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

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Tazeen Ahmad: Hi, good afternoon. Thanks for taking my questions. I guess, Ian, I just wanted to clarify a comment that you made regarding write-offs of certain batches of the company’s products that weren’t meeting quality specs. Which products were they? Can you share and have you resolved that issue? And then also maybe just to follow-up on comments that Doug made regarding inspections being completed. Can you also confirm whether or not FDA has any comments on the inspection? And if they have, have they been resolved? Thanks.

Doug Ingram: Sure. I’ll take the first one first. Yes, that was regarding the PMO, this is just part of our normal manufacturing process. If you look back over several quarters that happened. So, this is just something that’s part of the normal manufacturing process. And there is some batches that don’t meet specs and we have to write it off, but nothing to be concerned and should be expected to continue to go far.

Ian Estepan: And then as relates to the second question, all of the inspections are completed in any of the observations have been entirely satisfied. So we’re in great shape from an inspection perspective.

Operator: Thank you. Our next question comes from the line of Danielle Brill with Raymond James. Your line is now open.

Danielle Brill: Hi guys. Thanks so much. I actually have a couple of questions on EMBARK. I’m curious what percent of patients have completed that trial? Just trying to gauge how backend loaded enrollment was. And then also how frequently do you measure NSA? And how are missing data imputed? Thank you.

Doug Ingram: I’ll answer the last part, but you take the first part on the completion.

Louise Rodino-Klapac: Yes. So, the study was completely enrolled last fall in terms of the – so we can expect the one year endpoint to close out this fall with the study report early next year. In terms of the NSAA these are – the primary endpoint for the NSAA is at one year, but we measure it at intervals prior to that certainly part the one year endpoint.

Doug Ingram: We will have the data update on the staff plan when we announce the results.

Operator: Thank you. Our next question comes from the line of Mike Ulz with Morgan Stanley. Your line is now open.

Mike Ulz: Hey guys, thanks for taking the question. Just another one on the SRP-9001 launch. Do you have a sense of how many patients might want to switch from some of your PMO therapies and how do you plan to manage that? Thanks.

Doug Ingram: So let me say two things. First, we don’t anticipate at launch a significant impact on our current PMO revenue, just from a revenue perspective. In the long run, one might, one should assume some significant cannibalization, it won’t happen early on to the extent that the patient wants to switch from PMO to have access to the gene therapy, we will embrace that and being likely excited from them.

Operator: Thank you. Our next question comes from the line of Neena Bitritto-Garg with Citi. Your line is now open.

Neena Bitritto-Garg: Hey guys. Thanks for taking my question. I just wanted to go back to some of the questions on the payer conversation so far. Can you just tell us a little bit about whether any of your conversations so far have suggested that payers may wait to actually issue coverage determinations until they see the EMBARK data? And if so, how they may think about kind of restrictions and the coverage policy post EMBARK? Thanks.

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