Roivant Sciences Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the Roy Van Forth Quarter 2025 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. And to ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. We ask that you please limit to one question. And to withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Stephanie Lee. Please go ahead.

Good morning, and thanks for joining today's call to review business updates from Roy Vint's fourth quarter and fiscal year ended March 31, 2026. I'm Stephanie Lee with Roy Vint. Presenting today, we have Matt Glein, CEO of Oregon, and Drew Brumkin, CEO of Palmogans. For those dialing in via conference call, you can find the slides being presented today, as well as the press release announcing these updates on our IR website at www.investor.rogan.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I'll turn it over to Matt.

Thanks, Stephanie. Thank you, everyone, for dialing in this morning. I'm glad to be talking. We have an unexpectedly busy agenda with a bunch of topics. I'm looking forward to going through all of it, including, obviously, what we announced this morning, which is the preliminary open-label period data from the 1402 study in DGTRA. as well as a planned spotlight we've been planning to do for a while on Moseley getting into that data, which Drew will take us through, and some smaller updates on the representative program, although exciting. So a lot to cover. Before I get into all of that, use one small bit of executive privilege and wish my father, Jerry, a happy 75th birthday. Today is his 75th birthday. So happy birthday, Dad. He sometimes listens in on these calls. I don't know if he's listening in now. If not, I'll catch it on the replay. Okay, into the important topics now. Starting on important business topics now. Starting on slide five. Look, this has been a pretty wild 12 months for Roivant, and we continue to see just tremendous execution momentum across our development portfolio. An update that will get drowned in some of the other things for today, but is actually pretty great, is that PrEP-Citinib was awarded Breakthrough Designation, Break Therapy Designation, which just underscores indication selection and development there in terms of what that could mean for those patients. Obviously, also in this quarter, we announced LPP as an indication for BREPO, and that study is already enrolling. We're excited about how that's going. And then a ton of work ongoing in commercial prep for the launch in DM, which, assuming FDA goes as we expect it to, will launch by the end of September. You know, obviously the biggest data update for today in the FCRN franchise is what I mentioned earlier, which is that 1402 showed, we think, clinically meaningful, pretty exciting ACR response rates across ACR 2050 and 70 in the GDPR-A study in the open-label portion. We'll talk more about that, but that's obviously encouraging data that we're looking forward to spending some time on. We're also fully enrolled on CLE with top-line data expected in that study in the second half. And, you know, earlier in this quarter, we announced the failure of the betocumab studies in TED, but also that the hyperthyroid patients showed normalization, which was supportive of our GRADE studies, which are ongoing and continue to enroll well. Also, and then finally, hard to believe it was this quarter, but earlier this quarter, we also announced our $2.25 billion settlement with Moderna, and we expect to receive the first portion of that payment, the $950 million upfront in July. So just an incredibly busy quarter of execution for us and an incredibly busy fiscal year for us. It's really hard to believe how much has changed in a year for Royvent. None of that, though, is to say on slide six that we're done. And the next 12 months are also incredibly exciting. Obviously, one of the most important things going on, we will hopefully be launching brepacitinib. you know by the end of September the phase three study in Kenya sarcoidosis we expect to begin this year as well and we expect the NIU phase three top line data in the back half of this year so a transformative year for Breppo as all that comes around we'll spend time on this today but the Moseley PHLD phase 2b top line data is expected in the second half that also will potentially underscore that as a really important program and hopefully we'll Looking forward to that data and to talk more about it. Obviously, DRT-RA, some of the data is around today, but we're looking forward to providing a pretty significant update later this year with a little bit more data as well as detailed analysis we're doing at a patient level and hopefully with some feedback from FDA on a go-forward plan given what we've now seen. And then obviously we'll get the COC top line data as well. And then, you know, next year is a huge year with 1402 data in Graves and MG coming in. A ton to look forward to, and frankly, as much in the windshield as in the rearview mirror. I think I've got the car analogy right there. Great. Okay. I'm going to go in now without spending any more time on the preamble and talk a little bit about this DGTRA data, which I would call surprisingly good. We were pretty excited to see what we saw here. It is fantastic. It's been a little bit hard to process just how exciting this data is, and so we're still doing a lot of work on it. As a reminder on slide eight of what we're talking about today, so this was a unique study designed in a few ways. First of all, as I think everyone's aware, this was a study in heavily