Ladies and gentlemen, thank you for standing by. Welcome to the VALOR Phase III study results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you would need to press star one-one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one-one again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Stephanie Lee. Please go ahead. Good morning, and thanks for joining today's call to review the VALOR phase 3 study results. 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'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I'll turn it over to Matt. Thank you. Thanks, everyone, for joining this morning. These are always the fun calls to do. So I'm really excited today to take you through and to have Ben take us through the top-line results from the VALOR study. I was going to start with a super quick reminder on slide 3, which is that 2025 is a big year for Roivant. Earlier this year and up through actually even just a few weeks ago, we've been delivering a lot of data in our anti-FcRn franchise, establishing both the deeper IgG reduction matters and laying out some of the exciting opportunities that are to come in Graves' disease. But actually, in some ways, today is the main event of the year. And so today, we're excited to present the registrational data from our study of brepocitinib and dermatomyositis, which we think should enable, yeah, a truly transformative new treatment option for these patients. So yeah, really excited to get you that data. There's other things happening in the business as well, including continued progress. There's a lot of new information going on in the docket on our LNP litigation. We'll talk about all of that another time. But today, the focus is really on Brepo and what we can deliver for DM patients. On slide 4, as a reminder, brepocitinib has been at the top of our pipeline chart for a little bit here, and dermatomyositis has been our sort of next would-be commercial program for a while. This really becomes an incredible anchor for us overall with a drug that matters for patients that lays out the beginnings of what we think should be a franchise across other indications for brepocitinib and that sets the stage for other immunology launches at Immunovant and then beyond with mosliciguat. So just the beginning of a tremendously exciting period for our pipeline and couldn't be more excited that this foot has been correctly planted. On slide 5, we will take more time again in the future to talk about what the next few years looks like for Roivant. But this slide felt aspirational when we first presented it in June in that we just have an incredible wealth of opportunity coming in the near future here, starting with today's data. And then next up in the not-too-distant future, the NIU data also coming for brepocitinib. Then shortly thereafter, a launch of Brepo in DM, a launch of Brepo, hopefully in NIU, as well as data and multiple potentially registrational indications for Immunovant. So just a stacked period ahead and one that just obviously totally transforms the profile of what Roivant is as a company. So a really exciting beginning to a really exciting moment. And I know our whole team is looking forward to the next steps here. Anyway, on to the main event for today. So we're here to talk about the highlights of the phase III data for the Valor study. I'll walk through just a little bit of that on slide 7, as well as some background information. Then hand it over to Ben to take you through full detail on the study and the data. Look, in short, this study did everything we could possibly hope for. It succeeded with highly statistically significant, robust, consistent data across the primary and all the key secondary endpoints. We saw a nice clean dose response between 15 mg and 30 mg, and 30 mg clearly established itself as the optimal dose in this setting. The responses were rapid, deep, broad, clinically meaningful on both muscle and skin. We'll talk more about that. We had a mean TIS of 46.5, a delta of over 15 points with a very low p-value. Two-thirds of patients on Brepo had at least a 30 mg, had at least a moderate response at TIS 40 and nearly half had a major response at TIS 60. Onset was rapid. Median time to TIS 40 was about two months, and TIS and CDACI responses were significant as early as week four, and we were positive on, as I say, every endpoint we formally specified in the study. So just a really, really good outcome. Safety profile was consistent with prior clinical studies. We'll flash that up a little later in the presentation. I think that's pretty striking as well. And the FDA filing is planned for the beginning of next year. Just a couple of reminders on the backdrop here before we get into the data, starting on slide 8. Look, standard of care for these patients really is a combination of corticosteroids and off-label immunosuppressive therapies. And it has been unchanged since the 1980s. There has not been a truly novel therapy approved in a very long time. And IVIG got formal approval not that long ago, but it's still used in a small minority of patients. Only about 13% of patients are on IVIG-containing regimens, and some of those are on IVIGs they've been on for a very long time. There's just a ton of patient and physician needs. These are really sick patients, high morbidity, high mortality, a lot of disability. We'll talk more about how our treatment has benefited some of those symptoms in the study. But there's been really no targeted therapy approved. We're excited to be the first with this kind of data. Then lastly, and this is also an important backdrop for all of the data we're going to talk about today, these patients are on, and this is its own independent issue associated with being a dermatomyositis patient, high-dose corticosteroids, most requiring over 10 milligrams a day for a good portion of the year, which in and of itself is a problem. It sucks to be a patient on high-dose corticosteroids. It has its own sort