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]

Financial Data and Key Metrics Changes - For Q1 2025, the company's commercial revenue was $18.5 million, representing a 67% increase compared to the same period in 2024 [24] - The gross profit margin for Q1 was 84.7%, down from 86.4% in the same period of 2024, primarily due to volume discounts and product mix [25] - The net loss for Q1 was $13.9 million, improving from a net loss of $18.7 million in the same period in 2024 [28] 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 [24][30] - The company has expanded its product portfolio to include ReCell Go, ReCell Go Mini, Co Helix, and Permuderm, targeting both burn and trauma centers [13][21] 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 [5] - The trauma market is estimated to have approximately 270,000 cases annually in the US, which the new ReCell Go Mini product aims to address [8] 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 [20][52] - A significant shift in the commercial model has been implemented, moving from a service-oriented approach to a more focused selling-oriented approach [15][46] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, expecting to generate free cash flow in the second half of the year and achieve GAAP profitability in Q4 2025 [29][30] - The company is actively engaged in the public comment process for a proposed new technology add-on payment for ReCell, which could take effect on October 1 [20] Other Important Information - The company expects to save approximately $2.5 million per quarter in operating expenses due to recent transformations and operational efficiencies [27][29] - The annual meeting of stockholders is scheduled for June 4, encouraging participation [30] Q&A Session Summary Question: Response and performance of Co Helix during limited commercial launch - Management noted that early feedback from the limited market release of Co Helix was positive, with a notable case demonstrating faster graft readiness compared to other dermal matrices [33][34] Question: Revenue contributions from ReCell Go Mini - Management indicated that ReCell Go Mini is expected to be a material contributor to revenue, with plans to break out non-resale sales by Q3 [41][42] Question: Sales force adequacy to meet revenue targets - Management expressed confidence in the current sales force structure, which has been reconfigured to enhance selling capabilities across the product portfolio [43][46] Question: Revenue cadence expectations for the rest of the year - Management expects steady sequential growth throughout the year, with some weighting towards the back end as new product approvals are anticipated [48][49] Question: Status of the vitiligo initiative and reimbursement discussions - Management clarified that spending on the vitiligo initiative has been paused due to uncertainty in achieving reimbursement, focusing resources on acute wound care instead [52][53]

Market Opportunity - The company is positioned for leadership in a U S market exceeding $3 5 billion[7] - The Total Addressable Market (TAM) is scaling through portfolio expansion and efficient execution[7] - The company's TAM in the burn market alone is expanding from $450 million to $1 5 billion[9] Revenue Growth - The company has demonstrated sustained revenue growth with a strong Compound Annual Growth Rate (CAGR)[11] - In 2024, the company's commercial revenue reached $64 million[12] - The company estimates a CAGR of +47% through December 30, 2025, based on the midpoint of commercial revenue guidance for FY2025[12, 13] - The company's revenue has grown significantly from $10 million in 2019 to $64 million in 2024[12] Product Portfolio - The company's multi-product strategy enables case-level revenue growth[7] - The company's acute wound portfolio includes RECELL, Cohealyx, and PermeaDerm[9] - Potential revenue per case for a two-stage procedure (10% to 20% TBSA wound) could range from approximately $28,500 to $57,000[9]

