Roivant Sciences Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to a Royvent second quarter 2024 earnings call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Stephanie Lee. Ms. Lee, please go ahead.

Hi, thanks. Good morning. We're actually reviewing the third quarter ended December 31, 2024 for Roybent. I'm Stephanie Lee with Roybent presenting today. We have Matt Klein, CEO of Roybent. 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.coordinates.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 have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainty. And with that, I'll turn it over to Matt.

Thank you, Chef, and thank you, everybody, for listening. Good morning. I'm going to start on slide five, and thank you again for joining our third quarter results call. So, look, I wanted to just start by setting the stage. This is our first quarterly call in 2025. It is, we talked a little bit about this at the conference in January, but we think 2025 is just a pretty incredible year for us in terms of the setup and the opportunity. Obviously, that starts this quarter. with an opportunity to validate our NTF-CRN franchise as a potentially best-in-class franchise with data coming in MG and CIDP in the coming weeks. It continues in the middle of this year with a central registrational readout in dermatomyositis, which would set the stage for approval for commercial launch of brevacitinib. And so we're really excited about that program and excited also to talk today about a new indication for brevacitinib, in which we'll be starting a trial this year as well. And it's also a big year for our L&P litigation with Moderna and Pfizer-BioNTech with a jury trial currently scheduled for September and the summary judgment phase to take place in the second to third quarter of this year. So just a big year with a lot of important milestones, many of which we planted the seeds for years ago at this point, and so we're excited to see those results. Look, all of this ultimately on slide six comes down to our pipeline, which we think is one of the most exciting pipelines in late-stage biotech, obviously anchored by FCRN and brevisitinib, but with a number of other programs, including Lesley-Sigawat, which we unveiled last year, and also ongoing BD, which we'll talk a little more about later in this call. This year, really, on slide seven, is anchored around clinical execution, right? Obviously, in some sense, the dye has been cast for the MG and the CIDP data, which will be imminent. But there's an enormous amount of work ongoing to, we've now cleared six INDs and Immunovant. Those trials are all beginning now or have begun and are looking to initiate a number more by March of 2026. So just a ton of clinical work happening in Immunovant. Obviously, continuing to conduct the brepsytinib-DM study that we'll read out later this year, as well as the NIU data, the NIU study, which is ongoing, and then we've initiated our trial in Mosley and PHLD. So, between the data that we have coming and the work that we have to do, it's really a year-round clinical execution to drive that value. And then, you know, we have, obviously, a lot of exciting data coming this year. When we look at how we're sort of stacked for the future, Even beyond 2025, we have the potential for 10 plus indications with multi-blockbuster launches. In BRACO, we have a potential multi-blockbuster franchise in orphan immunology anchored by DM and hopefully subsequent to that, or hopefully DM and then subsequent to NIU. Approved concept study in sarcoid adding to that. And then in mostly by next year, by 2026, we hope to have by the end of next year, data on our phase two study which should, we hope, set us up for frontline use in PHLD and other respiratory disease. And all of that on slide nine is angered by what continues to be a major strength of ours, which is our cash balance. We have $5.2 billion in cash and marketable securities as of 12-31. That includes $500 million authorized for additional share buybacks. We've bought back about $1 billion in stock so far as of the end of 2024. We closed the sale of Dermavant to Organon, which is about $259 million. and removed all of our debt and meaningful retirement obligations while keeping a lot of upside in milestones. And we talked about that last year. And then this continues to be among the most fruitful or the most fruitful development environments we've ever seen. And I very much hope and expect that we'll be adding to that pipeline in the months to come. So I want to now turn to talk about a new opportunity for us, something that's probably a little bit further out, but something we're excited to get going on. It'll be public on clinicaltrials.gov soon, et cetera, et cetera. which is we have now initiated a new program for brepacitinib, our third indication. This is a proof-of-concept study in a disease called cutaneous sarcoidosis. So if you turn to slide 11, this is a, it fits really well, and I'll talk about this again in a second, into our strategy of prior advance for developing an indication with high-end that need that are specifically tailored to our dual TIK2JAK1 mechanism. First of all, in terms of sort of scope of disease, it's pretty similar, bluntly, to the