Quarterly Report for Quarter Ending June 30, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of AVITA Medical, Inc.'s ("we", "our", or "us") financial condition and results of operations should be read in conjunction with our unaudited Consolidated Financial Statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q as well as the "Note Regarding Forward-Looking Statements" on page 3.

Overview

We are a leading therapeutic acute wound care company delivering transformative solutions. Our solutions improve the healing outcomes for patients with traumatic injuries and surgical repairs, addressing critical healing needs that arise from unpredictable and life-changing events. At the forefront of our portfolio is RECELL® ("RECELL"), approved by the U.S. Food & Drug Administration (the "FDA") for the treatment of thermal burn wounds and full-thickness skin defects. RECELL harnesses the healing properties of a patient's own skin to create an autologous skin cell suspension, Spray-On Skin™, offering an innovative solution for improved clinical outcomes at the point of care. We entered into an exclusive multi-year development and distribution agreement with Collagen Matrix, Inc. dba Regenity Biosciences ("Regenity"). Regenity manufactures and supplies Cohealyx™, an AVITA Medical-branded, FDA-cleared, collagen-based dermal matrix. Under the agreement with Regenity, we hold the exclusive rights to market, sell, and distribute Cohealyx in the U.S., with the potential to expand such commercialization into the European Union, Australia, and Japan. In addition, in the United States, we hold the rights to manufacture and exclusively market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, under the terms of exclusive multi-year distribution and contract manufacturing agreements with Stedical Scientific, Inc.

The single-use RECELL Autologous Cell Harvesting Device ("RECELL Ease-of-Use" or "RECELL EOU") is approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects. Our next-generation device, RECELL GO® Autologous Cell Harvesting Device ("RECELL GO"), is FDA-approved to treat thermal burn wounds and full-thickness skin defects. RECELL GO introduces enhanced features that improve consistency and standardization across clinical settings. It consists of two components: the RECELL GO Processing Device (the "RPD") and the RECELL GO Preparation Kit (the "RPK"). The RPD is a multi-use, AC-powered device that controls the RPK. The RPK contains a single-use cartridge and the RECELL Enzyme™. The RPD regulates the pressure applied to disaggregate the cells and precisely controls the incubation time of the RECELL Enzyme to optimize cell yield and promote cell viability. RECELL GO mini® Autologous Cell Harvesting Device ("RECELL GO mini"), which was approved by the FDA in December 2024, is a line extension of RECELL GO, designed specifically to treat smaller wounds up to 480 cm2. It utilizes the same RPD but features a RECELL GO mini Preparation Kit, which includes a single-use RECELL GO mini cartridge optimized for smaller skin samples. These modifications are intended to align with the needs of clinicians treating smaller wounds, and to support broader adoption of the RECELL GO platform in trauma centers.

We are executing a focused commercial strategy centered on approximately 200 U.S. burn and trauma centers that represent the highest value and procedural volume within the acute wound care market. These institutions are core to our commercialization efforts due to their high concentration of complex inpatient cases and consistent procedural throughput. By prioritizing burn and trauma centers, we are targeting the most critical segments of acute wound care to maximize clinical impact and drive adoption across our portfolio.

To further our mission of improving clinical outcomes and establishing new standards of acute wound care, we have outlined the following strategic objectives:

Business Environment and Current Trends

Changes in reimbursement rates and coverage policy by third party payors may place additional financial pressure on hospitals and the broader healthcare system. These changes could reduce demand for our products, particularly if healthcare providers face lower margins or additional administrative burdens. For example, in 2025 the Centers for Medicare & Medicaid Services ("CMS") designated pricing responsibility for the Current Procedural Terminology ("CPT") code used with RECELL to the seven regional Medicare Administrative Contractors ("MACs"). Delay by the MACs in establishing and publishing reimbursement rates temporarily slowed clinician use of RECELL. As of March 2026, all seven MACs had published rates, restoring reimbursement clarity and supporting a return toward normalized utilization.

In July 2026, CMS released the 2027 Medicare Physician Fee Schedule ("PFS"), Hospital Outpatient Prospective Payment System, and Ambulatory Surgical Center ("ASC") proposed rules addressing Medicare payment for Skin Cell Suspension Autograft, the procedure performed using RECELL The proposed rules reflect the new Category I CPT code family effective January 1, 2027 and include proposed national physician relative value units based on American Medical Association recommended valuation, as well as proposed increases to hospital outpatient and ASC facility payment rates. If finalized, RECELL physician reimbursement would transition from the current regional MACs contractor-priced methodology to a more transparent, nationally published PFS. CMS is expected to issue final rules later this year, with implementation effective January 1, 2027.