Financial Performance - Total revenues for the three months ended March 31, 2025, were $18,514,000, representing a 67% increase from $11,104,000 for the same period in 2024[14] - Gross profit for the same period was $15,681,000, up from $9,591,000, indicating a significant improvement in profitability[14] - The net loss for the three months ended March 31, 2025, was $13,859,000, compared to a net loss of $18,658,000 for the same period in 2024, reflecting a reduction in losses by approximately 26%[14] - The company reported a comprehensive loss of $12,333,000 for the three months ended March 31, 2025, compared to a comprehensive loss of $19,839,000 for the same period in 2024[16] - Commercial sales revenue reached $18,450,000 for the three-months ended March 31, 2025, compared to $11,068,000 in 2024, reflecting a 66.5% growth[91] - The company reported a net loss of $13,859,000 for the three-months ended March 31, 2025, an improvement from a net loss of $18,658,000 in the same period of 2024[91] - Operating loss improved by 31% to $11.8 million for the three-months ended March 31, 2025, compared to $17.2 million in the prior year[122] Cash Flow and Liquidity - Cash and cash equivalents increased to $14,870,000 as of March 31, 2025, from $14,050,000 at the end of 2024, showing a positive cash flow trend[12] - Cash flow used in operating activities was $10,309,000 for the three months ended March 31, 2025, compared to $20,864,000 for the same period in 2024, indicating improved cash management[21] - As of March 31, 2025, the Company has an accumulated deficit of $373.7 million and used $10.3 million in cash for operating activities in Q1 2025, compared to $20.9 million in Q1 2024[28] - Cash and cash equivalents at the end of the period were $14.9 million, with sufficient reserves to fund operations for the next 12 months[129] - Net cash used in operating activities was $10.3 million for Q1 2025, a decrease from $20.9 million in Q1 2024, due to higher gross profit[133] - Net cash provided by investing activities was $10.8 million for Q1 2025, down from $15.1 million in Q1 2024, primarily due to lower cash inflows from marketable securities[134] Assets and Liabilities - The company had total liabilities of $74,063,000 as of March 31, 2025, slightly down from $74,968,000 at the end of 2024[12] - Total current assets decreased to $47,967,000 from $57,000,000, primarily due to a reduction in marketable securities[12] - The fair value of long-term debt was estimated at $41,464,000 as of March 31, 2025, down from $42,245,000 at the end of 2024[54] - The company has a contingent liability of $3.0 million as of March 31, 2025, related to the Regenity Agreement[97] Operating Expenses - Operating expenses for the three months ended March 31, 2025, totaled $27,508,000, slightly higher than $26,797,000 for the same period in 2024[14] - Total operating expenses increased by 3% or $0.7 million to $27.5 million compared to $26.8 million in the prior year[124] - Sales and marketing expenses rose by 17% or $2.2 million to $14.8 million, driven by increased salaries and commissions[125] - General and administrative expenses decreased by 29% or $2.6 million to $6.4 million, primarily due to reduced headcount and lower severance payments[126] - Research and development expenses increased by 21% to $6.3 million for the three-months ended March 31, 2025, compared to $5.2 million in the prior year[122] Product Development and Market Position - The RECELL GO Autologous Cell Harvesting Device was approved by the FDA in May 2024, introducing enhanced features for greater consistency in clinical settings[25] - The RECELL GO mini, approved in December 2024, is designed for smaller wounds up to 480 cm², supporting broader adoption in trauma centers[26] - The company initiated a full commercial launch of Cohealyx on April 1, 2025, expanding its therapeutic wound care portfolio[116] - The company plans to conduct post-market studies for Cohealyx and PermeaDerm in 2025 to support ongoing commercialization efforts[119] - The company aims to increase market penetration in U.S. burn centers and position RECELL GO as the standard of care in burn management[119] Compliance and Agreements - The company was not in compliance with the trailing 12-month net revenue covenant for Q1 2025, which was set at $73.0 million, but received a waiver for this covenant[30] - The trailing 12-month revenue covenant was amended to $73.0 million for Q1 2025, with a waiver received for non-compliance[131] - The company entered into a Distribution Agreement with Stedical, increasing its revenue share from 50% to 60% for PermeaDerm sales, with a target of $6.0 million in gross sales for 2025[94] - The company entered into a Credit Agreement providing a $90.0 million loan facility, with $40.0 million borrowed on the closing date[130] - The company filed several exhibits as part of its Quarterly Report on Form 10-Q, including amendments to its Certificate of Incorporation and Credit Agreement[152] Leadership and Governance - The management team is led by President and CEO James Corbett and CFO David O'Toole, indicating continuity in leadership[155] - The report includes certifications from the Chief Executive Officer and Chief Financial Officer, ensuring compliance with regulatory requirements[153]

