RCEL

EX-99.1

2 rcel-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

AVITA Medical Reports Third Quarter Results Delivers Strong Q3 With 53% Year-Over-Year Revenue Growth

Raises Full Year 2026 Revenue Guidance

VALENCIA, Calif., November 5, 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 third quarter ended September 30, 2026.

Third Quarter 2026 Financial Highlights

• Q3 total revenue increased 53% year over year and 20% sequentially to $26.1 million, driven primarily by continued growth in RECELL® and increasing adoption of Cohealyx®

• Gross margin was 84.0%, an increase of 270 basis points year over year, reflecting higher RECELL revenue and improvements in manufacturing efficiency

• Operating expenses were $24.6 million, flat to the prior quarter demonstrating continued expense discipline even as the Company supported higher performance-based compensation associated with commercial growth

• Net cash use improved to approximately $0.6 million, compared with $3.2 million in Q2 2026. Cash, cash equivalents and marketable securities totaled approximately $10.5 million at September 30, 2026

• Raised full-year 2026 revenue guidance to $92 million to $94 million and reaffirmed its expectation of achieving cash flow breakeven in Q4 2026

• Achieved the $85 million trailing twelve-month revenue milestone required to access the remaining $10 million under the Company’s credit facility with Perceptive Advisors LLC, and subsequent to quarter-end, drew the additional tranche, strengthening the Company’s cash reserves

• Based on improved operating performance and cash liquidity, the “going concern” qualification removed in the Quarterly Report on Form 10-Q

Business and Clinical Updates

• On November 4, 2026, the Centers for Medicare & Medicaid Services finalized national physician payment values and simplified billing codes for RECELL procedures, effective January 1, 2027

• PermeaDerm® I met its primary endpoint, demonstrating comparable clinical outcomes to allograft while reducing product costs by 70% and preparation time by 95.7%

Cary Vance, President and Chief Executive Officer of AVITA Medical, commented:

“AVITA delivered another strong quarter, with revenue increasing 53% year over year and gross margin reaching 84%. RECELL continued to drive our growth, supported by increasing adoption of Cohealyx, while disciplined expense management contributed to a substantial improvement in cash use. Based on our year-to-date performance and continued commercial momentum, we are raising our full-year revenue guidance and remain on track to achieve cash flow breakeven in the fourth quarter.”

David O'Toole, Chief Financial Officer, commented:

“Reaching $85 million in trailing twelve-month revenue reflects the continued execution of our commercial strategy and satisfied the revenue condition required to draw down the remaining $10 million under our credit facility with Perceptive Advisors LLC. This additional, minimally dilutive capital strengthens our liquidity as we advance toward cash flow

breakeven and cash generation in the fourth quarter. Based on our improved operating performance and liquidity, management concluded that the substantial doubt about our ability to continue as a going concern has been alleviated. Accordingly, the outstanding debt under the credit facility is now classified as a long-term liability on our balance sheet.”

Updated Financial Guidance

Based on its third-quarter performance, AVITA Medical is raising its full-year 2026 revenue guidance to $92 million to $94 million, from $86 million to $89 million. This updated range represents growth of approximately 28% to 31% compared with revenue of $71.6 million in 2025. Based on year-to-date results, our new guidance implies revenue of $24.9 to $26.9 million for the fourth quarter. The Company also reaffirms its expectation of achieving cash flow breakeven in the fourth quarter of 2026.

Third Quarter Financial Results

Total revenue was approximately $26.1 million in the three months ended September 30, 2026, an increase of 53% compared to $17.1 million in the prior-year period. Revenue growth in the quarter was driven by continued execution across the Company's key commercial portfolio, led by RECELL and supported by Cohealyx and PermeaDerm.

• RECELL (Q3 U.S. revenue of $22.4 million, approximately 20% growth compared to Q2 2026) continued to drive the business, reflecting higher procedure volumes and increased account ordering.

• Cohealyx (Q3 revenue of $2.1 million, approximately 21% growth compared to Q2 2026) continued to build commercial momentum, reflecting an expanding customer base and additional hospital value analysis committee (VAC) approvals.

• PermeaDerm (Q3 revenue of $0.6 million, essentially flat compared to Q2 2026) maintained stable revenue. Perm

8-K

0001762303false00017623032026-05-142026-05-14

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