Q3 2025 Roivant Sciences Ltd Earnings Call and Business Update

February 6, 2026

Speaker #1: Good day and thank you for standing by . Welcome to the Roy Van . Third quarter 2020 Earnings Conference Call . At this time , all participants are in a listen only mode .

Speaker #1: After the speaker's presentation , there will be a question and answer session . To ask a question during the session , you will need to press star one one on your telephone .

Speaker #1: You will then hear an automated message advising your hand is raised to withdraw your question. Please press star one one again. Please be advised that today's conference is being recorded.

Stephanie Lee Griffin: Good morning, and thanks for joining today's call to review positive phase 2 results for brepocitinib in cutaneous sarcoidosis and Roivant's financial results for the third quarter ended December 31, 2025. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant, and Ben Zimmer, CEO of Priovant. 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.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I would 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 file with the SEC for more information regarding these forward-looking statements and the related risks and uncertainties.

Speaker #1: I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

Speaker #2: Good morning , and thanks for joining today's call to review positive phase two results for in breakfast cutaneous sarcoidosis and Roivant's results . Financial third quarter ended for the December 31st , 2025 .

Q3 2025 Roivant Sciences Ltd Earnings Call and Business Update

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Q3 2025 Roivant Sciences Ltd Earnings Call and Business Update

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Friday, February 6th, 2026 at 1:00 PM

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Speaker #2: I'm Stephanie Lee with Roy presenting today . We have Matthew Gline CEO and Ben CEO of finance . 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 .

Speaker #2: We'll also be providing the current numbers as slides we present to help you follow along. I would like to remind you that we will be making certain forward-looking statements during today's presentation.

Speaker #2: We strongly encourage you to review the information that we filed with the SEC. For more information regarding these forward-looking statements and related risks and uncertainties.

Stephanie Lee Griffin: So with that, I'll turn it over to Matt.

Matt Gline: Thanks, Steph, and thanks, everyone, for dialing in and listening this morning. I'm going to start our presentation on slide 5. You know, I was sitting talking to the team, it was about a week ago today, looking at a draft of this morning's presentation and thinking that it was going to be a pretty boring 10-Q. We got together in December for the investor day. We had spoken at the J.P. Morgan Conference, and it turned out to have been a really busy week. So we have some great updates, obviously, most notably the phase 2 data in brepocitinib and CS, which Ben is going to present on momentarily. But truth is, terrific execution and progress across the board for us this quarter.

Speaker #2: And with that , I'll turn it over to Matt .

Speaker #3: Thanks , Jeff , and thanks , everyone for dialing listening this in and morning . I'm going to start presentation start our on slide five .

Speaker #3: I was sitting talking to the team . It was about a week ago today . at a draft of this morning's presentation and thinking that it was going to be a pretty boring 10-q .

Speaker #3: We'd December gotten together in for the Investor Day . We had . had spoken We to J.P. conference , and it turned Morgan out to have been a really busy week .

Speaker #3: So we have some great updates . Most Obviously . in phase two data and CS , which which Ben is going to present on momentarily .

Matt Gline: Obviously, that data is a highlight, but we also can announce today that the NDA for brepocitinib in dermatomyositis is in, that the phase 2b study for IMVT-1402 in GD has fully enrolled, that the phase 2 study for mosliciguat in PH-ILD has fully enrolled. And obviously, all of the updates that were known before, including the Immunovant offering earlier, that gets us now financed to Graves' launch, all behind us. So just a terrific quarter and a terrific set of updates even since early January, when we last got together. You know, on slide 6, 2026 is again a very busy year for us ahead. Obviously, some major events later in the year, the brepocitinib NIU phase 3, the pivotal readout in the second half.

Speaker #3: But terrific execution and progress across the board for us this quarter, that is the truth. Obviously, that data is a highlight, but we also can announce today that the NDA for repo is in, and for dermatomyositis; that the Phase 2 study for 1402 in TRA has fully enrolled; that the Phase 2 study for Mosley and Feld has fully enrolled; and obviously all the updates that were known before, including the Immunovant offering earlier.

Speaker #3: That gets us now financed to graves launch behind us . So just a terrific quarter and a terrific set of updates , even since January , early when we last got together , you know , on slide six .

Speaker #3: 2026 is again , a very busy year for ahead . Obviously , some major us events later in the year . The NIU phase three , the pivotal readout in the second half , we're now going to be starting this year .

Matt Gline: We're now going to be starting this year a phase three study in Breppo and cutaneous sarcoidosis. Ben will talk a little bit more about that. It's early days in getting that going, but that'll be this year. The phase two B data for Mosley is expected firmly in the second half of this year. We now know that because the study is fully enrolled obviously. Same thing with the DGRA data, where all of that, both the open label period and the randomized withdrawal period, will be done by the second half of this year. We also are getting proof of concept data in 1402 in CLE. And finally, we are still on track for the jury trial against Moderna starting on 9 March. So just a few weeks away now.

Speaker #3: A phase three study in cutaneous sarcoidosis . Ben , we'll talk a little bit more about that . But it's early days and But that'll getting that going .

