Participants

Stephanie Lee Griffin; Chief Operating Officer; Roivant Sciences Ltd

Matt Gline; Chief Executive Officer, Director; Roivant Sciences Ltd

Dave Risinger; Analyst; Leerink Partners LLC

Dennis Ding; Analyst; Jefferies LLC

Yaron Werber; Analyst; TD Cowen (Research)

Brian Cheng; Analyst; J.P. Morgan Securities LLC

Yatin Suneja; Analyst; Guggenheim Securities, LLC

Emma Gutstein; Analyst; Wolfe Research

Douglas Tsao; Analyst; H.C. Wainwright & Co., LLC

Presentation

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Roivant second quarter 2024 earnings call. (Operator Instructions) 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.

Stephanie Lee Griffin

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

Matt Gline

Thank you, Steph, and thank you, everybody, for listening. Good morning. I'm going to start on slide 5 and thank you again for joining our third quarter results call. So 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 NPS 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 -- central registrational readout in dermatomyositis, which would set the stage if we see approval for commercial launch of brepocitinib, and so we're really excited about that program, and excited also to talk today about a new indication for brepocitinib in which we'll be starting a trial this year as well.
And it's also a big year for our LNP litigation 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 6 comes down to our pipeline, which we think is one of the most exciting pipelines in late-stage biotech, obviously, anchored by FcRn and brepocitinib, but with a number of other programs, including mosliciguat, which we unveiled last year, and also ongoing (inaudible), which we'll talk a little more about later in this call.
This year, really, on slide 7, is anchored around clinical execution. Obviously, in some sense, the die 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 6 INDs that we advance 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 Immunovant.
Obviously, continuing to conduct the brepocitinib-DM study 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 mostly PLD. So between the data that we have coming and the work that we have to do, it's really a year around clinical execution to drive that value.
And then we have, obviously, a lot of exciting data coming this year when we look at how we're sort of stacked for the future. But even beyond 2025, in Immunovant, we have the potential for 10-plus indications with multi-blockbuster launches.
In brepo, we have a potential multi-blockbuster franchise, an orphan immunology anchored by DM and hopefully subsequent that or hopefully DM and the subsequent NIU, proven 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 II study, which we hope to set us up for frontline use in PH and other respiratory disease.
And all of that on slide 9 is anchored 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 bought back about $1 billion in stock so far as of the end of 2024.
We closed the sale of Dermavant to Organon, which were about $259 million, and moved all of our debt of meaningful (inaudible) obligations while keeping a lot of upside in milestones royalty. You talked about that last year. And then this continues to be among the most fruitful or the most fruitful redevelopment environments we've ever seen, and I very much hope and expect that we'll be adding to that pipeline in the month on.
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 will be public on the trials come soon, et cetera, which is we have now initiated a new program for brepocitinib, our third indication. This is a proof-of-concept study in a -- and is called cutaneous sarcoidosis.
So if you turn to slide 11, this is -- it fits really well, and I'll talk about this again in a second, to our strategy of Priovant and developing and indications with high unmet needs that are specifically tailored to our dual TYK2 JAK 1 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 30,000 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 about this dual TYK2 and JAK1 in brepocitinib is particularly well suited to the Th1 menophetotype sarcoidosis. So we're going to start a little bit about that.
And then it's aligned with DM and NIU in terms of a subscriber base concentration that overlap DM in terms of a potential orphan 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 and tailored to our unique mechanism, where we think any liabilities to the JAK class will be far outweighed by our ability to deliver meaningful benefit to these patients. Obviously, DM, NIU, both, in our view, met that. And yes, looks pretty similar.
It's got well through to 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 concept for JAK inhibition in 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 want opinion what we talk about here a lot -- of 37. And patients on 5 milligrams twice at [April] for six months, all of them achieved clinically meaningful reduction in CSAMI, and 6 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 on slide 14, just from a sort of physiology perspective. Th1-type immunity is the main polarization -- the predominant polarization of sarcoidosis skin and lung tissue. And we know that above regulation of Th1 cytokines like TYK2 [interferomy] as well, which we think gives us potentially exactly the right profile with dual inhibition TYK2 and JAK1, which are both obviously important to mediating that collection of cytokine. So we feel really good about coming at this with a uniquely big gun.
Brepo is generated on slide 15, particularly strong data in inflammatory skin disease. So these are all crossroad comparisons with whichever other JAK inhibitors have reasonable data available. But you can see alopecia in HS and black psoriasis, we have along the best-in-class. We're the best-in-class data in a crossroad 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 good data coming out of brepocitinib.
The study design, slated on 16, it's a 16-week study testing 2 doses, brepo 45 and brepo 15 as well as placebo. And yes, 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 sort of happened recently in our TSR and franchise at Immunovant, starting on slide 18. So we have, as you all have quite a bit of data coming this year, starting out with MG and CIDP this quarter, that we hope can bolster our confidence collectively, included your confidence, that deeper IgG reduction results in better clinical outcomes.
We've obviously now seen this across many clinical trials across 4 different anti-FcRn antibodies in 7 different indications. But we're going to get another 500 patients worth of data out of these batoclimab 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 Roivant or Immunovant 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 MG, this is just a reminder of that trial design -- external that we think is well suited to treating these patients where they're at. It is a 12-week induction study with 2 doses, high and low, followed by a rerandomization into a 12-week maintenance period, with either the sort of low dose from the first phase or 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 bato Phase IIb readout from period 1 of the CIP study. That design is shown on Page 20. I think you're all very familiar with these designs at this point. They are pretty complicated designs. But we're looking forward as well to the possibility after that period 1, which is highlighted in the red piece here, to be able to answer some questions about possible dose response 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 wall ring, our Phase I data suggests we're going to continue to be able to reach about 80% IgG suppression or the amounts we continued dosing of 600 milligrams delivered by a simple subcu injection.
1402 does not, in our Phase I data, appear to impact albumin LDLs. So no minimal effect there. We have convenient administration. We will be delivered by a market-proven user-friendly auto-injector that we're 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 the drug that we think could be best in class.
On slide 22, as a reminder, we will be starting our pivotal trials -- are starting our pivotal trials with a standard auto-injector. It's the only FcRn we think ever developed as a true subcu injector from inception. It levels us up a pretty well-proven technology. It will be a 2 mL injection volume. And this is a picture of the device. Needless to say, it looks like, while the other sort of likely successful auto injectors, and we think this is a real benefit. It's also less than 10 seconds in at home administration. We thank our HCP administration. So looking forward to continuing to address that form factor.
And then 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 II 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 [Roivant], 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 positions a little 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 6 INDs approved, and this is only 2 of them. We've also talked about with MG and CIP, but that leaves 2 unannounced, but nonetheless, IND-ed indications, and we're looking forward to talking about those soon. Obviously, a lot of news coming in the near term on Immunovant, 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 Genevant 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 important features of how that trial will progress, followed by the jury trial scheduled for September -- in second half of this year. So a year where we will really learn a significant piece of the answer to the -- at least (inaudible) a puzzle year. 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 to Q&A. So relatively straighforward quarter from a financial perspective, R&D expense of $142 million or adjusted of $131 million. G&A of $142 million or $71 million. End of the quarter, as we said, with $5.2 billion in cash, which excludes the $75 million milestone from the approval of atopic dermatitis from January as well as $113 million of external capital which was raised alongside Roivant's investment given the January private placement there. And no debt on the 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 record.
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.

