Q3 2025 Immunovant Inc Earnings Call

February 6, 2026

Operator: Good day, and thank you for standing by. Welcome to the Roivant Third Quarter 2025 Earnings Conference 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. 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. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

Speaker #2: Good day and thank you for standing by . Welcome to the revamped third Quarter 2021 Earnings Conference call . At this time , all participants are in a listen only mode .

Speaker #2: 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 #2: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one. Please be advised once again.

Stephanie Lee: Good morning, and thanks for joining today's call to review positive phase 2 results for brepocitinib and cutaneous sarcoidosis, and Roivant's financial results for Q3 ended 31 December 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 it 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 filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties.

Q3 2025 Immunovant Inc Earnings Call

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Q3 2025 Immunovant Inc Earnings Call

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

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Speaker #2: today's conference is that being recorded . I would now like conference to hand the over to your speaker Stephanie today , Lee . Please go ahead .

Speaker #3: Good morning, and thanks for joining today's call to review positive Phase 2 results for batoclimab in cutaneous sarcoidosis and Roivant's financial results for the third quarter ended December 31, 2025.

Speaker #3: I'm Stephanie Lee with presenting today , we have Macklin , CEO of Oregon , and Ben Zimmer , CEO of pregnant . For those dialing in via conference call , you can find the slides being today as well as the press release announcing these presented our IR website at WW .

Speaker #3: 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 .

Stephanie Lee: With that, I'll turn it over to Matt.

Speaker #3: We strongly encourage you to review the information that we filed with the SEC . For information more regarding these forward looking statements and related risks and uncertainties .

Matthew Gline: Thanks, Steph, and thanks everyone for dialing in and listening this morning. I'm going to start our presentation on slide 5. 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 had gotten 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 BREPO 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 #3: With that , I'll turn it over to Matt .

Speaker #4: Thanks , Jeff , and thanks , everyone for dialing in and listening this morning . I'm going to start our presentation on slide five .

Speaker #4: I was sitting talking It was to the team . about a week ago today looking draft of this at a morning's presentation and thinking that it was going to be a pretty boring 10-q .

Speaker #4: We'd gotten together in December for the Investor Day . We had had spoken to we JP Morgan and it turned conference , out to have been a really week .

Speaker #4: busy updates . some great Most Obviously . notably the phase So we have two data in repo and which CS , Ben is present on going to momentarily .

Matthew Gline: Obviously, that data is a highlight, but we also can announce today that the NDA for BREPO is in dermatomyositis, that the phase 2b study for 1402 in Graves' disease has fully enrolled, that the phase 2 study for Mosley and 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. On slide 6, 2026 is, again, a very busy year for us ahead. Obviously, some major events later in the year: the BREPO NIU phase 3 that the pivotal readout in the second half. We're now going to be starting this year a phase 3 study in BREPO in cutaneous sarcoidosis.

Speaker #4: Truth is, terrific execution and progress across the board for the quarter. Use this data. Obviously, that is a highlight, but we also can announce today that the NDA for Repo is in for dermatomyositis, and that the Phase 2 study for 1402 in DTRA has fully enrolled.

Speaker #4: That the phase two study for Mosley and Feld has fully enrolled and obviously all the updates that were known before , including the Immunovant offering earlier .

Speaker #4: That gets us financed to graves launch . Behind us . So just a terrific quarter and a terrific set of updates . Even early January , when we last got since together .

Speaker #4: You slide six , know , on 2026 is again , a very busy year for us ahead . Obviously , some major events later in the year .

Speaker #4: The NIU phase three , the pivotal readout in the second half , we're now be going to starting this A phase year . cutaneous sarcoidosis .

Matthew Gline: Ben will talk a little bit more about that. It's early days and getting that going, but that'll be this year. The phase 2b 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 Graves' disease 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. So a really, really busy year ahead for Roivant.

Speaker #4: we'll talk a Ben , little bit more about that . But it's early days and But that'll be this getting that going . year .

Speaker #4: The phase two B data for Moseley 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 DTG data where all of that , both the open label period and the randomized withdrawal period done will be by the second half of this year .

Speaker #4: We also are getting proof of concept 1402 , in data in CLL finally , we . are And still on track for the jury trial against Moderna starting on March 9th .