Speaker #3: be this The phase two data for Mosley is expected year . We firmly in the second half of this now know that because the study is fully enrolled , same thing with the data where all of that , both the open label period and the randomized withdrawal period will be done by the second half of this year .

Speaker #3: We also are getting proof of concept data in CLE 1402 , in and finally , we are still track on for the jury trial against Moderna starting on March 9th .

Matt Gline: So a really, really busy year ahead for Roivant. And really, if you look at slide 7, before we get again to the data for CS, you know, just a pipeline we're really proud of that continues to deliver across multiple dimensions with obviously Breppo with now 3 indications in pivotal registrational programs, multiple registrational programs for FcRN franchise, which we've talked about, and mosliciguat with top-line data coming in the second half. Really excited about where we are as a business, really excited about the pipeline. Couldn't be more excited for the beginning of 2026 here. Certainly, it's off to a good start. And with that, what I'm gonna do is turn to the phase 2 data for brepo in sarcoidosis.

Speaker #3: So just just a few weeks away now . So really , really busy year ahead for riven . And really , if you look at slide seven before we get to the again to the data for CS , just a pipeline , we're really proud of that continues to deliver across multiple dimensions with obviously with now three in indications pivotal registrational programs , multiple registrational programs for FCR enfranchise , many of which we've talked about coming in the .

Speaker #3: second half . with top line data So where we are really as a business , really Mosley excited about the pipeline more excited for the beginning of 2026 here .

Matt Gline: So I'm just really briefly on slide nine of the presentation. I'm just gonna walk through a couple of highlights, but mostly I'm gonna hand it over to Ben, to take you through the data in detail. And the short answer, and we keep saying this, and it's a tremendous fortune, I think, to be able to say, but this drug has done everything we could have asked for us, for it in this or of it in this study. You know, we had a significant, statistically significant. Remember, we had said before, the bar for clinical success here, we thought was sort of 5 points of CSAMI was clinically meaningful. You know, we got a placebo-adjusted almost 22 points, 21.6-point delta with a p-value.

Speaker #3: Certainly off to a good start with that. What I'm going to do is turn to the Phase 2 data for sarcoidosis.

Speaker #3: So really I'm just briefly on slide nine of the presentation. I'm just going to walk through a couple of highlights, but mostly I'm going to hand it over to Ben to take you through the data in detail.

Speaker #3: And the short answer and we keep saying this , it's a it's a tremendous fortune , I think , to be able to say , but this drug has done everything we could have us asked for for it in of it in this or this study .

Speaker #3: You know , we got a significant , statistically significant remember , we had said before the bar for clinical success here we thought was was sort of five points of was calamity , clinically meaningful .

Matt Gline: And again, this study was not powered for efficacy in this, in this endpoint. 100% of patients on brepo 45 compared to 14 on placebo had a 10-point improvement. Again, clinically meaningful was 5 points. 100% of patients on our high dose had at least a 10-point improvement. So, you know, just a tremendous outcome across the board. There's some great supportive data on some of the other endpoints as well, and with safety and tolerability, completely consistent with what we've seen for the compound in the past. So a really terrific outcome and in a disease that needs it, where there's never been a positive placebo-controlled study in an industry-sponsored study to our knowledge. So really a terrific day for those patients.

Speaker #3: You know , we got a placebo adjusted almost 22 points , 21 .6. delta with a p value . And again , the study was not powered for efficacy in this .

Speaker #3: In this endpoint, 100% of patients on 45 only placebo had—again, clinically meaningful was five points; a ten point improvement. 100% of patients on our high dose had at least a ten point improvement.

Speaker #3: at So , you know , just a tremendous outcome board . There's some great supportive data on some of the other endpoints as well .

Speaker #3: across the And with safety and completely consistent with what we've seen for the compound in the past . So really terrific outcome . And in a disease that needs it , where there's never been positive placebo controlled study in an industry sponsored study , to our knowledge .

Matt Gline: So with that, I'm going to hand it over to Ben to walk you through a little bit about cutaneous sarcoidosis as a reminder, and then, onto the study data, as well. Ben, take it away.

Speaker #3: really , a So terrific day for those that , I'm going to So with hand it patients . over to walk you through a little bit about Ben to sarcoidosis reminder .

Ben Zimmer: Great. Thanks so much. Great to be here with everyone. Starting on slide 10, I just wanted to, you know, bring back to what this disease is, walked through this at the Investor Day in December. But cutaneous sarcoidosis is a really debilitating skin disease, and among skin diseases, stands out for its rapid progression towards permanent scarring and destruction of tissue, as well as its disfiguring nature, given the particular prevalence on the face and scalp of the disease. Turning to slide 11, I would note that there's no approved therapies, not only for cutaneous sarcoidosis, but for any form of sarcoidosis.

Speaker #3: And then on to the study as well . data Ben , take it away .

Speaker #4: Great . to be here Thanks so with much . everyone . Starting on slide ten . Just to , you know , bring back to what this disease is .

