Sarepta Therapeutics, Inc. Q1 FY2025 earnings call

Doug Ingram discussed the challenging first quarter, Sarepta's position, ELEVIDYS sales, and guidance change. Dallan Murray talked about Q1 factors like safety event, administrative issues, flu season, and site capacity. Louise Rodino-Klapac spoke about ELEVIDYS data, LGMD portfolio, siRNA platform, and R&D progress. Specifically, Doug noted the challenging first quarter, Sarepta's position, ELEVIDYS sales, and guidance change; Dallan highlighted Q1 factors including safety event delays, administrative complexities, and site capacity imbalances; Louise discussed ELEVIDYS safety data, LGMD portfolio progress, siRNA platform plans, and R&D updates including upcoming R&D Day.

In the first quarter of 2025, Sarepta achieved $612 million in total net product revenue. The PMO franchise grew 5% to $237 million, and ELEVIDYS generated $375 million in sales, a 180% increase from the same quarter last year. ELEVIDYS contributed 70% of the total net product revenue.

Sarepta revised its net product revenue guidance for 2025 to $2.3 billion to $2.6 billion. This change is due to factors including the ELEVIDYS safety event, administrative complexities in gene therapy infusion, and site capacity imbalances. Q2 revenue is expected to be 20% lower than Q1, but demand is anticipated to pick up from summer onward.

Risks include a tragic safety event with an ELEVIDYS-infused boy leading to patient delays, administrative issues causing delays in gene therapy infusions, and site capacity imbalances where top sites are fully booked.

Q: Good afternoon, and thanks for taking my question. So, Doug, I just wanted to ask you, on those three factors that you mentioned right at the beginning of the call, the capacity issues, the administrative processes that you mentioned and the results of the patient death, leaving families to have questions, which one, if any, has been the biggest driver of potential downside pressure leading you to revised guidance? And then as 2Q has progressed, have any of those I guess, gotten worse because you're talking about 20% lower sales relative to 1Q and we're still pretty, I guess, relatively early into the quarter.

A: Thank you for your question. So first, on the balance, it is a mix of all three. I think the cycle times is probably the one that mechanically affects forward guidance the most. But there's a bit of a mix there. What we're seeing going forward is that it’s not a worsening. In fact, again, we don't have enough data on the cycle time issue to suggest that we're being overly conservative. But we're at a minimum confident that we've hit steady state. There's some reason to believe it might be a bit conservative. I mentioned earlier in the call, the first quarter had the most severe flu season, I think, in 15 years, and that caused some delays. There's the typical insurance changes that occur in the first quarter of every year. That causes some delays. There's a thesis that may be embedded in this four to six weeks additional cycle time might be some of that -- those particular first quarter issues. But I think for planning purposes, we're assuming and I certainly think you should also assume that we're at steady state for the year. We have a lot of work to do, we're trying to do even more efficiently, but I don't think we should assume that we will. On the safety event, the issue, of course, to remember is that in the when the safety event occurred, it was right before March. So right the last month of the quarter. So of course, those who needed additional information, we're going to have delays and that is going to flow through into the second quarter as well. So it shouldn't be at all surprising that the second quarter would be soft as a result of that and so we're, of course, we're seeing that. And that's going to take some time. We need to get out there. We need to get to the broader community. As I've mentioned before, in my prepared remarks, when we get to folks when the top thought leaders, which we were able to see right at the MDA conference when this all came out, it was quite clear that they were, to a person, at least from my interactions with them didn't see this as changing their prescribing behavior at all. And we get the same answer when we talk to families, we just need to get out to more and more families. If you wanted to say what are the signals kind of as we sit here today, the signals are, I guess, what you would call the green shoots because we are seeing start forms are coming in. I can't give you a split right now, but start forms are coming in, both for ambulatory and nonambulatory right now. So I think we are seeing the -- as we communicate and as we talk and as we educate, we're seeing that occur. And over time, there should be no difference in the reaction to this depending on whether you're ambulatory or nonambulatory because as you saw and as Dr. Louise Rodino-Klapac showed you, in fact, the data is quite clear that there's a minority of patients that get liver enzymes, it doesn't occur in any greater amount or any more severity either on liver enzymes or bilirubin on nonambulatory versus ambulatory patients. So I would say, we're seeing positivity when we actually get out there and we educate. And we've got a lot of work to do over the course of this year to get to those -- the secondary sites, where there is capacity one of our -- when I said earlier, one of our significant issues is we've been very, very successful with the big thought leaders, but those sites are often fully booked. So we really need to get to other sites and make sure that we are getting people to sites that have capacity, and we need to get more education out there, both to those physicians and to the broader family community, and then we'll continue to work on, on cycle times.