Full Press Release Details
AVITA Medical Reports Third Quarter Fiscal 2020
Financial Results and Company Update
U.S. RECELL System product sales of A$5.81M for fiscal third quarter
Valencia, Calif., USA, and Melbourne, Australia, 29 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, reported financial results for the fiscal third quarter ended 31 March 2020 (Q3) today in its Appendix 4C -
Quarterly Cash Flow Report filed with the Australian Securities Exchange (ASX).
U.S. Commercial Sales of RECELL System for Quarter Ended 31 March 2020
Product sales and other revenues for the third
quarter and nine months ended 31 March 2020 were as follows (unaudited):
| (Thousand Australian $ s) | Three Months Ended 31 March | Nine Months Ended 31 March | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| U.S. product sales | A$ | 5,809 | A$ | 2,206 | A$ | 15,083 | A$ | 3,308 | ||||||||
| International product sales | 148 | 189 | 558 | 900 | ||||||||||||
| Total product sales | 5,957 | 2,395 | 15,641 | 4,208 | ||||||||||||
| Other income (including BARDA) | 2,108 | 2,427 | 5,954 | 7,540 | ||||||||||||
| Total revenue | A$ | 8,065 | A$ | 4,822 | A$ | 21,595 | A$ | 11,748 |
Our strong fiscal third quarter results demonstrate continued growing adoption trends within both our existing and new
RECELL System customers, said Dr. Mike Perry, AVITA Medical s Chief Executive Officer. In the current COVID-19 environment, we are deploying various strategies, including supply redundancies and digital training, to drive usage
and continue serving burn surgeons and their patients. While severe burn treatments are not elective procedures, there has been a pause in enrollment in some of our clinical trials due to COVID-19; however, we
are advancing our pipeline and are currently developing the protocol and FDA Investigational Device Application for the RECELL vitiligo pivotal study. In addition, we are continuing to make progress toward redomiciling the Company to the United
States to better align the Company s corporate structure with our U.S. business operations.
Our commercial efforts in Q3 progressed well with quarterly growth exceeding 20% across both procedural volume and U.S. RECELL System revenue. Q3 represents
our strongest quarter since launching in the United
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States in January last year reflecting strong customer uptake, even with the COVID-19 pandemic beginning toward the end of the quarter. In the quarter
ended 31 March 2020, we also added nine new customers and certified an additional 21 surgeons, bringing our total to 69 customers and 205 certified burn surgeons, together with progressing our ongoing clinical investigations with first patient
enrollment in our soft tissue and pediatric partial thickness studies. All of these factors collectively demonstrate ongoing high interest in the RECELL System, together with consistent usage and acceptance across our growing customer base.
We have seen consistent growth since the launch of the RECELL System and we have, so far, been somewhat insulated from the
COVID-19 challenges to- date given the treatment of burns patients is generally not elective nor deferrable. While we didn t see any impact to the rate of burn
incidence or RECELL System utilization during the quarter, it continues to be difficult to predict the breadth of potential impacts over the coming months due to the current COVID-19 macroenvironment. These
considerations operate in addition to the overarching burn environment which is inherently lumpy and difficult to forecast.
additional information which builds on our two earlier news releases on our progress and COVID-19 implications:
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Review & 2020 Perspective
As we look back at Q3, this quarter represents one of our best performances since launch and included revenue
and procedural volume growth exceeding 20%. Q3 also marked the first quarter for the RECELL System to be utilized in more than 400 procedures marking continued strong endorsement of the unique benefits that the RECELL System offers.
