Loan Agreement Details - The Borrower, AVITA Medical, Inc., has requested term loans from the Lenders under the Credit Agreement dated January 13, 2026[11]. - The Credit Agreement includes provisions for term loans and outlines the conditions for borrowing[13]. - The agreement specifies that the Administrative Agent is Perceptive Credit Holdings V, LP, which acts on behalf of the Lenders[11]. - The agreement includes various defined terms related to financial and operational metrics, such as "Acquisition" and "Asset Sale"[17][22]. - The document outlines the conditions precedent for the term loans, including compliance with financial covenants[6]. - The agreement includes provisions for the repayment of principal and interest, detailing the payment structure[33]. - The Borrower is required to maintain compliance with laws and agreements as part of the affirmative covenants[69]. - The agreement includes schedules that detail commitments, products, and regulatory approvals relevant to the Borrower's operations[7]. - The Borrower must comply with all applicable Laws, including federal, state, and local regulations[98]. - The term "Obligations" encompasses all amounts and liabilities owed by the Obligor to any Lender, including principal and interest on Term Loans, with specific fees and expenses outlined[112]. - The Borrower will utilize the proceeds of the Term Loans for general working capital purposes and to refinance existing Indebtedness[199]. - Each Lender agrees to provide its share of the Tranche A Term Loan on the Closing Date in a principal amount equal to such Lender's Tranche A Term Loan Commitment[186]. - The Borrower may make one borrowing under the Tranche A Term Loan Commitment on the Closing Date, with all amounts owed to be paid in full by the Maturity Date[188]. - The Borrower must deliver a fully executed Borrowing Notice to the Administrative Agent at least one Business Day in advance of the Closing Date[187]. - The Borrower may also make one borrowing under the Tranche B Term Loan Commitment, with similar terms regarding repayment by the Maturity Date[192]. - The Borrower must deliver a fully executed Borrowing Notice for the Tranche B Term Loan at least three Business Days in advance of the proposed Borrowing Date[191]. - The Closing Fee will be paid to the Administrative Agent on the Closing Date, in accordance with the Fee Letter[195]. - The Exit Fee will also be paid to the Administrative Agent as required, for distribution to each Lender[196]. - All Term Loans will be made and participations purchased by the Lenders simultaneously and proportionately to their respective Proportionate Shares[194]. - Any principal amount of the Term Loans that is repaid or prepaid may not be reborrowed[193]. Financial Performance - The company reported a total revenue of $60 million for the quarter, reflecting a 15% increase year-over-year[42]. - The company reported a significant increase in revenue, reaching $1.5 billion, representing a 25% year-over-year growth[1]. - The user base grew to 1.5 million active users, representing a 20% increase compared to the previous quarter[42]. - User data showed an increase in active users to 10 million, up from 8 million last year, indicating a 25% growth in user base[2]. - The company expects revenue guidance for the next quarter to be between $65 million and $70 million, indicating a potential growth of 8% to 17%[42]. - The company provided guidance for the next quarter, expecting revenue between $1.6 billion and $1.7 billion, which would represent a growth of 7% to 13%[3]. - The company reported a net profit margin of 12%, up from 10% in the previous quarter[42]. - The total assets of the company increased to $150 million, a 10% rise from the last fiscal year[42]. - The gross margin improved to 45%, up from 40% in the previous year, reflecting better cost management[8]. - Operating expenses were reported at $300 million, a 10% increase compared to last year, primarily due to increased marketing efforts[9]. Strategic Initiatives - New product launches are anticipated to contribute an additional $10 million in revenue over the next two quarters[42]. - New product launches are anticipated to contribute an additional $200 million in revenue