RCEL 8-K
AVITA Medical, Inc. (RCEL)
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
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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:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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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 1.01 Entry into a Material Definitive Agreement.
On August 7, 2025, affiliates of OrbiMed Advisors, LLC (the “Lenders”) and AVITA Medical, Inc. (the “Company”) agreed to a fifth amendment (the “Fifth Amendment”) to the Credit Agreement, dated October 18, 2023, as previously amended (the “Credit Agreement”).
The Fifth Amendment modifies certain financial covenants under the Credit Agreement, including adjustments to the trailing 12-month revenue covenant as follows:
The previously established $115 million revenue covenant for all subsequent quarters through the maturity date of the debt remains in effect.
As a condition to the execution of the Fifth Amendment, the Company will issue to the Lenders 400,000 shares of the Company’s common stock, par value $0.0001 per share (the “Shares”). The offer and sale of Shares will be registered pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-271276) (the “Registration Statement”) and a prospectus supplement to be filed by the Company in connection therewith. A copy of the opinion of K&L Gates LLP relating to the legality of the issuance of the Shares is attached as Exhibit 5.1 hereto.
This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.
The foregoing description of the Fifth Amendment and the share issuance is qualified in its entirety by the full text of the Fifth Amendment, a copy of which is attached hereto as Exhibit 10.1 and is incorporated by reference herein.
Item 2.02 Results of Operations and Financial Condition.
On August 7, 2025, the Company issued a press release announcing its financial results for the second quarter ended June 30, 2025. 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. |
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Description of Exhibit |
5.1 |
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10.1 |
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23.1 |
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Consent of K&L Gates LLP with respect to Exhibit 5.1 (included in Exhibit 5.1) |
99.1 |
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Press release, dated August 7, 2025, issued by AVITA Medical, Inc. |
104 |
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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.
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AVITA Medical, Inc. |
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Date: |
August 7, 2025 |
By: |
/s/ David O’Toole |
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David O’Toole |
Exhibit 5.1
August 7, 2025
AVITA Medical, Inc.
28159 Avenue Stanford, Suite 220
Valencia, CA 91355
Ladies and Gentlemen:
We have acted as counsel to AVITA Medical, Inc., a Delaware corporation (the “Company”), in connection with the issuance and sale by the Company today of 400,000 shares (the “Shares”) of common stock, par value $0.0001 per share, of the Company (“Common Stock”), pursuant to the Waiver and Fifth Amendment to Credit Agreement, dated as of August 7, 2025 (the “Fifth Amendment”), which Fifth Amendment amends that certain Credit Agreement, dated as of October 18, 2023, as the Borrower (as defined therein), and ORCO IV LLC and ORBIMED ROYALTY & CREDIT OPPORTUNITIES IV OFFSHORE LP, as the Lenders (as defined therein, the “Lenders”), and ORCO IV LLC, as the Administrative Agent (as defined therein), as amended by that certain Waiver and First Amendment to Credit Agreement, dated as of November 30, 2023, as amended by that certain Second Amendment to Credit Agreement, dated as of May 28, 2024, as amended by that certain Third Amendment to Credit Agreement, dated as of November 7, 2024, as amended by that certain Fourth Amendment to Credit Agreement, dated as of February 13, 2025, as modified by that certain Waiver, effective as of March 31, 2025, and as modified by that certain Waiver, effective as of June 30, 2025 (as so amended and modified, the “Credit Agreement”). In accordance with the Securities Act of 1933, as amended (the “Securities Act”), and the rules and regulations promulgated thereunder, the Company has prepared and filed with the Securities and Exchange Commission (the “Commission”), the registration statement on Form S-3 (File No. 333-271276), filed with the Commission under the Securities Act of 1933, as amended (the “Securities Act”), including each of the Company’s reports that have been filed with the Commission under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and that are incorporated by reference in such registration statement (the “Registration Statement”), and the base prospectus, dated April 25, 2023 (the “Base Prospectus”), insofar as it pertains to the offering of the Shares, as supplemented by the prospectus supplement, dated August 7, 2025, relating to the offering of the Shares, to be filed by the Company with the Commission pursuant to Rule 424(b) under the Securities Act (the “Prospectus”).
