AVITA Medical Announces Preliminary 2023 Financial Highlights, Provides 2024 Financial Guidance and Business Update
January 10 2024 - 9:01AM
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a
commercial-stage regenerative medicine company focused on
first-in-class devices and autologous cellular therapies for skin
restoration, today announced preliminary unaudited financial
highlights for the fourth quarter and full-year 2023, provided
financial guidance for the first quarter and full-year 2024, and
announced completion of patient enrollment in its post-market
study, TONE.
Preliminary Fourth Quarter and Full-Year 2023 Financial
Highlights
- Commercial revenue for the fourth quarter 2023 is expected to
be approximately $14.1 million, an increase of approximately 50%
compared to same period in 2022
- Commercial revenue for the full-year 2023 is expected to be
approximately $49.8 million, an increase of approximately 46%
compared to full-year 2022
- Gross margin for the full-year 2023 is expected to be
approximately 84.5%
- As of December 31, 2023, approximately $89.1 million in cash,
cash equivalents, and marketable securities
“This was a transformative year for AVITA Medical as we focused
on accelerating our growth profile,” said Jim Corbett, Chief
Executive Officer of AVITA Medical. “We have made tremendous
progress over the last four quarters, with consecutive commercial
revenue growth rates of 40%, 42%, 51%, and 50%, respectively, over
the same periods in 2022. We remain committed to sustaining growth
and building our business in 2024.”
2024 Financial Guidance
- Commercial revenue for the first quarter 2024 is expected to be
in the range of $14.8 to $15.6 million, reflecting growth at the
lower bound of approximately 42% and upper bound of approximately
50% over the same period in the prior year
- Commercial revenue for the full-year 2024 is expected to be in
the range of $78.5 to $84.5 million, reflecting growth at the lower
bound of approximately 57% and upper bound of approximately 69%
over the full-year 2023
Business Update
In July 2023, the Company initiated TONE, a post-market study
treating patients with stable vitiligo. The purpose of TONE is to
evaluate repigmentation and to understand the impact of
repigmentation on improving quality of life for patients with this
disease. Key study endpoints include patient and clinician
satisfaction of treatment, burden of disease, and patient mental
health status. The Company believes that developing these
health-related quality-of-life indicators will help create a basis
to understand the impact of vitiligo on the mental health of
patients and the associated healthcare costs of treatment.
The Company completed enrollment of TONE with 109 patients at
investigational sites across the United States earlier than
anticipated. Patients will be followed for a 12-month period, with
the primary follow-up period being 6-months after treatment.
About AVITA Medical, Inc.AVITA Medical® is a
commercial-stage regenerative medicine company transforming the
standard of care for skin restoration with innovative devices and
autologous cellular therapies. At the forefront of our platform is
the RECELL® System, 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. RECELL harnesses the regenerative
properties of a patient’s own skin to create Spray-On Skin™ Cells,
delivering a transformative solution at the point-of-care. RECELL
enables improved clinical outcomes. This breakthrough technology
serves as the catalyst for a new treatment paradigm enabling
improved clinical outcomes.
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 Statements in this
press release may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements are subject to significant risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Forward-looking statements generally may 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,”
and similar words or expressions, and the use of future dates.
These statements are made as of the date of this release, and the
Company undertakes no obligation to publicly update or revise any
of these statements, except as required by law. For additional
information and other important factors that may cause actual
results to differ materially from forward-looking statements,
please see the “Risk Factors” section of the Company’s latest
Annual Report on Form 10-K and other publicly available filings for
a discussion of these and other risks and uncertainties.
Authorized for release by the Chief Financial Officer of AVITA
Medical, Inc.
Investor & Media Contact:
Jessica Ekeberg
Phone +1-661-904-9269
investor@avitamedical.com
media@avitamedical.com
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