Immunovant Q3 2025 Immunovant Inc Earnings Call | AllMind AI Earnings | AllMind AI
Q3 2025 Immunovant Inc Earnings Call
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 .
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 . franchise around perspective as anything you'd well .
[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.
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.
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.
Anthea Li: 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.
Speaker #7: Thanks very much. And let me add my thanks as well, Matt. And congrats, team. So, obviously, the data was phenomenal. I have a couple of questions.
Speaker #7: had First , with respect to the headline numbers , they were similar between the two arms . The press release obviously mentioned baseline different characteristics .
Speaker #7: 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 priority grant review ?
Ben Zimmer: Yeah, yeah. Sure. Thanks, Dave. Those are both great questions. On the CSAMI report, I think Ben hit on this well in his presentation as well. Look, I think if you look at the table, I can pull up the slides now in a second. But if you look at the table in the presentation on baseline characteristics, I'd say there are some relatively small. This is a small proof of concept study. It's a relatively small one in each arm. And so you can see some relatively significant differences on some aspects, including duration of disease as well as morphology of disease with more plaque-predominant patients, which are those more recalcitrant patients on our 45 arm than on our 15 arm. And I think that's probably in part what's responsible for the sort of headline numbers looking similar.
Matthew Gline: Yeah, yeah. Sure. Thanks, Dave. Those are both great questions. On the CSAMI report, I think Ben hit on this well in his presentation as well. Look, I think if you look at the table, I can pull up the slides now in a second. But if you look at the table in the presentation on baseline characteristics, I'd say there are some relatively small. This is a small proof of concept study. It's a relatively small one in each arm. And so you can see some relatively significant differences on some aspects, including duration of disease as well as morphology of disease with more plaque-predominant patients, which are those more recalcitrant patients on our 45 arm than on our 15 arm. And I think that's probably in part what's responsible for the sort of headline numbers looking similar.
Speaker #7: Could you talk about that a little Thanks so bit ? much . In DM , I'm talking about thank you .
Speaker #8: Yeah , sure .
Speaker #4: Thanks , Dave . Those are both great questions . You know the point . I think Ben hit on this well in his presentation as well .
Speaker #4: You know look I think if you look at the at the table , if I can pull up a second , but if you look at the table in the presentation on baseline characteristics , you know , I'd say there are some relatively small .
Speaker #4: of concept a small proof This is relatively small in each studies , a arm . And you so can see some relatively significant differences on some aspects , including , you duration of of disease as well as morphology of disease with more plaque predominant patients , which are those more recalcitrant patients our on on our 45 arm than on our 15 arm .
Ben Zimmer: You can see that they separate more, again, as Ben hit pretty well in the presentation, on the more stringent endpoints like the proportion of patients hitting a 10 or more point CSAMI benefit. So we feel pretty good about that translating into phase 3. And then on the FDA timeline, look, I think the answer to that question is DM is a severe disease with not a lot of options. And so there's certainly a chance, but that ultimately is up to FDA.
Matthew Gline: You can see that they separate more, again, as Ben hit pretty well in the presentation, on the more stringent endpoints like the proportion of patients hitting a 10 or more point CSAMI benefit. So we feel pretty good about that translating into phase 3. And then on the FDA timeline, look, I think the answer to that question is DM is a severe disease with not a lot of options. And so there's certainly a chance, but that ultimately is up to FDA.
Speaker #4: And I think that's probably in part what's responsible for the sort of headline numbers looking similar . And you can see that they separate more .
Speaker #4: Again , as Ben hit pretty well on the presentation on the on , the more stringent endpoints , like the proportion of patients hitting a ten or more point benefit .
Speaker #4: So we feel pretty good about that translating into into phase three . FDA And timeline , look , I think the answer to that question is DM is a severe disease with not a lot of options .
[Company Representative] (Priovant): Thank you.
Anthea Li: Thank you.
Ben Zimmer: Thanks, Dave.
Matthew Gline: Thanks, Dave.
Speaker #4: And so there's certainly a chance. But that ultimately is up to the FDA.
Stephanie Lee: Our next question comes from the line of Yaron Werber with TD Cowen. Your line is now open.
Operator: Our next question comes from the line of Yaron Werber with TD Cowen. Your line is now open.
Speaker #8: Thank you. Thanks, Dave.
[Analyst] (TD Cowen): Great. Thanks so much and congrats. Really nice to see this data. I got a couple of questions. One is price. The IVIG is around $180, but the concomitant total price for Vyvgart for these indications is around $870 gross. So maybe help us understand how you're thinking about pricing of BREPO. And then secondly, as you and I know this might be a little premature, but Pfizer owns 25% of the JV. You'll obviously consolidate all sales of BREPO. How do we handle their 25% ownership? Because you're not going to be paying a dividend, but I imagine you'll have to sort of give them their 25% of the profits. Where is that going to hit the P&L? Thank you.
Yaron Werber: Great. Thanks so much and congrats. Really nice to see this data. I got a couple of questions. One is price. The IVIG is around $180, but the concomitant total price for Vyvgart for these indications is around $870 gross. So maybe help us understand how you're thinking about pricing of BREPO. And then secondly, as you and I know this might be a little premature, but Pfizer owns 25% of the JV. You'll obviously consolidate all sales of BREPO. How do we handle their 25% ownership? Because you're not going to be paying a dividend, but I imagine you'll have to sort of give them their 25% of the profits. Where is that going to hit the P&L? Thank you.
Speaker #2: Our next question comes from the line of Yaron with Werber Cowan . Your now open TD line is .
Speaker #9: much . Thanks so congrats Great . And Really really nice to see this data . I a couple got of questions . One is price .
Speaker #9: The IVIg is around 180 . But concomitant total price for the Vyvgart for these indications around 870 gross . So maybe help us understand how you're thinking about pricing of and then secondly , as know this might be a little you and I premature , but from Pfizer owns 25% of the JV .
Speaker #9: Obviously, you'll consolidate all sales of Bravo. How do we handle their 25% ownership? Because you're not going to be paying a dividend.
Speaker #9: But I imagine you'll have to you know , sort of , give them their 25% of the of the profits . What is that going to hit the PNL ?
Ben Zimmer: Yeah. Thanks, Yaron. Those are both good questions. Look, I think on price, we obviously have not decided on a price yet. It's too early to have an answer to that question. What we've said before is taking bookends that are not so different from the ones you quoted there. I think our view is IVIG is probably a little bit more expensive than that in practice. That those bookends are a reasonable place to think about in terms of the pricing envelope for these indications is what we've said before. And I think that continues to stand. And I think it gives us a lot of room. So I think stay tuned, but this will be an orphan price drug. And then on what I think is really sort of an accounting math question. So we'll fully consolidate all of the results, losses, sales, everything.
Matthew Gline: Yeah. Thanks, Yaron. Those are both good questions. Look, I think on price, we obviously have not decided on a price yet. It's too early to have an answer to that question. What we've said before is taking bookends that are not so different from the ones you quoted there. I think our view is IVIG is probably a little bit more expensive than that in practice. That those bookends are a reasonable place to think about in terms of the pricing envelope for these indications is what we've said before. And I think that continues to stand. And I think it gives us a lot of room. So I think stay tuned, but this will be an orphan price drug. And then on what I think is really sort of an accounting math question. So we'll fully consolidate all of the results, losses, sales, everything.
Speaker #9: Thank you .
Speaker #4: Yeah . Thanks , those are both Look , I questions . think on price , we obviously have not decided on a It's price yet .
Speaker #4: To have an answer to that before we've said the question is what we're taking—that are not so—from the ones you quoted there.
Speaker #4: I bookings view is IVIg is think our probably a little bit more expensive in practice , that we , those bookends , are a reasonable think place to about in terms of the envelope for pricing these indications is what and I think we've said before , that continues to stand .
Speaker #4: I think it gives us a lot a lot of room . So , you know , I think stay tuned . But this will be a this will be an orphan price drug .
Speaker #4: Then , you know , on the what I think is really sort of an accounting math question . So we'll fully consolidate all of the results , losses , sales , everything .
Ben Zimmer: And then there'll be a below-the-line minority interest that attributes the portion of Pfizer's earnings. But again, it'll be below the net income line. And then in terms of how cash comes out, obviously, if we distribute cash out, Pfizer will get their portion of that cash, and we'll get our portion of that cash. The only other comment I'll make there is, and we said this elsewhere, the early portion of the relationship with Pfizer had dilution protection for their ownership sake. That's been exhausted now. And so for any further capital into Priovant, Pfizer will either need to match their portion of our spend or will be diluted and we'll wind up owning more.
Matthew Gline: And then there'll be a below-the-line minority interest that attributes the portion of Pfizer's earnings. But again, it'll be below the net income line. And then in terms of how cash comes out, obviously, if we distribute cash out, Pfizer will get their portion of that cash, and we'll get our portion of that cash. The only other comment I'll make there is, and we said this elsewhere, the early portion of the relationship with Pfizer had dilution protection for their ownership sake. That's been exhausted now. And so for any further capital into Priovant, Pfizer will either need to match their portion of our spend or will be diluted and we'll wind up owning more.
Speaker #4: And then there will be a line for minority interest that attributes the portion of Pfizer's earnings. But again, it'll be below the net income line.
Speaker #4: Then, in terms of how cash comes out, obviously if we distribute cash out, Pfizer will get their portion of that cash and we'll get our portion of that cash.
Speaker #4: The only comment I'll make there is this, and we've said it elsewhere: the early portion of the relationship with Pfizer had dilution protection for their ownership stake.