Question and Answer Session

Operator

(Operator Instructions)
David Risinger, Leerink Partners.

Dave Risinger

Great. Thanks very much. So congrats on all the progress, Matt. I have two questions, please. First, could you review the batoclimab efficacy bars for success ahead of the release of results in coming weeks? And then second, could you also discuss the additional batoclimab-GD data, the six month treatment-free remission results that are coming this summer, including what you're 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 months. And obviously, insofar as all of these questions get to sort of pre-data positioning, I think we finished our pre-data positioning of 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 and our own [head] study in J&J's [Sovrin] study in UCB's ITP study. And even at the individual patient level in our own and other people MG studies.
So 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 will 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 Immunovant -- obviously, in Graves' coming later this year. Look, we are excited about the Graves' data we generated in Phase II. I think it already offers a completely novel option with significant potential efficacy for a patient population that 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 of therapy and then also obviously for payers and others who I think will look at that data with interest. Thanks, Dave.

Dave Risinger

Thank you.

Operator

Dennis Ding, Jefferies.

Dennis Ding

Hi, good morning. Thanks for taking the 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 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 don't know, like 25%, 50%, 75% of the doses? Thank you.

Matt Gline

Yes. Thanks, Dennis. I appreciate the question. A couple of things. First of all, it's obviously a little bit difficult to comment on an ongoing litigation. So my answer will be couched in that -- or with that predicted. 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 1 [aero] 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 for example, if you were manufacturing like patented jet engines for US Air Force planes in World War 2 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 to the 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 have signed with Moderna, only one of them included express reference to 1498. And therefore, it seems 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.

Dennis Ding

Great. Thank you so much.

Operator

Yaron Werber, TD Cowen.

Yaron Werber

Great. Good morning. Thanks for taking. Matt, I got a couple of questions. Maybe just the first one on cutaneous sarcoidosis statistic, a really interesting opportunity. So as your -- thanks for that slide showing us the BEACON trial design. So this is a study that got 3 to -- 3 to 2 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 remitted ability, what would be good data from your KOL checks in terms of remission at six months? Thank you.

