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CONTENTS Corporate Information 3 Letter from the Chairman and CEO 4-5 Directors Report 6-24 Auditor s Independence Declaration 25 Consolidated Statement of Profit or Loss and Other Comprehensive Income 26 Consolidated St

Key Takeaway: Corporate Information 3 Letter from the Chairman and CEO 4-5 Directors Report 6-24 Auditor s Independence Declaration 25 Consolidated Statement of Profit or Loss and Other Comprehensive Income 26 Consolidated Statement of Financial Position 27 Consolidated State

Full Press Release Details

Corporate Information 3
Letter from the Chairman and CEO 4-5
Directors Report 6-24
Auditor s Independence Declaration 25
Consolidated Statement of Profit or Loss and Other Comprehensive Income 26
Consolidated Statement of Financial Position 27
Consolidated Statement of Cash Flows 28
Consolidated Statement of Changes in Equity 29-30
Notes to the Concise Financial Statements 31-36
Directors Declaration 37
Independent Auditor s Report 38-40
Shareholder Information 41-42
Corporate Information
This annual report covers the
consolidated entity comprising Avita Medical Limited (the Parent Company) and its controlled subsidiaries (the Company). The Parent Company s functional and presentation currency is AUD ($).
A description of the Company s operations and of its principal activities is included in the review of operations and activities in the Directors
Report on page 6. The Directors Report does not form part of the financial report.
Directors Solicitors
Mr Lou Panaccio (Non-Executive Chairman) K&L Gates
Dr Michael Perry (Executive Director) Level 25 South Tower, 525 Collins Street
Mr Jeremy Curnock Cook (Non-Executive Director) Melbourne VIC 3000, Australia
Mr Louis Drapeau (Non-Executive Director)
Mr Damien McDonald (Non-Executive Director) Auditor
Professor Suzanne Crowe (Non-Executive Director) Grant Thornton Audit Pty Ltd
Level 43 Central Park, 152-158 St Georges Terrace
Company Secretaries Perth, WA 6000 Australia
Mr Mark Licciardo and Ms Tamara Barr
of Mertons Corporate Services Pty Ltd Principal Bankers
National Australia Bank Limited
Registered Office 1238 Hay Street
c/o Mertons Corporate Services Pty Ltd West Perth, WA 6000 Australia
Level 7
330 Collins Street Stock Exchange
Melbourne VIC 3000, Australia Avita Medical Limited
Listed on the Australian Securities Exchange
Principal Place of Business (ASX Code: AVH)
28159 Avenue Stanford, Suite 220 Listed on the OTCQX International
Valencia, CA 91355 Marketplace in the US (Code: AVMXY)
USA
Internet Address
Share Register www.avitamedical.com
Computershare Investor Services Pty Limited
Level 11, 172 St Georges Terrace
Perth, WA 6000 Australia
AVITA MEDICAL LIMITED
LETTER FROM THE CHAIRMAN and CEO
It is our privilege to write to you after a truly transformative year at AVITA Medical. As you likely recall, we were granted approval by the U.S. Food and
Drug Administration (FDA) of the preliminary RECELL Autologous Cell Harvesting Device (RECELL System) for the treatment of acute thermal burns in adults in September 2018. Building upon that
success, in January of this year, we formally launched our U.S. sales field force, and began selling RECELL to burn centres in the U.S. This has been met by much enthusiasm from doctors, and we are very proud of the team in bringing this innovative
technology to burn patients.
Our ongoing successes are the result of the dedicated efforts and investments made over multiple years by our employees,
medical professionals, patients and shareholders. While our excellent regulatory team guided us to premarket approval in September 2018, the financial year 2019 was also a busy time for our commercial team. With our direct sales force of 21
representatives now deployed across the U.S., at our most recent update, we reported that we have sold product into 41 of the 134 U.S. burn centres to date, and 136 of 300 burn surgeons at 59 U.S. burn centres have been trained and have performed a
RECELL procedure. Note that U.S. burn centres follow a fairly standard process of evaluating the device and thereafter taking it through their hospital s Value Analysis Committee (VAC) before they are able to purchase the product. These
evaluations and VAC approvals usually take 6 or more months to complete, so we are extremely proud of our team s efforts in rapidly onboarding centres, as well as with the demand and interest for the product that we are seeing from surgeons.
