0001762303false00017623032023-08-102023-08-10

 

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): August 10, 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:

☐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.

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

Exhibit

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)

 

---

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:	August 10, 2023	By:	/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

 

 

“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

 

 

Financial Guidance

 

 

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.

Page 1

 

---

 

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.

 

# # #

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, 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.

 

 

CAUTIONARY NOTE REGARDING 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

Page 2

 

---

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.

 

 

FOR FURTHER INFORMATION:

Investors & Media AVITA Medical, Inc. Jessica Ekeberg Phone +1 661 904 9269 investor@avitamedical.com media@avitamedical.com

 

 

Page 3

 

---

AVITA MEDICAL, INC.

Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)

		As of
		June 30, 2023		December 31, 2022
ASSETS
Cash and cash equivalents		$ 37,485		$ 18,164
Marketable securities		28,562		61,178
Accounts receivable, net		5,754		3,515
BARDA receivables		442		898
Prepaids and other current assets		2,194		1,578
Inventory		3,058		2,125
Total current assets		77,495		87,458
Marketable securities long-term		2,754		6,930
Plant and equipment, net		1,598		1,200
Operating lease right-of-use assets		1,651		851
Corporate-owned life insurance asset		2,091		1,238
Intangible assets, net		456		465
Other long-term assets		285		122
Total assets		$ 86,330		$ 98,264
LIABILITIES, NON-QUALIFIED DEFERRED COMPENSATION PLAN SHARE AWARDS AND STOCKHOLDERS' EQUITY
Accounts payable and accrued liabilities		3,837		3,002
Accrued wages and fringe benefits		6,200		6,623
Current non-qualified deferred compensation liability		2,572		78
Other current liabilities		1,201		990
Total current liabilities		13,810		10,693
Non-qualified deferred compensation liability		1,224		1,270
Contract liabilities		374		698
Operating lease liabilities, long term		1,047		306
Total liabilities		16,455		12,967
Non-qualified deferred compensation plan share awards		1,228		557
Contingencies (Note 13)
Stockholders' equity:

Page 4

 

---

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		3		3
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")		(892)		(127)
Additional paid-in capital		343,769		339,825
Accumulated other comprehensive income		7,959		7,627
Accumulated deficit		(282,192)		(262,588)
Total stockholders' equity		68,647		84,740
Total liabilities, non-qualified deferred compensation plan share awards and stockholders' equity		$ 86,330		$ 98,264

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, 2023		June 30, 2022		June 30, 2023		June 30, 2022
Revenues		$ 11,753		$ 8,335		$ 22,303		$ 15,874
Cost of sales		(2,204)		(1,386)		(3,871)		(3,164)
Gross profit		9,549		6,949		18,432		12,710
BARDA income		530		551		1,157		1,285
Operating expenses:
Sales and marketing expenses		(10,003)		(5,332)		(16,543)		(10,160)
General and administrative expenses		(6,165)		(5,471)		(14,460)		(13,005)
Research and development expenses		(5,076)		(3,059)		(9,662)		(6,679)
Total operating expenses		(21,244)		(13,862)		(40,665)		(29,844)
Operating loss		(11,165)		(6,362)		(21,076)		(15,849)
Interest expense		(7)		(4)		(11)		(4)
Other income		801		109		1,526		137
Loss before income taxes		(10,371)		(6,257)		(19,561)		(15,716)
Provision for income tax		(13)		(4)		(43)		(8)
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		25,239,723		24,971,243		25,221,009		24,954,712

 

 

 

 

 

 

 

 

 

 

Page 6

 

---