of common complications and side effects. So given that backdrop, there's just a huge amount of room here for a new treatment. And then on slide nine, the truth is that DM has been a graveyard. Even many of the therapies currently used off-label have failed to generate statistically significant benefits in DM studies. And you can see many targeted therapies that failed in clinical trials on the left-hand side of this page across DM and other myositis. And that potentially makes brepocitinib the first approved sort of targeted medicine here. It's an oral once-daily selective inhibitor of TYK2 and JAK1. This is the first successful registrational trial for targeted therapy in DM, the first successful 52-week placebo-controlled trial for any therapy in DM, the first successful placebo-controlled trial for any once-daily oral therapy, and it's the largest interventional DM study ever conducted. On slide 10, and I think this is part of what contributed, frankly, to that success, the biology here is pretty good for us. That is, the number of things that we do across the pathobiology of dermatomyositis is broad, and many of these aspects are important from type I interferon activity to type II interferon activity, activity on IL-12 and IL-23, which we get from TYK2, activity from IL-6. Anyway, compared with other sort of contemplated or potential therapies out there, selective JAK1 inhibitors couldn't do everything that we can do. Selective TYK2 inhibitors can't do everything that we can do, and targeted antibodies against type I interferon also cannot do everything that we think we can do for these patients. I think it bears noting on slide 11, and we'll talk about many of these endpoints in more detail and the full data set across them all later in the presentation. But just taking a step back, we hit on everything. This is a broad data set. We hit on muscle-specific endpoints. We hit on skin-specific endpoints. We hit on endpoints that show achievement of clinical response together with steroid reduction. We hit with, in many cases, extremely low p-values. This is a very statistically convincing broad study that shows meaningful improvement across a variety of really important measures for these patients. And I think that, as an aggregate takeaway, is going to be really important to docs and patients as they go through this. So that's enough of sort of preamble for me. What I'm going to do now is hand it over to Ben on slide 12 to take you through the trial design and many of the specific data points that came out of it. Ben, take it away. Great. Thanks so much, Matt. Really excited to share this data with everyone today. Starting quickly on slide 12 with the study design, a few features of the design I would highlight that are distinct from some of the other completed or ongoing myositis trials. First is the 52-week placebo-controlled duration. Second is the fact that this is a study done in dedicated dermatomyositis patients, not pooled across multiple myositis subtypes. The third is a very aggressive steroid taper, which is not seen in most other myositis studies that have been completed. And then the fourth I would highlight is the inclusion of two doses. As you know, we went direct to phase III in this program. And really, 30 mg was the dose that we were hypothesizing would be the appropriate one in this population. And we included 15 mg as well to further add to the robustness of potential efficacy in 30 m g and establish the minimum efficacious dose for an NDA filing. Turning next to slide 13, we have the background information. As you can see, the arms were well-balanced across demographics, disease activity, and background medications. Two other points I would highlight. First is this is a moderate-to-severe population, highly active on both muscle disease and skin disease. And the second is this is really a study against background standard of care, as Matt walked through earlier. You can see large numbers of patients on both steroids and immunosuppressants. And as you can see, the background steroid dose for patients is extremely high across all three arms, over 10 mg per day of steroids and approximately three-quarters of the patients on steroids. This is really consistent with what we see in the real-world data in terms of how these patients are treated today and a big burden for the patients. Turning now to slide 14 with the disposition, I would highlight that the discontinuation rate we saw in placebo was more than twice what we saw in the brepocitinib 30 mg arm. And the number of patients requiring rescue medication in placebo was also twice what we saw in the Brepo 30 arm. So again, already here, beginning to speak to the therapeutic benefits seen by patients in the trial from brepocitinib. Slide 15, now turning to the main event, we see the primary endpoint results on the mean total improvement score over time. You can see very robust, clinically meaningful, and statistically rigorous data here. That big separation between Brepo 30 and placebo starting at week four, so very rapid onset of action, sustained at every single visit thereafter, all the way after the primary endpoint at 52 weeks. Whereas Matt walked through before, we have an extremely low p-value, clear dose-dependent response at every time point, again, really establishing 30 mg here as the appropriate dose for this population as we think about benefit-risk. I would also highlight the table on the bottom right of this slide, which is that these results, highly meaningful on their own, also occurred against the backdrop of the patients on brepocitinib 30 mg dramatically reducing their steroid burden during the trial. Over 60% achieved a minimal, at least, or at most a minimal steroid dose of 2.5 mg per day. And over 40% were able to come off steroids entirely. Both of those percentages are roughly twice what was achieved in the placebo group. You really have two things happening here at the same time. One is clinical