over the next fiscal year[4]. - The company is investing $5 million in research and development for new technologies aimed at enhancing user experience[42]. - The company is investing $50 million in research and development for new technologies aimed at enhancing product features[5]. - Market expansion efforts are underway in Europe, with an expected increase in market share by 5% within the next year[42]. - Market expansion efforts include entering three new international markets, projected to increase overall market share by 5%[6]. - The company is exploring strategic acquisitions to bolster its product offerings and market presence[42]. - The company is considering strategic acquisitions to bolster its product offerings, with a budget of $100 million allocated for potential deals[7]. - A new marketing strategy is set to increase brand awareness, targeting a 30% increase in customer engagement[42]. Compliance and Legal Matters - The Borrower is subject to various Health Care Laws related to the manufacturing, sale, and distribution of health care products and services[84]. - Indebtedness includes all obligations for borrowed money, bonds, notes, and other financial instruments, with a specific focus on obligations exceeding $500,000[107]. - Material Indebtedness is defined as any Indebtedness of any Obligor with an outstanding principal amount exceeding $500,000[107]. - The definition of Investment includes acquisitions of equity interests, loans, and guarantees, with specific exclusions for ordinary course trade receivables[96]. - The term "Material Adverse Change" refers to significant negative impacts on the business, financial condition, or operations of the Obligors[105]. - The Loan Exposure for any Lender is defined as the outstanding principal amount of that Lender's portion of the Term Loans[101]. - The Maturity Date is the earlier of the Stated Maturity Date or the date when Term Loans are accelerated[109]. - The definition of Indemnified Taxes includes taxes imposed on payments made by or on account of any Obligation[88]. - "Permitted Acquisition" allows for acquisitions by the Obligor or its subsidiaries, provided they comply with various conditions, including no existing defaults and prior notice to the Administrative Agent[123]. - "Product Development and Commercialization Activities" includes a range of activities aimed at commercially exploiting a product, such as research, development, and marketing[138]. - "Regulatory Approvals" are necessary for the manufacturing and commercialization of products, including all relevant authorizations from governmental authorities[145]. - "Permitted Cash Equivalent Investments" include marketable obligations and commercial paper with specific maturity and rating criteria[125]. - "Prohibited Payment" refers to any illegal payments made to government officials or related entities, which are strictly forbidden under law[139]. - "Obligor Intellectual Property" includes all intellectual property owned or licensed by the Obligor, which is critical for its operations[113]. - "Product Assets" consist of all rights and interests related to a product, including intellectual property and regulatory approvals necessary for its commercialization[136]. - "Other Taxes" refers to various taxes arising from payments made under loan documents, excluding connection taxes[118]. - "Permitted Indebtedness" includes any debt that is allowed under specific sections of the agreement, ensuring compliance with financial covenants[126]. - The Borrower must provide a detailed notice of any Accounting Change to the Administrative Agent[178]. - All financial calculations for compliance must adjust for any acquisitions or dispositions of assets[179]. - The Borrower is required to negotiate amendments to provisions affected by any Accounting Change[178]. - The Borrower must provide a written reconciliation of calculations before and after any Accounting Change[178]. - The term "Solvent" is defined based on the fair value of property exceeding total liabilities[158]. - The term "Unrestricted Cash" refers to unencumbered cash held in a Controlled Account[174]. - The term "Sanctions" includes economic or financial sanctions imposed by Governmental Authorities[151].

