false 0001762303 0001762303 2022-11-10 2022-11-10





Washington, D.C. 20549







Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 10, 2022



AVITA Medical, Inc.

(Exact name of registrant as specified in its charter)




Delaware   001-39059   85-1021707

(State or other jurisdiction

of incorporation)



File Number)


(IRS Employer

Identification No.)


28159 Avenue Stanford, Suite 220, Valencia, CA 91355   661.367.9170
(Address of principal executive offices, including Zip Code)   (Registrant’s telephone number, including area code)


(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   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 or Rule 12b-2 of the Securities Exchange Act of 1934. 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; Item 8.01 Other Events.

On November 10, 2022, AVITA Medical, Inc. (the “Company”), reported financial results for its third quarter 2022, and certain other business updates. A webcast of the event is available on the Company’s website under Investor Events and Presentations. In conjunction with the report, the Company released a press release attached hereto as Exhibit 99.1.

The information under Item 2.02, Item 8.01, and Exhibit 99.1 is preliminary, has not been audited, and is subject to change. The information disclosed 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.

(d) Exhibits




Description of Exhibit

99.1    AVITA Medical Reports Third Quarter 2022 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.

Date: November 14, 2022



/s/ Donna Shiroma

Name:   Donna Shiroma
Title:   General Counsel

Exhibit 99.1



AVITA Medical Reports Third Quarter 2022 Financial Results

November 10, 2022

VALENCIA, Calif. and MELBOURNE, Australia, Nov. 10, 2022 (GLOBE NEWSWIRE) — 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 ended September 30, 2022.

Third Quarter Highlights and Recent Updates:



Reported commercial revenue, which excludes BARDA revenue, of $9.0 million, a 30% increase compared to $6.9 million in the corresponding period in the prior year



Reported total revenue, which includes BARDA revenue, of $9.1 million compared to $7.0 million in the corresponding period in the prior year



Gross profit margin was 83%



Topline results from its pivotal randomized controlled trial evaluating the safety and effectiveness of the RECELL® System for healing of soft tissue repair with reduced donor skin



Co-primary endpoints were met for superiority relative to donor skin sparing and for non-inferiority relative to healing



Topline results from its pivotal randomized controlled trial evaluating the safety and effectiveness of the RECELL® System for repigmentation for stable vitiligo



Super-superiority was established for the primary endpoint



The Company plans U.S. Food and Drug Administration (FDA) submissions for soft tissue repair and vitiligo indications in December 2022



Breakthrough Device designation provided by the FDA for the RECELL System for soft tissue repair and vitiligo



The Japanese MHLW (Ministry of Health, Labor, and Welfare) granted the RECELL System marketing approval with pricing to end-customers equivalent to our U.S. pricing. Our partner in Japan, COSMOTEC, an M3 Company, will launch commercial RECELL in Japan in Q4 2022



As of September 30, 2022, the Company had $88.2 million in cash, cash equivalents, and marketable securities, with no debt

“Over the next 24 to 36 months, our growth is expected to be driven by the burns and soft tissue repair markets,” said Jim Corbett, AVITA Medical Chief Executive Officer. “Soft tissue repair will expand our hospital and treating physician call points by nearly three times. We are prepared to make the necessary investment in our commercial organization to support this expansion. This market opportunity expansion and the related revenue growth is the number one priority of AVITA Medical.”

Three Months Ended September 30, 2022 Financial Results

Our commercial revenue, which excludes BARDA revenue, increased by 30% or $2.1 million to $9.0 million in the three months ended September 30, 2022, compared to $6.9 million in the corresponding period in the prior year. Total revenue, which includes BARDA revenue, increased 30% or $2.1 million to $9.1 million compared to $7.0 million in the corresponding period in the prior year. The growth in commercial revenues was largely driven by deeper penetration within individual customer accounts along with the commencement of commercial sales with our partner COSMOTEC in Japan.

Gross profit margin decreased by 2% to 83% compared to the corresponding period in the prior year.

Total operating expenses increased by 16% or $2.0 million to $14.2 million compared to $12.3 million in the corresponding period in the prior year. The increase in operating expenses is attributable to higher compensation costs, pre-commercialization costs, research and development expenses, partially offset by lower share-based compensation expenses. Higher compensation costs were primarily a result of an expansion of our commercial team along with an increase in commissions which resulted from an increase in commercial revenues. In addition, we incurred severance costs in the current quarter associated with the termination of a former executive employee. Higher pre-commercialization costs are driven by activities related to future RECELL launches in soft tissue reconstruction and vitiligo. Increased research and development expenses resulted from ongoing development of next generation devices for an automated preparation of Spray-On Skin Cells. Higher research and development expenses were partially offset by lower clinical trial expenses for soft tissue reconstruction and vitiligo as trial participants were in less costly follow-up phases this period compared to more costly recruitment and treatment phases in the prior period. Share-based compensation expense was lower in the current period as certain performance milestones were met in the prior period, and there was a reversal in the current period of previously recognized expense for unvested awards related to the termination of an executive officer.

Net loss decreased by 6% or $0.4 million to $5.6 million, or $0.22 per share, compared to a net loss of $5.9 million, or $0.24 per share, in the corresponding period of the prior year.

Adjusted EBITDA* loss increased by 2% or $84 thousand to $4.0 million, compared to a loss of $3.9 million in the corresponding period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

2022 Revenue Guidance

Turning to guidance, full year 2022 commercial revenue (excluding BARDA revenues) is expected to be $33.0-34.0 million, an increase from our prior guidance of $30 million, and an approximate 33% increase year-over-year. We continue to project BARDA revenues of approximately $0.3 million in calendar year 2022.



