Sarepta Therapeutics Inc Q1 2025 Earnings Call Summary

The following is excerpted from the question-and-answer section of the transcript.

Question: Tazeen Ahmad - Bank of America Securities - Analyst : 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 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.

Question: Ritu Baral - TD Cowen - Analyst : Doug, I want to follow up on that last phrase that you mentioned, how do you direct patients to those sites with more capacity? Are we talking like more community sites and why aren't these sites sort of at capacity like the main centers? Is it a staffing issue? Is it a demand issue? How do you plan on doing that? And is this the point where you think about opening more sites?

Question: Louise Chen - Scotiabank - Analyst : I wanted to ask you, of the new guidance you gave, what percent of sales does ELEVIDYS represent? And also, are you planning or expecting that sales will recover starting in the third quarter?

Question: Andrew Tsai - Jefferies - Analyst : My question is around this -- following this patient death. Some investors are wondering about a worst-case scenario where ELEVIDYS is pulled from the market, something more drastic basically than what your revised guidance assumes. The appointment. And the appointment of Dr. Prasad today might not help with that narrative. So can you walk us through how you think about that potential risk, especially since you do have an accelerated approval in the non-ambulatory DMD.

Question: Eliana Merle - UBS - Analyst : Just in terms of a potential label update for ELEVIDYS, can you talk us through your latest expectations there for any potential update or conversations with the FDA after the patient death. I guess when could we potentially hear about a label update and what your expectations are for what this could look like? And then just in terms of the commercial uptake, you mentioned that there were some patients who were scheduled for late March that delayed their dosing. What proportion of those have now rescheduled their infusions?

Question: Brian Abrahams - RBC Capital Markets - Analyst : Maybe shifting gears to limb-girdle. Following the pre-BLA meeting, have you had any additional meetings with the new FDA leadership on the limb-girdle programs and curious their updated feedback on the accelerated approval path for 2E. And then I guess on 2E, is the emerging data still expected to be disclosed publicly by the middle of 2025? Or should we expect that that's going to be initially submitted to the agency? I didn't see anything in the press release or hear anything in your prepared remarks on data.

Question: Debjit Chattopadhyay - Guggenheim Securities - Analyst : So a couple of questions on 1 on limb-girdle. Is there a threshold for protein expression that the OTP wants to see? And number two, could you sort of quantify the number of nonambulant boys who have been treated on the commercial ELEVIDYS product?

Question: Salveen Richter - Goldman Sachs - Analyst : Can you remind us as to the time lines for seeing data from your confirmatory studies across both the exon skipping franchise but also ELEVIDYS?

Question: Brian Skorney - Baird - Analyst : I guess just in regards to the changes that CBER and meetings with the FDA, you said that you're expecting a decision on labeling update to ELEVIDYS no later than the fourth quarter. I'm just wondering, is there any sort of formal meetings that are held with CBER along with that? Or is it just sort of an internal review until they make that decision? And then when we first heard about the patient death, I know there's a complicating factor with the reactivation of latent virus. So I was just wondering if the wound up being a biopsy and if you had anything informative on that front.

Question: Michael Ulz - Morgan Stanley - Analyst : Maybe just another one on ELEVIDYS trends and more recently, just curious if there's been a shift in the age of the patients being treated or in the ambulatory status of those patients being treated?

Question: Joseph Schwartz - Leerink Partners - Analyst : We noticed the company recently hosted a meeting with PPMD after the patient death. I'm just wondering how impactful were these interactions? And I know that there's an upcoming annual conference in June, so I'm wondering what are the company -- what the company's plans now to interact with these organizations? And what do you think you need to emphasize with these families in order to underscore the positive risk benefit of ELEVIDYS?

Question: Yanan Zhu - Wells Fargo - Analyst : Great. First, I would like to ask for a clarification question regarding the uptick that you anticipate in the summertime for patient demand based on some leading indicators you're seeing. The question is, there must also be a leading indicator of some decline, and that's because you're lowering guidance how do we reconcile a decline and also an uptick? Could we assume that you're seeing pickup in pace of the starting -- patient's start forms coming in towards the more recent period. And then sorry about that long-winded question, a follow-up in much straightforward question about peak sales estimate, do you have any comment on whether you are changing your guidance on the peak sales and the time to reach that peak? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 06, 2025 / 8:30PM, SRPT.OQ - Q1 2025 Sarepta Therapeutics Inc Earnings Call

Question: Konstantinos Biliouris - BMO Capital Markets - Analyst : To the extent you can comment on that, can you talk a little bit about the decline of ELEVIDYS ex U.S. sales quarter-over-quarter? And to what extent those 3 headwinds you mentioned for U.S. may also apply ex U.S. at least anecdotally?

Question: Anupam Rama - JPMorgan - Analyst : Sorry about that. Just a quick clarification question. Louise, I think you said in April, you submitted a labeling update and had some of the patient -- what you knew about the patient death information. But what else was included within that labeling update, did it

Question: Biren Amin - Piper Sandler - Analyst : At the end of February, the company mentioned on its year-end call that there was ample site capacity for both infusion and follow-up. So I just want to kind of ask how site capacity change over the last 2 months? Or what -- or do you think it was more driven by patients being more cautious and need more handling before they sign up for administration? And I think on that last point, is there anything the company can do to provide risk mitigation strategies to physicians, given I think the community is looking for clarity that would derisk future events.

Question: David Hoang - Deutsche Bank - Analyst : So I just wanted to ask one on any anecdotal experience broadly for patients that have been dosed to date with commercial ELEVIDYS, what you hear from the docs and families -- match up with what you know from EMBARK in the clinical trial experience? And then just with the PMOs, how should we think about cannibalization of the products, given how the ELEVIDYS commercial uptake curve may be changing?

Question: Daniel Smith - H.C. Wainwright & Co. - Analyst : This is Dan on for Mitchell. So we were wondering with the FDA changes specifically Dr. Vinay Prasad, now homing fever. And given this expectation of having more data for approvals, how much your approach to clinical trial designs change? And do you see any impact to your development timeline?

Question: Rick Miller - Cantor Fitzgerald - Analyst : This is Rick Miller on for Kristen. Can you just talk about some of the administrative delays in infusion. I think you mentioned a specific Medical delay that you said was resolved. Was there something specific driving this? Any information requests from organization or anything like that you could speak about?

Question: Leo Watson - Mizuho Securities - Analyst : This is Leo on for Uy. Is there a reason that patients appear to be flocking towards the leading centers that have full capacity? Do you expect any of these leading sites to increase their site capacity? And to what extent does your updated guidance account for increased number of infusions at the secondary sites that you're not targeting?

Question: Andreas Argyrides - Oppenheimer & Co. - Analyst : With shares at current levels, how are you guys thinking about the opportunity for implementing the approved buyback.