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): November 09, 2023

 

 

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

 

(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 November 9, 2023, AVITA Medical, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2023. 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 report, 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 titled “AVITA Medical Reports Third Quarter Financial Results with 51% Revenue Growth over the same period in the prior year"
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:	November 09, 2023	By:	/s/ Donna Shiroma
			Donna Shiroma General Counsel

 

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Exhibit 99.1

 

 

 

AVITA Medical Reports Third Quarter Financial Results with 51% Revenue Growth over the Same Period the Prior Year

 

 

VALENCIA, Calif., November 9, 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 third quarter September 30, 2023.

 

Financial Highlights and Recent Updates

 

 

“We continue to execute our growth strategy, paving the way to profitability,” said Jim Corbett, Chief Executive Officer of AVITA. “We are diligently working through supplemental in-house testing to support the FDA’s review of our PMA supplement for RECELL GO. Once complete, we expect to submit a response to the FDA’s open questions on February 28, 2024. Under the Breakthrough Device program, we anticipate FDA approval on May 30, 2024, which positions us for a launch the following day.”

 

Future Milestones

 

 

“We have achieved significant commercial revenue growth rates for the last three quarters of 40%, 42% and 51%, respectively, over the same periods in the previous year,” said David O’Toole, Chief Financial Officer of AVITA Medical. “Further, we remain confident that our cash reserves position us to achieve our goals and reach profitability in 2025.”

 

 

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Financial Guidance

 

 

Third Quarter 2023 Financial Results

 

Our commercial revenue, which excludes Biomedical Advanced Research and Development Authority (BARDA) revenue, increased by 51% to $13.5 million in the three-months ended September 30, 2023, compared to $9.0 million in the same period in 2022. Total revenue, which includes BARDA revenue, increased by 50% to $13.6 million compared to $9.1 million in the same period in 2022.

 

Gross profit margin increased by 1.3% to 84.5% compared to 83.2% for the third quarter of 2022. The increase was largely driven by higher production associated with our increase in revenues and lower shipping costs.

 

Total operating expenses for the quarter were $21.0 million, compared to $14.2 million in the same period in 2022. The increase in operating expenses is primarily attributable to an increase of $5.1 million in sales and marketing costs. The increase in sales and marketing costs is a result of the expansion of our commercial organization in preparation of the commercial launch of full-thickness skin defects that happened in the second quarter. In addition, the increase in operating expenses included an increase of $0.6 million in R&D costs, and an increase of $1.1 million in G&A costs, primarily due to an increase in stock compensation expense.

 

Net loss was $8.7 million, or a loss of $0.34 per basic and diluted share, compared to a net loss of $5.6 million, or a loss of $0.22 per basic and diluted share, in the same period in 2022.

 

As of September 30, 2023, the Company had approximately $60.1 million in cash, cash equivalents, and marketable securities.

 

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 third quarter financial results and, recent business highlights on Thursday, November 9, 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.

 

About 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, full-thickness skin defects, and vitiligo. 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.

 

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Forward-Looking Statements
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 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.

 

Investor & Media Contact:

Jessica Ekeberg

Phone +1-661-904-9269

invesotr@avitamedical.com

media@avitamedical.com

 

 

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)

(Unaudited)

 

		As of
		September 30, 2023				December 31, 2022
ASSETS
Cash and cash equivalents		$	50,854			$	18,164
Marketable securities			9,264				61,178
Accounts receivable, net			5,875				3,515
BARDA receivables			201				898
Prepaids and other current assets			3,356				1,578
Inventory			4,377				2,125
Total current assets			73,927				87,458
Marketable securities long-term			-				6,930
Plant and equipment, net			1,862				1,200
Operating lease right-of-use assets			2,607				851
Corporate-owned life insurance ("COLI") asset			1,923				1,238
Intangible assets, net			459				465
Other long-term assets			236				122
Total assets		$	81,014			$	98,264
LIABILITIES, NON-QUALIFIED DEFERRED COMPENSATION PLAN SHARE AWARDS AND STOCKHOLDERS' EQUITY
Accounts payable and accrued liabilities			3,019				3,002
Accrued wages and fringe benefits			7,143				6,623
Current non-qualified deferred compensation liability			333				78
Other current liabilities			1,341				990
Total current liabilities			11,836				10,693
Non-qualified deferred compensation liability			3,361				1,270
Contract liabilities			365				698
Operating lease liabilities, long term			1,845				306
Total liabilities			17,407				12,967
Non-qualified deferred compensation plan share awards			629				557
Commitments and contingencies (Note 12)
Stockholders' equity:
Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 25,550,694 and 25,208,436 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively			3				3
Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2023 and December 31, 2022.			-				-
Company common stock held by the non-qualified deferred compensation plan ("NQDC Plan")			(1,290	)			(127	)
Additional paid-in capital			347,192				339,825
Accumulated other comprehensive income			7,977				7,627
Accumulated deficit			(290,904	)			(262,588	)
Total stockholders' equity			62,978				84,740
Total liabilities, non-qualified deferred compensation plan share awards and stockholders' equity		$	81,014			$	98,264

 

Page 4

 

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AVITA MEDICAL, INC.

Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

		Three-Months Ended								Nine-Months Ended
		September 30, 2023				September 30, 2022				September 30, 2023				September 30, 2022
Revenues		$	13,645			$	9,092			$	35,948			$	24,966
Cost of sales			(2,113	)			(1,530	)			(5,984	)			(4,694	)
Gross profit			11,532				7,562				29,964				20,272
BARDA income			212				904				1,369				2,189
Operating expenses:
Sales and marketing expenses			(10,532	)			(5,411	)			(27,075	)			(15,571	)
General and administrative expenses			(6,124	)			(5,004	)			(20,584	)			(18,009	)
Research and development expenses			(4,394	)			(3,799	)			(14,056	)			(10,478	)
Total operating expenses			(21,050	)			(14,214	)			(61,715	)			(44,058	)
Operating loss			(9,306	)			(5,748	)			(30,382	)			(21,597	)
Interest expense			(10	)			(6	)			(21	)			(10	)
Other income			615				170				2,141				307
Loss before income taxes			(8,701	)			(5,584	)			(28,262	)			(21,300	)
Income tax expense			(11	)			(4	)			(54	)			(12	)
Net loss		$	(8,712	)		$	(5,588	)		$	(28,316	)		$	(21,312	)
Net loss per common share:
Basic and Diluted		$	(0.34	)		$	(0.22	)		$	(1.12	)		$	(0.85	)
Weighted-average common shares:
Basic and Diluted			25,401,754				25,006,995				25,281,920				24,972,331

 

 

 

 

 

 

 

 

 

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v3.23.3

Document And Entity Information	Nov. 09, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 09, 2023
Entity Registrant Name	AVITA Medical, Inc.
Entity Central Index Key	0001762303
Entity Emerging Growth Company	true
Securities Act 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
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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