This opinion letter is being delivered in accordance with the requirements of Item 601(b)(5)(i) of Regulation S-K under the Securities Act.
In connection with rendering the opinions set forth below, we have examined (i) the Registration Statement; (ii) the Base Prospectus base prospectus dated April 25, 2023 included in the Registration Statement; (iii) the Prospectus; (iv) the Fifth Amendment; (v) the Credit Agreement; (vi) the Certificate of Incorporation of the Company as filed with the Secretary of State
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of the State of Delaware on April 17, 2020, as amended by the Certificate of Amendment of Certificate of Incorporation as filed with the Secretary of State of the State of Delaware on December 2, 2020 (the “Certificate of Incorporation”), (vii) the Amended and Restated Bylaws of the Company, adopted and effective as of May 15, 2025 (the “Bylaws” and, together with the Certificate of Incorporation, the “Company Organizational Documents”), (viii) resolutions adopted by the Company’s Board of Directors (the “Board of Directors”) on August 6, 2025 (the “Resolutions”), relating to the issuance and sale of the Shares pursuant to the Fifth Amendment, (ix) a certificate of good standing with respect to the Company obtained from the Secretary of State of the State of Delaware on August 6, 2025 (the “Good Standing Certificate”), and (x) a fact certificate executed and delivered by an officer of the Company with respect to certain matters (the “Fact Certificate”).
For purposes of this opinion letter, we have not examined any documents other than the documents listed above and assume there exists no provision in any document relating to the matters covered by our opinions below that we have not examined that is inconsistent with the documents listed above or our opinions below. We have conducted no independent factual investigation of our own but rather have relied solely upon our examination of the aforesaid documents, the statements and information set forth therein, including, without limitation, the representations and warranties of the parties to the parties made in the documents listed above and the additional matters recited or assumed in this opinion letter, all of which we assume to be true, complete and accurate in all respects. We have not independently established any of the facts so relied on.
For the purposes of this opinion letter we have made assumptions that are customary in opinion letters of this kind, including the assumptions that each document examined by us is accurate and complete, that each such document that is an original is authentic, that each such document that is a copy conforms to an authentic original, that all signatures on each such document are genuine, that no changes in the facts certified in the Fact Certificate have occurred or will occur after the date of the Fact Certificate and the legal capacity of all natural persons. We have further assumed that, except as expressly opined below as to the Company: (a) each party to the documents examined by us (i) is duly organized, validly existing and in good standing under the laws of its jurisdiction of organization, (ii) has the legal capacity, power and authority to execute, deliver, and perform its obligations under such documents, (iii) has taken all action necessary to duly authorize the execution and delivery of, and the performance of its obligations under, such documents, and (iv) has duly executed and delivered such documents; and (b) each of the documents examined by us constitutes the legal, valid, and binding obligation of each party thereto, enforceable against each such party in accordance with its terms.
In rendering our opinions below, we also have assumed that: (a) the issuance of all Shares will be duly recorded in the Company’s stock ledger upon issuance; (b) in accordance with Section 158 of the General Corporation Law of the State of Delaware (the “DGCL”), the Shares will be evidenced by certificates, duly executed and delivered, or the Board of Directors will adopt resolutions providing that all shares of Common Stock shall be uncertificated prior to the issuance of the Shares and, within a reasonable time after the issuance of any such Shares, the registered owner of such Shares will be given notice in writing or by electronic transmission in compliance with Section 151(f) of the DGCL; (c) there are no contracts with one or more current or prospective stockholders of the Company (or one or more beneficial owners of stock of the Company), in its or their capacity as such, within the meaning of Section 122(18) of the DGCL; (d) the consideration for the issuance of the Shares pursuant to the Fifth Amendment will equal or exceed the then par value of a share of Common Stock; and (e) the issuance of the Shares will not (A) have the effect,
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directly or indirectly, of increasing the proportionate shares of stock or securities convertible into stock, in each case, of the Company held by an interested stockholder (within the meaning of Section 203(c) of the DGCL) or (B) confer a benefit, directly or indirectly (except proportionately as a stockholder of the Company) of any loans, advanced, guarantees, pledges or other financial benefits (other than those expressly permitted in paragraphs (c)(3)(i)-(iv) of Section 203 of the DGCL) on an interested stockholder (within the meaning of Section 203(c) of the DGCL). We have not verified any of the foregoing assumptions.