other diseases that we are studying with brepo. There's somewhere between 30 and 50,000 cutaneous sarcoidosis patients with no approved therapies, and the uncontrolled disease can result in severe disfigurement. It's very tough for these patients. There is proof-of-concept data from about 20 JAK-treated patients, so not so different from what we've seen in some of the other indications we're studying. And then we think, and we'll talk more about this, dual TIK2 and JAK1 inhibition is particularly well-suited to the Th1 immunophenotype of sarcoidosis. So, we'll get to talk a little more about that. And then it's aligned with DM and NIU in terms of a prescriber-based concentration that overlaps with DM in terms of potential work and price point. So, we think it makes a lot of sense as a place for us to go from here. As a reminder on slide 12 of the overall strategy in BREPO, we're really focused on indications with very high unmet need tailored to our unique mechanism, where we think any liabilities under the JAK class will be far outweighed by our ability to deliver meaningful benefit to these patients. Obviously, DM and NIU both, in our view, met that. And CS looks pretty similar. It's got well-suited biology, a large unmet medical need, a similar patient prevalence. There is some proof of concept with JAK1 patients, and there's been nothing approved in the last 60 years. So, we're really excited to add this to our portfolio. There is, on slide 13, a little bit of proof of concept data. There was an investigator-initiated trial at Yale. providing proof of concept for JAK inhibition and cutaneous sarcoid. That was an open-label study of tofacitinib in 10 patients with long-standing CS. And considering that study, it was about 10 patients with CS, and the mean CSAMI is going to wind up being the endpoint we talk about here a lot, of 37. And patients on 5 milligrams twice an day of TOFA for six months, all of them achieved clinical immunopore reduction in CSAMI. and six of them achieved complete resolution of disease. So pretty remarkable data from that study. Again, with all the caveats of open-label studies. But for pretty sick patients, a big improvement. So that gives us a bit of comfort going into this proof-of-concept study. And then, you know, on slide 14, just from a sort of pathophysiology perspective, Th1 type immunity is the main polarization, the predominant polarization in sarcoidosis skin and lung tissue. And we know that there's more regulation of TTH1 cytokines like type 2 interferonol 12, which we think gives us potentially exactly the right profile with dual inhibition of TIK2 and JAK1, which are both obviously important in mediating that collection of cytokines. So, we feel really good about coming at this with a uniquely big gun. Breadbone has generated on slide 15 particularly strong data. in inflammatory skin disease. So, these are all cross-track comparisons with whichever other JAK inhibitors have reasonable data available. But, you know, you can see in alopecia, NHS, and plaque psoriasis, we have among the best-in-class or the best-in-class data in a cross-track comparison that's been seen. So, we feel pretty good as well about sort of entering into an inflammatory skin disease area where we have, again, good data coming out of RevCit. The study design is laid out on 16. It's a 16-week study testing two doses, BREP45 and BREP15, as well as a placebo. And, yeah, we hope to get data in the second half of next year. So more to come as that study starts enrolling. Cool. I'm going to move on now to just a reminder of what's upcoming and what's sort of happened recently in our NTFCRN franchise at Immunovans, starting on slide 18. So we have, as you all know, quite a bit of data coming this year, starting out with NG and CIDP this quarter, that we hope can bolster our confidence collectively, including your confidence, that deeper IgG reduction results in better clinical outcomes. We've obviously now seen this across many clinical trials, across four different anti-ester and antibodies in seven different indications. But we're going to get another 500 patients' worth of data out of these Botoclumab studies that we think will help us show how much better we can do with deeper IgG suppression across different indications for which patients and by which metrics. So, we're looking forward to generating that data, which, by the way, just as a reminder, nobody at Roivind or Mutavant has seen any of this data. So, any interpretation of my tone of voice should be no different from my tone of voice in the last six months. The upcoming data on slide 19 in MZ, this is just a reminder of that trial design. It's a trial that we think is well-suited to treating these patients where they're at. It is a 12-week induction study with two doses, high and low, followed by a re-randomization into a 12-week maintenance period with either the sort of low dose from the first phase or an every-other-week version of that. And we think this will give us, hopefully, a clear picture of potential dose response in that first period, as well as an understanding of what chronic treatment of these patients look like with the possibility of rescue therapy and so on. So feeling good about the trial design. We