On January 10, 2023 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported 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 (Press release, Vericel, JAN 10, 2023, View Source [SID1234626159]).
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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: View Source