Press release
Sarepta Therapeutics Announces First Quarter 2024 Financial Results and Recent Corporate Developments
Net product revenues for the first quarter 2024 totaled $359.5 million, a 55% increase over the same quarter of the prior year ELEVIDYS net revenues for the
About this update from Sarepta Therapeutics, Inc.
[{"type":"text","content":"\n\nNet product revenues for the first quarter 2024 totaled $359.5 million, a 55% increase over the same quarter of the prior year\n\n\n\n\nELEVIDYS net revenues for the quarter totaled $133.9 million\n\n\n\n\nAchieved GAAP Earnings of $36.1 million for the first quarter 2024 and non-GAAP Earnings of $78.2 million for the same period\n\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 first quarter 2024.\n\n\n“We are pleased to announce another strong quarter of growth from our four approved therapies, posting net product revenue of $359.5 million, a 55% increase over the same quarter of the prior year, and achieving profitability on a GAAP and non-GAAP basis,” said Doug Ingram, president and chief executive officer, Sarepta Therapeutics. “In particular, our recently approved gene therapy, ELEVIDYS, achieved nearly $134.0 million in net product revenue in the quarter. Although its initial label is quite narrow, ELEVIDYS has posted cumulative sales of over $334.0 million since its approval in June of last year, far exceeding performance of all other gene therapies approved in the last few years combined. Working with the FDA, we continue to productively prosecute our BLA supplement to expand the ELEVIDYS addressable population, with a target action date of June 21, 2024. If successful, 2024 could be the most profound year yet in our fight against the effects of Duchenne muscular dystrophy and a bellwether for the transformative potential of gene therapy for rare disease.”\n\n\nFirst Quarter 2024 and Recent Developments:\n\n\n\nU.S. FDA review of efficacy supplement to expand the ELEVIDYS indication is ongoing: The Company is currently awaiting U.S. Food and Drug Administration (FDA) Priority Review of its efficacy supplement to the Biologics License Application (BLA) for ELEVIDYS (delandistrogene moxeparvovec-rokl) where the review goal date is June 21, 2024. At acceptance of the BLA in February, the Agency also confirmed they are not planning to hold an advisory committee to discuss the supplement. The goals of the efficacy supplement are twofold:\n\n\n\n\nTo expand the labeled indication for ELEVIDYS as follows: “[ELEVIDYS is indicated for] the treatment of Duchenne muscular dystrophy (DMD) pat...