A summary of our quarterly commercial highlights is set out below:
| (United States $ s) | Quarter Ended | |||||||||||||||||||
| 31 March 2019 | 30 June 2019 | 30 Sept 2019 | 31 Dec 2019 | 31 March 2020 | ||||||||||||||||
| US RECELL Sales | $ | 1,577,341 | $ | 2,036,270 | $ | 3,183,030 | $ | 3,178,160 | $ | 3,861,530 | ||||||||||
| Cumulative. U.S. RECELL Sales | $ | 1,577,341 | $ | 3,613,611 | $ | 6,796,641 | $ | 9,974,801 | $ | 13,836,331 | ||||||||||
| New Accounts | 9 | 21 | 13 | 8 | 9 | |||||||||||||||
| Cumulative Accounts | 18 | 39 | 52 | 60 | 69 | |||||||||||||||
| Physicians Certified | 32 | 39 | 21 | 27 | 21 | |||||||||||||||
| Cumulative Physicians | 97 | 136 | 157 | 184 | 205 |
As we look back at a very successful quarter and think about the path ahead, it is clear that our customers are now operating
under challenging conditions, and this is creating a broad spectrum of commercial behavior which varies greatly and is driven by heterogeneic considerations such as:
Given the above, we are experiencing a wide degree of commercial variability across the United States, which is representative of the
inconsistent and regionalized nature of COVID-19 outbreaks. In regions where we see highly restrictive operating conditions or constrained burn treatment resources, our ability to be effective in those
locations is impacted by the number of our customers in those regions and, more importantly, the associated degree of RECELL System experience (i.e. our outcomes are impacted by regional COVID-19
considerations and whether the affected hospital is, for example, a super user ).
Independent of the above and despite burn procedures being
non elective, our experience tends to indicate
Avita Medical Limited c/o Mertons Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000
that the incidence of burns will not be immune from the lower levels of economic activity (e.g. manufacturing, retail, etc.) and reduced travel and road activity that are presently occurring in
the United States due to the COVID-19 pandemic. Similar to the experience with the declining number of car accidents and heart attacks, our best guess is that the number of burns patients could decline during
the COVID-19 overhang and that decline could potentially occur in the range of 0 to 20%.
unprecedented operating conditions, our commercial team continues to be highly active with our customers as circumstances permit. However, the lack of face-to-face time
with our customers and the fact that hospital resourcing is generally focused around COVID-19 means that new account accrual and the opportunity for our field force to assist newer accounts to develop broader
burns treatment experience (i.e. migrating from bigger to smaller burns, and using the RECELL System without autografting) is presently impaired.
Other Developments and Updates
reported across the United States, the COVID-19 pandemic has required hospitals and clinical research institutions to prioritize their resources, efforts and facilities to expand, and reserve, capacity for the
treatment of COVID-19 patients. The direct implication of this is that clinical investigational studies are not generally being actively pursued and, in consequence, enrollment in our existing clinical studies
(i.e. our soft tissue reconstruction pivotal, pediatric partial-thickness pivotal study and our vitiligo feasibility study) is largely paused pending further developments with COVID-19. We are hopeful that the
present re-prioritization of resources away from clinical studies will lessen in the short term to allow a restart of our studies. We will provide updates here as appropriate.
Over the last few months, we have been
exploring the possibility of advancing a pivotal study that would evaluate the safety and effectiveness of the RECELL System in the treatment of stable vitiligo patients. These efforts have incorporated a range of discussions with industry experts
and key opinion leaders for the purpose of determining essential elements of a potential clinical protocol including, among other things, primary endpoints, study population, and the treatment protocol.
The above efforts are now approaching completion and we are presently in the process of compiling an Investigational Device Exemption ( IDE )
application for the vitiligo pivotal study which we plan to submit to the U.S. Food & Drug Administration ( FDA ) before the end of June. The current proposal remains formative but is expected to incorporate the following
The Company believes the vitiligo market represents a large, attractive market, and one for which there is no approved therapy for patients. Vitiligo is an
autoimmune deficiency which creates enormous quality of
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life implications for patients and is comparable to the stigma experienced by patients suffering from psoriasis, acne or rosacea. Subject to receiving FDA approval for the IDE, the Company is
hopeful of being ready to initiate this pivotal study in the second half of 2020 (subject to COVID-19 developments). If the pivotal study thereafter successfully meets its endpoints, the Company will leverage
its existing premarket approval ( PMA ) to submit a PMA supplement to the FDA (as opposed to being required to submit a full PMA) thereby seeking to add a new indication for use (i.e. patients with stable vitiligo) to our existing
acute thermal burns indication.