Our opinion set forth below is limited to the General Corporation Law of the State of Delaware (the “DGCL”) and reported judicial decisions interpreting the DGCL. We express no opinion as to the laws, rules or regulations of any other jurisdiction, including, without limitation, the federal laws of the United States of America or any state securities or blue sky laws; we express no opinion with respect to the Corporate Transparency Act.
The Shares have been duly authorized for issuance by the Company and, upon issuance by the Company in consideration of the Lenders’ execution and delivery of the Fifth Amendment in accordance with the terms of the Fifth Amendment, will be validly issued, fully-paid and non-assessable.
We hereby consent to the filing of this opinion letter with the Commission as Exhibit 5.1 to the Company’s Current Report on Form 8-K and to the reference to this firm under the heading “Legal Matters” in the Prospectus Supplement. In giving this consent, we do not hereby admit that we are experts with respect to any part of the Registration Statement within the meaning of the term “expert” as used in Section 11 of the Securities Act or the rules and regulations promulgated thereunder by the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the SEC promulgated thereunder.
Yours truly,
/s/ K&L Gates LLP
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Exhibit 10.1
WAIVER AND FIFTH AMENDMENT TO CREDIT AGREEMENT
This WAIVER AND FIFTH AMENDMENT TO CREDIT AGREEMENT (this “Amendment”) is made and entered into as of August 7, 2025 by and among AVITA MEDICAL, INC., a Delaware corporation (the “Borrower”), ORCO IV LLC and ORBIMED ROYALTY & CREDIT OPPORTUNITIES IV OFFSHORE, LP, as Lenders, and ORCO IV LLC, as administrative agent for the Lenders (together with its Affiliates, successors, transferees and assignees, the “Administrative Agent”).
WHEREAS, the Borrower, the Lenders and the Administrative Agent entered into a Credit Agreement, dated as of October 18, 2023, as amended by that certain Waiver and First Amendment to Credit Agreement, dated as of November 30, 2023, as amended by that certain Second Amendment to Credit Agreement, dated as of May 28, 2024, as amended by that certain Third Amendment to Credit Agreement, dated as of November 7, 2024, as amended by that certain Fourth Amendment to Credit Agreement, dated as of February 13, 2025, as modified by that certain Waiver, effective as of March 31, 2025, and as modified by that certain Waiver, effective as of June 30, 2025 (as so amended and modified, the “Credit Agreement”), pursuant to which the Lenders have extended credit to the Borrower on the terms set forth therein;
WHEREAS, pursuant to Section 10.1 of the Credit Agreement, the Credit Agreement may be amended by an instrument in writing signed by each of the Borrower and the Lenders and acknowledged by the Administrative Agent;
WHEREAS, the undersigned Lenders comprise all Lenders under the Credit Agreement; and
WHEREAS, the Borrower and the Lenders desire to amend certain provisions of the Credit Agreement as provided in this Amendment.
NOW, THEREFORE, in consideration of the mutual agreements herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
“Fifth Amendment” means the Fifth Amendment to the Agreement, dated as of the Fifth Amendment Effective Date, among the Borrower, the Lenders and the Administrative Agent.
“Fifth Amendment Effective Date” means August 7, 2025.
Test Dates (Fiscal Quarter Ending) |
Product Revenue Base for the 12-month period ending on such Test Date |
September 30, 2025 |
$73,000,000 |
December 31, 2025 |
$77,000,000 |
March 31, 2026 |
$90,000,000 |
June 30, 2026 |
$103,000,000 |
September 30, 2026 and each Fiscal Quarter ending thereafter |
$115,000,000 |
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A general release does not extend to claims that the creditor or releasing party does not know or suspect to exist in his or her favor at the time of executing the release, and that if known by him or her, would have materially affected his or her settlement with the debtor or released party.
