Roivant Sciences Q3 2025 Roivant Sciences Ltd Earnings Call and Business Update | AllMind AI Earnings | AllMind AI
Q3 2025 Roivant Sciences Ltd Earnings Call and Business Update
Speaker #1: Good day and thank you for standing by . Welcome to the Roy Van . Third quarter 2020 Earnings Conference Call . At this time , all participants are in a listen only mode .
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Stephanie Lee Griffin: Good morning, and thanks for joining today's call to review positive phase 2 results for brepocitinib in cutaneous sarcoidosis and Roivant's financial results for the third quarter ended December 31, 2025. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant, and Ben Zimmer, CEO of Priovant. For those dialing in via conference call, you can find the slides being presented today, as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I would like to remind you that we will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we file with the SEC for more information regarding these forward-looking statements and the related risks and uncertainties.
Stephanie Lee Griffin: Good morning, and thanks for joining today's call to review positive phase 2 results for brepocitinib in cutaneous sarcoidosis and Roivant's financial results for the third quarter ended December 31, 2025. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant, and Ben Zimmer, CEO of Priovant. For those dialing in via conference call, you can find the slides being presented today, as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I would like to remind you that we will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we file with the SEC for more information regarding these forward-looking statements and the related risks and uncertainties.
Speaker #1: I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.
Speaker #2: Good morning , and thanks for joining today's call to review positive phase two results for in breakfast cutaneous sarcoidosis and Roivant's results . Financial third quarter ended for the December 31st , 2025 .
Q3 2025 Roivant Sciences Ltd Earnings Call and Business Update
Speaker #2: I'm Stephanie Lee with Roy presenting today . We have Matthew Gline CEO and Ben CEO of finance . For those dialing in via conference call , you can find the slides being presented today as well as the press release announcing these updates on our IR website at .
Speaker #2: We'll also be providing the current numbers as slides we present to help you follow along. I would like to remind you that we will be making certain forward-looking statements during today's presentation.
Speaker #2: We strongly encourage you to review the information that we filed with the SEC. For more information regarding these forward-looking statements and related risks and uncertainties.
Stephanie Lee Griffin: So with that, I'll turn it over to Matt.
Stephanie Lee Griffin: So with that, I'll turn it over to Matt.
Matt Gline: Thanks, Steph, and thanks, everyone, for dialing in and listening this morning. I'm going to start our presentation on slide 5. You know, I was sitting talking to the team, it was about a week ago today, looking at a draft of this morning's presentation and thinking that it was going to be a pretty boring 10-Q. We got together in December for the investor day. We had spoken at the J.P. Morgan Conference, and it turned out to have been a really busy week. So we have some great updates, obviously, most notably the phase 2 data in brepocitinib and CS, which Ben is going to present on momentarily. But truth is, terrific execution and progress across the board for us this quarter.
Matt Gline: Thanks, Steph, and thanks, everyone, for dialing in and listening this morning. I'm going to start our presentation on slide 5. You know, I was sitting talking to the team, it was about a week ago today, looking at a draft of this morning's presentation and thinking that it was going to be a pretty boring 10-Q. We got together in December for the investor day. We had spoken at the J.P. Morgan Conference, and it turned out to have been a really busy week. So we have some great updates, obviously, most notably the phase 2 data in brepocitinib and CS, which Ben is going to present on momentarily. But truth is, terrific execution and progress across the board for us this quarter.
Speaker #2: And with that , I'll turn it over to Matt .
Speaker #3: Thanks , Jeff , and thanks , everyone for dialing listening this in and morning . I'm going to start presentation start our on slide five .
Speaker #3: I was sitting talking to the team . It was about a week ago today . at a draft of this morning's presentation and thinking that it was going to be a pretty boring 10-q .
Speaker #3: We'd December gotten together in for the Investor Day . We had . had spoken We to J.P. conference , and it turned Morgan out to have been a really busy week .
Speaker #3: So we have some great updates . Most Obviously . in phase two data and CS , which which Ben is going to present on momentarily .
Matt Gline: Obviously, that data is a highlight, but we also can announce today that the NDA for brepocitinib in dermatomyositis is in, that the phase 2b study for IMVT-1402 in GD has fully enrolled, that the phase 2 study for mosliciguat in PH-ILD has fully enrolled. And obviously, all of the updates that were known before, including the Immunovant offering earlier, that gets us now financed to Graves' launch, all behind us. So just a terrific quarter and a terrific set of updates even since early January, when we last got together. You know, on slide 6, 2026 is again a very busy year for us ahead. Obviously, some major events later in the year, the brepocitinib NIU phase 3, the pivotal readout in the second half.
Matt Gline: Obviously, that data is a highlight, but we also can announce today that the NDA for brepocitinib in dermatomyositis is in, that the phase 2b study for IMVT-1402 in GD has fully enrolled, that the phase 2 study for mosliciguat in PH-ILD has fully enrolled. And obviously, all of the updates that were known before, including the Immunovant offering earlier, that gets us now financed to Graves' launch, all behind us. So just a terrific quarter and a terrific set of updates even since early January, when we last got together. You know, on slide 6, 2026 is again a very busy year for us ahead. Obviously, some major events later in the year, the brepocitinib NIU phase 3, the pivotal readout in the second half.
Speaker #3: But terrific execution and progress across the board for us this quarter, that is the truth. Obviously, that data is a highlight, but we also can announce today that the NDA for repo is in, and for dermatomyositis; that the Phase 2 study for 1402 in TRA has fully enrolled; that the Phase 2 study for Mosley and Feld has fully enrolled; and obviously all the updates that were known before, including the Immunovant offering earlier.
Speaker #3: That gets us now financed to graves launch behind us . So just a terrific quarter and a terrific set of updates , even since January , early when we last got together , you know , on slide six .
Speaker #3: 2026 is again , a very busy year for ahead . Obviously , some major us events later in the year . The NIU phase three , the pivotal readout in the second half , we're now going to be starting this year .
Matt Gline: We're now going to be starting this year a phase three study in Breppo and cutaneous sarcoidosis. Ben will talk a little bit more about that. It's early days in getting that going, but that'll be this year. The phase two B data for Mosley is expected firmly in the second half of this year. We now know that because the study is fully enrolled obviously. Same thing with the DGRA data, where all of that, both the open label period and the randomized withdrawal period, will be done by the second half of this year. We also are getting proof of concept data in 1402 in CLE. And finally, we are still on track for the jury trial against Moderna starting on 9 March. So just a few weeks away now.
Matt Gline: We're now going to be starting this year a phase three study in Breppo and cutaneous sarcoidosis. Ben will talk a little bit more about that. It's early days in getting that going, but that'll be this year. The phase two B data for Mosley is expected firmly in the second half of this year. We now know that because the study is fully enrolled obviously. Same thing with the DGRA data, where all of that, both the open label period and the randomized withdrawal period, will be done by the second half of this year. We also are getting proof of concept data in 1402 in CLE. And finally, we are still on track for the jury trial against Moderna starting on 9 March. So just a few weeks away now.
Speaker #3: A phase three study in cutaneous sarcoidosis . Ben , we'll talk a little bit more about that . But it's early days and But that'll getting that going .
Speaker #3: be this The phase two data for Mosley is expected year . We firmly in the second half of this now know that because the study is fully enrolled , same thing with the data where all of that , both the open label period and the randomized withdrawal period will be done by the second half of this year .
Speaker #3: We also are getting proof of concept data in CLE 1402 , in and finally , we are still track on for the jury trial against Moderna starting on March 9th .
Matt Gline: So a really, really busy year ahead for Roivant. And really, if you look at slide 7, before we get again to the data for CS, you know, just a pipeline we're really proud of that continues to deliver across multiple dimensions with obviously Breppo with now 3 indications in pivotal registrational programs, multiple registrational programs for FcRN franchise, which we've talked about, and mosliciguat with top-line data coming in the second half. Really excited about where we are as a business, really excited about the pipeline. Couldn't be more excited for the beginning of 2026 here. Certainly, it's off to a good start. And with that, what I'm gonna do is turn to the phase 2 data for brepo in sarcoidosis.
Matt Gline: So a really, really busy year ahead for Roivant. And really, if you look at slide 7, before we get again to the data for CS, you know, just a pipeline we're really proud of that continues to deliver across multiple dimensions with obviously Breppo with now 3 indications in pivotal registrational programs, multiple registrational programs for FcRN franchise, which we've talked about, and mosliciguat with top-line data coming in the second half. Really excited about where we are as a business, really excited about the pipeline. Couldn't be more excited for the beginning of 2026 here. Certainly, it's off to a good start. And with that, what I'm gonna do is turn to the phase 2 data for brepo in sarcoidosis.
Speaker #3: So just just a few weeks away now . So really , really busy year ahead for riven . And really , if you look at slide seven before we get to the again to the data for CS , just a pipeline , we're really proud of that continues to deliver across multiple dimensions with obviously with now three in indications pivotal registrational programs , multiple registrational programs for FCR enfranchise , many of which we've talked about coming in the .
Speaker #3: second half . with top line data So where we are really as a business , really Mosley excited about the pipeline more excited for the beginning of 2026 here .
Matt Gline: So I'm just really briefly on slide nine of the presentation. I'm just gonna walk through a couple of highlights, but mostly I'm gonna hand it over to Ben, to take you through the data in detail. And the short answer, and we keep saying this, and it's a tremendous fortune, I think, to be able to say, but this drug has done everything we could have asked for us, for it in this or of it in this study. You know, we had a significant, statistically significant. Remember, we had said before, the bar for clinical success here, we thought was sort of 5 points of CSAMI was clinically meaningful. You know, we got a placebo-adjusted almost 22 points, 21.6-point delta with a p-value.
Matt Gline: So I'm just really briefly on slide nine of the presentation. I'm just gonna walk through a couple of highlights, but mostly I'm gonna hand it over to Ben, to take you through the data in detail. And the short answer, and we keep saying this, and it's a tremendous fortune, I think, to be able to say, but this drug has done everything we could have asked for us, for it in this or of it in this study. You know, we had a significant, statistically significant. Remember, we had said before, the bar for clinical success here, we thought was sort of 5 points of CSAMI was clinically meaningful. You know, we got a placebo-adjusted almost 22 points, 21.6-point delta with a p-value.
Speaker #3: Certainly off to a good start with that. What I'm going to do is turn to the Phase 2 data for sarcoidosis.
Speaker #3: So really I'm just briefly on slide nine of the presentation. I'm just going to walk through a couple of highlights, but mostly I'm going to hand it over to Ben to take you through the data in detail.
Speaker #3: And the short answer and we keep saying this , it's a it's a tremendous fortune , I think , to be able to say , but this drug has done everything we could have us asked for for it in of it in this or this study .
Speaker #3: You know , we got a significant , statistically significant remember , we had said before the bar for clinical success here we thought was was sort of five points of was calamity , clinically meaningful .
Matt Gline: And again, this study was not powered for efficacy in this, in this endpoint. 100% of patients on brepo 45 compared to 14 on placebo had a 10-point improvement. Again, clinically meaningful was 5 points. 100% of patients on our high dose had at least a 10-point improvement. So, you know, just a tremendous outcome across the board. There's some great supportive data on some of the other endpoints as well, and with safety and tolerability, completely consistent with what we've seen for the compound in the past. So a really terrific outcome and in a disease that needs it, where there's never been a positive placebo-controlled study in an industry-sponsored study to our knowledge. So really a terrific day for those patients.
Matt Gline: And again, this study was not powered for efficacy in this, in this endpoint. 100% of patients on brepo 45 compared to 14 on placebo had a 10-point improvement. Again, clinically meaningful was 5 points. 100% of patients on our high dose had at least a 10-point improvement. So, you know, just a tremendous outcome across the board. There's some great supportive data on some of the other endpoints as well, and with safety and tolerability, completely consistent with what we've seen for the compound in the past. So a really terrific outcome and in a disease that needs it, where there's never been a positive placebo-controlled study in an industry-sponsored study to our knowledge. So really a terrific day for those patients.
Speaker #3: You know , we got a placebo adjusted almost 22 points , 21 .6. delta with a p value . And again , the study was not powered for efficacy in this .
Speaker #3: In this endpoint, 100% of patients on 45 only placebo had—again, clinically meaningful was five points; a ten point improvement. 100% of patients on our high dose had at least a ten point improvement.
Speaker #3: at So , you know , just a tremendous outcome board . There's some great supportive data on some of the other endpoints as well .
Speaker #3: across the And with safety and completely consistent with what we've seen for the compound in the past . So really terrific outcome . And in a disease that needs it , where there's never been positive placebo controlled study in an industry sponsored study , to our knowledge .
Matt Gline: So with that, I'm going to hand it over to Ben to walk you through a little bit about cutaneous sarcoidosis as a reminder, and then, onto the study data, as well. Ben, take it away.
Matt Gline: So with that, I'm going to hand it over to Ben to walk you through a little bit about cutaneous sarcoidosis as a reminder, and then, onto the study data, as well. Ben, take it away.
Speaker #3: really , a So terrific day for those that , I'm going to So with hand it patients . over to walk you through a little bit about Ben to sarcoidosis reminder .
Ben Zimmer: Great. Thanks so much. Great to be here with everyone. Starting on slide 10, I just wanted to, you know, bring back to what this disease is, walked through this at the Investor Day in December. But cutaneous sarcoidosis is a really debilitating skin disease, and among skin diseases, stands out for its rapid progression towards permanent scarring and destruction of tissue, as well as its disfiguring nature, given the particular prevalence on the face and scalp of the disease. Turning to slide 11, I would note that there's no approved therapies, not only for cutaneous sarcoidosis, but for any form of sarcoidosis.
