Summary of AVITA Medical FY Conference Call (December 04, 2025) Company Overview - **Company**: AVITA Medical (NasdaqCM:RCEL) - **Industry**: Therapeutic acute wound care - **Focus**: Acute wounds such as burns, gunshot wounds, and road rashes, aiming to expedite patient recovery and hospital discharge [2][3] Core Products - **RECELL**: First-in-class spray-on skin cell product approved by the FDA in 2019, used in burn centers and trauma centers across the U.S. [4] - **Cohelix**: Collagen-based dermal matrix, bioengineered in partnership with Regenity, which reduces gross margin but increases operating margin [6] - **PermeaDerm**: Biosynthetic dressing that allows visibility of the wound without removal, facilitating air exchange [6] Key Data and Performance Metrics - **RECELL Efficacy**: Patients using RECELL can be discharged 36% faster, with a study of 6,300 burn patients showing a six-day earlier discharge compared to traditional methods [4][17] - **Cost Discipline**: Achieved $10 million in annual cost reductions, maintaining SG&A costs for growth [5] - **Revenue Impact**: Estimated revenue loss of $10-$12 million due to reimbursement issues, with a focus on regaining momentum in 2026 [11][13] Market Potential - **Total Addressable Market (TAM)**: Estimated at $3.5 billion, with AVITA currently capturing about 5% of this market [17] - **Market Share**: Approximately 15%-20% market share in burn centers after five years of presence [17] Financial Performance - **Revenue**: Reported $17 million in revenue, down 13% year-over-year, primarily due to reimbursement challenges [19] - **Gross Margin**: RECELL products maintain a gross margin of 84%, though overall margins may decrease due to the mix of products sold [19][20] - **Cost Management**: Reduced expenses by 24% year-over-year, with a target of $23 million in expenses moving forward [20] Future Outlook - **2026 Guidance**: Anticipated revenue guidance to be provided in early January, with expectations of returning to a growth rate of 29% [20][21] - **International Expansion**: RECELL GO approved in the EU and UK, with pending approval in Australia, utilizing third-party distributors for market entry [15] Additional Insights - **Reimbursement Challenges**: Ongoing issues with CMS and MACs have impacted product usage and demand, but resolution efforts are underway [12][13] - **Patient-Centric Focus**: Emphasis on improving patient outcomes and reducing healthcare costs associated with prolonged hospital stays [16] This summary encapsulates the key points from the AVITA Medical FY Conference Call, highlighting the company's focus on acute wound care, product efficacy, market potential, financial performance, and future outlook.

Core Viewpoint - AVITA Medical, Inc. will present at the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025, at 8:30 a.m. EST, and management will be available for one-on-one meetings with registered investors [1]. Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on delivering transformative solutions to optimize wound healing and accelerate patient recovery [3]. - The company's flagship product, the RECELL System, is FDA-approved for treating thermal burn and trauma wounds, utilizing the patient's own skin to create Spray-On Skin™ Cells for improved clinical outcomes [3]. - In the U.S., AVITA Medical holds exclusive rights to manufacture and market PermeaDerm, a biosynthetic wound matrix, and Cohealyx™, a collagen-based dermal matrix [3]. International Market Presence - The RECELL System is approved for promoting skin healing in various applications, including thermal burn and trauma wounds, with regulatory clearances in Europe, Australia, and Japan (excluding RECELL GO) [4].

Core Insights - The company emphasizes the clinical superiority of its products, which not only enhance patient healing times but also support hospitals in achieving economic efficiency [1] Product Overview - PermeaDerm is identified as a biosynthetic dressing that stabilizes and protects wounds, with applications in trauma care and a need for scaffolding technology to aid in wound healing [2] - The RECELL product has transitioned from a manual to an automated process, improving healing by utilizing the patient's own skin, thus minimizing painful donor site issues [3] - PermeaDerm also plays a crucial role in providing protection and facilitating healing during the grafting process [3] Data-Driven Approach - The company aims to become more data-driven in its operations, which is essential for enhancing product effectiveness and overall business strategy [4]

