Neena Bitritto-Garg: Hey guys, congrats on the quarter and thanks for taking my question. Just kind of following up a little bit on the last question, just thinking about the pace of starts, and it seems like there was a little bit of a warehousing effect as you expected in fourth quarter, but just trying to get a sense for how we think about the pace of starts after Q1. Do you expect this kind of 1300 patients per quarter to be kind of a sustainable rate or should we expect the pace of new starts to kind of start to decline thereafter? And then just on the PHOENIX commentary, should we, I mean, how should we think about, kind of next steps post the PHOENIX top line? I mean, it sounds like you’re kind of guiding us to expect a decision on kind of the long-term kind of commercial status of RELYVRIO based more off of overall survival data, but just wanted to clarify if I heard that correctly. Thanks.
Margaret Olinger: So yes, Neena, thank you so much for the question and I’ll start, this is Margaret. So we just want to reiterate, we are very pleased with the growth we’re seeing in the second, in Q4 of 2022 and so far this year. And we are — and things are going really well. We’re seeing an initial bolus in demand. And to be honest with you, we just don’t know how big this bolus will be or how long it will last. But we expect continued growth and interest in demand as the initial prescribing has been relatively concentrated as I mentioned. We have a large untapped opportunity to build on in our ongoing outreach and education and efforts. We really see that we have a lot of runway ahead of us.
Josh Cohen: Yes, thanks Margaret. And just adding, so I think survival is definitely a key endpoint in ALS. I think it’s just a biological reality, but it takes a while for survival events to accrue, so I want to be really upfront about that. But I wanted to come back to we’re really confident in the trial design and execution. We’re really looking forward to this data. I’ll say personally, I can’t wait to unveil the PHOENIX data when we have that next year.
Justin Klee: Yes, and just one more point, as Margaret emphasized the demand, I think that’s on the plus side, right? We’re seeing early demand. It’s very concentrated so far so we have a lot of breadth and depth to continue to look forward to, I think as we expand this product. On the other hand though, insurance coverage is still something that is not complete yet, and I don’t believe it’s going to be appropriate to make an estimate about what our future demand is going to look like until we get fully closer to 100% of the insurance decisions being made. And again, as Margaret mentioned, at this point, we’re about a third of the way through that. So I think it’s too early for us to really know what that demand curve is going to look like Neena, again, how big and how long that bolus might last until we really understand what the full breadth of coverage is. It’s going well so far, but we’re only a third of the way through.
Neena Bitritto-Garg: Got it. That’s super helpful. Thank you.
Justin Klee: You’re welcome.
Operator: The next question is from Corinne Jenkins with Goldman Sachs. Please go ahead.
Corinne Jenkins: Yes, good afternoon and congratulations on the quarter, guys. Maybe to start, just in terms of the EMA questions, I know you shared a bit already, but can you just provide a little more clarity? Are these questions that you could answer with data that you currently have on hand or is there any risk that you might have to generate additional data to sufficiently answer those?
Josh Cohen: Yes, I think, the question as always with any regulator is what we have sufficient or is more data needed. I’d say, this drug has already been approved by two regulators. I think we have clear and strong scientific arguments to support the approval of this drug, but of course the regular has to decide that too. So we’re still going through the process. We’re still going through the back and forth, so it’s too early to know what the decision will be. But I think we have the right team and the right arguments to continue moving forward through the process.
Justin Klee: Yes and Corinne, I’ll just add to that. In the EMA, while we don’t know yet, our anticipation is that this may be a conditional marketing authorization and the conditioning marketing authorization the condition would likely be completion of the PHOENIX trial. So I think that’s an important part of your question, too.
Corinne Jenkins: Yes, that’s really helpful. And then you mentioned 10,000 patients on drug target kind of steady state. And in the past, we’ve talked about what the launch curve might look like with an initial bolus and then steadying out until we get to steady state. How are you thinking about it now that you’re in the market and seeing kind of the demand that you’ve had thus far?
Margaret Olinger: Yes. So we’re very excited about the opportunity in the long-term to hopefully be able to treat 10,000 patients at any given time. As you know, there’s 29,000 ALS patients suffering with this disease. Some patients we know will not be able to, just unfortunately, due to the natural progression of the disease, be able to access treatment to the drug. But we do know that really is all today is roughly 9,000, but the range is anywhere from 8,000 to 11,000. So we do have a goal and aspiration to become standard of care with the first drug to really have function plus survival on the long-term post hoc analysis. So that’s sort of our goal and aspiration and we feel confident that we can meet that goal. How long it will take us to get to that point?
I think it’s way too early in the launch to see that. And then just in terms of the slope of the ramp, to your point, it is very early months of the launch, but we are seeing very encouraged levels of interest from both people living with ALS and clinicians and we said that Q4, we ended with 13 people on therapy. We expect to double that by the end of Q1. And again, I just want to reiterate to everybody that is on a net basis, which should give you a good sense of how the launch is progressing. And while we do have that initial bolus of demand, we don’t know how big and how long that will last, we do really are very confident in the long runway we have ahead of us. So our focus remains on the 1,300 patients that are on therapy today and keeping them on therapy.
And then also, we’re very encouraged by the insurance favorability that we’re seeing, while it’s only a third at this point we have very broad access to date, and we’re encouraged at the future.