Speaker #4: Walk through this at the in December . But cutaneous sarcoidosis is a really debilitating skin disease . And diseases stands out its rapid progression among skin towards permanent scarring and destruction of tissue , as well as its disfiguring Given the nature .

Speaker #4: particular prevalence on the face and scalp of the disease . Turning to slide would note that 11 , I there's no approved therapies not only for cutaneous sarcoidosis , but for any form of sarcoidosis .

Ben Zimmer: And so as we think about our development program in CS, really a great opportunity for brepo to meet this overall unmet need and become the therapy of choice if we're going to be successful in phase 3, as we hope and expect we would be on the basis of this data, to really be a promising option for all patients with skin involvement in their sarcoidosis. That would include patients both with only skin involvement, as well as those with other organ involvement as well. Turning to slide 12, you know, really just briefly on, on here on the alignment between the pathobiology of the disease and the mechanism.

Speaker #4: And so, as we think about our program development in CS, it's really a great opportunity for us to meet this overall unmet need and become the therapy of choice.

Speaker #4: If we're going to be successful in phase three , as we hope and expect , we would be on the basis of this data to , you know to , really be option for all a patients with with skin involvement in their sarcoidosis .

Speaker #4: That would include patients both with only skin involvement, as well as those with other organ involvement, as well. Turning to slide 12.

Ben Zimmer: And I think this is important because, you know, as Matt alluded to, and I'll walk through in a bit more detail, we really have great data here that we're very excited about. And I think, you know, in a small study, you know, the data is very compelling. It's hard to argue with on its own, but it also really aligns with what you would expect to see given the mechanism of this drug. Sarcoidosis, all of the forms of sarcoidosis, including cutaneous disease, are driven by the polarization and recruitment of effector T cells, and particularly TH1 polarized cells. And brepo really distinctively inhibits TH1-related pathways by hitting both IL-12 through TYK2 and interferon gamma through JAK1.

Speaker #4: You know , really just briefly on here on the alignment pathobiology of the disease is think this important because , you as Matt mechanism .

Speaker #4: alluded And I to , and I'll walk through know , more in a bit detail , we have have data here that we're very excited And I think , you know , in a small study , you know , the data is very , very compelling .

Speaker #4: It's hard to argue with on its own . But but it also really aligns with what you would expect to see given the mechanism of this drug , sarcoidosis .

Speaker #4: All of the forms of including sarcoidosis , cutaneous are disease , are driven by the polarization and recruitment of effector T cells and particularly th one polarized cells and really distinctively inhibits Th1 related pathways by hitting both IL 12 through Tik two and interferon gamma through Jak1 .

Ben Zimmer: So, so really, an opportunity here mechanistically to see the benefits of JAK1/TYK2 inhibition specifically, and, and I think that's really part of what's flowing through to our, our clinical data that I'll, I'll walk through now. Slide 13, study design, very straightforward. 31 patients in the United States randomized 3 to 2 to 2 to brepo 45mg, 15mg, and placebo. 16-week study evaluated several different efficacy endpoints that I will walk through. On the baseline demographics and disease activity, slide 14, I, I do wanna highlight a few things.

Speaker #4: So , so really opportunity here mechanistically to see the benefits of jak1 two inhibition specifically . And I think that's really part of what's flowing through to our clinical walk I'll I'll through now .

Speaker #4: Slide 13 . Study design . Very straightforward . 31 patients in the United States randomized three to two to 2 to 45mg , 15mg and placebo .

Speaker #4: The 16-week study evaluated several different efficacy endpoints that I will walk through, focusing on the baseline demographics and disease activity. On slide 14, I do want to highlight a few things.

Ben Zimmer: First, if you look at the duration of disease and background damage of patients, brepo 45mg and placebo are very well balanced between those two arms, but 15mg are actually quite a bit lighter on duration of disease and damage, which, you know, would mean really a higher bar for both brepo 45mg and placebo. And then I would also call attention to the plaque-predominant morphology. You know, cutaneous sarcoidosis can present through both plaques and papules. In general, the plaques are viewed as more treatment-resistant, and you see this plaque-predominant morphology most pronounced and most common in the brepo 45mg arm, followed by 15mg, followed by placebo. So, you know, sort of punchline of this is, you know, there were some imbalances.

Speaker #4: look at First , if you the duration of disease and background damage of patients , 45mg and placebo , very well balanced between those two arms .

Speaker #4: But 15mg actually quite a bit on duration lighter of disease . And damage , which would mean really a higher bar for both 45 and placebo .

Speaker #4: And then I would also call attention to the plaque predominant morphology . You know , cutaneous sarcoidosis can can present through plaques and papules .

Speaker #4: general , the plaques are viewed more In treatment as . And resistant you see this plaque predominant morphology , most most pronounced and most common in the followed by 45mg arm , 15mg , followed by placebo .

