Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — JP Morgan Healthcare Conference 2022
40 slides from Avita Medical's conference presentation, Jan 11, 2022
Slide 1: AVITA Medical January 2022
For personal use only January 2022 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: Value Creation
Value Creation For personal use only Recent Key Accomplishments Projected Key Milestones • Vitiligo Pivotal Trial: Enrollment Completed • Vitiligo FDA Submission / Vitiligo Commercial • Soft Tissue Pivotal Trial: Enrollment Completed launch H2 22 / • Soft Tissue FDA Submission / Soft Tissue H2 23 •
Slide 4: AVITA Leadership Team
AVITA Leadership Team For personal use only 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 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.) APPROVED RECELL® Japan SUBMITTED Vitiligo (U.S.) ENROLLMENT COMPLETE Soft Tissue Recons
Slide 8: Market Opportunity of Pipeline Exceeds $22 Billion
Market Opportunity of Pipeline Exceeds $22 Billion For personal use only EXISTING PLATFORM NEW PLATFORMS: CELL BASED GENE THERAPY ~$15.8B Opportunity ~$6.8B Opportunity $0.6B Burns Vitiligo$5.2B $15B $0.8B $1B Rejuvenation Skin cells are Epidermolysis Soft Tissue genetically Bullosa modified > $22 B
Slide 9: Current Platform: Efficacy is Well Demonstrated
Current Platform: Efficacy is Well Demonstrated For personal use only PRODUCT IS WELL STUDIED Patients Number of Publications & (in Published Studies) Presentations ACUTE WOUNDS Highly De-risked 1,772 206 (Including Thermal Burns) Pipeline with DEFECTS/ >15,000 Patients 453 57 VITILIGO Treated Globa
Slide 10: 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 11: New C-Code Provides Additional Payment in the Outpatient Setting
New C-Code Provides Additional Payment in the Outpatient Setting For personal use only The Centers for Medicare and Medicaid C1832: Services (CMS) created Autograft suspension, including cell a new technology processing and application, and all Transitional Pass- system components This is a Medicare
Slide 12: New Ease of Use Device Submitted for FDA Approval
New Ease of Use Device Submitted for FDA Approval For personal use only New Device Reduced Simplified Improved number of steps Process Usability 94% of users of the RECELL System believe it will reduce their workload/allow them to perform other duties* Only 1 Set of Hands Required in the Sterile Fie
Slide 13: FDA Approval in Pediatric Full-Thickness & Larger Burns
FDA Approval in Pediatric Full-Thickness & Larger Burns FEWER PROCEDURES REQUIRED FOR DEFINITIVE CLOSURE VS For personal use only CONVENTIONAL AUTOGRAFT1 5.9 3.6 NBR Control RECELL 1.6 2.4 NUMBER OF TREATMENTS NUMBER OF TREATMENTS Pediatric Patients Adults with >50% TBSA ~25% of all burns 56% fewer
Slide 14: Japan – PMDA Review in the Final Phases
Japan – PMDA Review in the Final Phases For personal use only BACKGROUND PATIENT FUNNEL - BURNS ADDRESSABLE MARKET AVITA Commercial Partner: COSMOTEC, an M3 Company ~250,000 Incidence of Burns Needing Medical Treatment in Japan PATIENTS INDICATION: Burns ~6,000 Severe Burns (defined as hospital admi
Slide 15: Vitiligo: High Unmet Need, No FDA-Approved Products
Vitiligo: Hight Unmet Need, No FDA-Approved Products For personal use only SIGNIFICANT UNMENT NEED OPPORTUNITY ESTIMATION TOTAL MARKET Up to 2% of the 4.5M Prevalence of Vitiligo in the United States population affected (range 3-6.5 million) TOTAL ADDRESSABLE MARKET TAM 1.3M $5.2 Billion No FDA-appr
Slide 16: Vitiligo Study Completed in Two Quarters
Vitiligo Study Completed in Two Quarters Blinded, Randomized, Study Evaluating RECELL for Repigmentation of Stable Vitiligo in 23 Patients For personal use only RECELL® Vitiligo Study Patient from a Prior Study at 6 MONTHS 25 RECELL-treated area was 100% re-pigmented 20 N=23 15 Number of Subjects RE
Slide 17: RECELL Case: Repigmentation of the Nipple-Areola Complex
RECELL Case: Repigmentation of the Nipple-Areola Complex For personal use only Before RECELL® 12 months After RECELL® • 23 year old female with vitiligo. • Donor skin was harvested from adjacent unaffected areas. • Depigmented epidermis was removed using dermabrasion. • The cellular suspension was t
Slide 18: Soft Tissue Repair Will Expand the Burns Business to Encompass All Acute Wounds
Soft Tissue Repair Will Expand the Burns Business to Encompass All Acute Wounds Female, pregnant 28-year-old who For personal use only OPPORTUNITY ESTIMATION suffered from a de-gloving Injury TOTAL MARKET Open wounds >4.5M presented at the Emergency patients Department POST DEBRIDEMENT OF INJURY TOT
