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].

Core Insights - AVITA Medical, Inc. will host its inaugural Acute Wound Care Showcase 2025 on May 13, 2025, via webcast [1] - The event will feature presentations from key executives and provide an overview of the company's approach to acute wound care [2][3] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on optimizing wound healing and accelerating patient recovery [4] - The RECELL® System is a key product, approved by the FDA for treating thermal burn wounds and full-thickness skin defects, utilizing a patient's own skin to create Spray-On Skin™ Cells [4] - The company also markets Cohealyx™, a collagen-based dermal matrix, and PermeaDerm®, a biosynthetic wound matrix, in the U.S. [4] Product Portfolio - The Acute Wound Care Showcase will highlight the company's product portfolio, including RECELL®, Cohealyx™, and PermeaDerm® [2] - The RECELL System is approved for various applications internationally, including burns and full-thickness skin defects, with regulatory approvals in Australia, Europe, and Japan [5] Event Details - The event will include testimonials from physicians and patients, showcasing the clinical and economic benefits of AVITA's technologies [3] - A live Q&A session will conclude the event, allowing for direct engagement with attendees [3]

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, Jim Corbett, will present at TD Cowen's 45th Annual Health Care Conference on March 4, 2025 [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 optimize wound healing and accelerate patient recovery [3] - The RECELL® System is FDA-approved for treating thermal burn wounds and full-thickness skin defects [3] - The company also markets Cohealyx™, a collagen-based dermal matrix, and PermeaDerm®, a biosynthetic wound matrix in the U.S. [3] International Approvals - The RECELL System is approved for various applications in international markets, including burns and skin defects [4] - It holds TGA registration in Australia, CE mark approval in Europe, and PMDA approval in Japan [4]

Group 1 - Avita Medical Inc. (RCEL) shares have increased by 20.5% in the past four weeks, closing at $10.22, with a mean price target of $15.60 indicating a potential upside of 52.6% [1] - The average price targets from analysts range from a low of $11 to a high of $21, with a standard deviation of $3.71, suggesting a variability in estimates [2] - Analysts show a consensus that RCEL will report better earnings than previously estimated, which is a positive indicator for potential stock upside [4][9] Group 2 - The Zacks Consensus Estimate for RCEL has increased by 30% due to two upward revisions in earnings estimates over the last 30 days, with no negative revisions [10] - RCEL holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for near-term upside [11] - While consensus price targets may not be reliable for predicting exact stock gains, they can provide a directional guide for price movement [12]

Core Viewpoint - The sequential sales decline in Q4 2024 may be overlooked if 2025 demonstrates consistent sequential sales growth that shareholders are anticipating [1] Group 1 - The company is expected to show sequential sales growth in 2025, which could mitigate concerns from the decline in Q4 2024 [1]

Q4 2024 Earnings Presentation February 13, 2025 Forward-Looking Statements & Legal Disclaimers 2024.Q4 v9 P 3 WHO WE ARE Accelerated Recovery with Therapeutic Acute Wound Care OUR MISSION Our mission is to position AVITA Medical as a leading therapeutic acute wound care company delivering transformative solutions. Our technologies are designed to optimize wound healing, effectively accelerating the time to patient recovery. OUR IMPACT This presentation and the accompanying oral commentary are "forward-looki ...