Speaker #4: That that's been exhausted now . And any further so for enterprise and Pfizer , Pfizer will either need to match their match , their portion of our spend or will be diluted , and we'll wind up owning more .
Stephanie Lee: Thanks, Jeroen.
Matthew Gline: Thanks, Jeroen.
Ben Zimmer: Thank you.
Yaron Werber: Thank you.
Stephanie Lee: Our next question comes from the line of Brian Cheng with J.P. Morgan. Your line is now open.
Operator: Our next question comes from the line of Brian Cheng with J.P. Morgan. Your line is now open.
Speaker #8: Thank you .
[Analyst] (J.P. Morgan): Hi, Matt, and then congrats on the data here. 2 questions from us. As we think about the phase three, what's your latest thinking about the size and the dose that you have picked? And just curious if you have any thoughts about how we should think about the stability of efficacy going from a phase two to phase three for this indication. It seems that you have a pretty large gap going from 22 to the 5-point delta that seems clinically meaningful. How should we think about deterioration? And I have one quick follow-up as a housekeeping question. Thank you.
Brian Cheng: Hi, Matt, and then congrats on the data here. 2 questions from us. As we think about the phase three, what's your latest thinking about the size and the dose that you have picked? And just curious if you have any thoughts about how we should think about the stability of efficacy going from a phase two to phase three for this indication. It seems that you have a pretty large gap going from 22 to the 5-point delta that seems clinically meaningful. How should we think about deterioration? And I have one quick follow-up as a housekeeping question. Thank you.
Speaker #2: Our next question comes from the line of Brian Chang with J.P. Morgan . Your line is now open .
Speaker #10: Hi, Matt. And then congrats on the data here. Two questions from us as we think about the phase three. What's your thinking about the size latest, and the dose you have picked for that?
Speaker #10: And just curious if you have any thoughts about how we should think about the stability of efficacy going from a phase two to phase three for this indication , it seems that , you know , you have a pretty large gap , you know , going from 22 to the five point delta .
Speaker #10: That seems clinically, should be meaningful. How do we think about deterioration? And I have one quick follow-up, as a housekeeping question.
Ben Zimmer: Yeah, thanks, Brian. Look, I'm mostly going to hand over to Ben for these questions, but I'll just say it feels like we've got a fair amount of cushion in the quality of this data. And also, A, this was a relatively small study. There aren't a lot of other studies to go on in CS, so we kind of got to take our guidance from here. But it was nice to see a robust response. Ben, you want to talk a little bit about that and about whatever we can share at this point on phase 3 design?
Matthew Gline: Yeah, thanks, Brian. Look, I'm mostly going to hand over to Ben for these questions, but I'll just say it feels like we've got a fair amount of cushion in the quality of this data. And also, A, this was a relatively small study. There aren't a lot of other studies to go on in CS, so we kind of got to take our guidance from here. But it was nice to see a robust response. Ben, you want to talk a little bit about that and about whatever we can share at this point on phase 3 design?
Speaker #10: Thank you .
Speaker #4: Yeah , thanks . Thanks , Brian . Look , I'm mostly going to hand over to these Ben for questions , but I'll just say like we've got a fair amount of cushion in the quality of this data .
Speaker #4: And also , you know , a this was a relatively small study . There aren't a lot of other studies to go on in , in , in CS .
Speaker #4: So we kind of got to , got to take our guidance from here . But but it was nice to see a placebo response .
[Company Representative] (Priovant): Yeah, sure. I mean, first, just on erosion, obviously, it would be hard to do any better than this. But I think that the minimum clinically important difference, as we've discussed, is 5 points. Here we have over 20 points. We could have significant erosion and still have a very compelling dataset and a very compelling product profile for patients and physicians. That said, I would also note this was a US-only study, but 15 sites for the 31 patients. So this was a multi-center, multi-dose, placebo-controlled trial, very rigorous for a smaller proof of concept study. So while I think that there's always some risk of erosion, in particular, while the very low placebo rate is consistent with natural disease course, you can never be sure of the behavior of placebo in these inflammatory disease trials, particularly when you move to larger global trials.
Ben Zimmer: Yeah, sure. I mean, first, just on erosion, obviously, it would be hard to do any better than this. But I think that the minimum clinically important difference, as we've discussed, is 5 points. Here we have over 20 points. We could have significant erosion and still have a very compelling dataset and a very compelling product profile for patients and physicians. That said, I would also note this was a US-only study, but 15 sites for the 31 patients. So this was a multi-center, multi-dose, placebo-controlled trial, very rigorous for a smaller proof of concept study. So while I think that there's always some risk of erosion, in particular, while the very low placebo rate is consistent with natural disease course, you can never be sure of the behavior of placebo in these inflammatory disease trials, particularly when you move to larger global trials.
Speaker #4: Ben , you want to talk a little bit about that and about whatever whatever we can share at this point on phase three design .
Speaker #5: Yeah , sure . I mean , first , just on on erosion , you know , obviously it would be it would be hard to do any better , any better than this .
Speaker #5: But I think that , you know , the minimum clinically difference as we've discussed is five points here . We have over 20 points .
Speaker #5: We could have significant erosion and still have a very compelling data set and a very compelling product for profile for patients and physicians .
Speaker #5: that said , You know , I would also note this was a it was a US only study , but , you know , 15 , 15 sites for the 31 patients .
Speaker #5: So , you know , this was a multicenter , multi-dose , placebo controlled trial , very rigorous for a , you know , for a smaller proof of concept study .
Speaker #5: So I think that there's , you know , there's always , you know , some risk of of erosion in particular , while the very low placebo rate is consistent with natural disease course , you know , you can never be sure of the behavior of placebo in these inflammatory disease trials , particularly when you move to larger global trials .
[Company Representative] (Priovant): But broadly speaking, I think this data gives us an incredible cushion to still have an effect size in phase 3 that maybe is as large or maybe is not quite as large, but still would be extremely compelling. As far as the design of the phase 3, in terms of size, I think we would probably be looking at sort of similar size per arms to the DM trial, roughly. But we need to kind of take this data into consideration and think more about the powering and have final discussions with FDA on it, including as related to the indication safety set that they would want to see to support approval. So we'll have more to share on that after we engage with FDA. And the same is true on dose.
Ben Zimmer: But broadly speaking, I think this data gives us an incredible cushion to still have an effect size in phase 3 that maybe is as large or maybe is not quite as large, but still would be extremely compelling. As far as the design of the phase 3, in terms of size, I think we would probably be looking at sort of similar size per arms to the DM trial, roughly. But we need to kind of take this data into consideration and think more about the powering and have final discussions with FDA on it, including as related to the indication safety set that they would want to see to support approval. So we'll have more to share on that after we engage with FDA. And the same is true on dose.
Speaker #5: But , you know , broadly speaking , I think , you know , this this gives data us an incredible cushion to to still have , you know , an effect size in phase three that is as maybe large or quite as is not large , but still maybe be compelling as far as design phase three in terms the of in terms of of the size , you know , I think we would probably be at looking , you know , at sort of similar size per arms you to , know , the DM trial roughly .
Speaker #5: But we need to , you know , kind of take , take this data into consideration and think more about the powering . And , you know , have final discussions with FDA on it , including as related to the the in indication safety set that they would want to see to support So we'll have approval .
Speaker #5: more to share on that after we engage with FDA . And you know , the same is true on on dose . You know , I would say that , you know , I think our incoming hypothesis to to this trial is that you know , 45mg , is based on the the of 1500 patient data .
[Company Representative] (Priovant): I would say that I think our incoming hypothesis to this trial is that 45 milligrams, based on the totality of the 1,500 patient data we have, is a very compelling potential option for these patients, balancing benefit and risk. And certainly, I would say in totality, this data reinforces that. You see really excellent efficacy results from the 45 milligram arm, including on some of these higher bar, more stringent endpoints, starting to see real separation with 15 milligrams. And then certainly, in terms of the safety data, nothing that would suggest the overall safety profile of 45 milligrams that we've seen across all of the different indications in which it's been studied, that nothing in this data to suggest there's anything specific to cutaneous sarcoidosis separate from those. So I think, broadly speaking, I would say we're very excited about 45 milligrams coming into the study.
Ben Zimmer: I would say that I think our incoming hypothesis to this trial is that 45 milligrams, based on the totality of the 1,500 patient data we have, is a very compelling potential option for these patients, balancing benefit and risk. And certainly, I would say in totality, this data reinforces that. You see really excellent efficacy results from the 45 milligram arm, including on some of these higher bar, more stringent endpoints, starting to see real separation with 15 milligrams. And then certainly, in terms of the safety data, nothing that would suggest the overall safety profile of 45 milligrams that we've seen across all of the different indications in which it's been studied, that nothing in this data to suggest there's anything specific to cutaneous sarcoidosis separate from those. So I think, broadly speaking, I would say we're very excited about 45 milligrams coming into the study.
Speaker #5: totality We have . You know , a very compelling potential option for for these patients , balancing benefit and risk . And would say in certainly , I totality , this data reinforces that , you see , know , really excellent efficacy results from the 45 milligram arm , including on some you these higher bar , more stringent endpoints starting to see real separation And then with 15mg .
Speaker #5: certainly in terms of the in terms of safety data , nothing that would suggest the the overall safety profile of 45mg that we've seen across all of the different indications in which it's studied been that , you know , nothing in this data to suggest there's anything specific to cutaneous sarcoidosis separate from those .