The macroeconomic environment may have unexpected adverse effects on businesses and healthcare institutions globally that may, in turn, negatively impact our consolidated operating results. There remains significant uncertainty in the current macroeconomic environment due to factors including supply chain shortages, increased cost of healthcare, changes to inflation rates, a competitive labor market, tariffs, and other related global economic and geopolitical conditions. If these conditions continue or worsen, they could adversely impact our future operating results.

Geopolitical conditions may also impact our operations. Although we do not have operations in Russia, Ukraine, the Middle East, or Asia (outside of Japan), the continuation or threat of military conflicts in these regions or any escalation of conflicts beyond their current scope may further weaken the global economy resulting in additional inflationary pressures or supply chain constraints.

Recent Developments

On January 13, 2026, we entered into a five-year credit facility with Perceptive Advisors LLC providing up to $60 million in available capital. At closing, we drew $50 million and used a portion of the proceeds to repay our existing debt, resulting in net proceeds of approximately $6.0 million after repayment of our prior debt and certain related transaction fees. This credit facility includes an option to access an additional $10.0 million through the first quarter of 2027, subject to the achievement of a certain revenue milestone. This facility also establishes trailing twelve-month revenue covenants aligned with our current operating trajectory, including $68.5 million for the quarter ended March 31, 2026, $69.0 million for the quarter ended June 30, 2026, and $73.0 million for the year ending December 31, 2026. As of June 30, 2026, we were in compliance with these covenants. For additional information, see Liquidity and Capital Resources below.

On April 6, 2026, we entered into a ten-year agreement with the Biomedical Advanced Research and Development Authority ("BARDA"), part of the U.S. Department of Health and Human Services, with a total potential value of up to $25.5 million. Under the agreement, we will maintain a supply of RECELL for deployment in burn mass casualty incidents and provide associated readiness and support services. The agreement provides approximately $4.0 million in access and maintenance fees over the ten-year term, with additional potential revenue tied to procurement options exercised by BARDA. Costs to fulfill the BARDA emergency preparedness performance obligation, which consist of billed costs to BARDA incurred in connection with emergency deployment services, are incremental and expected to be recovered.

In April 2026, we announced positive interim results from our Cohealyx I post-market clinical study, demonstrating a statistically significant reduction in mean time to autografting readiness of approximately 20 days compared to a literature-derived benchmark (13.6 days versus 33.2 days; p<0.001). These findings support the potential of Cohealyx to improve clinical outcomes and enhance efficiency in the treatment of full-thickness wounds.

We participated in the American Burn Association 2026 Annual Meeting in April, where independent investigators and clinical partners presented data and case studies reflecting real-world use of RECELL, Cohealyx, and PermeaDerm across a range of wound care applications. These presentations highlighted evolving clinical experience with our products and their use across different stages of wound management.

In April 2026, RECELL GO received Therapeutic Goods Administration certification in Australia and was listed on New Zealand's Web Assisted Notification of Devices database by Medsafe, enabling commercialization in both markets. These regulatory authorizations expand the international availability of RECELL GO and support our distributor-led commercialization strategy in Australia and New Zealand.

In June 2026, clinical data highlighting the first documented use of RECELL GO in the United Kingdom was presented at the 2026 British Burn Association Annual Meeting. The case series, involving 17 patients treated at Stoke Mandeville Hospital, demonstrated successful use of RECELL GO across burn and reconstructive procedures, with investigators reporting favorable clinical outcomes, uncomplicated donor-site healing, and workflow benefits through standardized cell preparation.

Results of Operations for the three-months ended June 30, 2026 compared to the three-months ended June 30, 2025.

The table below summarizes the results of our operations for each of the periods presented (in thousands).

*nm = not meaningful

Total revenues increased by 18%, or $3.3 million, to approximately $21.7 million, compared to $18.4 million in the same period in the prior year. The growth in revenues was largely driven by increased contributions from Cohealyx, RECELL GO mini in trauma and smaller wounds, and continued normalization in RECELL utilization following the resolution of MAC-related reimbursement headwinds.