improvement relative to placebo. The second is simultaneous steroid reduction relative to placebo. We think that as we think about what actually matters to patients in the real world and what they're experiencing in the real world, which is both the direct symptoms of dermatomyositis and the toxicities of high-dose chronic steroids, this is going to be extremely compelling. Slide 16 has the TIS response data. As you can see, over two-thirds of patients achieved a moderate response or TIS 40 in the Brepo 30 arm. Nearly half achieved a major response of TIS 60. We're very excited about this result. Slide 17 contextualizes this a bit. As I mentioned upfront, it's really hard to think about direct comparisons of this data to other trials because the patient population and endpoints are so different. I think the closest endpoint durations are so different. I think probably the closest assessment would be the ProDERM trial of IVIG, which had a pretty similar patient population. That study was only placebo-controlled for a much shorter time period, but open-label IVIG was evaluated out to 40 weeks, and you can see the response rates that we achieved with Brepo 30 compare favorably to what IVIG was able to achieve, even in an open-label setting. Our data, of course, achieved in a placebo-controlled setting with the steroid reduction impacts that I have walked through before in the IVIG trial. Steroids were held constant. Slide 18 again speaks to this intersection of therapeutic benefit and simultaneous steroid reduction. As you can see, over half of patients were able to simultaneously achieve a moderate TIS response with minimal or no steroid burden, and over a third of patients on Brepo 30 were able to achieve both a major TIS response and minimal or no steroid burden out to one year, so again, we think this is going to be very compelling to patients and physicians. Slide 19, we move to the skin-specific data. This shows the CDACI, which is the gold standard endpoint for measuring skin disease in dermatomyositis. Again, you see similar to the TIS, statistically significant separation from placebo as early as week four, sustained at every visit out to week 52, and clear dose-dependent response. Again, establishing 30 mg, as we had hypothesized, coming in as the appropriate dose for this patient population. Slide 20 will note that about 60% of the patients in the trial came in with moderate-to-severe skin disease, and this is reflective, again, of the real world, where this is a moderate-to-severe skin disease that is refractory is a large share of dermatomyositis patients, and this is a highly morbid patient population, really in need of new therapies, and you can see very compelling data for this large subset of patients. The Brepo 30 mg patients achieved, on average, 63% reduction in skin disease burden, and 44% of them were able to meet the standards for cutaneous clinical remission much more than in placebo. And we think that that's really a very powerful data point in terms of the ability to generate very deep reductions in skin disease burden for these moderate-to-severe skin disease patients, which again represents a large portion, both of this study specifically and the real-world patient population. And I think coming into the readout, there was probably more confidence in skin and maybe some more questions about whether brepocitinib would also be able to provide benefit on muscle disease. And as you can see on slide 21, that question has now been pretty definitively answered. And the answer is yes, brepocitinib can help muscle disease in very meaningful ways for dermatomyositis patients. We see a few distinct data points here that all speak to that. First, I would note and remind everyone that the TIS itself is a global endpoint, but heavily weighted towards muscle disease. And particularly for a patient coming in with moderate-to-severe muscle disease at baseline, it's impossible to generate benefit on the TIS unless muscle disease is improving. And for that subset of patients, which was 75% of the study, not a small subset, you saw very significant benefit on TIS consistent with the overall study results. MMT-8, which was a physician-administered assessment of motor strength, also very good data. We hit stat sig there. And 72% of patients on Brepo 30 mg achieved a seven-point increase or greater, which is very meaningful. And then finally, this may be less familiar to people, but I actually think it is probably the most important data point on this slide, which is the HAQ-DI. This is a patient-reported outcome. It's a questionnaire that measures daily living activities, like ability to walk up five steps, ability to get out of a car, ability to dress oneself. These are the ways that muscle weakness in the end actually matters to patients in the real world. And this is a scale where the scores range from 0 to 3, where 0 is no impairment and 3 is basically completely physically disabled. And so against that backdrop of 0.3 point placebo-adjusted improvement is extremely meaningful. And again, as we think about bringing this drug to patients in the real world, that's the kind of thing that's going to matter a lot to them. And we're excited over time to continue to report out more of the patient-reported outcomes as well, which we think are going to be a very important feature of brepocitinib. Slide 22, we've covered this already through some of the data, but I would just really highlight that as you would expect with the TYK2 JAK1 mechanism of action, we saw very rapid onset with confirmed benefit as early as week four. As I mentioned before, stat sig separation from placebo on both TIS and CDACI at week four, and then the average patient achieved the minimal clinically meaningful response on TIS at 32 days, TIS 20, or 32 days, one month, and then in two months, the average patient achieved moderate response of TIS 40. So again, this is very rapid onset of action, but then importantly, as