Roivant Sciences Ltd. (NASDAQ:ROIV) Q3 2024 Earnings Call Transcript

Roivant Sciences Ltd. (NASDAQ:ROIV) Q3 2024 Earnings Call Transcript February 10, 2025

Roivant Sciences Ltd. beats earnings expectations. Reported EPS is $0.23, expectations were $-0.24.

Operator: Ladies and gentlemen, thank you for standing by. Welcome to a Roivant Sciences Ltd. second quarter 2024 earnings call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question and answer session. To ask a question during this session, you would need to press star one one on your telephone. You would 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 like now to turn the conference over to Stephanie Lee. Miss Lee, please go ahead.

Stephanie Lee: Hi. Thanks. Good morning. We are actually reviewing the third quarter ended December 31, 2024, for Roivant Sciences Ltd. I am Stephanie Lee, and presenting today, we have Matt Gline, CEO. 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 investors.roivant.com. We will 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 have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. So with that, I will turn it over to Matt.

Matt Gline: Thank you, Stephanie, and thank you everybody for listening. Good morning. I am 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 obviously, 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 API CRM 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 registrational readout in dermatomyositis, which would set the stage if we see approval for commercial launch of brepasitinib.

And so we are really excited about that program and excited also to talk today about a new indication for brepasitinib in which we will be starting a trial this year as well. And it is also a big year for our LNP 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 are 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 brepasitinib, both with a number of other programs including monthly ciguat, which we unveiled last year.

And also ongoing BD which we will 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 die has been cast for the MG and the CIDP data, which will be imminent. But there is an enormous amount of work ongoing. We have cleared six INDs at Abutavant. 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 at Immunavand. Obviously, continuing to conduct the preps study that we got later this year as well as the NAU data, the NRE study which is ongoing, and then we have initiated our trial in mostly BHLP. So between the data that we have coming and the work that we have to do, it is really a year around 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 are sort of stacked for the future, even beyond 2025, in the event we have the potential for ten plus indication blockbuster launches in Breco, we have a potential multi-blockbuster franchise in orphan immunology anchored by DM and hopefully, substitute to NER hopefully, DM and then substitute to NIU. Proof of concept study in sarcoid adding to that and then mostly by next year by 2026, we hope to have by the end of next year data on our phase two study which we hope set us up for frontline use in PHLP and other respiratory disease. And all of that on slide nine is anchored by what continues to be a major strength of ours, which is our cash balance.

We have $5.2 billion in cash market as of December 31. That includes $500 million authorized for additional share buybacks. We bought back about $1 billion so far as of the end of 2024. We closed the sale of dermaVant to Organon. We received about $259 million and removed all of our debt as meaningful retirement obligations while keeping a lot of upside and milestones royalties. We talked about that last year. And then, this continues to be among the most fruitful or the most fruitful group all the environments we have ever seen. And I very much hope and expect that we will 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 is probably a little bit further out, but something we are trying to get going on.

It will be public and put on trials.com soon, etcetera. Which is we have now initiated a new program for brepasitinib, our third indication. This is a proof of concept study and it is called cutaneous sarcoidosis. So if you turn to slide eleven, this is a it fits really well. I will talk about this again in a second. Into our strategy of private developing an indications with high unmet need that are specifically tailored to our dual z two jack one mechanism. First of all, in terms of sort of scope of disease, it is pretty similar bluntly to the other diseases that we are studying with REPO. There are somewhere between thirty and fifty thousand cutaneous sarcoidosis patients. With no approved therapies at the uncontrolled disease can result in severe dyspnea.

It is very tough for these patients. There is proof of concept data from about twenty JAK treated patients. So not so different from what we are seeing in some of the other indications we are studying. And then we think and we will talk about this dual tick two and jack one inhibition is particularly well suited to the t h one mimicking type of sarcoidosis. So we will get to talk a little more about that. And then it is aligned with the m and n I u in terms of a driver base concentration that overlaps with the m in terms of potential open price point. We think it makes a lot of sense as a place for us to go from here. As a reminder, on slide twelve of the overall strategy in really focus on indications with very high unmet need tailor to our unique mechanism.

