Full Press Release Details
Announces Preliminary Fourth-Quarter and Full-Year 2022 Financial Results and Accelerated Launch Timeline for MACI Arthroscopic Program
Total Revenue Expected to be Approximately $164 to $165 Million
Full-Year Revenue Expected to be at the High End of Guidance Range, with Fourth Quarter Revenue Growth of Approximately 24%
Arthroscopic Commercial Launch Now Planned for 2024
CAMBRIDGE, Mass., January 10, 2023 (GLOBE
NEWSWIRE) -- 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
Recent Business Highlights and Updates
"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
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.
are registered trademarks of Vericel Corporation. NexoBrid is a registered trademark of MediWound Ltd. and is used
and Unaudited Nature of Reported Results
Our 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 Statements
Vericel 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.
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.
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.