we've walked through before, actually sustained out to a full year. It's not just a quick benefit that then fades over time, and then finally, with the efficacy data on slide 23, Matt made this point already. I would just reemphasize it. And here you can see the exact data. But this is an incredibly robust and broad result across a significant number of different endpoints. The primary endpoint, critically important, we also included in the statistical analysis plan nine ranked key secondary endpoints. Every single one of those hit with clinically meaningful data and extremely low p-values, as you can see on the right hand of the slide. And again, just to repeat what Matt said, this includes measurements of muscle disease, skin disease, time to onset of benefit, the intersection of clinical response and steroid sparing, and really just a very robust, compelling data set that we're really excited to bring to FDA and then ultimately to doctors and patients in the real world. Then on slide 24, turning to safety, as Matt mentioned, the safety data here, I think, really reinforces our incoming hypothesis that brepocitinib could provide a potentially very favorable benefit-risk profile to patients with dermatomyositis. You see, generally speaking, well-balanced across the arms in terms of all of the data here. I would highlight in particular that adverse events of special interest, including cardiovascular events, thromboembolic events, and malignancies, were well-balanced across the arms. In fact, as you can see on the slide, the frequency of these occurred with a greater frequency in placebo in this study. I think what that speaks to is just the fact that the background rates of these events, both from underlying disease as well as from the toxicities of steroids and ISTs, are large in this population. There's a high unmet need for new therapies. This is a very robust safety database in just DM for a rare disease population, 241 patients out to one year. But I would also remind everyone also that the Brepo safety database overall includes 1,500 patients and subjects, well-characterized safety profile that appears consistent with approved JAK and TYK2 inhibitors. And finally, yeah, just to wrap up on slide 25 before handing it back to Matt, we're really excited by this result. And we think it can really meaningfully improve the lives of patients. I've spent, as you can imagine, a lot of time over the last few years with physicians who spend a lot of their medical practice treating these patients with patients themselves, patient advocacy groups. And these are extremely sick people who really need a new medicine. And I'm really proud of the fact that in a space that's been a bit of a graveyard for drug development, we've been able to break through this. Proud of our development team at Priovant for delivering on this outcome. Really appreciative of all the investigators and site staff who have worked so hard to deliver it. And most of all, to the patients who volunteered their time to participate in this, including in a 52-week placebo-controlled trial, which is for a very sick patient with a risk of being on placebo, really volunteering their time and life to help advance research. So really appreciative of all that, really excited about what this means. And I'll hand it back to Matt. Yeah, thanks, Ben. And I'll just reiterate, Ben, thanks. This is incredibly exciting data. This is everything really we could have hoped for in this study. It will really matter to patients. I'm excited to watch the Priovant team carry that forward. I want to reiterate, Ben, thanks for the patients and the investigators who partnered with us in the study, for our partner, Pfizer, for their work on the program, to the entire Priovant team who has worked truly tirelessly on this for a number of years, to the Roivant team who was also incredibly heavily involved over time. Just a great outcome and a lot of people working on it. Look, I'll turn it over to Q&A in just a second. There's a lot more to talk about in terms of the future, both for the program specifically and for Roivant. We're going to hold an investor day on Thursday, December 11th. There will be an in-person component for those who want to be in New York. So we'll talk more about that in the future. And I look forward to seeing many of you there and on various calls between now and then. With that, I will stop yapping and turn this call over to the operator for Q&A. Thank you. As a reminder, to ask a question, please press star one-one on your telephone and wait for your name to be announced. And to withdraw your question, please press star one-one again. And the first question will come from Dennis Ding of Jefferies. Your line is open. Hi, good morning. Thanks for the question. And congrats on the really strong data here. I had a question on just in terms of doctor feedback. Have you done market research or survey work with rheumatologists and where they see Brepo sitting in? And I know you said TIS is an artificial clinical trial endpoint that's not really relevant in practice. But what endpoint really resonates with these DM doctors? And if there's any way to quantify what percentage of their DM patients would they prescribe Brepo to, given the data you have? Thanks. Yeah, great. Thanks. Thanks, Dennis. Thanks for listening. And thanks for the question. On the conversations with docs, I'm actually going to turn it over to Ben in a second, who has a ton of those conversations all the time and can talk about feedback from rooms. Look, I think in terms of what endpoint resonates with docs and with us as we look at this data, I'll make two comments. One is all of them in aggregate is one answer to that question. That is the robustness of the data set, the breadth of the data set. I think there will be an overpowering effect to people looking at this data of seeing that it has effects in lots of different places. That said, I'll call out what Ben called out in