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

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Operator: Thank you. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.

Salveen Richter: Good afternoon. Thanks for taking my question. With regard to manufacturing, can you just provide us with some details of where you stand on inventory as you look to this launch? And then the breadth of your manufacturing relationships in order to address the supply that’s required over at least the first year or second or first two years of launch year?

Doug Ingram: Sure. So we are building inventory as we speak to be ready for launch. So that’s obviously an ongoing activity with Catalent. It’s a high priority for us, and fortunately also a high priority for Catalent. So we’re in great shape there. And that’s great for launch and we’re in great shape there. If you look down the road longer term, of course, we also have our relationship with Thermo Fisher. We have an entire standalone site with Thermo Fisher. One of the decisions we made in connection with our BLA submission was not to try to get two sites approved at the same time. The complexity associated with that would have created a significant risk of delay. And I think as we’ve said, a million times. Delay is not something that patients with Duchenne can have.

So what we will do post-launch is work with the division to get the Thermo Fisher site up and running and qualified as well. The good news is that launch this – our site with Catalent and our suites with Catalent is sufficient to launch the therapy and serve the community.

Operator: Thank you. Our next question comes from the line of Gil Blum with Needham and Company. Your line is now open.

Gil Blum: Good afternoon everyone, and thanks for taking our question. Doug, in your earlier comments, you mentioned that the company’s planning to start some of the other studies including a non-ambulatory patients and the clearing of antibody studies. What about planning a study in younger patients? I’m assuming that with – as with all gene therapy, younger is usually better. Thank you.

Doug Ingram: Yes, well, let me comment on that last piece first. It is extremely important that we get to younger patients as well. I want to be very clear. But I want to be also clear that there – from our perspective there is no place across this journey of Duchenne where the intervention of a therapy like 9001 that can restore functional dystrophin to patients won’t be beneficial. There is no trial that’s beyond value that’s important to remember. So if you’re 19 years old and you’ve been in a wheelchair for five years, you are as valuable to us as a very young child. So that’s why we’re very focused on the non-ambulant side, but we aren’t focused on the very young as well. We’ve already dosed kids that are down to three years old. Louise you might want to comment on other plans we have to dose much younger children as well.

Louise Rodino-Klapac: Yes. Correct, we dosed three year olds in our 103 Study, and then we’re also planning an additional study along with Roche to dose even younger than the three year olds and that will begin in short-term.

Operator: Thank you. Our next question comes from the line of Tazeen Ahmad with Bank of America. Your line is now open.

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