Financial Results - Commercial revenue for Q2 2025 was $18.4 million, representing a 21% increase compared to $15.2 million in Q2 2024 [8][12] - Net loss for Q2 2025 improved to $9.9 million, or a loss of $0.38 per share, compared to a net loss of $15.4 million, or a loss of $0.60 per share in Q2 2024 [8][16] - Total operating expenses decreased to $26.1 million in Q2 2025 from $28.7 million in Q2 2024, primarily due to reductions in sales and marketing expenses [8][14] Business Update - Demand for RECELL was dampened in the first half of 2025 due to delays in provider payments, leading to a backlog of unpaid claims [6][9] - The Centers for Medicare and Medicaid Services (CMS) approved New Technology Add-on Payment (NTAP) for the RECELL System for inpatient trauma wounds [8][10] - AVITA anticipates recovery in RECELL demand in the second half of 2025 as claims backlog is resolved [10] Clinical Highlights - RECELL reduces hospital stays by 36% based on real-world analysis from the national burn registry over five years [5][8] - Cohealyx achieves autograft readiness in as little as five days, with first clinical results published [8] Strategic Developments - The company amended credit terms with OrbiMed, lowering revenue covenants and issuing common stock in lieu of cash payment [8][11] - Michael Tarnoff, MD, FACS, was appointed to the Board of Directors, bringing extensive healthcare leadership experience [8] Guidance Adjustments - Full-year 2025 revenue guidance was revised to a range of $76 million to $81 million, down from previous guidance of $100 million to $106 million [11][15] - The company expects to reach cash flow break-even in Q2 2026 and GAAP profitability in Q3 2026, later than previously anticipated [11][15]

Core Insights - AVITA Medical, Inc. has appointed Dr. Michael Tarnoff as a non-executive Director to its Board of Directors, effective August 6, 2025, to enhance its focus on patient-centric wound-healing technologies [1][2] - The company has also announced the resignation of Lou Panaccio as Board Chair, with Cary Vance elected to take over the position effective August 7, 2025 [2][3] Company Developments - Dr. Tarnoff's extensive experience includes 23 years at Tufts Medical Center and leadership roles at Medtronic and Covidien, which will contribute to AVITA's growth in therapeutic acute wound care [4][7] - Cary Vance, with over 25 years of executive leadership in the healthcare industry, is expected to drive innovation and support the company's mission [5][7] Product and Technology Focus - AVITA Medical specializes in therapeutic acute wound care, with its flagship product, the RECELL System, designed to optimize wound healing and accelerate patient recovery [6][8] - The RECELL System is FDA-approved for treating thermal burn wounds and trauma wounds, utilizing a patient's own skin to create Spray-On Skin Cells [6][8]

Core Insights - AVITA Medical, Inc. will report its second quarter 2025 financial results on August 7, 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 wounds and full-thickness skin defects, utilizing a patient's own skin to create Spray-On Skin Cells [3] - In the U.S., AVITA Medical has exclusive rights to manufacture and distribute 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 burns and full-thickness skin defects [4] - The system is TGA-registered in Australia, has received CE mark approval in Europe, and has PMDA approval in Japan [4]

Core Insights - AVITA Medical's RECELL technology demonstrates significant clinical benefits, including reduced hospital stays for burn patients, as highlighted in a recent study presented at the British Burn Association Annual Meeting [1][3] - The RECELL system utilizes a small sample of a patient's skin to create Spray-On Skin™ Cells, which leads to faster healing and less pain compared to traditional skin grafting methods [2][5] - The analysis of over 6,300 patients indicates a reduction in hospital stay by an average of 6.2 days or 35.7% when treated with RECELL compared to split-thickness autografts, resulting in approximately $300 million in cost savings over five years [8] Company Overview - AVITA Medical is a leader in therapeutic acute wound care, focusing on innovative solutions that enhance wound healing and accelerate patient recovery [5] - The RECELL System is FDA-approved for treating thermal burn wounds and full-thickness skin defects, and it is used in over 130 burn centers across the United States [4][5] - The company also holds exclusive rights to manufacture and distribute other wound care products, including PermeaDerm and Cohealyx™ [5] Market Impact - The RECELL technology is gaining traction in international markets, with approvals in Australia, Europe, and Japan for various skin healing applications [6] - The findings from the national registry analysis provide a clearer understanding of how RECELL influences clinical decisions and patient outcomes, reinforcing its economic value in healthcare [3][8]