Where we think any liabilities into the jack class will be far outweighed by our ability to deliver meaningful benefit to these patients. Obviously, DM and I both in our view net net that and CS what we look pretty similar. It is well suited to biology, a larger unmet medical need a similar patient prevalence. There is some proof of concept with JAC one patients, and there has been nothing approved in the last sixty years. So we are really excited to add this to our portfolio. There is, on slide thirteen, 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 toplacitinib, in ten patients with longstanding CS.

And considering that study was about ten patients with CS and it means see, Sammy is gonna learn the thing and what we talked about here a lot. Of thirty-seven and patients on five milligrams twice of a total for six months, all of them achieve clinical meaningful reduction in CSAMITY. And six of them achieved complete resolution of disease. So pretty remarkable data from the 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 fourteen, just from a sort of pathophysiology perspective, PH one type immunity is the main polarization the predominant polarization in sarcoidosis skin and lung tissue.

And we know that more of a regulation of TTH one cytokines like type two and or ferrominol twelve. Which we think gives us potentially exactly the right profile with dual inhibition of TIC two and JAC one. Which are both obviously important in moving that collection side of guidance. So we feel we feel really good about coming at this with a uniquely big gun. Premo has generated on slide fifteen particularly strong data in inflammatory skin disease. These are all cross-track comparisons with whichever other jack inhibitors have reasonable data available. But, you know, you can see in alopecia, NHS, and flaxoriasis, we have among the best in class with the best in class data and across our comparison that has been seen. So we feel pretty good as well about sort of entering into inflammatory skin disease area where we have, again, good data coming out of reps at that.

The study design is later on sixteen. It is a sixteen-week study. Testing two doses, BREPO forty-five and BREPO fifteen. 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 am gonna move on now to just a reminder of what is upcoming and what has sort of happened recently, you know, in our DFCRN franchisee and Immunomedovave. Starting on slide eighteen, so we have, as you all know, quite a bit of data coming this year starting out with MGN C NDP this quarter. That we hope can bolster our confidence collectively, including your confidence, that deeper IgG reduction results in better clinical outcomes. We have obviously now seen this across many clinical trials across four different anti sertent antibodies in seven different indications.

We are gonna get another five hundred patients worth of data out of these piplumab 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 are looking forward to generating that data, which, by the way, just as a reminder, nobody at Roivant Sciences Ltd. or Univert 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 nineteen in MD, this is just a reminder of that trial design. It is a twelve-week induction study with two doses high and low. Followed by a rerandomization into a twelve-week maintenance period. With either a sort of low dose from the first phase or in every other week or so 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 looks like with the possibility of rescue therapy and so on. So that feeling good about the trial design. We also have our upcoming battle phase two b rehab from period one of the CX study. That design is shown on page twenty. I think you are all very familiar with these designs at this point. It is a pretty complicated design. But we are looking forward as well to the possibility after that period one, which is the highlighted red piece here to being able to answer some questions about possible dose response and treatment and response rates. In the twelve-week randomized period.

Fourteen o two on slide twenty one continues in our view to have a combination of potentially best-in-class attributes that we do not see in other programs. Have deep IUG wall ring. Our phase one data suggests we are gonna continue to be able to reach about eighty percent IgG suppression or thereabouts, we continue dosing six hundred milligrams delivered by a simple subcu injection. Fourteen o two does not, in our phase one data, appear to impact albumin or LDLs, so no minimal effect there. We have convenient administration. We will be delivered by a market-proven user-friendly auto injector that we are launching with. We will highlight that again in a second. 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 a best in class.

Slide twenty two as a reminder, we will be starting our pivotal trials or are starting our pivotal trials with a standard auto injector. It is the only FCRM we can ever develop as a true sub queue injector from inception. Whether there is a pretty well-proven technology. It will be a two ml injection volume and this is a picture of the device too. Let us just say it looks like all of the others are likely successful auto injectors and we think this is a real benefit. It is also less than ten seconds in at-home administration. We think or it should be administration. So looking forward to continuing to press that form factor. And then, you know, on slide twenty three, look, the main event to me in the long run here is getting fourteen o two into indications that really matter.

