Sarepta Therapeutics reported strong third-quarter 2024 financial results, marked by a significant revenue increase and positive net income. Net product revenue reached $429.8 million, a 39% year-over-year surge. This growth is largely attributed to the successful launch and expanded label of ELEVIDYS, their gene therapy for Duchenne muscular dystrophy (DMD). ELEVIDYS alone generated $181.0 million in net product revenue, surpassing previous projections. Including royalties from Roche’s ex-US ELEVIDYS sales, total ELEVIDYS revenue reached $190.5 million.
The company’s other PMO therapies for DMD, EXONDYS 51, VYONDYS 53, and AMONDYS 45, also performed well, collectively contributing $248.8 million in net product revenue during the quarter. Notably, the launch of ELEVIDYS hasn’t significantly impacted sales of these established treatments. Sarepta is prioritizing its portfolio and advancing its pipeline, anticipating a Biologics License Application submission for one Limb-girdle muscular dystrophy (LGMD) program by mid-2025, with two additional LGMD programs entering clinical trials.
Financially, Sarepta achieved a GAAP net income of $33.6 million and a non-GAAP net income of $67.0 million for Q3 2024. This positive performance contrasts with a net loss in the same period of the previous year. Total revenues for the first nine months of 2024 totaled $1.24 billion, a 47% increase compared to the same period in 2023. This increase reflects ELEVIDYS’ launch and label expansion, alongside collaboration revenue from Roche’s declined option to acquire ex-US rights to an early-stage Duchenne program. Additional revenue streams included contract manufacturing and royalty payments from Roche related to ELEVIDYS.
Cost of sales, excluding amortization of in-licensed rights, rose due to ELEVIDYS’ launch. Research and development expenses increased in Q3 2024 due to costs associated with terminating a manufacturing and supply agreement, offset by decreased spending on other programs. However, for the nine months, research and development expenses decreased due to ELEVIDYS commercial batch capitalization. Selling, general, and administrative expenses increased due to ongoing commercialization efforts for ELEVIDYS, litigation matters, charitable contributions, and compensation expenses. Other income increased significantly compared to the previous year, primarily due to a one-time impairment of a strategic investment in 2023. The company uses non-GAAP financial measures to evaluate operational performance and cash requirements internally and to provide investors with a clearer comparison of period-to-period results.
Sarepta’s product portfolio addresses DMD through exon skipping technology. EXONDYS 51, VYONDYS 53, and AMONDYS 45 are PMO-based therapies targeting specific exons of the dystrophin gene. ELEVIDYS is a gene therapy delivering a transgene for micro-dystrophin production. Each product has specific indications, safety information, and prescribing details available in their respective full Prescribing Information.
Sarepta’s focus remains on developing precision genetic medicines for rare diseases. With over 40 programs in development, the company leverages a multi-platform approach encompassing gene therapy, RNA, and gene editing technologies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.