Core Insights - AVITA Medical, Inc. announced the first clinical publication evaluating Cohealyx™, a collagen-based dermal matrix, which showed significantly faster wound bed vascularization and autograft readiness compared to conventional matrices, achieving readiness in 5 to 10 days instead of the typical two to four weeks [1][2][3] 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 [6] - The company’s flagship product, the RECELL System, is FDA-approved for treating thermal burn wounds and full-thickness skin defects, utilizing a patient's own skin to create Spray-On Skin Cells [6][7] Clinical Findings - In a case series at The Ohio State University Wexner Medical Center, two patients with complex hand wounds treated with Cohealyx achieved autograft readiness in 7 to 13 days, demonstrating accelerated integration and vascularization [2][3] - The publication highlights that these outcomes can significantly reduce patient burden and lower associated complication risks [2] Technological Innovation - Cohealyx is bioengineered using proprietary TetraPure Technology, featuring crosslinked, purified collagen types I and III, which supports optimal cellular migration and rapid revascularization [3] - Preclinical studies indicated wound bed readiness as early as day 7, and the recent publication serves as the first clinical validation of these findings [3] Publication Details - The full paper titled "A Bovine Dermal Collagen Matrix (BDCM) Advances Readiness to Autografting: A Case Series" is available online, providing further insights into the clinical efficacy of Cohealyx [4]

Core Insights - AVITA Medical's RECELL technology has been awarded "Best New Technology Solution – Surgical" at the 2025 MedTech Breakthrough Awards, highlighting its innovative approach in acute wound care [1][4] - RECELL has treated over 30,000 patients globally and is FDA-approved for thermal burn wounds and full-thickness skin defects, demonstrating significant clinical benefits such as reduced donor skin requirements and faster recovery times [2][6] - The introduction of RECELL GO enhances procedural consistency and surgical team coordination, making it suitable for high-volume burn and trauma centers [3] Company Overview - AVITA Medical specializes in therapeutic acute wound care, focusing on technologies that optimize wound healing and accelerate patient recovery [6] - The RECELL System utilizes a patient's own skin to create Spray-On Skin Cells, providing an innovative solution for improved clinical outcomes [6][7] - In addition to RECELL, AVITA holds exclusive rights to manufacture and distribute PermeaDerm and Cohealyx in the U.S., expanding its product portfolio in wound care [6] Awards and Recognition - Dr. Katie Bush, Senior Vice President of Scientific & Medical Affairs at AVITA Medical, received the 2025 Emerald Pinnacle Healthcare Award, recognizing exceptional innovation and leadership in the medical device sector [5]

Core Insights - AVITA Medical, Inc. has been recognized for its RECELLⓇ technology, winning the "Best New Technology Solution – Surgical" at the 2025 MedTech Breakthrough Awards, highlighting its innovative approach in acute wound care [1][4] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on delivering transformative solutions, with its flagship product being the RECELL System, which is FDA-approved for treating thermal burn wounds and full-thickness skin defects [6][7] - The RECELL System utilizes a patient's own skin to create Spray-On Skin™ Cells, optimizing wound healing and accelerating recovery times [6] Product Benefits - RECELL has treated over 30,000 patients globally and requires significantly less donor skin compared to traditional grafting methods, which reduces donor-site pain and accelerates healing [2][4] - The introduction of RECELL GO enhances procedural consistency and surgical team coordination, making it suitable for high-volume burn and trauma centers [3] Recognition and Awards - In addition to the MedTech Breakthrough Award, Dr. Katie Bush, Senior Vice President of Scientific & Medical Affairs at AVITA Medical, received the 2025 Emerald Pinnacle Healthcare Award for her contributions to innovation and leadership in the medical device sector [5] Market Approvals - The RECELL System is approved for various applications in international markets, including burns and vitiligo, and has received regulatory approvals in Australia, Europe, and Japan [7]

Summary of AVITA Medical (RCEL) Update / Briefing May 13, 2025 Company Overview - **Company**: AVITA Medical - **Industry**: Therapeutic Acute Wound Care - **Transformation**: Shifted from a regenerative tissue company to a therapeutic acute wound care company, focusing on acute wounds rather than chronic wounds [2][6][67] Core Products and Innovations - **Resell Technology**: A flagship product that allows for skin regeneration using a small sample of healthy skin, processed into a sprayable suspension [29][30] - **Product Portfolio**: - **Resell**: First and only in its category, with a significant skin-sparing effect [30] - **Permeoderm**: A biosynthetic dressing that replicates lost epidermis, reducing dressing changes and trauma during application [38][40] - **Cohelix**: A collagen-based dermal matrix designed for faster wound bed preparation and revascularization [49][51] Market Opportunity - **Total Addressable Market (TAM)**: Expanded from $455 million in burns to $3.5 billion in the U.S. across trauma and skin grafts [17][67] - **Patient Impact**: Products aim to reduce hospital length of stay and improve healing times, with significant cost savings for healthcare providers [34][46][57] Financial Performance - **Revenue Growth**: Reported $18.5 million in commercial revenue, a 67% increase from the previous year [68] - **Profitability**: Expected to achieve GAAP profitability by Q4 2025, with a reaffirmed revenue guidance of $100 million to $106 million for the year [70][94] Clinical Evidence and Studies - **Clinical Trials**: Ongoing studies to validate the effectiveness of Cohelix and Permeoderm, with interim results expected throughout 2025 [82][83] - **Patient Testimonials**: Positive patient experiences highlight the effectiveness of Resell in reducing healing time and improving cosmetic outcomes [61][66] Strategic Initiatives - **Sales Model Transformation**: Streamlined sales force from 108 to 82, focusing on efficiency and broader product adoption [75][93] - **Manufacturing Agreement**: Collaboration with Stethical Scientific to reduce costs and improve profitability for Permeoderm [80][81] Future Outlook - **Growth Strategy**: Plans to expand product offerings and market presence in trauma centers, leveraging the new product portfolio [89][90] - **Long-term Vision**: Aiming for sustained profitability and cash flow generation, with a focus on enhancing clinical and economic evidence [102][103] Key Takeaways - AVITA Medical is positioned for significant growth in the therapeutic acute wound care market, with innovative products that address critical patient needs and improve healthcare efficiency [67][101]