the presentation, which is the HAQ-DI, talking about sort of patient experience living with disability. I think being able to show real separation on those sort of activities of daily living. I'm not sure that every DM patient is walking around thinking about their HAQ-DI score every day. But I think that is something where those patients are going to their doctors. And they're not saying, "Oh, my CDACI feels like it's a little bit worse this week." They're saying, "I can't climb up the stairs," or, "I can't lift things." And I think the HAQ-DI really shows our ability to benefit there. So I think those are really good endpoints t here. Ben, do you want to talk about what rheums say about treatment paradigm? Yeah. I mean, I think that there's a lot of the enthusiasm. We've done research of many different forms. I would say, broadly speaking, there is very high enthusiasm for new targeted therapies to help nearly all patients. Again, as we mentioned, the standard of care there is mostly high-dose steroids as well as ISTs. So I think very high levels of enthusiasm for a new medicine. Ultimately, every doctor would assess individually for each patient whether to prescribe it. But I would certainly think of the kind of broad eligible patient population here as nearly all DM patients, and then obviously whether it's prescribed is ultimately a patient-by-patient determination. I would also just add, again, from all the conversations I've had with rheums and derms, the steroid-sparing benefit here is, I think, very meaningful. Again, this ability to simultaneously drive clinical improvement with minimal to no steroid burden. I think the intersection of those two distinct but related benefits is really going to resonate. And that's something that I think I would highlight in particular about this data. Thanks, Dennis. Great questions. Thank you. And our next question will come from Brian Cheng with J.P. Morgan. Your line is open. Hey, guys. Thanks for taking our question. And truly congrats on the data. Maybe just first on the trial data. Can you comment on the treatment compliance in the high dose? And when it comes to the extent of the rescue medication, can you also kind of give us more color on what medications are being used and for how long? And then I have a quick follow-up. Thank you. Yeah. Thanks, Brian. Obviously, good question. And I think you can tell from the disposition slide on 14, both in terms of discontinuation rates that obviously patients on drugs discontinued at a low rate, right, only 7%, and a meaningfully lower rate than on placebo, that at some meaningful level, compliance was quite good. That is, these patients were excited to be in the study, excited to stay in the study. And the patients who were on drugs stayed in the study more. In terms of rescue, I think you sort of answered that question. I'm sure docs use a variety of things. But the most important thing you use for short-term rescue for flare-ups is steroids and increase of steroids relative to the taper protocol. And I think most of these rescued patients included a meaningful component of increased steroids because they weren't getting what they needed. Right. And then based on the profile and receptivity of Priovant among the physicians that we spoke to, and also considering the existing off-label use of JAK in this space, how should we think about pricing at this point in a grand scheme of things? How much flexibility do you have? Will you be able to anchor this to a rare disease pricing? Thanks, Brian. Also, great question. The most important answer to it is we're not going to talk specifically about pricing in advance of an approved product. Look, I think it's too early to talk about it beyond what we've already said. And I'll make two points. One is this is a novel mechanism. Dual inhibition of JAK1 and TYK2 is not approved anywhere else. So it's a completely novel mechanism. It's not like we have to be referencing or anchored to any other approved therapy. In dermatomyositis, it is a severe disease with high morbidity and high mortality. Among the sort of approved or sort of in development alternatives, IVIG, where approved, is a $250,000-a-year kind of a therapy. If you look at the FcRn space, where another agent is in development, for example, that is significantly more expensive. I think as a severity and patient population, certainly the market appears open to rare disease pricing. It is a novel drug. We think that is a reasonable place to be. That is where we are at today. I think the data is. Thank you, Brian. Thank you. Congrat s again. Our next question will come from Corinne Jenkins with Goldman Sachs. Your line is open. Thanks. I will add my congratulations to you all on this data. Maybe two quick questions for me. Maybe first, can you speak to how the kind of robust skin and muscle disease activity you saw might point to any additional indication expansion opportunities with the drug? I I know, obviously, you saw robust activity across both of those. And then can you also just talk to the sequencing you anticipate as we look forward to some of the clinical-stage assets that are in development? How do these data kind of inform your expectations for Brepo sequence and the treatment paradigm as you look forward on a three-to-five-year view? Yeah. On the first question there on indication expansion, I'll just say we have, let's say, suspected all along that Brepo was a very potent, powerful drug that would work in a variety of settings across a variety of different markers. Both the Roivant team and the Priovant team have been thinking expansively about places that we can go. And I think we have lots of ideas, so stay tuned. And I think this data is supportive of the breadth of those opportunities. But so is the other eight positive data sets we have for Brepo and other indications already. In terms of how it fits into the treatment paradigm in the medium to long term, I think Ben sort of hit at this in