Matthew Gline: And really, if you look at slide 7 before we get, again, to the data for CS, just a pipeline we're really proud of that continues to deliver across multiple dimensions, with obviously BREPO with now 3 indications in pivotal registrational programs, multiple registrational programs for FcRn franchise, which we've talked about, and Mosley with top-line data coming in the second half. So 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 off to a good start. And with that, what I'm going to do is turn to the phase 2 data for BREPO and sarcoidosis. So I'm just really briefly on slide 9 of the presentation.

Speaker #4: So just just a few weeks away now . So a really , really busy year ahead for riven . And really , if you look at slide seven before we get again to the to the data for CS , just a pipeline , we're really proud of that continues to deliver across multiple dimensions with the with now three in pivotal Registrational programs , multiple registrational programs for FCR enfranchise , many of which we've talked about Mosley topline data with So in the second as a where we are business , really coming excited about half .

Speaker #4: really excited about the couldn't be for the more excited beginning of . I 2026 here . Certainly off start . And to a good with that , what I'm going to do is turn to the phase two data for for an sarcoidosis .

Matthew Gline: 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. And the short answer—and we keep saying this, it's a tremendous fortune, I think, to be able to say—but this drug has done everything we could have asked for it in this study. We had a statistically significant—remember, we had said before the bar for clinical success here we thought was sort of five points of CSAMI was clinically meaningful. We got a placebo-adjusted almost 22 points, 21.6-point delta with a p-value. And again, this study was not powered for efficacy in this endpoint. 100% of patients on BREPO 45, versus 14% on placebo, had a 10-point improvement. Again, clinically meaningful was five points. 100% of patients on our high dose had at least a 10-point improvement.

Speaker #4: I'm just really briefly So 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 .

Speaker #4: And detail . And the answer . And we keep saying this . It's a it's a tremendous fortune , I to be able to say , but this drug has done everything we could have asked for for us this or of it in this study .

Speaker #4: You know , we a got significant , statistically significant remember we had said before , the bar for clinical success here we thought was was sort of five points of system was clinically meaningful .

Speaker #4: You know , we got a placebo adjusted almost 22 points , 21 .6. delta with a p value . And study was not powered for efficacy in this .

Speaker #4: In this endpoint , 100% of patients on 45 , placebo only 14 on clinically had a pin point meaningful Again , was five points .

Matthew Gline: So 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. 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 #4: 100% of patients on our high dose had at least a ten point improvement . So , you know , just a outcome tremendous across the board .

Speaker #4: There's some great supportive data on some of the other endpoints as well, and safety and tolerability are consistent with what we've seen for the compound in the past.

Speaker #4: So 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 .

Speaker #4: So really a terrific day for those patients . So with that I'm going to hand it over to Ben to walk you through a little bit about sarcoidosis reminder .

Ben Zimmer: Great. Thanks so much. Great to be here with everyone. Starting on slide 10, I just wanted to bring back to what this disease is, walk through this at the Investor Day in December. But cutaneous sarcoidosis is a really debilitating skin disease. And among skin diseases, it 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 #4: And then, on to the study data as well. Ben, take it away.

Speaker #5: Thanks so Great . much . Great to be here with everyone . Starting ten . I on slide just wanted to , you know , bring back to what this disease is , walk through this at the Investor Day in December .

Speaker #5: 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 , as well tissue as its disfiguring nature .

Speaker #5: Given the particular prevalence on the face and scalp of the disease to . Turning to slide 11 , I would note that no there's approved therapies not only for cutaneous sarcoidosis , but for any form of sarcoidosis .

Ben Zimmer: 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, really just briefly here on the alignment between the pathobiology of the disease and the mechanism. I think this is important because, 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. I think in a small study, the data is very, very compelling.

Speaker #5: And so as we think about our development program in CS , really a great opportunity for us to meet this overall unmet need and become the therapy of choice .

Speaker #5: 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 to , you know , really be promising option for all patients with with skin involvement in their sarcoidosis .

Speaker #5: That would include patients both with only skin involvement, as well as those with other organ involvement, as well. Turning to slide 12.

Speaker #5: You know , really just briefly on here on the between the pathobiology of the disease and the mechanism . 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 great have have data here that we're very excited about .

