st degree 2nd degree 2nd degree 3rd degree Wound Size 0-9.9%* 10-19.9% 20-29.9% 30-39.9% 40%+ Total Body Surface Area (TBSA)
Slide 18: Account Adoption Varies By User Type
Account Adoption Varies By User Type For personal use only 120% • RECELL used by all surgeons. Super User • Consistent use across all burns which may ~25% Sales require a skin graft” 100% • Burn Dedicated Team Penetration to Peak Share 80% • Consistent use on a subset of burn types 60% Standard • He
Slide 19: Promotion and Education Amplified During The Pandemic
Promotion and Education Amplified During The Pandemic For personal use only Flexible Live and Interactive All Training Virtual Reality - Customized Remote Case Digital Available Live Establishing Peer-to-Peer Support Promotion or Virtual Revolutionary Programs Program ~1,900 RECELL training events r
Slide 20: Vitiligo: Unmet Need, No FDA-Approved Products
Vitiligo: Unmet Need, No FDA-Approved Products For personal use only SIGNIFICANT UNMENT NEED LIMITED EFFICACY OF 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
Slide 21: Established RECELL Track Record in Vitiligo
Established RECELL Track Record in Vitiligo 1,000 patients treated internationally and 8 peer-reviewed publications showing positive outcomes For personal use only POTENTIAL RECELL BENEFITS AT 6 MONTHS RECELL-treated area was 100% re-pigmented For stable vitiligo of all types (segmental & non- segme
Slide 22: 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 23: Traumatic Soft Tissue Injury: High Confidence in Positive Outcomes
Traumatic Soft Tissue Injury: High Confidence in Positive Outcomes RECELL used by multiple surgeons in traumatic wounds with positive outcomes For personal use only TREATMENT DAY 1 YEAR RECELL demonstrated a compelling POST-RECELL TREATMENT value proposition in these particular wound types: Abrasion
Slide 24: Soft Tissue Injury Repair: Significant Strategic Overlap to Burns
Soft Tissue Injury Repair: Significant Strategic Overlap to Burns Synergistic with current commercial focus For personal use only OPPORTUNITY ESTIMATION Significant Same Treatment Unmet Need Protocol to Burns TOTAL MARKET Open wounds Reduction of donor site morbidity Consistent treatment protocol an
Slide 25: Early Intervention for Pediatric 2nd Degree Burns (Scalds)
Early Intervention for Pediatric 2nd Degree Burns (Scalds) A unique subset of burns For personal use only • 30% of burns occur between 1 and 15 years of age of • Scalds frequently present as "indeterminate depth", for which 45% are estimated to be associated with which conventional treatment involve
Slide 26: Early Intervention May Avoid Scarring and Disfigurement
Early Intervention May Avoid Scarring and Disfigurement For personal use only OPPORTUNITY ESTIMATION TOTAL MARKET Scalds related ER ~95K visits in the United States TOTAL ADDRESSABLE TAM MARKET RECELL eligible ~$150 22.5K procedures Million SERVICEABLE AVAILABLE SAM MARKET Estimated number of eligib
Slide 27: 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 28: 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’s Spray-On SkinTM Cells technology DEBILITATING AVITA AND GATES CENTER C
Slide 29: Epidermolysis Bullosa Could Be a Meaningful Opportunity
Epidermolysis Bullosa Could Be a Meaningful Opportunity and Open Doors to Other Genetically Correctable Skin Disorders For personal use only Multi-Billion Dollar Market for Potential Future Indications in Skin, Estimated ~$750M Total Addressable Market in RDEB Which Could be Amenable to Gene Correct
Slide 30: 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 31: Corporate
For personal use only Corporate
Slide 32: Intellectual Property: Robust and Expanding Patent Estate
Intellectual Property: Robust and Expanding Patent Estate For personal use only EXPANDING PORTFOLIO TO SUPPORT CURRENT AND ROBUST PROTECTION ACROSS PATENT FAMILIES FUTURE INDICATIONS Cell Suspension Next Generation RECELL devices to improve ease of Commercial RECELL device, composition Preparation T
Slide 33: Experienced Leadership Team
Experienced Leadership Team For personal use only Dr. Michael S. Perry Erin Liberto Andrew Quick Kathy McGee Donna Shiroma Sean Ekins CEO CCO CTO COO General Counsel V.P. of Finance >30 years experience 20 years experience 25 years experience 25 years experience 20 years experience 19 years experien
Slide 34: Financial Overview (USD)
Financial Overview (USD) For personal use only $19.11 (in $000s) FY 2018 FY 2019 FY 2020 Share Price1 U.S. Sales - 4,404 13,800 $411 Million Total Revenue 929 5,474 14,263 Market Capitalization1 BARDA Income 7,734 5,921 3,926 $0.0 Cash 10,986 20,174 73,639 (Zero) Debt 12 Months Ended June 30 Analyst
Slide 35: Value-Creating Milestones
Value-Creating Milestones For personal use only Upcoming Key Milestones in CY ‘21 • Vitiligo: Last patient enrolled in clinical study - H2 Key Accomplishments in CY ‘20 • EB: Initial proof of concept for delivery of genetically modified cells in suspension - H1 • Telomerase: Initial proof of concept
Slide 36: AVITA Medical: Transforming Lives with Skin Regeneration
AVITA Medical: Transforming Lives with Skin Regeneration For personal use only • Revolutionary treatment using a patient’s own skin for life-changing Life-Changing outcomes Outcomes • Published health economic model demonstrating hospital cost savings • FDA-approved RECELL System for the treatment o
Slide 37: 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 38: 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 in patients 18 years of age and older. The RECELL® device is used by an appropriately-licensed healthcare professional a
Slide 39: Appendix
For personal use only Appendix
Slide 40: AVITA Medical Board of Directors
AVITA Medical Board of Directors For personal use only Dr. Michael S. Perry Lou Panaccio, Chairman Professor Suzanne Crowe Jeremy Curnock Cook Louis Drapeau CEO, AVITA Medical Non-Executive Director Sonic Professor Emeritus Burnet Institute, Managing Director of Healthcare Limited, Non- Principle Re
Slide 41: BARDA Program
BARDA Program For personal use only • U.S. Biomedical Advanced Research and Development Authority • Mandate: disaster preparedness and response • The RECELL System was the first FDA approved product in the BARDA portfolio • Providing sizable non-dilutive funding • Total estimated contract value $80.