also have our upcoming battle phase 2b readout from period one of the CIGP study. That design is shown on page 20. I think you're all very familiar with these designs at this point. These are pretty complicated designs, but we're looking forward as well to the possibility after that period one, which is the highlighted in red piece here, to be able to answer some questions about possible dose response and treatment and response rates in the 12-week randomized period. Look, 1402 on slide 21 continues, in our view, to have a combination of potentially best-in-class attributes that we don't see in other programs. We have deep IgG lowering. Our Phase I data suggests we're going to continue to be able to reach about 80% IgG suppression or thereabouts with continued dosing of 600 milligrams delivered by a simple sub-Q injection. 1402 does not, in our Phase I data, appear to impact albumin or LDLs, so no minimal effect there. We have convenient administration. We will be delivered by a market-proving, user-friendly auto-injector that we will be launching with. We'll highlight that again in a second. And as a reminder, we have IP out to 2043, not including extensions, so a really long runway with a drug that we think could be best in class. By slide 22, as a reminder, we will be starting our pivotal trials or are starting our pivotal trials with a standard auto-injector. It's the only FCRM we think ever developed as a true sub-Q injector from inception. It leverages a pretty well-proven technology. It'll be a 2 mL injection volume, and this is a picture of the device, needless to say. It looks like all of the others are widely successful auto injectors, and we think this is a real benefit. It's also less than 10 seconds in at-home administration, we think, or HCP administration. So looking forward to continuing to press that form factor. And then, you know, on slide 23, look, the main event to me in the long run here is getting 1402 into indications that really matter. We are tremendously excited about Graves' disease, where we have, we think, first in class and best in class potential in an indication with extremely high unmet need, where we have run our own phase two study that shows that we lower autoantibody levels and that we have a high response rate with a good dose response. that sets us up well for success. We think both from Immunovant and from the world, you're going to be hearing a lot more about Graves' disease in the months and years to come, and we are excited to be at the front of that pack with an agent that we think is maximally positioned to deliver benefit to those patients. And then we've also announced at Immunovant that we're running a study in difficult to treat rheumatoid arthritis. We talked about that late last year. We are excited for that trial. We think it sets us up for a quick answer on how much we can do for these patients who have not a lot of other options once you get into that corner of the RA landscape. As we said, there are six IMDs approved, and this is only two of them. We've also talked about MG and CIUP, but that leaves two unannounced, but nonetheless, IMD clear indications, and we're looking forward to talking about those soon. Obviously, a lot of news coming in the near term in advance, so I'm sure we'll be in touch collectively in the near future. Finally, in terms of major upcoming milestones in 2025. We've talked only a little bit over time on these calls about the Genovant LMP litigation. We are hoping for the decision from the Pfizer-BioNTech Markman hearing in the first half of this year, so that could be upcoming. Obviously not on any fixed calendar, so it could, in theory, come any time. And then in the second quarter, third quarter of this year, we will have the important summary judgment phase in the Moderna trial. where we will learn from the important features of how that trial will progress, followed by the jury trial scheduled for September and the second half of this year. So a year where we will really learn a significant piece of the answer to the, at least in the journal puzzle here. So looking forward to that playing out as well. So I'll wrap up quickly with a financial update on slide 27 and then open up the Q&A. So relatively straightforward quarter from a financial perspective. R&D expense of 142 or adjusted of 131, G&A of 142 or adjusted of 71. And, you know, end of the quarter, as we said, with $5.2 billion in cash, which excludes the $75 million milestone from the approval of HOP dermatitis from January, as well as $113 million of external capital, which was raised alongside Roy's investment in January private placement there. And no debt on a balance sheet following the close of the Organon transaction. And so that's about that on the finance side. Look, on slide 29, we feel like we have a quite rich catalyst calendar coming with a bunch of important milestones, some of which we've talked about for this year, some of which sort of stacking the year beyond. And again, continue to be excited about adding to our pipeline, hopefully in the near future with some really exciting things we have on our racket. So with that, I will end my prepared remarks and turn it back over to the operator for Q&A. Thank you again for listening.

Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. And our first question will come from David Reisinger with Lyric Publications. partners. Your line is open.

Great. Thanks very much. So congrats on all the progress, Matt. I have two questions, please. First, could you review the Botoclumab efficacy bars for success ahead of the release of results in coming weeks? And then second, could you also discuss the additional Botoclumab GD data, the six-month treatment-free remission results that are coming this summer, including what you're hoping to see. Thanks so much.

Thanks, Dave. I appreciate the question. I confess we anticipated that it would be among the earlier questions asked this morning. Look, we have had a lot to say on this over the past month. And obviously, insofar as all of these questions get to sort of pre-data positioning, I think we finished our predated positioning with the $330 million stock that we bought in January. So I don't have a ton to add. Obviously, our view is that deeper is better has been pretty well established in our own GRAVES trial, in our own TED study, in J&J's Sjogren's study, in UCB's ITP study, and even at the individual patient level in our own and other people's MG studies. so you know i've said over and over again in some ways i think this data is a little bit less interesting to us than it seems to be to other people because it mostly is a referendum in my mind on what an mg study is able to show that said i think what we're looking for is a nice clear dose response between the two doses i think if we saw that it would give us confidence that an mg study is able to differentiate in a way that sets us up well for best in class and i think we're looking across the evidence for other things that can help us structure our 1402-MG program for maximal success. I'm glad you asked about the six-month remission data for Munivant, obviously in Graves coming later this year. We are excited about the Graves data we generated in Phase 2. I think it already offers a completely novel option with significant potential efficacy for a patient population that's had nothing. Obviously, the dream here is that not only can we get these patients under control, but that we can get at least some of the patients who are under control to stay controlled off therapy. And so my hope is that we see, I don't know exactly what the number is, but some reasonable rate, some percentage of the patients who got controlled in the initial study stay controlled off drug for a period of time after the study ended. And that's something that we think will be helpful both for patients who want to know that there's a path off therapy, and then also obviously for payers and others who I think will look at that data with interest. Thanks, Dave.

Thank you.

And the next question will come from Dennis Dean with Jefferies. Your line is open.

Hi, good morning. Thanks for taking our question. We had a question around the LNP litigation and the upcoming summary judgment. Can you help us understand the range of outcomes as it relates to 1498, meaning will the judge rule that, you know, either Moderna or the U.S. government will be liable for all the patent infringement liabilities, or could there be a middle scenario based on terms within the contract where Moderna would only be liable for damages for, I don't know, like 25, 50, 75% of the doses? Thank you.

Yes, thanks, Dennis. Appreciate the question. A couple things. First of all, it's obviously a little bit difficult to comment on an ongoing litigation, so my answers will be couched in that or with that predicate. Second of all, just as a reminder for those who are a little bit less close to it on 1498, what 1498 represents is a World War I era section of the U.S. Patent Code that is designed for government contractors who have been asked by the government to manufacture an infringing product for the government to allow the government to take on infringement liability. For example, if you were manufacturing patented jet engines for U.S. Air Force planes in World War II or something like that. So Moderna has asked for the court to acknowledge that they can use that defense for at least some of the vaccine that they have sold. They have attempted twice to get claims removed on that basis, first in an initial motion to dismiss, and then the U.S. government filed a statement of interest in the case early in 2023. And in both cases, the court declined their request So I think that is one piece of evidence. In the statement of interest moment, one thing that happened is, so 1498 has two prongs to it. There's a for the government prong and there's a with authorization and consent of the government prong. And in the statement of interest from the DOJ in early 2023, the government pointed out that of the two contracts they had signed with Moderna, Only one of them included express reference to 1498. And therefore, it seemed to them that perhaps that one was not made with authorization and consent. Anyway, we'll learn more about that in the summary judgment phase. But suffice it to say, therefore, the answer is there could be a range of outcomes on that point.

Great. Thank you so much.

And our next question will come from Yaron Werber with TD Cohen. Your line's open.