We had another strong showing this year at the leading U.S. burn conference, the 51st annual meeting of the American Burn Association (ABA), and we were
able to report the positive results obtained in patient treatment using the RECELL System in a broad range of patient populations and burn types. This year we had 10 presentations highlighting successful outcomes and our presentation reporting on
use in paediatric patients was selected, out of over 500 submissions, as one of the Best of the Best Abstracts at the meeting. Additionally, our 2018 publication in the Journal of Burn Care & Research of the RECELL System
pivotal trial in second-degree burns was recognized during the The Year in Review: The Top Journal Publications session of the ABA meeting. While those two examples certainly underscore our overall success in the field, during the
financial year 2019 we delivered over 50 RECELL presentations at over 15 conferences and medical meetings.
With our success in adult burns having been
demonstrated, we are now working to expand our RECELL FDA label to include paediatric burns and scalds, as well as trauma indications. Paediatric burns is a large market and one that unfortunately touches many patients and families. FDA has approved
an Investigational Device Exemption (IDE) for our U.S. Soft-Tissue Repair Clinical Study, which we have confidence will provide robust pivotal data in support of a trauma indication.
Our R&D efforts continue to progress, and we have also spent this last year building our pipeline of future opportunities. In addition to paediatric burns
and trauma wounds, we ve also made strides in the clinic with our vitiligo treatment, which presents a relatively untapped market for us to pursue. In June 2019, RECELL System data were presented at the 24th annual World Congress of Dermatology
Meeting June 10-15, 2019, in Milan, Italy. Three posters at the World Congress of Dermatology highlighted the potential use of the RECELL System for the treatment of vitiligo and facial acne scars. In the
financial year 2021, AVITA expects to commence a pivotal/registration study of the RECELL System for the treatment of patients with vitiligo and anticipates, in collaboration with COSMOTEC, an M3 Group company, securing market approval and
reimbursement of the RECELL System in Japan.
Outside of the U.S., we continue to supply and support our existing users while maintaining our plan to
devote limited commercial resources to the select geographical regions in which the RECELL System is already approved for sale. We continue to supply and support our existing users. We will continue to make investments where it makes sense, such as
in our announced collaboration agreement with COSMOTEC for Japan. Our expectation is that in the near term, we will devote most of our commercial efforts and resources to ensuring a successful and growing U.S. presence, the largest market for the
treatment of burns. As we achieve successes in securing new indications via our advancement s efforts, especially in vitiligo, our commercial plan will likely broaden geographically.
On September 19, 2019 we filed a registration statement on Form 20-F under the Securities Exchange Act of 1934
with the Securities and Exchange Commission ( SEC ) relating to the registration in the United States of our class of American Depositary Shares representing ordinary shares of the Company. The registration statement was declared effective
by the SEC on September 27, 2019, and the Company has commenced trading of our American Depositary Shares on The Nasdaq Capital Market on October 1, 2019. We view the Nasdaq listing as a natural extension of our growth plan and an exciting
next step for AVITA Medical. Our transition to a senior U.S. exchange provides broader access to investors in the United States and worldwide, building on our established ASX shareholder base.
Overall, it s a time of much growth at AVITA and we continue to be immensely excited about the
opportunities available to us to make a material difference in the lives of patients. Our Board of Directors is committed to working alongside management to achieve these results and to consistently deliver value for our shareholders. We truly
appreciate the ongoing support of all our shareholders, employees, the Biomedical Advanced Research and Development Authority (BARDA), medical professionals and patients, and we look forward to updating you on our future successes.