his conversations with the room. But in general, I think the answer is we view every dermatomyositis patient as an eligible potential recipient here. As you saw in the slide deck, only a very small percentage of these patients are on IVIG. And many are on off-label therapies that have not been proven to work. I think the existence of an oral medication with a compelling broad data set is going to create a real change in how these patients think about treatment. And frankly, almost everything else in development is also injectable. And so for the foreseeable future, it will be differentiated even as other agents may enter the market. So we think we have a lot of opportunity. Great. Thank you. Thanks, Corinne. And our next question will come from Yaron Werber with TD Cowen. And your line is open. Great. Thanks so much. And congrats really on the consistency of the data pretty much all across the board. Maybe just a couple of questions. Number one, the safety profile looks really clean and safe. And there's actually more dropouts on placebo relating to AEs. Can you discuss that? It was 11% on placebo versus 6% on Brepo. And then I think there's probably going to be a little confusion on the CDACI, on the 12% versus 7%, which shows you a 5% delta. What's clinically meaningful? We believe from physicians anything with CDACI different over 5% is clinically meaningful. So getting to 12% is pretty good. But want to know your thoughts. Thank you. Yes, thanks. Look, I think I'll take the CDACI question and maybe ask Ben to talk a little bit about the safety piece. Look, I think, first of all, just to be clear, the CDACI is not a percent. It's a scale. And so these are sort of numerical values just to be clear on what the data is. Look, I think the short answer is 12 points on CDACI is a very large clinically meaningful benefit for these patients. Maybe the way to think about this is if you just flip back to slide 20 in the deck you have in front of you. Remember that 44% of the patients on Brepo 30 achieved what we would call cutaneous clinical remission by the end of the study. So I think that gives you a sense of how significant these results are. Look, I think that is an indicator that the CDACI data I think is going to be viewed as extraordinarily lovely by dermatologists to treat these patients. Ben, do you want to comment on the safety question? Yeah, sure. I mean, I think your observation is astute. I think what the AEs leading to treatment discontinuation speaks to in the placebo arm is, as we mentioned, this is really a study on top of standard of care. And standard of care has significant safety burden in this population. There's also just reasonably high background rates of a lot of events for dermatomyositis patients just from the underlying disease. This is a very severe, highly inflammatory systemic condition that affects multiple organ systems. And I think you see that in the placebo data here. And that's consistent with what you would see in terms of background cohorts and published literature as well in terms of just dermatomyositis patients overall. So I think what it speaks to really is that what these patients need is novel efficacious steroid-sparing treatments. And I think that that's what our data set supports Brepo to be. Thanks Yaron. Great questions. And our next question will come from Prakhar Agrawal with Cantor Fitzgerald. Your line is open. Hi. Thank you for taking my questions. And congratulations on the really strong data. Maybe just following up on the CDACI and specifically on slide 19, the placebo response was also a little bit higher than what we typically expect on CDACI. So I was wondering if there was any explanation for the placebo as well, which saw seven points decrease on CDACI. And then just a couple of follow-ups. Do you plan to file for just one dose, which is the 30 mg? And if you can provide your perspective on what percentage of DM patients might be on off-label JAKs? I know it is a little bit of a hard data point to get, but any benchmark would be super helpful. Thank you. Yeah, perfect. Thanks. Look, I think on the placebo point, first of all, I just want to remind you of something that Ben said in his last answer, which is that this is not a study against placebo really. It is a study against standard of care. And these patients are in active therapy. And so part of the explanation for placebo here is that. The other piece of it that I think is notable is, remember, you're talking about normal, but this is the first time anyone studied this out to 52 weeks. And if you sit and you look at the 12 and 16 and even 24-week time points, I think those numbers are probably more in line with what you expect in other studies. Obviously, also across immunology, we've seen placebo rates change over time. And so I think there's a little component of that too. In terms of dose, look, I think this study makes very clear that 30 mg is the correct dose for this patient population. And I think that will be our intention. Ben, do you want to add something to that? Yeah. I would just add on. I agree with all of that. And I would just add, again, as an anecdotal example, in the old [Palmyra] study, the placebo on CDACI was 7.5 points at 24 weeks, not 52. So I think that this is a very difficult and challenging area to do drug development. That is what we've seen through all of the failed trials. And I think just important to bear that in mind. I think, as Matt said, 52 weeks is critical. But even at shorter time points, you'd see in placebo rates and other trials behave similarly or even with more placebo response. Thank you. Both good questions. Appreciate it, Prakhar. And the next question will come from, excuse me, Andy Chen with Wolfe Research. Your line is open. Hi. This is Emma Han for Andy. Thanks for taking our question and congrats on the data. I believe Ben mentioned more patient-reported outcomes will be reported at some point in time at a later date. When can