Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies
for the sports medicine and severe burn care markets, today
announced preliminary, unaudited financial results for the fourth
quarter and year ended December 31, 2022 and an accelerated launch
timeline for MACI® arthroscopic delivery, which is now anticipated
to be launched in 2024.
Preliminary, Unaudited Fourth-Quarter and Full-Year 2022
Financial Results
- Total net revenue for full-year 2022 expected to be
approximately $164 to $165 million
- MACI net revenue for full-year 2022
expected to be approximately $132 million
- Burn Care net revenue for full-year
2022 expected to be approximately $32.5 million
- Fourth quarter MACI revenue growth
expected to be approximately 24% versus prior year
- Expect tenth straight quarter with
positive adjusted EBITDA and Operating Cash Flow
- As of December 31,
2022, the Company had approximately $140 million in cash and
investments and no debt
Recent Business Highlights and Updates
- Following a Type C meeting with the FDA, the Company is
planning to initiate a human factors validation study to support
expanding the MACI label to include arthroscopic administration of
MACI for the treatment of cartilage defects of the knee and now
anticipates an accelerated potential commercial launch of
arthroscopic MACI in 2024
- Announced FDA approval of NexoBrid® (anacaulase-bcdb) on
December 28, 2022 for the removal of eschar in adults with deep
partial-thickness and/or full-thickness thermal burns, with U.S.
commercial availability expected in the second quarter of 2023
- Expect to hold a
pre-IND meeting with the FDA in the first half of 2023 to discuss
the MACI development program for the treatment of cartilage defects
in the ankle
“We made tremendous progress advancing our pipeline and
expanding our business in 2022, highlighted by an accelerated
regulatory pathway for the MACI arthroscopic delivery program and
the recent approval of NexoBrid,” said Nick Colangelo, President
and CEO of Vericel. “We also had very strong MACI performance to
close the year and we look forward to building on this momentum in
2023 across both of our franchises, as we expect accelerating total
revenue growth this year and further acceleration in 2024 driven by
a full year of NexoBrid on the market and the planned launch of
arthroscopic MACI.”
Vericel is scheduled to present at the 41st Annual J.P. Morgan
Healthcare Conference at 10:30 a.m. ET (7:30 a.m. PT) on Wednesday,
January 11, 2023. A webcast of the presentation will be available
on the Investor Relations section of the Vericel Corporation
website at: http://investors.vcel.com.
About Vericel Corporation Vericel is a leader
in advanced therapies for sports medicine and severe burn care. The
Company manufactures and markets two cell therapy products in the
United States. MACI® (autologous cultured chondrocytes on porcine
collagen membrane) is an autologous cellularized scaffold product
indicated for the repair of symptomatic, single or multiple
full-thickness cartilage defects of the knee with or without bone
involvement in adults. Epicel® (cultured epidermal autografts) is a
permanent skin replacement for the treatment of patients with deep
dermal or full thickness burns greater than or equal to 30% of
total body surface area. Vericel also holds an
exclusive license for North American rights to NexoBrid®
(anacaulase-bcdb), a biological orphan product containing
proteolytic enzymes, which is indicated for eschar removal in
adults with deep partial-thickness and/or full-thickness
burns. For more information, please visit www.vcel.com.
Epicel® and MACI® are registered trademarks of Vericel
Corporation. NexoBrid® is a registered trademark of MediWound Ltd.
and is used under license to Vericel Corporation. © 2023 Vericel
Corporation. All rights reserved.
Preliminary and Unaudited Nature of Reported
ResultsOur revenue expectations for the fourth quarter and
full-year ended 2022, as well as our estimates concerning adjusted
EBITDA, operating cash flows, cash and investments are preliminary,
unaudited and are subject to change based on the completion of
ongoing internal control, review, and audit procedures. As a
result, these amounts may differ materially from the amounts that
will be reflected in the Company’s consolidated financial
statements for the year ended December 31, 2022. Accordingly, you
should not place undue reliance on this preliminary estimate.
Forward-Looking StatementsVericel cautions you
that all statements other than statements of historical fact
included in this press release that address activities, events or
developments that we expect, believe or anticipate will or may
occur in the future are forward-looking statements. Although we
believe that we have a reasonable basis for the forward-looking
statements contained herein, they are based on current expectations
about future events affecting us and are subject to risks,
assumptions, uncertainties and factors relating to our operations
and business environment, all of which are difficult to predict and
many of which are beyond our control. Our actual results may differ
materially from those expressed or implied by the forward-looking
statements in this press release. These statements are often, but
are not always, made through the use of words or phrases such as
“anticipates,” “intends,” “estimates,” “plans,” “expects,”
“continues,” “believe,” “guidance,” “outlook,” “target,” “future,”
“potential,” “goals” and similar words or phrases, or future or
conditional verbs such as “will,” “would,” “should,” “could,”
“may,” or similar expressions.
Among the factors that may result in differences are the
inherent uncertainties associated with our expectations concerning
expected revenue results for the fourth quarter and full-year ended
2022, adjusted EBITDA, operating cash flow, and estimates of our
cash and investments as of December 31, 2022. Vericel’s revenue
expectations for the fourth quarter and full-year ended 2022, as
well as its estimates concerning adjusted EBITDA, operating cash
flow, and cash and investments are preliminary, unaudited and are
subject to change during ongoing internal control, review, and
audit procedures. Additional factors that could cause actual
results to differ materially from those set forth in the
forward-looking statements include, but are not limited to,
uncertainties associated with our expectations regarding future
revenue, growth in revenue, market penetration for MACI, Epicel,
and NexoBrid, growth in profit, gross margins and operating
margins, the ability to achieve or sustain profitability,
contributions to adjusted EBITDA, the expected target surgeon
audience, potential fluctuations in sales and volumes and our
results of operations over the course of the year, timing and
conduct of clinical trial and product development activities,
timing and likelihood of the FDA’s potential approval of the
arthroscopic delivery of MACI to the knee or the use of MACI to
treat cartilage defects in the ankle, the estimate of the
commercial growth potential of our products and product candidates,
competitive developments, changes in third-party coverage and
reimbursement, the ultimate timing of the commercial launch of
NexoBrid in the United States, physician and burn center adoption
of NexoBrid, supply chain disruptions or other events affecting
MediWound Ltd.’s ability to manufacture and supply sufficient
quantities of NexoBrid to meet customer demand, negative impacts on
the global economy and capital markets resulting from the conflict
in Ukraine, global geopolitical tensions or record inflation and
the ongoing or future impacts of the COVID-19 pandemic on our
business or the economy generally.
These and other significant factors are discussed in greater
detail in Vericel’s Annual Report on Form 10-K for the year ended
December 31, 2021, filed with the Securities and Exchange
Commission (SEC) on February 24, 2022, Vericel’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2022, filed with
the SEC on November 9, 2022, and in other filings with the SEC.
These forward-looking statements reflect our views as of the date
hereof and Vericel does not assume and specifically disclaims any
obligation to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this release except as required by law.
Investor Contact:Eric Burnsir@vcel.com+1 (734)
418-4411
Media Contact:Julie Downsmedia@vcel.com
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