Full Press Release Details
AVITA Medical Provides Preliminary Top Line Results
for the Third Quarter and COVID-19 Update
Valencia, Calif., USA, and Melbourne,
Australia, 6 April 2020 AVITA Medical Limited (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, today announced preliminary
estimates of its top line results for the three months ended 31 March 2020, together with an operating update relating to the COVID-19 pandemic.
Preliminary Estimates of Top Line Results for Three Month Period Ended 31 March 2020
On a preliminary estimate basis, AVITA Medical expects its results of operations for the three months ended 31 March 2020 to reflect:
( IFRS ). Please see Non-IFRS Financial Measures and Other Items for more information.
The Australian Securities Exchange (ASX) Appendix 4C Quarterly Cash Flow Report ( 4C Cash Flow Report ) is scheduled to be filed with ASX during the
week commencing 27 April 2020.
We are pleased with the continued growth trajectory of the RECELL System during the last quarter, said
Dr. Mike Perry, AVITA Medical s Chief Executive Officer. The onset of COVID-19 has created challenges for society in general, so it is pleasing to see that the unique benefits of the RECELL System, including reducing the length of
stay in hospital for burn patients, are still being well received. While it is difficult to predict the medium- to long-term implications of the pandemic, we are committed to preserving the safety, health, and wellbeing of our employees, customers,
and the burn patients we serve and are well capitalized to do so. We are operating in alignment with the guidelines of the World Health Organization, Centers for Disease Control, and local agencies, and our priority is to make sure the RECELL System
is readily available for the treatment of burn patients. We expect the current environment will negatively impact the pace of enrollment of our investigational studies, and so we are continuing to adapt our practices and policies in line with daily
Avita Medical Limited c/o Mertons
Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000
Operating Update Related to the COVID-19 Pandemic
With governments launching unprecedented public-health and economic responses to the expanding COVID-19 pandemic, we provide the following overview of the
operating measures that we have implemented in the communities in which we operate:
Developments in relation to COVID-19
are a day-by-day proposition that the Company monitors closely, and it will adapt its practices and policies in line with those changes. The Company provides the following information and guidance in relation to the potential impact of COVID-19 on
Avita Medical Limited c/o Mertons
Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000
Corporate Presentation
An updated corporate presentation
will also be available on the Company s website later today.
Authorized for release by the Chief Executive Officer of Avita Medical Limited.
Non-IFRS Financial Measures and Other
The foregoing information and estimates are preliminary in nature and are subject to revision as we prepare our 4C Cash Flow Report and other
disclosures as of and for the three months ended 31 March 2020, including all disclosures required by ASX Listing Rules. Because we have not completed our normal quarterly closing and review procedures for the three months ended 31 March 2020, and
subsequent events may occur that require material adjustments to these results, the final results and other disclosures for this period may differ materially from these estimates. These estimates should not be viewed as a substitute for the full
disclosure of our 4C Cash Flow Report. These estimated results of operations should be read together with subsequent filings and announcements, including any subsequent press release announcing the Company s earnings for the quarter ended 31
Non-IFRS Financial Measures and Other Items
We use the following measures of financial performance which are not presented in accordance with IFRS:
Avita Medical Limited c/o Mertons
Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000
U.S. RECELL Sales is a non-GAAP financial measure used by management in evaluating sales performance, and
product acceptance, within the United States and for the purposes of making strategic decisions. Management believes that the presentation of U.S. RECELL Sales provides useful information to investors regarding our revenue results because they
assist both investors and management in analyzing and benchmarking the performance and value of our business. U.S. RECELL Sales provides indicators of product performance that are not affected by currency fluctuations. Accordingly, management
believes that this measurement is useful for comparing general sales performance from period to period in the Company s largest market.
AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns,
chronic wounds, and aesthetics indications. AVITA Medical s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient s own skin. The
medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES ), an autologous suspension comprised of the patient s skin cells necessary to regenerate natural healthy
epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
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 indicated for use in the treatment of acute thermal burns in patients 18
years and older. 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 8,000 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
marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.
To learn more, visit www.avitamedical.com.
REGARDING FORWARD-LOOKING STATEMENTS
This letter 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 letter
Avita Medical Limited c/o Mertons
Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000
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
letter 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 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 letter. 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 letter 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:
Avita Medical Limited c/o Mertons
Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000