Sarepta Therapeutics a leader in precision genetic medicine for rare diseases, has announced its financial results for the third quarter of 2024, showcasing strong revenue growth and significant progress in its portfolio.
“We’re pleased to report another strong quarter, with $429.8 million in net product revenue, marking a 39% year-over-year increase,” said Doug Ingram, President and CEO of Sarepta Therapeutics. “The launch of ELEVIDYS is progressing as planned, with net product revenue for the quarter totaling $181.0 million, surpassing our expectations. Including royalties from Roche’s ex-U.S. sales, ELEVIDYS generated a total of $190.5 million. Our three PMO therapies—EXONDYS 51, VYONDYS 53, and AMONDYS 45—contributed an additional $248.8 million, reflecting strong performance despite the new launch.”
Ingram also highlighted Sarepta’s progress on its pipeline, including its efforts in Limb-Girdle Muscular Dystrophy (LGMD) programs. By mid-2025, Sarepta plans to submit a Biologics License Application for one LGMD treatment, with two others set to enter clinical trials.
Key Developments in Q3 2024:
- Program Discontinuation: Sarepta has decided to discontinue the SRP-5051 (vesleteplirsen) development program based on current data, including FDA feedback and the evolving treatment landscape for Duchenne muscular dystrophy.
- New Data at WMS 2024: Sarepta presented new data from its neuromuscular portfolio at the 2024 World Muscle Society Congress. Highlights include:
- Positive MRI and functional outcomes from the SRP-9001 EMBARK study, showing improved muscle health and disease stabilization.
- Cardiac MRI data confirming SRP-9001’s safety profile, with no adverse cardiac effects compared to placebo after one year.
- Long-term data from SRP-9001-101, the longest available for any Duchenne gene therapy, showing significant functional improvements over five years, including a clinically meaningful increase in the North Star Ambulatory Assessment (NSAA) score.
- Publication in Nature Medicine: Results from the EMBARK study of delandistrogene moxeparvovec were published in Nature Medicine, highlighting its clinically meaningful efficacy and safety profile in young Duchenne patients.
Financial Overview:
- Total Revenues: For Q3 2024, Sarepta reported total revenues of $467.2 million, up 41% from $331.8 million in the same period last year. This increase is largely attributed to the launch of ELEVIDYS and its expanded label.
- Net Income: Sarepta posted a GAAP net income of $33.6 million for Q3 2024, reversing a net loss of $40.9 million in Q3 2023. Non-GAAP net income for the quarter was $67.0 million, a 113% increase from the prior year.
- Research and Development: R&D expenses rose by $30.2 million in Q3, primarily due to costs associated with the termination of a collaboration agreement with Thermo Fisher. R&D spending for the nine months ended September 30, 2024, decreased by $77.3 million, driven by the capitalization of ELEVIDYS commercial batches.
- Operating Income: Sarepta achieved a GAAP operating income of $22.2 million in Q3 2024, a significant improvement from the operating loss of $20.8 million in Q3 2023.
Cash Position: As of September 30, 2024, Sarepta held $1.4 billion in cash, cash equivalents, and investments, providing strong financial stability for ongoing initiatives.
Looking Ahead: Sarepta is poised for continued growth, with robust commercial execution of ELEVIDYS and advancing its pipeline of treatments for rare genetic diseases. The company remains focused on advancing its therapeutic candidates for Duchenne and Limb-Girdle Muscular Dystrophy, aiming to expand its portfolio of approved therapies by 2025.
For further details, a webcast of the Q3 earnings call is available under the investor relations section of Sarepta’s website.