we expect those results, and what can we expect? Thank you. I think in terms of what you can expect, I think the short answer to that question, thanks for the question, is if you look at this data set overall, I think it supports a highly active agent, and I think you can expect to see exciting outcomes in those PROs where patients were excited to be in the study, excited to be on drug. I think that's reflected in the discontinuation rates. I think it's reflected in the overall data set, so I think you'll see data that supports the profile that we're happy for. In terms of timing and process from here, obviously, those PROs are incredibly important for medical communication, for talking to physicians, for getting the physician-patient community excited about the drug. And so I think what you should expect in terms of timing is that we will use those at conferences. We'll use those at medical meetings. We'll use those as we get out and engage with that community. And I think that's going to be an important part of our activities over the next 12 to 18 months. So I think we'll see data come in that window and beyond. And the next question will come from Sam Slutsky with LifeSci Capital. Your line is open. Hey. Good morning. Thanks for taking the questions and great work on this update. Just two from me. Just any details you're able to provide on commercialization plans as you think about the number of sales reps, and then how quick you can ramp up the infrastructure for the launch, and then second question is, it looks like about 20% of patients in the study had a history of ILD. Just remind me, did you measure if there was any impact on ILD symptoms or progression? And then do any of the drugs used now for dermatomyositis have an impact here? Thanks. Great question, Sam, and I'm going to let Ben take that one. Yeah. On ILD, the results, first of all, this is a myositis study, a general myositis study, no study on ILD specifically. The TIS is a global endpoint. And so patients with ILD, that would factor into the physician's global and patient's global assessments. The results among patients with ILD at baseline are consistent with the overall patient population. None of the approved drugs to date have ILD-specific data, so I think that finding is encouraging that these patients would be appropriate for brepocitinib use to treat their overall myositis, and then the second question, hold on, sorry, commercialization, but Max and Shimon were too. The main point I would make is just this is a rare disease, and I think one of the distinctive features of a rare disease is that there's high overlap between the KOLs, clinical trial sites, and eventual prescribers of the medicine, and I think we at Priovant, in executing this trial, have been in the trenches with these physicians and patient community for several years, and I think that is really something that we're excited about as we look towards gearing up to launch the drug. I think more generally, it would just be kind of a typical rare disease structure in terms of the commercial team and organization. Yeah. Yeah. Thanks. On the commercial side, just to echo what Ben said, I think, look, it's a very concentrated prescriber base. We know a huge percentage that the Priovant team has done a great job engaging with the dermatomyositis treating physicians. We know a huge percentage of these docs. And I think there's a lot that we can learn, have learned from other recent launches in similarly rare patient populations that we have studied closely and that we're going to carry forward into this launch as well. So I think, look, I think we're building all the right pieces there. Thank you. Appreciate the questions. Thanks. And our next question will come from Samantha Semenkow with Citi. Your line is open. Hi. Good morning. Thanks very much for taking the question. And I'll add my congratulations on the data today as well. Just building on that prior question, I was wondering if you could speak a little bit to the DM landscape right now. I think, Matt, you mentioned there are only roughly 13% of patients on IVIG. I'm wondering if there are any dynamics outside of maybe IVIG just not being a suitable treatment for the majority of DM patients. I know the data today likely speaks for itself in terms of potentially driving adoption. But is there anything you can share about your expectations on what that could look like over time and how that compares to what we've seen for IVIG thus far? Thanks very much. Yeah. Thanks, Sam. I think the short answer to that question is IVIG is a very challenging thing to use. You're talking about multiple days a month for literally hours a day in an infusion center. And so I think for some patients, it's the best option for them. But I think the short answer is just the market has spoken. And by the way, I think the fact that only 13% of patients are on IVIG is a reminder that that's not really the sort of "compset" in any meaningful way. That that's a pretty specialized therapy. And that really what we're looking at here is going after the broader population who are sort of suffering through on high-dose steroids and other things and maybe even off-label therapies in a good way. And look, the other thing that we see over and over and over again in these rare disease markets is that with a highly effective therapy and with someone out there sort of talking to docs about treatment, that you see diagnosis and treatment rates go up in these patient populations with new options. So I think we're also looking to help with that. And again, I think having a once-daily oral format is going to be a huge help, especially relative to the profile of IVIG. So I think all of those things combined paint just a totally different picture. Thanks, Sam. And the next question will come from Yatin Suneja with Guggenheim. Your line is open. Guys, let me add my congratulations as well. Clear win here. Very nicely executed study. So two quick ones