AVITA Medical Updates Full Year 2023 Guidance
November 20 2023 - 4:15PM
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a
regenerative medicine company leading the development and
commercialization of first-in-class devices and autologous cellular
therapies for skin restoration, today announced an update to its
full year 2023 guidance. This update is a result of
slower-than-anticipated progression through the customer’s Value
Analysis Committee (VAC) processes, driven by the expanded label
applications of its newest indication, full-thickness skin defects.
“Our expanded label for full-thickness skin defects opens up an
abundance of exciting applications,” Jim Corbett, Chief Executive
Officer of AVITA Medical. “With a wider range of potential uses,
more clinicians within the hospital are engaged in the VAC process,
leading to longer hospital approval timelines. Although the VAC
processes are taking longer than anticipated, we expect that once
completed, the process will yield positive approvals and an
expanded market opportunity. The broader clinical involvement
validates the substantial market opportunity this expanded label
represents, which is greater than 10 times the size of the burn
market.”
As a result of these dynamics, the Company is revising its
expected full year 2023 commercial revenue from the previously
disclosed range of $51 million to $53 million to a range of
approximately $49.5 million to $50.5 million, with lower and upper
bounds reflecting growth rates of approximately 45% and 48%,
respectively, over the same period in 2022.
About AVITA Medical, Inc.AVITA Medical® is a
regenerative medicine company leading the development and
commercialization of devices and autologous cellular therapies for
skin restoration. The RECELL® System technology platform, approved
by the Food and Drug Administration for the treatment of thermal
burn wounds and full-thickness skin defects and for repigmentation
of stable depigmented vitiligo lesions, harnesses the regenerative
properties of a patient’s own skin to create Spray-On Skin™ cells.
Delivered at the point-of-care, RECELL enables improved clinical
outcomes. RECELL is the catalyst of a new treatment paradigm and
AVITA Medical is leveraging its proven and differentiated
capabilities to develop first-in-class cellular therapies for
multiple indications.
In international markets, our products are approved under the
RECELL System brand to promote skin healing in a wide range of
applications including burns, full-thickness skin defects, and
vitiligo. The RECELL System is TGA-registered in Australia,
received CE-mark approval in Europe and has PMDA approval in
Japan.
To learn more, visit www.avitamedical.com.
Forward-Looking Statements This press release
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 press release 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 press release is subject to risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by such statements. Applicable risks and uncertainties
include, among others, the timing and realization 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 press
release. 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 press release
speak only as of the date of this release, and we undertake no
obligation to update or revise any of these statements.
Investor & Media Contact:Jessica
EkebergPhone +1-661-904-9269
investor@avitamedical.commedia@avitamedical.com
Authorized for release by the Chief Financial Officer of AVITA
Medical, Inc.
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