Core Insights - AVITA Medical, Inc. announced preliminary financial results for Q4 and fiscal year 2025, along with an outlook for fiscal year 2026, highlighting a shift from stabilization to growth execution [1][2] Financial Performance - Total net revenues for Q4 2025 were approximately $17.6 million, a decrease from $18.4 million in Q4 2024 [6] - Total revenues for the full year 2025 were approximately $71.6 million, an increase of about 11% compared to $64.3 million in 2024, aligning with the company's revised revenue guidance [6] - Full year 2026 revenue is expected to be in the range of approximately $80 to $85 million, representing growth of approximately 12% to 19% compared to 2025 [6] Capital Structure and Financing - The company closed a five-year credit facility with Perceptive Advisors, providing up to $60 million in capital, with an initial funding of $50 million [2][4] - The proceeds from the credit facility will be used to repay outstanding debt and support the growth of the acute wound care portfolio [2][4] - The new credit facility includes trailing twelve-month (TTM) revenue covenants, with an initial TTM revenue covenant set at $68.5 million for Q1 2026 and $73 million for the full year 2026 [3] Clinical and Commercial Developments - The Cohealyx-I study is fully enrolled, and the PermeaDerm-I study has surpassed 75% enrollment as of December 2025, with data expected later in 2026 [6] - The company is positioned to leverage its differentiated position in acute wound care for value creation through commercial execution and clinical advancement [4]

Core Insights - AVITA Medical, Inc. has appointed Joe Woody as a new non-executive Director, while Lou Panaccio has retired after serving as Chairman for over a decade [1][7] Company Leadership Changes - Joe Woody brings over two decades of leadership experience in the medical technology sector, having previously served as CEO of Avanos Medical and President and CEO of Acelity Holdings [2] - Lou Panaccio has been recognized for his significant contributions to the company's commercial and operational strategy during his tenure [2][3] Company Overview - AVITA Medical specializes in therapeutic acute wound care, focusing on innovative solutions that optimize wound healing and accelerate patient recovery [4] - 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 [4] - In addition to RECELL, AVITA holds exclusive rights to market and distribute PermeaDerm and Cohealyx, both of which are advanced wound care products [4] International Market Presence - The RECELL System is also approved in international markets for a variety of applications, including thermal burn and trauma wounds, with regulatory clearances in Europe, Australia, and Japan [5]

Core Insights - AVITA Medical, Inc. is a leading company in therapeutic acute wound care, focusing on innovative solutions for wound healing [3][4] - The CEO, Cary Vance, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026 [1] - The RECELL System is a key product that utilizes a patient's own skin to create Spray-On Skin™ Cells, enhancing clinical outcomes [3] Company Overview - AVITA Medical specializes in technologies that accelerate patient recovery from wounds [3] - The RECELL System is FDA-approved for treating thermal burn and trauma wounds, and is also recognized in international markets [4] - The company holds exclusive rights to market and distribute PermeaDerm and Cohealyx™, which are additional wound care products [3][4] Presentation Details - A live audio webcast of the upcoming presentation will be available on AVITA Medical's website [2] - A replay of the webcast will be accessible after the event concludes [2]

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 - AVITA Medical reported a commercial revenue of $17.1 million for Q3 2025, a 13% decrease from $19.5 million in Q3 2024, primarily due to reimbursement challenges [6][10] - The company expects full-year revenue for 2025 to be between $70 million and $74 million, down from previous guidance of $76 million to $81 million [16] - AVITA Medical's cash management improved, with net cash use decreasing to $6.2 million in Q3 from $10.1 million in Q2 2025 [9][15] Financial Results - Commercial revenue for Q3 2025 was $17.1 million, a decrease of $2.5 million or 13% compared to the same period in 2024 [6][10] - Operating expenses decreased by 24% to $23.0 million, down from $30.2 million in Q3 2024, reflecting cost management strategies [12][9] - Net loss improved to $13.2 million, or $0.46 per share, compared to a net loss of $16.2 million, or $0.62 per share, in Q3 2024 [14] Other Quarterly Milestones - The company is focusing on approximately 200 key U.S. burn and trauma centers, targeting an addressable market of roughly $1.3 billion [3][8] - AVITA Medical received CE Mark approval for RECELL GO® in September, allowing for commercialization in Europe, starting with Germany, Italy, and the UK [5] - The reimbursement environment for RECELL has normalized, with all seven Medicare Administrative Contractors confirming payment rates [4] Clinical and Regulatory Milestones - RECELL demonstrated its effectiveness in achieving wound closure with less donor skin and faster healing, supported by data from over 8,000 patients [7] - Real-world data indicated a 36% reduction in hospital stay length and approximately $42,000 in cost savings per patient compared to traditional methods for treating second-degree burns [7] Portfolio Execution - AVITA Medical's strategy focuses on an integrated portfolio of RECELL, Cohealyx, and PermeaDerm, aiming for disciplined growth in the acute wound care market [8] - The company currently serves about 5% of the $1.3 billion addressable market, indicating significant growth potential [8]

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]