Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Investor Presentation (February 2020)
36 slides from Avita Medical's investor presentation, Feb 19, 2020
Slide 1: AVITA Medical
For personal use only AVITA Medical Dr. Mike Perry, CEO February 2020
Slide 2: Disclaimer
Disclaimer This presentation is made available by AVITA Medical Limited (“AVITA”, “the Company”, or “we”). It is intended to provide background For personal use only information only, and may not be reproduced or redistributed in whole or in part nor may its contents be disclosed to any other person
Slide 3: AVITA Medical: Transformation Through Regeneration
AVITA Medical: Transformation Through Regeneration INJURIES For personal use only Spray-On SkinTM Enables Skin Regeneration • In-patient Burns • Out-patient Burns • Pediatric Scalds RECELL harnesses the skin’s own regeneration capabilities • Soft Tissue Reconstruction • Traumatic Wounds • Standard o
Slide 4: A Common Goal & Deep Clinical Experience
INJURIES Thermal burns, pediatric A Common Goal & Deep Clinical Experience scald, surgical wounds, For personal use only degloving injuries, accidents, abrasions, Patients Peer Reviewed pretibial lacerations (In studies) Publications 858 Burns 75 1st PMA approved burn product in >20 years* DEFECTS A
Slide 5: Skin Grafting is Unchanged for More Than Years
Skin Grafting is Unchanged for More Than 50 Years For personal use only Split-Thickness Skin Grafts (STSG) are “Medieval” Dermatome skin harvesting from new donor site New (second) donor wound created via skin harvesting KEY SHORTCOMINGS OF STSG • Large donor area required • Multiple complex, costly
Slide 6: Challenges with Split-Thickness Skin Graft Outcomes
Challenges with Split-Thickness Skin Graft Outcomes For personal use only Scarring, functional impairment, pigmentation, infection … Donor Site Infection Risk Donor Site Scarring / Failure to Heal Pigmentation and Discoloration Scarring, Atrophy, Contracture Normal skin restoration (re-epithelialize
Slide 7: The RECELL Solution ... Spray-On Skin
The RECELL Solution ... Spray-On Skin™ For personal use only Cell Harvesting Device that delivers AUTOLOGOUS Spray-On Skin™ Cells within 30 minutes at the point of care Fresh (non-cultured cells) with the ACTIVATED “free edge healing cascade” Treatment area = DONOR SPARING 80x donor area (credit car
Slide 8: The RECELL Solution ... Spray-On Skin (Continued)
The RECELL Solution ... Spray-On Skin™ (Continued) For personal use only Full range of skin cell types COMPLETE with re-pigmentation 2x PMA randomized controlled trials ESTABLISHED SAFETY 1st PMA burn product approval in> 20 yrs & EFFECTIVENESS 8K+ clinical uses & 50+ Publications ROBUST HEALTH ECON
Slide 9: RECELL's "Free Edge" Advantage
RECELL’s “Free Edge” Advantage For personal use only Healing Process without RECELL Healing Process with RECELL Free edge limits signaling to wound boundary (i.e. outside → in) Spray-On SkinTM signals from within the wound (i.e. inside → out) • The wound boundary acts as a “free edge” between injure
Slide 10: RECELL Delivers Life-Changing Outcomes
RECELL Delivers Life-Changing Outcomes For personal use only Case Series Presented at 50th Annual ABA Meeting (2018) Treatment Day Day 7 Day 21 3 Months 1 Year 1 Year • Compassionate Use case • Reintroduction of melanocytes resulted Skin + • 12-year-old girl with 2nd-degree facial burn and in an exc
Slide 11: $2 Billion Opportunity and Existing U.S. Premarket Approval
$2 Billion Opportunity* and Existing U.S. Premarket Approval For personal use only Future Markets >$2B >$2B Expand Within Burns ~$550M ~$600M + Cell / Gene Therapy PMA Secured + Early ~$250M Commercialization Current ~$450M Market ~$200M Outpatient Pediatric Trauma Total Potential In-patient Burns B
Slide 12: Burns Franchise
For personal use only Burns Franchise 11
Slide 13: Burn Injury Framework
TARGET Burn Injury Framework For personal use only Superficial Wound Superficial Partial Deep Partial Full Thickness Wound Thickness Wound Thickness 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) Affecte
Slide 14: Burn Market Segmentation
Burn Market Segmentation For personal use only Current Burn Market ~14,000 $200M In-patient Burns: FDA PMA secured / Commercializing RECELL Eligible Patients ~110,000 Future Burn Markets Outpatient Burns: $450M 2nd/3rd Degree Enhance Reimbursement & Launch Adult Burn Injuries ~65,000 $250M Pediatric
Slide 15: 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 16: Published Health Economic Savings – Patient & Hospital Benefits
Published Health Economic Savings – Patient & Hospital Benefits RECELL Reduces Overall Hospital Costs For personal use only Transforming Care Reduces costs and accelerates recovery by decreasing the number of painful procedures and length of stay in hospital 30% 35% 35% Reduction in Fewer Cost Lengt
Slide 17: Strong Adoption of the RECELL System
Strong Adoption of the RECELL System For personal use only PMA Early Commercialization Underway 350 70 300 60 250 50 Procedural Volumes Sites (VAC) 200 40 150 30 100 20 50 10 0 0 Q4 18 Q1 19 Q2 19 Q3 19 Q4 19 New Sites Total Sites Procedures RECELL System procedural growth increasing quarter-on-quar
Slide 18: Second Target Market: Out-patient Burns
