Priya Singhal: Yes. And I think that’s important because we have filed for an intravenous maintenance like — we’ve already completed this filing Q1 2024, and really that has come from three lines of evidence. The Study 201, which was the Phase 2 study, the GAAP period modeling, as well as open-label extension in the Phase 3. So that’s what’s informed our maintenance IV filing. And really, it will be decided along with the FDA on what is the appropriate time for transition from IV biweekly to weekly now — up to four-weekly. And in addition, following that, we’ll have the subcutaneous maintenance discussion. So really, it’s very systematic and we need to first get through all the IV maintenance. And in parallel, we have the SC maintenance. I hope that makes sense.
Chuck Triano: Thanks, Priya. Let’s move to the next question, please.
Operator: We’ll go next to Jay Olson with Oppenheimer.
Jay Olson: Oh, hey. Thanks for providing this update. It seems like compared to previous quarters, you’re focusing more on your three commercial launches and relatively less on the R&D pipeline. Is there any particular reason for that shift in focus? And how much more work do you plan to do to optimize your R&D portfolio? Thank you.
Chris Viehbacher: I’ll start. I mean, I think we have first — four data readouts coming in midyear. So, I think, we felt we’d have more data when we — it makes sense to bring back the R&D when we’ve got more data. I would say actually from a prioritization point of view, and Priya, you can weigh-in here, but I think we’ve largely done the job of having projects that are either projects of conviction, or projects where we’re waiting the data outcome. They’re in-flight and just given the nature of neuroscience projects, we wait — we need to wait and see what the data say. I think you’re going to find us much more disciplined about whether we progress or not. Our go/no-go decisions, I think have all been clearly defined for those.
I think the next job is really now to build out the pipeline, as I talked about earlier, that we want to diversify our business a little bit more than we have in the past. So, Priya is certainly working along with Jane on thinking about what things we can additionally bring into the pipeline from outside. But, Priya, I don’t know whether you want to add anything there.
Priya Singhal: Thanks, Chris. I think you covered it. That’s exactly right. We are very excited about our four readouts. We are preparing for them. We have already worked through go/no-go criteria. And we continue to remain very excited about the rest of the pipeline that’s in mid and late-stage, particularly our anti-tau ASO BIIB080, as well as our two Phase 3 programs in SLE, litifilimab as well as dapi that we just talked about, and with litifilimab also in cutaneous lupus. So, we have a number of projects in early phase development, and we’re trying to be very disciplined about making sure that we make evidence and data-based decisions.
Chuck Triano: Thanks. Thanks, Priya. Next question, please.
Operator: We’ll go next to Chris Raymond with Piper Sandler.
Chris Raymond: Thanks. Just maybe a strategic question on your biz dev strategy. So, Chris, I heard your comments around diversifying away from neurology. You guys have been saying that for a while and your deals are focused on areas other than MS. But there is actually, if you look across the industry, some decent early innovation in MS. Even with your business on the decline, our checks still indicate that Biogen remains a trusted company and there’s an awful lot of value, I would argue with that market presence. I guess maybe just the question here strategically is, is your activities in business development, is that due to your view of the need to diversify away from MS strategically? Or is it a view that you just haven’t seen an early asset worth licensing, or is there some other underlying dynamic of the MS market that has led you guys to prioritize other areas? Thanks.
Chris Viehbacher: Yes, well, there’s a little bit of a lot of the above in there. I think the first is, we haven’t abandoned MS. We do have programs in research early. The unmet need in MS has really narrowed. It’s really the progressive form, which is a very tough indication really to go after. But we have programs still in ALS. And in fact, I think the fact that QALSODY was approved has actually proven to be an enormous scientific achievement. It may not be a major financial achievement, but this really opens up the field to having a biomarker where you can tell whether something is working or not in ALS. And so, we have a number of programs in ALS. We’re in Huntington’s. We have a program in Parkinson’s, as you know. We’ve got TAU, which I think between TAU and lupus, we see as programs of high conviction within the company.
So, we feel that — I think you’re right. We are very well-placed. Neurology, I wouldn’t just say MS, but neurology. But the reality is that, we sit there with programs that are very difficult to predict, very expensive, very long running. And when you actually look at the ability to do external deals, that field is also very narrow. There’s just not that many people working in the CNS space. So we’re by no means abandoning it. And in fact, the fact that we go after these really tough diseases is really a source of pride within Biogen. And I have to say, I continue to be amazed at the capability and talent we have within the organization. But the reality is, we need to have more predictable results out of R&D. And I think we do have a lot of that capability within the company.
I don’t see us ever — moving — going left turn into oncology or something like that. But I do think we have a legitimacy and being in rare diseases and expanding into immunology. And in fact, I think what we’ve been doing in MS and in fact lupus is really an indicator of that. So, I think we’re going to continue to branch out, but it also branches out our opportunity set for collaboration, and not just diversifying our portfolio.
Chuck Triano: Thanks, Chris. And can we take our last question, please, operator?
Operator: Yes. We’ll go next to Terence Flynn with Morgan Stanley.
