Our website address is www.avitamedical.com. Information contained on our website is not
part of or incorporated into this report. We make our periodic reports, together with any amendments, available on our website, free of charge, as soon as reasonably practicable after we electronically file or furnish the reports with the Securities
and Exchange Commission (SEC) or with the Australian Securities Exchange (ASX). The SEC maintains an internet site, www.sec.gov, which contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC. Copies of announcements made by the Company to the ASX are available on ASXs website (www.asx.com.au).
Corporate History
AVITA Therapeutics,
Inc. (now AVITA Medical, Inc), a Delaware corporation, was originally formed in April 2020. The former parent company of the AVITA Group, AVITA Medical Pty Limited (AVITA Medical) was formed under the laws of the Commonwealth of
Australia in December of 1992 and has operated as AVITA Medical since 2008. AVITA Medicals ordinary shares originally began trading in Australia on the ASX on August 9, 1993. AVITA Medicals ordinary shares, in the form of American
Depositary Shares (ADSs), began trading on the NASDAQ Stock Market LLC (NASDAQ) on October 1, 2019 under the ticker symbol RCEL.
On June 29, 2020, a statutory scheme of arrangement was implemented under Australian law to change the domicile of the AVITA Group from
Australia to the U.S. Under the scheme of arrangement, AVITA Therapeutics became the new parent company of the AVITA Group, and all ordinary shares in AVITA Medical (including ordinary shares represented by ADSs) held by securityholders were
exchanged for shares of common stock or CHESS Depositary Interests (CDIs). As a result, the existing listing of AVITA Medical Ltd. on the ASX (as its primary listing) and on NASDAQ (as its secondary listing) was inverted and
replaced with a new listing of AVITA Therapeutics on NASDAQ (as its primary listing) under the existing ticker symbol, RCEL, and on the ASX (as its secondary listing) under the existing ticker symbol, AVH. AVITA
Therapeutics shares of common stock trade on NASDAQ and its CDIs trade on ASX (with five CDIs trading on ASX representing one share of common stock on NASDAQ). On December 2, 2020, AVITA Therapeutics, Inc., changed its corporate name to
AVITA Medical, Inc. after filing a Certificate of Amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware. The Companys change of name was registered with the Australian Securities and Investments
Commission effective as from 6 January 2021. The Companys common stock continues to trade on NASDAQ under the symbol RCEL and the Companys CDIs continue to trade on the ASX under the ticker symbol AVH.
COVID-19 Business Update and Risks Associated with COVID-19
The global COVID-19 pandemic presents significant risks to us and may have far reaching impacts on our
business, operations, and financial results and condition, directly and indirectly, including, without limitation, impacts on: the health of our management and employees; manufacturing, distribution, marketing and sales operations; research and
development activities, including clinical activities; and customer and patient behaviors.
Beginning in March 2020, the COVID-19 pandemic began impacting our operations and financial results. For example, on March 19, 2020, the Executive Department of the State of California issued Executive Order
N-33-20, ordering all individuals in the State of California to stay at home or at their place of residence except as needed to maintain continuity of operations of
federal critical infrastructure sectors. Our primary operations are located in Santa Clarita and Ventura, California. We have taken a variety of steps to address the impact of the COVID-19 pandemic, while
attempting to minimize business disruption. Essential staff in manufacturing and limited support functions have continued to work from our locations following appropriate hygiene and social distancing protocols. To reduce the risk to our employees
and their families from potential exposure to COVID-19, all other staff have been required to work from home (excluding our field force). We have restricted
non-essential travel to protect the health and safety of our employees and customers.
Moreover,
beginning in March 2020, access to hospitals and other customer sites was restricted to essential personnel, which has negatively impacted our ability to promote the use of the RECELL System with physicians, and to enroll our clinical studies. In
addition, some hospitals and other burn centers suspended the treatment of burn patients or re-distributed those patients to other treatment facilities and, together with a general reduction in broader
economic activity (e.g., reduced travel, reduced mobility, suspension of certain business operations, etc.), this resulted in a reduction in the volume of burn procedures using the RECELL System in the immediate period following the implementation
of those protective measures. In addition, more recently we have experienced periodic enrollment cessation due to COVID-19 as well as having individuals excluded because they have contracted COVID-19.
Approximately 50% of the Companys revenues (excluding BARDA) come from twenty accounts
with physicians and hospitals. These accounts as well are susceptible to the effects of COVID-19 and COVID-19 restrictions. To the extent that COVID-19 or other factors cause such physicians or hospitals to be unable to treat patients or delay the treatment of patients using the RECELL System in a particular quarter, or make patients unavailable because of
COVID-19, our revenues could be negatively affected.
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