Elutia Announces Sale of Orthobiologics Business Unit for Cash Proceeds of Up to $35 Million
18 Setembro 2023 - 5:08PM
Elutia Inc. (Nasdaq: ELUT) (“Elutia”), a company pioneering
drug-eluting biomatrix products, today announced the divestiture of
the Company’s Orthobiologics business unit to Berkeley Biologics
LLC, a wholly owned subsidiary of GNI Group Ltd. Elutia will
receive cash proceeds of up to $35 million, comprised of an upfront
payment at closing of $15 million plus potential earnout payments
of up to $20 million over a five-year period. The transaction is
expected to close in the fourth quarter of 2023.
This transaction represents a pivotal milestone
in Elutia’s progress toward pioneering the drug-eluting biomatrix.
The Company continues to make progress towards gaining U.S. Food
and Drug Administration clearance for CanGaroo® RM, the Company’s
lead drug-eluting product. CanGaroo RM features an advanced
biomatrix and the drugs rifampin and minocycline (RM) for extended
antibiotic protection for cardiac pacemakers and defibrillators, a
$28 billion market. Elutia is targeting the first half of 2024 for
the launch of CanGaroo RM. The Company’s pipeline also includes an
RM version of its SimpliDerm® biomatrix for use in breast
reconstruction procedures.
“Our mission is to provide physicians with the
wound healing benefits of natural biological materials combined
with the power of targeted therapeutics so that their patients can
thrive without compromise,” said Dr. Randy Mills, President and
Chief Executive Officer of Elutia. “With the development of the
drug-eluting biomatrix, we are creating a new biosurgery paradigm
to deliver better surgical outcomes. This transaction allows us to
focus our efforts on bringing this valuable technology to market,
with the confidence that our Orthobiologics business and team are
in great hands with Berkeley Biologics.”
Mizuho Securities USA LLC acted as advisor to
Elutia Inc. in connection with this transaction.
About Elutia
Elutia develops and commercializes biologic
products to improve compatibility between medical devices and the
patients who need them. With a growing population in need of
implantable technologies, Elutia’s mission is humanizing medicine
so patients can thrive without compromise. For more information,
visit www.Elutia.com.
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Forward-looking statements can be identified
by words such as “projects,” “may,” “will,” “could,” “would,”
“should,” “believes,” “expects,” “anticipates,” “estimates,”
“intends,” “plans,” “potential,” “promise” or similar references to
future periods. All statements contained in this press release that
do not relate to matters of historical fact should be considered
forward-looking statements, including any statements and
information concerning our plans for the closing of the sale of the
Orthobiologics business, which is subject to customary closing
conditions; any statements regarding the maximum $20 million in
earnout payments forming part of the consideration, which payments
are conditioned upon satisfaction of certain metrics; our
expectations for our focus on drug-eluting biomatrix technology
aimed at improving surgical outcomes; and the timing of the launch
of CanGarooRM. Forward-looking statements are based on management’s
current assumptions and expectations of future events and trends,
which affect or may affect our business, strategy, operations or
financial performance, and actual results may differ materially
from those expressed or implied in such statements due to numerous
risks and uncertainties. Forward-looking statements are inherently
subject to risks and uncertainties, some of which cannot be
predicted or quantified, and other important factors that may cause
actual results, performance or achievements to differ materially
from those contemplated or implied in this press release,
including, but not limited to: risks associated with shifting focus
to our drug-eluting biomatrix solutions in the cardiovascular and
breast reconstruction areas and away from our Orthobiologics
business; risks regarding the ability to successfully execute or
realize the anticipated benefits under our distribution
arrangements with LeMaitre Vascular and Sientra; our inability to
generate sufficient revenue to achieve or sustain profitability;
adverse changes in economic conditions and instability and
disruption of credit markets; our ability to continue as a going
concern; risks regarding the occurrence of any event, change or
other circumstances that could give rise to the right of Berkeley
Biologics LLC to terminate the definitive agreement with Elutia for
the disposition of our Orthobiologics business; delays in
completing the proposed disposition of Orthobiologics; the failure
to obtain required regulatory approvals for the disposition of the
Orthobiologics business, or to meet any of the other closing
conditions to the proposed transaction on a timely basis or at all;
our ability to successfully execute or achieve expected benefits
from the divestiture of our Orthobiologics business; our products
and our ability to enhance, expand, develop and commercialize our
product offerings; the impact on our business of the recall of a
single lot of our FiberCel product and the discontinuation of its
sales by our distribution partner; consequences of our recall of a
single lot of one of our viable bone matrix products and market
withdrawal of all of our viable bone matrix products; our
dependence on our commercial partners; the impact of the bankruptcy
of Surgalign Holdings, Inc., a significant customer of the Company,
on our future revenues; physician awareness of the distinctive
characteristics, and acceptance by the medical community, of our
products; the ability to obtain regulatory approval or other
marketing authorizations; and our intellectual property rights, and
other important factors which can be found in the “Risk Factors”
section of Elutia’s public filings with the Securities and Exchange
Commission (“SEC”), including Elutia’s Annual Report on Form 10-K
for the year ended December 31, 2022, as such factors may be
updated from time to time in Elutia’s other filings with the SEC,
including Elutia’s Quarterly Reports on Form 10-Q, accessible on
the SEC’s website at www.sec.gov and the Investor Relations page of
Elutia’s website at https://investors.elutia.com. Because
forward-looking statements are inherently subject to risks and
uncertainties, you should not rely on these forward-looking
statements as predictions of future events. Any forward-looking
statement made by Elutia in this press release is based only on
information currently available and speaks only as of the date on
which it is made. Except as required by applicable law, Elutia
expressly disclaims any obligations to publicly update any
forward-looking statements, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Investors:Matt SteinbergFINN
Partnersmatt.steinberg@finnpartners.com
Elutia (NASDAQ:ELUT)
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