Adjusted EBITDA is a non-GAAP financial measure. See the appendix to this release for a discussion of non-GAAP financial measures, including a reconciliation to the most closely correlated GAAP measure.

Webcast and Conference Call Information

The Company will host a conference call to discuss the third quarter financial results after NASDAQ market close on Thursday, November 10, 2022, at 1:30 p.m. Pacific Time (being Friday, November 11, 2022, at 8:30 a.m. Australian Eastern Daylight 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. The live webinar can be accessed 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 acute thermal burns in both adults and children, 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 and validated cost savings. 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, including soft tissue repair and repigmentation of stable vitiligo lesions.

AVITA Medical’s first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is approved for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.

The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 15,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com) for a full description of indications for use and important safety information including contraindications, warnings, and precautions.

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.

* Use of non-GAAP Measure

AVITA Medical’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. AVITA Medical has provided in this release certain financial information that has not been prepared in accordance with GAAP. AVITA Medical’s management believes that the non-GAAP adjusted EBITDA described in the release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding AVITA Medical’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in AVITA Medical’s industry. However, the non-GAAP financial measures that AVITA Medical uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.


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 statement. 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




Consolidated Balance Sheets

(In thousands, except share and per share data)



     As of  
     September 30, 2022     December 31, 2021  



Cash and cash equivalents

   $ 23,613     $ 55,511  

Marketable securities

     60,559       29,649  

Accounts receivable, net

     3,553       3,118  

BARDA receivables

     792       308  

Prepaids and other current assets

     1,041       1,213  

Restricted cash

     202       201  


     1,960       2,132  







Total current assets

     91,720       92,132  

Marketable securities, long-term

     4,012       19,692  

Plant and equipment, net

     1,226       1,262  

Operating lease right-of-use assets

     1,029       1,544  

Corporate-owned life insurance asset

     948       304  

Intangible assets, net

     449       443  

Other long-term assets

     548       638  







Total assets

   $ 99,932     $ 116,015  









Accounts payable and accrued liabilities

     3,118       2,708  

Accrued wages and fringe benefits

     4,776       5,363  

Other current liabilities

     1,619       1,075  

Total current liabilities

     9,513       9,146  

Non-qualified deferred compensation plan liability

     1,016       262  

Contract liabilities

     740       952  

Operating lease liabilities, long-term

     405       918  

Other long-term liabilities

     —         113  







Total liabilities

   $ 11,674     $ 11,391  







Non-qualified deferred compensation plan share awards

     272       —    

Contingencies (Note 12)


Shareholders’ Equity:


Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 25,030,902 and 24,925,743 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

     3       3  

Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2022 and December 31, 2021

     —         —    

Company common stock held by the non-qualified deferred compensation plan

     (127     —    

Additional paid-in capital

     337,995       332,484  

Accumulated other comprehensive income

     7,350       8,060  

Accumulated deficit

     (257,235     (235,923







Total shareholders’ equity

   $ 87,986     $ 104,624  







Total liabilities and shareholders’ equity

   $ 99,932     $ 116,015  








Consolidated Statements of Operations

(In thousands, except share and per share data)



     Three-Months Ended
September 30,
    Nine-Months Ended
September 30,
     2022     2021     2022     2021  


   $ 9,092     $ 7,020     $ 24,966     $ 26,089  

Cost of sales

     (1,530     (1,088     (4,694     (5,287













Gross profit

     7,562       5,932       20,272       20,802  













BARDA income

     904       374       2,189       1,384  

Operating expenses:


Sales and marketing expenses*

     (5,411     (3,518     (15,571     (11,313

General and administrative expenses*

     (5,004     (5,349     (18,009     (16,046

Research and development expenses*

     (3,799     (3,388     (10,478     (11,471













Total operating expenses

     (14,214     (12,255     (44,058     (38,830













Operating loss

     (5,748     (5,949     (21,597     (16,644

Interest expense

     (6     (9     (10     (21

Other income

     170       16       307       25  













Loss before income taxes

     (5,584     (5,942     (21,300     (16,640

Income tax expense

     (4     (6     (12     (23













Net loss

   $ (5,588   $ (5,948   $ (21,312   $ (16,663













Net loss per common share:



   $ (0.22   $ (0.24   $ (0.85   $ (0.69


   $ (0.22   $ (0.24   $ (0.85   $ (0.69

Weighted-average common shares:



     25,006,995       24,905,403       24,972,331       24,174,811  


     25,006,995       24,905,403       24,972,331       24,174,811  



Total operating expenses include impact of share-based compensation as follows:


(In thousands)    Three Months Ended
September 30,
     Nine Months Ended
September 30,
     2022      2021      2022      2021  

Sales and marketing expenses

   $ 408      $ 291      $ 1,022      $ 592  

General and administrative expenses

     761        1,251        4,071        3,353  

Research and development expenses

     267        300        689        640  














   $ 1,436      $ 1,842      $ 5,782      $ 4,585  













Reconciliation of reported Net Loss (GAAP) to Adjusted EBIDTA (NON-GAAP) Measure – Unaudited


(In thousands)    Three Months Ended
September 30,
    Nine Months Ended
September 30,
     2022     2021     2022     2021  

Net Loss

   $ (5,588   $ (5,948   $ (21,312   $ (16,663

Depreciation expense

     130       147       388       429  

Patent Amortization

     8       27       50       88  

Share-based expense

     1,436       1,842       5,782       4,585  

Interest Expense

     6       9       10       21  

Income Tax Expense

     4       6       12       23  













Adjusted EBITDA (Non-GAAP)

   $ (4,004   $ (3,917   $ (15,070   $ (11,517