Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Q4 2022 Earnings Call Transcript

Tazeen Ahmad: Can you give us a sense of how the doctors’ offices or facilities that the patients would have to go to might have to make any adjustments? Is the infrastructure already there for high demand for the physicians to be able to meet the potential volume demand that we would expect upon an approval? I don’t know what your checks are telling you but I’d love to hear some color on that.

Doug Ingram: Yes. I mean, I think the first thing I’ll say is that we start in a very good place, probably in a very privileged place because of SMA and because of Zolgensma. So a significant percentage of the experts — neuromuscular experts that would be treating patients with Duchenne muscular dystrophy with 9001 have previous experience with zalgentima. So we’re starting with at a good place. Now certainly, I’m going to turn this over to Dallan to provide any additional color that I missed but I would say there’s certainly a lot of work still that we need to do to make sure that very specific to 9001, the sites are up, ready to go, properly educated and ready to make this therapy a success. Our goal at launch is to have about 50 of those sites up and running. That would serve just about 80% of the Duchenne community and then over time to be up as high as about 70 sites over the course of the next couple of quarters beyond that. But Dallan, what have I missed there?

Dallan Murray: No, I think you covered it, Doug. And I think these sites are really at the forefront of precision genetic medicine. And they have a lot on their plates but they’re absolutely heroic and they are — we’re working already with whatever we can do from an educational standpoint prior to approval that is compliant and appropriate. So the team is out there today engaging with the sites. Every site is different. But they are — it’s — these are centers of excellence that are already treating these patients, the Duchenne muscular dystrophy patients. So they’ll be ready to go and we’ll be ready to go.

Operator: Our next question comes from the line of Robert Fink of Guggenheim.

Robert Fink: This is Robert on for Debjit. How quickly can Sarepta reimbursement agreements in place following approval in the race to launch?

Doug Ingram: I’ll turn this over to Dallan as well. The short answer is that we’re going to be ready to go on day 1. It doesn’t mean kids are going to get infused on day 1. There’s a process here, the access and reimbursement process and having to get tested for neutralizing antibodies and the policies have to get finalized. But the team is already doing an enormous amount of work with not only sites but payers right now so that we’re in a position to begin to serve the community day 1 post approval, assuming that we’re fortunate and get approved. Dallan?

Dallan Murray: Yes. Yes, we’ll be ready in terms of day 1. And we’re already engaging with payers. And so I think we’re going to do everything we can to accelerate that for eligible patients on day 1 and learn the lessons from past launches.

Ian Estepan: One thing just to add to that — I think one thing just to add to that is that you guys have good precedent on what you’ve seen in terms of our launches for our PMO exon skipping franchise. And obviously, to Doug’s and Dallan’s point, it takes time to get patients on therapy and through the access and reimbursement system. And obviously, there’s state Medicaid and getting through the drug utilization review board process, right? So it is going to take a couple of quarters for patients to work through and you’ve seen that before. But then once we really work through those reimbursement steps, I think you’re going to see very, very strong uptake.

Operator: Our next question comes from the line of Gena Wang of Barclays.