Ben Zimmer: 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. BREPO really distinctively inhibits TH1-related pathways by hitting both IL-12 through TYK2 and interferon gamma through JAK1. Really an opportunity here mechanistically to see the benefits of JAK1 TYK2 inhibition specifically. I think that's really part of what's flowing through to our clinical data that 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. A 16-week study evaluated several different efficacy endpoints that I will walk through.

Speaker #5: And I think , you know , in a small study , you know , the data is very , very It's compelling . argue with on its own .

Speaker #5: But but it also really aligns with what you would expect to see given the mechanism of this drug , sarcoidosis or all of the forms of sarcoidosis , including cutaneous disease , are are driven by the polarization recruitment of effector T cells and particularly Th1 polarized cells and distinctively really inhibits Th1 related pathways by hitting both IL 12 through Tik two and interferon through Jak1 .

Speaker #5: So, so really, an opportunity here mechanistically to see the benefits of JAK1/2 inhibition specifically. And I think really that's flowing, that's part of what's coming through to our clinical data that I'll, I'll walk through now.

Speaker #5: Slide 13 . Study design . Very straightforward . 31 patients in the United States randomized three to two to 2 to 45mg , 15mg in placebo , 16 week study evaluated several different efficacy endpoints that I will walk through on the baseline demographics and disease activity .

Ben Zimmer: On the baseline demographics and disease activity, slide 14, I do want to highlight a few things. 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 would mean really a higher bar for both BREPO 45 and placebo. And then I would also call attention to the plaque-predominant morphology. 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 sort of the punchline of this is there were some imbalances.

Speaker #5: Slide 14 I do want to highlight a few things . First , if you look at the duration of disease background damage of and patients , 45mg and placebo , very well balanced between those two arms .

Speaker #5: But actually quite 15mg a bit lighter on duration of disease . And which damage , you would mean really a higher bar for both 45 and placebo .

Speaker #5: And then I would also call attention to the plaque predominant morphology . You know , cutaneous sarcoidosis can can present through both plaques papules .

Speaker #5: and In general , the are plaques viewed as more treatment resistant . And you see this plaque predominant . Morphology . Most , most pronounced and most common in 45mg arm , followed by 15mg , followed by placebo .

Ben Zimmer: Those imbalances actually made it harder for BREPO 45 milligrams to demonstrate efficacy, both compared to placebo and as compared to BREPO 15 milligrams. And in spite of that, as I'll 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 CSAMI activity score change from baseline. 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 two-point reduction. So as a reminder, the IGAs are a standard FDA-supported endpoint for cutaneous disease.

Speaker #5: So , you , sort of punch line of this is , you know , there imbalances . Those imbalances actually made it harder for 45mg to demonstrate efficacy , both as compared to placebo and as compared to 15mg .

Speaker #5: 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 means to Sammy activity score change from baseline .

Speaker #5: You know, both doses separate from placebo as early as week 1 for the first time point evaluated, and this is sustained at every visit out to week 16.

Speaker #5: At the end of the trial , and then on the right here , we see the achievement of a investigator's global assessment zero one and a two point reduction .

Speaker #5: 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 in used igas other skin indications , scores with from 0 to 4 clear , almost clear , mild , moderate and severe .

Ben Zimmer: 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 end at a 0 or 1 is a very high bar. And notably, it's a high enough bar that 0 placebo patients cleared it. So you may be confused: where's 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 stat-sig improvement at week 12 and 16. And then here on this higher bar endpoint, you do start to see BREPO 15 milligrams begin to—sorry, BREPO 45 milligrams begin to separate some from the 15 milligram dose arm. Slide 16 has the CSAMI responder data.

Speaker #5: So to both a two point reduction and end , a 0 or 1 is is a very high bar . And , you know , notably it's a it's a high enough bar that zero placebo patients cleared it .

Speaker #5: So you may be confused . Where's the placebo line . The placebo line in the x axis line are the same thing on this .

Speaker #5: Here is the chart again. You can see for both doses, there is really significant improvement in arms at week four, and substantial improvement at week eight.

Speaker #5: And then stat sig improvement at week 12 and 16 . And here on this higher bar end point you do start to see 15mg begin to sorry 45mg begin to separate some from the arm .

