Press release
Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2022 Financial Results and Recent Corporate Developments
Total revenues, which consist of net product revenues and collaboration revenues, for the fourth quarter and full-year 2022 totaled $258.4 million and $933.0
About this update from Sarepta Therapeutics, Inc.
[{"type":"text","content":"\n\nTotal revenues, which consist of net product revenues and collaboration revenues, for the fourth quarter and full-year 2022 totaled $258.4 million and $933.0 million, respectively\n\n\nNet product revenues for the fourth quarter and full-year 2022 totaled $235.9 million and $843.8 million, respectively\n\n\nFourth quarter 2022 net product revenues increased approximately 32% over the fourth quarter of 2021; full-year 2022 net product revenues increased approximately 38% over the prior year\n\n\nMid-cycle meeting complete; FDA does not plan to hold advisory committee for SRP-9001\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the fourth quarter and full-year 2022.\n\n“Sarepta’s proven ability to launch Duchenne therapies and effectively serve the Duchenne patient community was once again on display in 2022 as we delivered nearly $236 million and $844 million in net product revenue for the quarter and year, respectively, and grew at 32% for the quarter and 38% for the year. Sarepta achieved these stellar results by prioritizing our patients and without taking a single price increase in over 6 years,” said Doug Ingram, Sarepta’s president and chief executive officer. “2023 will be a bellwether year for the patient community we serve and for the promise of gene therapy. Sarepta continues to work toward the May 29, 2023 action date for our gene therapy SRP-9001 Biologics License Application, answering questions, preparing for scheduled pre-approval inspections and preparing for launch. As of the mid-cycle review, which is now complete, the FDA posed CMC questions which have been answered by Sarepta, formally confirmed that there are no significant safety issues of concern and informed Sarepta that they are not planning to hold an Advisory Committee for this application.”\n\nFourth Quarter 2022 and Recent Developments:\n\n\nSRP-9001 Biologics License Application (BLA) accepted for filing and granted Priority Review by U.S. FDA: In November, the FDA accepted Sarepta’s BLA seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulant individuals with Duchenne muscular dystrophy. SRP-9001 has been granted Priority Review by the FDA, with a regulatory action date...