Ben Zimmer: Great. Thanks so much. Great to be here with everyone. Starting on slide 10, I just wanted to, you know, bring back to what this disease is, walked through this at the Investor Day in December. But cutaneous sarcoidosis is a really debilitating skin disease, and among skin diseases, stands out for its rapid progression towards permanent scarring and destruction of tissue, as well as its disfiguring nature, given the particular prevalence on the face and scalp of the disease. Turning to slide 11, I would note that there's no approved therapies, not only for cutaneous sarcoidosis, but for any form of sarcoidosis.
Speaker #3: And then on to the study as well . data Ben , take it away .
Speaker #4: Great . to be here Thanks so with much . everyone . Starting on slide ten . Just to , you know , bring back to what this disease is .
Speaker #4: Walk through this at the in December . But cutaneous sarcoidosis is a really debilitating skin disease . And diseases stands out its rapid progression among skin towards permanent scarring and destruction of tissue , as well as its disfiguring Given the nature .
Speaker #4: particular prevalence on the face and scalp of the disease . Turning to slide would note that 11 , I there's no approved therapies not only for cutaneous sarcoidosis , but for any form of sarcoidosis .
Ben Zimmer: And so as we think about our development program in CS, really a great opportunity for brepo to meet this overall unmet need and become the therapy of choice if we're going to be successful in phase 3, as we hope and expect we would be on the basis of this data, to really be a promising option for all patients with skin involvement in their sarcoidosis. That would include patients both with only skin involvement, as well as those with other organ involvement as well. Turning to slide 12, you know, really just briefly on, on here on the alignment between the pathobiology of the disease and the mechanism.
Ben Zimmer: And so as we think about our development program in CS, really a great opportunity for brepo to meet this overall unmet need and become the therapy of choice if we're going to be successful in phase 3, as we hope and expect we would be on the basis of this data, to really be a promising option for all patients with skin involvement in their sarcoidosis. That would include patients both with only skin involvement, as well as those with other organ involvement as well. Turning to slide 12, you know, really just briefly on, on here on the alignment between the pathobiology of the disease and the mechanism.
Speaker #4: And so, as we think about our program development in CS, it's really a great opportunity for us to meet this overall unmet need and become the therapy of choice.
Speaker #4: If we're going to be successful in phase three , as we hope and expect , we would be on the basis of this data to , you know to , really be option for all a patients with with skin involvement in their sarcoidosis .
Speaker #4: That would include patients both with only skin involvement, as well as those with other organ involvement, as well. Turning to slide 12.
Ben Zimmer: And I think this is important because, you know, as Matt alluded to, and I'll walk through in a bit more detail, we really have great data here that we're very excited about. And I think, you know, in a small study, you know, the data is very compelling. It's hard to argue with on its own, but it also really aligns with what you would expect to see given the mechanism of this drug. Sarcoidosis, all of the forms of sarcoidosis, including cutaneous disease, are driven by the polarization and recruitment of effector T cells, and particularly TH1 polarized cells. And brepo really distinctively inhibits TH1-related pathways by hitting both IL-12 through TYK2 and interferon gamma through JAK1.
Ben Zimmer: And I think this is important because, you know, as Matt alluded to, and I'll walk through in a bit more detail, we really have great data here that we're very excited about. And I think, you know, in a small study, you know, the data is very compelling. It's hard to argue with on its own, but it also really aligns with what you would expect to see given the mechanism of this drug. Sarcoidosis, all of the forms of sarcoidosis, including cutaneous disease, are driven by the polarization and recruitment of effector T cells, and particularly TH1 polarized cells. And brepo really distinctively inhibits TH1-related pathways by hitting both IL-12 through TYK2 and interferon gamma through JAK1.
Speaker #4: You know , really just briefly on here on the alignment pathobiology of the disease is think this important because , you as Matt mechanism .
Speaker #4: alluded And I to , and I'll walk through know , more in a bit detail , we have have data here that we're very excited And I think , you know , in a small study , you know , the data is very , very compelling .
Speaker #4: It's hard to argue with on its own . But but it also really aligns with what you would expect to see given the mechanism of this drug , sarcoidosis .
Speaker #4: All of the forms of including sarcoidosis , cutaneous are disease , are driven by the polarization and recruitment of effector T cells and particularly th one polarized cells and really distinctively inhibits Th1 related pathways by hitting both IL 12 through Tik two and interferon gamma through Jak1 .
Ben Zimmer: So, so really, an opportunity here mechanistically to see the benefits of JAK1/TYK2 inhibition specifically, and, and I think that's really part of what's flowing through to our, our clinical data that I'll, I'll walk through now. Slide 13, study design, very straightforward. 31 patients in the United States randomized 3 to 2 to 2 to brepo 45mg, 15mg, and placebo. 16-week study evaluated several different efficacy endpoints that I will walk through. On the baseline demographics and disease activity, slide 14, I, I do wanna highlight a few things.
Ben Zimmer: So, so really, an opportunity here mechanistically to see the benefits of JAK1/TYK2 inhibition specifically, and, and I think that's really part of what's flowing through to our, our clinical data that I'll, I'll walk through now. Slide 13, study design, very straightforward. 31 patients in the United States randomized 3 to 2 to 2 to brepo 45mg, 15mg, and placebo. 16-week study evaluated several different efficacy endpoints that I will walk through. On the baseline demographics and disease activity, slide 14, I, I do wanna highlight a few things.
Speaker #4: So , so really opportunity here mechanistically to see the benefits of jak1 two inhibition specifically . And I think that's really part of what's flowing through to our clinical walk I'll I'll through now .
Speaker #4: Slide 13 . Study design . Very straightforward . 31 patients in the United States randomized three to two to 2 to 45mg , 15mg and placebo .
Speaker #4: The 16-week study evaluated several different efficacy endpoints that I will walk through, focusing on the baseline demographics and disease activity. On slide 14, I do want to highlight a few things.
Ben Zimmer: First, if you look at the duration of disease and background damage of patients, brepo 45mg and placebo are very well balanced between those two arms, but 15mg are actually quite a bit lighter on duration of disease and damage, which, you know, would mean really a higher bar for both brepo 45mg and placebo. And then I would also call attention to the plaque-predominant morphology. You know, cutaneous sarcoidosis can present through both plaques and papules. In general, the plaques are viewed as more treatment-resistant, and you see this plaque-predominant morphology most pronounced and most common in the brepo 45mg arm, followed by 15mg, followed by placebo. So, you know, sort of punchline of this is, you know, there were some imbalances.
Ben Zimmer: First, if you look at the duration of disease and background damage of patients, brepo 45mg and placebo are very well balanced between those two arms, but 15mg are actually quite a bit lighter on duration of disease and damage, which, you know, would mean really a higher bar for both brepo 45mg and placebo. And then I would also call attention to the plaque-predominant morphology. You know, cutaneous sarcoidosis can present through both plaques and papules. In general, the plaques are viewed as more treatment-resistant, and you see this plaque-predominant morphology most pronounced and most common in the brepo 45mg arm, followed by 15mg, followed by placebo. So, you know, sort of punchline of this is, you know, there were some imbalances.
Speaker #4: look at First , if you the duration of disease and background damage of patients , 45mg and placebo , very well balanced between those two arms .
Speaker #4: But 15mg actually quite a bit on duration lighter of disease . And damage , which would mean really a higher bar for both 45 and placebo .
Speaker #4: And then I would also call attention to the plaque predominant morphology . You know , cutaneous sarcoidosis can can present through plaques and papules .
Speaker #4: general , the plaques are viewed more In treatment as . And resistant you see this plaque predominant morphology , most most pronounced and most common in the followed by 45mg arm , 15mg , followed by placebo .
Ben Zimmer: Those imbalances actually made it harder for brepo 45 milligrams to demonstrate efficacy, both as compared to placebo and as compared to brepo 15 milligrams. And in spite of that, as I walk through, we really see exceptional data from the brepo 45 milligram dose arm. So turning to slide 15 to get into the efficacy results. On the left hand of this slide, you see the mean to CSAMI activity score change from baseline. You know, both doses, statistically significant separation from placebo as early as week 4, the first time point evaluated, and then sustained at every visit out to week 16 at the end of the trial. And then on the right here, we see the achievement of Investigator's Global Assessment 0/1 and a 2-point reduction.
Ben Zimmer: Those imbalances actually made it harder for brepo 45 milligrams to demonstrate efficacy, both as compared to placebo and as compared to brepo 15 milligrams. And in spite of that, as I walk through, we really see exceptional data from the brepo 45 milligram dose arm. So turning to slide 15 to get into the efficacy results. On the left hand of this slide, you see the mean to CSAMI activity score change from baseline. You know, both doses, statistically significant separation from placebo as early as week 4, the first time point evaluated, and then sustained at every visit out to week 16 at the end of the trial. And then on the right here, we see the achievement of Investigator's Global Assessment 0/1 and a 2-point reduction.
Speaker #4: So , you know , sort of line of punch this is , you know , there were some imbalances . Those imbalances actually made it harder for 45mg to demonstrate efficacy , as compared to placebo and as compared to 15mg .
Speaker #4: And in spite of that , as I walk through , we we really see exceptional data from the 45 milligram dose arm so turning to slide 15 to get into the into the efficacy results on the left hand of this slide , you see the mean to Sammy activity score change from baseline .
Speaker #4: You know both doses separated statistically from placebo at the first time point evaluated, and then that separation was sustained at every visit out to week 16.
Speaker #4: At the end of the trial . And then on the right here , we see the achievement of a investigator's assessment . Zero one and a two point reduction .
Ben Zimmer: So as a reminder, this is, you know, the IGAs are a standard FDA supported endpoint for cutaneous disease. This is similar to the IGAs used in other skin indications, with scores from 0 to 4, clear, almost clear, mild, moderate, and severe. So to achieve both a 2-point reduction and a zero or one, it is, it's a very high bar. And, you know, notably, it's a high enough bar that 0 placebo patients cleared it. So you may be confused, where is the placebo line? The placebo line and the x-axis line are the same thing on this chart. And you see here, again, some early progress for both dose arms at week 4, really significant or substantial improvement at week 8, and then a stat sig improvement at week 12 and 16.
Ben Zimmer: So as a reminder, this is, you know, the IGAs are a standard FDA supported endpoint for cutaneous disease. This is similar to the IGAs used in other skin indications, with scores from 0 to 4, clear, almost clear, mild, moderate, and severe. So to achieve both a 2-point reduction and a zero or one, it is, it's a very high bar. And, you know, notably, it's a high enough bar that 0 placebo patients cleared it. So you may be confused, where is the placebo line? The placebo line and the x-axis line are the same thing on this chart. And you see here, again, some early progress for both dose arms at week 4, really significant or substantial improvement at week 8, and then a stat sig improvement at week 12 and 16.
Speaker #4: So as a reminder , this is , you know , the IGA is are a standard FDA supported endpoint for cutaneous disease . This is similar to the igas used in other skin indications , with scores from 0 to 4 clear , almost clear mild , moderate and severe .
Speaker #4: So to achieve both a two point reduction and to end at a 0 or 1 , is is a very high bar , you know , notably it's .
Speaker #4: a it's a And high enough bar that zero placebo patients cleared it . So you may be confused . Where's the placebo line .
Speaker #4: The placebo line and the x-axis line are the same thing on this chart. See here, again, some progress—and you see that early for both dose arms at week four.
Ben Zimmer: In here, on this higher bar endpoint, you do start to see brepo 15mg begin to sepa-- Sorry, brepo 45mg begin to separate some from the 15 milligram dose arm. Slide 16 has the CSAMI responder data. Again, really compelling data. I think this chart on the left, quite remarkable. As Matt alluded to, we were hoping to see a mean improvement of 5 points, and what we saw was not only a mean far in excess of that, but we saw 100% of patients in the brepo 45mg arm achieve twice that, twice the minimum clinically important difference. So, you know, really every brepo 45mg patient, a responder in this trial, and as I'll walk through momentarily, that's really corroborated by an independent patient-reported outcome as well.
Ben Zimmer: In here, on this higher bar endpoint, you do start to see brepo 15mg begin to sepa-- Sorry, brepo 45mg begin to separate some from the 15 milligram dose arm. Slide 16 has the CSAMI responder data. Again, really compelling data. I think this chart on the left, quite remarkable. As Matt alluded to, we were hoping to see a mean improvement of 5 points, and what we saw was not only a mean far in excess of that, but we saw 100% of patients in the brepo 45mg arm achieve twice that, twice the minimum clinically important difference. So, you know, really every brepo 45mg patient, a responder in this trial, and as I'll walk through momentarily, that's really corroborated by an independent patient-reported outcome as well.
Speaker #4: Really significant or substantial improvement at week eight . And then stat sig improvement at week 12 and 16 . And here on this higher bar end point you do start to see Brembo 15mg begin to sorry , 45mg begin to separate some from the arm 15 milligram dose .
Speaker #4: Slide 16 has the SASAME responder data again—really compelling data. I think this chart on the left is quite remarkable. As Matt alluded to, we were hoping to see a mean improvement of five points.
Speaker #4: And what we saw was was not only a mean far in excess of that , but we saw 100% of patients in the 45 milligram arm achieve twice that , twice the minimum clinically important difference .
Speaker #4: So , you know , really every 45 milligram patient , a responder in this trial and as I'll walk through momentarily that that's really by an corroborated independent patient reported outcome as well .
