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

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Doug Ingram: We intend to launch this therapy and work with payers to get access to this therapy immediately. I would remind folks that we have three approved therapies today, EXONDYS, VYONDYS, and AMONDYS, all of them were approved via accelerated approval pathway. And the team has done, in my opinion, an absolutely brilliant job of working with payers to ensure rapid access for patients who are amenable to those three therapies. We’ll take that same execution focus, we will apply it to 9001 and we anticipate that payers are going to respond well given the robustness of our data and that kids are going to have access immediately.

Operator: Thank you. Our next question comes from the line of Tim Lugo with William Blair. Your line is now open.

Tim Lugo: Yes, thanks for taking the question and best of luck, obviously. Can you talk about how you view capital deployments in a post-approval role ? You obviously have a lot of studies we’ve talked about. You have to build the label out yourself in the girdle and to leave your pipeline is described as 40 compound feet. So that sounds like a lot of R&D. And I’d love to hear your thoughts around that, which is probably money extremely well spent. But maybe if that also influences your thoughts around pricing of 9001?

Doug Ingram: Well, I’m going to say two things. I’m going to turn this to Ian who can comment about capital deployment in a more general sense. I mean, let’s first – we are going to significantly focus on research and development and the like, of course. And we will continue to do that deep into the future. That notwithstanding we will, our current plans, assuming that we’re approved and our plans come to fruition would have us being profitable next year as relates to the pricing of 9001. The pricing of 9001 will occur in the context of the pharmacoeconomic models we use to ensure that the value is appropriate for that therapy. And that, as I’ve said before, that the value brought to the patients and their lives from this therapy is much greater than the cost of the healthcare system. But beyond that, Ian, do you want to comment on the capital deployment plan?

Ian Estepan: Yes, no, I think you’re exactly right. We’re obviously going to continue to invest in R&D, but we’re also going to be focused on profitability and follow metrics that will guide that and ensure returns for shareholders. But obviously as investing in our R&D is going to lead to continued growth and we are going to be focused on moving programs forward that have high probability of success based on the data which we generate. We also think the market conditions right now lend itself to being in a position to partner or acquire technologies that we think are scientific breakthroughs as we continue to build out our pipeline. So we’re going to be very consistent with the approach that we’ve used previously to obviously put us in a position where we’re one of the leading emerging biotech companies and we’re not going to stray from that.

Operator: Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Your line is now open.

Kristen Kluska: Hi, good afternoon and best wishes to your team this month. Can you talk about the latest as it relates to looking at some of the ways you’re looking to address pre-treatments for those with pre-existing antibodies to AAV? I saw that you’re presenting with Hansa some preclinical data at ASGCT, the agenda was literally just released about an hour ago. So can you talk about some of those efforts please?

Doug Ingram: Yes. So there are two approaches, and there’s more to say beyond this. But we can tell you, broadly, there are two approaches that we’re taking right now. One is of course with our partner Hansa and imlifidase to cleave and therefore remove antibodies that we stand in the way of a child getting 9001 and the other is using apheresis to clear antibodies.

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