Financial Data and Key Metrics Changes - For Q3 2025, the company reported approximately $17 million in revenue, a 13% decline from $19.5 million in the same period last year, primarily due to reimbursement disruptions [4][16] - The full-year revenue outlook has been revised to a range of $70 million-$74 million, down from the previous guidance of $76 million-$81 million [4][16] - Gross profit margin for the quarter was 81.3%, down from 83.7% in Q3 2024, driven by product mix changes [16][17] - Operating loss improved by 34% year-over-year, decreasing to $9.2 million from $13.8 million in the prior year [19] Business Line Data and Key Metrics Changes - The ReCell product line is expected to see renewed demand as reimbursement clarity improves, with significant progress made in provider reimbursement rates [5][10] - Cohelix and PermeaDerm are emerging as complementary growth drivers, with VAC submissions underway in about one-third of target accounts [12] Market Data and Key Metrics Changes - The total addressable market for AVITA's portfolio in U.S. burn and trauma hospitals is approximately $3.5 billion, with the company currently serving about 5% of this segment [9] - The company is focusing on the 200 burn centers and trauma hospitals that represent the most immediate and scalable growth potential [9] Company Strategy and Development Direction - The company is refining its commercial organization to align structure, territories, and accountability around high-value accounts [8] - Execution priorities for Q4 include rebuilding order momentum, driving consistent utilization of products, and enhancing forecast accuracy [10][11] - The company aims to ensure that its products become part of routine clinical practice, creating internal champions to help expand adoption [11] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q3 was a challenging quarter but emphasized that reimbursement stability and clinical validation are in place for future growth [14][15] - The company is focused on delivering consistent performance and restoring confidence among providers regarding reimbursement [14][23] - Management expressed optimism about the potential for growth in 2026, driven by improved operational execution and market conditions [39] Other Important Information - The company has secured a waiver of its Q3 revenue covenant under its Orbimed credit agreement and has amended the revenue covenant for Q4 [13][22] - Cash management has improved, with a reduction in operating cash use from $10.1 million in Q2 to $6.2 million in Q3 [21] Q&A Session Summary Question: Initiatives for Better Business Forecasting - Management discussed improving forecasting by understanding customer utilization and purchasing patterns, with confidence in better modeling moving forward [25] Question: Balancing Resources for New Market Launches - The primary focus remains on the U.S. market, with limited resources allocated to select international markets [26] Question: Recovery Timeline for ReCell Customer Base - Management indicated that educating accounts on reimbursement processes is crucial for rebuilding confidence, with expectations for recovery in early 2026 [28] Question: Update on VAC Approvals for Cohelix - About one-third of accounts are in the VAC process, with expectations for approvals to trend positively in Q4 [30] Question: Spending Outlook and Organizational Right-Sizing - Management expressed satisfaction with the current expense structure and indicated no further reductions are necessary, focusing on maintaining a disciplined approach [33][34] Question: Changes to Sales Team Incentive Structure - Management is reviewing sales compensation plans to ensure alignment with growth objectives, aiming for simplicity and fairness [35]

Core Insights - AVITA Medical's RECELL System is positioned as a standard of care for acute wound treatment, demonstrating significant clinical and economic benefits across various wound types and patient populations [1][3][5] Clinical Evidence - A systematic review of 99 peer-reviewed studies involving over 8,000 patients across 13 countries confirms that the RECELL System consistently delivers strong outcomes, achieving wound closure with less donor skin and faster healing [3][4] - The RECELL System reduces donor site burden by up to 97.55% and meets or exceeds outcomes observed with traditional split-thickness skin grafts (STSG) [7] Economic Impact - Real-world data from the American Burn Association's registry shows that RECELL treatment results in a 36% average reduction in hospital stays, equating to a 5.6-day decrease [4][8] - The estimated cost savings per patient treated with RECELL is over $42,000, allowing hospitals to treat an additional 13 patients per bed annually [8] Patient Outcomes - RECELL treatment leads to improved patient recovery, with 83% of patients discharged home compared to 70% for STSG [8] - The findings highlight the ability of RECELL to accelerate recovery and enhance resource utilization in healthcare settings [5][8]

Core Insights - AVITA Medical, Inc. will report its third quarter 2025 financial results on November 6, 2025, after U.S. market close [1] - A conference call and webcast will be held on the same day to discuss financial results and business highlights [1] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on delivering transformative solutions [3] - The company's flagship product, the RECELL System, is FDA-approved for treating thermal burn and trauma wounds, utilizing a patient's own skin to create Spray-On Skin™ Cells [3] - In the U.S., AVITA Medical also has rights to manufacture and exclusively market PermeaDerm, a biosynthetic wound matrix, and Cohealyx™, a collagen-based dermal matrix [3] International Market Presence - The RECELL System is approved for various applications in international markets, including thermal burn and trauma wounds, with regulatory clearances in Europe, Australia, and Japan (excluding RECELL GO) [4]

