Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Q1 2023 Earnings Call Transcript

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Doug Ingram: So the short answer is, we’re going to start that study before the end of this year. We will align with the agency on that along the way. We’ve got, work to do there. Obviously we’ve been prioritizing 9001 right now. The functional endpoint would likely be a form of NSAA, which I think it’s called NSAD, if I’m not mistaken. It’s been adapted for limb-girdle, but we’ll obviously also be looking at expression and safety with respect to 9003.

Operator: Thank you. Our next question comes from the line of Ritu Baral with TD Cowen. Your line is now open.

Unidentified Analyst: Hi guys, this is on for Ritu today. Can you confirm the timing of Embark topline data? Have there been any changes to that? And then any updates for your long-term revenue guidance of $4 billion in 2025? How will you be revising this if 9001 is approved this month?

Doug Ingram: Our forecast assume approval this month. So I’m sorry, what the first question was?

Unidentified Analyst: Embark readout.

Doug Ingram: Yes, no there’s been no change in the Embark readout; the Embark was fully enrolled as of September of last year. It’s going, swimmingly it’s obviously blinded. So it’s being executed swimmingly and we anticipate top line really again of this year, early next year.

Operator: Thank you. Our next question comes from the line of Brian Skorney with Baird. Your line is now open.

Brian Skorney: Hey, good afternoon. Thanks for taking my question. I guess kind of jumping off, on some of the questions around the ability to successfully conclude Embark that you mentioned, can you just talk to us about study conduct and is there any risk that accelerated approval could put study conduct at risk? I think you said before that most U.S. patients have actually had their last visit. So can you just kind of review what you would say to someone questioning whether or not you’re going to be able to successfully maintain study conduct on Embark once you have commercially available 9001 under AA?

Doug Ingram: There’s no risk, zero risk. A study was enrolled, fully enrolled September of last year. All of the kids in part one of the study have received their doses. The kids on crossover are being dosed even as we speak. Any kid that has yet to be dosed will be dosed in the next few months at maximum. So the March is going very well. We’ll read out on time, regardless on whether we received accelerated approval, there’s no reasonable risk to that study.

Operator: Thank you. Our next question comes from the line of Anupam Rama with JPMorgan. Your line is now open.

Anupam Rama: Hey guys thanks so much for taking the question. On SRP-9003, could we see any portions of the Voyagene data this year? May be starting ahead of the commercial material Phase 3? I think the CRO only is committed to like enrollment completion, but not data itself potentially, but just wondering if we could do see some this year?

Doug Ingram: Yes. I’m sorry for jumping in there. We – it’s not clear whether we’d have data this year, so we’ll update you later in the year on that.

Operator: Thank you. I would now like to hand the conference back over to Doug Ingram for closing remarks.

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