Current Platform ~$450M TAM Second Target (Burn) Market Out-patient burns For personal use only ~430,000 Next outpatient burns Generation Device ~37% focused on improved are 2nd and 3rd degree efficiencies and ease of use Step 1: Pursue more favorable reimbursement Step 2: RECELL “2.0” approval for
Slide 19: Third Target Market: Pediatric Patients
Current Platform ~$250M TAM Third Target (Burn) Market: Pediatric Patients A unique subset For personal use only • 30% of burns occur between 1 and 15 years of age ~45% Estimated to be associated with scalds • Scalds frequently present as “indeterminate depth” burns • Skin defects healing > 3 weeks
Slide 20: Soft Tissue Reconstruction
For personal use only Soft Tissue Reconstruction 19
Slide 21: Soft Tissue Grafting is Times Larger Than Burns
Current Platform ~$550M TAM Soft Tissue Grafting is 5 Times Larger Than Burns For personal use only Road rash Significant Strong Interest Synergistic with Current Unmet Need In RECELL Commercial Efforts Reduction of donor site 89% of respondents 70% of accounts morbidity and donor in surgeon researc
Slide 22: Soft Tissue Reconstruction Closely Aligned to Burns
Current Platform ~$550M TAM Soft Tissue Reconstruction Closely Aligned to Burns For personal use only Target Expands to ~250 Total Centers* Current Future AVITA Burn AVITA Trauma Target: ~132 75 Target: Burn and Level 1 ~200 High Volume Trauma Centers* Level 1 Trauma Burn Dedicated Centers* Centers*
Slide 23: Defects
For personal use only Defects 22
Slide 24: More Than 1,000 Vitiligo Patients Treated Internationally
Current Platform ~$600M TAM More Than 1,000 Vitiligo Patients Treated Internationally For personal use only SIGNIFICANT UNMET NEED RECELL VALUE PROPOSITION Up to 2% of the population affected • Over 1,000 vitiligo patients treated internationally with RECELL (~6.5M in the US)* • 8 publications of RE
Slide 25: Deep Experience in Chronic (Non-healing) Wounds
Adjacency Deep Experience in Chronic (Non-healing) Wounds For personal use only THE OPPORTUNITY RECELL VALUE PROPOSITION Chronic wounds fail to heal 50% of the time • RECELL kick starts healing by providing healthy multi- phenotype single skin cells directly to the wound bed Failure to heal leads to
Slide 26: Genetic Errors
For personal use only Genetic Errors 25
Slide 27: RECELL in Genetic Skin Defects
RECELL in Genetic Skin Defects For personal use only CURRENT PLATFORM FUTURE PLATFORM RECELL delivers healthy epidermal RECELL as a delivery platform for cells from one part to another… modified epidermal cells … +Gx +Gx Harvest for direct +Gx reintroduction Harvest + Cell Modification +Gx 26 * In t
Slide 28: Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa
Research Program Exploring Cell-Based Gene Therapy for Epidermolysis Bullosa (EB) For personal use only The Challenge The Opportunity Debilitating Curative Skin fragility, disability, cancer Correct underlying genetic defect Efficient High unmet need Simplify manufacturing, No FDA-approved treatment
Slide 29: Sponsored Research: Combining RECELL + Gates Center Technologies
Sponsored Research ... Combining RECELL + Gates Center Technologies For personal use only Cell Tissue Gene transfer / Cell selection, Maturation into Transplan- separation, sampling editing1 expansion skin sheets tation isolation Current Process (Other products in development) Potential Benefit Pote
Slide 30: RECELL Well-Suited to Rejuvenation
Research Program RECELL Well-Suited to Rejuvenation For personal use only Skin Rejuvenation* • Americans spend >$16.5B in aesthetic procedures annually • >3M aesthetic procedures per year (US) aimed to improve skin tightness, texture & evenness in skin tone • Consumers desire superior results over c
Slide 31: Corporate
For personal use only Corporate 30
Slide 32: Intellectual Property
Intellectual Property For personal use only ROBUST PROTECTION… …ACROSS GEOGRAPHIES Cell Suspension Preparation Technique / Device Canada • Commercial RECELL device, composition of matter, and associated methods of use United States Europe China Cell Suspension And Use Thereof Japan • Method of prepa
Slide 33: Experienced Leadership Team
Experienced Leadership Team For personal use only Dr. Michael S. Perry David McIntyre Tim Rooney Erin Liberto Andrew Quick Donna Shiroma CEO CFO CAO CCO CTO General Counsel >30 years 25 years 25 years 17 years 25 years 20 years experience experience experience experience experience experience Affili
Slide 34: AVITA Medical: Transformation Through Regeneration
AVITA Medical: Transformation Through Regeneration INJURIES For personal use only Spray-On SkinTM Enables Skin Regeneration • In-patient Burns • Out-patient Burns • Pediatric Scalds RECELL harnesses the skin’s own regeneration capabilities • Soft Tissue Reconstruction • Traumatic Wounds • Standard o
Slide 35: Thank you
For personal use only Thank you 34
Slide 36: References
References Sources of certain information included in this presentation are set out below for convenience. Page 4: Kowal, S et al. Cost-effectiveness of the Use of Autologous Cell Harvesting Device Compared to Standard of Care for Treatment of Severe Burns in the United States. Adv Ther. 2019; 36(7)
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