[Company Representative] (Priovant): We're even more excited about it coming out of the study. 15mg also performed very well, and that's great to see. It really just speaks to the overall efficacy potential of the product. And so we'll kind of have a final update on that after we engage with the agency.
Ben Zimmer: We're even more excited about it coming out of the study. 15mg also performed very well, and that's great to see. It really just speaks to the overall efficacy potential of the product. And so we'll kind of have a final update on that after we engage with the agency.
Speaker #5: So I think , you know , broadly speaking , I we're very excited would say about study 45mg coming into the even more it coming excited about study .
Speaker #5: 15 mg also performed very well, and that's great to see. It really just speaks to the overall efficacy potential of the product.
[Analyst] (J.P. Morgan): Got it. Thanks, Ben. And maybe just one quick one on the housekeeping side. So looking at the 10-Q from Immunovant, can you give us a little bit more color on the return for certain rights around batoclimab, HanAll? Is there any read-through to how we should think about the setup for the TED data readout later this year? Thank you.
Brian Cheng: Got it. Thanks, Ben. And maybe just one quick one on the housekeeping side. So looking at the 10-Q from Immunovant, can you give us a little bit more color on the return for certain rights around batoclimab, HanAll? Is there any read-through to how we should think about the setup for the TED data readout later this year? Thank you.
Speaker #5: And so we'll kind of have a final update on that after we engage the agency with it.
Speaker #10: Thanks , Got it . Ben . And maybe just one quick one on the housekeeping side . So looking at the 10-q from Immunovant , can you give us a little bit more color on the return for certain rights around pertuzumab back to normal any ?
Ben Zimmer: No, it was the short answer to that question. Meaning, there's no read-through or anything. It's just as we get closer to that data, depending on what we decide to do with batoclimab and if we decide to further develop it, we'll have to make a decision around how to work together with NHAL on next steps there. So that's really it. Nothing to say.
Matthew Gline: No, it was the short answer to that question. Meaning, there's no read-through or anything. It's just as we get closer to that data, depending on what we decide to do with batoclimab and if we decide to further develop it, we'll have to make a decision around how to work together with NHAL on next steps there. So that's really it. Nothing to say.
Speaker #10: read Is through to there how we should think about the test setup for the data readout later this year ? Thank you .
Speaker #4: No . The short answer to that , meaning no . Read through anything . It's you know , as we get closer to that data , depending on what we decide to do Mab , if we decide to further with have to make a decision around how to how to work together with all the there .
[Analyst] (J.P. Morgan): Great. Thank you, Matt.
Brian Cheng: Great. Thank you, Matt.
Ben Zimmer: Thanks, Brian.
Ben Zimmer: Thanks, Brian.
Stephanie Lee: Our next question comes from the line of Dennis Ding with Jefferies. Your line is now open.
Operator: Our next question comes from the line of Dennis Ding with Jefferies. Your line is now open.
Speaker #4: next steps it . Nothing , So that's really nothing , nothing to say .
Speaker #10: Thank you, great, Matt.
Speaker #8: Thanks , Brian .
Matthew Gline: Good morning. This is Anthea on for Dennis. Thanks for taking our questions and congratulations on the data. I wanted to ask two questions on upcoming catalysts. First, on Daubert, can you explain how important Dr. Mitchell's testimony is to the case in proving direct infringement and whether or not there's any risk to that being taken out, so to speak, ahead of trial? And then on PH-ILD, thoughts on the competitive landscape and if sotatercept could work in the disease as well? Thank you.
Anthea Li: Good morning. This is Anthea on for Dennis. Thanks for taking our questions and congratulations on the data. I wanted to ask two questions on upcoming catalysts. First, on Daubert, can you explain how important Dr. Mitchell's testimony is to the case in proving direct infringement and whether or not there's any risk to that being taken out, so to speak, ahead of trial? And then on PH-ILD, thoughts on the competitive landscape and if sotatercept could work in the disease as well? Thank you.
Speaker #2: Our next question comes from the line of Dennis Ding with Jefferies. Your line is open.
Speaker #6: Good morning .
Speaker #11: Anthea On This is for Dennis . Thanks for taking our questions . And congratulations on the data . I wanted to ask two questions on upcoming catalysts .
Speaker #11: First , on Daubert . Can you explain how important Doctor Mitchell's testimony is to the case in proving direct and whether or not there's any risk to that being taken out ?
Speaker #11: speak , ahead of trial So to ? And then on filled thoughts on the competitive landscape and if so , could work in the disease as well .
Ben Zimmer: Thanks. Both great questions. Look, on Daubert, as we said, we really can't talk too much about an ongoing litigation. There are a variety of Daubert motions in front of the court. What they are are visible, and the judge will make a decision on all of them. And anything within the range is possible. Obviously, we're hoping for favorable test outcomes in each case. On the PH-ILD question, look, I think the answer is, in theory, any drug that improves PVR could work in PH-ILD. Systemic vasodilation has not in and of itself been a great approach in PH-ILD, but sotatercept certainly could work in PH-ILD. Right now, we are slated, I believe, to be the first non-prostacyclin, non-prostacyclin in PH-ILD. I suspect, given the amount of unmet patient need, there will be others behind us.
Matthew Gline: Thanks. Both great questions. Look, on Daubert, as we said, we really can't talk too much about an ongoing litigation. There are a variety of Daubert motions in front of the court. What they are are visible, and the judge will make a decision on all of them. And anything within the range is possible. Obviously, we're hoping for favorable test outcomes in each case. On the PH-ILD question, look, I think the answer is, in theory, any drug that improves PVR could work in PH-ILD. Systemic vasodilation has not in and of itself been a great approach in PH-ILD, but sotatercept certainly could work in PH-ILD. Right now, we are slated, I believe, to be the first non-prostacyclin, non-prostacyclin in PH-ILD. I suspect, given the amount of unmet patient need, there will be others behind us.
Speaker #11: Thank you .
Speaker #8: . Thanks
Speaker #4: Both . Both questions . great Look on . As we said , can't talk we really too much about an ongoing litigation . There are a variety of motions in front of the court .
Speaker #4: What is visible, and the—they are, are judged; the judge will make a decision on all of them. And anything within the range is possible.
Speaker #4: hoping for hoping Obviously , we're for outcomes favorable in each case . On question filed , I look , I think the answer is in theory , any drug that improves PVR could work in filled systemic vasodilation has of not , in and itself , been a great approach failed , in it certainly could work but in failed .
Speaker #4: Right now we are believe , to slated , I be the first non prostacyclin non treprostinil failed . I suspect , given the amount of unmet patient need , there will be others behind us .
Ben Zimmer: But I think we have a really favorable profile as we enter that space. Thanks, Anthea.
Matthew Gline: But I think we have a really favorable profile as we enter that space. Thanks, Anthea.
Matthew Gline: Thank you.
Anthea Li: Thank you.
Speaker #4: I think we But have a really favorable profile as we enter that , as we enter that space .
Stephanie Lee: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.
Operator: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.
Speaker #8: Thanks .
Speaker #6: Thank
Speaker #6: .
Matthew Gline: Good morning, team. Thank you so much for all the color. As an Immunovant covering analyst, I would love to spend time on 1402 and get some color around the here and near-term RA readout. Obviously, the study's upside. Help us understand, as the study's coming to an end, reading out, what do you hope to see and how you're sort of preparing for filing and how soon you could actually get ready for that first phase 2 registrational study to be shared. And then I'll jump back in the queue.
Operator: Good morning, team. Thank you so much for all the color. As an Immunovant covering analyst, I would love to spend time on 1402 and get some color around the here and near-term RA readout. Obviously, the study's upside. Help us understand, as the study's coming to an end, reading out, what do you hope to see and how you're sort of preparing for filing and how soon you could actually get ready for that first phase 2 registrational study to be shared. And then I'll jump back in the queue.
Speaker #2: comes question Our next from the
Speaker #2: of you Rahimi with Piper Sandler . Your line is now open .
Speaker #12: morning , team . Good Thank you so much the color as an immune event . Covering analyst would love to spend time on on 1402 and get some color around the here near-term or a readout .
Speaker #12: Obviously the studies upsides . Help us understand you know studies coming to an end , reading out , what do you hope to see and how you're sort of for preparing filing and how soon you could actually get ready for that first phase ?
Ben Zimmer: Thanks. Appreciate the question. Look, I think in terms of expectations for RA, I think the short answer to that question is, on the one hand, these are patients with high unmet need. And so in some sense, the bar for efficacy is relatively low compared to what we may be used to seeing in RA. On the other hand, there's just very little precedent data for drugs in late-stage RA with sort of this level of pretreatment. And so it's hard to know. I think we're doing some work on that very question now, and we will share some guidance on what would cause us to run the second study before we put out that data. So I'd say stay tuned for that. Remember, these are burned-out patients with pretty tough disease at this point.
Matthew Gline: Thanks. Appreciate the question. Look, I think in terms of expectations for RA, I think the short answer to that question is, on the one hand, these are patients with high unmet need. And so in some sense, the bar for efficacy is relatively low compared to what we may be used to seeing in RA. On the other hand, there's just very little precedent data for drugs in late-stage RA with sort of this level of pretreatment. And so it's hard to know. I think we're doing some work on that very question now, and we will share some guidance on what would cause us to run the second study before we put out that data. So I'd say stay tuned for that. Remember, these are burned-out patients with pretty tough disease at this point.
Speaker #12: Three Registrational study to be shared . And then I'll jump back in the Q .