Ben Zimmer: 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 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. And then you see on the right-hand side of this chart, achievement of a CSAMI less than 5. Notably, there's 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.

Speaker #5: Slide 16 has the sasame responder data again really compelling data . I think this chart on the left quite as Matt remarkable alluded to , we were hoping to see a mean improvement of of five points .

Speaker #5: And what we saw was was not only a mean in that , excess of but saw we 100% of patients in the 45 milligram arm achieve that , twice twice the minimum clinically important difference .

Speaker #5: So , you know , really every 45 milligram patient , a responder in this trial and as I'll walk through momentarily that that's really corroborated by an independent patient reported outcome as well .

Speaker #5: And then you see right on the hand side of this chart, achievement of a SESAME less than five. Notably, this is not an improvement by less than five.

Speaker #5: This means that the absolute score by the end of the trial is less , five or is a standard for functional remission . And you see 62% of 45 milligram patients achieving that , to compared no placebo patients .

Ben Zimmer: You see 62% of BREPO 45mg patients achieving that compared to no placebo patients. So again, this data is quite in line with the IGA two-point improvement to 0/1 that I walked through before. 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, again, a pretty established standard metric in inflammatory skin disease trials. You see excellent data here with the placebo group worsening, BREPO 45mg and 15mg, both improving substantially, well above the minimum clinically important difference. Again, here with BREPO 45mg outperforming 15mg modestly, and both doses really far better than placebo. Slide 18, we have the KSQ skin domain. So this is the King's Sarcoidosis Questionnaire. It's a PRO for sarcoidosis overall, not just limited to skin disease.

Speaker #5: So so again , this data are quite in line with the IGA two point improvement to zero one that I walked through before .

Speaker #5: So so again seeing pretty consistent data here across multiple endpoints . Turning now to the patient reported outcomes . Slide 17 has the Skindex 16 .

Speaker #5: This a again a pretty established standard metric in inflammatory skin disease trials . You see excellent data here with the placebo group worsening 45mg 15mg .

Speaker #5: and improving substantially well minimum the clinically important above difference . Again here with 45mg outperforming 15 modestly and both doses really far better than than placebo .

Speaker #5: Slide 18 . We the csq skin domain . So this is the king sarcoidosis questionnaire . It's a pro for sarcoidosis . Overall not limited to just skin disease .

Ben Zimmer: What we focused on in our initial TLR was the skin-specific domains. 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. Finally, on the efficacy side, I alluded to this before, but on slide 19, we would call it the patient's global impression of change. 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? 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. Notably, 100% of BREPO 45 mg patients reported that they have improved, again, consistent with the CSAMI data where we saw a 100% response rate. So very compelling here.

Speaker #5: What we focused on in our initial TLR was the skin specific domains . you see here very in line with the Skindex . And in terms of in terms of the in terms of the data .

Speaker #5: So just yet another data point , a very compelling evidence of benefit and finally , on the efficacy side , I alluded to this before , but on slide 19 would call it the patients global of change .

Speaker #5: So this is single a question where patients are asked since they started taking the study medication , how would they describe the overall change in their sarcoidosis symptoms .

Speaker #5: And they can answer no change or some degree of improvement or some degree of worsening . think this I is a powerful endpoint for its simplicity and notably , 100% of 45 milligram patients they reported that improved again , consistent with the Sasame data , where we saw 100% response rate .

Ben Zimmer: BREPO 15mg, also very considerable improvement for most patients, although two patients in the BREPO 15mg group did not only did not report improvement, but actually reported worsening. Then in the placebo group, very little improvement. And most patients reported either worsening or no change. Turning to Slide 20, safety data. I think, very well, BREPO was very well tolerated during this study with no SAEs in the study and all adverse events were graded mild or moderate in severity. So again, the backdrop of this efficacy data in particular, certainly the safety data we see 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 #5: So, so very compelling here. Fifteen milligrams also showed very considerable improvement for most patients, although two patients in the 15 mg group did not.

Speaker #5: 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 .

Speaker #5: Turning to slide 20 . Safety data . You , you very very well was well know , I tolerated think know no say during in the this study .