Ben Zimmer: Those imbalances actually made it harder for brepo 45 milligrams to demonstrate efficacy, both as compared to placebo and as compared to brepo 15 milligrams. And in spite of that, as I walk through, we really see exceptional data from the brepo 45 milligram dose arm. So turning to slide 15 to get into the efficacy results. On the left hand of this slide, you see the mean to CSAMI activity score change from baseline. You know, both doses, statistically significant separation from placebo as early as week 4, the first time point evaluated, and then sustained at every visit out to week 16 at the end of the trial. And then on the right here, we see the achievement of Investigator's Global Assessment 0/1 and a 2-point reduction.

Speaker #4: So , you know , sort of line of punch this is , you know , there were some imbalances . Those imbalances actually made it harder for 45mg to demonstrate efficacy , as compared to placebo and as compared to 15mg .

Speaker #4: And in spite of that , as I walk through , we we really see exceptional data from the 45 milligram dose arm so turning to slide 15 to get into the into the efficacy results on the left hand of this slide , you see the mean to Sammy activity score change from baseline .

Speaker #4: You know both doses separated statistically from placebo at the first time point evaluated, and then that separation was sustained at every visit out to week 16.

Speaker #4: At the end of the trial . And then on the right here , we see the achievement of a investigator's assessment . Zero one and a two point reduction .

Ben Zimmer: So as a reminder, this is, you know, the IGAs are a standard FDA supported endpoint for cutaneous disease. This is similar to the IGAs used in other skin indications, with scores from 0 to 4, clear, almost clear, mild, moderate, and severe. So to achieve both a 2-point reduction and a zero or one, it is, it's a very high bar. And, you know, notably, it's a high enough bar that 0 placebo patients cleared it. So you may be confused, where is the placebo line? The placebo line and the x-axis line are the same thing on this chart. And you see here, again, some early progress for both dose arms at week 4, really significant or substantial improvement at week 8, and then a stat sig improvement at week 12 and 16.

Speaker #4: So as a reminder , this is , you know , the IGA is are a standard FDA supported endpoint for cutaneous disease . This is similar to the igas used in other skin indications , with scores from 0 to 4 clear , almost clear mild , moderate and severe .

Speaker #4: So to achieve both a two point reduction and to end at a 0 or 1 , is is a very high bar , you know , notably it's .

Speaker #4: a it's a And high enough bar that zero placebo patients cleared it . So you may be confused . Where's the placebo line .

Speaker #4: The placebo line and the x-axis line are the same thing on this chart. See here, again, some progress—and you see that early for both dose arms at week four.

Ben Zimmer: In here, on this higher bar endpoint, you do start to see brepo 15mg begin to sepa-- Sorry, brepo 45mg begin to separate some from the 15 milligram dose arm. Slide 16 has the CSAMI responder data. Again, really compelling data. I think this chart on the left, quite remarkable. As Matt alluded to, we were hoping to see a mean improvement of 5 points, and what we saw was not only a mean far in excess of that, but we saw 100% of patients in the brepo 45mg arm achieve twice that, twice the minimum clinically important difference. So, you know, really every brepo 45mg patient, a responder in this trial, and as I'll walk through momentarily, that's really corroborated by an independent patient-reported outcome as well.

Speaker #4: Really significant or substantial improvement at week eight . And then stat sig improvement at week 12 and 16 . And here on this higher bar end point you do start to see Brembo 15mg begin to sorry , 45mg begin to separate some from the arm 15 milligram dose .

Speaker #4: Slide 16 has the SASAME responder data again—really compelling data. I think this chart on the left is quite remarkable. As Matt alluded to, we were hoping to see a mean improvement of five points.

Speaker #4: And what we saw was was not only a mean far in excess of that , but we saw 100% of patients in the 45 milligram arm achieve twice that , twice the minimum clinically important difference .

Speaker #4: So , you know , really every 45 milligram patient , a responder in this trial and as I'll walk through momentarily that that's really by an corroborated independent patient reported outcome as well .

Ben Zimmer: Then you see on the right-hand side of this chart, achievement of a CSAMI less than 5. Notably, this is not an improvement by less than 5. This means that the absolute score by the end of the trial is 5 or less, which is a standard for functional remission, and you see 62% of brepo 45mg patients achieving that, compared to no placebo patients. So, so again, this data are quite in line with the IGA 2-point improvement to 0/1 that I walked through before. So, so again, seeing pretty consistent data here across multiple endpoints. Turning now to the patient-reported outcomes. Slide 17 has the Skindex-16. This is a, again, a pretty established standard metric in inflammatory skin disease trials.

Speaker #4: You see on the right, and then hand this side of achievement of a less than five. Notably, this is not an improvement by less than five.

Speaker #4: This means that the absolute score by the end of the trial is five or less , which is a standard for functional remission .

Speaker #4: And you see 62% of 45 milligram patients achieving, compared to none of the placebo patients. So again, this data are quite consistent with the IGA two-point improvement to zero or one that I walked through before.

Speaker #4: So so again seeing pretty consistent data here across multiple endpoints . Turning now to the patient reported outcomes . Slide 17 has the Skindex 16 .

