RCEL Avita Medical Inc

 

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): January 07, 2025

 

 

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:

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On January 7, 2025, AVITA Medical, Inc. issued a press release announcing an update to its expected fourth quarter and full year 2024 revenue and provided its 2025 financial guidance. A copy of the press release is attached hereto as Exhibit 99.1.

The information under this Item 2.02 and Exhibit 99.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 and shall not be deemed incorporated by reference into any filing made under the Securities Act of 1933 except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

99.1	AVITA Medical Updates Expected Fourth Quarter and Full Year 2024 Revenue, Provides 2025 Financial Guidance
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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:	January 7, 2025	By:	/s/ David O'Toole
			David O'Toole Chief Financial Officer

 

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AVITA Medical Updates Expected Fourth Quarter and Full Year 2024 Revenue, Provides 2025 Financial Guidance

 

VALENCIA, Calif., January 7, 2025 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced an update to its fourth quarter and full-year 2024 commercial revenue guidance.

For the quarter ended December 31, 2024, AVITA Medical now expects commercial revenue to be approximately $18.4 million, reflecting growth of around 30% over the same period in 2023. Previously provided fourth-quarter guidance was in the range of $22.3 million to $24.3 million. Based on these quarterly results, the company expects full-year 2024 commercial revenue to be approximately $64.3 million, reflecting growth of about 29% over the full year 2023. Previously provided full-year 2024 revenue guidance was in the range of $68.0 million to $70.0 million.

The revision in fourth-quarter guidance is attributable to a combination of factors, with slower-than-expected purchasing activity being the primary driver. Several of the company’s hospital accounts adjusted their inventory levels at the end of their fiscal year, resulting in reduced purchasing during December. While this type of behavior is common at year-end, the extent was more pronounced than we had anticipated, contributing to less revenue in the quarter. We expect normal purchasing activity for these accounts to resume in the first quarter, with deferred purchases from the fourth quarter rolling over.

At the same time, the company continues to scale its business, including the ongoing integration of an expanded sales force and the launch of new products that are expected to drive long-term growth. In 2024, AVITA Medical introduced the first new addition to its portfolio, PermeaDerm®, which is a biosynthetic, transparent wound matrix. In June, the company received FDA approval for its next-generation device, RECELL GO™, followed by FDA approval in December for RECELL GO mini, designed to treat smaller wounds. RECELL GO will continue to drive adoption in both new and existing accounts. Additionally, in December, the FDA cleared Cohealyx™, a new collagen-based dermal matrix branded by AVITA Medical and co-developed with Regenity Biosciences. These initiatives, particularly the launches of RECELL GO and Cohealyx, remain central to the company’s growth strategy and broader business potential.

“We grew our revenue in 2024 by approximately 29% over the prior year. We achieved this growth despite lower-than-expected fourth-quarter revenue,” said Jim Corbett, CEO of AVITA Medical. “We remain confident in our long-term growth trajectory as we continue to scale our business. Our strategic investments in our people and new products position us to continue to drive significant growth and sustainable success. We are focused on executing our plan, delivering value to our shareholders, and improving patient outcomes.”

2025 Financial Guidance

 

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Webcast and Conference Call Information

AVITA Medical plans to report its financial results for the fourth quarter and full year 2024 after the close of the U.S. financial markets on Thursday, February 13, 2025. A conference call and webcast are scheduled for that day at 1:30 p.m. Pacific Time (Friday, February 14, 2024, at 8:30 a.m. Australian Eastern Daylight Time) to discuss its results in further detail.

About AVITA Medical, Inc.

AVITA Medical® is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with innovative devices. At the forefront of our platform is the RECELL® System, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ Cells, delivering a transformative solution at the point-of-care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. In the United States, AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, and 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, full-thickness skin defects, and vitiligo. 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.

 

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,” “expect,” “intend,” “could,” “would,” “may,” “will,” “believe,” “continue,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “outlook,” “guidance,” “future,” 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; anticipated market share growth and revenue generation from certain 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.

 

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Investor & Media Contact:

Jessica Ekeberg

Phone +1-661-904-9269

investor@avitamedical.com

media@avitamedical.com

Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.

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v3.24.4

Document And Entity Information	Jan. 07, 2025
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Jan. 07, 2025
Entity Registrant Name	AVITA Medical, Inc.
Entity Central Index Key	0001762303
Entity Emerging Growth Company	true
Entity File Number	001-39059
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	85-1021707
Entity Address, Address Line One	28159 Avenue Stanford
Entity Address, Address Line Two	Suite 220
Entity Address, City or Town	Valencia
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	91355
City Area Code	661
Local Phone Number	367-9170
Entity Information, Former Legal or Registered Name	N/A
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	RCEL
Security Exchange Name	NASDAQ

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