RCEL

8-K

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 14, 2026

AVITA Medical, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-39059

85-1021707

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

28159 Avenue Stanford

Suite 220

Valencia, California

91355

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 661 367-9170

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

RCEL

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On May 14, 2026, the Company issued a press release announcing its financial results for the first quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information furnished in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description of Exhibit

99.1

Press release, dated May 14, 2026, issued by AVITA Medical, Inc.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AVITA Medical, Inc.

Date:

May 14, 2026

By:

/s/ David O’Toole

David O’Toole Chief Financial Officer

EX-99.1

2 rcel-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

AVITA Medical Reports Fourth Quarter and Full Year 2025 Financial Results

VALENCIA, Calif., February 12, 2026 (GLOBE NEWSWIRE) — AVITA Medical®, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering transformative solutions (“AVITA Medical,” or the “Company”), today reported financial results for the fourth quarter and full year ended December 31, 2025.

Fourth Quarter 2025 Financial Highlights and Recent Business Updates

• Total revenue of $17.6 million, compared to $18.4 million in the fourth quarter of 2024, reflecting the lingering impact of reimbursement headwinds throughout 2025.

• Gross profit margin of 81.2%, reflecting product mix and inventory-related adjustments.

• Net use of cash improved for the second consecutive quarter to approximately $5.1 million, compared to $6.2 million in the third quarter, underscoring continued progress in cash efficiency.

• Operating expenses decreased 5% to $24.7 million, compared with $26.1 million in the corresponding period last year, reflecting a lower cost base.

• Net loss of $11.6 million, or a loss of $0.38 per basic and diluted share, compared to $11.6 million, or a loss of $0.44 per share, in the fourth quarter of 2024.

• In January, the Company announced the refinancing of its existing debt under a new credit facility with Perceptive Advisors LLC, securing up to $60 million of committed capital to strengthen the Company’s capital structure and support long-term growth.

• As of January 2026, six of the seven Medicare Administrative Contractors (MACs) have published payment rates for RECELL, further removing a key constraint on utilization experienced in 2025.

• Cohealyx I study fully enrolled, and PermeaDerm I study surpassed 75% enrollment, in December 2025; data from both clinical studies expected in 2026.

• Data presented at the 2026 Boswick Burn & Wound Symposium in January included the first surgeon-reported integrated use of RECELL®, PermeaDerm®, and Cohealyx™ within a staged wound care pathway, highlighting the practical application of the Company’s product portfolio.

Full-Year 2025 Financial Highlights

• Total revenues of approximately $71.6 million for full year 2025, compared to $64.3 million for full year 2024, representing an increase of approximately 11%, within the Company’s revised revenue guidance for the year.

• Gross profit margin was 82.1%.

• Net loss of $48.6 million, or a loss of $1.74 per basic and diluted share, compared to a net loss of $61.8 million, or a loss of $2.39 per basic and diluted share, in the prior year.

Cary Vance, Interim Chief Executive Officer of AVITA Medical, commented:

“The fourth quarter marked the close of a year of stabilization and the beginning of a more execution-focused phase, for the Company. While reimbursement disruption and operational transition weighed on revenue performance in 2025, those issues are now largely behind us, and we are seeing early signs of normalization in clinician use of RECELL. We enter 2026 with a clearer commercial focus and a validated portfolio that supports growth through deeper utilization within our core burn and trauma centers, with our priority centered on delivering consistent, execution-led growth quarter by quarter.”

David O'Toole, Chief Financial Officer, commented:

“Throughout 2025, we took deliberate actions to reduce our operating cost base and improve cash efficiency, resulting in sequential improvement in cash use during the second half of the year and a more disciplined and sustainably lower cost structure. In January, we refinanced our existing debt under a new credit facility with Perceptive Advisors on terms better aligned with our operating trajectory. With less restrictive covenants, this new credit facility will allow the organization to focus on execution and operating discipline as we enter 2026.”

Financial Guidance

• Full year 2026 revenue expected in the range of $80 to $85 million, representing growth of approximately 12% to 19% compared to 2025 revenue.

Fourth Quarter Financial Results

Total revenue was $17.6 million in the three months ended December 31, 2025, representing a decrease of $0.8 million, or 4%, compared to $18.4 million in the corresponding period in the prior year. The reduction in revenue was largely driven by MAC reimbursement headwinds, partially offset by increased revenue from new product launches and expanding adoption within the Company’s established markets.

Gross profit margin was 81.2% versus 87.6% in Q4 2024, reflecting product mix and inventory-related adjustments. RECELL-only gross margin was 83.1% for the quarter. The Company shares the average sales price for Cohealyx at 50% and for PermeaDerm at 60%. Despite the positive economics of these arrangements, they result in an overall decrease in the gross margin percentage. Therefore, the product mix is expected to continue to impact the overall gross margin perc