Ben Zimmer: You see excellent data here, with the placebo group worsening, brepo 45 milligrams and 15 milligrams, both improving substantially, well above the minimum clinically important difference. Again, here with brepo 45 milligrams outperforming 15 modestly, and both doses really far better than placebo. Slide 18, we have the KSQ skin domain, so this is the King Sarcoidosis Questionnaire. It's a PRO for sarcoidosis overall, not just limited to skin disease. What we focused on in our initial TLR was the skin-specific domains, and you see here very in line with the Skindex in terms of the data. So just yet another data point of very compelling evidence of benefit.

Speaker #4: This is, again, a pretty established standard metric in inflammatory skin disease data trials. Excellent. You see here, with the placebo group, both worsening and improving. Both 45 mg and 15 mg.

Speaker #4: Substantially well above the clinically minimum important difference here with. Again, 45 mg outperforming 15 mg modestly, and both doses really far better than placebo.

Speaker #4: Slide 18 . We have the csq skin domain . So this is the king sarcoidosis questionnaire . It's a pro for sarcoidosis . Overall not just limited to skin disease .

Speaker #4: What we focused on in initial our TLR was the skin specific domains . And you see here very in line with the Skindex .

Speaker #4: And in terms in terms of of the of the data . So just yet another data point , a very compelling evidence of benefit finally , the on efficacy side , I alluded to this before , but on slide 19 would call it the patients global impression of change .

Ben Zimmer: And, and finally, on the efficacy side, I, I alluded to this before, but, on slide 19, we call it the patient's global impression of change. So this is a single question where patients are asked, since they started taking the study medication, how would they describe the overall change in their sarcoidosis symptoms? And they can, answer no change, or, some degree of improvement, or some degree of worsening. I think this is a powerful endpoint for its simplicity, and notably, 100% of brepo 45mg patients reported that they improved, again, consistent with the CSAMI data, where we saw 100% response rate. So, so very compelling here. Brepo 15mg, also very considerable improvement for most patients, although 2 patients in the brepo 15mg group did not,

Speaker #4: this is a single So question where patients are asked started taking the study medication , how would they describe the overall change in their sarcoidosis symptoms .

Speaker #4: And they can answer no change or some degree of improvement or some degree of worsening . I think this is a powerful endpoint for its simplicity and notably , 100% of 45 milligram patients reported that they improved again , consistent with the Sasame data , where we saw 100% response rate .

Speaker #4: So , so very compelling here . 15mg also very considerable improvement for most patients , patients in the 15mg group did not . Not only did not report improvement , but actually reported worsening and then group , in the very little improvement .

Ben Zimmer: Not only did not report improvement, but actually reported worsening. And then, in the placebo group, very little improvement, and most patients reported either worsening or no change. Turning to slide 20, safety data. You know, I think, you know, very well—Brepo was very well tolerated during this study. We had no SAEs in the study, and all adverse events were graded mild or moderate in severity. So, you know, again, the backdrop of this efficacy data, in particular, certainly, you know, the safety data we see would, you know, would tee up a potentially very favorable benefit-risk profile for brepocitinib for these patients. Obviously, we have over 1,500 patients of data in brepocitinib, and so the overall safety database is characterized by much more than just these results.

Speaker #4: And most patients reported either, or change worsening to slide. Turning to slide 20. Safety data, I think you know very well. You know, it was well tolerated during this study.

Speaker #4: We had in this no assays study . And all adverse were events graded mild or moderate in in severity . So , you know , against the backdrop of this efficacy data in particular , certainly , you know , safety data , we see would , you know , would tee up a potentially very favorable benefit risk profile for brepocitinib for these patients .

Speaker #4: Obviously , we have over 1500 patients of of data in Brepocitinib . And so the overall safety database is characterized by by much than than more just these results .

Ben Zimmer: But, you know, certainly here, you know, nothing that would really add anything to what's already known about the drug from that perspective. And I think, again, starting to dose it now in this particular patient population, I think we see the early signs of a very indication-specific, compelling benefit-risk profile. So just to wrap up very quickly before handing it back to Matt, you know, really compelling of benefit. The effect sizes we see here are extremely large. We see them very consistently across multiple different endpoints, including independent patient-reported and physician-reported assessments, very high response rates, including the 100% response rate for the brepocitinib 45 milligrams arm, and a rapid onset of action sustained over time. So, you know, really exciting results.

Speaker #4: But you know, certainly here, you know, nothing really to add that would anything to what's already known about the drug. From that perspective.

Speaker #4: And I think , again , dose it now in this patient particular I signs we early think of a very indication specific , compelling benefit risk profile .

Speaker #4: So just to wrap up quickly before handing it back to Matt, you know, really compelling, very evidence of benefit. The effect sizes we see here are extremely large.

Speaker #4: We see them very consistently across multiple different endpoints , including independent patient reported and physician reported assessments very response high rates , including the 100% response rate for the 45mg arm and a rapid onset of action sustained over time .

Ben Zimmer: We're really excited to move this ahead to phase 3, and potentially have the first approved therapy for sarcoidosis. So I look forward to discussing any questions later, and I'll hand it back to Matt.