Speaker #5: We had study . And all adverse events were graded mild or moderate in in severity . So , you know , against the backdrop of this efficacy data in particular , certainly , you safety know , data , we see would you know , would tee up a potentially very favorable benefit risk profile for for these patients .

Speaker #5: have Obviously we over 1500 patients of of data in Brepocitinib . And so the overall safety database is characterized by by much than than just these results .

Ben Zimmer: But certainly here, 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, really compelling evidence 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 BREPO 45mg arm, and a rapid onset of action sustained over time. So really exciting results. We're really excited to move this ahead to phase 3 and potentially have the first approved therapy for sarcoidosis.

Speaker #5: But you know , certainly here you know , nothing that would really add anything to what's already known about the drug . perspective .

Speaker #5: think , again , starting to dose it now in this patient particular population , I think early of a the the we signs very indication specific , benefit compelling risk profile .

Speaker #5: to very wrap up quickly before So just handing it back to Matt really , you know , compelling evidence of benefit . The effect sizes we see here extremely large .

Speaker #5: We see them very consistently across different multiple endpoints , including independent patient reported and physician reported assessments . Very high response rates , including the 100% response rate for the 45mg arm and a rapid onset of action sustained over time .

Speaker #5: So , you know , really exciting results . We're really excited to move this ahead to phase three . And potentially have the first approved therapy for for sarcoidosis .

Ben Zimmer: I look forward to discussing any questions later, and I'll hand it back to Matt.

Operator: Thanks, Ben. Yeah, look, we're just terrifically excited about this data, about what it means for us and what it means for these patients. On slide 22, just sort of as a reminder of what the picture for brepocitinib now looks like, people toss around the phrase pipeline and a product for a lot of different products. I feel at this point, looking across the indication set for BREPO, even with what we've talked about already with CS, DM, 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. And we continue to add legs of the stool or opportunities that grow into these sort of first-in-class orphan inflammatory diseases that are high unmet need, important areas. And I think we've got more to come there. So stay tuned.

Matthew Gline: Thanks, Ben. Yeah, look, we're just terrifically excited about this data, about what it means for us and what it means for these patients. On slide 22, just sort of as a reminder of what the picture for brepocitinib now looks like, people toss around the phrase pipeline and a product for a lot of different products. I feel at this point, looking across the indication set for BREPO, even with what we've talked about already with CS, DM, 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. And we continue to add legs of the stool or opportunities that grow into these sort of first-in-class orphan inflammatory diseases that are high unmet need, important areas. And I think we've got more to come there. So stay tuned.

Speaker #5: So I look forward to discussing any questions later . And I'll hand it back to Matt .

Speaker #4: Ben . Thanks , Yeah . we're Look , terrifically just excited about this data and about what it us means for and what it means patients .

Speaker #4: for these You know , on slide 22 , sort of as a reminder of what the Brepocitinib now picture for looks you like , know , people toss around pipeline in a product for a lot of different products .

Speaker #4: I feel at this point , looking across the indications set for Rhepo , even with what we've talked about already with Csdm and NIU , where we get to a very large addressable patient population , these are patients who every one of these indications lacks efficacious therapies and is in need options .

Speaker #4: And we of continue to add of the legs stool or opportunities that that grow into these sort of first in class orphan inflammatory diseases that , that are , that are , you know , high unmet need , important areas .

Operator: 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 going to breeze through a couple of other highlights or updates across the portfolio, a little quick financial update, and then we'll do Q&A at the end. Super quickly on slide 24, as a reminder, IMVT-1402 remains a huge focus for us at Immunovant. We think we've got an FcRn with potential best-in-class efficacy with a safety profile that looks favorable even within the class. Obviously, convenient administration with a subQ autoinjector. And we use the phrase again here, pipeline and product potential, again, with Graves' among our lead indications where we're expecting pivotal data in 2027. We're now, as I mentioned earlier, expecting the DGTRA data later this year. And that study is fully enrolled.

Matthew Gline: 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 going to breeze through a couple of other highlights or updates across the portfolio, a little quick financial update, and then we'll do Q&A at the end. Super quickly on slide 24, as a reminder, IMVT-1402 remains a huge focus for us at Immunovant. We think we've got an FcRn with potential best-in-class efficacy with a safety profile that looks favorable even within the class. Obviously, convenient administration with a subQ autoinjector. And we use the phrase again here, pipeline and product potential, again, with Graves' among our lead indications where we're expecting pivotal data in 2027. We're now, as I mentioned earlier, expecting the DGTRA data later this year. And that study is fully enrolled.