Great. Good morning. Thanks for taking. Matt, I got a couple of questions. Maybe just the first one on cutaneous sarcoidosis. This looks like a really interesting opportunity. So as you're, thanks for that slide showing us the beacon trial design. So this is a study that's got three to three to two randomization. Can you give us a little bit of a sense, sort of how do you power it? What do you want to see in terms of Delta over placebo? And then secondly, just for the Graves disease in terms of remittive ability, what would be good data from your KOL checks in terms of remissions at six months? Thank you.

Yes. Thanks, Jeroen. Those are both great questions. I appreciate them both. Oncutaneous sarcoid You know, I think the short answer is this is a proof-of-concept study. This is less about sort of powering for some specific stat-sig outcome. And more bluntly, again, there has not been, I mean, there have been some studies run in sarcoid where CSAMI was measured, but there has not been a lot of sort of research into the indication. So we're really trying to get a sense for what the placebo bar looks like, what dose response looks like, how these patients respond to therapy. Obviously, the sort of 100% meaningful improvement rate in the IIT study was encouraging, but there was no placebo in that study. And so I think we're trying to get a sense for what these response rates look like overall. And I think the benefit of the placebo arm here is to give us something to shoot for in a larger phase three study later once we understand kind of what that patient population looks like. So I think that's really what it is. And the reason we're so heavily randomized in favor of drug, first of all, is we have two doses, but second of all, is because we're looking for the study to enroll pretty quickly so that we can get this information and get on with a bigger later stage study. On Graves, you know, look, we've had quite a lot of conversations with KOLs about Graves' disease, and we think there's a lot of enthusiasm for a new treatment option. The truth is there's a lot of enthusiasm for a new treatment option among prescribers, even if it does not bring about remission. But I think patients would be excited to see a remittive benefit. Look, I think, you know, therefore, any meaningful amount of remission I think would be encouraging to see here. and would set us up well to detect a signal in the phase three study that we've got designed with a similar outcome in mind. I don't know that we've set a numeric bar at this point. Maybe we'll talk a little bit more about that as we get closer, but my guess is even if a couple of patients who got off therapy managed to stay in remission, we'd be pretty happy with that outcome.

Thank you.

And our next question will come from Brian Ching with J.P. Morgan. Your line is open.

Hey, guys. Thanks for taking our questions this morning. We have two. First, on immune events, there are certainly a lot of investor questions on how the high-dose Patoka map is going to look compared to the low-dose. But just curious if you can tell us the level of your commitment you have today to advance 1402 specifically into MG and CIDP regardless of what the data show. Will you still proceed in both indication with both pivotal studies?

Thanks for the question. I appreciate it. Look, I think like any reasonable people, we're going to look at that data and take signal from it in terms of what we think of MG and CIDP and how to develop there. MG and CIDP are huge markets where there is a lot of unmet need, and we bring unique things to the table literally no matter what this data shows in terms of form factor, in terms of dosing schedule relative to some of the other trials. So I don't think this data alone is going to inform that question, but obviously in terms of how we think we will play in MG and what we think our share will look like, that'll depend on how likely we think we are to be able to differentiate in these studies on efficacy. One reminder, obviously, we think 340 and 680 are pretty much exactly the same from an IgG suppression perspective as 300 and 600 and 1402. And we think 340 will suppress IgG, you know, in the mid-60s. And if it does, that'll be pretty similar to what our competitors do. So, we think this study will give us a relatively decent read on what an MG study is capable of showing, for example.

Okay. And then on the new cyclidosis indication for PREVO, the phase 2B can seem to be a relatively small study. So can you give us a sense of the trials powering on the CSAMI score? How do you assume the placebo will perform in a target indication, in a target population? And just wondering if the choice of cyclidosis here for PREVO here today has anything to do with, you know, the infrastructure they already built with Canavent. Thanks

Yeah, perfect, Brian. Thanks for that question. We are really excited about the change in sarcoid. Look, the study's small here. I think for starters, again, the IIT study had a very large effect size, and so I think if it's going to look anything like that, powering is not going to be a question. This is not, though I said this before, not really about, like, powering for stats saved on C-SAMI, although I hope we hit it, obviously. This is really about signal finding. It's really about understanding the sort of range of parameters and giving us some information about dose ranging that we can use to design a phase three that serves for registration purposes. So, you know, I think there's not a lot of studies done historically on sesame, so there's not a ton of information, but docs mostly believe placebo response is going to be pretty low, which sort of makes sense if you think about what the disease looks like and how it presents. So, you know, I think that's the hope, but we'll see in the study, obviously.

