Alisha Alaimo: Yes. I think when you look at the US and the market penetration, and you probably saw in the analogs on the slide that the launch has gone very well thus far. And as I also said, we’ve made it through sort of the catch-up population. We have a lot of really good things in-place right now that we are launching in parallel to identify and hopefully get to the rest of the population. The way in which we think about this market though is, we do have two sets of patients. You have a set that are highly engaged with their physicians, and you have another set who haven’t been engaged, probably over the last two to five years. We have enough data and analytics to understand exactly where these physicians are, and how the patients have moved through them.
And so, with that, we are now identifying a lot of these offices, especially in the community who could have a patient or two that might be diagnosed with general ataxia, but not Friedreich’s. And so, what I referred to earlier on the call is expanding the field force footprint. We have a very targeted approach to these offices in order to, again, increase the market penetration. Now, as you see with something like a SPINRAZA, we’ve also performed very well, and also have driven quite a good market penetration with that product, even though there’s competitors in the marketplace. With SKYCLARYS, with no competitor really in the market, we expect to continue over the next several years to penetrate this for as far as we can go. We know that there are 4,500 approximate patients that could have Friedreich’s ataxia.
And so, what we’re doing is planning everything that we can to get to as many of them as quickly as possible.
Chuck Triano: Thanks, Alisha.
Chris Viehbacher: Yes. And on Europe, in some ways the single-payer systems actually are really ideal for rare diseases. A lot of patients in the US, even if you have reimbursement, even if you have insurance coverage, there are an awful lot of hurdles that the US healthcare system imposes upon patients. And a lot of those, we don’t really see in Europe. And so, I think we’re seeing a rapid uptake. Again, there’s — there is a catch-up on population. So there’s — and there’s a difference between patients on treatment and revenue-generating patients. So first, we have — we have actually the commercial launch in Germany because we can get reimbursement relatively quickly. Other countries will come online as we go through the individual country reimbursement processes, but our objective is actually build up the patients.
So there’s a number who are on free drug at the moment through these EAPs, some of the EAPs you can charge for. So, it’s going to be a little lumpy as we look at the revenue line. But I’d say we’re extremely encouraged by the uptake of patients. And then, ex-US in Latin America, that could well be a story for 2025. I think you may see our first launch in Brazil in early part of 2025.
Chuck Triano: Great. Thanks, Chris. Can we move to the next question, please?
Operator: Yes. We’ll go next to Umer Raffat with Evercore.
Umer Raffat: Hi, guys. Thanks for taking my question. I have one for Priya, if I may. I know there’s the late-stage lupus readout with the CD40 ligand antibody this summer. I also realize the time point on this readout is week 48 instead of week 24. And I guess my question is, knowing that there wasn’t a clear dose-response on efficacy in the prior trial, could you speak to how the B cell impact was different between doses and whether the prolonged duration could actually help the B cell impact on this upcoming readout? Thank you.
Priya Singhal: Thanks, Umer. We have looked at the Phase 2 study very carefully, and we have decided and we included the 48-week endpoint on BICLA for this Phase 3 study. And ultimately, we’re looking for a meaningful change on the primary endpoint, and the key secondary endpoints for SLE such as severe flare prevention and patients achieving low disease activity. We also think that the BICLA is a sensitive, clinically meaningful composite measure of SLE disease activity, and requires disease improvement across all body systems with moderate or severe baseline activity without worsening and the need for escalation in background medications. So we modified the trial, we are — we have refined the population, and we think that this is going to be really important as we kind of look forward to the readout.
The other piece I think here to keep in mind is that we considered how we can modify the population for this study and get to an answer really quickly to bring potentially dapi to patients. So I hope that answers your question.
Chuck Triano: Thanks, Priya. Let’s go to the next question, please.
Operator: We’ll go next to Michael Yee with Jefferies.
Michael Yee: Hey, guys. Thanks. I wanted to revisit SKYCLARYS comments. I know you said you were planning to add patients month-to-month. Can you just talk about the trajectory of SKYCLARYS this year as it relates to also any offsets like discontinuation rates, et cetera, et cetera, how does that factor into it? And also, will you book Germany revenues this year? So just talk about the dynamics of revenues for SKYCLARYS. And if I may sneak in one clarification. Priya said subcu induction filing for LEQEMBI Q1 2026. I just wanted to clear that’s what she said? Thank you so much.
Priya Singhal: Yes. The outcome and the filing will be in that period, but we’ll communicate more on this once we optimize the dose and we go forward.
Michael Yee: Okay. And SKYCLARYS?
Alisha Alaimo: Yes. So for SKYCLARYS, it is quite complicated month-to-month, I will say, because you have patients, obviously, that we’re getting via the start forms, which I will say for the highly engaged population we are pretty much maxing that out now. We absolutely know who they are and we’ve captured them through the physicians. But then, you’re also going to have a discontinuation rate as you have noted, and you’re going to have patients that are being pulled off the start forms, putting on to product. And then of course, you may have them miss a dose or two, right? So then, there’s compliance. So month-to-month, it will be lumpy because you can say you add 50 patients, but then you have other dynamics going on in the patient population.