for me. First one is on steroid tapering potential. Could you maybe talk about how or if there is a potential to capture that on a label and how that would work? That's number one, and second one is on the responder rate, right? If you look at the responder rate up to week 52, look, pretty compelling, almost better than IVIG or in line with IVIG. But the mean reduction is a little bit different. Why that might be the case? Thank you. Yeah. Look, I think on the question of steroid sparing and how that shows up on a label, I think there's a few different things there. One is, as a reminder, among our key secondary endpoints was an endpoint that specifically showed both TIS response and minimal steroid burden. So that's a key secondary in the study. Also, obviously, the sort of clinical trial section of the label will describe the trial. It will describe the way the trial was won, the use of steroid tapering as a feature of the trial, and so I think all of those aspects will be clearly present in the script. Obviously, any labeling decision are a function of discussion with FDA, but clearly, the sort of steroid-sparing nature of the study is deeply embedded in every aspect of the trial and in every aspect of the data. The other thing, of course, is as part of our medical communication strategy, this is something docs care a lot about, and you can imagine there will be a lot of discussion on the week 52 responder rates in terms of how the difference between the responder rates and the mean IVIG changes. Look, I think the short answer is there's just some evidence of some really extraordinary responses in a lot of patients in the data. And I think that has contributed to the data you're looking at here. It's just really exciting numbers. Yeah. I mean, it's different studies, different endpoint durations. When you look at the individual patient level, these are somewhat noisy endpoints, which makes it all the more striking, the level of statistical significance that we've been able to achieve on our primary endpoint. And I think, yeah, we're really excited about the response rates we see, including the response rates that are tied to minimal or no steroid burden, as well as Matt pointed out, one of the key secondaries. Our crack team of real-time experts had another useful reminder, which is that just as a reminder, steroid tapering was included in the Benlysta U.S. label and SLE. So there is also precedent for steroid sparing winding up in labels for similar structures. Thanks. Great questions, [Paul]. And our next question will come from Douglas Tsao with H.C. Wainwright. Your line is open. Hi. Good morning. And congratulations on the data. I'm just curious, and I know it was maybe it was a robust study, but not super big. Did you see different results across patients who might have more skin or muscle involvement, just given the mechanism of action as it seemed sort of best suited for Brepo? And along those lines, when you talk to KOLs, are there certain types of patients they might want to start using Brepo in first before sort of expanding and, as they gain experience, start to use more broadly? Thank you. Yeah. Thanks. It's a great question. I'm a little hurt only because this is the largest interventional study in DM ever run. And so but I hear you. It's only 240 patients. Look, the short answer to your question is we saw extremely consistent response. In fact, on the slide in the deck, which I'm blanking on the page number right now that shows the muscle-specific subset, you can see where we looked at a subset of patients with a lot of muscle disease, and they had a slightly larger increase in TIS than the patient population as a whole. And so, look, it's clear that we saw benefit across both. In terms of where people want to use Brepo first, look, this is easy for us to say today. And obviously, we're still carrying out these conversations, and we'll be a lot. And Ben's team will be spending a lot of time with the rheum community in the days and weeks to come. I think the answer is they want to use Brepo everywhere. I think these are, but it's a new treatment option in the field that really hasn't had any in a long time. I think docs are, from our experience, just tremendously excited about having it and using it everywhere they can. So I think that's what it comes down to for us. And Matt, just as a follow-up, I mean, did you see any difference in terms of patients with significant skin involvement? No. We also looked at the TIS among patients with moderate to severe skin disease at baseline. And that data is also very consistent with the study as a whole. And as we walked through the cutaneous-specific results for those patients, they were very compelling. So I think really a very broad set of benefits we see here. Actually, even to come back to the mechanism slide that Matt showed, I think that's consistent with brepocitinib, consistent with the novel mechanism of dual TYK2 JAK1 inhibition in terms of being able to hit multiple of the inflammatory pathways involved in DM pathobiology. So I think, again, ties together nicely in terms of why we see this as a very compelling potential treatment option for these patients. Okay. Great. Thank you. Thank you, Doug. I show no further questions in the queue at this time. I would now like to turn the call back over to Matt for closing remarks. Thank you. Look, thanks, everyone, for listening this morning. I want to re-extend a huge note of gratitude to the investigators and patients in the study today and trust us with their care. I want to re-extend a huge note of gratitude to Ben and to the entire team at Priovant. It is impossible to overstate the number of sleepless nights that go into something like this to the Roivant team and to investors like you. Thank you for your support. We will be back in touch soon. In the meantime, everybody have a great day. This concludes today's conference call. Thank you for participating. You may now disconnect.