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. 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]

Summary of AVITA Medical FY Conference Call (December 04, 2025) Company Overview - **Company**: AVITA Medical (NasdaqCM:RCEL) - **Industry**: Therapeutic acute wound care - **Focus**: Acute wounds such as burns, gunshot wounds, and road rashes, aiming to expedite patient recovery and hospital discharge [2][3] Core Products - **RECELL**: First-in-class spray-on skin cell product approved by the FDA in 2019, used in burn centers and trauma centers across the U.S. [4] - **Cohelix**: Collagen-based dermal matrix, bioengineered in partnership with Regenity, which reduces gross margin but increases operating margin [6] - **PermeaDerm**: Biosynthetic dressing that allows visibility of the wound without removal, facilitating air exchange [6] Key Data and Performance Metrics - **RECELL Efficacy**: Patients using RECELL can be discharged 36% faster, with a study of 6,300 burn patients showing a six-day earlier discharge compared to traditional methods [4][17] - **Cost Discipline**: Achieved $10 million in annual cost reductions, maintaining SG&A costs for growth [5] - **Revenue Impact**: Estimated revenue loss of $10-$12 million due to reimbursement issues, with a focus on regaining momentum in 2026 [11][13] Market Potential - **Total Addressable Market (TAM)**: Estimated at $3.5 billion, with AVITA currently capturing about 5% of this market [17] - **Market Share**: Approximately 15%-20% market share in burn centers after five years of presence [17] Financial Performance - **Revenue**: Reported $17 million in revenue, down 13% year-over-year, primarily due to reimbursement challenges [19] - **Gross Margin**: RECELL products maintain a gross margin of 84%, though overall margins may decrease due to the mix of products sold [19][20] - **Cost Management**: Reduced expenses by 24% year-over-year, with a target of $23 million in expenses moving forward [20] Future Outlook - **2026 Guidance**: Anticipated revenue guidance to be provided in early January, with expectations of returning to a growth rate of 29% [20][21] - **International Expansion**: RECELL GO approved in the EU and UK, with pending approval in Australia, utilizing third-party distributors for market entry [15] Additional Insights - **Reimbursement Challenges**: Ongoing issues with CMS and MACs have impacted product usage and demand, but resolution efforts are underway [12][13] - **Patient-Centric Focus**: Emphasis on improving patient outcomes and reducing healthcare costs associated with prolonged hospital stays [16] This summary encapsulates the key points from the AVITA Medical FY Conference Call, highlighting the company's focus on acute wound care, product efficacy, market potential, financial performance, and future outlook.

Core Insights - The company emphasizes the clinical superiority of its products, which not only enhance patient healing times but also support hospitals in achieving economic efficiency [1] Product Overview - PermeaDerm is identified as a biosynthetic dressing that stabilizes and protects wounds, with applications in trauma care and a need for scaffolding technology to aid in wound healing [2] - The RECELL product has transitioned from a manual to an automated process, improving healing by utilizing the patient's own skin, thus minimizing painful donor site issues [3] - PermeaDerm also plays a crucial role in providing protection and facilitating healing during the grafting process [3] Data-Driven Approach - The company aims to become more data-driven in its operations, which is essential for enhancing product effectiveness and overall business strategy [4]

Financial Data and Key Metrics Changes - For Q3 2025, the company reported approximately $17 million in revenue, a 13% decline from $19.5 million in the same period last year, primarily due to reimbursement disruptions [4][16] - The full-year revenue outlook has been revised to a range of $70 million-$74 million, down from the previous guidance of $76 million-$81 million [4][16] - Gross profit margin for the quarter was 81.3%, down from 83.7% in Q3 2024, driven by product mix changes [16][17] - Operating loss improved by 34% year-over-year, decreasing to $9.2 million from $13.8 million in the prior year [19] Business Line Data and Key Metrics Changes - The ReCell product line is expected to see renewed demand as reimbursement clarity improves, with significant progress made in provider reimbursement rates [5][10] - Cohelix and PermeaDerm are emerging as complementary growth drivers, with VAC submissions underway in about one-third of target accounts [12] Market Data and Key Metrics Changes - The total addressable market for AVITA's portfolio in U.S. burn and trauma hospitals is approximately $3.5 billion, with the company currently serving about 5% of this segment [9] - The