Okay, thank you. Thanks, Brian.

And our next question will come from Yatin Senajal with Guggenheim. Your line is open.

Hey, guys. Thank you for taking my question. So the question is on the recent investment you made in Immunoman. Could you just talk about why that investment was made or what was your thought process to make it before the data versus after the data? And then if part of the question is that the valuation is attractive, you made the investment now, why not bring the whole asset back? in-house and sort of take advantage of the dislocation in pricing?

Yes. Thank you, Yann. It's a great set of questions. Obviously, we made the investment because we thought it was attractive. We thought the opportunity was attractive. We thought there was a good possibility that it would be validated with the data that we're going to generate, and so we were excited to be able to put that in place. You know, I think we also felt that in the hopeful event that the MG data is clean and successful, that we'd like for Mutavant to be able to message to the market that the company is funded through Graves data if we choose to run it that way. And we think that's a pretty powerful statement to be able to make, especially given just how excited we are about Graves and what we think that could mean as an opportunity. So I think there was a lot attractive to us about the timing and the setup of that investment. In terms of why not bring the whole asset in-house, look, we participated super pro rata in the financing because we liked the opportunity and wanted to own more of it. I think that's clear. It would be a large investment for us to own the entire thing now. It would require either billions of dollars of cash or billions of dollars of stock, and our stock is not currently valued at a place where we're that excited to issue a ton of it. We've been buying it back. So I think steps in a direction that we care about and continue to be incredibly enthusiastic about what our FCRN franchise could be.

One more question, if I may, and this is regarding the data, the minimum data that's coming up. I think there is increasing focus in terms of, you know, the relative better efficacy or a little bit more efficacy that you have to show versus other FCRN. It is our understanding that in many different classes, a drug with similar efficacy and maybe some differentiation can still get significant share. So do you really need to produce more efficacy than other FCRN player? I'm just curious how you are benchmarking the data relative to the others.

Yeah, well, thanks. I appreciate that question. I think, first of all, to be clear, if your question is what is the bar for Immunovant to have a commercially valuable, important therapy across indications, I think there is basically nothing that could come out of this MG study that could take us off that trajectory, given the quality of the molecule we have, the depth of IgG suppression, the form factor. I don't think this data is a referendum on the commercial viability of 1402 at all. In MG, where it is more of a referendum, I completely agree with what you just said. I think that if the drug, look, we have other competitors in the FCRN space that have showed bluntly less good data than F-Cortisumab and are still expecting to launch those drugs. Those companies are expecting to launch those drugs, and I think those drugs are expected to be commercial successes with pretty meaningful sales, either because they bring a form factor benefit or a dosing regimen benefit, or just because MG is a large market with a lot of different entrants, and there's an opportunity for multiple therapies. We bring a lot to the table that has nothing to do with generating an efficacy differential. We talked about the autoinjector. We bring a simple sub-Q autoinjector. We bring chronic dosing in our study. So there's a whole bunch of things that I think we bring to the table that mean that we don't, in my opinion, for commercial viability, need to show a delta. Obviously, the bigger delta we show in efficacy, the more share I expect we will ultimately take in the class. That's sort of tautological, and I hope we show a meaningful delta that everyone can understand. And I hope that means we're gonna be a leader in the class in MG. But I completely agree with the point that you've made that in order to be commercially successful, we don't need that. My impression, to be blunt, when everybody has been asking me about the bar for the MG data, has not been that they were asking me, what do you think the bar is for a commercially successful drug? The question that I think they've been asking me is, what do I think the bar is for near-term market reaction? And my answer mostly has been that But I think the people asking me that question are supposed to be better at it than I am.

So anyway, but totally agree with the point you're asking about, yeah. Thank you. Thank you.

And our next question will come from Emma Gutstein with Wolf Research. Your line is open.