Ben Zimmer: Then you see on the right-hand side of this chart, achievement of a CSAMI less than 5. Notably, this is not an improvement by less than 5. This means that the absolute score by the end of the trial is 5 or less, which is a standard for functional remission, and you see 62% of brepo 45mg patients achieving that, compared to no placebo patients. So, so again, this data are quite in line with the IGA 2-point improvement to 0/1 that I walked through before. So, so again, seeing pretty consistent data here across multiple endpoints. Turning now to the patient-reported outcomes. Slide 17 has the Skindex-16. This is a, again, a pretty established standard metric in inflammatory skin disease trials.
Ben Zimmer: Then you see on the right-hand side of this chart, achievement of a CSAMI less than 5. Notably, this is not an improvement by less than 5. This means that the absolute score by the end of the trial is 5 or less, which is a standard for functional remission, and you see 62% of brepo 45mg patients achieving that, compared to no placebo patients. So, so again, this data are quite in line with the IGA 2-point improvement to 0/1 that I walked through before. So, so again, seeing pretty consistent data here across multiple endpoints. Turning now to the patient-reported outcomes. Slide 17 has the Skindex-16. This is a, again, a pretty established standard metric in inflammatory skin disease trials.
Speaker #4: You see on the right, and then hand this side of achievement of a less than five. Notably, this is not an improvement by less than five.
Speaker #4: This means that the absolute score by the end of the trial is five or less , which is a standard for functional remission .
Speaker #4: And you see 62% of 45 milligram patients achieving, compared to none of the placebo patients. So again, this data are quite consistent with the IGA two-point improvement to zero or one that I walked through before.
Speaker #4: So so again seeing pretty consistent data here across multiple endpoints . Turning now to the patient reported outcomes . Slide 17 has the Skindex 16 .
Ben Zimmer: You see excellent data here, with the placebo group worsening, brepo 45 milligrams and 15 milligrams, both improving substantially, well above the minimum clinically important difference. Again, here with brepo 45 milligrams outperforming 15 modestly, and both doses really far better than placebo. Slide 18, we have the KSQ skin domain, so this is the King Sarcoidosis Questionnaire. It's a PRO for sarcoidosis overall, not just limited to skin disease. What we focused on in our initial TLR was the skin-specific domains, and you see here very in line with the Skindex in terms of the data. So just yet another data point of very compelling evidence of benefit.
Ben Zimmer: You see excellent data here, with the placebo group worsening, brepo 45 milligrams and 15 milligrams, both improving substantially, well above the minimum clinically important difference. Again, here with brepo 45 milligrams outperforming 15 modestly, and both doses really far better than placebo. Slide 18, we have the KSQ skin domain, so this is the King Sarcoidosis Questionnaire. It's a PRO for sarcoidosis overall, not just limited to skin disease. What we focused on in our initial TLR was the skin-specific domains, and you see here very in line with the Skindex in terms of the data. So just yet another data point of very compelling evidence of benefit.
Speaker #4: This is, again, a pretty established standard metric in inflammatory skin disease data trials. Excellent. You see here, with the placebo group, both worsening and improving. Both 45 mg and 15 mg.
Speaker #4: Substantially well above the clinically minimum important difference here with. Again, 45 mg outperforming 15 mg modestly, and both doses really far better than placebo.
Speaker #4: Slide 18 . We have the csq skin domain . So this is the king sarcoidosis questionnaire . It's a pro for sarcoidosis . Overall not just limited to skin disease .
Speaker #4: What we focused on in initial our TLR was the skin specific domains . And you see here very in line with the Skindex .
Speaker #4: And in terms in terms of of the of the data . So just yet another data point , a very compelling evidence of benefit finally , the on efficacy side , I alluded to this before , but on slide 19 would call it the patients global impression of change .
Ben Zimmer: And, and finally, on the efficacy side, I, I alluded to this before, but, on slide 19, we call it the patient's global impression of change. So this is a single question where patients are asked, since they started taking the study medication, how would they describe the overall change in their sarcoidosis symptoms? And they can, answer no change, or, some degree of improvement, or some degree of worsening. I think this is a powerful endpoint for its simplicity, and notably, 100% of brepo 45mg patients reported that they improved, again, consistent with the CSAMI data, where we saw 100% response rate. So, so very compelling here. Brepo 15mg, also very considerable improvement for most patients, although 2 patients in the brepo 15mg group did not,
Ben Zimmer: And, and finally, on the efficacy side, I, I alluded to this before, but, on slide 19, we call it the patient's global impression of change. So this is a single question where patients are asked, since they started taking the study medication, how would they describe the overall change in their sarcoidosis symptoms? And they can, answer no change, or, some degree of improvement, or some degree of worsening. I think this is a powerful endpoint for its simplicity, and notably, 100% of brepo 45mg patients reported that they improved, again, consistent with the CSAMI data, where we saw 100% response rate. So, so very compelling here. Brepo 15mg, also very considerable improvement for most patients, although 2 patients in the brepo 15mg group did not,
Speaker #4: this is a single So question where patients are asked started taking the study medication , how would they describe the overall change in their sarcoidosis symptoms .
Speaker #4: And they can answer no change or some degree of improvement or some degree of worsening . I think this is a powerful endpoint for its simplicity and notably , 100% of 45 milligram patients reported that they improved again , consistent with the Sasame data , where we saw 100% response rate .
Speaker #4: So , so very compelling here . 15mg also very considerable improvement for most patients , patients in the 15mg group did not . Not only did not report improvement , but actually reported worsening and then group , in the very little improvement .
Ben Zimmer: Not only did not report improvement, but actually reported worsening. And then, in the placebo group, very little improvement, and most patients reported either worsening or no change. Turning to slide 20, safety data. You know, I think, you know, very well—Brepo was very well tolerated during this study. We had no SAEs in the study, and all adverse events were graded mild or moderate in severity. So, you know, again, the backdrop of this efficacy data, in particular, certainly, you know, the safety data we see would, you know, would tee up a potentially very favorable benefit-risk profile for brepocitinib for these patients. Obviously, we have over 1,500 patients of data in brepocitinib, and so the overall safety database is characterized by much more than just these results.
Ben Zimmer: Not only did not report improvement, but actually reported worsening. And then, in the placebo group, very little improvement, and most patients reported either worsening or no change. Turning to slide 20, safety data. You know, I think, you know, very well—Brepo was very well tolerated during this study. We had no SAEs in the study, and all adverse events were graded mild or moderate in severity. So, you know, again, the backdrop of this efficacy data, in particular, certainly, you know, the safety data we see would, you know, would tee up a potentially very favorable benefit-risk profile for brepocitinib for these patients. Obviously, we have over 1,500 patients of data in brepocitinib, and so the overall safety database is characterized by much more than just these results.
Speaker #4: And most patients reported either, or change worsening to slide. Turning to slide 20. Safety data, I think you know very well. You know, it was well tolerated during this study.
Speaker #4: We had in this no assays study . And all adverse were events graded mild or moderate in in severity . So , you know , against the backdrop of this efficacy data in particular , certainly , you know , safety data , we see would , you know , would tee up a potentially very favorable benefit risk profile for brepocitinib for these patients .
Speaker #4: Obviously , we have over 1500 patients of of data in Brepocitinib . And so the overall safety database is characterized by by much than than more just these results .
Ben Zimmer: But, you know, certainly here, you know, nothing that would really add anything to what's already known about the drug from that perspective. And I think, again, starting to dose it now in this particular patient population, I think we see the early signs of a very indication-specific, compelling benefit-risk profile. So just to wrap up very quickly before handing it back to Matt, you know, really compelling of benefit. The effect sizes we see here are extremely large. We see them very consistently across multiple different endpoints, including independent patient-reported and physician-reported assessments, very high response rates, including the 100% response rate for the brepocitinib 45 milligrams arm, and a rapid onset of action sustained over time. So, you know, really exciting results.
Ben Zimmer: But, you know, certainly here, you know, nothing that would really add anything to what's already known about the drug from that perspective. And I think, again, starting to dose it now in this particular patient population, I think we see the early signs of a very indication-specific, compelling benefit-risk profile. So just to wrap up very quickly before handing it back to Matt, you know, really compelling of benefit. The effect sizes we see here are extremely large. We see them very consistently across multiple different endpoints, including independent patient-reported and physician-reported assessments, very high response rates, including the 100% response rate for the brepocitinib 45 milligrams arm, and a rapid onset of action sustained over time. So, you know, really exciting results.
Speaker #4: But you know, certainly here, you know, nothing really to add that would anything to what's already known about the drug. From that perspective.
Speaker #4: And I think , again , dose it now in this patient particular I signs we early think of a very indication specific , compelling benefit risk profile .
Speaker #4: So just to wrap up quickly before handing it back to Matt, you know, really compelling, very evidence of benefit. The effect sizes we see here are extremely large.
Speaker #4: We see them very consistently across multiple different endpoints , including independent patient reported and physician reported assessments very response high rates , including the 100% response rate for the 45mg arm and a rapid onset of action sustained over time .
Ben Zimmer: We're really excited to move this ahead to phase 3, and potentially have the first approved therapy for sarcoidosis. So I look forward to discussing any questions later, and I'll hand it back to Matt.
Ben Zimmer: We're really excited to move this ahead to phase 3, and potentially have the first approved therapy for sarcoidosis. So I look forward to discussing any questions later, and I'll hand it back to Matt.
Speaker #4: So , you really exciting results . We're really excited to move this ahead to phase three and potentially have the first approved therapy for for sarcoidosis .
Matt Gline: Thanks, Ben. Yeah, look, we're, we're just terrifically excited about this data, about what it, what it means for us and what it means for these patients. You know, on slide 22, just sort of as a reminder of what the picture for brepocitinib now looks like. You know, people toss around the phrase pipeline in a product for a lot of different products. I feel at this point, looking across the indication set for, for Breppo, even with what we've talked about already with CFDM and NIU, where we get to a very large addressable patient population, these are patients who, in every one of these indications, lacks efficacious therapies, and is in need of options.
Matt Gline: Thanks, Ben. Yeah, look, we're, we're just terrifically excited about this data, about what it, what it means for us and what it means for these patients. You know, on slide 22, just sort of as a reminder of what the picture for brepocitinib now looks like. You know, people toss around the phrase pipeline in a product for a lot of different products. I feel at this point, looking across the indication set for, for Breppo, even with what we've talked about already with CFDM and NIU, where we get to a very large addressable patient population, these are patients who, in every one of these indications, lacks efficacious therapies, and is in need of options.
Speaker #4: So I look forward to discussing any questions later . And I'll hand it back to Matt .
Speaker #3: Ben . Thanks , Yeah . Look , we're just terrifically excited about this data and about what it us means for it means for and what patients .
Speaker #3: You know, on slide 22, just sort of as a reminder of what the picture for Brepocitinib is now like, you know, people toss around the phrase "pipeline in a product" for a lot of different products.
Speaker #3: I feel I, at this looking point, across the indication set for what we've—even with what we've talked about already with CSBM and NIU—where we get to a very large addressable patient population, these are patients who, in every one of these indications, lack efficacious therapies and are in need of options.
Matt Gline: We continue to add legs of the stool or opportunities that grow into these sort of first-in-class orphan inflammatory diseases that are, you know, high unmet need, important areas. And I think we've got more to come there, so stay tuned. But just starting to feel like brepocitinib is a really important medicine for us and hopefully for patients. So looking forward to continuing that journey. I'm gonna breeze through a couple of other highlights or updates across the portfolio, do a quick financial update, and then we'll do Q&A at the end. You know, super quickly on slide 24, as a reminder, IMVT-1402 remains a huge focus for us at Immunovant.
Matt Gline: We continue to add legs of the stool or opportunities that grow into these sort of first-in-class orphan inflammatory diseases that are, you know, high unmet need, important areas. And I think we've got more to come there, so stay tuned. But just starting to feel like brepocitinib is a really important medicine for us and hopefully for patients. So looking forward to continuing that journey. I'm gonna breeze through a couple of other highlights or updates across the portfolio, do a quick financial update, and then we'll do Q&A at the end. You know, super quickly on slide 24, as a reminder, IMVT-1402 remains a huge focus for us at Immunovant.
Speaker #3: continue And we to add legs of the stool or opportunities that grow that into these sort of first in class orphan inflammatory diseases that that are are , that , you know , high unmet need , important And I areas .
Speaker #3: think we've got we've got more to come there . So stay tuned . But but but just starting to feel like brepocitinib is a is a really important medicine for us .
Speaker #3: And hopefully for patients . So looking forward to continuing that that journey . I'm going to breeze through a couple of other highlights or updates across the portfolio real Financial we'll do quick .
Speaker #3: And hopefully for patients . So looking forward to continuing that that journey . I'm going to breeze through a couple of other highlights or updates across the portfolio real Financial Q&A update and then we'll do at the end .
Speaker #3: You know quickly on , super slide 24 . As a reminder , IBD 1402 remains a huge focus for at us Immunovant . We think got an Fcrn with we've potential best in class efficacy with a profile that looks , you know , favorably within the class .
Matt Gline: We think we've got an FcRN with potential best-in-class efficacy, with a safety profile that looks, you know, favorably within the class. Obviously, convenient administration with a subQ auto-injector. We're pleased again here, pipeline and product potential, again, with Graves among our lead indications, where we're, you know, expecting pivotal data in 2027. We're now, as I mentioned earlier, expecting the D2-DRA data, later this year, and that study is fully enrolled. We actually enrolled 170 patients in that study, up from the anticipated 120, originally, and that was in part just due to speed of enrollment and the level of enthusiasm, from the patient and doc community.
