Financial Data and Key Metrics Changes - Commercial revenue for Q2 2025 was $18.4 million, a 21% increase year-over-year, but flat sequentially due to reimbursement issues [6][45] - Gross profit margin for Q2 was 81.2%, down from 86.1% in the same period of 2024, primarily due to product mix and higher inventory reserves [45][46] - Net loss for Q2 was $9.9 million, or $0.38 per share, showing a 36% improvement from a net loss of $15.4 million, or $0.60 per share, in Q2 2024 [48] Business Line Data and Key Metrics Changes - The ReCell system, particularly ReCell Go, contributed significantly to revenue growth despite headwinds [45] - New products Co Helix and PermaDerm also contributed to revenue, with Co Helix showing strong early adoption [45][46] - Operating expenses decreased to $26.1 million from $28.7 million in Q2 2024, driven by reductions in sales and marketing costs [47] Market Data and Key Metrics Changes - The company experienced a 20% reduction in demand for ReCell in the first half of 2025 due to claims processing issues [15] - Recent data from the US National Burn Registry indicated a 36% reduction in hospital stay for burn patients treated with ReCell, enhancing its market value proposition [9][18] Company Strategy and Development Direction - The company is focused on resolving reimbursement issues and expects a rebound in demand for ReCell in the second half of 2025 [16][54] - A new outcomes-based partnership agreement has been established to incentivize hospitals to adopt ReCell, potentially increasing revenue significantly [26] - The company is expanding its product portfolio with Co Helix and Permuderm, targeting trauma centers and enhancing its competitive position [35][37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery in the second half of 2025, citing strong early indicators of demand and successful interactions with Medicare contractors [51][54] - The company revised its full-year 2025 revenue guidance to $76 million to $81 million, down from a previous estimate of $100 million to $106 million, reflecting the impact of the first half challenges [50][52] - Management highlighted the importance of clinical data showing the benefits of ReCell, which strengthens hospital economics and patient outcomes [54] Other Important Information - The company secured a waiver for its revenue covenant and amended its credit agreement with OrbiMed, demonstrating confidence in its long-term strategy [49] - The company is preparing for the launch of ReCell GO Mini, designed for smaller trauma wounds, which is expected to enhance adoption in outpatient settings [31][76] Q&A Session Summary Question: Update on claims backlog resolution - Management indicated that there has been significant progress in resolving claims processing issues, with increased interactions between Medicare contractors and stakeholders since June [58][61] Question: Premium for ReCell compared to traditional methods - Management noted that ReCell utilization and payment are expected to be significantly higher than traditional methods, with a notable premium as wound size increases [64] Question: Co Helix VAC approvals - Management refrained from disclosing specific VAC approval numbers but indicated that over 25% of burn centers have VAC approvals pending, which is a positive sign for early product adoption [67][70] Question: Update on ReCell GO Mini rollout - Management reported that the ReCell GO Mini is performing well, particularly in level one and two trauma centers, and is gaining traction among trauma surgeons [75][78] Question: Cash balance and burn rate - Management confirmed that the minimum cash balance requirement of $10 million has not been waived, and they do not expect to fall below this threshold [84][85] Question: ATM status and share availability - Management confirmed that the ATM is still in place, with approximately 3.8 million shares available for sale [89]

Financial Performance - Commercial revenue for Q2 2025 was $18.4 million, representing a 21% increase compared to $15.2 million in Q2 2024[10] - Net loss 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 the same period last year[16] - Total revenues for Q2 2025 reached $18,418,000, a 14.8% increase from $15,195,000 in Q2 2024[29] - Sales revenue for the first half of 2025 was $36,551,000, up 39.2% from $26,287,000 in the same period of 2024[29] - Gross profit for Q2 2025 was $14,949,000, compared to $13,084,000 in Q2 2024, reflecting a gross margin improvement[29] - Operating loss for Q2 2025 was $11,148,000, an improvement from a loss of $15,624,000 in Q2 2024[29] - Net loss for the first half of 2025 was $23,779,000, down from $34,051,000 in the first half of 2024, indicating a reduction in losses[29] - The company reported a basic and diluted net loss per share of $0.38 for Q2 2025, an improvement from $0.60 in Q2 2024[29] Expenses and Guidance - Total operating expenses decreased to $26.1 million in Q2 2025 from $28.7 million in Q2 2024, primarily due to a reduction in sales and marketing expenses[12] - AVITA adjusted its full-year 2025 revenue guidance to a range of $76 million to $81 million, down from the previous guidance of $100 million to $106 million[13] - Research and development expenses for the first half of 2025 were $11,400,000, compared to $10,081,000 in the same period of 2024, indicating continued investment in innovation[29] Cash Flow and Assets - As of June 30, 2025, AVITA had approximately $15.7 million in cash, cash equivalents, and marketable securities[18] - Cash and cash equivalents decreased to $12,216,000 as of June 30, 2025, from $14,050,000 at the end of 2024[27] - Total assets decreased to $58,134,000 as of June 30, 2025, down from $79,711,000 at the end of 2024[27] - Total liabilities increased to $70,981,000 as of June 30, 2025, compared to $74,968,000 at the end of 2024[27] Market Demand and Future Outlook - Demand for RECELL declined by approximately 20% in the first half of 2025, leading to an estimated revenue decline of about $10 million during this period[7] - The company anticipates reaching cash flow break-even in Q2 2026 and GAAP profitability in Q3 2026, later than previously expected[9] - RECELL reduces hospital stays by 36% according to real-world analysis of the national burn registry over five years[5] - AVITA received a waiver for the trailing 12-month net revenue covenant under its credit agreement with OrbiMed, which had been set at $78 million[17] Profitability Metrics - The gross profit margin for Q2 2025 was 81.2%, down from 86.1% in the same period last year, primarily due to product mix and higher inventory reserves[11]

Financial Performance & Outlook - Second quarter commercial revenue reached $18.4 million, a 21% increase compared to Q2 2024[8] - A backlog in unpaid provider claims impacted RECELL performance, resulting in an estimated $10 million reduction in RECELL revenue[14] and a ~20% drop in demand[13] - Full-year 2025 revenue guidance revised from $100 million - $106 million to $76 million - $81 million, reflecting a growth of ~19% to 27% compared to FY2024[38] - The company now anticipates cash flow break-even in Q2 2026 and GAAP profitability in Q3 2026[38] - Net loss decreased by 35.7%, and operating expenses decreased by 9.1%[37] Product Impact & Clinical Data - RECELL treatment achieves a significant 36% reduction in hospital Length of Stay (LOS) for patients with deep second-degree burns <30% total body surface area[11, 17] - Cohealyx enables autograft readiness in five to ten days, offering a faster path to healing for full-thickness wounds[11, 24] Market Expansion & Strategy - The U S Total Addressable Market (TAM) for burn and trauma with multi-product strategy is estimated at $3.5 billion[33] - Two major hospitals are expanding RECELL use to burns <20% TBSA, potentially adding ~150 additional patients per month[29] - VAC submissions are now active in ~25% of the ~130 U S burn centers[30]

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]