Speaker #4: Thanks . Appreciate the question . Look , I think in terms of expectations for . I think the the short answer to that question is .
Speaker #8: I .
Speaker #4: On the these are patients with high one hand , so in some sense , the bar for efficacy is is relatively low compared to what we may be used to seeing in RA On the .
Speaker #4: other hand , there's just very little precedent data for drugs in late stage RA sort of with this level of pre-treatment . And so it's hard to know .
Speaker #4: You know , I think we're doing some work on that question now , and we will share some guidance on what would cause us to run the second study before we put out that data .
Speaker #4: So I'd say stay tuned for that . Remember , these are these are burned out patients with with disease at this point pretty tough .
Ben Zimmer: So obviously, if we're excited about the data, there's a potential for it to be a big product. Obviously, we will engage with the agency once we've got the data and think about what a plan looks like. I think the base case expectation should be that this is one of a couple of studies that we'll have to run just because this is a relatively smaller randomized withdrawal trial. But we'll see the data, and then we'll have a better answer to that question. Thanks, Yasmeen.
Matthew Gline: So obviously, if we're excited about the data, there's a potential for it to be a big product. Obviously, we will engage with the agency once we've got the data and think about what a plan looks like. I think the base case expectation should be that this is one of a couple of studies that we'll have to run just because this is a relatively smaller randomized withdrawal trial. But we'll see the data, and then we'll have a better answer to that question. Thanks, Yasmeen.
Speaker #4: So you know , obviously if we if we're excited about the data , there's a potential for it to be a big product .
Speaker #4: Obviously we will engage with the we've got the data and think about what the plan like looks agency once . I think the base case expectation should be that this is this is one of a couple of studies that will have to run just because because this is a relatively just randomized small withdrawal But , you trial .
Matthew Gline: Okay. Thanks.
Matthew Gline: Okay. Thanks.
Stephanie Lee: Our next question comes from the line of Prakhar Agrawal with Cantor. Your line is now open.
Stephanie Lee: Our next question comes from the line of Prakhar Agrawal with Cantor. Your line is now open.
Speaker #4: know , we'll see the data we'll have a and then better answer to that question . Thanks , Yasmin .
Speaker #12: Thanks .
[Analyst] (Cantor): Hi. Good morning, and thanks for taking my questions. And congrats on these amazing results. So maybe on BREPO in CS, just wanting to better understand the market opportunity here. You've talked about 40,000 eligible patients. Would all of these be eligible for BREPO therapy and meet the inclusion/exclusion criteria for the trial? And if that's the case, do you think this is a similar size opportunity as dermatomyositis? And maybe just one follow-up on the phase 3 design. Would the time point of the endpoint be 16 weeks, similar to your phase 2, given you already have the safety database? Or would you have to test longer, just trying to figure out if there's any ways to accelerate development here? Thank you so much.
Prakhar Agrawal: Hi. Good morning, and thanks for taking my questions. And congrats on these amazing results. So maybe on BREPO in CS, just wanting to better understand the market opportunity here. You've talked about 40,000 eligible patients. Would all of these be eligible for BREPO therapy and meet the inclusion/exclusion criteria for the trial? And if that's the case, do you think this is a similar size opportunity as dermatomyositis? And maybe just one follow-up on the phase 3 design. Would the time point of the endpoint be 16 weeks, similar to your phase 2, given you already have the safety database? Or would you have to test longer, just trying to figure out if there's any ways to accelerate development here? Thank you so much.
Speaker #2: Our next question comes from the line of Prakash Agrawal with Cantor . Your line is now open .
Speaker #13: Hi. Good morning, and thanks for taking my questions. And congrats on these amazing results. Maybe, on repo in CS, I just wanted to better understand the market opportunity here.
Speaker #13: You've talked about 40,000 eligible patients . Would all of these be eligible for therapy . And meet the inclusion exclusion criteria for the And if trial ?
Speaker #13: that's the case , do you think this is similar or size opportunity as dermatomyositis and maybe just one follow up on the phase three design .
Speaker #13: Would the timepoint of the endpoint be 16 week similar to your phase two , given your you already safety have the database , or would you test longer have to just trying to figure out if there is any ways to accelerate development here .
Ben Zimmer: Yeah, thanks. Thanks, Parker. Great questions. Look, I think the short answer on market opportunity is this is a patient population that's sick with high unmet need. And assuming our phase 3 data looks similar to our phase 2 data, I think a lot of these patients are going to be enthusiastic about a better treatment option. It's probably a modestly smaller indication than dermatomyositis, just in terms of total end. I mean, obviously, DM is 40,000 patients in treatment, but 70+ thousand total patients. So I'd probably think of this as an exciting opportunity, but a little bit smaller than the DM opportunity, although, again, depends on the phase 3 data. And then I think the short answer on phase 3 design is let's just wait until we've had the conversation with FDA before we sort of talk about final outcomes.
Matthew Gline: Yeah, thanks. Thanks, Parker. Great questions. Look, I think the short answer on market opportunity is this is a patient population that's sick with high unmet need. And assuming our phase 3 data looks similar to our phase 2 data, I think a lot of these patients are going to be enthusiastic about a better treatment option. It's probably a modestly smaller indication than dermatomyositis, just in terms of total end. I mean, obviously, DM is 40,000 patients in treatment, but 70+ thousand total patients. So I'd probably think of this as an exciting opportunity, but a little bit smaller than the DM opportunity, although, again, depends on the phase 3 data. And then I think the short answer on phase 3 design is let's just wait until we've had the conversation with FDA before we sort of talk about final outcomes.
Speaker #13: Thank you so much .
Speaker #4: thanks . Yeah , Thanks . Great questions . Look , I think the short answer on market opportunity is this patient is a population that's sick with high And unmet need .
Speaker #4: know , assuming our phase three data looks similar to our phase two data , I of these think a lot patients are going to be enthusiastic about a better treatment It's option .
Speaker #4: probably a modestly smaller indication than dermatomyositis . terms Just in of total N . I mean , obviously DM is 40,000 patients in treatment , but 70 plus thousand total patients .
Speaker #4: I So probably think of this as an exciting opportunity . But a little bit smaller than the DM opportunity . Although again , it depends on the phase And three data .
Ben Zimmer: But we're going to be looking to leverage as much as we can of what we've learned from the phase two study. Obviously, to the extent that we can match parameters on which we're confident, we'll do that. Thanks for the questions.
Matthew Gline: But we're going to be looking to leverage as much as we can of what we've learned from the phase two study. Obviously, to the extent that we can match parameters on which we're confident, we'll do that. Thanks for the questions.
Speaker #4: Then, you know, I think the short answer on phase three design is, let's wait until we've had a conversation with the FDA before.
Speaker #4: We sort of talk about final outcomes, but we're going to be looking to leverage as much as we can of what we've learned from the phase 2 study.
Speaker #4: And obviously, to the extent that we can match which we're parameters on, we'll do that. Thanks for the questions.
Stephanie Lee: Thank you. Our next question comes from the line of Samantha Semenova with Citi. Your line is now open.
Operator: Thank you. Our next question comes from the line of Samantha Semenova with Citi. Your line is now open.
Speaker #2: Thank you . Our next question comes of Samantha Semenko with Citi . Your line is now from the line open .
[Analyst] (Citi): Hi. Good morning. Thanks very much for taking the question, and congrats on this very good safety data. I'm wondering what percentage of patients in the Beacon study had organ involvement, if you have that? And were you able to collect any data that would allow you to assess whether brepocitinib impacted organ-specific manifestations? And then just as a follow-up there, do you see a path to expand into other forms of sarcoidosis with brepocitinib? Thank you.
Samantha Semenkow: Hi. Good morning. Thanks very much for taking the question, and congrats on this very good safety data. I'm wondering what percentage of patients in the Beacon study had organ involvement, if you have that? And were you able to collect any data that would allow you to assess whether brepocitinib impacted organ-specific manifestations? And then just as a follow-up there, do you see a path to expand into other forms of sarcoidosis with brepocitinib? Thank you.
Speaker #6: Hi . Good morning . Thanks very the much for taking question . And congrats this . on good faith data . I'm wondering what percentage of patients in the beacon had study organ involvement .
Speaker #6: you If have that , and were you able to collect any data that would to assess whether Brepocitinib impacted organ specific manifestations ? And then just as a follow up , there , do you see a path to expand into other forms of sarcoidosis with brepocitinib ?
Ben Zimmer: Yeah, thanks. Look, I'll take the second of those questions, which is certainly something we will evaluate in terms of further places to study BREPO. And as I said before, we have ideas inside and outside sarcoidosis that are exciting. So stay tuned, and we'll be back with it. On the first question, in terms of patients with organ involvement and what we can learn from it, Ben, anything you'd share about that?
Matthew Gline: Yeah, thanks. Look, I'll take the second of those questions, which is certainly something we will evaluate in terms of further places to study BREPO. And as I said before, we have ideas inside and outside sarcoidosis that are exciting. So stay tuned, and we'll be back with it. On the first question, in terms of patients with organ involvement and what we can learn from it, Ben, anything you'd share about that?
Speaker #6: Thank you .
Speaker #4: Yeah . Thanks . Look , I'll take the second of those questions , which certainly it's something we will evaluate in terms of further places to study .
Speaker #4: And as I said before, we have ideas inside sarcoidosis that are exciting. So stay tuned, and we'll be back with it.