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 For personal use only relative to conventional autografting Patient treated for necrotizing fasciitis RECELL® Soft Tissue Study N=65 20 70 18 65 60 16 Number
Slide 20: Soft Tissue Synergies with Current Commercial Burn Focus
Soft Tissue Synergies with Current Commercial Burn Focus Expanded Acute Wounds Sales Team Will For personal use only Target a Total of 366 Centers Reimbursement in Place Able to leverage existing CPT & Outpatient C Code ~50% of Burn Centers are also Same Treatment Protocol to Burns Level 1 / Level 2
Slide 21: 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 22: Cell Based Gene Therapy Development Activity
Cell Based Gene Therapy Development Activity For personal use only Proof of Concept Study Objectives: Develop a ‘Spray-on’ suspension delivery system FDA Interaction FOUR of modified cells and establish proof-of-concept KEY STEPS IND-enabling Studies Target IND-enablement by establishing preclinical
Slide 23: Sizeable Market Opportunity Estimated in EB, Given Orphan Pricing Potential
Sizeable Market Opportunity Estimated in EB, Given Orphan Pricing Potential For personal use only OPPORTUNITY ESTIMATION POTENTIAL COMPETITIVE ADVANTAGES Suspension is potentially more cost effective to 25-50,000 US Prevalence of Epidermolysis Bullosa generate, transport and apply vs cultured sheet
Slide 24: Skin Regeneration from Corrected Autologous Skin Cell Suspension
Skin Regeneration from Corrected Autologous Skin Cell Suspension For personal use only Successful reverse-differentiation (induced pluripotency) and gene correction of In Vivo Evaluation of Gene-corrected Skin Cells Recessive Dystrophic Epidermolysis Bullosa Immunocompromised (RDEB) Skin Cells mouse
Slide 25: Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa
Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa For personal use only THE CHALLENGE THE OPPORTUNITY DEBILITATING Skin fragility, CURATIVE: Technology for precise correction of disability, cancer genetic defect & banking for future use (vs ameliorating symptoms) HIGH UNMET NEED No FDA-app
Slide 26: Reverse Aging of Skin Cells Derived using the RECELL Device
Reverse Aging of Skin Cells Derived using the RECELL Device For personal use only Successful delivery of mRNA-hTERT & expression in Skin Cells Derived from RECELL In Vivo Evaluation of mRNA-hTERT Modified Skin Cells Point-of-Care Immunocompromised hTERT modification mouse model Skin cells harvested
Slide 27: Exploring Novel RNA-Based Approach for Rejuvenation
Exploring Novel RNA-Based Approach for Rejuvenation For personal use only Patient Funnel and Addressable Market ~8.3M PEOPLE/Yr People Who Underwent Facial Aesthetic Procedures Aimed at Improving Skin Tightness, Texture & Evenness in Skin Tone 1 • Patented RNA technology for delivery of • Patented a
Slide 28: Corporate
For personal use only Corporate
Slide 29: Financial Overview
Financial Overview For personal use only 12 Months Ended June 30 $11.13 (USD in $000s) 2018 2019 2020 2021 Share Price1 Commercial Sales 929 5,474 14,263 21,483 BARDA Sales - - - 7,749 $277 Million Total Revenue 929 5,474 14,263 29,232 Market Capitalization1 Gross Profit 383 4,203 11,290 23,283 BARD
Slide 30: 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 31: Value Creation
Value Creation For personal use only Recent Key Accomplishments Projected Key Milestones • Vitiligo Pivotal Trial: Enrollment Completed • Vitiligo FDA Submission / Vitiligo Commercial • Soft Tissue Pivotal Trial: Enrollment Completed launch H2 22 / • Soft Tissue FDA Submission / Soft Tissue H2 23 •
Slide 32: 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 33: 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
Slide 34: Revolutionary treatment using a patient's own skin for life-changing outcomes
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 35: 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 35
Slide 36: RECELL Spray-On Skin Treats 80cm2 of Skin from a 1cm2 Biopsy
RECELL Spray-On SkinTM 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
Slide 37: 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 38: 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) 38
Slide 39: 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 40: Published Health Economic Model: Demonstrates Patient and Health Care System Benefits
Published Health Economic Model: Demonstrates Patient and Health Care System Benefits RECELL saves the hospital money in in-patient scenarios where the burn is For personal use only 10% Total Body Surface Area (TBSA) or greater Transforming Care Can reduce costs and accelerate recovery by decreasing