AVITA MEDICAL LIMITED
Your Directors present their
report with respect to the results of Avita Medical Limited (the Company ) for the year ended 30 June 2019 and the of the Company at that date. Avita Medical Limited is a company limited by shares that is incorporated and domiciled
in Australia. The Company has prepared this consolidated financial report incorporating the entities that it controlled during the financial period.
The names and details of the Company s
Directors in office during the financial year and until the date of this report are as follows. Directors were in office for this entire period unless otherwise stated.
(Non-Executive Chairman)
Mr Panaccio is a healthcare businessman with extensive experience progressing companies from concept to commercialisation, was appointed to the role of
Chairman of the Board, effective from 1 July 2014. Mr Panaccio possesses more than 30 years executive leadership experience in healthcare services and life sciences, including more than 20 years board-level experience. Mr Panaccio
is currently a Non-Executive Director of ASX50 company and one of the world s largest medical diagnostics companies, Sonic Healthcare Limited, where he has served since 2005. In addition to his Sonic
Healthcare Limited role, Mr Panaccio is Non-Executive Director of Unison Housing Limited, Non-Executive Chairman of Genera Biosystems Limited, and a Non-Executive Director of Rhythm Biosciences Limited. Mr Panaccio has also served in executive and board roles with Melbourne Pathology Group, Monash IVF Group, Primelife Corporation Limited, Health Networks
Australia Group and other private entities. During the past three years Mr Panaccio has also served as a Director of the following other listed companies:
(Executive Director)
Dr Perry was appointed to the Board on 4 February 2013 and currently serves as Chief Executive Officer of the Company. From 2016 2017, he served as
Senior Vice President and Chief Scientific Officer of Global Business Development and Licensing for Novartis AG. From 2014 2016, Dr Perry served as Chief Scientific Officer of Novartis Cell and Gene Therapy Unit and from 2012
2014 he served as Vice President and Global Head of Stem Cell Therapy for Novartis Pharmaceuticals Corp, a US affiliate of Switzerland-based Novartis AG. Dr Perry, based in the United States, has previously served as the Global Head of R&D at
Baxter Healthcare, President and CEO of Cell & Gene Therapy at Novartis affiliates Systemix Inc. and Genetic Therapy, Inc., VP Regulatory Affairs at Sandoz Pharmaceuticals Corp., Director of Regulatory Affairs at Schering-Plough
Corporation, and Chairman, CEO or CMO at several early-stage biotech companies. He also previously served as a Venture Partner with Bay City Capital, LLC based in San Francisco California. During the past three years Dr Perry has also served as a
Director of the following other listed companies:
(Non-Executive Director)
Mr Curnock Cook was appointed to the Board on 19 October 2012 and is currently on several boards of International Healthcare and Biotechnology companies.
He is the former head of the life science private equity team at Rothschild Asset Management, was responsible for the launch of the first dedicated biotechnology fund for the Australian market and the conception and launch of the International
Biotechnology Trust. He is currently the Managing Director of Bioscience Managers Pty Ltd, responsible for the BM Asia Pacific Healthcare Fund, Chairman of International Bioscience Managers Ltd and Avena Therapeutics and Non-Executive Director of Rex Bionics Pty Ltd, SummatiX Ltd and Smart Matrix Ltd. During the past three years Mr Curnock Cook has also served as a director of the following other listed companies:
AVITA MEDICAL LIMITED
DIRECTORS REPORT (continued)
(Non-Executive Director)
Mr Louis Drapeau was appointed to the Board on 13 January 2016 and brings considerable expertise in both the biotech sector and the financial
rigour required of US public companies. Mr Drapeau is an Independent Director at AmphliPhi Biosciences Corporation (NYSE) and Surface Pharmaceuticals, Inc. Mr Drapeau has held senior positions with Insite Vision Inc., Nektar Therapeutics and
BioMarin Pharmaceutical, Inc., and has been an Audit Partner at Arthur Andersen LLP. Mr Drapeau has formally been an Independent Director at Bio-Rad Laboratories, (NYSE), InterMune, Inc. (NASDAQ), Bionovo,