[Company Representative] (Priovant): Yeah. Around 60% of the patients had some pulmonary involvement, and around 30%, inclusive of that 60%, had some other organ involvement, mostly ocular involvement. We did take some exploratory endpoints related to those in the trial. We haven't analyzed that yet. Ultimately, the study was not designed or set up to evaluate benefit in those other organ systems. So I don't expect us to learn anything too meaningful from that. But it's certainly something we will take a look at. And I think the important point to note is this was a real-world cutaneous sarcoidosis population, given many of these patients do have multiple organs involved.
Ben Zimmer: Yeah. Around 60% of the patients had some pulmonary involvement, and around 30%, inclusive of that 60%, had some other organ involvement, mostly ocular involvement. We did take some exploratory endpoints related to those in the trial. We haven't analyzed that yet. Ultimately, the study was not designed or set up to evaluate benefit in those other organ systems. So I don't expect us to learn anything too meaningful from that. But it's certainly something we will take a look at. And I think the important point to note is this was a real-world cutaneous sarcoidosis population, given many of these patients do have multiple organs involved.
Speaker #4: On the first question , in terms of patients with organ involvement and what we can learn from it , Ben , anything you'd share about that ?
Speaker #5: Yeah . Around 60% of the patients had some involvement around 30% inclusive of that , 60% had some organ other involvement , mostly ocular involvement .
Speaker #5: did take some exploratory related to endpoints those in the trial . We analyzed haven't that yet . Ultimately , study was not , the you know , designed or set up to evaluate benefit in those other organ systems .
Speaker #5: So I don't expect us to learn anything too meaningful from that . But it's certainly something we will we will look at . And take a I think the important point to note is this was a real cutaneous world sarcoidosis population .
Speaker #5: You know , given these many of these patients do have multiple organs involved .
Stephanie Lee: Thank you.
Operator: Thank you.
Ben Zimmer: Thanks, Sam.
Matthew Gline: Thanks, Sam.
Stephanie Lee: Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is now open.
Stephanie Lee: Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is now open.
Speaker #2: Thank you . Our next question comes from the line of yotsunoha with Guggenheim . Your line is now open .
[Analyst] (Guggenheim): Hey, guys. Thank you for taking my question. Quick one for me on BREPO, on the data that you provided. If you look at the curves, they continue to deepen over 16 weeks. So I'm just curious to understand from you, how should we think about further? Do you expect further deepening, further separation? Just talk about if somebody gets treated for a year, how should we think about it? And then, if you can just talk about the scope and the size of the phase 3 study (I don't know if you touched on that already), should it be similar to what you did in DM? Thank you so much.
Yatin Suneja: Hey, guys. Thank you for taking my question. Quick one for me on BREPO, on the data that you provided. If you look at the curves, they continue to deepen over 16 weeks. So I'm just curious to understand from you, how should we think about further? Do you expect further deepening, further separation? Just talk about if somebody gets treated for a year, how should we think about it? And then, if you can just talk about the scope and the size of the phase 3 study (I don't know if you touched on that already), should it be similar to what you did in DM? Thank you so much.
Speaker #14: Hey , guys . Thank you for my taking question . A quick one for me on on the data that you provided . If you look at the curves , they continue to deepen over 16 weeks .
Speaker #14: Curious to, from your understanding, how should we think about what you expect going forward? Do we expect further deepening, further separation? Just talking about if somebody gets it for a year, how should we think it should be treated?
Speaker #14: And about then , you know , if you can talk about the scope just and the size , I don't know if you touched on that already the should it be phase three study , similar to what you in in DM ?
Speaker #14: And about then , you know , if you can talk about the scope just and the size , I don't know if you touched on that already the should it be phase three study , similar to what you in in did Thank you so much .
Ben Zimmer: Yeah. Thanks. I mean, just to reiterate on phase 3, and I think Ben shared a thought about that. But I think in general, until we talk to FDA, it's hard to commit to a specific study design. So I think let us get through that, and then we'll be back with a full recounting of the study design. But I think we're prepared to run and enroll a nice, sizable study if that's what we need to do. I think we feel good about what we need there. And then in terms of, look, in terms of continued deepening, we're just looking at this data for the first time this week. So I think we're continuing to explore all of the various features. I think it's funny. One of the KOLs who was also involved with the study gave a quote to some journalists.
Matthew Gline: Yeah. Thanks. I mean, just to reiterate on phase 3, and I think Ben shared a thought about that. But I think in general, until we talk to FDA, it's hard to commit to a specific study design. So I think let us get through that, and then we'll be back with a full recounting of the study design. But I think we're prepared to run and enroll a nice, sizable study if that's what we need to do. I think we feel good about what we need there. And then in terms of, look, in terms of continued deepening, we're just looking at this data for the first time this week. So I think we're continuing to explore all of the various features. I think it's funny. One of the KOLs who was also involved with the study gave a quote to some journalists.
Speaker #4: Yes . Thanks . I mean , just to reiterate on phase three , and I think , Ben , you know , shared a thought about that , but but I think in general , until we talk to FDA , hard it's to it's hard to commit to a study design .
Speaker #4: specific So I think let us get through that and then we'll be back with a with a full accounting of the , of the study design .
Speaker #4: But I think we're , prepared to run and enroll a nice sizable study if that's what we need to do . I think we I think we feel we feel good about what we need there .
Speaker #4: And then in terms of look , in terms of continued , we're just looking at this deepening data for the first time this week .
Speaker #4: So I think we're continuing to explore all of the various features . I think , you know , it's funny , one of the one of the Coles who was who was also involved with the study gave a quote to some , some journalists , when do you think his comment was if the data had been half as good and there had been twice as many side still would have been a great outcome .
Ben Zimmer: What he thinks his comment was, if the data had been half as good and there had been twice as many side effects, it still would have been a great outcome. Look, obviously, long story short, there are certainly potential ways for this data to be even better with longer therapy, with other parameters. But I think the answer is if we can come close to replicating this in a phase 3 program, it'd be a huge win. So I think we should be all set there.
Matthew Gline: What he thinks his comment was, if the data had been half as good and there had been twice as many side effects, it still would have been a great outcome. Look, obviously, long story short, there are certainly potential ways for this data to be even better with longer therapy, with other parameters. But I think the answer is if we can come close to replicating this in a phase 3 program, it'd be a huge win. So I think we should be all set there.
Speaker #4: Look , obviously , long story short , there are certainly potential ways data to be even better with longer therapy with other parameters , but I think the answer is if we can , if we can come replicating this in a phase three program , would be it'd be close to a huge win .
Stephanie Lee: Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is now open.
Operator: Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is now open.
Speaker #4: So, you know, I think we should be all set there.
Speaker #14: Excellent , guys . Thank you .
Speaker #2: Thank you . Our next comes question from the line of Douglas Tassell with H.C. Wainwright . Your line is now open .
[Analyst] (H.C. Wainwright): Hi. Good morning. Thanks for taking the questions. I guess, Matt, I'm just curious, with BREPO, how broad are you now thinking about the opportunity, right? I mean, I think we've seen great results, obviously, in CS today, on DM, as well as NIU. There is obviously a lot of data with JAK inhibitors in various indications, but not necessarily full randomized trials or proof of concept. I mean, is that the breadth of universe, or is there other white space that you're also thinking about where JAKs haven't been explored at all, but perhaps it's worth exploration just given the magnitude of effects that you're starting to see? Thank you.
Douglas Tsao: Hi. Good morning. Thanks for taking the questions. I guess, Matt, I'm just curious, with BREPO, how broad are you now thinking about the opportunity, right? I mean, I think we've seen great results, obviously, in CS today, on DM, as well as NIU. There is obviously a lot of data with JAK inhibitors in various indications, but not necessarily full randomized trials or proof of concept. I mean, is that the breadth of universe, or is there other white space that you're also thinking about where JAKs haven't been explored at all, but perhaps it's worth exploration just given the magnitude of effects that you're starting to see? Thank you.
Speaker #15: Hi . Good Thanks for morning . taking the questions . I guess , Matt , I'm just curious with repo , broad how are you now opportunity , right ?
Speaker #15: about the ? Thinking I you know , I mean , we've seen great results . Obviously , in CS today on DM as well as NIU .
Speaker #15: You know , there is obviously a lot of data with , you know , with Jack inhibitors in various indications . But not necessarily , you know , full randomized trials or proof of concept .
Speaker #15: is that I mean , the breadth of universe or is there other white space that you're also about thinking where Jax hasn't been explored at ?
Speaker #15: But perhaps it's worth all given the exploration, just the magnitude of effect that you're seeing. Thank you.
Ben Zimmer: Sorry. Yeah. How broad are we thinking about the BREPO opportunity? Thanks, Doug. Great question. Look, I think the short answer is I think you can see from our indication selection already that we've been creative and thoughtful in going after indications with high unmet need, including lots of places where JAKs have not been explored. And I think there's a lot of opportunity here. I'll just reiterate something Ben said. And Ben, if you want to do it again as well, I think it's a really good point to hit. Look, I think anywhere that TYK and JAK are both important is a particular area of focus for it because it gets at the uniqueness of our mechanism. And I think we've done a really nice job, again, thanks to Ben and a bunch of people at Roivant's as well, the Priovant team, on exploring that biology.
Matthew Gline: Sorry. Yeah. How broad are we thinking about the BREPO opportunity? Thanks, Doug. Great question. Look, I think the short answer is I think you can see from our indication selection already that we've been creative and thoughtful in going after indications with high unmet need, including lots of places where JAKs have not been explored. And I think there's a lot of opportunity here. I'll just reiterate something Ben said. And Ben, if you want to do it again as well, I think it's a really good point to hit. Look, I think anywhere that TYK and JAK are both important is a particular area of focus for it because it gets at the uniqueness of our mechanism. And I think we've done a really nice job, again, thanks to Ben and a bunch of people at Roivant's as well, the Priovant team, on exploring that biology.
