Then understanding well enough, and then go through the administrative process that exists to get approvals, to get antibody tests, to get an infusion date and to get infused. So, this is a really unique population in light of that, obviously give a shout up to the team, it is particularly impressive when one considers that we did $200 million in that product revenue this year. So, what Dallan was really talking about, when we were talking about, this is just simply that as we work through the prevalent population, this is a really unique population, and much narrowed than you might imagine the four to five. And so, by the middle of this year, assuming now label expansion, you would get to a place where you begin to be treating the incident population as opposed to some abolished prevalent population in this group.
Now, the good news is that we have a June 21 date for our request for label expansion. So, hopefully by July we will have a broader label, and we will be able to serve a much greater percentage of the population.
Operator: Thank you. Our next question comes from the line of David Hoang with Citigroup. Your line is now open.
David Hoang: Hi. Thanks for taking the question. I just wanted to ask a little bit more about the suspension of manufacturing you have in the works. How active something like that come online and once that is operationalized, how might that improve your margins?
Douglas Ingram: So, we are excited about where we are from a suspension perspective. There’s still a ton of more work to do, but a couple of things to think about. We are very advanced actually in those suspension works that we are doing, not just SRP-9001, but we are actually getting great results from a suspension perspective with some of our limb-girdle programs. A couple of our sarcoglycan programs actually transitioned through suspension, and we are making great progress there. When we focus specifically on ELEVIDYS, we are in engineering realms right now. On suspension, we have done 500 liter, we are doing another 500 liter. We will start in the next month or so, 2,000 liter. We are so far getting not only really tremendous enhancement on yields, but really good product qualities.
If all goes well, our goal is to have this suspension process available commercially by 2026. That’s a moon shot goal on our part, and we are keeping the patients front and center, we are going to try to move as fast as possible. But hopefully we have the history to prove that we can cope with audacious plans and serve them. So, we are really excited about that. As far as what that might do, both from a capacity perspective as we go around the world with our partnership, and a COGS perspective, that’s going to require more work and more clarification as we get these runs done, but it won’t be modest. It will be multiples. And we are seeing multiple times greater yields with suspension than we get with our ICLS process, which Ian mentioned; filter it right now and 80% margin.
So, you will probably hear in my voice certain amount of enthusiasm for our manufacturing approach and our suspension approach, and it is still early days and we are just in engineering realm trying out. But we are very, very excited about this could mean for our ability to bring this therapy across the world and at a lower cost of goods as we go across the world.
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. Maybe just a quick one on timing, since the PDUFA date was granted two months ahead of expectations, just curious if the thinking now is you’ll probably get a decision close to the PDUFA date, or is the FDA still really committed to rapidly reviewing this? And we might get an answer sooner? Thanks.
Douglas Ingram: I have more reason to believe that the FDA isn’t committed to rapidly reviewing this. With that said, there is still lot of work to be done, and I think it would be a dream for all of us to assume that our target completion date of June 21 is the date on which we are going to get the answer on this. So, we are planning for June 21, even though we are going to get so many things. We try to move as fast as possible, but we are assuming June 21 is when we are going to get on label expansion request answered.
Operator: Thank you. Our next question comes from the line of Danielle Brill with Raymond James. Your line is now open.
Unidentified Analyst: Hey, guys. This is Alex on for Danielle. Thanks for taking the question. Maybe the PMO confirmatory trials are fully enrolled, could you just remind us whether we should expect data for the MIS51ON this year?
Douglas Ingram: No, we shouldn’t. It doesn’t read out until 2026.
Operator: Thank you. Our next question comes from the line of Brian Skorney with Baird. Your line is now open. Brian Skorney with Baird, your line is now open.
Unidentified Analyst: Hi, this is Charlie on for Brian. Thanks for taking our question. So, we were just wondering if you’ve heard anything from Roche regarding timelines with the EMA as well as. If the European opportunity were to come online, would there be any supply limitations resulting from that? I know you’re very comfortable with the expansion of the label, but bringing on a whole another constant. Do you think you’d have to do any prioritization between regions? Thank you.
Douglas Ingram: Well, Roche is publicly saying that their goal is to submit in 2024. And then, as it relates to supply, our supply plans include our partner Roche.
Operator: Thank you.
Dallan Murray: And just one quick follow-up just to the previous question around MIS51ON and the timing, just one thing to remind everyone is that this is a dose that compares the doses of the drug. And so, the data which we’ll read out will be comparative from the 30 mg/kg compared to either a 100 mg or 200 mg/kg. And there’s no risk of the drug being pulled off the market.
Operator: Thank you. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Your line is now open.
Richard Miller: Hi, this is Rich Miller on for Kristen. Thanks for taking our question. Since launching, are you able to talk about if and how the profiles of DMD patients that are looking to get on a ELEVIDYS have changed? Or to put it another way, I imagine you had highly engaged caregivers who were ready for a ELEVIDYS on day one. So, are you seeing more patients coming forward now after a few months of commercial experience or caregivers to get their child in line for a ELEVIDYS? Thanks.