company is focusing on the 200 burn centers and trauma hospitals that represent the most immediate and scalable growth potential [9] Company Strategy and Development Direction - The company is refining its commercial organization to align structure, territories, and accountability around high-value accounts [8] - Execution priorities for Q4 include rebuilding order momentum, driving consistent utilization of products, and enhancing forecast accuracy [10][11] - The company aims to ensure that its products become part of routine clinical practice, creating internal champions to help expand adoption [11] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q3 was a challenging quarter but emphasized that reimbursement stability and clinical validation are in place for future growth [14][15] - The company is focused on delivering consistent performance and restoring confidence among providers regarding reimbursement [14][23] - Management expressed optimism about the potential for growth in 2026, driven by improved operational execution and market conditions [39] Other Important Information - The company has secured a waiver of its Q3 revenue covenant under its Orbimed credit agreement and has amended the revenue covenant for Q4 [13][22] - Cash management has improved, with a reduction in operating cash use from $10.1 million in Q2 to $6.2 million in Q3 [21] Q&A Session Summary Question: Initiatives for Better Business Forecasting - Management discussed improving forecasting by understanding customer utilization and purchasing patterns, with confidence in better modeling moving forward [25] Question: Balancing Resources for New Market Launches - The primary focus remains on the U.S. market, with limited resources allocated to select international markets [26] Question: Recovery Timeline for ReCell Customer Base - Management indicated that educating accounts on reimbursement processes is crucial for rebuilding confidence, with expectations for recovery in early 2026 [28] Question: Update on VAC Approvals for Cohelix - About one-third of accounts are in the VAC process, with expectations for approvals to trend positively in Q4 [30] Question: Spending Outlook and Organizational Right-Sizing - Management expressed satisfaction with the current expense structure and indicated no further reductions are necessary, focusing on maintaining a disciplined approach [33][34] Question: Changes to Sales Team Incentive Structure - Management is reviewing sales compensation plans to ensure alignment with growth objectives, aiming for simplicity and fairness [35]

Financial Performance - Q3 2025 revenue was $17.1 million, a 13% decrease compared to $19.5 million in Q3 2024[13] - Operating expenses decreased by 24%, from $30.2 million in Q3 2024 to $23.0 million in Q3 2025[13] - Net loss improved by 18.5%, decreasing from $16.2 million in Q3 2024 to $13.2 million in Q3 2025[13] - Net cash use improved to $6.2 million in Q3 compared to $10.1 million in Q2[14] - The company raised $13.8 million through a private placement in August[16] Gross Margin - Gross margin was 81.3% in Q3 2025, a decrease of 240 bps compared to 83.7% in Q3 2024, while RECELL-only gross margin was 83.6% for the quarter[13] Market and Strategy - The company is focusing on approximately 200 key burn and trauma centers[11, 12] - The U S total addressable market (TAM) is estimated to be over $3.5 billion[11] - The company is active in approximately 90% of target sites, representing a $1.3 billion U S total addressable market, and currently serves approximately 5% of this TAM[12] Reimbursement - All seven Medicare Administrative Contractors (MACs) have published or confirmed payment rates for RECELL[7]

Financial Performance - Total revenues for the three months ended September 30, 2025, were $17,062,000, a decrease of 12.7% compared to $19,546,000 for the same period in 2024[18]. - Net loss for the three months ended September 30, 2025, was $13,187,000, compared to a net loss of $16,205,000 for the same period in 2024, representing a 18.6% improvement[21]. - Gross profit for the nine months ended September 30, 2025, was $44,505,000, an increase of 14.0% from $39,031,000 for the same period in 2024[18]. - Total revenues for the nine months ended September 30, 2025, increased by 18% to $54.0 million compared to $45.8 million in the same period last year, driven by deeper market penetration and new accounts[158]. - Commercial revenue from the RECELL product was $15,427,000 for the three months ended September 30, 2025, compared to $19,059,000 for the same period in 2024, indicating a decline of about 19.3%[108]. - The Company recorded a net loss of $13,187,000 for the three months ended September 30, 2025, compared to a net loss of $16,205,000 for the same period in 2024, showing an improvement in loss[108]. - The Company’s basic net loss per share for the three months ended September 