refractory patients. Every patient in this study, in addition to failing steroids and DMARs, also had to fail at least two advanced lines of therapy. So most commonly, that's two of, for example, TNFs, JAKs, and IL-6s. And we'll talk a little bit about that. There's obviously some other things that could be in that bucket as well. uh the study also had a pretty strict entry criteria on auto antibody positivity we had a a criteria on aqua positive above a certain level and that was also uh specific to the study of the design and then the other way which the study was unique is it was a randomized withdrawal study with two periods first an open label active treatment period of 16 weeks at high dose 1402 600 milligrams followed by a period to 12-week re-randomization where acr 20 responders at week 14 and 16 both are re-randomized into a 12-week randomized withdrawal period, where some of them stay on 600, some go down to 300, and some go down to placebo. What we have to share today is preliminary data. We're still actually cleaning and finalizing it all, but it shouldn't move very much from here. On the top line treatment effect from period one, period two is still ongoing with more than half of patients still being dosed in the study. So we don't have any data or information about period two to share today. And then even for period one, there's a whole bunch of data like IgG, for example, that we haven't analyzed fully and are not ready to share. So nothing... nothing to say about it other than that we're going to be sharing a pretty limited subset of this data today. On slide 9, you can see baseline characteristics for the patients in the study. We went over the 165 valuable patients. I'm not going to go through all of this in detail other than to say this is quite a sick patient population. Obviously, by design, it's refractory, and we'll talk more about that in a second. But, for example, if you look at the DAS28 CRP score of 6.1, that's quite high for a study like this. There's a bunch of measures on here that suggest a quite sick population, which was the goal, right? This is the population that we set out to enroll, and so we feel good about who's in the study. On prior lines of therapy, specifically on 10, so you can see on the right-hand side, we succeeded with our entry criteria, that is basically all of these patients have failed more than two advanced therapy mechanisms. And that's very different than either the NIPO study or really any of the later line RA studies that have been run. And actually, one thing that we're highlighting here is really interesting. 65% of these patients roughly have failed specifically JAK inhibitors. And notably, and we'll highlight this elsewhere as well, basically every single one of the patients who fail the JAK inhibitor also fail the TNF. So this is a TNF and JAK refractory patient population that we're focused on. So, look, slide 11 is the headline here, and the headline is, with all the appropriate caveats for an open-label study, these numbers are high. We saw 73% of patients roughly with ACR20 responses, and not just that, but we saw quite deep responses. We saw over half of patients with an ACR50 and over a third of patients with an ACR70 And notably, once you get out to the deeper end of that with ACR50s and ACR70s, you just don't see a lot of placebo response in that level of responder analysis. And so, you know, it feels to us like looking at this data. There's something going on that's meaningful and interesting with this drug and something that merits enthusiasm and a lot of further investigation. And we're certainly doing all that work now as we get ready to take the program forward. I'll highlight on slide 12. The one other bit of interesting data from the study that we're able to present today, which is we pulled out the subset of patients who are JAK experienced. Remember, those patients, 107 of them are both JAK and TNF experienced, all of them. Some of them have also failed something else as well. And one of the things that I think is maybe most exciting about this data is it's basically fully preserved in that subset. And so as you think about that opportunity where these patients have really failed all of the most advanced options available to them, we're able to deliver the in an open-level setting, pretty exciting response rates for those patients, which I think bodes well for the exact biological thesis with which we ran the study to begin with, that autoantibody positivity is an orthogonal mechanism to some of the other anti-inflammatory options, and that for aqua-positive patients, this could be an effective treatment option. So look, I think on slide 13, just to reiterate what we're showing here, look, these are sick patients, a difficult-to-treat patient population who have failed a lot or all of the available options and come in with highly active disease. We showed really great response rates in the data that we're excited to see how they evolve through the rest of this study and on deeper patient-level analysis. And also notably, this is the largest patient population dose with IMD-1402 to date. It was safe and well-polarized in the study, nothing new drug-related from a safety signal perspective identified. So a clean data set overall and further underscoring what we think we've got with 1402. Pass forward from here, obviously you look at this data and you feel pretty good about what this could be. You know, significant potential benefit, a differentiated mechanism, a difficult to treat population with not a lot of options. So we're