Sarepta Therapeutics Q3 2024 Financial Results and Corporate Updates

Sarepta Therapeutics, Inc., a prominent name in precision genetic medicine for rare diseases, recently announced its financial results for the third quarter of 2024. The company witnessed a robust performance, recording a net product revenue of $429.8 million for the quarter, a significant 39% increase compared to the same period last year. A major contributor to this growth was the successful launch of ELEVIDYS, generating $181.0 million in net product revenue for the quarter, surpassing earlier projections. With the inclusion of royalty revenue from Roche's ex-US sales of ELEVIDYS, the total performance for this product reached $190.5 million.

In addition to the success of ELEVIDYS, Sarepta's three PMO products—EXONDYS 51, VYONDYS 53, and AMONDYS 45—also performed well, collectively achieving approximately $248.8 million in net product revenue for the quarter. This performance reflects the company's effective commercial strategies and a lack of immediate competition from the new ELEVIDYS launch.

Doug Ingram, President and CEO of Sarepta Therapeutics, expressed satisfaction with the company's quarterly performance and emphasized the importance of strategic decisions in portfolio prioritization and pipeline progress. By mid-2025, Sarepta aims to submit a Biologics License Application for one of its Limb-girdle muscular dystrophy programs and initiate clinical trials for two others. These efforts are expected to pave the way for the next generation of approved therapies.

In the third quarter of 2024, Sarepta decided to halt the SRP-5051 (vesleteplirsen) development program. This decision was influenced by the risk-benefit analysis, FDA feedback, and the evolving therapeutic landscape for Duchenne muscular dystrophy.

At the 2024 World Muscle Society Congress, Sarepta presented new data from its neuromuscular portfolio, highlighting several key findings from the SRP-9001 clinical development program. Notable results included skeletal muscle MRI data from the EMBARK Study (9001-301), showing improvements in patients treated with SRP-9001 compared to placebo, as well as cardiac MRI data indicating no adverse effects on cardiac safety. Additionally, five-year functional results from Study SRP-9001-101, the longest-term data for a gene therapy in Duchenne, demonstrated stability or slowed disease progression in patients treated with SRP-9001 compared to natural history.

The publication of efficacy and safety results from Part 1 of the EMBARK study of delandistrogene moxeparvovec-rokl in Nature Medicine further validated the clinical benefits of this gene therapy for Duchenne muscular dystrophy. EMBARK is a global, randomized, double-blind, placebo-controlled Phase 3 clinical study involving patients aged 4 to 7 years.

Sarepta's financial highlights for the third quarter of 2024 showed a total revenue of $467.2 million, a 41% increase from the same period in 2023. The company's GAAP operating income reached $22.2 million, a significant improvement from a loss of $20.8 million in the previous year. On a non-GAAP basis, operating income was $74.9 million, nearly doubling from $37.7 million in the third quarter of 2023. GAAP net income stood at $33.6 million, a dramatic turnaround from a loss of $40.9 million in the prior year, while non-GAAP net income was $67.0 million, up from $31.5 million.

For the nine months ended September 30, 2024, total revenues increased by $397.0 million to $1.243 billion, driven primarily by the launch and expanded label of ELEVIDYS. The company's GAAP operating income for this period was $56.4 million, a stark contrast to a loss of $292.4 million in the previous year. Non-GAAP operating income also showed significant improvement at $216.5 million, up from a loss of $123.5 million. GAAP net income for the nine months was $76.2 million, compared to a loss of $581.6 million in 2023, while non-GAAP net income rose to $191.9 million from a loss of $146.1 million.

Overall, Sarepta Therapeutics demonstrated strong financial performance and strategic advancements in its genetic medicine portfolio, positioning itself for continued growth and innovation in treatments for rare diseases.