Speaker #4: Yeah . How broad are thinking about the opportunity ? Thanks , Doug . Great . Great question . Look , I , I look I think the short answer is I can see think you from our indication selection that already we've been creative and thoughtful in going after with indications high unmet need , including lots of places where jaks have not been explored .
Speaker #4: You know , I there's think there's a lot of opportunity here . I'll just reiterate something , Ben said . And Ben , if you want to , if you want to do it again , well , I think it's a really good point to hit .
Speaker #4: Look, I think anywhere that Tyk and JAK are both important is a particular area of focus for it, because it gets at the uniqueness of our mechanism.
Speaker #4: And I think we've done a really nice job . Again , thanks to Ben and a bunch of people as well . And the team exploring that biology , I think we have more ideas in that category than anything .
Ben Zimmer: I think we have more ideas in that category. Ben, anything you'd like to add there mechanistically or otherwise?
Matthew Gline: I think we have more ideas in that category. Ben, anything you'd like to add there mechanistically or otherwise?
[Company Representative] (Priovant): No. I mean, I think I covered it earlier. I would say that the answer is both. I think there are some indications where there's maybe some IITs or clinical reports from off-label use of other JAK inhibitors where we think TYK2, JAK1 inhibition is really optimally suited for it. And I think those are indications we're evaluating that would obviously be highly de-risked. I also think, to your point, as we continue to see more and more excellent data here, I think we're definitely looking into some, obviously, higher risk, but also exciting potential opportunities where there's less proof of concept. And we would see what we end up with there.
Ben Zimmer: No. I mean, I think I covered it earlier. I would say that the answer is both. I think there are some indications where there's maybe some IITs or clinical reports from off-label use of other JAK inhibitors where we think TYK2, JAK1 inhibition is really optimally suited for it. And I think those are indications we're evaluating that would obviously be highly de-risked. I also think, to your point, as we continue to see more and more excellent data here, I think we're definitely looking into some, obviously, higher risk, but also exciting potential opportunities where there's less proof of concept. And we would see what we end up with there.
Speaker #4: You sort of mechanistically, or otherwise, add their—you know.
Speaker #5: No , I mean , I covered it earlier , I would , I would I think say that the is answer both . I think there are some indications where there's maybe some IIT's clinical reports from off label use of other Jak inhibitors , where we think tyk2 jak1 inhibition is really optimally suited for it .
Speaker #5: And I think indications we're evaluating that would obviously be highly de-risked . I also think as we to your point , as we continue to see more and more excellent data here , I think we're definitely looking into some , you know , to some obviously higher risk .
Speaker #5: But also exciting potential opportunities where there's less proof of concept and , you know , we would see what we end up with there .
[Analyst] (H.C. Wainwright): Matt, if I can, one follow-up. Just obviously, business development has always been such a big part of the Roivant story. But just given the sort of expanding horizons for both BREPO as well as IMVT-1402, how are you thinking about capital allocation in terms of external versus sort of just internal R&D investment? Thank you.
Douglas Tsao: Matt, if I can, one follow-up. Just obviously, business development has always been such a big part of the Roivant story. But just given the sort of expanding horizons for both BREPO as well as IMVT-1402, how are you thinking about capital allocation in terms of external versus sort of just internal R&D investment? Thank you.
Speaker #15: And Matt , if I can one follow up just , you know , obviously business development has always been such a big part of the story .
Speaker #15: But just given the sort of expanding horizons for both as well as , you know , Imv , you know . 1402 how are you thinking about capital allocation in terms external versus sort of just internal R&D investment ?
Ben Zimmer: Dollars go to the best opportunity wherever they are. The short answer to that question. Look, we're funded through profitability on our existing portfolio. Obviously, things like running the phase 3 program in cutaneous sarcoidosis are no-brainers at this point, and we're definitely going to do it. And adding additional indications for BREPO or for 1402 or for Mosley are attractive options because those mechanisms are strong and will work in other places. That said, and I'm sitting across the table from Ayuk right now, the world's full of attractive opportunities, and we look at all of them. So I think we've absolutely got opportunities to deploy sort of externally as well. And it continues to be a core part of what we believe we are good at. Thanks, Doug.
Matthew Gline: Dollars go to the best opportunity wherever they are. The short answer to that question. Look, we're funded through profitability on our existing portfolio. Obviously, things like running the phase 3 program in cutaneous sarcoidosis are no-brainers at this point, and we're definitely going to do it. And adding additional indications for BREPO or for 1402 or for Mosley are attractive options because those mechanisms are strong and will work in other places. That said, and I'm sitting across the table from Ayuk right now, the world's full of attractive opportunities, and we look at all of them. So I think we've absolutely got opportunities to deploy sort of externally as well. And it continues to be a core part of what we believe we are good at. Thanks, Doug.
Speaker #15: Thank you .
Speaker #4: Dollars go to the opportunity wherever are . they Is the short answer to that question . Look , we're funded through profitability on our existing portfolio know .
Speaker #4: You obviously three program in cutaneous the phase like running things sarcoidosis are no at this brainers point . And we're do it . going to And adding additional indications for 1402 or for Mosley are attractive options because those mechanisms are strong and will work in other places .
Speaker #4: That said , and I'm sitting across the table from you right now , the world's full of attractive opportunities , and we look at all of them .
Speaker #4: So I think , you know , we've got opportunities to deploy sort of externally as well . And it continues to be a core part of what we what we believe we are good at .
Stephanie Lee: Thank you. Our next question comes from the line of Derek Archila with Wells Fargo. Your line is now open.
Operator: Thank you. Our next question comes from the line of Derek Archila with Wells Fargo. Your line is now open.
Speaker #4: Thanks , Doug .
[Analyst] (Wells Fargo): Hey. Good morning, and congrats on the data. Thanks for taking the questions. So just quickly on Immunovant, in terms of we saw positive data for nipocalimab in systemic lupus. So curious about how you think about the read-through to cutaneous. And then second question, just in terms of commercial synergy between BREPO and 1402, obviously, we're Immunovant covering analysts. So just curious how you think about fielding a sales force in the most cost-effective manner to leverage both BREPO and 1402 between the two companies. Thanks.
Derek Archila: Hey. Good morning, and congrats on the data. Thanks for taking the questions. So just quickly on Immunovant, in terms of we saw positive data for nipocalimab in systemic lupus. So curious about how you think about the read-through to cutaneous. And then second question, just in terms of commercial synergy between BREPO and 1402, obviously, we're Immunovant covering analysts. So just curious how you think about fielding a sales force in the most cost-effective manner to leverage both BREPO and 1402 between the two companies. Thanks.
Speaker #2: Our next Thank you . question comes from the line Derek Archilla with Wells of Fargo . Your line is now open .
Speaker #16: Hey , good morning and congrats on Thanks for taking the questions . So just quickly on Immunovant of , you in terms know , we saw positive data for Mab in systemic lupus .
Speaker #16: So . Curious about how you think about the read through to cutaneous . And then second question , just in terms of synergy commercial eight we're immunovant obviously analysts .
Speaker #16: So . Curious about how you think about the read through to cutaneous . And then second question , just in terms of synergy commercial eight we're immunovant obviously covering and 1402 , So just curious how you think about fielding a sales force and the most cost effective manner to leverage both , you know , and ?
Ben Zimmer: Yeah, thanks. Look, these are both really good questions and important areas for us. On SLE, first of all, I was on record long before the BREPO study in SLE saying that anybody who isn't afraid of a lupus study is, I think, the word I use is an idiot. And so I'll say congrats to J&J on the positive data in SLE. It's always impressive when people are able to deliver those kind of results. It certainly supports the use of FcRns in diseases with a lot of complicated immune activity going on at the same time. There's probably some read-through to CLE in the sense that in the sense that there's some pathophysiological overlap there. But every lupus study of any kind is its own special flower, and will have to be successful in CLE on our own.
Matthew Gline: Yeah, thanks. Look, these are both really good questions and important areas for us. On SLE, first of all, I was on record long before the BREPO study in SLE saying that anybody who isn't afraid of a lupus study is, I think, the word I use is an idiot. And so I'll say congrats to J&J on the positive data in SLE. It's always impressive when people are able to deliver those kind of results. It certainly supports the use of FcRns in diseases with a lot of complicated immune activity going on at the same time. There's probably some read-through to CLE in the sense that in the sense that there's some pathophysiological overlap there. But every lupus study of any kind is its own special flower, and will have to be successful in CLE on our own.
Speaker #16: 1402 between the two companies ? Thanks .
Speaker #4: Yeah , thanks . Look , these are , these are these are both really good questions and areas important for us on SL .
Speaker #4: First of all, I was on record long before the study in SL as saying that being afraid of a lupus study is—I think the word I used is—an idiot.
Speaker #4: And so I'll say congrats to J&J on the positive data in SL . It's always when people impressive are able to deliver those kind of results .
Speaker #4: It certainly supports use of the fcrn in in diseases with a lot of complicated immune activity going on at the same time , there's probably some read through to CLL in the sense that that there's in the sense some pathophysiological there .
Speaker #4: But you know overlap , every lupus study of own any kind special is is its its own flower . And we'll have to be special successful in CLL on own .