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed by their respective officers thereunto duly authorized as of the day and year first above written.
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AVITA MEDICAL, INC. as the Borrower |
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By: |
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Name: James Corbett |
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Title: Chief Executive Officer |
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[Signature Page to Waiver and Fifth Amendment to Credit Agreement]
ORCO IV LLC By: OrbiMed Royalty & Credit Opportunities IV, LP, its Member
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By: OrbiMed ROF IV LLC, |
its General Partner
By: OrbiMed Advisors LLC, its Managing Member |
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By: |
Name: Matthew Rizzo |
Title: Member |
ORBIMED ROYALTY & CREDIT OPPORTUNITIES IV OFFSHORE, LP,
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By: OrbiMed ROF IV LLC, |
its General Partner
By: OrbiMed Advisors LLC, its Managing Member |
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By: |
Name: Matthew Rizzo |
Title: Member |
[Signature Page to Waiver and Fifth Amendment to Credit Agreement]
Solely for purposes of Section 6:
ORBIMED ROYALTY & CREDIT OPPORTUNITIES IV, LP,
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By: OrbiMed ROF IV LLC, |
its General Partner
By: OrbiMed Advisors LLC, its Managing Member |
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By: |
Name: Matthew Rizzo |
Title: Member |
[Signature Page to Waiver and Fifth Amendment to Credit Agreement]
ACKNOWLEDGED BY: ORCO IV LLC By: OrbiMed Royalty & Credit Opportunities IV, LP, its Sole Member
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By: OrbiMed ROF IV LLC, |
its General Partner
By: OrbiMed Advisors LLC, its Managing Member |
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By: |
Name: Matthew Rizzo |
Title: Member |
[Signature Page to Waiver and Fifth Amendment to Credit Agreement]
Exhibit 99.1
AVITA Medical Reports Second Quarter 2025 Financial Results, Updates Full-Year Guidance, and Highlights Continued Clinical Innovation
VALENCIA, Calif., August 7, 2025 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering transformative solutions, today reported financial results for the second quarter ended June 30, 2025.
Financial Results
Business Update
Clinical Highlights
Jim Corbett, Chief Executive Officer of AVITA Medical, commented: “Although the first half of 2025 tested our resilience and slowed our pace, a resolution is now underway and our strategic direction hasn’t changed. The data tells the story: RECELL reduces hospital stays by 36%, Cohealyx achieves graft readiness in as little as five days. We’re also grateful for CMS’s support in expanding access to RECELL for Medicare beneficiaries with inpatient trauma wounds with the NTAP. We’re accelerating time to heal, time to recover, and time to deliver value, to patients and providers alike.”
Business update: Delay in provider payment dampened RECELL demand in the first half of 2025
In November 2024, the Centers for Medicare and Medicaid Services (CMS) announced new Category I CPT codes for the use of RECELL as part of its 2025 rule update. Unlike the standard process, CMS did not assign a national payment rate. Instead, it assigned pricing responsibility to the Medicare Administrative Contractors (MACs) under a process known as contractor pricing, an approach CMS occasionally uses when initiating long-term code changes.
Following the implementation of the new codes, claims for the use of RECELL were submitted starting in January 2025. Under the contractor pricing model, it is the MACs' responsibility to adjudicate claims by either assigning a payment rate and reimbursing the claim, or denying the claim, which would allow the provider to appeal and trigger an adjudication through that process. However, in this instance, MACs neither assigned a price or assigned an inadequate price and failed to adjudicate claims in a timely manner. As a result, claims accumulated from January through June, creating a significant backlog of unpaid claims and inadequately paid claims to providers for RECELL procedures. This lack of resolution created uncertainty among providers regarding payment expectations and timelines, which led to a reduction in RECELL utilization during the first half of the year.
While AVITA continued receiving payment for RECELL, this provider reimbursement issue constrained demand meaningfully impacting revenue. For example, across AVITA’s top ten hospital accounts, RECELL revenue declined by approximately $5 million when comparing the second half of 2024 to the first half of 2025. The Company estimates that overall demand for RECELL declined by approximately 20% with revenue declining by approximately $10 million during this period.