Speaker #4: And I think we've got we've got more to come there . So tuned . But stay but but just starting to feel like brepocitinib is a is a really important medicine for us .

Speaker #4: And hopefully for So looking patients . forward to continuing that that journey . I'm going to breeze through a couple of other highlights or updates across the do we'll do quick .

Speaker #4: real end . You Q&A at the know quickly on , super slide 24 . As a reminder , IBD 1402 remains a huge for focus us at Immunovant .

Speaker #4: think We 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 subcu autoinjector .

Speaker #4: And we pipeline and product potential again with Graves among our lead indications, where we're expecting pivotal data in 2027. We're now, as I mentioned earlier, expecting the DTRA data later this year.

Operator: We actually enrolled 170 patients in that study up from the anticipated 120 originally. That was in part just due to speed of enrollment and the level of enthusiasm from the patient and doc community. Moving over to Mosley on 25, and we'll definitely spend some time later this year talking more about PH-ILD and Mosley and setting the stage for what we expect there. But that study is fully enrolled with thanks to those patients, investigators, and to the Pulmovant team. PH-ILD remains an exciting opportunity for us where 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.

Matthew Gline: We actually enrolled 170 patients in that study up from the anticipated 120 originally. That was in part just due to speed of enrollment and the level of enthusiasm from the patient and doc community. Moving over to Mosley on 25, and we'll definitely spend some time later this year talking more about PH-ILD and Mosley and setting the stage for what we expect there. But that study is fully enrolled with thanks to those patients, investigators, and to the Pulmovant team. PH-ILD remains an exciting opportunity for us where 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.

Speaker #4: that And 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 moving over to Moseley 25 .

Speaker #4: And we'll definitely spend some time later this year talking more about the FELT stage for what setting, and we expect Moseley. But that study is fully enrolled, with thanks to those patients, investigators, and to the team. It remains an exciting opportunity for us.

Speaker #4: Where where targeted delivery gets at a lung is the disease , where 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 , where there aren't very many existing therapies .

Operator: And then, as I think you know, we showed really the best ever PVR reductions in the PAH population. And if that translates, we may be able to get some best-in-class efficacy as well. So 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, and as before, I'm not going to spend a ton of time talking about this today because we're so close in here, but the jury trial in the Moderna case is scheduled for 9 March. We continue to make progress there.

Matthew Gline: And then, as I think you know, we showed really the best ever PVR reductions in the PAH population. And if that translates, we may be able to get some best-in-class efficacy as well. So 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, and as before, I'm not going to spend a ton of time talking about this today because we're so close in here, but the jury trial in the Moderna case is scheduled for 9 March. We continue to make progress there.

Speaker #4: Bluntly , we expect or hope for tolerability benefits . And then , you know , as I think you know , we that showed 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 as well .

Speaker #4: So excited about about what we could do there later this year efficacy it'll be a really important part of our story in the coming months .

Speaker #4: And finally, then as before, I'm not going to spend a ton of time talking about this today because we're so close. But the, in here.

Operator: The sort of major update there in the recent weeks is that we got earlier this week the first of the summary judgment decisions, which covered a few things and had to put some takes generally in it. 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 hoping for in this trial where almost all of the doses that we had asserted are going to be covered in this jury trial. So looking forward to that and obviously more to come there. Finally, just a really brief financial update on slide 28. 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.

Matthew Gline: The sort of major update there in the recent weeks is that we got earlier this week the first of the summary judgment decisions, which covered a few things and had to put some takes generally in it. 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 hoping for in this trial where almost all of the doses that we had asserted are going to be covered in this jury trial. So looking forward to that and obviously more to come there. Finally, just a really brief financial update on slide 28. 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 #4: jury Moderna case trial in the is scheduled for March 9th . We continue to progress there . And the sort of make major update there in the recent weeks is that we got earlier this week .

Speaker #4: the We got first of the summary judgment decisions , which covered a few things , and had to put some takes generally . And 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 going to be covered in this jury trial .