Speaker #4: So , you really exciting results . We're really excited to move this ahead to phase three and potentially have the first approved therapy for for sarcoidosis .

Matt Gline: Thanks, Ben. Yeah, look, we're, we're just terrifically excited about this data, about what it, what it means for us and what it means for these patients. You know, on slide 22, just sort of as a reminder of what the picture for brepocitinib now looks like. You know, people toss around the phrase pipeline in a product for a lot of different products. I feel at this point, looking across the indication set for, for Breppo, even with what we've talked about already with CFDM and NIU, where we get to a very large addressable patient population, these are patients who, in every one of these indications, lacks efficacious therapies, and is in need of options.

Speaker #4: So I look forward to discussing any questions later . And I'll hand it back to Matt .

Speaker #3: Ben . Thanks , Yeah . Look , we're just terrifically excited about this data and about what it us means for it means for and what patients .

Speaker #3: You know, on slide 22, just sort of as a reminder of what the picture for Brepocitinib is now like, you know, people toss around the phrase "pipeline in a product" for a lot of different products.

Speaker #3: I feel I, at this looking point, across the indication set for what we've—even with what we've talked about already with CSBM and NIU—where we get to a very large addressable patient population, these are patients who, in every one of these indications, lack efficacious therapies and are in need of options.

Matt Gline: We continue to add legs of the stool or opportunities that grow into these sort of first-in-class orphan inflammatory diseases that are, you know, high unmet need, important areas. And I think we've got more to come there, so stay tuned. But just starting to feel like brepocitinib is a really important medicine for us and hopefully for patients. So looking forward to continuing that journey. I'm gonna breeze through a couple of other highlights or updates across the portfolio, do a quick financial update, and then we'll do Q&A at the end. You know, super quickly on slide 24, as a reminder, IMVT-1402 remains a huge focus for us at Immunovant.

Speaker #3: continue And we to add legs of the stool or opportunities that grow that into these sort of first in class orphan inflammatory diseases that that are are , that , you know , high unmet need , important And I areas .

Speaker #3: think we've got we've got more to come there . So stay tuned . But but but just starting to feel like brepocitinib is a is a really important medicine for us .

Speaker #3: And hopefully for patients . So looking forward to continuing that that journey . I'm going to breeze through a couple of other highlights or updates across the portfolio real Financial we'll do quick .

Speaker #3: You know quickly on , super slide 24 . As a reminder , IBD 1402 remains a huge focus for at us Immunovant . We think got an Fcrn with we've potential best in class efficacy with a profile that looks , you know , favorably within the class .

Matt Gline: We think we've got an FcRN with potential best-in-class efficacy, with a safety profile that looks, you know, favorably within the class. Obviously, convenient administration with a subQ auto-injector. We're pleased again here, pipeline and product potential, again, with Graves among our lead indications, where we're, you know, expecting pivotal data in 2027. We're now, as I mentioned earlier, expecting the D2-DRA data, later this year, and that study is fully enrolled. We actually enrolled 170 patients in that study, up from the anticipated 120, originally, and that was in part just due to speed of enrollment and the level of enthusiasm, from the patient and doc community.

Speaker #3: Obviously convenient administration subcu with a . And appraise here pipeline and product potential again with graves among our lead indications we're where expecting pivotal data in 2027 , we're now , mentioned as I earlier , expecting the Dtra data later this year .

Speaker #3: And that study is fully enrolled . We enrolled 170 patients in that study , up from the anticipated 120 And that was in part just due to speed of enrollment and the level of enthusiasm from the patient community moving over to Moseley on 25 .

Matt Gline: Moving over to mosliciguat on 25, and we'll definitely spend some time later this year, talking more about PH-ILD and mosliciguat and setting the stage for what we expect there. But that study is fully enrolled, with thanks to those patients, investigators, and the Pulmovant team. PH-ILD remains an exciting opportunity for us, where, you know, targeted delivery gets at a disease where lung is the primary site of disease activity. We think we have a convenient once-daily dosing regimen in a disease where existing therapies mostly have multiple daily inhalations, and where there aren't very many existing therapies, bluntly. We expect or hope for tolerability benefits. And then, you know, as I think you know, we showed that really the best ever PVR reductions in the PAH population.

Speaker #3: And we'll definitely spend some time later this year talking more about pH Moseley and setting the stage for what we there expect. But that study is fully enrolled, with thanks to those patients, investigators, and the team remains.

Speaker #3: An area where we see an exciting opportunity is where targeted delivery gets at a disease where the primary lung is the site of disease activity.

Speaker #3: We think we have a convenient dosing once daily regimen in a disease where existing therapies mostly have multiple daily inhalations , where there aren't very many existing therapies .

Speaker #3: Bluntly , we expect or hope for tolerability benefits . And then , you know , as I think you know , we showed that really the best ever PVR reductions in the PA population , if that translates , we may be able to get we be able to get some best in class efficacy as well .