Matt Gline: We think we've got an FcRN with potential best-in-class efficacy, with a safety profile that looks, you know, favorably within the class. Obviously, convenient administration with a subQ auto-injector. We're pleased again here, pipeline and product potential, again, with Graves among our lead indications, where we're, you know, expecting pivotal data in 2027. We're now, as I mentioned earlier, expecting the D2-DRA data, later this year, and that study is fully enrolled. We actually enrolled 170 patients in that study, up from the anticipated 120, originally, and that was in part just due to speed of enrollment and the level of enthusiasm, from the patient and doc community.
Speaker #3: Obviously convenient administration subcu with a . And appraise here pipeline and product potential again with graves among our lead indications we're where expecting pivotal data in 2027 , we're now , mentioned as I earlier , expecting the Dtra data later this year .
Speaker #3: And that study is fully enrolled . We enrolled 170 patients in that study , up from the anticipated 120 And that was in part just due to speed of enrollment and the level of enthusiasm from the patient community moving over to Moseley on 25 .
Matt Gline: Moving over to mosliciguat on 25, and we'll definitely spend some time later this year, talking more about PH-ILD and mosliciguat and setting the stage for what we expect there. But that study is fully enrolled, with thanks to those patients, investigators, and the Pulmovant team. PH-ILD remains an exciting opportunity for us, where, you know, targeted delivery gets at a disease where lung is the primary site of disease activity. We think we have a convenient once-daily dosing regimen in a disease where existing therapies mostly have multiple daily inhalations, and where there aren't very many existing therapies, bluntly. We expect or hope for tolerability benefits. And then, you know, as I think you know, we showed that really the best ever PVR reductions in the PAH population.
Matt Gline: Moving over to mosliciguat on 25, and we'll definitely spend some time later this year, talking more about PH-ILD and mosliciguat and setting the stage for what we expect there. But that study is fully enrolled, with thanks to those patients, investigators, and the Pulmovant team. PH-ILD remains an exciting opportunity for us, where, you know, targeted delivery gets at a disease where lung is the primary site of disease activity. We think we have a convenient once-daily dosing regimen in a disease where existing therapies mostly have multiple daily inhalations, and where there aren't very many existing therapies, bluntly. We expect or hope for tolerability benefits. And then, you know, as I think you know, we showed that really the best ever PVR reductions in the PAH population.
Speaker #3: And we'll definitely spend some time later this year talking more about pH Moseley and setting the stage for what we there expect. But that study is fully enrolled, with thanks to those patients, investigators, and the team remains.
Speaker #3: An area where we see an exciting opportunity is where targeted delivery gets at a disease where the primary lung is the site of disease activity.
Speaker #3: We think we have a convenient dosing once daily regimen in a disease where existing therapies mostly have multiple daily inhalations , where there aren't very many existing therapies .
Speaker #3: Bluntly , we expect or hope for tolerability benefits . And then , you know , as I think you know , we showed that really the best ever PVR reductions in the PA population , if that translates , we may be able to get we be able to get some best in class efficacy as well .
Matt Gline: If that translates, we may be able to get some best-in-class efficacy as well. So we're really excited about what we could do there later this year. I think it'll be a really important part of our story in the coming months. And then finally, as before, I'm not going to spend a ton of time talking about this today, because we're so close in here with the jury trial and the Moderna case is scheduled for 9 March. We continue to make progress there, and the sort of major update there in the recent weeks is that we got the... Earlier this week, we got the first of the summary judgment decisions, which covered a few things and had some puts and takes generally in it.
Matt Gline: If that translates, we may be able to get some best-in-class efficacy as well. So we're really excited about what we could do there later this year. I think it'll be a really important part of our story in the coming months. And then finally, as before, I'm not going to spend a ton of time talking about this today, because we're so close in here with the jury trial and the Moderna case is scheduled for 9 March. We continue to make progress there, and the sort of major update there in the recent weeks is that we got the... Earlier this week, we got the first of the summary judgment decisions, which covered a few things and had some puts and takes generally in it.
Speaker #3: So we're really excited about about what we could do there later this year and think it'll be a really important part of our story in the coming months .
Speaker #3: And then finally, as before, I'm not going to spend a ton of time talking about this today because we're so close in here.
Speaker #3: But the jury is Moderna case trial in the scheduled for We continue March 9th . progress make to there . And the sort of major update there in the recent weeks is got earlier this week .
Matt Gline: But one thing we were quite happy with is the favorable decision on Section 1498, which sets us up for the case that we were sort of quote, unquote, "hoping for in this trial," where almost all of the doses that we had asserted are gonna be covered in this jury trial. So, you know, looking forward to that and obviously more to come there. Finally, just a really brief financial update on slide 28. You know, R&D expense of $165, adjusted non-GAAP of $147 for the quarter, G&A of $175, adjusted non-GAAP of $71, for a total non-GAAP net loss of $167.
Matt Gline: But one thing we were quite happy with is the favorable decision on Section 1498, which sets us up for the case that we were sort of quote, unquote, "hoping for in this trial," where almost all of the doses that we had asserted are gonna be covered in this jury trial. So, you know, looking forward to that and obviously more to come there. Finally, just a really brief financial update on slide 28. You know, R&D expense of $165, adjusted non-GAAP of $147 for the quarter, G&A of $175, adjusted non-GAAP of $71, for a total non-GAAP net loss of $167.
Speaker #3: that we We got the first of the summary judgment decisions , which covered a few things , and had to put some takes generally in it .
Speaker #3: But one thing we were quite happy with is the favorable decision on Section 1498, which sets us up for the case that we were sort of, quote unquote, hoping for in this, where almost all of the doses that we had asserted are going to be covered in this jury trial.
Speaker #3: So looking forward to that . And and obviously more to come there . Finally , just a really brief financial update on on slide 28 .
Speaker #3: You know , R&D expense of 165 , adjusted non-GAAP of 147 for the quarter , G&A of 175 , adjusted non-GAAP of 71 , for a total total non-GAAP net loss of 167 .
Matt Gline: Cash remains very strong, $4.5 billion of consolidated cash in the business, so plenty of capital to get us, you know, to profitability with dry powder to do other things as well. As a reminder, we still have share buyback authorization, and are happy to have that sort of capability. You know, on slide 30, as discussed, just a really catalyst-rich period ahead of us. A couple of these things checked off now. Obviously, the beginnings of the summary judgment also make progress, and just feeling good across the board with a lot more updates to come this year. It should be a big year for us. And a big few years on slide 31, before I go to Q&A.
Matt Gline: Cash remains very strong, $4.5 billion of consolidated cash in the business, so plenty of capital to get us, you know, to profitability with dry powder to do other things as well. As a reminder, we still have share buyback authorization, and are happy to have that sort of capability. You know, on slide 30, as discussed, just a really catalyst-rich period ahead of us. A couple of these things checked off now. Obviously, the beginnings of the summary judgment also make progress, and just feeling good across the board with a lot more updates to come this year. It should be a big year for us. And a big few years on slide 31, before I go to Q&A.
Speaker #3: Cash remains very strong , $4.5 billion of of consolidated cash in the business . So plenty of capital to get us to profitability with dry powder to do well things as .
Speaker #3: reminder , As a other we still have share buyback authorization and are happy to that sort of happy to have capability . You know , on slide 30 .
Speaker #3: As , as discussed , just a really catalyst rich period ahead of us . A couple of these things checked off . Now , obviously , the beginnings of the summary judgment make also progress .
Speaker #3: And just feeling good across the board with a lot , a lot more updates to come this year . It should be a big year for us and a big few years on slide 31 , before I go to Q&A , you know , multiple commercial launches potential in the coming years .
Matt Gline: You know, multiple commercial launches potential in the coming years. Obviously, Breppo and DM would be first with that NDA now in. Multiple NDA and BLA filings, we continue to have even sort of more future POC study readouts, even among the ones we've already announced. And now nine or more pivotal study readouts, including cutaneous sarcoidosis, coming over this timeline, which is just a really exciting slate for us to build on. So with that, thank you again for listening. I'm gonna stop talking and open up the line for Q&A. Thank you, operator.
Matt Gline: You know, multiple commercial launches potential in the coming years. Obviously, Breppo and DM would be first with that NDA now in. Multiple NDA and BLA filings, we continue to have even sort of more future POC study readouts, even among the ones we've already announced. And now nine or more pivotal study readouts, including cutaneous sarcoidosis, coming over this timeline, which is just a really exciting slate for us to build on. So with that, thank you again for listening. I'm gonna stop talking and open up the line for Q&A. Thank you, operator.
Speaker #3: Obviously . And DM would be first with that NDA now in multiple NDA and Bla filings . We continue to have even sort of more future POC study readouts , even among the ones we've already And now nine or more pivotal study readouts , including cutaneous sarcoidosis coming over this timeline , which is just a really exciting slate for us to build on .
Ben Zimmer: Thank you. As a reminder, to ask a question at this time, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster.
Operator: Thank you. As a reminder, to ask a question at this time, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster.
Speaker #3: So with that, thank you again for listening. I'm going to stop, stop talking and open up the line for Q&A.
Speaker #3: Thank you . Operator .
Speaker #1: Thank you . As a reminder to ask a question at this time , please press Star One on your telephone and wait for your name to be announced .
Speaker #1: To withdraw your question, please press star, one, one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Corinne Johnson with Goldman Sachs.
Operator: Our first question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is now open.
Operator: Our first question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is now open.
Corinne Jenkins: Good morning, guys, and thanks for the question. You know, I think you've mentioned today and previously that you'd consider further development expansion opportunities for brepocitinib, and I'm, I'm curious how these data kind of inform the direction you'd like to go. Maybe you could also help us kind of size the opportunity set, particularly with respect to, like, what person of the patient population you think are great candidates for this relative to NIU and dermatomyositis. Thanks.
Corinne Jenkins: Good morning, guys, and thanks for the question. You know, I think you've mentioned today and previously that you'd consider further development expansion opportunities for brepocitinib, and I'm, I'm curious how these data kind of inform the direction you'd like to go. Maybe you could also help us kind of size the opportunity set, particularly with respect to, like, what person of the patient population you think are great candidates for this relative to NIU and dermatomyositis. Thanks.
Speaker #1: Your line is now open.
Speaker #5: Good morning , guys , and thanks for the question . You know , I think you've mentioned today and previously that you'd consider further development expansion opportunities for I'm curious them .
Speaker #5: how these data And can inform the direction you'd like to go . Maybe you could also help us kind of size the opportunity set , particularly with respect to person of the like what patient you think population are great candidates for this relative to NIU and dermatomyositis .
Matt Gline: Yeah, perfect, Corinne. Thanks. That's a great question. Look, I think, the first thing is we are absolutely enthusiastic about further development of brepo. We have other indications that Ben and the team are hard at work at. I don't... I think what I would say the main thing about this data is just that it continues to underscore how strong an agent brepo can be in these patient populations that need it and sort of drives enthusiasm, but I don't know that it reveals anything specific or new. Other than, you know, we're continuing to think about other forms of surrogates, et cetera. SCS is another indication where we will be the first and only drug approved, if we're successful, from here.
Matt Gline: Yeah, perfect, Corinne. Thanks. That's a great question. Look, I think, the first thing is we are absolutely enthusiastic about further development of brepo. We have other indications that Ben and the team are hard at work at. I don't... I think what I would say the main thing about this data is just that it continues to underscore how strong an agent brepo can be in these patient populations that need it and sort of drives enthusiasm, but I don't know that it reveals anything specific or new. Other than, you know, we're continuing to think about other forms of surrogates, et cetera. SCS is another indication where we will be the first and only drug approved, if we're successful, from here.
Speaker #5: Thanks .
Speaker #3: Yeah . Perfect . Corinne , thanks . That's a it's a great question . Look , I think the first thing is we are about further development absolutely we .
Speaker #3: And have other hard at are indications and the team that Ben work at . I don't I think the what I would say , the main thing about this data is just that it continues to underscore how strong an agent can be in these patient populations that need it , and sort of drives enthusiasm .
Speaker #3: But I don't know that it reveals anything specific or new other than we're continuing to think about, continuing to think about other forms of sarcoidosis, etc.
Matt Gline: And then on patient population, look, I think this is right in the sweet spot of what we've been trying to do, not just bluntly for brepo, but across the different drugs we're developing, where, you know, we're in this kinda large orphan market. And again, we might do things outside of this category, but it's been, it's been a really good space for us and for others with tens of thousands of patients, a big opportunity, high unmet need, and we think it'll be the kind of thing that we can tractably launch and that we can, that we can make a successful franchise around. So, so it feels great from an ability to benefit these patients' perspective and from a, from a commercial perspective as well. Ben, anything you'd add there?
Matt Gline: And then on patient population, look, I think this is right in the sweet spot of what we've been trying to do, not just bluntly for brepo, but across the different drugs we're developing, where, you know, we're in this kinda large orphan market. And again, we might do things outside of this category, but it's been, it's been a really good space for us and for others with tens of thousands of patients, a big opportunity, high unmet need, and we think it'll be the kind of thing that we can tractably launch and that we can, that we can make a successful franchise around. So, so it feels great from an ability to benefit these patients' perspective and from a, from a commercial perspective as well. Ben, anything you'd add there?
Speaker #3: , as CS is another indication where we will be the first and only drug approved for successful from here . And then on patient population .
Speaker #3: Look , I think this is right in the sweet spot of what we've been trying to do , not just bluntly for , but different across the drugs were developing where , you know , we're in this kind of large orphan market .
Speaker #3: And again , things outside of this we might do category , but it's been it's been a really good space for us and for others with tens of thousands of patients , a big opportunity , high unmet need .