Encouragingly, multi-jurisdictional efforts by the American Medical Association and industry stakeholders have resulted in meaningful progress. In July, multiple MACs have indicated their intent to adjudicate and pay claims under the new codes and the remaining MACs are expected to follow. In light of this development, AVITA anticipates continued resolution of this issue, with RECELL demand recovering in the second half of 2025 as the MACs adjudicate the claims backlog.
As a result of slower than expected sales in the first half, significantly compounded by the ongoing reimbursement issue, AVITA has adjusted its full-year guidance as follows:
David O'Toole, Chief Financial Officer of AVITA Medical, commented: “While we’ve revised our 2025 guidance, our long-term outlook remains intact. We’re pleased to have OrbiMed’s continued partnership and their willingness to accept equity in lieu of a cash fee reflects strong alignment with our long-term strategy and confidence in the value of the business we’re building. Regarding gross margin and gross profit, our gross margin percentage will decline, and gross profit will increase as revenue from PermeaDerm and Cohealyx grows. With our disciplined cost structure, together with stronger revenue expected in the second half of the year, we now anticipate reaching cash flow break-even and GAAP profitability in 2026 as reimbursement pathways stabilize and adoption progresses.”
Second Quarter 2025 Financial Results
Commercial revenue was $18.4 million in the three-months ended June 30, 2025, an increase of $3.2 million, or 21%, compared to $15.2 million in the corresponding period in the prior year. The growth in commercial revenue was largely driven by deeper penetration within customer accounts, new accounts for trauma wounds and, to a lesser extent, new product launches.
Gross profit margin was 81.2% compared to 86.1% in the corresponding period in the prior year. The gross margin for only RECELL products was 84.3% for the quarter, which the Company expects to 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, higher inventory reserve, and other adjustments. 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 the gross margin percentage. Therefore, the product mix is expected to continue to have an impact on the overall gross margin percentage while increasing the gross profit and, given that expenses associated with this revenue do not increase significantly, operating profit on a quarterly basis.
Total operating expenses for the quarter were $26.1 million, compared to $28.7 million in the same period in 2024. The decrease is primarily attributable to a $2.0 million reduction in sales and marketing expenses, which resulted from lower employee-related costs such as salaries, benefits and stock-based compensation due to cost reduction initiatives. Additionally, G&A expenses decreased by $0.8 million, also attributable to lower salaries, benefits and stock-based compensation. These decreases were partially offset by increased R&D costs of $0.2 million, because of an increase in headcount. Due to the recent commercial field transformation and additional operational efficiencies that were
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implemented, the Company expects to continue to reduce operating expenses by approximately $2.5 million per quarter going forward.
Other income, net increased by $0.9 million, resulting in an income of $2.5 million compared to $1.6 million in the prior period. In the current period, other income, net includes non-cash gains of $1.2 million from the change in fair value of warrants, $0.9 million from the change in fair value of debt, and $0.4 million from our investments. In the prior period, income consisted of a non-cash gain of $2.1 million from the change in fair value of warrant liability and $0.7 million from our investments, which was offset by a non-cash charge of $1.2 million due to the change in fair value of debt.
Net loss was $9.9 million, or a loss of $0.38 per basic and diluted share, compared to a net loss of $15.4 million, or a loss of $0.60 per basic and diluted share, in the same period in 2024.
On June 30, 2025, AVITA received a waiver for the trailing 12-month net revenue covenant under its credit agreement with OrbiMed, related to the second quarter of 2025, which had been set at $78.0 million. On August 7, 2025, the Company entered into its fifth amendment to its credit agreement with OrbiMed, revising the trailing 12-month (“TTM”) revenue covenants for the period spanning July 1, 2025, through June 30, 2026. Under the amended terms, the TTM revenue covenant thresholds are as follows:
Q3 2025: $73 million
Q4 2025: $77 million
Q1 2026: $90 million
Q2 2026: $103 million
Beginning in Q3 2026, the TTM revenue covenant will be $115 million and will remain at that level for all subsequent quarters through the maturity of the debt. In consideration for this fifth amendment to the OrbiMed credit agreement, AVITA agreed to issue 400,000 unrestricted common shares to OrbiMed in lieu of a cash fee.
