27 August 2021 the Manager ASX Announcements Australian
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27 August 2021 The Manager ASX Announcements Australian Securities Exchange Level 4 20 Bridge Street Sydney NSW 2000 Dear Sir / Madam ASX Appendix 4E (Preliminary Final Report) & Annual Report on Form 10-K Please find attached the following documents: • ASX Appendix 4E (Preliminary Final Report) for the 12-month period ended June 30, 2021 • Annual Report for the 12-month period ended June 30, 2021 (“Annual Report”) The Annual Report is prepared in accordance with U.S. Generally Accepted Accounting Principles (US GAAP) and is reported on Form 10-K. The Company will report its quarterly results for the three (3) month period ending September 30, 2021 on Form 10-Q and will hold a Company webcast to discuss those results in early November. Authorized by Dr Mike Perry Chief Executive Officer AVITA Medical, Inc. (ARBN 641 288 155) 28159 Avenue Stanford, Suite 220 Valencia, CA 91355 P +1(661) 367-9170 | f +1 (661) 367-9180 | avitamedical.com Registered Office: c/- Mertons Corporate Services Pty Limited Level 7, 330 Collins Street, Melbourne VIC 3000 Australia Appendix 4E Preliminary Final Report 30 June 2021 AVITA MEDICAL, INC. ARBN 641 288 155 Results for announcement to the market (In thousands, except net tangible asset backing per ordinary security) Movement June 2021 June 2020 Financial Results USD USD Sale of goods Up 105% 29,232 14,263 Other income Down 55% 2,072 4,612 Loss for the period attributable to owners of the parent Down 37% 26,583 42,030 Total comprehensive loss attributable to owners of the parent Down 37% 26,470 42,068 Record date for determining entitlements to dividends N/A – no dividends are proposed to be paid Net Tangible Asset Backing June 2021 June 2020 Net tangible asset backing per common stock outstanding $4.57 $3.3556 • Annual financial results: This report is based on the accompanying consolidated 2021 Financial Statements which have been audited by Grant Thornton LLP with the Report of Independent Registered Public Accounting Firm included in the 2021 Financial Statements. In this report, all references to “dollars” or “$” are to the currency of the United States. • Changes in control over entities: There were no entities over which AVITA Medical, Inc.’s (”Company”) control has been gained or lost during the fiscal year ended June 30, 2021. By way of background, the Company changed its corporate name from AVITA Therapeutics, Inc. to AVITA Medical, Inc., effective December 2, 2020 (United States time), after successfully filing a Certificate of Amendment of Certificate of Incorporation with the Secretary of State of Delaware. The Company’s change of name was registered with the Australian Securities and Investments Commission effective as from January 6, 2021. The Company’s common stock continues to trade on The NASDAQ Stock Exchange LLC under the symbol “RCEL” and its CHESS Depositary Interests continue to trade on the Australian Securities Exchange under the ticker symbol, “AVH”. • Details of dividends and dividend reinvestment plans: No dividends have been declared or proposed. • Details of associates or joint ventures: N/A • Set of accounting standards used in compiling the report: The audited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (US GAAP) and are denominated in U.S. dollars. • Details of audit disputes or audit qualification: None. Results of Operations: Total net revenue increased 105% to $29.2 million, compared to $14.3 million in the corresponding period in the prior year. RECELL® commercial revenues were $21.5 million, while RECELL revenues associated with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response (“BARDA”) were $7.7 million. Revenues associated with BARDA were attributable to the purchase of RECELL units for emergency preparedness by BARDA. RECELL commercial revenues increased by 50% or $7.2 million. Gross profit margin was 80% compared with 79% in the same period in the prior year, driven largely by lower shipping costs and increased production along with the extension of our shelf-life. BARDA income consisted of funding from BARDA, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under ongoing USG Contract No. HHSO100201500028C. Under the BARDA contract, income of $2.1 million was recognized during the year ended June 30, 2021, compared to income of $3.9 million for the year ended June 30, 2020. BARDA income declined as a result of the wind-down of certain activities associated with supporting the U.S. FDA approval of the RECELL System as well as the compassionate use, continued access programs and pivotal trials for the treatment of pediatric scald injuries. Total operating expenses decreased 10% or $6 million to $51.9 million, compared with $57.9 million incurred in the same period in