Speaker #3: And we think it will be the kind of thing that we can tractably launch and that we can, that we can feel successful and make a franchise great from, benefit these ability to patients from around.
Ben Zimmer: I would just add that, you know, I think, and this is something we've felt already, but this data really enforces that, of the alignment of TYK2/JAK1 inhibition to T cell polarization, both as we see here, predominantly Th1 driven, but also Th17 driven. And, you know, the mechanism of TYK2/JAK1 inhibition really does align to that through IL-12 and interferon gamma, for Th1, IL-6 and IL-23 for Th17. And I think, you know, that's really one of the mechanistic hypotheses around the distinctive benefits of TYK2/JAK1 inhibition. You know, others are obviously the type one interferon suppression that's very important in dermatomyositis, in addition to the T cell polarization.
Ben Zimmer: I would just add that, you know, I think, and this is something we've felt already, but this data really enforces that, of the alignment of TYK2/JAK1 inhibition to T cell polarization, both as we see here, predominantly Th1 driven, but also Th17 driven. And, you know, the mechanism of TYK2/JAK1 inhibition really does align to that through IL-12 and interferon gamma, for Th1, IL-6 and IL-23 for Th17. And I think, you know, that's really one of the mechanistic hypotheses around the distinctive benefits of TYK2/JAK1 inhibition. You know, others are obviously the type one interferon suppression that's very important in dermatomyositis, in addition to the T cell polarization.
Speaker #3: —perspective, and from a commercial perspective as well. Then, anything you'd add there?
Speaker #4: would just I that , you add know , I think and this is something we've felt already , but this data really enforces that of the alignment of Tyk2 jak1 inhibition to T cell polarization .
Speaker #4: Both as we see here , predominantly Th1 driven , but also Th17 driven . And , you know , the mechanism of Tyk2 jak1 inhibition really does align to that through IL , IL 12 and interferon gamma for th one , IL six and IL 23 for for Th17 .
Speaker #4: And I think you know, that's really one of the mechanistic hypotheses around the distinctive benefits of TYK2/JAK1. You know, others— inhibition.
Speaker #4: are You obviously the type one interferon suppression . That's very important in dermatomyositis . In addition to the T cell polarization . But really I kind of enforces highlight that this but that would NIU , has some overlapping mechanism as obviously well , where really we had strong phase two data , excited to see that phase three result .
Ben Zimmer: But I would kind of highlight that this data really enforces that NIU, you know, has some overlapping mechanism as well, where obviously we had really strong phase 2 data. Excited to see that phase 3 result. But I think just as we think about not just kind of the unmet need of indications as Matt articulated, but also diseases where TYK2/JAK1 inhibition is going to really be, in our view, potentially better than any other form of immunosuppression. I think this data, you know, kind of reinforces some of our hypotheses there.
Ben Zimmer: But I would kind of highlight that this data really enforces that NIU, you know, has some overlapping mechanism as well, where obviously we had really strong phase 2 data. Excited to see that phase 3 result. But I think just as we think about not just kind of the unmet need of indications as Matt articulated, but also diseases where TYK2/JAK1 inhibition is going to really be, in our view, potentially better than any other form of immunosuppression. I think this data, you know, kind of reinforces some of our hypotheses there.
Speaker #4: But I think we think just as about not just kind of the unmet need of indications , as is met articulated , but also diseases where Tyk2 jak1 inhibition is going really be , in our to view , a potentially better than than any other form of immunosuppression .
Corinne Jenkins: Yeah, thanks, and congrats on the data.
Corinne Jenkins: Yeah, thanks, and congrats on the data.
Speaker #4: I think this data kind of reinforces some of our hypotheses. There.
Matt Gline: Thanks, Corinne.
Matt Gline: Thanks, Corinne.
Operator: Thank you. Our next question comes from the line of David Risinger with Leerink Partners. Your line is now open.
Operator: Thank you. Our next question comes from the line of David Risinger with Leerink Partners. Your line is now open.
Speaker #5: Thanks, and congrats on the data.
Speaker #3: Thanks .
Speaker #1: Thank you. Our next question comes from the line of David Risinger with Leerink Partners. Your line is now open.
David Risinger: Thanks very much, and let me add my congrats as well, Matt and team. So, obviously, the data was phenomenal. I had a couple questions. First, with respect to the headline CSAMI numbers, you know, 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.
David Risinger: Thanks very much, and let me add my congrats as well, Matt and team. So, obviously, the data was phenomenal. I had a couple questions. First, with respect to the headline CSAMI numbers, you know, 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.
Speaker #6: Thanks And let me much . well . Matt . And team . So obviously the data was phenomenal . I had couple questions .
Speaker #6: First, with respect to the headline numbers, they were similar between the two arms. The press release obviously mentioned different baseline characteristics.
Speaker #6: Could you just add a little more color on that second question? 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?
Matt Gline: Thanks, Dave.
Matt Gline: Thanks, Dave.
David Risinger: Thank you.
David Risinger: Thank you.
Matt Gline: Yeah, yeah. Sure. Thanks, Dave. Those are both great questions. You know, on the CSAMI report, I think Ben hit on this well in his presentation as well. You know, look, I think if you look at the table, I can pull up the slides in 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... This is a small proof of concept studies, a relatively small entity charm.
Matt Gline: Yeah, yeah. Sure. Thanks, Dave. Those are both great questions. You know, on the CSAMI report, I think Ben hit on this well in his presentation as well. You know, look, I think if you look at the table, I can pull up the slides in 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... This is a small proof of concept studies, a relatively small entity charm.
Speaker #6: Could you talk about that a little bit? Thanks so much. In DM, I'm talking about thank you.
Speaker #7: Yeah , sure .
Speaker #3: Thanks , Dave . Those are both great questions . You know I the point Ben hit on I think this well in his presentation as well .
Speaker #3: You know look I think if you look at the at the table , if I can pull up the slides in a second .
Speaker #3: But if you look at the table in the presentation on baseline characteristics , you know , I'd say there are some relatively small this is of concept small proof studies , a relatively small you arm .
Matt Gline: You can see some relatively significant differences on some aspects, including, you know, 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. And 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.
Matt Gline: You can see some relatively significant differences on some aspects, including, you know, 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. And 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.
Speaker #3: can see some relatively in each significant differences on some aspects , including , you duration of disease as well as morphology of disease with more plaque predominant are those more recalcitrant patients patients , which our on on our 45 arm than on our 15 arm .
Speaker #3: 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 #3: Again, as Ben went on to hit pretty well in the presentation, the more stringent endpoints, like the proportion of patients hitting a ten or more point.
Matt Gline: 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.
Matt Gline: 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 #3: Sesame benefit . So we feel pretty good about that translating into into phase three . 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 .
David Risinger: Thank you.
David Risinger: Thank you.
Matt Gline: Thanks, Dave.
Matt Gline: Thanks, Dave.
Speaker #3: And so, there's certainly a chance. But that ultimately is up to the FDA.
Operator: 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 #7: Thank you. Thanks, Dave.
Corinne Jenkins: Great. Thanks so much, and congrats. Really, really nice to see this data. I got a couple of questions. One is price. The IVIG is around $180, but the concomitant sort of price for VYVGART for these indications around $870 gross.
Yaron Werber: Great. Thanks so much, and congrats. Really, really nice to see this data. I got a couple of questions. One is price. The IVIG is around $180, but the concomitant sort of price for VYVGART for these indications around $870 gross.
Speaker #1: Our next question comes from the line of Yaron with open TD line is now your Werber . Cowan , .
Speaker #8: Great . much . And Thanks so congrats . Really really nice to see this data . I got a couple of questions . One is price .
Speaker #8: The IVIg is around 180 . But the concomitant total price for Vyvgart for these around 870 gross . So maybe help us understand how you're thinking about pricing of and then secondly , as you and I might be a little premature , but from Pfizer know this owns 25% of the JV .
Yaron Werber: ... 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? 'Cause you, you're not gonna be paying a dividend, but I imagine you'll have to sort of, you know, give them their 25% of the profits. Where is that gonna hit the P&L? Thank you.
Yaron Werber: ... 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? 'Cause you, you're not gonna be paying a dividend, but I imagine you'll have to sort of, you know, give them their 25% of the profits. Where is that gonna hit the P&L? Thank you.
Speaker #8: You'll obviously consolidate all sales of how handle their 25% ownership ? Because you're not going to be paying a dividend . But I imagine you'll have to sort of , you know , give them their 25% of the of the profits .
Matt Gline: Yeah. Thanks, Jerome. Those are both good questions. Look, I, I think on price, it's, we obviously have not decided on a price yet. It's, 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 IDH is probably a little bit more expensive than that in practice. That, that those bookends are a reasonable place to think about in terms of the pricing envelope for these indications, is, is what we've said before, and I think that continues to stand. I think it gives us a lot of, a lot of room. So, so you know, I think you know, stay tuned, but this will be a, this will be an orphan price drug.
Matt Gline: Yeah. Thanks, Jerome. Those are both good questions. Look, I, I think on price, it's, we obviously have not decided on a price yet. It's, 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 IDH is probably a little bit more expensive than that in practice. That, that those bookends are a reasonable place to think about in terms of the pricing envelope for these indications, is, is what we've said before, and I think that continues to stand. I think it gives us a lot of, a lot of room. So, so you know, I think you know, stay tuned, but this will be a, this will be an orphan price drug.
Speaker #8: What is that going to hit the P&L? Thank you.
Speaker #3: Thanks . Yeah . Gerald . Those are good both questions . Look , I think price , it's . We obviously have not decided on It's price yet .
Speaker #3: Too early to have an answer to that, we've said. The question before is taking bookings that are not the ones you quoted there.
Speaker #3: I think our view is IVIg is probably a little bit more expensive than that in practice , that we , the those bookends are a reasonable place to think about in terms of the pricing envelope for these what we've said before , and I think that continues to I think stand .
Matt Gline: And then, you know, on the... What I think is really sort of a, an accounting math question, so we'll fully consolidate all of the results, losses, sales, everything, 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 stake.
Matt Gline: And then, you know, on the... What I think is really sort of a, an accounting math question, so we'll fully consolidate all of the results, losses, sales, everything, 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 stake.
Speaker #3: 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 #3: Then , you know , on the what I think is sort of really an accounting math question . So we'll fully consolidate all of the results , losses , sales , everything .
Speaker #3: And then there'll be a below the line minority interest that , that , that the portion of Pfizer's attributes earnings . But again it'll be below the net income line .
Speaker #3: And then in terms of how cash comes out , obviously if we distribute cash out , Pfizer will get portion of that their cash and we'll get our portion of that cash .
Speaker #3: The only other comment I'll make there is, and we've said this elsewhere, a portion of the early relationship with Pfizer had dilution protection for their ownership stake.
Matt Gline: 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 we'll be diluted, and we'll wind up owning more.
Matt Gline: 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 we'll be diluted, and we'll wind up owning more.
Speaker #3: That that's been so for any further capital now . And enterprise and Pfizer advisor will either need to match their match . Their portion of our or spend will be diluted wind up owning more .
Yaron Werber: Thank you.
Yaron Werber: Thank you.
Matt Gline: Thanks, Jerome.
Matt Gline: Thanks, Jerome.
Operator: 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 #7: Thank you .
Brian Cheng: Hi, Matt and Ben. Congrats on the data here. 2 questions from us. As we think about the phase 3, 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 2 to phase 3 for this indication. It seems that, you know, you have a pretty large gap, you know, going from 22 to the 5-point delta that seems clinically meaningful. How should we think about the duration? And I have a 1 quick follow-up as a housekeeping question. Thank you.
Brian Cheng: Hi, Matt and Ben. Congrats on the data here. 2 questions from us. As we think about the phase 3, 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 2 to phase 3 for this indication. It seems that, you know, you have a pretty large gap, you know, going from 22 to the 5-point delta that seems clinically meaningful. How should we think about the duration? And I have a 1 quick follow-up as a housekeeping question. Thank you.
Speaker #1: Our next question comes from the line of Brian Chang with J.P. Morgan . Your line is now open .
Speaker #9: Hi , madam . Then congrats on the data here . Two 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 ?
Speaker #9: 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 indication ?
Speaker #9: three for this It seems that , you know , you pretty have a large gap , you know , going from 22 to the five point delta .
Speaker #9: That seems clinically meaningful . How should we think about deterioration ? And I . As have one quick housekeeping follow up question . Thank you .
Matt Gline: Yeah, thanks. Thanks, Brian. Look, I'm mostly going to hand over 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, you know, A, this was a relatively small study. B, there aren't a lot of other studies to go on in CS, so we kinda gotta take our guidance from here. But, but it was nice to see a local super response. Ben, you want to talk a little bit about that and about whatever we can share at this point on phase 3 design?
Matt Gline: Yeah, thanks. Thanks, Brian. Look, I'm mostly going to hand over 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, you know, A, this was a relatively small study. B, there aren't a lot of other studies to go on in CS, so we kinda gotta take our guidance from here. But, but it was nice to see a local super 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 #3: Yeah , thanks . Thanks , Brian . I'm Look , mostly going 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 .
Speaker #3: 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 #3: So we kind of got to , got to take our guidance from here . But but it was nice to see a low placebo response .
Ben Zimmer: Yeah, sure. I mean, first, just on erosion, you know, obviously, it would be hard to do any better than this. But I think that, you know, the minimum clinically important difference is, as we've discussed, the 5 points. Here we have over 20 points. We could have significant erosion and still have a very compelling data set and a very compelling product profile for patients and physicians. You know, that said, I would also note this was a US-only study, but, you know, 15 sites for the 31 patients. So, you know, this was a multicenter, multi-dose, placebo-controlled trial, very rigorous for a smaller proof of concept study.