As of June 30, 2025, the Company had approximately $15.7 million in cash, cash equivalents, and marketable securities.
Webcast and Conference Call Information
AVITA Medical will host a conference call on Thursday, August 7, 2025, at 1:30 p.m. Pacific Time (Friday, August 8, 2025, at 6:30 a.m. Australian Eastern Standard Time) to discuss its second quarter 2025 financial results and recent business and clinical highlights. The live webcast will be available under the Events & Presentations section of the AVITA Medical website at ir.avitamedical.com. To participate by telephone, please register in advance to receive dial-in details and a personal PIN at https://register-conf.media-server.com/register/BI2760d86b79a7479f830f23dd916bd991. A replay of the webcast will be available shortly after the live event.
About AVITA Medical, Inc.
AVITA Medical® is 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. At the forefront of our platform is the RECELL® System, approved by the FDA for the treatment of thermal burn and trauma wounds. RECELL harnesses the healing properties of a patient’s own skin to create Spray-On Skin™ Cells, offering an innovative solution for improved clinical outcomes at the point-of-care. In the U.S., AVITA Medical also holds the exclusive rights to manufacture, market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, and the exclusive rights to market, sell, and distribute Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix.
In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns and full-thickness skin defects. The RECELL System, excluding RECELL GO®, is TGA-registered in Australia, has received CE mark approval in Europe, and has PMDA approval in Japan.
To learn more, visit www.avitamedical.com.
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “guidance,” “intend,” “look forward,” “may,” “outlook,” “project,” “target,” “will,” “would,” and similar words or expressions, and the use of future dates. Forward-looking statements include, but are not limited to, statements relating to the timing and realization of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, as well as other economic or political conditions outside of the Company’s control. These statements are made as of the date of this release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.
Investor & Media Contact:
Ben Atkins
Phone +1-805 341 1571
Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.
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AVITA MEDICAL, INC.
Consolidated Balance Sheets
(In thousands, except share and per share data)
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As of |
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June 30, 2025 |
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December 31, 2024 |
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ASSETS |
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Cash and cash equivalents |
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$ |
12,216 |
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$ |
14,050 |
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Marketable securities |
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3,474 |
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21,835 |
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Accounts receivable, net |
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11,343 |
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11,786 |
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Prepaids and other current assets |
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1,684 |
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2,060 |
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Inventory |
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7,536 |
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7,269 |
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Total current assets |
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36,253 |
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57,000 |
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Plant and equipment, net |
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9,689 |
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10,018 |
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Operating lease right-of-use assets |
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3,132 |
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3,571 |
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Corporate-owned life insurance (“COLI”) asset |
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2,913 |
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3,006 |
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Intangible assets, net |
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5,308 |
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5,570 |
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Other long-term assets |
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839 |
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546 |
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Total assets |
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$ |
58,134 |