Douglas Ingram: Yes, I would say in the broadest of strokes, there is going to be a substantial demand for this therapy. I don’t think that’s changed; I think it’s what we anticipated. Before launch, I don’t think it’s changed after launch. Duchenne muscular dystrophy is a devastating disease and the opportunity that’s offered by a ELEVIDYS is an important one. I think physicians understand that, families with Duchenne muscle dystrophy, boys understand that as well. But, Dallan, if you have any additional color on this or views, please share them.
Dallan Murray: No, I think broadly speaking, you’re exactly right, Doug. It’s — we’re not seeing a real major change in terms of the patients coming in. It is, as we set up, we’re on a small population. And so, as soon as they’re getting diagnosed and have had their discussions with the docs, they’re coming in through the enrollment forms. And so, we’re just working through those patients as fast as they can — as we can, prior to them aging out. But no major differences in for example, there wasn’t a big kind of bolus of patients that initially came in, and now that’s different. It’s just a — it’s been a steady clip, essentially.
Operator: Thank you. Our next question comes from the line of Anupam Rama with J.P. Morgan. Your line is now open.
Anupam Rama: Hey, guys. Thanks so much for taking the question. At the conference in January, you talked about 70 sites being active and about half of those sites had dosed patients. Can you give us a sense of where you are kind of now in the first couple months of the year? Thanks so much.
Douglas Ingram: Yes. I mean, I believe that, that remains the accurate answer, but, Dallan, you can give us an update if there’s any change in that.
Dallan Murray: No, Anupam, it really hasn’t changed all that much. There’s obviously more than there was then, and there’s a higher proportion of sites that have dosed, but we’re actively looking at this on a daily basis, and we have this flexible model where we can bring on new sites, get them trained and up and ready as needed. So, we’ve got more than enough sites up and running and we’ve throughout — we’ve got great geographic coverage, but the team is also ready to support and serve as needed out there.
Douglas Ingram: I really do want to give kudos to this team for where we are. The — I think everybody knows the goal was to try to get to 50 — as much as 50 sites in 2024. 2023 — by the end of 2023, which would have been — would have been record-smashing for a gene therapy launch, and that there was going to be this aspiration that maybe someday we could get to 70 sites that would be trained and up and running. And this team got, as you know, to over 70 sites in 2023, but also the way they got there is something that gives me an enormous amount of pride, which is, as I said earlier in this call, recall, we don’t prioritize revenue over patient safety and great outcomes. Far more important for us to ensure great outcomes, and this team has done a ton in that direction.
These 70 sites that are activated because they’ve all been well-trained, they’re in good shape to be able to safely infuse this therapy and get good outcomes and consistent outcomes, which is important. We have a very laudable safety profile for a full body infusion gene therapy, and we want to ensure that remains the case over the long-term, not the short-term. And then, of course, there’s a lot of other programs around that, the ability to access experts so that every physician has an opportunity to get the right kinds of information to inform the way they not only infuse, but monitor patients and react is something that has been — that is unique. I’m not sure anyone else has ever done the kind of work we’ve done. So, we’re in great shape right now to serve this community and serve it responsibly.
So, I’m really proud of where the team is right now. And frankly, it also explains our revenue in 2023.
Dallan Murray: Thanks, Doug. And as you were speaking, that team did get us just a direct answer to Anupam’s question. And we’re closing in on 60% of the sites have dosed. So, it just, exactly as you said, it’s just increasing as we go.
Anupam Rama: Okay. Thank you.
Operator: Thank you. I’d now like to turn the call back over to Doug Ingram for closing remarks.
Douglas Ingram: Thank you, Shannon, and thank you all for joining us today. Thank you for your insightful questions. We appreciate it. At the risk of repeating myself I think 2023 was an extraordinarily important year for Sarepta. We — a lot of folks on this team, in concert with the patient community and investigators and physicians, frankly, moved heaven and earth to get us where we are today, which is, I think, a fast-maturing, fully integrated biotech organization committed to bringing a better life to patients with Duchenne muscular dystrophy, limb-girdles, and other serious rare diseases. 2024 is actually going to be even more significant if we’re successful, and that’s going to put us in a position where we can do a lot of good for a lot of rare disease patients and where we can reward those who have stuck with us and invested in a better life for these patients.
So, I will remind you with the — if we are successful this year and we broaden the label for ELEVIDYS and we can meet our goals this year. We are going to leverage our acumen and our financial strength and the talent of this team. And through both advancing our internal pipeline but looking to external innovation, we will have the goal of growing even after ELEVIDYS. Not incrementally, but in multiples. So, we are going to build for ourselves a very big ambition if we are successful in 2024. With that said, we need to focus on 2024 and be successful, and the team is prepared to do that. And I look forward to updating you along the way as well. So, thank you and have a lovely evening.
Operator: This concludes today’s conference call. Thank you for your participation. You may now disconnect.