30, 2025, was $(0.46), an improvement from $(0.62) in the same period of 2024[126]. Operating Expenses - Operating expenses for the three months ended September 30, 2025, totaled $23,028,000, down from $30,162,000 in the same period of 2024, reflecting a 23.5% reduction[18]. - General and administrative expenses decreased by 25% to $7.2 million for the three months ended September 30, 2025, compared to $9.6 million in the prior year[154]. - General and administrative expenses decreased by 22%, or $5.8 million, to $20.3 million compared to $26.1 million in the same period last year[162]. - Research and development expenses decreased by 2%, or $0.4 million, to $15.1 million compared to $15.5 million in the same period last year[163]. - The company’s stock-based compensation for the nine months ended September 30, 2025, was $8.146 million, compared to $10.698 million in the same period of 2024, indicating a reduction in compensation expenses[28]. - Stock-based payment expenses for the three months ended September 30, 2025, totaled $2.783 million, a decrease from $4.080 million for the same period in 2024[122]. Cash Flow and Liquidity - Cash and cash equivalents increased to $15,422,000 as of September 30, 2025, compared to $14,050,000 as of December 31, 2024[16]. - The company utilized $25.757 million in cash for operating activities during the nine months ended September 30, 2025, a decrease from $40.858 million used in the same period of 2024, indicating improved cash flow management[28]. - The company reported cash, cash equivalents, and marketable securities totaling $23.3 million as of September 30, 2025, providing a liquidity buffer for ongoing operations[34]. - As of September 30, 2025, the company had approximately $15.4 million in cash and cash equivalents and $7.9 million in marketable securities[165]. - The company completed a private placement on August 12, 2025, raising $14.8 million, which will be used for working capital requirements[166]. - Net cash used in operating activities was $25.8 million for the nine months ended September 30, 2025, down from $40.9 million in the same period last year[175]. - Net cash provided by investing activities was $12.4 million for the nine months ended September 30, 2025, compared to $34.9 million in the same period last year[176]. - Net cash provided by financing activities increased to $14.7 million for the nine months ended September 30, 2025, from $2.5 million in the same period last year[177]. Assets and Liabilities - Total current assets decreased to $41,367,000 as of September 30, 2025, from $57,000,000 as of December 31, 2024, a decline of 27.4%[16]. - Total liabilities increased to $70,394,000 as of September 30, 2025, compared to $74,968,000 as of December 31, 2024[16]. - The total stockholders' equity (deficit) as of September 30, 2025, was $(6,666,000), a decrease from $4,499,000 as of December 31, 2024[16]. - The company had accrued interest income receivable of $32,000 as of September 30, 2025, down from $121,000 as of December 31, 2024[62]. - Total intangible assets as of September 30, 2025, amounted to $5,830,000, with a net carrying amount of $5,204,000 after accumulated amortization of $626,000[8]. - The composition of the inventory as of September 30, 2025, included $2.1 million in raw materials, $100,000 in work in process, and $5.0 million in finished goods, totaling $7.2 million[97]. Debt and Financing - The Company entered into a credit agreement providing for a five-year senior secured credit facility of up to $90.0 million, with $40.0 million available on the Closing Date[84]. - As of September 30, 2025, the interest rate on the outstanding debt was 12.28%[86]. - The long-term portion of the credit facility has been classified as a current liability due to the Company's debt servicing obligations[38]. - The Company has not made any repayments on the outstanding debt balance as of September 30, 2025[85]. - The Company is actively evaluating strategies to obtain additional funding, including a potential equity financing of up to $200.0 million[39]. - There is substantial doubt about the Company's ability to continue as a going concern if it cannot maintain compliance with the minimum cash balance covenant[37]. Regulatory and Compliance - The Company was not in compliance with the trailing 12-month net revenue covenants for Q1 2025 ($73.0 million) and Q2 2025 ($78.0 million), but received waivers for both quarters[36]. - The trailing 12-month revenue covenant has been amended to $73.0 million for Q3 2025, $77.0 million for Q4 2025, $90.0 million for Q1 2026, and $103.0 million for Q2 2026, with a $115.0 million covenant for subsequent quarters[36]. - The Company entered into a sixth amendment to the Credit Agreement on November 5, 2025, amending the trailing 12-month revenue covenant to $70.0 million for the quarter ending December 31, 2025[128]. - The