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$ |
79,711 |
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LIABILITIES, NON-QUALIFIED DEFERRED COMPENSATION PLAN SHARE AWARDS AND STOCKHOLDERS’ EQUITY (DEFICIT) |
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Accounts payable and accrued liabilities |
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$ |
7,267 |
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$ |
6,294 |
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Accrued wages and fringe benefits |
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7,941 |
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10,451 |
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Loan facility |
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42,216 |
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- |
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Current non-qualified deferred compensation (“NQDC”) liability |
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339 |
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2,094 |
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Contingent liability |
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3,000 |
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- |
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Other current liabilities |
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1,839 |
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1,319 |
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Total current liabilities |
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62,602 |
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20,158 |
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Loan facility - long-term |
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- |
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42,245 |
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Non-qualified deferred compensation liability |
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3,800 |
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2,969 |
|
Contract liabilities |
|
|
307 |
|
|
|
324 |
|
Operating lease liabilities, long-term |
|
|
2,372 |
|
|
|
2,840 |
|
Contingent liability, long-term |
|
|
- |
|
|
|
3,000 |
|
Warrant liabilities |
|
|
1,900 |
|
|
|
3,432 |
|
Total liabilities |
|
|
70,981 |
|
|
|
74,968 |
|
Non-qualified deferred compensation plan share awards |
|
|
45 |
|
|
|
244 |
|
Commitments and contingencies |
|
|
|
|
|
|
||
Stockholders' equity (deficit): |
|
|
|
|
|
|
||
Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 26,613,678 and 26,354,042, shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively |
|
|
3 |
|
|
|
3 |
|
Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at June 30, 2025 and December 31, 2024 |
|
|
- |
|
|
|
- |
|
Company common stock held by the non-qualified deferred compensation plan |
|
|
(1,296 |
) |
|
|
(1,319 |
) |
Additional paid-in capital |
|
|
374,073 |
|
|
|
367,568 |
|
Accumulated other comprehensive loss |
|
|
(2,079 |
) |
|
|
(1,939 |
) |
Accumulated deficit |
|
|
(383,593 |
) |
|
|
(359,814 |
) |
Total stockholders’ equity (deficit) |
|
|
(12,892 |
) |
|
|
4,499 |
|
Total liabilities, non-qualified deferred compensation plan share awards and stockholders’ equity (deficit) |
|
$ |
58,134 |
|
|
$ |
79,711 |
|
|
|
|
|
|
|
|
||
Page 5
AVITA MEDICAL, INC.
Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
|
|
Three-Months Ended |
|
|
Six-Months Ended |
|
||||||||||
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
|
June 30, 2025 |
|
|
June 30, 2024 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales revenue |
|
$ |
18,226 |
|
|
$ |
15,183 |
|
|
$ |
36,551 |
|
|
$ |
26,287 |
|
Lease revenue |
|
|
192 |
|
|
|
12 |
|
|
|
381 |
|
|
|
12 |
|
Total revenues |
|
|
18,418 |
|
|
|
15,195 |
|
|
|
36,932 |
|
|
|
26,299 |
|
Cost of sales |
|
|
(3,469 |
) |
|
|
(2,111 |
) |
|
|
(6,303 |
) |
|
|
(3,624 |
) |
Gross profit |
|
|
14,949 |
|
|
|
13,084 |
|
|
|
30,629 |
|
|
|
22,675 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales and marketing |
|
|
(14,314 |
) |
|
|
(16,302 |
) |
|
|
(29,147 |
) |
|
|
(28,942 |
) |
General and administrative |
|
|
(6,666 |
) |
|
|
(7,519 |
) |
|
|
(13,057 |
) |
|
|
(16,481 |
) |
Research and development |
|
|
(5,117 |
) |
|
|
(4,887 |
) |
|
|
(11,400 |
) |
|
|
(10,081 |
) |
Total operating expenses |
|
|
(26,097 |
) |
|
|
(28,708 |
) |
|
|
(53,604 |
) |
|
|
(55,504 |
) |
Operating loss |
|
|
(11,148 |
) |
|
|
(15,624 |
) |
|
|
(22,975 |
) |
|
|
(32,829 |
) |
Interest expense |
|
|
(1,252 |
) |
|
|
(1,347 |
) |
|
|
(2,485 |
) |
|
|
(2,703 |
) |
Other income, net |
|
|
2,484 |
|
|
|
1,611 |
|
|
|
1,693 |
|
|
|
1,544 |
|
Loss before income taxes |
|
|
(9,916 |
) |
|
|
(15,360 |
) |
|
|
(23,767 |
) |
|
|
(33,988 |
) |
Income tax expense |
|
|
(4 |
) |
|
|
(33 |
) |
|
|
(12 |
) |
|
|
(63 |
) |
Net loss |
|
$ |
(9,920 |
) |
|
$ |
(15,393 |
) |
|
$ |
(23,779 |
) |
|
$ |
(34,051 |
) |
Net loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
$ |
(0.38 |
) |
|
$ |
(0.60 |
) |
|
$ |
(0.90 |
) |
|
$ |
(1.32 |
) |
Weighted-average common shares: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
|
26,367,548 |
|
|
|
25,760,278 |
|
|
|
26,400,366 |
|
|
|
25,699,030 |
|
Page 6