Ben Zimmer: We like cutaneous lupus in part because we know that derms are pretty good at reading those kinds of endpoints. So we feel good about that. Again, CLE is a different competitive landscape than SLE, and we're watching that as well. On the sort of commercial question, look, the first thing I'll say is, even bluntly, within a big pharma company these days, the truth is that for de novo launches, mostly you deploy a field apparatus that is specific to the program because you want to engage with those very specific physicians because you want sort of full share of voice of your field force on the product. So I'm not sure I think of "sales force" as the most important commercial synergy.
Matthew Gline: We like cutaneous lupus in part because we know that derms are pretty good at reading those kinds of endpoints. So we feel good about that. Again, CLE is a different competitive landscape than SLE, and we're watching that as well. On the sort of commercial question, look, the first thing I'll say is, even bluntly, within a big pharma company these days, the truth is that for de novo launches, mostly you deploy a field apparatus that is specific to the program because you want to engage with those very specific physicians because you want sort of full share of voice of your field force on the product. So I'm not sure I think of "sales force" as the most important commercial synergy.
Speaker #4: our like We cutaneous lupus , in part because we know that derms are pretty good at reading those kinds of endpoints . And so we feel good about that .
Speaker #4: Again, CLL is a different competitive landscape than SL, and we're watching that as well on the sort of commercial question.
Speaker #4: Look , the first thing I'll say is even , within a bluntly big pharma company these days , the , the truth is that for novo de launches , mostly you deploy a field , a field apparatus that is specific to the program because you want to engage with those very specific physicians , because you you want sort of want full voice share of your field force on the product .
Ben Zimmer: We are definitely thinking about things like contracting expansively to make sure that we can get maximal benefit from commercial scale across the portfolio. There definitely are areas where that is top of mind for us that I think will translate to benefit both for the commercial performance of BREPO and for the commercial performance of 1402 as those launches progress. Thanks, Derek.
Matthew Gline: We are definitely thinking about things like contracting expansively to make sure that we can get maximal benefit from commercial scale across the portfolio. There definitely are areas where that is top of mind for us that I think will translate to benefit both for the commercial performance of BREPO and for the commercial performance of 1402 as those launches progress. Thanks, Derek.
Speaker #4: And so I'm not sure I think of like quote unquote , Salesforce as the most important commercial synergy , but we are definitely thinking about things like contracting expansively to make sure that we can maximal benefit from get across the commercial scale are And there definitely areas portfolio .
Speaker #4: Is top of mind for us, but will, I think, translate to benefit both for the commercial performance of, and for the commercial performance of, those launches in progress.
Stephanie Lee: Our next question comes from the line of Ash Verma with UBS. Your line is now open.
Operator: Our next question comes from the line of Ash Verma with UBS. Your line is now open.
Speaker #4: Thanks , Derek .
[Analyst] (UBS): Hi. Thanks for taking our questions. So for batoclimab, just upcoming the TED results, the data that you're expecting, just curious how you're thinking about that in the light of recent we've got setback in TED. In your case, how confident are you that a positive Graves' disease readout would translate to success in thyroid eye disease? Thanks.
Operator: Hi. Thanks for taking our questions. So for batoclimab, just upcoming the TED results, the data that you're expecting, just curious how you're thinking about that in the light of recent we've got setback in TED. In your case, how confident are you that a positive Graves' disease readout would translate to success in thyroid eye disease? Thanks.
Speaker #2: Our next question comes from the line of Ash Verma with UBS. Your line is now open.
Speaker #17: Oh , hi . Thanks for taking our questions . So for Barros , just upcoming the Ted results , the data that you're expecting .
Speaker #17: Just curious how you're thinking about that in the light of recently , we've got set back in Ted . In your case , how you that confident are a positive graves disease readout would translate to success in disease ?
Ben Zimmer: Thanks. Look, I appreciate the question. Obviously, TED is out there, and that data is coming when we have both studies in the first half of this year. I don't think there's a ton to say about that at this point. Those studies are going to happen, and we'll put the data out. Obviously, we know from our own phase 2 study in TED as well as from our own phase 2 work in Graves' that the drug is active in patients with hyperthyroidism. And I think that should translate in both indications to some degree of efficacy.
Matthew Gline: Thanks. Look, I appreciate the question. Obviously, TED is out there, and that data is coming when we have both studies in the first half of this year. I don't think there's a ton to say about that at this point. Those studies are going to happen, and we'll put the data out. Obviously, we know from our own phase 2 study in TED as well as from our own phase 2 work in Graves' that the drug is active in patients with hyperthyroidism. And I think that should translate in both indications to some degree of efficacy.
Speaker #17: Thanks thyroid eye .
Speaker #4: Thanks . Look , appreciate question the . Obviously , is Ted is is out that data is coming when we have both studies in the first half of this year , I there's like a of ton don't think a ton to say about that point .
Speaker #4: at this Those are going to are we'll put the data out . Obviously , we know from our own phase two study happen , and as well as from our own phase two work in graves that the drug is active in patients with hypothyroidism .
Ben Zimmer: We don't think there's a lot of read-through from TED either in argenx's case, and argenx, obviously, also doesn't as well, or in our own situation to Graves' disease in the sense that we have, look, obviously, both we have all of our phase 2 data in Graves, and the diseases are pretty different. The TED study enrolled mostly euthyroid patients, so they're pretty different fundamentally in terms of who was in the studies. So I feel like we are confident in the efficacy or potential efficacy of FcRns in Graves' disease and not particularly focused on what information there is from TED. Obviously, once we get the TED data and can talk about it, there will be information there from patients who happen to be hyperthyroid at various points in that study and how those patients looked.
Matthew Gline: We don't think there's a lot of read-through from TED either in argenx's case, and argenx, obviously, also doesn't as well, or in our own situation to Graves' disease in the sense that we have, look, obviously, both we have all of our phase 2 data in Graves, and the diseases are pretty different. The TED study enrolled mostly euthyroid patients, so they're pretty different fundamentally in terms of who was in the studies. So I feel like we are confident in the efficacy or potential efficacy of FcRns in Graves' disease and not particularly focused on what information there is from TED. Obviously, once we get the TED data and can talk about it, there will be information there from patients who happen to be hyperthyroid at various points in that study and how those patients looked.
Speaker #4: , you know , And I think that translate in indications to both should efficacy . And we don't think there's a lot of read through from Ted either in our case and our obviously also doesn't as well or in our own situation in graves disease to grave's disease , in the sense that we have look , obviously both what we have all of our phase two data in graves and the diseases are pretty different , like the Ted study enrolled mostly Euthyroid patients .
Speaker #4: So they're pretty different fundamentally in terms of who was in the studies . So I feel like we are confident in the efficacy or efficacy of fcrn in graves potential disease .
Speaker #4: And not not particularly focused on what information there is from Ted . Obviously , once the we get Ted data and can talk about it , there will be information there from patients who happen to be hypothyroid at various points in that study , and how those patients looked , and we'll take full advantage of that data in optimizing our graves program .
Ben Zimmer: We'll take full advantage of that data in optimizing our Graves' program. But beyond that, I'd say not much read-through between the programs. Looking forward to getting all of that TED data together once we've got it. Thanks, Ash.
Matthew Gline: We'll take full advantage of that data in optimizing our Graves' program. But beyond that, I'd say not much read-through between the programs. Looking forward to getting all of that TED data together once we've got it. Thanks, Ash.
Speaker #4: But beyond that , I'd say not much , not much . Read through the programs and looking forward to getting all that data Once we've together .
Stephanie Lee: Our next question comes from the line of Thomas Smith with Leerink Partners. Your line is now open.
Operator: Our next question comes from the line of Thomas Smith with Leerink Partners. Your line is now open.
Speaker #4: Got it. Thanks, Ash.
Speaker #2: Our next question comes from the line of Thomas Smith with Leerink Partners. Your line is now open.
[Analyst] (Leerink Partners): Hey, guys. Good morning. Thanks so much for the updates and for taking our questions. Great to see the rapid enrollment and the over-enrollment for 1402 and Graves', and appreciate the update on the data timing. I just wanted to clarify. Should we expect that you'll report both the open-label and randomized data from this study together, or is there potential we could see some of that open-label period one data first? And then as a follow-up, we noticed on slide 31, the expectation for Graves' launch by the end of 2028, but not MG, although you're expecting phase 3 data for both indications in 2027. Just wanted to ask if that's purely a function of data timing there or if there's some other strategic considerations with respect to pricing or competitive landscape. Thanks so much.
Thomas Smith: Hey, guys. Good morning. Thanks so much for the updates and for taking our questions. Great to see the rapid enrollment and the over-enrollment for 1402 and Graves', and appreciate the update on the data timing. I just wanted to clarify. Should we expect that you'll report both the open-label and randomized data from this study together, or is there potential we could see some of that open-label period one data first? And then as a follow-up, we noticed on slide 31, the expectation for Graves' launch by the end of 2028, but not MG, although you're expecting phase 3 data for both indications in 2027. Just wanted to ask if that's purely a function of data timing there or if there's some other strategic considerations with respect to pricing or competitive landscape. Thanks so much.
Speaker #18: Hey , guys . Good morning . Thanks so much for the updates and for taking our questions . Great to see the rapid enrollment and the enrollment for 1402 in Tra , and appreciate the update on the data timing .
Speaker #18: I just wanted to clarify , should we expect that you'll report both the open label and randomized this study data from together , or is there potential we could see some of that open period .