Core Insights - AVITA Medical, Inc. is hosting its Acute Wound Care Showcase 2025 virtually, focusing on innovations in acute wound care and patient outcomes [1][2] - The event features presentations from key executives and clinicians, highlighting the company's technologies such as RECELL, Cohealyx, and PermeaDerm [1][3] - The RECELL System is a significant product that utilizes a patient's own skin to create Spray-On Skin™ Cells, enhancing wound healing and recovery [3] Company Overview - AVITA Medical is recognized as a leading therapeutic acute wound care company, aiming to optimize wound healing and accelerate patient recovery [3] - The RECELL System is FDA-approved for treating thermal burn wounds and full-thickness skin defects, showcasing the company's innovative approach to wound care [3] - In international markets, the RECELL System has received various approvals, including TGA registration in Australia, CE mark in Europe, and PMDA approval in Japan [4]

Financial Data and Key Metrics Changes - Revenue for the first quarter increased by 67% compared to the same period in the prior year, reaching $18.5 million [6][25] - Gross profit margin for the first quarter was 84.7%, down from 86.4% in the same period of 2024 [26] - Net loss for the first quarter was $13.9 million, improving from a net loss of $18.7 million in the same period in 2024 [30] Business Line Data and Key Metrics Changes - The launch of ReCell Go Mini and Co Helix is expected to significantly contribute to revenue growth throughout 2025 [25][32] - The commercial lineup now includes ReCell, ReCell Go, ReCell Go Mini, Co Helix, and Permeoderm, providing a broad spectrum of products for both burn and trauma centers [14][15] Market Data and Key Metrics Changes - The US addressable market for the company has expanded from approximately $500 million to over $3.5 billion annually, marking a seven-fold increase [6][22] - The trauma market is estimated to have approximately 270,000 cases annually in the US, which ReCell Go Mini targets [10] Company Strategy and Development Direction - The company is focusing on acute wound care, stepping back from further commercial investment in the vitiligo indication due to uncertainty in reimbursement [21][56] - A significant shift in the commercial model has been implemented, transitioning from a service-oriented approach to a more focused selling-oriented approach [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential for strong results driven by the expanded product portfolio and operational efficiencies [22][32] - The company expects to generate free cash flow in the second half of the year and achieve GAAP profitability in Q4 of 2025 [31][32] Other Important Information - The company has secured a waiver for its first-quarter trailing twelve-month revenue covenant with OrbiMed, which had been set at $73 million [31] - The annual meeting of stockholders is scheduled for June 4 [32] Q&A Session Summary Question: Can you share any response or performance impressions of Co Helix? - Management noted that early feedback has been positive, with a case from Ohio State demonstrating a seven-day graft readiness, which is faster than other dermal matrices [36][37] Question: How is the rollout of ReCell Go Mini going? - The response has been good, particularly from existing accounts in the trauma area, with opportunities to provide more value to trauma surgeons [41][42] Question: What are the expected revenue contributions from the new launches? - Management indicated that while they are not ready to provide specific guidance, they expect these products to be material contributors to revenue [45] Question: Is the sales force adequately staffed to meet revenue targets? - Management expressed confidence in the current staffing levels and the reconfigured sales model, which focuses on a selling-oriented approach [47][49] Question: What is the expected revenue cadence for the rest of the year? - Management anticipates steady sequential growth throughout the year, with some weighting towards the back end as new products gain traction [51][52] Question: What is the current status of the vitiligo initiative? - The company has paused spending on vitiligo due to uncertainty in reimbursement and is focusing resources on acute wound care instead [56][58]