Inc. (NASDAQ), and Inflazyme Pharmaceuticals Ltd (TSE). He has an MBA from Stanford University. During the past three years Mr Louis Drapeau has also served as a director of the following other listed companies:
(Non-Executive Director)
UK-based Mr Damien McDonald was appointed to the Board on 13 January 2016 and has a proven track record of
achieving value in the medical device space. Mr McDonald is currently CEO of LivaNova PLC having previously served as Chief Operating Officer. Prior to that, he was a Group Executive and Corporate Vice President at NYSE-listed Danaher Corporation, a
multinational science and technology innovation company that acquires and produces life science and industrial products and brands, where he led a $1.5 billion group of dental consumable companies. Earlier in his tenure, he was Group President
of Kerr where he and his team focused on building a strong research and development pipeline while improving operational performance utilising the Denaher Business System. He has also previously worked for Merck &Co, Johnson &
Johnson and Zimmer. He has bachelor s degrees in both pharmacy and economics from the University of Queensland, a master s degree in International Economics from the University of Wales, and an MBA from IMD of Lausanne, Switzerland. During
the past three years Mr Damien McDonald has also served as a director of the following other listed companies:
Professor Suzanne Crowe (AM)
(Non-Executive Director)
Professor Suzanne Crowe AM was appointed to the Board on 13 January 2016.
Australian-based, she is a physician-scientist and company director with extensive expertise in supporting companies with their medical and scientific strategies. Prof Crowe is a Principal Research Fellow of the Australian National Health and
Medical Research Council. She is a Principal Specialist in Infectious Diseases at The Alfred Hospital, Melbourne and Adjunct Professor of Medicine and Infectious Diseases at Monash University, Melbourne, and has published more than 200 peer-reviewed
papers. Prof Crowe is a member of the Australian Institute of Company Directors and is a Director of St Vincents Health Australia. Prof Crowe was appointed as a Member of the Order of Australia (AM) in 2011 to recognise her service to medical
research in HIV/AIDS. She has medical and MD degrees from Monash University, an internal medicine specialist qualification in Infectious Diseases from the Royal Australasian College of Physicians, and a Diploma in Medical Laboratory Technology from
the Royal Melbourne Institute of Technology.
(Joint Company Secretary)
Mark Licciardo, (B Bus (Acc), GradDip CSP, FGIA, GAICD) was appointed as Joint Company Secretary on 19 March 2018. Mark is Managing Director of Mertons
Corporate Services Pty Ltd (Mertons) which provides company secretarial and corporate governance consulting services to ASX listed and unlisted public and private companies. Prior to establishing Mertons, he was Company Secretary of the Transurban
Group and Australian Foundation Investment Company Limited. He has also had an extensive commercial banking career with the Commonwealth Bank and State Bank Victoria. Mark is a former Chairman of the Governance Institute Australia (GIA) in Victoria
and the Melbourne Fringe Festival, a fellow of GIA, the Institute of Chartered Secretaries (CIS), the Australian Institute of Company Directors (AICD) and former Non-Executive Director of iCar Asia Limited. Mr
Licciardo is currently a Non-Executive Director of ASX listed Frontier Digital Ventures Limited and Mobilicom Limited as well as several other public and private companies.
AVITA MEDICAL LIMITED
DIRECTORS REPORT (continued)
(Joint Company Secretary)
Kate Goland, (CPA, GIA (Cert))
was appointed as Joint Company Secretary on 19 March 2018 until 11 September 2019. Kate works with Mertons Corporate Services and is an experienced accounting and company secretarial professional. She has demonstrated expertise in
supporting clients in meeting their corporate obligations and ASIC compliance requirements. She joined Mertons from BDO where she assisted clients within the company secretarial division. Kate is a current Company Secretary of various public and
private companies. She has a strong understanding of corporate compliance matters.
Last updated: Oct 11, 2019