Ben Zimmer: Yeah, sure. I mean, first, just on erosion, you know, obviously, it would be hard to do any better than this. But I think that, you know, the minimum clinically important difference is, as we've discussed, the 5 points. Here we have over 20 points. We could have significant erosion and still have a very compelling data set and a very compelling product profile for patients and physicians. You know, that said, I would also note this was a US-only study, but, you know, 15 sites for the 31 patients. So, you know, this was a multicenter, multi-dose, placebo-controlled trial, very rigorous for a smaller proof of concept study.
Speaker #3: Ben , you want to talk a little bit about that and about whatever whatever we can share at phase this point on three design ?
Speaker #4: Yeah , sure . I mean , first , on on just erosion , you know , obviously it would be it would be hard to do any better , any better than this .
Speaker #4: But I think that , you know , the minimum clinically important difference is we've discussed is five points here . We have over 20 points .
Speaker #4: We could have significant rosion and still have a very compelling data very compelling set and a product for profile for and patients physicians .
Speaker #4: You know , that said , I would also note this was a it was a US only study , but , you know , 15 , 15 sites for the 31 patients .
Speaker #4: So , you know , this was a multicenter , multi-dose , placebo controlled trial , very rigorous for a , for a you know , smaller proof of concept study .
Ben Zimmer: So while I think that there's, you know, there's always, you know, some risk 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. But, you know, broadly speaking, I think, you know, this data gives us an incredible cushion to still have, you know, an effect size in phase 3 that, you know, maybe is as large or maybe is not quite as large, but still would be extremely compelling.
Ben Zimmer: So while I think that there's, you know, there's always, you know, some risk 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. But, you know, broadly speaking, I think, you know, this data gives us an incredible cushion to still have, you know, an effect size in phase 3 that, you know, maybe is as large or maybe is not quite as large, but still would be extremely compelling.
Speaker #4: So while I think that you know , there's , 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 .
Speaker #4: But , you know , broadly speaking , I think , this you know , this data gives us an incredible cushion to to still have , you know , an effect three that size in is as maybe phase large maybe not is large , but still would be extremely quite as compelling as far as the design of the phase or three in terms of in terms of size , you know , I think we would probably be looking at , you know , at sort of similar size per arms to , you know , the DM trial roughly .
Ben Zimmer: As far as the design of the phase 3, in terms of size, you know, I think we would probably be looking at, you know, sort of similar size per arms to the DM trial, roughly. But we need to, you know, kind of take this data into consideration and, you know, 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 you know, the same is true on dose.
Ben Zimmer: As far as the design of the phase 3, in terms of size, you know, I think we would probably be looking at, you know, sort of similar size per arms to the DM trial, roughly. But we need to, you know, kind of take this data into consideration and, you know, 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 you know, the same is true on dose.
Speaker #4: 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 safety set that they would want to see to support approval .
Speaker #4: So, we'll have more to share on that after we engage with the FDA. And, you know, the same is true on dose.
Ben Zimmer: You know, I would say that, you know, I think our incoming hypothesis to this trial is that 45 milligrams, you know, is based on the totality of the 1,500 patient data we have, you know, 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 to see results from the 45 milligram arm, including on some of these, you know, higher bar, more stringent endpoints, starting to see real separation with 15 milligrams.
Ben Zimmer: You know, I would say that, you know, I think our incoming hypothesis to this trial is that 45 milligrams, you know, is based on the totality of the 1,500 patient data we have, you know, 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 to see results from the 45 milligram arm, including on some of these, you know, higher bar, more stringent endpoints, starting to see real separation with 15 milligrams.
Speaker #4: You know , I would say that , you know , I think our incoming hypothesis to , to this trial is that 45mg , you is know , based totality on the of the 1500 patient data .
Speaker #4: have , you know , We a very compelling potential option for for these patients , balancing benefit and risk . And certainly , I would say in totality , this data reinforces that , you see , you know , really excellent efficacy results from the 45 milligram arm , on some of including these higher bar , more stringent endpoints , starting to see real separation with 15mg .
Ben Zimmer: 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, you know, nothing in this data to suggest there's anything specific to cutaneous sarcoidosis separate from those. So I think, you know, broadly speaking, I would say we're very excited about 45 milligrams coming into the study. We're even more excited about it coming out of the study. You know, 15 milligrams 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: 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, you know, nothing in this data to suggest there's anything specific to cutaneous sarcoidosis separate from those. So I think, you know, broadly speaking, I would say we're very excited about 45 milligrams coming into the study. We're even more excited about it coming out of the study. You know, 15 milligrams 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 #4: And certainly then in terms of the in terms of the safety data , nothing that would suggest the the overall safety of profile 45mg that we've seen across all of the different indications in which it's been studied that that , nothing in this data to suggest there's anything specific to cutaneous separate from sarcoidosis those .
Speaker #4: So I think , you know , broadly speaking , I would say we're very excited about 45mg coming into the study or even more excited about it coming study out of the , 15mg also performed very well .
Speaker #4: And that's great to see . It really just overall speaks to the efficacy potential of of the product . And so we'll kind of have a have a update on that after we engage with the agency .
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 back to 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 back to 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 #9: Got it . Thanks , Ben . And maybe just one quick one on the side . So housekeeping 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 and is there any read through to how we should think about the setup for the data readout later this year ?
Matt Gline: No is the short answer to that question. Well, meaning there's no read-through or anything. It's just, you know, 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, how to work together with HanAll on next steps there. So that's really it. Nothing, nothing to, nothing to say.
Matt Gline: No is the short answer to that question. Well, meaning there's no read-through or anything. It's just, you know, 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, how to work together with HanAll on next steps there. So that's really it. Nothing, nothing to, nothing to say.
Speaker #9: Thank you .
Speaker #3: short answer to that question No , the , meaning no . Read through anything . It's just , you know , as we get closer to that data , depending on what we decide to do with Mab , if we decide to further develop it , we'll have to make a decision around how to how to work together with Hannah on next steps it .
Brian Cheng: Great. Thank you, Matt.
Brian Cheng: Great. Thank you, Matt.
Matt Gline: Thanks, Brian.
Matt Gline: Thanks, Brian.
Operator: 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 #3: that's really Nothing , nothing , there . nothing to say So .
Speaker #9: Thank you, great. Matt.
Speaker #7: Thanks , Brian .
[Analyst] (Jefferies): 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 calls. 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 sotasercept could work in the disease as well? Thank you.
[Analyst] (Jefferies): 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 calls. 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 sotasercept could work in the disease as well? Thank you.
Speaker #1: Our next question comes from the line of Dennis Ding with Jefferies. Your line is now open.
Speaker #5: Good morning .
Speaker #10: This Anthea On for Dennis . Thanks for taking our questions . And on the congratulations . I wanted to ask questions on upcoming data catalysts .
Speaker #10: First , on Daubert , can you explain how important Doctor Mitchell's testimony is to the case ? Improving direct infringement whether or and not there's any risk to that being taken out ?
Speaker #10: So to speak , ahead of trial ? And then on filled thoughts on the competitive landscape . And if so , could work in the disease as well .
Matt 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 outcomes in each case. On the PHILD question, look, I think the answer is, in theory, any drug that improves PVR could work in PHILD. Systemic vasodilation has not, in and of itself, been a great approach in PHILD, but sotasercept certainly could work in PHILD. Right now, we are slated, I believe, to be the first non-prostacyclin, non-troponin in PHILD.
Matt 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 outcomes in each case. On the PHILD question, look, I think the answer is, in theory, any drug that improves PVR could work in PHILD. Systemic vasodilation has not, in and of itself, been a great approach in PHILD, but sotasercept certainly could work in PHILD. Right now, we are slated, I believe, to be the first non-prostacyclin, non-troponin in PHILD.
Speaker #10: Thank you .
Speaker #3: Thanks both . Both great questions . Look on Dabur . As really we said , we too much can't talk about an ongoing litigation .
Speaker #3: There are a variety of motions in front of the court . What they visible are are judge will make a , and the of them .
Speaker #3: And anything range within the is possible . Obviously , we're hoping for hoping for favorable test outcomes in each case . On Floyd , question .
Speaker #3: Look , I think answer is the in theory , any drug that improves PVR could work in filled systemic vasodilation has not , in and of itself , been a great in approach failed .
Speaker #3: But it certainly could work in filled right now , we are slated , I believe , to be the filed . I suspect given the amount of unmet patient need there will be others us .
Matt Gline: I suspect, given the amount of unmet patient need, there will be others behind us, but I think we have a really favorable profile, as we enter that space. Thanks, Anthea.
Matt Gline: I suspect, given the amount of unmet patient need, there will be others behind us, but I think we have a really favorable profile, as we enter that space. Thanks, Anthea.
[Analyst] (Jefferies): Thank you.
[Analyst] (Jefferies): Thank you.
Speaker #3: But behind I think we have a really favorable profile as we enter that , as we enter that space .
Operator: Our next question comes from the line of Yasmin Rahimi with Piper Sandler. Your line is now open.
Operator: Our next question comes from the line of Yasmin Rahimi with Piper Sandler. Your line is now open.
Speaker #7: Thanks .
Speaker #5: Thank you .
Speaker #1: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.
Yasmin Rahimi: Good morning, team. Thank you so much for all the color. As an Immunovant covering analyst, would love to spend time on 1402 and get some color around the near and near term RA readout. Obviously, the study's upside. Help us understand, you know, as the study is 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 3 registrational study to be shared? And then I'll jump back in the queue.
Yasmin Rahimi: Good morning, team. Thank you so much for all the color. As an Immunovant covering analyst, would love to spend time on 1402 and get some color around the near and near term RA readout. Obviously, the study's upside. Help us understand, you know, as the study is 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 3 registrational study to be shared? And then I'll jump back in the queue.
Speaker #11: Morning, good team. Thank you so much, all, for the color for us on the immune event. Covering analysts would love to spend time on 1402 and get some color around the near-term or a readout.
Speaker #11: Obviously the studies upsides . Help us understand you know , as the study is coming to an end , reading out , what do you hope to see and how you're sort of preparing filing and how for you could actually get ready for that first phase ?
Matt 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. You 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.
Matt 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. You 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.
Speaker #11: Three registrational studies to be shared, and then I'll jump back in the Q.
Speaker #7: Thanks .
Speaker #3: Appreciate the .
Speaker #7: Question .
Speaker #3: Look , I think in terms of expectations for . I think the the short answer to that question is , on the one hand , these are high unmet need .
Speaker #3: so in And the bar for some sense , is is relatively low compared to we may be what used to seeing in . there's just On the very little other hand , Ras precedent data for drugs in late stage RA with sort of this level of pre-treatment .
Speaker #3: And so it's hard to know . 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 .
Matt Gline: Remember, these are, these are burned-out patients with pretty tough disease at this point. So you know, you know, obviously, if we-- if we're excited about the data, there's a potential for it to be a, 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, 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, you know, we'll see the data and then we'll have a better answer for that question. Thanks, Yasmin.
Matt Gline: Remember, these are, these are burned-out patients with pretty tough disease at this point. So you know, you know, obviously, if we-- if we're excited about the data, there's a potential for it to be a, 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, 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, you know, we'll see the data and then we'll have a better answer for that question. Thanks, Yasmin.
Speaker #3: So I'd say stay tuned for that . Remember , these are these are patients burned out with tough with pretty this point . So you know , obviously if we if we're excited about the data , there's a potential for it to be product .
Speaker #3: Obviously we a big will engage with the agency once we've got the data and think about what the plan looks like . 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 just because this is a relatively smaller , randomized withdrawal trial .
Yasmin Rahimi: Thanks.
Yasmin Rahimi: Thanks.
Operator: Our next question comes from the line of Prakhar Agrawal with Cantor. Your line is now open.
Operator: Our next question comes from the line of Prakhar Agrawal with Cantor. Your line is now open.
Speaker #3: But , you know , we'll see the data and then we'll have a better answer to that question . Thanks .
Speaker #5: Thanks . Thanks
Brian Cheng: Hi, good morning, and thanks for taking my questions, and congrats on these amazing results. So maybe on brepo and 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?
Prakhar Agrawal: Hi, good morning, and thanks for taking my questions, and congrats on these amazing results. So maybe on brepo and 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?
Speaker #1: next . Our question comes from line of the Prakash Agarwal with Cantor . Your line is now open .
Speaker #12: Hi . Good morning and thanks for taking my questions and congrats on these amazing results . maybe on repo in CS , just wanting to better understand the market opportunity You've talked about 40,000 eligible patients .
Speaker #12: all of these be Would eligible for therapy . And meet the inclusion exclusion criteria for the trial ? And if that's the case , do you think this is similar or size opportunity as dermatomyositis .
Prakhar Agrawal: ... Maybe just one follow-up on the phase 3 design. Would the time point of the endpoint be 16-week, similar to your phase 2, given your, you already have the safety database, or would you have to test longer? Just trying to figure out if there is any ways to accelerate development here. Thank you so much.
Prakhar Agrawal: ... Maybe just one follow-up on the phase 3 design. Would the time point of the endpoint be 16-week, similar to your phase 2, given your, you already have the safety database, or would you have to test longer? Just trying to figure out if there is any ways to accelerate development here. Thank you so much.
Speaker #12: And maybe just one follow up on the phase three design . Would the time point endpoint be of the 16 week similar to your phase two , given your you already have the safety database , or would you have to test longer just trying to figure out if there is any ways to accelerate development here .
