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

Date of Report (Date of earliest event reported): August 10, 2023



AVITA Medical, Inc.

(Exact name of Registrant as Specified in Its Charter)






(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)






28159 Avenue Stanford

Suite 220


Valencia, California



(Address of Principal Executive Offices)


(Zip Code)


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



(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




Name of each exchange on which registered

Common Stock, par value $0.0001 per share




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.

AVITA Medical, Inc. will report its second quarter 2023 financial results after the close of the U.S. financial markets on Thursday, August 10, 2023. In conjunction with the report, the Company has issued a press release attached hereto as Exhibit 99.1. AVITA Medical will host a conference call and webcast August 10, 2023 at 1:30 p.m. Pacific Time to discuss its financial results and recent business highlights. A replay of the call will be available shortly after the conclusion of the call on the Company's website.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits


No. Description of Exhibit

99.1 Press release titled “AVITA Medical Reports Second Quarter Financial Results"

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



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.






August 10, 2023


/s/ David O'Toole




David O'Toole, Chief Financial Officer






AVITA Medical Reports Second Quarter Financial Results


VALENCIA, California, August 10, 2023 — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today reported financial results for the second quarter June 30, 2023.


Financial Highlights and Recent Updates


Commercial revenue of $11.7 million, a 42% increase compared to $8.2 million for the same period in 2022
Received Food and Drug Administration (FDA) approval of premarket approval (PMA) supplement for the use of RECELL to treat full-thickness skin defects on June 7
Initiated commercial launch of full-thickness skin defects, along with additional eligible burn procedures, with expanded U.S. commercial organization on June 8
Received FDA approval of PMA application to use RECELL for repigmentation of stable depigmented vitiligo lesions on June 16
Submitted PMA supplement for automated cell disaggregation device, RECELL GO™, which maintains the FDA Breakthrough Device designation
As of June 30, 2023, $68.8 million in cash, cash equivalents, and marketable securities, with no debt


“We had an extraordinary second quarter with significant revenue growth, two landmark FDA approvals, and a pivotal FDA submission” said Jim Corbett, AVITA Medical Chief Executive Officer. “As anticipated, our expanded U.S. commercial organization was fully prepared for the FDA approval of full-thickness skin defects. Our proactive preparation enabled us to initiate the commercial launch the day after receiving FDA approval. Additionally, our PMA supplement for RECELL GO is on track, and we expect approval before the end of the year. Collectively, these approvals and submission mark significant advancement of our platform, empowering us to continue to unlock our growth potential.”


Future Milestones


Anticipate FDA approval of RECELL GO by December 27, 2023
Conducting post-market study with vitiligo patients to demonstrate the repigmentation and mental health benefits of treatment with RECELL, and reduction of associated health care costs
Pursuing site of service reimbursement for the use of RECELL in the physician office setting, which is expected in 2025


Financial Guidance


Commercial revenue for the third quarter 2023 is expected to be in the range of $13 to $14 million
Raising commercial revenue for the full year 2023 from $49 to $51 million to an expected range of $51 to $53 million
Gross margin for the full year 2023 expected to be in the range of 83% to 85%


Second Quarter 2023 Financial Results


Our commercial revenue, which excludes Biomedical Advanced Research and Development Authority (BARDA) revenue, increased by 42% to $11.7 million in the three-months ended June 30, 2023, compared to $8.2 million in the same period in 2022. Total revenue, which includes BARDA revenue, increased by 41% to $11.8 million compared to $8.3 million in the same period in 2022.

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Gross profit margin decreased by 2% to 81% compared to 83% for the second quarter of 2022. The decrease was largely driven by lower production in one month of the quarter caused by the need to qualify new vendors for certain manufacturing components.


Total operating expenses for the quarter increased by 53% to $21.1 million, compared to $13.9 million in the same period in 2022, primarily due to the significant increase of the commercial organization in preparation of the full-thickness skin defect launch. Additionally, our research and development expenses increased by approximately $2.0 million due to ongoing development of the RECELL GO device and costs associated with our Medical Science Liaison team.


Net loss was $10.4 million, or a loss of $0.41 per share, compared to a net loss of $6.3 million, or a loss of $0.25 per share, in the same period in 2022.


BARDA income consisted of funding from the Biomedical Advanced Research and Development Authority, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under ongoing USG Contract No. HHSO100201500028C.


Webcast and Conference Call Information

The Company will host a conference call to discuss the second quarter financial results and, recent business highlights on Thursday, August 10, 2023, at 1:30 p.m. Pacific Time. To access the live call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. A simultaneous webcast of the call will be available via the Company’s website at https://ir.avitamedical.com.


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


# # #


AVITA Medical® is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. The RECELL® System technology platform, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects and for repigmentation of stable depigmented vitiligo lesions, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells. Delivered at the point-of-care, RECELL enables improved clinical outcomes. RECELL is the catalyst of a new treatment paradigm and AVITA Medical is leveraging its proven and differentiated capabilities to develop first-in-class cellular therapies for multiple indications.


In international markets, our products are approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, soft tissue repair, vitiligo, and aesthetics. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe and has PMDA approval in Japan.


To learn more, visit www.avitamedical.com.




This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this press release include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational, and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those

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expressed or implied by such statements. Applicable risks and uncertainties include, among others, 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, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this press release. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.




Investors & Media

AVITA Medical, Inc.

Jessica Ekeberg

Phone +1 661 904 9269





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Consolidated Balance Sheets

(In thousands, except share and per share data)






As of



 June 30, 2023


 December 31, 2022


Cash and cash equivalents


 $ 37,485


 $ 18,164

Marketable securities



Accounts receivable, net





BARDA receivables



Prepaids and other current assets








Total current assets





Marketable securities long-term



Plant and equipment, net





Operating lease right-of-use assets



Corporate-owned life insurance asset





Intangible assets, net



Other long-term assets





Total assets

 $ 86,330

 $ 98,264






Accounts payable and accrued liabilities



Accrued wages and fringe benefits





Current non-qualified deferred compensation liability



Other current liabilities





Total current liabilities



Non-qualified deferred compensation liability





Contract liabilities



Operating lease liabilities, long term





Total liabilities



Non-qualified deferred compensation plan share awards





Contingencies (Note 13)

Stockholders' equity:





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Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 25,447,615 and 25,208,436 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively



Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at March 31, 2023 and December 31, 2022.





 Company common stock held by the non-qualified deferred compensation plan ("NQDC Plan")



Additional paid-in capital





Accumulated other comprehensive income



Accumulated deficit





Total stockholders' equity



Total liabilities, non-qualified deferred compensation plan share awards and stockholders' equity


 $ 86,330


 $ 98,264

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Consolidated Statements of Operations

(In thousands, except share and per share data)





Three-Months Ended


Six-Months Ended



June 30, 2023


June 30, 2022


June 30, 2023


June 30, 2022












 $ 11,753


 $ 8,335


$ 22,303


 $ 15,874

Cost of sales









Gross profit









BARDA income









Operating expenses:









Sales and marketing expenses









General and administrative expenses









Research and development expenses









Total operating expenses









Operating loss









Interest expense









Other income









Loss before income taxes









Provision for income tax









Net loss


 $ (10,384)


 $ (6,261)


 $ (19,604)


 $ (15,724)

Net loss per common share:









Basic and Diluted


 $ (0.41)


 $ (0.25)


 $ (0.78)


 $ (0.63)

Weighted-average common shares:









Basic and Diluted



















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