Independent of the above efforts, the Company already has an IDE for a vitiligo pilot study and recently entered into a
research collaboration with the University of Massachusetts. As previously disclosed, this pilot study (n=10) will also include patients who have vitiligo lesions that have been stable for at least one year. This study will provide incremental
learnings and data, operating in parallel with the Company s new efforts to bring forward a pivotal study with the FDA as discussed above.
In early March 2020, we
announced the initiation of a pivotal trial for the treatment of pediatric scald injuries with enrollment of the first patient at the Arizona Burn Center at Valleywise Medical Health Center in Phoenix, AZ. This study seeks to demonstrate that
treatment with the RECELL System of partial-thickness burn injuries within 72-hours can safely and effectively increase the incidence of healing at day 10 when compared to a standard wound dressing. This study
is ongoing, but enrollment is paused given the COVID-19 pandemic.
Additionally, the Company has a second
pediatric study which is commonly referred to as the pediatric donor study . This is a randomized clinical study to compare the healing of a donor site in pediatric patients treated with the RECELL System versus conventional care (i.e.
standard dressings only). This study was conceived more than three (3) years ago and prior to the PMA, and the growing commercial adoption, of the RECELL System in the United States. Given the premarket approval of the RECELL System and the
resultant strong early adoption, the Company believes that there is little clinical utility, and little practical benefit, in continuing this study (including no ability for this study to expand our existing approved burn indication). For these
reasons, the Company is actively pursuing terminating this study (but continuing with the pediatric partial thickness study mentioned above).
A study titled A pilot multi-centre prospective randomized controlled trial of RECELL for the treatment of venous leg
ulcers, by Paul D. Hayes, Keith G. Harding, Susan M. Johnson, Charles McCollum, Luc Teot, Kevin Mercer, and David Russell published online in the International Wound Journal in February and will also publish in the June print edition of
Intention to Redomicile to the United States of America
On 20 April 2020, we announced our intention to redomicile from Australia to the United States. Under the proposed redomiciliation, AVITA Therapeutics,
Inc. 2 ( AVITA US ) will become our new parent company.
Avita Medical Limited c/o Mertons Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000
While the group will have a new parent company as a result of the redomiciliation, underlying operations,
business and assets of the group will remain completely unchanged.
Since 2018, the Company has had no physical business presence, and only one
(1) employee, in Australia. In addition, our immediate commercial focus is on unlocking the U.S. market, where we currently source virtually all of our revenue. Against this background, the beneficial owners of a majority of our shares are now
located outside Australia, with ~50% of shares being beneficially owned by investors in the United States alone.
The redomiciliation proposal therefore
provides the Company with the opportunity to align our corporate structure with our business and beneficial ownership, and has the added benefit of providing a familiar investment offering (versus our existing American Depositary Shares) to
investors in the United States, which is the world s largest capital market in terms of market capitalization and trading volume. Importantly, the proposal allows us to substantially reduce our financial reporting and compliance burden and save
costs, while not impacting the quantity of financial information provided to investors or disrupting trading on either the ASX or NASDAQ.
which will be implemented pursuant to a scheme of arrangement under Australian law, is subject to approval by shareholders (at a shareholders meeting currently tentatively scheduled for 15 June 2020) and orders of the Federal Court of
Australia as well as regulatory review by various government bodies, including the Australian Securities and Investments Commission and the Foreign Investment Review Board. The Company is anticipating that it will be in a position to send to
shareholders in mid-May 2020 a Scheme Booklet that will contain a detailed explanation of the redomiciliation proposal, including the advantages, disadvantages and risks of the proposal, together with an
Independent Expert s report that will set out whether, in the expert s opinion, the proposal is in the best interests of shareholders as a whole.
We have received a number of enquiries since the proposal was announced on 20 April 2020 and, as such, for ease of reference we set out below some key
features of the redomiciliation proposal. It is however important that shareholders appreciate that the below is a brief and high level overview of some key aspects of the proposal (if implemented), and the Board of Directors
strongly encourages shareholders to review the Scheme Booklet in detail when they receive it and to take part in the shareholders meeting. Further, shareholders should consult their financial, legal, taxation or other independent and qualified
professional adviser if they have any questions in relation to the proposal.
Avita Medical Limited c/o Mertons Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000