Roivant Sciences (NASDAQ:ROIV) reported fourth-quarter financial results on Wednesday. The transcript from the company’s fourth-quarter earnings call has been provided below.
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The full earnings call is available at https://edge.media-server.com/mmc/p/6w4qcx9w
Summary
Roivant Sciences reported strong execution momentum with multiple strategic updates, including a $2.25 billion settlement with Moderna and advancements in their drug development pipeline.
Financially, the company maintains a robust position with $4.3 billion in cash and no debt, and they continue active share repurchase programs.
Key clinical developments include promising data from the 1402 study in a difficult-to-treat rheumatoid arthritis population, and ongoing progress in launching Brepocitinib for dermatomyositis by September, pending FDA approval.
The company highlighted its strategic focus on Moseli, an inhaled SGC activator, with upcoming Phase 2 data expected in the second half of 2026, targeting PH-ILD with a potentially first-in-class treatment.
Roivant Sciences remains optimistic about future data releases and indicated a strong pipeline with significant upcoming milestones in multiple therapeutic areas.
Full Transcript
OPERATOR
Ladies and gentlemen, thank you for standing by. Welcome to the Roivant fourth 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 one one 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 one one again. Please be advised that today’s conference is being recorded. I would like now to turn the conference over to Stephanie Lee from Roivant Sciences. Please go ahead.
Stephanie Lee
Good morning and thanks for joining today’s call to review business updates from Roivant’s fourth quarter and fiscal year ended March 31, 2026. I’m Stephanie Lee with Roivant Presenting today we have Matt Glein, CEO of Roivant and Drew Frumpkin, CEO of Pulmovant. For those dialing in via conference call, you can find the slides being presented today as well as a press release announcing these Updates on our IR website at www.investor.roivant.com. We will also be providing the current slide numbers as we present to help you follow along. I’d like to remind you that We will be making certain forward looking statements during today’s presentation. We strongly encourage you to review the information that we have filed with the U.S. Securities and Exchange Commission for more information regarding these forward looking statements and related risks and uncertainties. And with that I’ll turn it over to Matt.
Matt Glein (CEO)
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 D3TRA as well as a plan spotlight we’ve been planning to do for a while on Mosely, getting into that data, which Drew will take us through and some smaller updates on the PrEP Sentinel program. Although exciting, so a lot to cover. I want to, before I get into all 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 5. 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 Breakthrough Therapy designation Sarcoidosis, 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 Brevacitinib and that study is already enrolling. We’re exciTED (thyroid eye disease) about how that’s going. And then a ton of work ongoing in commercial prep for the launch for DM which assuming FDA goes as we expect it to, will launch by the end of September. 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 ACR20, 50 and 70 in the D3TRA (dual therapy for refractory arthritis) 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 (cutaneous lupus erythematosus) with top line data expecTED (thyroid eye disease) in that study in the second half. And earlier in this quarter we announced the failure of the bapineuzumab studies in TED (thyroid eye disease), but also that the hyperthyroid patients showed normalization which was supportive of our Graves’ studies which are ongoing. Continue to enroll. Well also and then finally hard to believe it was this quarter. But earlier this quarter we also announced our two and a quarter billion dollar 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 Roivantt. None of that though is to say on slide 6 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 brevacitinib for primary, hopefully launching brevacitinib in Dermatomyositis by the end of September. The phase three study in cannium sarcoidosis we expect to begin this year as well and we expect The NIU (non-infectious uveitis) Phase 3 top line data in the back half of this year. So a transformative year for brepo as all of that comes around. We’ll spend time on this today, but the Moseli PHLD (pulmonary hypertension with interstitial lung disease) Phase 2B top line data is expecTED (thyroid eye disease) in the second half. That also will potentially underscore that as a really important program and hopefully look forward to that data and to talk more about it, obviously D3TRA (dual therapy for refractory arthritis), 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 to see all the PoC (proof of concept) topline data as well. And then next year is a huge year with 1402 data enGraves’s and MG coming in a ton to look forward to and frankly as much in the windshield 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 D3TRA data, which I would call surprisingly good. We were pretty exciTED (thyroid eye disease) to see what we saw here. It has slowly 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 8 of what we’re talking about today, this was a unique study design 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 DMARDs, also had to fail at least two advanced lines of therapy. So most commonly that’s two of for example TNs, JAK inhibitors and IL-6 inhibitors and we’ll talk a little bit about that. There’s obviously some other things that could be in that bucket as well. The study also had a pretty strict entry criteria on autoantibody-positive. We had a criteria on aqua-positive above a certain level and that was also specific to the study of design. And then the other way in 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 600mg followed by a period two 12 week re randomization where ACR20 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 Vect 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 to say about it other than that we’re going to be sharing a pretty limiTED (thyroid eye disease) subset of this data today. On slide 9 you can see baseline characteristics for the patients in the study with 165 valuable patients. I’m not going to go through all of this in detail other than 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 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 