Hi, good morning. This is Emma on for Andy. Thanks for taking our question. Just one question from us. With the top line DM readout expected in the second half of 2025 with potential registration on the table and with also Argenix's recent success in DM, I guess, what are your expectations for the BREPO Phase 3 readout and the future just competitive landscape if Argenix successfully completes its Phase 3? Thank you.

Yeah, thanks. It's a great question, and we're obviously really excited for it. You know, we are – With the exception of IVIG, it was already approved as sort of undisputed first-in-class new mechanism in DM. And we are, if the data are successful and the drug is approved, years ahead of any competitor that we are aware of in dermatomyositis at this point. So I think we get to describe that market, basically, in terms of how it comes together and how it gets positioned. There's obviously always a benefit. At least some patients prefer orals versus injectors. And so regardless of the comparative efficacy, I think we have a form factor differentiation that's going to matter. There's tons of unmet need. And honestly, I think there's room for multiple additional new mechanisms in dermatomyositis if it comes to it. So I think from that perspective, it's all a good setup. And what I think the trial really needs to do is just succeed. And I think with that, we will have a big opportunity. That said, because I can't quite help myself, look, JAK inhibitors have been very, very good mechanisms for treating inflammatory disease. And I think we have a real shot of delivering meaningful efficacy for these patients. And the JAK inhibition has the potential to be, or especially JAK inhibition combined with TIK2 inhibition, has the potential to be a best overall mechanism, at least among the things currently being studied. But obviously, we won't know the answer to that for years and years. as those other mechanisms for this data. Thank you.

Great. I appreciate the results.

And our next question will come from Douglas So with HCW. Your line is open.

Hi. Good morning. Thanks for taking the questions. And Matt, I guess just maybe starting with berkacitinib, and obviously we now have another indication, I'm just curious if you have thoughts on sort of the pace that you would potentially roll out additional indications with barcocitinib, just given the fact that it seems to be an asset that could have fairly broad applicability across a range of orphan indications, which I know sort of has been your initial focus. Thank you. Do I have a follow-up?

Yeah, sure. No, that's a great question. Thank you. Look, we're obviously excited about continuous sarcoid that we've unveiled today. And what I can say is that we are actively evaluating a number of other indications that we think would fit well into the paradigm for BREPO. And I think we're not unveiling them at some predetermined pace based on a goal or expectation. We're unveiling them as we get primed, ready, and good to go with each successive new indication. And so I think my hope is that you can expect more in the period to come here, but let's see what we get.

I mean, I guess, Matt, as a follow-up, I mean, it's like, you know, Immunivant has talked about sort of 10 studies over a certain amount of period, and I get you don't want to necessarily commit to that similar timing, but do you think that that's a fair number of opportunities that Prevo could ultimately be relevant in?

Yeah, look... Sure.

I think the answer is there is probably a very long list of opportunities that Brepo could, I mean, you can ask CHAT GPT with deep reasoning for a list of inflammatory orphan indications with tens to low hundreds of thousands of patients. There's a long list of them, and I think we are spoiled for choice in terms of places where patients might benefit. And so I think what we're doing is spending our time picking our spots figuring out which indications have the right set of competitive dynamics, the right sort of leaning into both JAK1 and TIK2, which is something that creates a competitive moat for us, things that have a patient population that is sized for our competitive landscape and price point. And then, frankly, making sure that we scale operationally to match the sort of level of activity ongoing and private so that we continue to run good studies and generate good data. And obviously, we're really happy with the job that team has done, is doing, and are excited to keep investing in them. So, look, I think there are a lot of possible places to go. I'm not giving a number today, but I think we're choosing our spots and moving at Royman's pace, which is to say, hopefully.

Okay, great. Thank you. Thanks, Doug.

I show no further questions in the queue at this time. I would now like to turn the call back over to Matt Glein for closing remarks.

Great. Well, thank you, everybody, for listening this morning. Thank you to the Roivant team, the ImmuneVent team, the PriVent team, all of the Vent teams at Roivant for their hard work, the patients and investigators who helped us progress. And looking forward to a big year in 2025 and excited to get back on the phone and talk about more updates probably pretty soon. So thanks, everybody.

Have a good day.

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