actively working right now to get ready to talk to FDA about this data and plan a path forward. The data is encouraging. I'll make one comment about it, which is the depth of responses. is exactly what's exciting about the data set. It's exactly what makes us believe there is something beyond placebo happening in the data set. But as you'll recall, the randomized withdrawal period, the primary endpoint of period two is do patients taken off drug lose their ACR20 response in 12 weeks, which was a relatively short period to begin with and almost certainly would have been fine if we had seen more marginal benefit on ACR20. But the truth is, once you're looking at ACR 50 and 70 responders, I think the bar has actually gotten a fair amount higher for period two. And so paradoxically, I think we still have a good shot of success there. But in some ways, period two was less meaningful than it might otherwise have been. And I think there are plenty of scenarios where we don't see a p-value in period two and continue forward with the drug given the overall quality of this data. And conversely, depending on FDA's feedback, potentially situations where we do see a p-value of period two and just need to make sure we're comfortable with the plan forward. So I think much more interesting than the period two data at this point is more patient-level analysis as well as the results of those FDA discussions. And we expect to share all of that in the second half of this year. We're working on it right now. And my hope, given the quality of this data, is that we'll be coming back to you with an enthusiastic update about next steps here that lay the groundwork for just a really big opportunity. Remember, we presented some data at our investor day suggesting this is at least a 70,000 patient population and some more specific revised commercial analysis that Immunovant has now done that looks like that number could be 85,000 or higher. It's a big patient population indeed and I think, you know, underscoring that the speed with which this trial was rolled, the enthusiasm that physicians have for putting patients on study is just further evidence that there's really something interesting here. And with that, I actually just want to also just give a shout out to the Immunomat team who have continued to execute really well. Obviously, the data itself is strong, but also the speed of enrollment, the speed with which we're moving through these studies, the full enrollment on CLE. And I think that spans all of our programs. I think we're excited about that. what obviously what private has been able to do with representative from clinical enrollment perspective uh we're excited about the speed of enrollment from moseley obviously the quality of that data we'll find out soon uh but uh but look really excited about what we've been able to do across the portfolio clinical execution so so much appreciation for the enormous number of people who are working toward those goals Cool. I'm going to pivot now to Moseley-Sigawatt and do a little bit of a data preview there because, you know, the next time we get together, that data could potentially be very close in front of us. And so we wanted to get out ahead of that and give people a chance to just ground themselves in what's coming, as we did last year around this time or a little later for BREPO in Nevada, Massachusetts. Look, I'll do a little bit of an introduction here, and then you all heard from Drew back yesterday in December. He's in the room with me and is going to talk through a little bit more about the program. Intense on that medical need. These patients, in the extreme significant proportion of them, die. They're very sick. There is currently only one approved mechanism with two therapies, and we think there's probably 200,000 patients across the U.S. and Europe, and that one mechanism for prostenal is underscoring multiple really great launches at this point. So we're excited to see the commercial enthusiasm and excited to see these patients have access to something that provides real benefit already, and we're hoping to add to that. Moseley has a completely differentiated mechanism of action for the disease. It's an STC activator. It's an inhaled STC activator. It is potentially the first non-fiprofenol that could be available for these patients. We expect this to be a polypharmacy combination therapy market, as PAH has been, and we think Moseley has a chance to be First line has a chance to be a major part of the treatment paradigm, and we're just looking forward to getting this data moving forward there. In our phase one data across healthy volunteers, pulmonary hypertension patients, and Drew will remind us of this data specifically, we saw among the best PVR reductions to date, and one thing we're going to remind people of today is that Although we saw a 38% PVR reduction in some of those patients, basically anything that has ever showed 20 plus percent PVR reductions has been able to deliver clinically meaningful benefit. I think it's true that there has not been any class of drug showing a 20 plus percent PVR reduction that has not gone on to be a commercially successful class of drugs. And then finally, as a reminder, unsurprisingly, the top line data from that study is on track, and we expect to get it in the second half of 2026. It's a 135-patient study. So with that, I'm going to hand it over to Drew, who's going to take you through the next handful of slides here on the program, and then I'll come back for a little summary at the end and the rest of the presentation.