Nippon study or really any of the later line RA studies that have been run. And actually one thing that we’re highlighting today, because I think it’s particularly 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 failed a JAK inhibitor also failed 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 of 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 ACR 50 and over a third of patients with an ACR 70. And notably, once you get onto the deeper end of that with ACR 50s and ACR70s, you just don’t see a lot of placebo response in that level of responder analysis. And so 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 thing 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 were able to deliver in an open label 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-positive is an orthogonal mechanism, 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 (thyroid eye disease) 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 dosed with IMVT-1402 to date. It was safe and well toleraTED (thyroid eye disease) in the study. Nothing new drug relaTED (thyroid eye disease) from a safety signal perspective identified. So a clean data set overall and further underscoring what we think We’ve got with 14.02 path forward from here. Obviously you look at this data and you feel pretty good about what this could be. Significant potential benefit, a differentiaTED (thyroid eye disease) 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 period too, and just need to make sure we’re comfortable with the plan forward. So I think much more interesting than the period 2 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 (thyroid eye disease) some data at our Investor day suggesting this is at least a 70,000 patient population and some more specific revised commercial analysis, but Immunovant has now done that. Looks like that number could be 85,000 or higher. It’s a big patient population in need. And I think underscoring that the speed with which this trial enrolled, the enthusiasm that physicians have for putting patients on study, is just further evidence that there’s really something interesting here. And with that, actually, I just want to also just give a shout out to the Immunovant 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 (thyroid eye disease) about what obviously what Private’s been able to do with Brev sitting in from a clinical enrollment perspective. We’re exciTED (thyroid eye disease) about the speed of enrollment for Moseley. Obviously the quality of that data. We’ll find out soon, but look really exciTED (thyroid eye disease) about what we’ve been able to do across the portfolio in clinical execution. So much appreciation for the enormous number of people who are working toward those goals. Cool. I’m going to pivot now to Moseley Cigarette and do a little bit of a data preview there because the next time we get together, that data could potentially be very close in front of us. And so we wanTED (thyroid eye disease) 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 Brevacitinib in drivenomystitis. Look, I’ll do a little bit of an introduction here. And then you all heard from Drew back at Investor Day in December. He’s in the room with me and is going to talk through a little bit more about the program, look intense on that medical need. These patients, in the extreme, a 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 US and Europe. And that one mechanism for prosthenol is underscoring multiple really great launches at this point. So we’re exciTED (thyroid eye disease) to see the commercial enthusiasm and exciTED (thyroid eye disease) to see these patients have access to something that provides real benefit already. And we’re hoping to add to that. Mosely has a completely differentiaTED (thyroid eye disease) mechanism of action for the disease. It’s an SDC activator, it’s an inhaled SCC activator. It is potentially the first non verprostenol that could be available for these patients. We expect this to be a polypharmacy combination therapy market, as PAH has been. And we think Mosely 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 and 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, that 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 drugs 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 135 patients studied. 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.
Drew Frumpkin (CEO)
Drew, that’s great. Thank you. Thanks. Amelia, Matt and I can tell you there’s a lot of excitement about Moseli ciguat. So Moseli is an inhaled SGC activator that’s delivered directly to the lungs to activate SGC and restore impaired SGC function. SGC is a key enzyme in the NO-SGC-cGMP pathway. And in oxidative stress environments like pH, I, L D, nitric oxide may be reduced and the SGC binding site can become impaired leading to SGC dysfunction.
Drew Frumpkin (CEO)
Now, typically, SGC is activated when nitric oxide engages SGC in the presence of hemet and CGMP is then produced. Unlike cgmp SGC stimulators that requires nitric oxide and heme to activate the sgc. Inhaled Mosasigua binds to the heme pocket independent of the need for NO and heme producing cgmp, which results in vasodilation of the pulmonary arteries and potential reduction of fibrosis and inflammation of the lung tissue. Next slide. So we know many pulmonary diseases are heterogeneous in nature and that fact can make patient treatment complex.
Drew Frumpkin (CEO)
To start, there’s disease of the pulmonary vasculature and disease of the lung parenchyla. The combination of these two disorders is embodied in pulmonary hypertension with interstitial lung disease, which is the first indication we’re exploring in our phase two focus study. We believe Moseley has the potential to address both the pulmonary vascular and the lung parenchymal diseases experienced with patients with ph I L, D. Moseley, next slide. I want to make sure that all I’m going to do is call out the slide numbers. If everyone’s got. Okay, okay, let me pull out the slide numbers. Okay, thank you very much. I appreciate that. I want to make sure we’re advancing. Okay. Most of these preclinical properties led Bayer to take mosase into phase one trials and and a total of 170 patients including healthy volunteers and patients with group one pulmonary arterial hypertension (PAH) and group four CFAP. In the phase one study, Fire studied Moseley, CGWAT and 132 healthy volunteers and 38 pH patients. The healthy volunteers underwent studies with single and multiple dose formats and Moseley proved to be well tolerated, …
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