Release Date: November 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Sarepta Therapeutics Inc (SRPT, Financial) reported a strong quarter with total net product revenue of approximately $430 million, marking a 39% growth compared to the previous year.
- The company achieved profitability on both a GAAP and non-GAAP basis in the third quarter.
- Sarepta's PMO sales, including exon 51, 53, and 45, reached approximately $149 million, exceeding analyst expectations.
- The company is making significant progress in its R&D pipeline, with plans to file a BLA for SRP-9003 to treat limb-girdle muscular dystrophy in 2025.
- Sarepta's launch of the therapy '11' has been successful, driven by strong demand and positive trends in access and reimbursement.
Negative Points
- Sarepta Therapeutics Inc (SRPT) decided to discontinue the SRP 50 plus development program due to safety concerns and evolving treatment landscapes.
- The company faced increased R&D expenses, partly due to the termination of a commercial manufacturing and supply agreement.
- There is a potential risk of cannibalization of the PMO franchise by the new therapy '11', although not yet materialized.
- The company is experiencing challenges in scaling site capacity and ensuring sites are well-educated and equipped to manage patients.
- Sarepta's PPMO program faced setbacks due to safety concerns, leading to the discontinuation of the entire PPMO franchise.
Q & A Highlights
Q: Can you clarify the guidance for the rest of the year and what the base number is for the 100% upside from what you've just reported?
A: We feel very comfortable with the guidance we gave before, which was 100% above the guidance that we had for Q3. We are also very confident in our long-term projections, which would have peak year sales across the four approved therapies at $5 billion or more. (Douglas Ingram, CEO)
Q: Can you provide more details on the discontinuation of the PPMO program and the concerns about hypomagnesemia?
A: We are discontinuing the entire PPMO franchise due to safety concerns, including prolonged hypomagnesemia. The decision was based on discussions with the FDA and our own benefit-risk assessment. The evolving landscape of Duchenne, including the approval of Elevidys, also influenced this decision. (Douglas Ingram, CEO)
Q: Can you help reconcile the number of patients treated with Elevidys in the US and the implications for Q4 sales?
A: We are using revenue as our metric and remain confident in our guidance. We have dosed a significant number of patients, including late ambulatory and non-ambulatory ones, and the launch is going well. (Douglas Ingram, CEO)
Q: What progress have you made in conversations with payers on broader coverage policies, and what proportion of patients are on Medicaid?
A: It's about 50% commercial and 50% Medicaid. Interactions with both are very productive, benefiting from the amount of evidence and data supporting Elevidys. The quality of discussions with payers has improved significantly. (Douglas Ingram, CEO)
Q: Can you discuss the split of patients on Elevidys in the third quarter across ambulatory versus non-ambulatory from a commercial standpoint?
A: While there is some bias towards ambulatory patients, we are seeing a significant percentage of start forms for late ambulatory and non-ambulatory patients. We are confident this will continue to increase over time. (Douglas Ingram, CEO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