We are tremendously excited about Graves at Easley. 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 alright. To anybody levels, and that we have a high response rate with the good dose response that sets us up well for success. We think both from a but of ant and from the world, you are gonna be hearing a lot more about Graves disease in the months and years to come. We are excited to be at the front of that pack with an agent that we think is maximally positioned to benefit those patients. And then we have also announced at a that we are running a study in difficult to treat rheumatoid arthritis. 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 INDs approved, and this is only two of them. We have also talked about MG and CAMP, but that leads to unannounced. But nonetheless, IMV cleared indications and we are looking forward to talking about those soon. Obviously, a lot of news coming in the near term. On an event, so I am sure we will be in touch collectively in the near future. Finally, in terms of major upcoming milestones in 2025, we have talked only a little bit over time on these calls about the gentleman and LNP litigation. We are hoping for the decision from the Pfizer BioNTech Markman Market 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 anytime. 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 core important features of how that trial will progress. Followed by the jury trial scheduled for September in the second half of this year. So a year where we will really learn a significant piece of the answer to the at least Moderna puzzle here. So looking forward to that playing out as well. So I will wrap up quickly with a financial update. On slide twenty seven and then open up the Q&A. So relatively straightforward quarter from a financial perspective. And R&D expense of one forty two or adjusted of one thirty one.

G&A of one forty two or the seventy one and you know, end of the quarter, as we said, was $5.2 billion in cash, which excludes the seventy-five million dollar milestone from the approval of a taupermatitis from January as well as hundred thirteen million dollars of external capital raised alongside Roizen’s investment. In January. Private placement there. And no debt on the balance sheet following the close of the order on transaction. And so that is about that on the finance side. On slide twenty nine, we feel like we have a quite rich catalyst calendar coming. With a bunch of important milestones. So we have talked about for this year. Some of which are 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 by the very remarks. Turn it back over to the operator for Q&A. Thank you again for listening.

Q&A Session

Operator: Thank you. 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. And our first question will come from David Risinger with Leerink Partners. Your line is open.

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

Matt Gline: 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, in so far as all of these questions get to sort of pre-data positioning, I think we finished our pre-data positioning with the $330 million stock that we bought in January. So I do not have a ton to add. Obviously, our view is that deeper is better has been pretty well established. In our own Graves’ trial and our own head study, in J&J’s Sjogren study and I UCB’s ITP study and even at the individual patient level in our own and other people’s MMG studies. So, you know, I have 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 than what an MG study is able to show.

That said, I think what we are 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. I think we are looking across the evidence for other things that can help us structure our fourteen o two mg program for maximal success. I am glad you asked about the six-month remission data. For Nunavut. Obviously, Engraves coming later this year. Look, we are excited about the great data we generated in phase two. I think it already offers a completely novel option with significant potential efficacy for a patient population that has 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 do not 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 is something that we think will be helpful, well, for patients who want to know that there is a path off therapy. Then also, obviously, for payers and others who I think will look at that data with interest. Thanks, Dave.

Operator: And the next question will come from Dennis Ding with Jefferies. Your line is open.

Dennis Ding: 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 fourteen ninety-eight? Meaning, will the judge rule that, you know, either Moderna or the US 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 do not know, like, twenty-five, fifty, seventy-five percent of the doses. Thank you.

Matt Gline: Yes. Thanks, Dennis. Appreciate the question. A couple of things. First of all, it is obviously a little bit difficult to comment on 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 fourteen ninety-eight, what fourteen ninety-eight represents is a World War one era section of the US 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. But just for example, if you were manufacturing, like, patented jet engines for US air force planes in World War two 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 US 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 fourteen ninety-eight has two prongs to it. There is a the government prong and there is 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 fourteen ninety-eight. And therefore, it seemed to them that perhaps that one was not made with authorization consent.

Anyway, we will 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.

Dennis Ding: Great. Thank you so much.

Operator: And our next question will come from Yaron Werber with TD Cohen. Your line is open.

Yaron Werber: 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 if you are thanks for that slide showing us the beacon trial design.

Matt Gline: So this is a study that has got three to three to two randomization 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 remitted ability, what would be good data from your payroll checks in terms of remissions at six months? Thank you.

Yaron Werber: Yes. Thanks, Yaron. Those are both great questions. I appreciate them both. On cutaneous sarcoid, you know what? 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 of what we again, there has not been and there have been some studies run-in Zarcoid where CSAMI was measured there has not been a lot of some research into indication we are 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 hundred percent meaningful improvement rate in the IIT study was encouraging. But there was no placebo in that study. And so I think we are 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 is really what it is. And the reason we are so heavily randomized in favor of drug of all, is we have two doses, but second of all is because we are looking for the study to enroll pretty quickly. That we can get this information and get on with a bigger later stage study. On Graves, you know, look, we have had quite a lot of conversations with KOLs about Graves’ disease, and we think there is a lot of enthusiasm for a new treatment option. The truth is there is 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, you know, a little bit of benefit. Look. I think you know, therefore, any meaningful amount of permission, I think, would be encouraging to see here would set us up well to detect the signal in the phase three study that we have got designed a similar outcome in mind. I do not know if we have set a numeric bar at this point. Maybe we will 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 would be pretty happy with that. Thank you.