Revenue and Growth - Commercial revenue for Q1 2025 was $18.5 million, representing a 67% increase from $11.1 million in Q1 2024[9] - The company expects full-year 2025 commercial revenue to be between $100 million and $106 million, reflecting a growth of approximately 55% to 65% compared to 2024[7] - Total revenues increased to $18,514 million for the three months ended March 31, 2025, compared to $11,104 million for the same period in 2024, representing a 66% growth[25] Profitability and Loss - Net loss for Q1 2025 was $13.9 million, or a loss of $0.53 per share, an improvement from a net loss of $18.7 million, or a loss of $0.73 per share, in Q1 2024[13] - Operating loss decreased to $11,827 million from $17,206 million, showing an improvement of 31%[25] - Net loss narrowed to $13,859 million, compared to a net loss of $18,658 million in the prior year, reflecting a 26% reduction[25] - Net loss per common share improved to $(0.53) from $(0.73) year-over-year[25] Expenses - Total operating expenses for Q1 2025 were $27.5 million, an increase from $26.8 million in Q1 2024, driven by higher sales and marketing expenses[11] - Total operating expenses increased to $27,508 million from $26,797 million, a rise of 2.6%[25] - Research and development expenses rose to $6,284 million, compared to $5,194 million, marking a 21% increase[25] - Sales and marketing expenses increased to $14,834 million from $12,640 million, reflecting a 17% increase[25] - Interest expense decreased to $1,233 million from $1,356 million, a reduction of 9%[25] Cash and Financial Position - As of March 31, 2025, the company had approximately $25.8 million in cash, cash equivalents, and marketable securities[14] - The company anticipates generating free cash flow in the second half of 2025 and achieving GAAP profitability in Q4 2025[7] Product Development and Launches - The company launched RECELL GO mini in February 2025 and initiated the nationwide launch of Cohealyx on April 1, 2025, expanding its product portfolio significantly[4] - The company expects to receive the CE mark for RECELL GO in the EU by mid-2025, preparing to meet supply demands upon approval[7] Gross Profit and Margin - Gross profit margin for Q1 2025 was 84.7%, down from 86.4% in the same period last year, primarily due to volume discounts and product mix[10] - Gross profit rose to $15,681 million, up from $9,591 million year-over-year, indicating a 64% increase[25] - The average sales price for Cohealyx is 50% and for PermeaDerm is 60%, which impacts the overall gross margin percentage[10] Shareholder Information - Weighted-average common shares increased to 26,253,565 from 25,637,783, indicating a 2.4% rise[25]

Core Insights - AVITA Medical has transitioned from a single-product company focused on burn treatment to a multi-product platform in the therapeutic acute wound care market, with a market opportunity expanding from $455 million to over $3.5 billion [3][6]. Financial Performance - For Q1 2025, AVITA Medical reported commercial revenue of $18.5 million, a 67% increase from $11.1 million in Q1 2024, driven by deeper customer penetration and new product launches [6][9]. - The gross profit margin for the quarter was 84.7%, down from 86.4% in the same period last year, primarily due to volume discounts and product mix [10]. - Total operating expenses increased to $27.5 million from $26.8 million in Q1 2024, with a notable rise in sales and marketing expenses [11]. Product Developments - The company launched RECELL GO mini in February 2025, targeting smaller wounds in U.S. trauma centers, and initiated the nationwide launch of Cohealyx on April 1, 2025 [6][9]. - AVITA Medical aims to drive adoption of RECELL GO and Cohealyx while continuing to develop clinical data for its products [7]. Future Guidance - The company expects full-year 2025 commercial revenue to be between $100 million and $106 million, reflecting a growth of approximately 55% to 65% compared to 2024 [7]. - AVITA Medical anticipates generating free cash flow in the second half of 2025 and achieving GAAP profitability in Q4 2025 [7]. Cash Position and Liabilities - As of March 31, 2025, AVITA Medical had approximately $25.8 million in cash and marketable securities, with a waiver secured for the first quarter trailing 12-month revenue covenant [14]. - Total liabilities stood at $74.1 million, with long-term debt at $41.5 million [23].