Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Q4 2022 Earnings Presentation
19 slides from Avita Medical's earnings presentation, Mar 1, 2023
Slide 1: Accelerating Our Growth Profile
For personal use only Accelerating Our Growth Profile Q4 2022 Investor Presentation NASDAQ: RCEL ASX: AVH ©Copyright 2023 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: Who is AVITA Medical?
Who is AVITA Medical? For personal use only Regenerative medicine company transforming the standard of care for skin restoration with its innovative cellular technology platform, the RECELL® System RECELL System includes autologous cell harvesting device that prepares, produces, and delivers regener
Slide 4: What is RECELL?
What is RECELL? For personal use only RECELL enables regeneration of healthy Treatment using RECELL skin 3. Autologous suspension sprayed onto treatment areas of patient 2. RECELL processes healthy skin and disaggregates cells to produce regenerative autologous suspension, Spray-On Skin Cells 1. Pat
Slide 5: One Platform. Multiple Indications.
One Platform. Multiple Indications. For personal use only U.S. 2022 2023 2024 2025 INDICATION Outpatient Code BURNS Ease of Use Device (Approved) Japan: Approval, Reimbursement, Launch Automated Device Automated Device Submission: Q2 Approval: Q1 FDA Approval: June SOFT TISSUE PMA Supplement (Expect
Slide 6: Year in Review: Continued Growth and Expansion
Year in Review: Continued Growth and Expansion For personal use only 2022 Accomplishments Strong U.S. RECELL • Commercial Revenue Growth: Commercial Growth • Fourth quarter 2022: 37% same quarter prior year 10,000 • New RECELL Device: 9,000 • FDA approval and launch of new “Ease of Use” device 8,000
Slide 7: Soft Tissue Repair Opportunity
Soft Tissue Repair Opportunity Female, pregnant 28-year-old who For personal use only suffered from a de-gloving injury Submitted PMA Supplement in December 2022 Expect FDA approval in June 2023 POST DEBRIDEMENT OF INJURY Following approval, launching July 2023 Significant synergies between
Slide 8: RECELL's Perceived Advantages Vary Depending on Wound Type
RECELL’s Perceived Advantages Vary Depending on Wound Type For personal use only Intent to Use Fasciotomy & Degloving Extremely Likely Necrotizing Skin Infection Flap Donor Site / Abrasion Neutral Crush Amputation Traumatic hematoma Laceration Not At All Likely Unlike with Burns, most surgeons would
Slide 9: Overlap of Burns and Soft Tissue Repair
Overlap of Burns and Soft Tissue Repair Existing Burns Market Broadened by Soft Tissue Repair For personal use only Sales Team Will Target a Total of +1,000 Centers 25,000 Targeted Burn ~110,000 Targeted Acute Wound Procedures Procedures + SOFT TISSUE ~10,000 Targeted Burn BURNS MARKET Procedures MA
Slide 10: Synergies of Burns and Soft Tissue Repair
Synergies of Burns and Soft Tissue Repair For personal use only • Soft Tissue Repair in-patient reimbursement: same DRG code as Burns; effective immediately upon FDA approval • Soft Tissue Repair out-patient transitional pass-through code (TPTC): same code as Burns; effective immediately upon FDA ap
Slide 11: Vitiligo Opportunity
Vitiligo Opportunity Submitted PMA application in December 2022 with study results: First-in-class re-pigmentation For personal use only • Primary endpoint: proportion of study sites achieving ≥80% re- transplantation of melanocytes pigmentation for RECELL-treated sites vs Control at Week 24 Patie
Slide 12: Growth Enabler: Automated Device for All Indications
Growth Enabler: Automated Device for All Indications For personal use only KEY UPDATES • New RECELL Automated Device in development for Soft Tissue Repair / Burns (automated device for Vitiligo to follow): • FDA Submission expected in June 2023 • FDA Approval expected by January 2024 • Protected by
Slide 13: 2023: A Year of Inflection
2023: A Year of Inflection U.S. Market For personal use only Expecting FDA approvals for two indications: Soft Tissue Repair and Vitiligo Burns Soft Tissue Repair: launching in July 2023; Patients ~5x market expansion will fuel revenue growth ~35,000 Vitiligo Vitiligo: ~5x patient population o
Slide 14: Financial Overview: Q4 2022
Financial Overview: Q4 2022 For personal use only Unaudited Three-Months Unaudited 12-Months Ended Ended December 31 December 31 (USD in $000s) 2021 2022 2021 2022 Commercial Sales 6,843 9,363 25,091 34,051 BARDA Sales 93 92 7,934 370 Total Revenue 6,936 9,455 33,025 34,421 Gross Profit 6,119 8,108
Slide 15: Looking Ahead
Looking Ahead For personal use only Financial Guidance Commercial revenue, excluding BARDA revenue: • Q1 2023: $10 - $11 million • 2023: $49 – $51 million Future Milestones • Expansion of U.S. field sales organization in Q2 2023: from 30 to ~70 professionals • Expected approval of PMA supplement for
Slide 16: Summary
Summary Burns For personal use only • Core Burn centers will continue to penetrate, adopt and grow • Burns utilization will expand, accessing ~30% of market not currently called on by AVITA Medical Burns sales team • Strong healthcare economics drive in-patient adoption; TPTC broadens coverage Soft
Slide 17: 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 18: 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 For personal use only are outside the control of the Company and cannot be mitigated. Acco
Slide 19: 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