Operator: And our next question will come from Brian Cheng with JP Morgan. Your line is open.

Brian Cheng: Hey, guys. Thanks for taking my questions this morning. We have two. First on ImmunoVAN. There are certainly a lot of investor questions on how the high dose at tokamap is going to look compared to the low dose. But just curious, you know, if you can tell us the level of your commitment you are you have today to advance fourteen o two specifically into MG and CICP, regardless of what the data show, will you still proceed in both indication with both pivotal studies?

Matt Gline: For the question. I appreciate it. Look. I think like any reasonable people gonna look at that data and take signal from it in terms of what we think of MG and CIDB 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 data shows in terms of form factor, in terms of dosing schedule relative to some of the other trials. So I do not think this data alone is gonna 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 will depend on how likely we think we are to be able to differentiate in these studies on efficacy. One reminder, Josh, we think three forty and six eighty are pretty much exactly the same from an IgG suppression perspective as three hundred and six hundred fourteen o two.

And we think three forty will suppress IgG you know, in the mid-sixties. And if it does, that will be pretty similar to what our competitors do. So we think the study will give us a relatively decent read on what an MG study is capable of showing, for example.

Brian Cheng: Okay. And then on the neo cyclodosis indication, for Prebo, the phase two b can seem to be a relatively small study. So can you give us a sense of the trials powering on the CSA MI score? How do you assume the placebo will perform in a target indication a target population. And just wondering if the choice of psycho doses here for Preval here today has anything to do with you know, this infrastructure they already built with Canavan.

Matt Gline: Yeah. Perfect, Brian. Thanks for that question. We are really excited. Changing our code. Look, to say small here, I think for starters, again, the IIT study had a very large effect size. And so I think if it is gonna look anything like that, powering is not gonna be a question. This is like, I said this, we are not really about, like, powering for stats saved on CCI. I am like, I do not believe it obviously. This is really about signal finding. It is really about understanding the sort of range of parameters and giving us some information about those ranging that we can use to design a phase three that serves for registration purposes. So you know, I think there is not a lot of studies done historically on CCMIs, so there is not a ton of information.

But docs mostly believe placebo response is gonna be pretty low. Sort of makes sense when you think about what the disease looks like and how it presents. So, you know, I think that is best both, but we will see in the study, obviously.

Brian Cheng: Okay. Thank you. Thanks, Brian.

Operator: And our next question will come from Yatin Suneja with Guggenheim. Your line is open.

Yatin Suneja: Hey, guys. Thank you for taking my question. So the question is on the recent investment you made in ImmunoGen. 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 evaluation is attractive, you made the investment now, why not bring the whole asset in house and sort of take advantage of the dislocation in pricing.

Matt Gline: Thank you, Yatin. It is 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 we validated with data that we are gonna 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 would like for ImmunoVet 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 is a pretty powerful statement to be able to make, especially given just how excited we are about Graves. 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 like the opportunity and wanted to own more of it. I think that is 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 excited the issue a ton of it. We have been buying it back. So I think, you know, steps in a direction that we care about and continue to be incredibly enthusiastic about what our FCR franchise could be.

Yatin Suneja: Got it. One more question, if I may. And this is regarding the data, the ImmunoVent data that is 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 FCRM pair? I am just curious, like, how you are benchmarking the data relative to the others.

Matt Gline: Yeah. Well, thanks. I appreciate that question. I think, first of all, to be clear, your question is what is the bar for Immunavant 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 expression, the form factor. I do not think this data is a referendum on the commercial viability of fourteen o two at all. In MG, where it is more of a referendum, I completely agree with what you just said. I think that if this if the if the drug look, we have other competitors in the FCRN space, but have showed likely less good data than Efra Hijimod and are still expecting to launch those drugs.