Slide 42: Japan Is an Attractive Opportunity for AVITA Medical
Japan Is an Attractive Opportunity for AVITA Medical For personal use only • On March 3, 2019, AVITA announced a collaboration with COSMOTEC Company, Ltd, an M3 Group company to market and distribute the RECELL System for the treatment of burns and other wounds in Japan. M3 Inc. is a publicly traded
Slide 43: Health Economic Model Demonstrates RECELL Cost Savings
Health Economic Model Demonstrates RECELL Cost Savings 2019 ABA presentation using Arizona Burn Center data For personal use only Total Annual Budget Impact (800 Burn Patients) Estimated savings of $28 million (16%) annually for single burn center Foster, K., et al. Budget impact of autologous cell
Slide 44: RECELL Process For Autologous Cell Harvesting and Application
RECELL Process For Autologous Cell Harvesting and Application For personal use only 1 2 3 HARVEST INCUBATE DISAGGREGATE 4 5 6 RINSE FILTER APPLY 44
Slide 45: Flexible Treatment Offering – Small Burns & Pigmentation
Flexible Treatment Offering – Small Burns & Pigmentation 31-year-old female │ ̴11% TBSA │DPT Face │RECELL alone For personal use only 9 DAYS 2 MONTHS TREATMENT DAY POST-RECELL TREATMENT POST-RECELL TREATMENT After 7 days of no progressive healing with Day 11, patient was discharged with 100% 2 month
Slide 46: Promote Healing in Challenging Areas
Promote Healing in Challenging Areas 40-year-old male │<10% BSA │ DPT Face │ RECELL alone For personal use only 1 WEEK 5 MONTHS TREATMENT DAY POST-RECELL® TREATMENT POST-RECELL® TREATMENT After 24 days of no progressive healing At 1 week, 95% re-epithelialization At 5 months, minimal scarring and wi
Slide 47: Point-of-Care Treatment for Fast Treatment
Point-of-Care Treatment for Fast Treatment 85-year-old female│ ~5% BSA│Mixed-Depth Burn to Forearm│RECELL + 2:1 STSG For personal use only 2 WEEKS 24 WEEKS TREATMENT DAY TREATMENT DAY POST-RECELL® TREATMENT POST-RECELL® TREATMENT Mixed-depth flame burn injury Spray-On Skin Cells were 100% wound clos
Slide 48: Restoration of Pigmentation in Full-Thickness Facial Burn
Restoration of Pigmentation in Full-Thickness Facial Burn 56-year-old male│ ~5% BSA│FT Burn to Face│RECELL Alone For personal use only DAY 6 ONE MONTH TREATMENT DAY POST-RECELL® TREATMENT POST-RECELL® TREATMENT Patient treated with Spray-On 100% wound closure by post- Restoration of pigmentation by
Slide 49: Treatment of Full-Thickness Injury with Bone and Tendon Exposed
Treatment of Full-Thickness Injury with Bone and Tendon Exposed 73-year-old male│ ~12% BSA│FT Burn to Leg│RECELL + 3:1 STSG For personal use only MONTH 1 MONTH 1 MONTH 2 MONTH 6 (RESULTS WITH SOC) (PLACEMENT OF BTM) (RECELL APPLIED) POST-RECELL® TREATMENT Treatment Day Day 6 One Month Tibia and tend
Slide 50: Reduced Donor Skin Requirements Compared to Control
Reduced Donor Skin Requirements Compared to Control 48-year-old male │<10% BSA │ DPT Forearm │ RECELL alone For personal use only 16 WEEKS TREATMENT DAY 16 WEEKS (CONTROL) POST-RECELL® TREATMENT Patient part of randomized Vancouver Scar Scale had Patient experienced 98% clinical trial. Spray-On Skin
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