Centers for Medicare & Medicaid Services approved a New Technology Add-On Payment for the RECELL System, allowing up to $4,875 in additional reimbursement per case from October 1, 2025, to September 30, 2026[141]. Product Development and Market Strategy - The company’s RECELL GO mini device was approved by the FDA in December 2024, expanding its product offerings for treating smaller wounds[32]. - Cohealyx, a new collagen-based dermal matrix, was commercially launched in the U.S. on April 1, 2025, aimed at supporting cellular migration and revascularization[144]. - The Company aims to increase market penetration in U.S. burn centers and expand the adoption of the RECELL portfolio for traumatic and surgical wounds[143]. - 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[111]. - The Regenity Agreement allows the Company to market and distribute Cohealyx in the U.S. and potentially in the EU, Japan, and Australia, with an initial term of five years[113]. Stock and Equity - The company’s total common stock increased from 25,682,078 shares at December 31, 2023, to 30,493,111 shares by September 30, 2025, indicating growth in equity financing[25]. - The Company raised $14.8 million through the issuance of 17,201,886 CDIs on August 12, 2025, equivalent to 3,440,377 shares of Common stock[118]. - The Company has an outstanding total of 5,147,459 share options as of September 30, 2025, an increase from 3,540,208 options at the end of 2024[122]. - The Company’s stockholders approved an amendment to increase the share reserve under the 2020 Omnibus Incentive Plan by an additional 2,500,000 shares, totaling 6,750,000 shares[119]. Miscellaneous - The report includes various exhibits related to corporate governance and agreements, such as the Certificate of Incorporation and amendments[194]. - The report was signed by the Interim Chief Executive Officer and Chief Financial Officer, indicating compliance with the Securities Exchange Act of 1934[196][198]. - The date of the report is November 6, 2025, reflecting the company's ongoing regulatory obligations[197].

Financial Performance - Commercial revenue for Q3 2025 was $17.1 million, a 13% decrease from $19.5 million in Q3 2024[6] - Total revenues for the three months ended September 30, 2025, were $17,062,000, a decrease of 12.7% compared to $19,546,000 for the same period in 2024[30] - Net loss improved to $13.2 million, or $0.46 per share, from a net loss of $16.2 million, or $0.62 per share, in Q3 2024[15] - Operating loss for the three months ended September 30, 2025, was $9,153,000, an improvement from a loss of $13,806,000 in the same quarter of 2024[30] - Net loss for the nine months ended September 30, 2025, was $36,966,000, compared to a net loss of $50,256,000 for the same period in 2024, indicating a reduction in losses[30] Expenses and Liabilities - Operating expenses decreased by 24%, or $7.2 million, to $23.0 million compared to $30.2 million in the same period last year[13] - Research and development expenses for the nine months ended September 30, 2025, were $15,148,000, slightly down from $15,510,000 in the previous year[30] - Total liabilities increased to $70,394,000 as of September 30, 2025, compared to $74,968,000 at the end of 2024[28] Cash and Assets - Cash, cash equivalents, and marketable securities totaled $23.3 million as of September 30, 2025, reflecting a net use of cash of $6.2 million[16] - Cash and cash equivalents increased to $15,422,000 as of September 30, 2025, up from $14,050,000 at the end of 2024[28] - Total current assets decreased to $41,367,000 as of September 30, 2025, from $57,000,000 at December 31, 2024[28] - The company’s additional paid-in capital increased to $392,782,000 as of September 30, 2025, from $367,568,000 at December 31, 2024[28] Market and Product Development - RECELL GO® received CE Mark approval, enabling commercialization in Europe, starting with Germany, Italy, and the United Kingdom[7] - A global review of over 8,000 patients confirmed RECELL's ability to achieve wound closure with less donor skin and faster healing[8] - The company is focusing on approximately 200 U.S. burn and trauma centers, targeting an addressable market of roughly $1.3 billion[9] Future Outlook - The company expects full-year 2025 revenue in the range of $70 million to $74 million, down from prior guidance of $76 million to $81 million[17] - AVITA Medical is exploring opportunities to enhance financial flexibility and plans to provide an update on capital and growth plans in Q1 2026[19] Profitability - The gross profit margin was 81.3%, down from 83.7% in the prior year, primarily due to product mix and inventory-related adjustments[12] - Gross profit for the nine months ended September 30, 2025, was $44,505,000, representing an increase of 14.2% from $39,031,000 in the prior year[30]

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]