Speaker #4: So looking forward to that . And , and obviously more to come there . Finally , just a really brief financial on update on slide 28 , you know , R&D expense of 165 , adjusted non-GAAP of 147 for the quarter , A of 175 , adjusted non-GAAP of 71 , for a total total non-GAAP net loss of 167 .

Operator: Cash remains very strong, $4.5 billion of consolidated cash in the business. So plenty of capital to get us 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. 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 should be a big year for us. And a big few years on slide 31 before I go to Q&A. Multiple commercial launches potential in the coming years. Obviously, BREPO and DM would be first with that NDA now in. Multiple NDA and BLA filings.

Matthew Gline: Cash remains very strong, $4.5 billion of consolidated cash in the business. So plenty of capital to get us 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. 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 should be a big year for us. And a big few years on slide 31 before I go to Q&A. Multiple commercial launches potential in the coming years. Obviously, BREPO and DM would be first with that NDA now in. Multiple NDA and BLA filings.

Speaker #4: Cash remains very strong . $4.5 billion of 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 .

Speaker #4: As a reminder , we still have share and buyback authorization happy to happy to are have that sort of capability . You know , on slide 30 .

Speaker #4: As , as discussed really catalyst , , just a rich period ahead of us . A couple of these things checked off . Now , obviously , at the beginnings of the summary judgment , also make progress .

Speaker #4: And just good across the board with a lot , a lot more updates to come this year , should be a big year for us and a big few years on slide 31 , before I go to Q and a multiple commercial launches potential in the coming years is obviously and DM would be with that NDA .

Operator: We continue to have either sort of more future POC study readouts, even among the ones we've already announced, and now 9 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 going to stop talking and open up the line for Q&A. Thank you, operator.

Matthew Gline: We continue to have either sort of more future POC study readouts, even among the ones we've already announced, and now 9 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 going to stop talking and open up the line for Q&A. Thank you, operator.

Speaker #4: Now in first multiple NDA and Bla filings , we continue to have sort of even more future POC study readouts . Even among the ones we've already announced .

Speaker #4: 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 .

Stephanie Lee: Thank you. As a reminder, to ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is now open.

Operator: Thank you. As a reminder, to ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is now open.

Speaker #4: So with that , thank you again for listening . I'm going to stop talking and , stop open up the line for Q&A .

Speaker #4: Thank you . Operator .

Speaker #2: Thank you. As a reminder, to ask a question at this time, please press one on your telephone and wait for your name to be announced.

Speaker #2: To withdraw your question , please press star one again . one Please stand by while we compile the Q&A roster . Our first question comes from the line of Corinne Johnson with Goldman Sachs .

Matthew Gline: Good morning, guys, and thanks for the question. I think you've mentioned today and previously that you consider further development expansion opportunities for brepocitinib. 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 what portion of the patient population you think are great candidates for this relative to NIU and dermatomyositis. Thanks.

Corinne Jenkins: Good morning, guys, and thanks for the question. I think you've mentioned today and previously that you consider further development expansion opportunities for brepocitinib. 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 what portion of the patient population you think are great candidates for this relative to NIU and dermatomyositis. Thanks.

Speaker #2: Your line is now open.

Speaker #6: 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 them .

Speaker #6: And I'm curious how these data can inform the direction you'd like to go . Maybe you could us kind of also help size the opportunity set , particularly with respect to like what portion of the patient population you think are great candidates for this relative to NIU and dermatomyositis .

Ben Zimmer: Yeah, perfect, Corinne. Thanks. It'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. But 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 we're continuing to think about continuing to think about other forms of sarcoidosis, etc. CS is another indication where we will be the first and only drug approved if we're successful from here.

Matthew Gline: Yeah, perfect, Corinne. Thanks. It'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. But 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 we're continuing to think about continuing to think about other forms of sarcoidosis, etc. CS is another indication where we will be the first and only drug approved if we're successful from here.

Speaker #6: Thanks .

Speaker #4: Perfect . Yeah . Corinne . Thanks . That's a it's a great question . Look , I think the first thing is we absolutely development .

Speaker #4: about further enthusiastic And are we have are and the team other that Ben hard at 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 enthusiasm .

