Investors: Press Release
AVITA Therapeutics Provides Company Update and Revised Corporate Presentation
U.S.RECELL® System Sales:
July represented the highest monthly sales for RECELL Systems in
the United Statessince launch in January 2019.
Unaudited sales for the RECELL System in July were U.S.
- July also witnessed very broad utilization of the RECELL System with 57 unique account orders, and more than 90 physicians using the RECELL System.
AVITA expects quarterly revenue in the September quarter to resume growth, and for sales to exceed the U.S.
$3.9 millionpreviously reported for the three (3) months ended June 30, 2020.
Recall that in the quarter ended
June 30, 2020revenue was deeply impacted by COVID in the United Stateswith sales in the month of April down approximately 25% (versus the previous month).
- Revenue then recovered in both May and June to deliver a flat sequential quarterly revenue result from the March quarter to the June quarter.
- Recall that in the quarter ended
- July represented the highest monthly sales for RECELL Systems in
As previously advised, the
U.S. Food & Drug Administration(FDA) granted an investigational device exemption (IDE) to support a vitiligo pivotal study on July 2nd, 2020.
- Since receipt of the IDE, the Company has worked aggressively to obtain investigational review board approval (IRB) to support initiation of this study, together with commencing contracting discussions with potential clinical sites.
AVITA expects to treat our first vitiligo patient during
- There is a very high degree of both patient and clinical site enthusiasm in participating in our vitiligo pivotal study. Further, the Company continues to believe that the RECELL System is uniquely positioned to offer vitiligo patients a single curative therapy given that the RECELL System has been used to treat over 1,000 vitiligo patients internationally, and has been shown to provide patient benefits to vitiligo patients in eight (8) peer-reviewed publications.
- AVITA is also actively endeavoring to increase the number of clinical studies participating in each of our clinical studies. Additional clinical study sites have recently been added to both the pediatric scald and the soft tissue pivotal studies, and more sites are expected to be onboarded over the next few months.
- As previously advised, the
The Company expects to release its Annual Report for the twelve (12) months ended
June 30, 2020on August 28th.
The Company will participate both in the Morgan Stanley Virtual 18th Annual Global Healthcare Conference and the
Cantor Global Healthcare Conference, which are both scheduled to take place in September.
- A copy of the Company’s revised corporate presentation is available on the Company’s website.
- The Company expects to release its Annual Report for the twelve (12) months ended
For more detailed information on the Company’s recent developments, please see our press release dated
Authorized for release by the Chief Executive Officer of
AVITA Therapeutics’ first
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
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE 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 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 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.
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