Total Revenues: $413.5 million for Q1 2024, up from $253.5 million for Q1 2023, an increase of approximately 63%.
Net Product Revenue from ELEVIDYS: $133.9 million for Q1 2024.
Net Product Revenue from PMO Franchise: $225.5 million for Q1 2024, compared to $231.5 million for Q1 2023.
EXONDYS 51: $120.2 million
AMONDYS 45: $71.9 million
VYONDYS 53: $33.5 million
GAAP Net Income/Loss: Net income of $36.1 million ($0.38 per basic and $0.37 per diluted share) for Q1 2024, compared to a net loss of $516.8 million ($5.86 per basic and diluted share) for Q1 2023.
Non-GAAP Net Income/Loss: Net income of $78.2 million ($0.73 per basic and diluted share) for Q1 2024, compared to a net loss of $87.7 million ($0.99 per diluted share) for Q1 2023.
Cost of Sales: $50.6 million for Q1 2024, up from $35 million for Q1 2023.
Future Guidance
Label Expansion: Preparing for potential label expansion for ELEVIDYS, suggesting readiness for a broader patient population and signaling possible future revenue growth.
Collaboration Revenue: Highlights a singular $48 million collaboration revenue recognized from Roche, suggesting no similar revenues should be expected in future periods specific to this item.
Quality Control: Noted increase in cost of sales partly due to the write-off of certain product batches, indicating ongoing investments in quality control and potential impacts on future profitability.
Trends, Market Conditions, Sentiment
Gene Therapy Leadership: Sarepta continues to position itself as a leader in gene therapy, with a strong emphasis on Duchenne muscular dystrophy treatments.
Regulatory Engagement: Improved engagement with the FDA and optimism for future approvals, especially for gene therapies, indicating a positive regulatory environment.
Real-World Evidence: Highlighting real-world evidence supporting the efficacy of their treatments, which could strengthen their market position and payer negotiations.
Market Demand: Significant physician and patient demand for their approved therapies, especially ELEVIDYS, suggesting strong future sales potential upon label expansion.
Community Support: Continuous support from the Duchenne community and institutional partners, reflecting positively on Sarepta’s commercial execution and future market penetration.
Notable Quotes
Douglas Ingram, CEO: “2024 will be a pivotal year for Sarepta and for the patients that we serve.”
Dallan Murray, Chief Customer Officer: “We stand ready to deliver ELEVIDYS to a broader patient population following a potential label expansion.”
Louise Rodino-Klapac, Chief Scientific Officer: “The analysis found that eteplirsen-treated patients survived 5.4 years longer compared to a controlled natural history group of Duchenne patients.”
Ian Estepan, CFO: “…with no similar activity in 2023 and an increase in write-off of certain batches of our product, not meeting our quality specifications during the 3 months ended March 31, 2024.”