Matt Gline: If that translates, we may be able to get some best-in-class efficacy as well. So we're really excited about what we could do there later this year. I think it'll be a really important part of our story in the coming months. And then finally, as before, I'm not going to spend a ton of time talking about this today, because we're so close in here with the jury trial and the Moderna case is scheduled for 9 March. We continue to make progress there, and the sort of major update there in the recent weeks is that we got the... Earlier this week, we got the first of the summary judgment decisions, which covered a few things and had some puts and takes generally in it.

Speaker #3: So we're really excited about about what we could do there later this year and think it'll be a really important part of our story in the coming months .

Speaker #3: And then finally, as before, I'm not going to spend a ton of time talking about this today because we're so close in here.

Speaker #3: But the jury is Moderna case trial in the scheduled for We continue March 9th . progress make to there . And the sort of major update there in the recent weeks is got earlier this week .

Matt Gline: But one thing we were quite happy with is the favorable decision on Section 1498, which sets us up for the case that we were sort of quote, unquote, "hoping for in this trial," where almost all of the doses that we had asserted are gonna be covered in this jury trial. So, you know, looking forward to that and obviously more to come there. Finally, just a really brief financial update on slide 28. You know, R&D expense of $165, adjusted non-GAAP of $147 for the quarter, G&A of $175, adjusted non-GAAP of $71, for a total non-GAAP net loss of $167.

Speaker #3: that we We got the first of the summary judgment decisions , which covered a few things , and had to put some takes generally in it .

Speaker #3: But one thing we were quite happy with is the favorable decision on Section 1498, which sets us up for the case that we were sort of, quote unquote, hoping for in this, where almost all of the doses that we had asserted are going to be covered in this jury trial.

Speaker #3: So looking forward to that . And and obviously more to come there . Finally , just a really brief financial update on on slide 28 .

Speaker #3: You know , R&D expense of 165 , adjusted non-GAAP of 147 for the quarter , G&A of 175 , adjusted non-GAAP of 71 , for a total total non-GAAP net loss of 167 .

Matt Gline: Cash remains very strong, $4.5 billion of consolidated cash in the business, so plenty of capital to get us, you know, to profitability with dry powder to do other things as well. As a reminder, we still have share buyback authorization, and are happy to have that sort of capability. You know, on slide 30, as discussed, just a really catalyst-rich period ahead of us. A couple of these things checked off now. Obviously, the beginnings of the summary judgment also make progress, and just feeling good across the board with a lot more updates to come this year. It should be a big year for us. And a big few years on slide 31, before I go to Q&A.

Speaker #3: Cash remains very strong , $4.5 billion of of consolidated cash in the business . So plenty of capital to get us to profitability with dry powder to do well things as .

Speaker #3: reminder , As a other we still have share buyback authorization and are happy to that sort of happy to have capability . You know , on slide 30 .

Speaker #3: As , as discussed , just a really catalyst rich period ahead of us . A couple of these things checked off . Now , obviously , the beginnings of the summary judgment make also progress .

Speaker #3: And just feeling good across the board with a lot , a lot more updates to come this year . It should be a big year for us and a big few years on slide 31 , before I go to Q&A , you know , multiple commercial launches potential in the coming years .

Matt Gline: You know, multiple commercial launches potential in the coming years. Obviously, Breppo and DM would be first with that NDA now in. Multiple NDA and BLA filings, we continue to have even sort of more future POC study readouts, even among the ones we've already announced. And now nine or more pivotal study readouts, including cutaneous sarcoidosis, coming over this timeline, which is just a really exciting slate for us to build on. So with that, thank you again for listening. I'm gonna stop talking and open up the line for Q&A. Thank you, operator.

Speaker #3: Obviously . And DM would be first with that NDA now in multiple NDA and Bla filings . We continue to have even sort of more future POC study readouts , even among the ones we've already And now nine or more pivotal study readouts , including cutaneous sarcoidosis coming over this timeline , which is just a really exciting slate for us to build on .

Ben Zimmer: Thank you. As a reminder, to ask a question at this time, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster.

Operator: Thank you. As a reminder, to ask a question at this time, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster.

Speaker #3: So with that, thank you again for listening. I'm going to stop, stop talking and open up the line for Q&A.

Speaker #3: Thank you . Operator .

Speaker #1: Thank you . As a reminder to ask a question at this time , please press Star One on your telephone and wait for your name to be announced .

Speaker #1: To withdraw your question, please press star, one, one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Corinne Johnson with Goldman Sachs.

Operator: Our first question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is now open.

Corinne Jenkins: Good morning, guys, and thanks for the question. You know, I think you've mentioned today and previously that you'd consider further development expansion opportunities for brepocitinib, and I'm, I'm curious how these data kind of inform the direction you'd like to go. Maybe you could also help us kind of size the opportunity set, particularly with respect to, like, what person of the patient population you think are great candidates for this relative to NIU and dermatomyositis. Thanks.

Speaker #1: Your line is now open.

Speaker #5: Good morning , guys , and thanks for the question . You know , I think you've mentioned today and previously that you'd consider further development expansion opportunities for I'm curious them .