Matt Gline

Yes. Thanks, Yaron. Those are both great questions. I appreciate them both. On cutaneous sarcoid, I think the short answer is this is a proof-of-concept study. This is less about sort of powering for some specific static outcome. And more of, again, there has not been -- I mean, there have been some studies run in sarcoid where CSAMI was measured, but there's not been a lot 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 rates 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 are here is to give us something to shoot for in a larger Phase III 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, 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', 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 new treatment option among prescribers, even if it does not bring about remission. But I think patients will be excited to see a remitted benefit.
Look, I think, therefore, any meaningful amount of remission, I think would be encouraging to see here and what set us up well to detect a signal in the Phase III 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 the mission would be pretty happy with that. Thanks, Yaron.

Operator

Brian Cheng, JPMorgan.

Brian Cheng

Hi, guys. Thanks for taking our questions this morning. We have two. First on Immunovant. There's certainly a lot of investor questions on how the high dose batoclimab 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 indications or pivotal studies?

Matt Gline

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 will 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 to 600 to 1402. And we think 340 will suppress in the mid-60s. 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 neuocyclodoses indication for brepo, the Phase II BEACON 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 the target population? And just wondering if the tours of psychodosis here for brepo here today, has anything to do with the infrastructure that you already built with Kinevant? Thanks.

Matt Gline

Yes. Perfect. Brian, thanks for that question. We are really excited about cutaneous sarcoid. Look, the study small here, I think for starters, again, the IIT study had a very large effect size -- and so I think it was going to look anything like that, powering is not going to be your question. This is not -- though I said is we're not really about like powering for [stating] on CSAMI. 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 III that service for registration purposes.
So I think there's not a lot of studies done historically on CSAMI, so there's not a ton of information. But docs emotionally believe placebo response is going to be pretty low, which sort of makes sense when you think about what the disease looks like and how it presents. So I think that's best hope, but we'll see you in the study, obviously.

Brian Cheng

Thank you

Matt Gline

Thanks, Brian

Operator

Yatin Suneja, Guggenheim.

Yatin Suneja

Hey guys, thank you for taking my question. The question is on the recent investment you made in Immunovant. 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 devaluation 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

Yes. Thank you, Yatin. 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 -- we thought there was a good possibility that it be validated with the data that we're going to generate. And so we were excited to be able to put that in place.
I think -- we also felt that in the hopeful event that the MG data is clean and successful, that we'd like for Immunovant to be able to message to the market that the company is funded through Graves' data, which used 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's -- 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'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 back. So I think steps in the direction that we care about and continue to be incredibly enthusiastic about what our FcRn franchise could be.

Yatin Suneja

Got it. One more question, if I may. And this is regarding the data, the Immunovant data that's coming up. I think there is increasing focus in terms of the relative better efficacy or a little bit more efficacy that you have to show versus other FcRn.
And 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 play? I'm just curious like how you are benchmarking the data to the others.

Matt Gline

Yes. 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 and 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 is -- look, we have other competitors in the FcRn space that have showed won't be less good data than [efgartigimod], and are still expecting to launch those drugs.
Those companies expect a lot of 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 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 bring -- we talked about the auto-injector. We bring a simple subcu auto-injector. 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 on efficacy, the more share, I expect we will ultimately take in the class that's sort of total logical. And I hope we show a meaningful delta that everyone can understand, and I hope that means we're going to 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 right. Thank you.

Yatin Suneja

Thank you.

Operator

Emma Gutstein, Wolfe Research.

Emma Gutstein

This is Emma on for Andy. Thank you 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 argenx's recent success in DM, I guess what are your expectations for the brepo Phase III readout and the future just competitive landscape if argenx successfully completes its Phase III? Thank you.

Matt Gline

Yes, thanks. It's a great question, and we're obviously really excited for (inaudible). We are -- the exception of [IVIG] was already approved, the sort of undisputed first-in-class new mechanism in DM. And we are -- if the data are successful and 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 set up. 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 diseases. 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 in which combined with TYK2 inhibition has the potential to be a best overall mechanism, at least along the things currently being studied. But obviously, we won't know the answer to that for years and years. as those other mechanisms at data. Thank you.

Emma Gutstein

Great. I appreciate the results.

Operator

Douglas Tsao, HCW.

Douglas Tsao

Hi, good morning. Thanks for taking the question. And Matt, I guess just maybe starting with brepocitinib, 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 brepocitinib, 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. And I have a follow-up.

Matt Gline

No, that's a great question. Thank you. Look, we're obviously excited about cutaneous 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 paradigm for brepo.
And I think we're not unveiling them at some predetermined pace based on goal or expectation, we're unveiling them as we get prime 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 can.

Douglas Tsao

I mean, I guess, Matt, as a follow-up, I mean, it's like Immunovant 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 brepo can ultimately be relevant in?

Matt Gline

Yes, look -- Sure. I think the answer is there is probably a very long list of opportunities that brepo could -- you can ask ChatGPT 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 TYK2, which is something that creates a competitive moat for us, things that have a patient population which 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 in 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 Roivant's pace, which is to say I hope.

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 Roivant team, the Immunovant team, the Priovant 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 2025, and excited to get back on the phone and talk about more updates probably pretty soon. So thanks, everybody. Have a good day.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

Stephanie Lee Griffin

Goodbye.