Gross profit margin was 81.9% compared to 81.2% in the corresponding period in the prior year. Note that the gross margin for RECELL products only was 86.0% for the quarter, which we believe will remain in this range for future quarters. The increase in the overall gross margin percentage from the prior year was primarily caused by lower volume discounts offset by product mix. The Company shares the average sales price for Cohealyx at 50% and for PermeaDerm at 60%. Although these arrangements are highly beneficial, they inevitably result in an overall decrease in gross margin percentage. Therefore, the product mix is expected to continue to impact the overall gross margin percentage while increasing the gross profit and, given that expenses associated with this revenue do not increase significantly, the operating profit on a quarterly basis.

Total operating expenses decreased by 6% or $1.5 million to $24.6 million, compared with $26.1 million in the corresponding period in the prior year.

Sales and marketing expenses decreased by 5%, or $0.7 million, to $13.6 million, compared to $14.3 million in the corresponding period in the prior year. Lower costs in the current year are due to decreases in selling expenses of $0.9 million, offset by higher other selling expenses of $0.2 million. The decrease in selling expenses is due to lower commissions and marketing spend.

General and administrative expenses decreased by 10%, or $0.7 million, to $6.0 million, compared to $6.7 million in the same period in the prior year. Lower costs in the current year are due to decreases in stock-based compensation of $0.5 million and professional fees of $0.4 million, offset by an increase in salaries and benefits of $0.2 million. The decrease in stock-based compensation is due to reduced grant activity.

Research and development expenses of $5.1 million were consistent compared to the same period in the prior year.

Other income, net decreased by $1.8 million to $0.7 million from $2.5 million in the prior period. In the current period, other income, net consists of $0.5 million in income related to our investments and a non-cash gain of $0.2 million related to the change in fair value of the loan facility. The prior period income consisted of non-cash gains of $1.2 million related to the change in fair value of warrants, $0.9 million related to the change in fair value of loan facility, and $0.4 million in income related to our investments.

Results of Operations for the six-months ended June 30, 2026 compared to the six-months ended June 30, 2025.

The table below summarizes the results of our operations for each of the periods presented (in thousands).

*nm = not meaningful

Total revenues increased by 11%, or $4.0 million, to approximately $41.0 million, compared to $36.9 million in the same period in the prior year. The growth in revenues was largely driven by increased contributions from Cohealyx, RECELL GO mini in trauma and smaller wounds, and continued normalization in RECELL utilization following the resolution of MAC-related reimbursement headwinds.

Gross profit margin was 81.8% compared to 82.9% in the corresponding period in the prior year. Note that the gross margin for RECELL products only was 85.5% for the six-months ended June 30, 2026, which we believe will remain in this range for future quarters. The decrease in the overall gross margin percentage from the prior year was primarily caused by product mix. The Company shares the average sales price for Cohealyx at 50% and for PermeaDerm at 60%. Although these arrangements are highly beneficial, they inevitably result in an overall decrease in gross margin percentage. Therefore, the product mix is expected to continue to impact the overall gross margin percentage while increasing the gross profit and, given that expenses associated with this revenue do not increase significantly, the operating profit on a quarterly basis.

Total operating expenses decreased by 8% or $4.5 million to $49.2 million, compared with $53.6 million in the corresponding period in the prior year.

Sales and marketing expenses decreased by 9%, or $2.7 million, to $26.4 million, compared to $29.1 million in the corresponding period in the prior year. Lower costs in the current year are due to decreases in selling expenses of $1.5 million, salaries and benefits of approximately $0.8 million, and professional fees of $0.8 million, offset by higher other selling expenses of $0.4 million. The decrease in salaries and benefits is due to the reduction of our sales force as part of cost savings initiatives which began in the second quarter of the prior year. The decrease in selling expenses is due to lower commissions and reduced marketing spend. The decrease in professional fees is due to lower consulting costs. The increase in other selling expenses is due to higher travel spend.

General and administrative expenses decreased by 8%, or $1.0 million, to $12.0 million, compared to $13.1 million in the same period in the prior year. Lower costs in the current year are due to a decrease in stock-based compensation of $1.9 million, offset by an increase in deferred compensation expense of $0.9 million. The decrease in stock-based compensation is due to higher forfeitures, decreased headcount, and reduced grant activity. The increase in deferred compensation expense is driven by a higher stock price used to calculate the deferred compensation liability.

Research and development expenses decreased by 6%, or $0.7 million, to $10.7 million, compared to $11.4 million in the same period in the prior year. Lower costs in the current year are due to decreases in research and development expenses of $0.5 million and professional fees of $0.2 million. The decrease in research and development expenses is due to lower product testing costs. The decrease in professional fees is due to lower clinical trial costs associated with PermeaDerm and Cohealyx post-market studies.