Matt 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, you know, assuming our phase III data looks similar to our phase II 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 neuromyelitis optica, just in terms of total end. I mean, obviously, DM is, you know, 40,000 patients in treatment, but 70,000+ thousand total patients. So, you know, 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 III data.
Matt 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, you know, assuming our phase III data looks similar to our phase II 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 neuromyelitis optica, just in terms of total end. I mean, obviously, DM is, you know, 40,000 patients in treatment, but 70,000+ thousand total patients. So, you know, 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 III data.
Speaker #12: Thank you so much .
Speaker #3: Yeah , thanks . Thanks . Great questions . Look , I think the short answer on market opportunity is a this is patient population that's sick with high unmet need .
Speaker #3: And you know, assuming phase three data looks similar to our phase two data, I think a lot of these patients are going to be enthusiastic about a better treatment option.
Speaker #3: It's probably a modestly smaller than dermatomyositis . indication Just in terms of total N . I mean , DM obviously is 40,000 patients in treatment , but 70 plus thousand total patients .
Matt Gline: And then, you know, I think the short answer on Phase III design is let's just wait until we've had the conversation with FDA before we start to 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 II study, and obviously, to the extent that we can match parameters on which we're confident, we'll do that. Thanks for the questions.
Matt Gline: And then, you know, I think the short answer on Phase III design is let's just wait until we've had the conversation with FDA before we start to 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 II study, and obviously, to the extent that we can match parameters on which we're confident, we'll do that. Thanks for the questions.
Speaker #3: So, I probably think of this as an exciting opportunity, but a little bit smaller than the DM opportunity. Although, again, data.
Speaker #3: And then depends on the phase three , you know , I think the short answer on phase three design is let's just wait until we've had the conversation with FDA before .
Speaker #3: sort of We 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 two study .
Prakhar Agrawal: Mm-hmm. Thank you.
Prakhar Agrawal: Mm-hmm. Thank you.
Speaker #3: And obviously, to the extent that we can match parameters on confidence, which we will, we'll do that. Thanks for the questions.
Operator: Our next question comes from the line of Samantha Semenkow with Citi. Your line is now open.
Operator: Our next question comes from the line of Samantha Semenkow with Citi. Your line is now open.
Speaker #1: Thank you . Our next question comes from the line of Samantha Semenko with city . Your line is now open .
Samantha Semenkow: Hi, good morning. Thank you very much for taking the question, and congrats on this very good phase 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. Thank you very much for taking the question, and congrats on this very good phase 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 #5: Hi . Good for taking morning . the question . Thanks very much congrats And on this . Very faith good data wondering what .
Speaker #5: I'm of percentage 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 Brexit have impacted organ specific manifestations , and then just as a follow up , do you see there , a path to expand into other forms of sarcoidosis with Brepocitinib ?
Matt 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. 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?
Matt 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. 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 #5: Thank you .
Speaker #3: Yeah . Thanks . Look , I'll take the second of those questions , which is certainly it's something we will evaluate in terms of further places to study .
Speaker #3: And as I said before , we have ideas inside sarcoidosis that are exciting . stay So we'll be back tuned and with it .
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, you know, 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, you know, given that 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, you know, 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, you know, given that many of these patients do have multiple organs involved.
Speaker #3: 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 #4: Around Yeah . 60% of the patients had some pulmonary involvement and around 30% inclusive of that , 60% had other some organ involvement , mostly ocular We did involvement .
Speaker #4: take some exploratory endpoints related to those in the trial . We analyzed haven't that yet . Ultimately , the study was not , you know , designed or set up to evaluate benefit in those other organ systems .
Speaker #4: So I don't expect us to learn anything too meaningful from that. But it's certainly something we will take a look at.
Speaker #4: think And I the important point to note is this was a real world cutaneous sarcoidosis population . You know , given these many of these patients do have multiple organs involved .
Operator: Thank you.
Samantha Semenkow: Thank you.
Ben Zimmer: Thanks, Sam.
Ben Zimmer: Thanks, Sam.
Operator: Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is now open.
Operator: Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is now open.
Speaker #1: Thank you . Our next question comes from the line of yotsunoha with Guggenheim . Your line is now .
Prakhar Agrawal: Hey, guys. Thank you for taking my question. Quick one for me on brepo, on the data that you provided. Like, 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, you know, further... Do you expect further deepening, further separation? Just talk about, you know, if somebody gets treated for a year, how should we think about it? And then, you know, if you can just talk about the scope and the size, I don't know if you touched on that already, of the phase 3 study. 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. Like, 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, you know, further... Do you expect further deepening, further separation? Just talk about, you know, if somebody gets treated for a year, how should we think about it? And then, you know, if you can just talk about the scope and the size, I don't know if you touched on that already, of the phase 3 study. Should it be similar to what you did in DM? Thank you so much.
Speaker #13: Hey , guys . Thank you for taking my question . A quick one for me on Bravo , on the data that you provided .
Speaker #13: Like if you look at the curves , they continue to deepen over 16 weeks . So I'm just curious to from understand you how should we think about further ?
Speaker #13: Do you expect further deepening, further separation? Just talk about if somebody gets treated for a year—how should we think about it?
Speaker #13: you can And then , just talk about the you know , if scope and the size , I don't know if you touched on that already of the Should it similar to what you did in in DM ?
Matt Gline: Yeah, thanks. I mean, just to reiterate on phase 3, and I think Ben, you know, shared a thought about that, but I think in general, until we talk to FDA, it's, like, hard to commit to a specific study design. So I think, like, 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. And 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 the various features.
Matt Gline: Yeah, thanks. I mean, just to reiterate on phase 3, and I think Ben, you know, shared a thought about that, but I think in general, until we talk to FDA, it's, like, hard to commit to a specific study design. So I think, like, 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. And 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 the various features.
Speaker #13: Thank you so much .
Speaker #3: Yes . Thanks . I mean , just to reiterate on phase three , and I think , Ben , you know , shared a thought about that , but but in I think general we until we talk to FDA , it's hard to it's hard to commit to a specific study design .
Speaker #3: So I think like let us get through that and then we'll be back with a with a full accounting of the , of the study design .
Speaker #3: But I think we're we're 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 #3: And then in terms in terms of of deepening continued just looking , we're at this data for the week . first time this So I think we're continuing to explore all of the various features .
Matt Gline: I think, you know, it's funny, one of the KOLs who was also involved with the study gave a quote to some journalists. What do you think 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 III program, it'd be a huge win. So, you know, I think we should be all set there.
Matt Gline: I think, you know, it's funny, one of the KOLs who was also involved with the study gave a quote to some journalists. What do you think 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 III program, it'd be a huge win. So, you know, I think we should be all set there.
Speaker #3: I think , you know , it's funny , one of the one of the Kols who was was also involved with the study , gave a quote to some , some journalists .
Speaker #3: do you think his When 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 .
Speaker #3: Look , obviously , long story short , there are certainly potential ways for this data to be even better with longer therapy . other With but I think parameters , the answer is if we can , if we can come close to replicating this in a phase three program , would be it'd be a huge win .
Prakhar Agrawal: Excellent, guys. Thank you.
Yatin Suneja: Excellent, guys. Thank you.
Operator: 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 #3: So , you know , I think we should be we should be all set there .
Speaker #13: guys . Excellent , Thank you .
Speaker #1: Thank you . Our next question comes from the line of Tassell with Douglas H.C. Wainwright . Your line is now open .
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, you know, we've seen great results, obviously, in CS today, on DM as well as NIU. You know, there is obviously a lot of data, with JAK inhibitors, in various indications, but not necessarily, you know, 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 effect 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, you know, we've seen great results, obviously, in CS today, on DM as well as NIU. You know, there is obviously a lot of data, with JAK inhibitors, in various indications, but not necessarily, you know, 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 effect that you're starting to see? Thank you.
Speaker #14: Hi . Good morning . Thanks for taking the questions . I guess , Matt , I'm just curious with how broad now are you thinking about the opportunity , I mean , right ?
Speaker #14: I you know , think , we've results . great seen Obviously , in CS today on DM as well as NIU . You know , there is obviously a lot of data with , you know , with , Jack inhibitors in various indications .
Speaker #14: But not necessarily , , full randomized you know trials or proof of concept . I mean , is that the breadth of universe or is other there white you're also thinking about space that where Jax hasn't been at explored all ?
Speaker #14: But it's worth, perhaps, exploration, just given the magnitude of effect that starting you're—thank you.
Matt Gline: ... Sorry, could you just, yeah, how broad are we thinking about the brepo opportunity? Thank you, Doug. Great, 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, you know, I think there's a lot of opportunity here. I'll just reiterate something Ben said, and Ben, if you wanna do it again as well, I think it's a really good point to hit.
Matt Gline: ... Sorry, could you just, yeah, how broad are we thinking about the brepo opportunity? Thank you, Doug. Great, 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, you know, I think there's a lot of opportunity here. I'll just reiterate something Ben said, and Ben, if you wanna do it again as well, I think it's a really good point to hit.
Speaker #3: Yeah . How broad are thinking about the opportunity ? Thanks , Doug . Great . Great question . I Look , , I look I think the short is I answer think you can see from our indication selection that already we've been creative and thoughtful in going after indications with high unmet need , including lots of places where jaks have not been explored .
Speaker #3: think You know , I there's there's a lot of opportunity here . I'll just reiterate something , Ben said . And Ben , if you want to , you want to do it again .
Matt Gline: Look, I think anywhere that TYK and JAK are both important is a particular area of focus for it, 'cause it gets at the uniqueness of our mechanism, and I think we've done a really nice job, again, thanks to, to Ben and, and a bunch of people at Roivant as well, the private team, on exploring that biology. I think we have more ideas in that category. Ben, anything you need to add there, mechanistically or otherwise?
Matt Gline: Look, I think anywhere that TYK and JAK are both important is a particular area of focus for it, 'cause it gets at the uniqueness of our mechanism, and I think we've done a really nice job, again, thanks to, to Ben and, and a bunch of people at Roivant as well, the private team, on exploring that biology. I think we have more ideas in that category. Ben, anything you need to add there, mechanistically or otherwise?
Speaker #3: Well , I think it's a really good point to hit . Look , I think anywhere that tick and Jack are both important is a particular area of focus for it , because it gets at the uniqueness of our mechanism .
Speaker #3: And I think we've done a really nice job . Again , Ben thanks to and a bunch of people as well on the team exploring that biology , I think we have more ideas in that category than You sort of add their anything .
Ben Zimmer: No, I mean, I think I covered it earlier. I would say that the answer is both. I think there are some, you know, 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, you know, highly de-risked. I also think as we... To your point, as we continue to see more and more excellent data here, I, you know, I think we're definitely looking into some, you know, to some obviously, higher risk, but also exciting potential opportunities where there's less proof of concept and, you know, 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, you know, 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, you know, highly de-risked. I also think as we... To your point, as we continue to see more and more excellent data here, I, you know, I think we're definitely looking into some, you know, to some obviously, higher risk, but also exciting potential opportunities where there's less proof of concept and, you know, we would see what we end up with there.
Speaker #3: mechanistically or otherwise .
Speaker #4: No , I mean , I think I covered it earlier , I would say would , I that the answer is both . I think there are some indications where there's maybe some IIT's or clinical reports from off label use of other Jak where we inhibitors , think tyk2 jak1 inhibition is really optimally suited for it .
Speaker #4: And I are think those indications we're evaluating that would obviously highly be de-risked . I also think as we to your point , as we continue to see more and more excellent data here , you know , I think we're definitely looking into some , you know , to some obviously higher risk , but also exciting potential opportunities where there's less of proof concept you and , know , we would see what we end up with there .
Douglas Tsao: Matt, if I can, one follow-up, just, you know, obviously, business development has always been such a big part of the Roivant story, but just given the sort of expanding horizons for both brepocitinib as well as, you know, 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, you know, obviously, business development has always been such a big part of the Roivant story, but just given the sort of expanding horizons for both brepocitinib as well as, you know, IMVT-1402, how are you thinking about capital allocation in terms of external versus sort of just internal R&D investment? Thank you.
Speaker #14: And Matt , if I can one follow up just , you know , obviously business development has always been such a big part of the more story .
Speaker #14: But just given the sort of expanding horizons for both repo as well as , you Imv , you know , 1402 how are know , about capital you thinking allocation in terms of external versus sort of internal R&D investment ?
Matt Gline: Dollars go to the best opportunity wherever they are, is the short answer to that question. Look, we're funded through profitability on our existing portfolio. You know, obviously, things like running the phase three program with cutaneous sarcoidosis are no-brainers at this point, and we're definitely gonna do it. And adding additional indications for brepocitinib or for 1402 or for mosliciguat are attractive options because those mechanisms are strong and will work in other places. That said, and I'm sitting across the table from Mayukh right now, the world's full of attractive opportunities, and we look at all of them. So I think, you know, 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. Thank you, Doug.
Matt Gline: Dollars go to the best opportunity wherever they are, is the short answer to that question. Look, we're funded through profitability on our existing portfolio. You know, obviously, things like running the phase three program with cutaneous sarcoidosis are no-brainers at this point, and we're definitely gonna do it. And adding additional indications for brepocitinib or for 1402 or for mosliciguat are attractive options because those mechanisms are strong and will work in other places. That said, and I'm sitting across the table from Mayukh right now, the world's full of attractive opportunities, and we look at all of them. So I think, you know, 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. Thank you, Doug.
Speaker #14: you Thank .
Speaker #3: Dollars go to the best wherever they are . Is the short answer to that question . Look , we're funded through profitability on our existing portfolio know .
Speaker #3: You obviously things like running the phase three program in cutaneous sarcoidosis are no brainers at this definitely point . And we're going to do it and add additional indications for 1402 or for Mosley .