Speaker #4: But I don't know that it reveals anything specific or new other than, you know, we're continuing to think about continuing to think about other forms of sarcoidosis, etc.

Ben Zimmer: 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 we're in this kind of large orphan market. And again, we might do things outside of this category, but 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 make a successful franchise around. So it feels great from an ability to benefit these patients' perspective and from a commercial company perspective as well. Ben, anything you'd add there?

Corinne Jenkins: 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 we're in this kind of large orphan market. And again, we might do things outside of this category, but 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 make a successful franchise around. So it feels great from an ability to benefit these patients' perspective and from a commercial company perspective as well. Ben, anything you'd add there?

Speaker #4: , 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 #4: Look , I think this is right in the sweet spot of what we've been trying to do , not just bluntly for , but across the different drugs were developing know , we're in where , you kind of large orphan market .

Speaker #4: And again , we might do things outside of this category , but it's been it's really good been a space for us and for others with tens of thousands of patients , a big opportunity , high unmet need .

Speaker #4: And we think it'll be the kind of thing that we can tractably launch and that we can that we can make a it feels great from an successful benefit these patients ability to perspective and from a commercial from a .

[Company Representative] (Priovant): I would just add that 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 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 that's really one of the mechanistic hypotheses around the distinctive benefits of TYK2 JAK1 inhibition. Others are obviously the type 1 interferon suppression that's very important in dermatomyositis in addition to the T-cell polarization. But I would kind of highlight that this data really enforces that. NIU has some overlapping mechanism as well where obviously we had really strong phase 2 data. Excited to see that phase 3 result.

Ben Zimmer: I would just add that 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 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 that's really one of the mechanistic hypotheses around the distinctive benefits of TYK2 JAK1 inhibition. Others are obviously the type 1 interferon suppression that's very important in dermatomyositis in addition to the T-cell polarization. But I would kind of highlight that this data really enforces that. NIU has some overlapping mechanism as well where obviously we had really strong phase 2 data. Excited to see that phase 3 result.

Speaker #4: Then So add there .

Speaker #5: I would just add—I think, and this is something we've felt already—the data really enforces that, of the alignment of TYK2/JAK1 inhibition to T-cell polarization.

Speaker #5: 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 Th1 , IL six and 23 IL for Th17 .

Speaker #5: And I know, thank you, that's really one of the mechanistic hypotheses around the distinctive benefits of TYK2 JAK1 inhibition. You know, others are obviously the type 1 interferon suppression.

Speaker #5: very That's important in dermatomyositis . In addition to the T cell polarization . data really that highlight I would kind of enforces but NIU , you know , has some overlapping mechanism as well , where obviously we had really strong phase two data , excited to see that phase three result .

[Company Representative] (Priovant): 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 kind of reinforces some of our hypotheses there.

Ben Zimmer: 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 kind of reinforces some of our hypotheses there.

Speaker #5: just as we think about not the just kind of unmet need of indications as is articulated , but also diseases where Tyk2 jak1 inhibition is going to really be , in our view , a potentially better than than any other form of immunosuppression .

Matthew Gline: Thanks. Thanks for congrats on the data.

Corinne Jenkins: Thanks. Thanks for congrats on the data.

Speaker #5: I think this data kind of reinforces some of our hypotheses. There.

Ben Zimmer: Thanks, Corinne.

Stephanie Lee: Thank you. Our next question comes from the line of David Risinger with Leerink Partners. Your line is now open.

Speaker #6: congrats Thanks and on the data .

Speaker #4: Thanks .

Speaker #2: Thank you. Our next question comes from the line of David Risinger with Leerink Partners. Your line is now open.

[Analyst] (Leerink Partners): Thanks very much. And let me add my congrats as well, Matt and team. So obviously, the data was phenomenal. I had a couple of questions. First, with respect to the headline CSAMI numbers, they were similar between the two arms. The press release obviously mentioned different baseline characteristics. Could you just add a little more color on that? Second, with respect to the FDA timeline, obviously, Octagam is approved for dermatomyositis. But is there a chance for the FDA to elect to grant priority review? Could you talk about that a little bit? Thanks so much. In DM, I'm talking about. Thank you.

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Q3 2025 Immunovant Inc Earnings Call

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Q3 2025 Immunovant Inc Earnings Call

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