Speaker #18: One label data first and then as a follow up , we noticed on slide 31 the expectation for graves launch by the end of 28 , but not milligrams , although you're expecting phase three data for both indications in 27 .
Speaker #18: I just wanted to ask purely a function of data timing . if there's some other if that's There , or strategic with respect considerations to competitive landscape .
Ben Zimmer: Thanks. Thanks, Doug. I appreciate both questions. Look, I think on the data release timing for the RA study, I don't think we've made a final decision on how exactly we'll put that data out and when. But I think it's reasonably likely now that we know both are coming this year that we'll wait for the randomized withdrawal period before we talk about it. Obviously, that first period is open-label, and so we'll get some information from it as we go on. And then I don't think there's much to read into the exclusion from MG in 2028. In fact, there's probably some possibility it actually does, in fact, also launch in 2028. And so I think stay tuned, once we get that data, once those studies are, once we know the exact timeline of those studies; we'll be able to provide more guidance on specific launch timelines.
Matthew Gline: Thanks. Thanks, Doug. I appreciate both questions. Look, I think on the data release timing for the RA study, I don't think we've made a final decision on how exactly we'll put that data out and when. But I think it's reasonably likely now that we know both are coming this year that we'll wait for the randomized withdrawal period before we talk about it. Obviously, that first period is open-label, and so we'll get some information from it as we go on. And then I don't think there's much to read into the exclusion from MG in 2028. In fact, there's probably some possibility it actually does, in fact, also launch in 2028. And so I think stay tuned, once we get that data, once those studies are, once we know the exact timeline of those studies; we'll be able to provide more guidance on specific launch timelines.
Speaker #18: Thanks so much .
Speaker #4: Thanks . Thanks . I appreciate I appreciate both questions . think Look , I on the data release timing for the RA study , I don't think we've made a final decision on how exactly we'll put that data out and when , but I think it's reasonably likely now that we know both are coming this year , that we'll wait for the for the randomized withdrawal period before we talk about it .
Speaker #4: Obviously , that first period is open label . And so we'll get some information from it as it as as we go on then I .
Speaker #4: And I don't think there's much to read into the exclusion from. In fact, it's probably some possibility it actually does. In fact, also launch in 2028.
Speaker #4: And so , you know , I think stay tuned . And once we get that once those data , studies are the exact of those studies , we'll be able to provide more , more guidance on specific launch timelines .
[Analyst] (Leerink Partners): Got it. Thanks, Matt.
Thomas Smith: Got it. Thanks, Matt.
Ben Zimmer: Thank you.
Matthew Gline: Thank you.
Stephanie Lee: Our next question comes from the line of Alex Thompson with Stifel. Your line is now open.
Stephanie Lee: Our next question comes from the line of Alex Thompson with Stifel. Your line is now open.
Speaker #18: Thanks . Got it . That .
[Company Representative] (Priovant): Hey, great. Thanks for taking my question. Maybe one on sort of the competitive landscape in Graves. I guess with argenx entering the area and maybe trying to follow their strategy of chasing fast-follower indications here, how confident are you that you could maintain your lead in Graves if argenx were to run maybe 26-week studies or even one instead of two studies? Thanks.
Alex Thompson: Hey, great. Thanks for taking my question. Maybe one on sort of the competitive landscape in Graves. I guess with argenx entering the area and maybe trying to follow their strategy of chasing fast-follower indications here, how confident are you that you could maintain your lead in Graves if argenx were to run maybe 26-week studies or even one instead of two studies? Thanks.
Speaker #19: Thank you Our
Speaker #19: .
Speaker #2: Next question comes from the line of Alex Thompson with Stifel. Your line is now open.
Speaker #20: Hey , great . Thanks for taking my question . Maybe , one on sort of the competitive maybe graves , I guess with Argenx entering the area and maybe trying to follow their strategy of chasing fast follower indications here , how confident are you that you can your maintain lead in graves if Argenx were to run , maybe even 26 week studies or one instead of two studies ?
Ben Zimmer: Obviously, the extent of our lead in Graves'. Thank you for the question. The extent of our lead time in Graves' will depend a little bit on argenx's study design and what they decide to do. And until we know what that design is, it's going to be hard to say. Certainly, shorter studies will be faster than longer studies mechanically. I think we have a lead in Graves' that will be significant. Roughly, no matter what design argenx runs, we have great relationships with those KOLs and doc community. We've been out there. One of our studies is also 26 weeks. As a reminder, the 2503 study is 26 weeks. So look, I think the answer is we will have a significant lead in Graves' disease. How significant that lead is may depend a little bit on what the competition does.
Matthew Gline: Obviously, the extent of our lead in Graves'. Thank you for the question. The extent of our lead time in Graves' will depend a little bit on argenx's study design and what they decide to do. And until we know what that design is, it's going to be hard to say. Certainly, shorter studies will be faster than longer studies mechanically. I think we have a lead in Graves' that will be significant. Roughly, no matter what design argenx runs, we have great relationships with those KOLs and doc community. We've been out there. One of our studies is also 26 weeks. As a reminder, the 2503 study is 26 weeks. So look, I think the answer is we will have a significant lead in Graves' disease. How significant that lead is may depend a little bit on what the competition does.
Speaker #20: Thanks .
Speaker #4: Obviously the extent of our lead in grace . Thank you for the question . The extent of our lead in time graves will depend a little bit on our study design and what they decide to do .
Speaker #4: And until we know what that design is , it's going to be hard to say . Certainly shorter studies will be faster than longer studies .
Speaker #4: Mechanically , I think we have a lead in graves that will be significant , roughly , no matter what design Argenx runs . We have great those relationships with coals and that community been out .
Speaker #4: there . One of our We've studies is also 26 weeks . As reminder , a the 2503 study is 26 weeks . So look , I think the answer is have a significant lead in graves disease .
Ben Zimmer: But this is also one of those, whatever, going to need to outrun the bear situations or whatever. I think mostly our focus is just getting those studies done and out as quickly as we can and getting out into that population. And it's such a large and exciting population that it just doesn't really matter. The other thing I'll say is, as a reminder, we feel like we showed pretty conclusively in our phase 2 data that the deeper IgG suppression that we expect to deliver will matter in this population, and I think especially on remission. And I think that will also be a significant factor in Graves' Disease. So looking forward to getting all of that data together. Thank you very much.
Matthew Gline: But this is also one of those, whatever, going to need to outrun the bear situations or whatever. I think mostly our focus is just getting those studies done and out as quickly as we can and getting out into that population. And it's such a large and exciting population that it just doesn't really matter. The other thing I'll say is, as a reminder, we feel like we showed pretty conclusively in our phase 2 data that the deeper IgG suppression that we expect to deliver will matter in this population, and I think especially on remission. And I think that will also be a significant factor in Graves' Disease. So looking forward to getting all of that data together. Thank you very much.
Speaker #4: How we will significant that lead is may depend a little bit on what the competition does , but this is also one of those .
Speaker #4: to outrun the bear Whatever . No need situations or whatever . I mostly our think focus is just getting those studies done and out as quickly as we getting out can , and into that population , and it's such a large and exciting population that it just doesn't .
Speaker #4: It doesn't it doesn't really matter . The other thing I'll say is , as a reminder , we feel like we should be conclusively in our phase two data , that the deeper IgG suppression that we expect to deliver will matter in this population .
Speaker #4: And I think especially on remission. And I think that will also be a significant factor in Graves' disease. So, so looking forward to getting all that data. Thank you for your together.
Stephanie Lee: Thank you. This concludes the question and answer session. I'd now like to turn the call back over to Matthew Gline for closing remarks.
Operator: Thank you. This concludes the question and answer session. I'd now like to turn the call back over to Matthew Gline for closing remarks.
Speaker #4: .
Speaker #20: Thanks , .
Speaker #20: Matt
Speaker #2: Thank you . And this concludes the question and answer session . I'd now like to turn the call back over to Matthew Gline for remarks closing .
Matthew Gline: Great. Thank you, operator. Thank you, everybody, for the good questions. Thank you all for listening this morning. I want to once again thank everybody involved in all of this, particularly with the cutaneous sarcoidosis data, the patients and investigators involved in that program, as well as the Priovant team for the execution there, but also everybody at Roivant and all of the patients and investigators on all of our studies. And look, we've got a lot more to come this year, so I'm sure we'll be back together soon. And I'm looking forward to continuing the discussion. Thank you, everybody, and have a great day.
Matthew Gline: Great. Thank you, operator. Thank you, everybody, for the good questions. Thank you all for listening this morning. I want to once again thank everybody involved in all of this, particularly with the cutaneous sarcoidosis data, the patients and investigators involved in that program, as well as the Priovant team for the execution there, but also everybody at Roivant and all of the patients and investigators on all of our studies. And look, we've got a lot more to come this year, so I'm sure we'll be back together soon. And I'm looking forward to continuing the discussion. Thank you, everybody, and have a great day.
Speaker #4: Thank you . Great . Operator . Thank you , everybody for the good you all questions . Thank for listening this morning . I want to once again , thank everybody involved in all of this , including particularly with the sarcoidosis data , the patients and investigators involved in that program , as well as the team for their execution there , but also everybody to all of the patients , investigators on all of our studies .
Stephanie Lee: This concludes today's conference. Thank you for your participation. You may now disconnect.
Operator: This concludes today's conference. Thank you for your participation. You may now disconnect.
Speaker #4: And look , we've got a lot more to come this year . So I'm sure we'll be back together soon . And I'm looking forward to continuing the discussion .
Speaker #4: everybody and have Thank you a great day .