Other income, net decreased by $1.4 million to $0.3 million from $1.7 million in the prior period. In the current period, other income, net consists of a non-cash gain of $0.5 million related to the change in fair value of the loan facility and $0.5 million in income related to our investments, offset by a non-cash charge of $0.6 million related to the change in fair value of warrants and $0.1 million in other income, net. The prior period expense consisted of non-cash gains of $1.5 million related to the change in fair value of warrants and $0.2 million related to the change in fair value of loan facility, plus $0.8 million in income related to our investments offset by $0.8 million in debt issuance costs.

Liquidity and Capital Resources

Overview

Our Consolidated Financial Statements have been prepared on the basis that we will continue as a going concern for the next 12 months. We had approximately $9.1 million in cash and cash equivalents and $2.0 million in marketable securities as of June 30, 2026. We have funded our research and development activities, and more recently our substantial investment in sales and marketing activities, through the sales of our products, the issuance of equity securities, and debt financing. If capital is not available to us when amounts are needed, we could be required to delay, scale back, or abandon commercial activities and development programs and other operations, which could adversely impact our business, financial condition, and operating results.

Based on our liquidity position and current forecast of operating results and cash flows, management determined there is substantial doubt about our ability to continue as a going concern over the next twelve months following the date of issuance of these Consolidated Financial Statements, due to our debt repayment obligations, historical negative cash flows, and recurring losses. As a result, we may require additional liquidity to continue our operations over the next twelve months.

On January 13, 2026 (the "Closing Date"), we entered into a Credit Agreement and Guaranty (the "Credit Agreement"), and Security Agreement (the "Security Agreement"), by and among us, as borrower, Avita Medical Americas, LLC, a wholly-owned subsidiary of the Company, as guarantor (the "Guarantor," taken together with the Company, the "Obligors") and Perceptive Credit Holdings V, LP as a lender and the administrative agent (the "Lender," and the "Administrative Agent," as applicable). The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $60 million (the "Loan Facility"), of which (i) $50 million was funded on the Closing Date (the "Initial Commitment Amount"), and (ii) $10 million will be made available, at our discretion by notice to the Administrative Agent on or before March 31, 2027, subject to satisfaction of a certain net revenue requirement (the "Additional Commitment Amount"). On the Closing Date, we closed on the Initial Commitment Amount, less certain fees and expenses payable to or on behalf of the Lender. Simultaneously with the closing of the Initial Commitment Amount, we repaid in full and terminated all of our obligations and commitments under our previous credit agreement (the "Refinancing Transaction").

During the term of the Loan Facility, interest payable in cash shall accrue on any outstanding amounts under the Loan Facility at a rate per annum equal to the greater of (x) the SOFR rate for such period, and (y) 4.00% plus, in either case, 7.50%. Upon the occurrence and during the continuance of an event of default, any outstanding amount under the Loan Facility will bear interest at a rate of 4% in excess of the otherwise applicable rate of interest.

On the Closing Date, we agreed to issue to the Lender, subject to shareholder approval, warrants to purchase up to 650,000 shares of Common Stock, par value $0.0001 per share, at an exercise price set at the lower of two 10-day VWAPs: (i) the 10-day VWAP ending on the business day immediately prior to the Closing Date, which VWAP is $3.4019; or (ii) the 10-day VWAP ending on the business day immediately prior to the issuance date of the warrants. On June 3, 2026, our shareholders approved the issuance of such warrants. On June 8, 2026, we issued a warrant covering up to 650,000 shares of Common Stock at an exercise price of $3.4019 per share, of which 500,000 shares are immediately exercisable, with an additional 150,000 shares that will vest and become exercisable if we close on the Additional Commitment Amount.

Under the terms of the Credit Agreement, and as set forth in a fee letter between us, and the Lender and the Administrative Agent (the "Fee Letter"), we will pay certain fees with respect to the Loan Facility, including a prepayment premium ranging from 1% to 10% of the amount of the Loan Facility that is prepaid upon any voluntary or mandatory prepayment (including as a result of an acceleration), together with certain other fees and expenses of the Lender.

The Credit Agreement contains certain customary events of default, including with respect to nonpayment of principal, interest, fees or other amounts; material inaccuracy of a representation or warranty; failure to perform or observe covenants; material defaults on other indebtedness; insolvency; loss of certain key permits, persons and contracts; material adverse effects; certain regulatory matters; and change of control.

