Avita Medical, Inc. · NASDAQ:RCEL
Avita Medical — Q1 2023 Earnings Presentation
18 slides from Avita Medical's earnings presentation, May 16, 2023
Slide 1: Accelerating Our Growth Profile
For personal use only Accelerating Our Growth Profile Q1 2023 Investor Presentation NASDAQ: RCEL ASX: AVH ©Copyright 2023 AVITA Medical. All Rights Reserved.
Slide 2: Legal Disclaimers
Legal Disclaimers 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 presentation, includi
Slide 3: Who is AVITA Medical?
Who is AVITA Medical? Regenerative medicine company transforming the standard of care for skin restoration with its innovative cellular technology platform, the RECELL® System For personal use only RECELL System includes autologous cell harvesting device that prepares, produces, and delivers regener
Slide 4: What is RECELL?
What is RECELL? RECELL enables For personal use only 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. U.S. For personal use only 2022 2023 2024 2025 INDICATION Outpatient Code BURNS Ease of Use Device (Approved) Japan: Approval, Reimbursement, Launch RECELL GO Device RECELL GO Device Submission*: Q2 Approval: Q1 FDA Approval: June SOFT TISSUE PMA Supplement (Expec
Slide 6: 2023 Highlights & Milestones
2023 Highlights & Milestones 2023 Q1 • Commercial Revenue Growth: Strong U.S. RECELL For personal use only • First quarter 2023: 40% same quarter prior year Commercial Growth 12,000 • Field Sales Organization: • Initiated recruiting and hiring process; grew from 30 to 69 towards goal of 70 10,000 •
Slide 7: Soft Tissue Repair Opportunity
Soft Tissue Repair Opportunity Female, pregnant 28-year-old who suffered from a de-gloving injury Submitted PMA Supplement in December 2022 For personal use only 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 Intent to Use For personal use only 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 Meaningful Broaden Acute Wounds Business by Soft Tissue Repair Indication 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
Slide 10: Synergies of Burns and Soft Tissue Repair
Synergies of Burns and Soft Tissue Repair • Soft Tissue Repair in-patient reimbursement: same DRG code as Burns; effective immediately upon FDA approval For personal use only • 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 • Primary endpoint: proportion of study sites achieving ≥80% re- transplantation of melanocytes For personal use only pigmentation for RECELL-treated sites vs Control at Week 24 Patie
Slide 12: 2023: A Year of Inflection
2023: A Year of Inflection U.S. Market Expecting FDA approvals for two indications: Soft Tissue Repair and Vitiligo For personal use only Soft Tissue Repair: launching in July 2023; Burns ~5x market expansion will fuel revenue growth Patients ~35,000 Vitiligo: ~5x patient population of Burns a
Slide 13: Financial Overview: Q1 2023
Financial Overview: Q1 2023 Unaudited Three-Months For personal use only Ended March 31 (USD in $000s) 2022 2023 Commercial Sales 7,446 10,458 BARDA Sales 93 92 Total Revenue 7,539 10,550 Gross Profit 5,761 8,883 BARDA Income 734 627 Cash, Cash Equivalents & 95,054 77,640 Marketable Securities Analy
Slide 14: Looking Ahead
Looking Ahead Financial Guidance For personal use only Commercial revenue, excluding BARDA revenue: • Q2 2023: $10.7 - $11.7 million • 2023: $49 – $51 million Future Milestones • Expected approval of PMA supplement for soft tissue repair indication in June 2023 followed by commercial launch on July
Slide 15: Summary
Summary Burns • Core Burn centers will continue to penetrate, adopt and grow For personal use only • 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 16: Revolutionary treatment using a patient's own skin
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 17: 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 are outside the control of the Company and cannot be mitigated. Accordingly, an investment
Slide 18: Important Safety Information
Important Safety Information • 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 prepare autologous RES® Rege