Those companies are expected to launch those drugs. I think those drugs are expected to be commercial successes with pretty meaningful sales. Either because they bring a form factor benefit or dosing regimen benefit or just because MG is a large market with a lot of different entrants and there is an opportunity for multiple therapies, we bring a lot to the table that has nothing to do generating an efficacy differential. We bring we talked about the auto injector. We bring a simple subcu auto injector. We bring chronic dosing in our study. So there is a whole bunch of things that I think we bring to the table. Mean that we do not, in my opinion, for commercial viability, need to show a delta. Obviously, the bigger delta we show an efficacy, the more share I expect we will ultimately take in the class.

That is sort of total logical, and I hope we show a meaningful delta that everyone can understand. And I hope that means we are gonna be a leader in the class in MG. But I completely agree with the point that you made that in order to be commercially successful, we do not need that. My impression to be blunt when everybody has been asking me about the bar for the MD data it 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 have 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 but but totally agree with the point.

You are asking what I got. Thank you.

Yatin Suneja: Thank you.

Operator: And our next question will come from Emma Gutzine with Wolfe Research. Your line is open.

Emma Gutzine: Hi. Good morning. This is Emma on for Andy Chen. 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 argenexx as the recent success in DM. I guess, what are your expectations for the BREPO Phase three readout and the future just competitive landscape if argenex successfully completes its Phase three. Thank you.

Matt Gline: Yeah. Thanks. It is a great question, and we are obviously really excited for Ramon Visitis. You know what? We are the exception of IVIG was already approved 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 we get to describe that market, basically. In terms of how it comes together and how it gets positioned. Alright. There is obviously always a benefit at least some patients prefer orals versus injectors, and so regardless of the comparative efficacy, I think we have a four-factor differentiation that is gonna matter. There is tons of unmet need, and honestly, I think there is room for multiple additional new mechanisms in dermatomyositis if it comes to it.

So, you know, I think from that perspective, it is all a good setup, but 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 cannot 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 your especially JAK inhibition combined with two inhibition has the potential to be a best overall mechanism least among the things currently being studied. But, obviously, we will not know the answer to that for years and years.

Emma Gutzine: Great. Appreciate the response.

Operator: And our next question will come from Douglas Tsao with HCW. Your line is open.

Douglas Tsao: Hi. Good morning. Thanks for taking the questions. And Matt, I guess, just maybe starting with represent notes and obviously we now have another indication. I am just curious if you have thoughts on sort of those the pace that you would potentially roll out additional indications with bracositinib 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. You. Do I have a follow-up?

Matt Gline: You too. No. That is a great question. Thank you. We are obviously excited about continuous start-up that we have 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 Prepo. And I think we are not unveiling them at some predetermined pace based on a goal or expectation. We are unveiling them as we get primed, ready, and good to go with each successive new indication. And so I think hope is that you can expect more in the period to come here, but let us see what we get.

Douglas Tsao: I mean, I guess, Matt, as a follow-up, I mean, it is like, you know, ImmunoVent has talked about sort of ten studies over a certain amount of period. And I get you do not want to necessarily commit to that similar timing, but do you think that that is it their number of opportunities that that Provo could ultimately be relevant to?

Matt Gline: Yeah. Look. Sure. I think the answer is there is probably a very long list of opportunities that Brevo could. You can ask chat CPT with deep reasoning for a list of inflammatory, orphan, and indications with tens to low hundreds of thousands of patients. There is 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 are 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 jack one and tick two, which is something that creates a competitive mode for us. Things that have a patient population with a size 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 in private. That we continue to run good studies and generate good data. Obviously, we are really happy with the job that team has done is doing are excited to keep investing in them. So look, I think there are a lot of possible places to go. I am not sort of giving a number today. But I think we are choosing our spots and even at Robin’s pace, which is to say, hopefully.

Douglas Tsao: Okay. Great. Thank you.

Matt Gline: Thanks, Doug.

Operator: I show no further questions in the queue. At this time. I would now like to turn the call back over to Matt Gline for closing remarks.

Matt Gline: Great. Well, thank you everybody for listening this morning. Thank you to the enrollment team, the mid-event team, the private event team, all of the vent teams at Roivant Sciences Ltd. for their hard work, the patients and investigators who will help us progress. And looking forward to a big year in 2025. Excited to get back on the phone and talk about more updates probably pretty sure. So thanks, everybody. Have a good day.

Operator: This concludes today’s conference call. Thank you for joining. Goodbye.