the prior year. Sales and marketing expenses decreased $1 million or 7% to $14.7 million, compared to $15.7 million recognized in the same period in the prior year. The decrease in sales and marketing expenses is primarily due to fewer conferences, lower travel expenses due to COVID-19 related travel restrictions and higher costs incurred in the prior year associated with the product launch. General and administrative expenses decreased 32% or $10.6 million to $22.4 million compared with $33 million recognized in the same period in the prior year. The decrease was driven by higher share-based compensation expenses in the prior year associated with certain performance milestones being met along with higher costs related to the Avita group’s recomiciliation to the United States (which is discussed in further detail in the Company’s Form 10-K that is annexed to this Appendix 4E). Research and development expenses increased 61% or $5.6 million to $14.8 million, compared to $9.2 million recognized in the same period in the prior year. The increase was primarily attributed to the ramping up of clinical trials related activities for treatment of vitiligo as well as other research and development costs associated with furthering the Company’s pipeline. Net loss after tax decreased 37% or $15.4 million to $26.6 million, over the $42 million recognized in the same period in the prior year. The decrease in net loss was driven by higher revenue during the year, and lower operating expenses described above. Update on the Company’s Cash Position: The Company had cash, cash equivalents and restricted cash of $110.9 million at June 30, 2021 compared to $73.8 million at June 30, 2020. Net cash used in operating activities was $25.9 million and $22.7 million during the years ended June 30, 2021, and 2020, respectively. The increase during the 2021 fiscal year was primarily due to higher BARDA receivables attributable from the purchase of RECELL units by BARDA. Net cash used in investing activities was $1.2 million and $0.8 million during the years ended June 30, 2021, and 2020, respectively. Cash flows used for investing activities were primarily attributable to payments for the purchase of property and equipment. Net cash provided by financing activities was $64 million and $77.1 million for the years ended June 30, 2021, and 2020, respectively. The AVITA group completed a series of financing activities during the years ended June 30, 2021, and 2020 and received proceeds from the issuance of shares and exercise of options. Liquidity and Capital Resources: We aim to manage capital so that the Company continues as a going concern while also maintaining optimal returns to stockholders and benefits for other stakeholders. We also aim to maintain a capital structure that ensures the lowest cost of capital available to the Company. We regularly review the Company’s capital structure and seek to take advantage of available opportunities to improve outcomes for the Company and its stockholders. For the year ended June 30, 2021, there were no dividends paid and we have no plans to commence the payment of dividends. We have no committed plans to issue further shares on the market but will continue to assess market conditions and the Company’s cash flow requirements to ensure the Company is appropriately funded in order to continue its operations and pursue its various opportunities. 2 There is no significant external borrowing at the reporting date. Neither the Company nor any of the subsidiaries are subject to any externally imposed capital requirement. On March 1, 2021, the Company issued 3,214,250 shares of common stock at the offering price of $21.50 per share. The gross proceeds from the offering were approximately $69.1 million. The Company incurred $5.1 million in capital issuance expenses. Please refer to our audited consolidated financial statements with accompanying notes, which are attached hereto. Additional information Additional Appendix 4E disclosure requirements and commentary on these results are contained in the attached Form 10-K Annual Report for the period ended June 30, 2021. 3 Table of Contents e UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39059 AVITA MEDICAL, INC. (Exact name of registrant as specified in its charter) Delaware 85-1021707 (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) 28159 Avenue Stanford Suite 220 Valencia, CA 91355 (Address of principal executive offices and Zip Code) Registrant’s telephone number, including area code: (661) 367-9170 Securities registered pursuant to Section 12(b) of the Act: Trading Name of each exchange Title of each class Symbol on which registered Common Stock, par value $0.0001 per share RCEL The NASDAQ Stock Market LLC Securities registered pursuant to section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.