The Credit Agreement contains a number of customary representations, warranties, and covenants that, among other things, will limit or restrict our ability to (subject to certain qualifications and exceptions): create liens and encumbrances; incur additional indebtedness; merge, dissolve, liquidate or consolidate; make acquisitions, investments, advances or loans; dispose of or transfer assets; pay dividends or make other payments in respect of their capital stock; redeem or repurchase certain debt; engage in certain transactions with affiliates; and enter into certain restrictive agreements. Among such covenants, the Credit Agreement includes a financial maintenance test that requires us to maintain a specified minimum net revenue for each trailing twelve-month period ending on the last day of a fiscal quarter occurring prior to the maturity date of the Loan Facility, with the first such test occurring as of the fiscal quarter ended March 31, 2026. In addition, the Credit Agreement requires us to maintain, in the aggregate, at least $5 million of unrestricted cash at all times. Pursuant to the Security Agreement, all obligations under the Credit Agreement are guaranteed and secured by substantially all of our assets.

The following table summarizes our cash flows for the periods presented (in thousands):

Net cash used in operating activities was $13.6 million and $20.5 million during the six-months ended June 30, 2026 and 2025, respectively. The decrease in net cash used in operations was primarily due to increased gross profit, decreased operating expenses, and the timing of working capital outlays.

Net cash provided by investing activities was $5.9 million and $17.8 million during the six-months ended June 30, 2026 and 2025, respectively. The decrease in cash provided by investing activities is primarily attributable to lower cash inflows from maturities of marketable securities in the current year.

Net cash provided by financing activities was $6.5 million and $0.9 million during the six-months ended June 30, 2026 and 2025, respectively. The increase in cash provided by financing activities is primarily due to the Loan Facility entered into on January 13, 2026.

Capital Management and Material Cash Requirements

We aim to manage capital so that we can continue as a going concern while also maintaining optimal returns to stockholders, as well as other benefits for our stakeholders. We also aim to maintain a capital structure that ensures the lowest cost of capital available to us. We regularly review our capital structure and seek to take advantage of available opportunities to improve outcomes for us and our stockholders.

For the six-months ended June 30, 2026, there were no dividends paid and we have no plans to commence the payment of dividends.

Under the terms of the Regenity Agreement, we have an obligation to make an additional $3.0 million payment on or before January 4, 2027 to guarantee development and manufacturing capacity (and related resources), contingent on positive results of certain clinical studies. With the exception of the milestone payments under the Regenity Agreement, we do not have any other purchase commitments or long-term contractual obligations, except for lease obligations as of June 30, 2026.

Subsequent to June 30, 2026, on August 5, 2026, we entered into a Global Amendment of the Distribution and Manufacturing Agreements with Stedical (the "Global Amendment"). Under the terms of the Global Amendment, in exchange for a $500,000 fee we will hold the right of first offer and refusal to expand our exclusive distribution territory to include all or a portion of the European Union, the United Kingdom, and/or Australia. In addition, our share of revenue from PermeaDerm sales will increase to 67% for products sold in sheet form, subject to increased revenue sharing in the event our gross margin on those products exceeds 50%, and to 80% for products sold in glove form, subject to increased revenue sharing in the event our gross margin on those products exceeds 35%. For 2026, we are required to reach total PermeaDerm revenue sharing payments of $1.0 million, with 20% growth minimums each year through 2030. All previous minimum revenue sharing payment requirements under the Distribution Agreement were waived.

Also under the Global Amendment, Stedical may pursue the commercialization of PermeaDerm in certain U.S. markets not currently served by us. We will sell PermeaDerm for such sales to Stedical at a ten percent premium to our actual manufacturing costs. For PermeaDerm manufactured for Stedical to sell outside of the U.S., primarily in Asia, we will sell such PermeaDerm to Stedical at $200 per carton plus a 10% manufacturing fee, subject to a reasonable volume cap.

In addition, we have no material off-balance sheet arrangements (as defined in the applicable rules and regulations established by the SEC) that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. While we have no committed plans to issue further shares on the market, we will continue to assess market conditions.

Critical Accounting Estimates

Except as disclosed in Note 2 to our Consolidated Financial Statements, there have been no material changes to our critical accounting policies and estimates from the information provided in Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," included in the 2025 Annual Report.