Speaker #5: how these data And can inform the direction you'd like to go . Maybe you could also help us kind of size the opportunity set , particularly with respect to person of the like what patient you think population are great candidates for this relative to NIU and dermatomyositis .

Matt Gline: Yeah, perfect, Corinne. Thanks. That's a great question. Look, I think, the first thing is we are absolutely enthusiastic about further development of brepo. We have other indications that Ben and the team are hard at work at. I don't... I think what I would say the main thing about this data is just that it continues to underscore how strong an agent brepo can be in these patient populations that need it and sort of drives enthusiasm, but I don't know that it reveals anything specific or new. Other than, you know, we're continuing to think about other forms of surrogates, et cetera. SCS is another indication where we will be the first and only drug approved, if we're successful, from here.

Speaker #5: Thanks .

Speaker #3: Yeah . Perfect . Corinne , thanks . That's a it's a great question . Look , I think the first thing is we are about further development absolutely we .

Speaker #3: And have other hard at are indications and the team that Ben work at . I don't I think the what I would say , the main thing about this data is just that it continues to underscore how strong an agent can be in these patient populations that need it , and sort of drives enthusiasm .

Speaker #3: But I don't know that it reveals anything specific or new other than we're continuing to think about, continuing to think about other forms of sarcoidosis, etc.

Matt Gline: And then on patient population, look, I think this is right in the sweet spot of what we've been trying to do, not just bluntly for brepo, but across the different drugs we're developing, where, you know, we're in this kinda large orphan market. And again, we might do things outside of this category, but it's been, it's been a really good space for us and for others with tens of thousands of patients, a big opportunity, high unmet need, and we think it'll be the kind of thing that we can tractably launch and that we can, that we can make a successful franchise around. So, so it feels great from an ability to benefit these patients' perspective and from a, from a commercial perspective as well. Ben, anything you'd add there?

Speaker #3: , as CS is another indication where we will be the first and only drug approved for successful from here . And then on patient population .

Speaker #3: Look , I think this is right in the sweet spot of what we've been trying to do , not just bluntly for , but different across the drugs were developing where , you know , we're in this kind of large orphan market .

Speaker #3: And again , things outside of this we might do category , but it's been it's been a really good space for us and for others with tens of thousands of patients , a big opportunity , high unmet need .

Speaker #3: And we think it will be the kind of thing that we can tractably launch and that we can, that we can feel successful and make a franchise great from, benefit these ability to patients from around.

Ben Zimmer: I would just add that, you know, I think, and this is something we've felt already, but this data really enforces that, of the alignment of TYK2/JAK1 inhibition to T cell polarization, both as we see here, predominantly Th1 driven, but also Th17 driven. And, you know, the mechanism of TYK2/JAK1 inhibition really does align to that through IL-12 and interferon gamma, for Th1, IL-6 and IL-23 for Th17. And I think, you know, that's really one of the mechanistic hypotheses around the distinctive benefits of TYK2/JAK1 inhibition. You know, others are obviously the type one interferon suppression that's very important in dermatomyositis, in addition to the T cell polarization.

Speaker #3: —perspective, and from a commercial perspective as well. Then, anything you'd add there?

Speaker #4: would just I that , you add know , I think and this is something we've felt already , but this data really enforces that of the alignment of Tyk2 jak1 inhibition to T cell polarization .

Speaker #4: Both as we see here , predominantly Th1 driven , but also Th17 driven . And , you know , the mechanism of Tyk2 jak1 inhibition really does align to that through IL , IL 12 and interferon gamma for th one , IL six and IL 23 for for Th17 .

Speaker #4: And I think you know, that's really one of the mechanistic hypotheses around the distinctive benefits of TYK2/JAK1. You know, others— inhibition.

Speaker #4: are You obviously the type one interferon suppression . That's very important in dermatomyositis . In addition to the T cell polarization . But really I kind of enforces highlight that this but that would NIU , has some overlapping mechanism as obviously well , where really we had strong phase two data , excited to see that phase three result .

Ben Zimmer: But I would kind of highlight that this data really enforces that NIU, you know, has some overlapping mechanism as well, where obviously we had really strong phase 2 data. Excited to see that phase 3 result. But I think just as we think about not just kind of the unmet need of indications as Matt articulated, but also diseases where TYK2/JAK1 inhibition is going to really be, in our view, potentially better than any other form of immunosuppression. I think this data, you know, kind of reinforces some of our hypotheses there.

Speaker #4: But I think we think just as about not just kind of the unmet need of indications , as is met articulated , but also diseases where Tyk2 jak1 inhibition is going really be , in our to view , a potentially better than than any other form of immunosuppression .

Corinne Jenkins: Yeah, thanks, and congrats on the data.

Speaker #4: I think this data kind of reinforces some of our hypotheses. There.

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Q3 2025 Roivant Sciences Ltd Earnings Call and Business Update

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Q3 2025 Roivant Sciences Ltd Earnings Call and Business Update

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