Speaker #3: Are attractive options because those mechanisms are strong and will work in other places . That said , and I'm sitting across the table from York right now , the world's full of attractive opportunities , and we look at all of them .
Speaker #3: 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 .
Operator: 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 #3: We are good at . Thanks , Doug .
Derek Archila: Hey, good morning, and congrats on the data. Thanks for taking the questions. So just quickly on Immunovant in terms of, you know, 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, you know, commercial synergy between Breppo and 1402. Obviously, we're an Immunovant covering analyst, so just curious how you think about fielding a sales force in the most cost-effective manner to leverage both, you know, Breppo 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, you know, 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, you know, commercial synergy between Breppo and 1402. Obviously, we're an Immunovant covering analyst, so just curious how you think about fielding a sales force in the most cost-effective manner to leverage both, you know, Breppo and 1402 between the two companies. Thanks.
Speaker #1: Our next Thank you . question comes from the line of Derek Archilla with Wells Fargo . Your line is now open .
Speaker #15: Hey , good morning and congrats on the data . Thanks for taking the questions . So just quickly on Immunovant in terms of , you know , we saw positive data for Nipocalimab in systemic lupus .
Speaker #15: So about how you think about the read through to cutaneous . And then second question , just in terms of commercial synergy between Rhepo we're obviously immunovant covering analysts .
Speaker #15: So just curious how about you think fielding a sales force in the most cost effective manner to leverage both , you know , and 1402 between the two companies ?
Matt Gline: Yeah, thanks. Look, these are, these are both really good questions, and important areas for us. You know, on SLE, first of all, I was on record long before the Breppo study in SLE, as saying that anybody who wasn't afraid of a lupus study is, I think the word I used 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.
Matt Gline: Yeah, thanks. Look, these are, these are both really good questions, and important areas for us. You know, on SLE, first of all, I was on record long before the Breppo study in SLE, as saying that anybody who wasn't afraid of a lupus study is, I think the word I used 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.
Speaker #15: Thanks .
Speaker #3: Yeah , thanks . Look , these are , these are these are both really good questions and important areas for us . on SL You know , , first of all , I was on record long before the study in SLE as saying that anybody who isn't afraid of a lupus study is , I think the word an I use is idiot .
Speaker #3: 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.
Speaker #3: It certainly supports the use of 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 some in the sense pathophysiological overlap But you there .
Matt Gline: But, you know, every lupus study of any kind is its own special flower and will have to be successful in CLE, on our own. We like cutaneous lupus in part because we know that rheumatologists are pretty good at reading those kinds of endpoints, and so we feel good about that. Again, CLE is a different competitive landscape than SLE, and we're watching that bar 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 voice share of your field force on the product.
Matt Gline: But, you know, every lupus study of any kind is its own special flower and will have to be successful in CLE, on our own. We like cutaneous lupus in part because we know that rheumatologists are pretty good at reading those kinds of endpoints, and so we feel good about that. Again, CLE is a different competitive landscape than SLE, and we're watching that bar 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 voice share of your field force on the product.
Speaker #3: , every lupus study of any kind is its own is special its own special flower . And we'll have to be successful in CLL on our own .
Speaker #3: We like cutaneous lupus , in part because we know that firms are pretty good at reading those kinds of endpoints . And so we feel good about that .
Speaker #3: Again , CLL is a different competitive landscape than SLE . And we're watching that bar as well on the sort of commercial question .
Speaker #3: Look , the first thing I'll say is even bluntly a big pharma company these days , the , the truth de novo is that for 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 want you want sort of full voice share of your field force on the product .
Matt Gline: I'm not sure I think of, like, quote-unquote, "sales force" as the most important commercial synergy, but we are definitely thinking about things like contracting expansively to make sure that we can get maximal benefit from commercial scale across the portfolio. And 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 Breppo and for the commercial performance of 1402 as those launches progress. Thanks, Derek.
Matt Gline: I'm not sure I think of, like, quote-unquote, "sales force" as the most important commercial synergy, but we are definitely thinking about things like contracting expansively to make sure that we can get maximal benefit from commercial scale across the portfolio. And 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 Breppo and for the commercial performance of 1402 as those launches progress. Thanks, Derek.
Speaker #3: And so I'm not sure I think of like quote unquote as , Salesforce the most important commercial synergy , but we are definitely thinking about things like contracting expansively to make sure that we can get maximal benefit from scale across the commercial portfolio .
Speaker #3: And definitely, there are areas where that is top of mind for us, but I think will translate to benefit both for the commercial performance of, and for the commercial performance of 1402.
Operator: Our next question comes from the line of Ashwani Verma with UBS. Your line is now open.
Operator: Our next question comes from the line of Ashwani Verma with UBS. Your line is now open.
Speaker #3: those As launches progress . Thanks , Derek .
Ben Zimmer: Oh, 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 VYVGART setback in TED. In your case, how confident are you that a positive Graves' disease readout will translate to success in thyroid eye disease? Thanks.
Ashwani Verma: Oh, 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 VYVGART setback in TED. In your case, how confident are you that a positive Graves' disease readout will translate to success in thyroid eye disease? Thanks.
Speaker #1: Next comes question four from the line of Ash Verma with UBS. Your line is open now.
Speaker #16: Oh , hi . Thanks for taking our questions . So for Barros , just upcoming Ted the results , the data that you're expecting .
Speaker #16: curious Just how you're thinking about that in the light of recent . We've got setback in Ted . In your how case , confident are you that a positive graves disease readout translate to would success in thyroid eye disease ?
Matt Gline: ... Thanks. Look, 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, like, a ton to say about that at this point. Those studies are gonna 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. You know, I think that should translate in both indications to some degree of efficacy.
Matt Gline: ... Thanks. Look, 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, like, a ton to say about that at this point. Those studies are gonna 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. You know, I think that should translate in both indications to some degree of efficacy.
Speaker #16: Thanks .
Speaker #3: Thanks . Look , appreciate the question . Obviously , Ted is is 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 like a of a ton say about that ton to at this point .
Speaker #3: Those studies going to are put the out . happen , and we'll data know from Obviously , we phase two study our own well as from our own that phase two work in the drug is in active patients with hyperthyroidism .
Matt Gline: We don't think there's a lot of read-through from TED, either in argenx's case, and argenx obviously also does it as well, or in our own situation in Graves' disease to Graves' disease, in the sense that we have... Look, obviously both - well, we have all of our phase 2 data in Graves, and the diseases are pretty different. Like, 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 FcRN in Graves' disease and not particularly focused on what information there is from TED.
Matt Gline: We don't think there's a lot of read-through from TED, either in argenx's case, and argenx obviously also does it as well, or in our own situation in Graves' disease to Graves' disease, in the sense that we have... Look, obviously both - well, we have all of our phase 2 data in Graves, and the diseases are pretty different. Like, 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 FcRN in Graves' disease and not particularly focused on what information there is from TED.
Speaker #3: know , And , you I think should both that translate in indications to some efficacy . degree of 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 graves disease in to grave's disease , in the 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 #3: 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 FcRn disease, and in Graves, not particularly focused on what information there is from TED.
Matt Gline: 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, and we'll take full advantage of that data in optimizing our Graves program. But beyond that, I'd say not much, not much read-through between the programs, and looking forward to getting all that TED data together once we've got it. Thanks, Ash.
Matt Gline: 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, and we'll take full advantage of that data in optimizing our Graves program. But beyond that, I'd say not much, not much read-through between the programs, and looking forward to getting all that TED data together once we've got it. Thanks, Ash.
Speaker #3: Obviously , once we get the Ted data and can talk about be it , there will information there from happen to patients who be various points hyperthyroid at study , and in that how those patients looked .
Speaker #3: And we'll take advantage of that full data in optimizing our graves program . that , I'd But beyond say not much , not much .
Speaker #3: Read through the and looking programs, getting forward to all that data together once we've got it. Thanks, Ash.
Operator: 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 #1: Our next question comes from the line of Thomas Smith with Leerink Partners . Your line is now open .
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 IMVT-1402 in D2CRA, 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 potentially 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 IMVT-1402 in D2CRA, 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 potentially 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 #17: 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 Dutra , and appreciate on the update timing .
Speaker #17: 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 Dutra , and appreciate on the update the data I just wanted to clarify , should we expect that you'll report both the open label and from this study together , or is there randomized data potential we could see some of that open period .
Speaker #17: label data One then as a follow first and up , we noticed on slide expectation for 31 the graves launch 28 , but not milligrams , although you're expecting phase three data for both indications in 27 .
Speaker #17: just I wanted to ask if of data timing some if there's other purely a there , or that's function strategic considerations with respect to pricing or competitive landscape .
Matt Gline: Thanks. Thanks. I appreciate, 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, 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.
Matt Gline: Thanks. Thanks. I appreciate, 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, 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.
Speaker #17: Thanks so much .
Speaker #3: Thanks . Thanks . I appreciate I appreciate both I questions . Look , think on the data release timing for the 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 randomized the withdrawal period .
Speaker #3: Before we talk about it . Obviously , that first period is open label . And so we'll information get some from it as it we go as as .
Speaker #3: then I don't think there's much to read And into the exclusion from MG in 2028 . In fact , there's probably some possibility actually does .
Matt Gline: So, you know, I think, stay tuned, and 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, more guidance on specific launch timelines.
Matt Gline: So, you know, I think, stay tuned, and 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, more guidance on specific launch timelines.
Speaker #3: In fact , also it launch in 2028 . And so , you know , I think stay tuned . And once we get data , once those that studies are the timeline of those studies , we'll be able to provide more , more guidance on specific launch timelines
Thomas Smith: Got it. Thanks for that.
Thomas Smith: Got it. Thanks for that.
Matt Gline: Thank you.
Matt Gline: Thank you.
Operator: Our next question comes from the line of Alex Thompson with Stifel. Your line is now open.
Operator: Our next question comes from the line of Alex Thompson with Stifel. Your line is now open.
Speaker #3: . Got it .
Speaker #17: Thanks . That .
Alex Thompson: Hey, great. Thanks for taking my question. Maybe, maybe one on sort of the competitive landscape in Graves. I guess with argenx entering the area and maybe trying to follow their, you know, strategy of, of chasing fast follower indications here, like, how confident are you that you can maintain your lead in Graves if argenx were to run maybe 26-week studies or even 1 instead of 2 studies? Thanks.
Alex Thompson: Hey, great. Thanks for taking my question. Maybe, maybe one on sort of the competitive landscape in Graves. I guess with argenx entering the area and maybe trying to follow their, you know, strategy of, of chasing fast follower indications here, like, how confident are you that you can maintain your lead in Graves if argenx were to run maybe 26-week studies or even 1 instead of 2 studies? Thanks.
Speaker #18: .
Speaker #1: Next, our thank you question comes from the line of Thompson Alex at Stifel. Your line is now open.
Speaker #19: Hey , great . Thanks for taking my question . Maybe , 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 can maintain your lead in graves if Argenx were to run , maybe 26 week studies or even one instead of two studies ?
Matt 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 gonna 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.
Matt 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 gonna 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.
Speaker #19: Thanks .
Speaker #3: Obviously , the extent of our lead . Thank you for the The extent of question . our lead in time graves depend a will our on study design and what they decide to do .
Speaker #3: And until we know what that design is , it's going to be hard to Certainly shorter say . studies will be faster than longer studies .
Speaker #3: Mechanically , I think we have a lead in graves that will be significant roughly no matter design Argenx runs . We have great relationships with those kols and that out We've been One of our there .
Speaker #3: community . 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 .
Matt Gline: How significant that lead is may depend a little bit on what the competitive competition does, but this is also one of those, whatever, don't 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... it doesn't really matter. The other thing I'll say is, as a reminder, we showed pretty conclusively in our phase two 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 that data together.
Matt Gline: How significant that lead is may depend a little bit on what the competitive competition does, but this is also one of those, whatever, don't 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... it doesn't really matter. The other thing I'll say is, as a reminder, we showed pretty conclusively in our phase two 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 that data together.
Speaker #3: How significant that lead is may depend a little bit on what the competition does , but this is also one of those Whatever .
Speaker #3: . No need to outrun the bear situations or whatever . I think mostly our focus is just getting those studies done quickly and out as as we can , and getting out into that population , and it's such a large and exciting population that it just doesn't .
Speaker #3: It doesn't it doesn't really matter . The other thing I'll say is , as a reminder , we showed pretty feel like we in our conclusively phase two data that the deeper IgG suppression that we expect to deliver will matter in this population .
Speaker #3: And I think especially on remission . And I think that will also be a significant factor in graves disease . so looking So forward to getting all that data together .
Alex Thompson: Thank you.
Alex Thompson: Thank you.
Matt Gline: Thanks, Matt.
Matt Gline: Thanks, Matt.
Operator: Thank you, and 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, and this concludes the question and answer session. I'd now like to turn the call back over to Matthew Gline for closing remarks.
Speaker #3: Thank you for .
Speaker #19: Thanks .
Speaker #18: Matt .
Speaker #1: 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 .
Matt 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, including particularly with the sarcoidosis data, the patients and investigators involved in that program, as well as the Priovant team for their execution there, but also everybody at Roivant and all of the patient 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.
Matt 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, including particularly with the sarcoidosis data, the patients and investigators involved in that program, as well as the Priovant team for their execution there, but also everybody at Roivant and all of the patient 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 #3: Thank you . Operator . Great . 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 , including particularly with the sarcoidosis data , the patients in 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 .
Operator: 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 #3: 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 #3: Thank you everybody and have a great day .