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 third quarter 2023
financial highlights and the closing of a debt financing facility
for up to $90 million with OrbiMed, a healthcare investment firm.
The non-dilutive capital provides financial flexibility to support
portfolio expansion, global initiatives, and the further
development and commercialization of approved indications.
For the third quarter ended September 30, 2023, preliminary
commercial revenue was $13.5 million, a 50% increase compared to
approximately $9.0 million for the same period in 2022. Gross
margin for the third quarter was approximately 84.5%. Guidance for
full year 2023 commercial revenue remains unchanged and is expected
to be in the range of $51 to $53 million.
Under the terms of the Credit Agreement (the “Credit Agreement”)
with OrbiMed, the Company borrowed $40 million at closing. In
addition, an aggregate of an additional $50 million is available in
two tranches at the Company’s option, based on the achievement of
certain revenue thresholds. The Credit Agreement has a five-year
term that matures in October 2028. AVITA Medical also issued
OrbiMed a warrant to purchase 409,661 shares of the Company’s
common stock, with an exercise price of $10.9847.
“After another strong quarter, we are excited to be partnering
with OrbiMed,” said Jim Corbett, Chief Executive Officer of AVITA
Medical. “This transaction provides us with the capital to execute
strategic growth initiatives as we continue to transform our
business. We believe this financing provides us with sufficient
capital to meet our goals without the near-term need of equity
financing and positions us to reach profitability during 2025.”
Matthew Rizzo, General Partner of OrbiMed, added, “We are
excited to support AVITA Medical as they pursue their strategic
objectives, providing them with the necessary capital for financial
flexibility, enabling future portfolio expansion, global
initiatives, and the continued advancement and commercialization of
their approved indications, solidifying their position as a leader
in regenerative medicine.”
Further details regarding the Credit Agreement, Pledge and
Security Agreement, and the Warrant are set out in a Form 8-K filed
by the Company with the U.S. Securities and Exchange Commission on
October 18, 2023, and disclosed on the Australian Securities
Exchange.
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.
About OrbiMedOrbiMed is a healthcare investment
firm, with approximately $17 billion in assets under management.
OrbiMed invests globally across the healthcare industry through a
range of private equity funds, public equity funds, and
royalty/credit funds. OrbiMed’s team of over 100 professionals is
based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai,
London, Herzliya and other key global markets.
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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