Core Insights - Australia's Medical Services Advisory Committee (MSAC) has recommended amendments to the Medicare Benefits Schedule to include the use of autologous skin cell suspension (ASCS) prepared with RECELL for treating severe acute burn wounds in both adults and children [1][2] Company Overview - AVITA Medical, Inc. is a leading therapeutic acute wound care company focused on delivering transformative solutions that optimize wound healing and accelerate patient recovery [4] - The RECELL System is at the forefront of AVITA Medical's platform, approved by the U.S. Food and Drug Administration for treating thermal burn and trauma wounds [4] Clinical Impact - MSAC's endorsement highlights RECELL's clinical effectiveness, demonstrating that it is as safe and effective as traditional autologous skin grafting while offering superior outcomes in donor site sparing and reducing the need for additional grafting procedures [2][3] - RECELL can shorten hospital stays, alleviate patient pain, and minimize scarring, thus improving overall patient outcomes [2][3] Treatment Applications - The MSAC recommendation supports the use of RECELL for adult patients with burns covering 20% or more of total body surface area (TBSA) and pediatric patients with burns covering 10% or more TBSA, including whole-of-face burn wound closure [7]

Core Points - AVITA Medical has appointed Cary Vance as Interim CEO following the departure of Jim Corbett from the CEO position and the Board [1][4] - The Board plans to engage an executive search firm to find a permanent CEO, considering both internal and external candidates [2] - Cary Vance has over 30 years of experience in the healthcare industry and has held leadership roles in several innovative companies [3] Company Overview - AVITA Medical specializes in therapeutic acute wound care, focusing on innovative solutions to optimize wound healing and accelerate patient recovery [7] - The company's flagship product is the RECELL System, which is FDA-approved for treating thermal burn and trauma wounds, utilizing a patient's own skin to create Spray-On Skin™ Cells [7][8] - AVITA Medical also holds exclusive rights to market and distribute PermeaDerm and Cohealyx™, enhancing its product portfolio in wound care [7] Financial Performance - Preliminary revenue for the third quarter of 2025 is expected to be approximately $17 million [5][9] - The company has secured a waiver for the third quarter 2025 trailing 12-month net revenue covenant with OrbiMed and is in discussions to redefine future covenants [5] Leadership Transition - Jan Stern Reed has been appointed as Lead Independent Director, supporting the transition in leadership [1][4] - Cary Vance expressed commitment to advancing the company's innovative solutions and focusing on unlocking the full potential of its product portfolio [4]

Core Insights - AVITA Medical, Inc. has received New Technology Add-on Payment (NTAP) reimbursement approval from CMS for its RECELL system, effective October 1, 2025, for treating acute, non-burn trauma and surgical full-thickness wounds [1][2][8] - The NTAP will provide hospitals with supplemental reimbursement of up to $4,875 per case, in addition to standard CMS payments, and will remain in effect until September 30, 2026 [2][8] - The NTAP designation highlights the clinical value and innovation of RECELL, which reduces the need for donor skin and associated complications compared to traditional skin grafting methods [3][4] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on optimizing wound healing and accelerating patient recovery through innovative solutions [5] - The RECELL System, approved by the FDA, utilizes a patient's own skin to create Spray-On Skin Cells, offering a transformative approach to wound treatment [5] - In addition to RECELL, AVITA Medical holds rights to manufacture and distribute PermeaDerm and Cohealyx™, enhancing its product portfolio in the wound care market [5] Clinical Evidence - A multicenter, randomized-controlled trial published in the Journal of Trauma and Acute Care Surgery (2024) demonstrated that RECELL, when used with a widely meshed autograft, achieved comparable wound closure to standard skin grafting while requiring 27% less donor skin [4] - The study indicated that healing and safety outcomes were similar between RECELL and traditional methods, suggesting that RECELL can mitigate donor site complications without compromising results [4]

Company Overview - AVITA Medical, Inc. (NASDAQ: RCEL) specializes in full-thickness wound reconstruction with a comprehensive product portfolio [1] - The company offers RECELL and RECELL GO for point-of-care autologous "Spray-On Skin" applications [1] - Additional products include Cohealyx for graft-ready dermis and PermeaDerm as a protective biosynthetic cover, developed in partnership [1] Leadership and Expertise - Myriam Hernandez Alvarez holds multiple degrees in Electronics and Telecommunication Engineering, Computer Science, Business Management, and Computer Applications, showcasing a strong academic background [1]