Roivant Sciences Q3 2025 Earnings Call Transcript

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February 10, 2025
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Operator

Ladies and gentlemen, thank you for standing by. Welcome to Roy Vent Second Quarter twenty twenty four Earnings Call. At this time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you would need to press 11 on your telephone.

Operator

You would then hear an automated message advising your hand is raised. I would like now to turn the conference over to Stephanie Lee. Ms. Lee, please go ahead.

Stephanie Lee Griffin
Stephanie Lee Griffin
Vice President of Special Projects at Roivant Sciences

Hi, thanks. Good morning. We're actually reviewing the third quarter ended 12/31/2024 for Rigent. I'm Stephanie Lee with Rigent presenting today. We have Mac Klein, CEO of Rigent.

Stephanie Lee Griffin
Stephanie Lee Griffin
Vice President of Special Projects at Roivant Sciences

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.organics.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 uncertainties. And with that, I'll turn it over to Matt.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Thank you, Jeff, 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

It is absolutely 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 anti CRM franchise as a potentially best in class franchise with data coming in MG and CIPP in the coming weeks. It continues in the middle of this year with a registrational central registration readout in dermatomyositis, which would set the stage if we see approval for commercial launch of prepracitinib. And so we're really excited about that program and excited also to talk today about a new indication for brepacitinib, in which we'll be starting a trial this year as well.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

And it's 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'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 prefacitinib with a number of other programs including lebliciguat, 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?

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 that have been revamped. Those trials are all beginning now or have begun and are looking to initiate a number more by March of twenty twenty six. So just a ton of clinical work happening to get ImmunoVant. Obviously, continuing to conduct the brepsitinib DM study that will 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 Moseley PHLD.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 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, in Viretovat, we have the potential for 10 plus indications with multi blockbuster launches. In BRAF O, we have a potential multi blockbuster franchise in orphan immunology anchored by DM and hopefully subsequent to that hopefully DM and subsequent to NIU, approved 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 PHLD and other respiratory disease.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 $5,200,000,000 in cash and marketable securities as of twelvethirty one. That includes $500,000,000 authorized for about additional share buybacks. We bought back about $1,000,000,000 in stock so far as of the end of twenty twenty four. We closed the acquisition, the sale of Dermovant to Organon received about $259,000,000 and removed all of our debt as meaningful retirement obligations while keeping a lot of upside and milestones.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

We're Elkies talked about that last year. And then this continues to be among the most fruitful or the most fruitful group 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 will be public at inflatrials.gov soon, etcetera, which is we have now initiated a new program for brepacitinib, our third indication.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

This is a proof concept study in as he's called cutaneous sarcoidosis. So if you turn to Slide 11, this is it fits really well, I'll talk about this again in a second, into our strategy of prativant for developing indications with high end net need that are specifically tailored to our dual TIC2JAK1 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 RECCO. There's somewhere between thirty thousand and fifty thousand cutaneous sarcoidosis patients, with no approved therapies, and the uncontrolled disease can result in severe disfigurement. It's very tough for these patients.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

There is proof of concept data from about 20 JAK treated patients. So not so different from what we're seeing in some of the other indications we're studying. And then we think and we'll talk more about this dual TIK2 and JAK1 inhibitors particularly well suited to the TH1 immunopitotype of sarcoidosis. So we're going 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 REPO, 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, what it looks pretty similar. It's got well suited biology, a large unmet medical need, a similar patient prevalence.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

There is some proof of concept with JAK1 patients and there's been nothing approved in the last sixty 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 in cutaneous sarcoid. That was an open label study of tofacitinib in 10 patients with longstanding CS.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

And considering that study, it was about ten patients with CS and the means, C SAME is going to end up being what we talked about here a lot of thirty seven. And patients on five milligrams twice at A of TOFA for six months, all of them achieved clinical meaningful reduction in SESAME 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 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

And we know that there's more up regulation of TTH1 cytokines like type two interferonimyleth weld, which we think gives us potentially exactly the right profile with dual inhibition of TIK2 and JAK1, which are both obviously important in leading that collection of cytokines. So we feel we feel really good about coming at this with a uniquely big gun. Repoam has generated on Slide 15 particularly strong data in inflammatory skin disease. So these are all cross draw comparisons with whichever other JAK inhibitors have readable data available. But you can see in alopecia, NHS and black psoriasis, we have among the best in class or the best in class data on a cross draw comparison that's been seen.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 brevicitinib. The study design is laid on 16, it's a sixteen week study, testing two doses, Brepco forty five and Brepco fifteen, as well as a 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's sort of happened recently in our anti FCRM franchise at Immunozant starting on Slide 18.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

So we have, as you all know, quite a bit of data coming this year, starting out with MEG 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 SNR antibodies in seven different indications. But we're going to get another 500 patients worth of data out of these pitoclonal 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 rooibund or mutavent 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

The upcoming data on Slide 19 in MD, this is just a reminder of that trial design. It's trial that we think is well suited to treating these patients where they're at. It is a twelve week induction study with two doses high and low, followed by a re randomization into a twelve week maintenance period with either the sort of low dose from the first phase or in 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

We also have our upcoming VADO Phase IIb readout from period one of the CIP 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 red piece here, to be able to answer some questions about possible dose response and treatment and response rates in the twelve week randomized period.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

But fourteen oh two 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 IUG lowering. Our Phase one data suggests we're going to continue to be able to reach about 80% IgG suppression or over the amounts. We continue dosing six hundred milligrams delivered by a simple subcu injection. Fourteen oh two does not in our Phase one data appear to impact albumin or LDLs, so no minimal effect there.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

We have convenient administration. We will be delivered via a market proving user friendly auto injector that we are launching with. We'll highlight that again in a second. And as a reminder, we have IP out to 2,043, not including extensions. So a really long runway with a drug that we think could be a best in class.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

On 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've ever developed as a true subcu injector from inception. It leveraged a pretty well proven technology. It'll be a two ml injection volume. And this is a picture of the device, needless to say, it looks like all of the other sort of widely successful auto injectors and we think this is a real benefit.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

It's also less than ten seconds in at home administration, we think or HEP administration. So looking forward to looking forward to continuing to grasp that form factor. And then on Slide 23, look, the main event to me in the long run here is getting fourteen oh two 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 auto antibody 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 Immutivant and from the world, you're going to be hearing a lot more about Graves' disease in the months and years to come.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 elutivant 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 INDs approved and this is only two of them.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

We've also talked about MEG and CIP, but that leaves two unannounced, but nonetheless IND cleared 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 GenaVent LMP litigation. We are hoping for the decision from the Pfizer BioNTech Markman hearing in the first half of this year.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

So that the 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 Board 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 Moderna puzzle here. So looking forward to that playing out as well.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

So I'll wrap up quickly with a financial update on Slide 27 and then open up the Q and A. So relatively straightforward quarter from a financial perspective, R and D expense of $142,000,000 or adjusted of $131,000,000 G and A of $142,000,000 or just $71,000,000 and end of the quarter as we said with $5,200,000,000 in cash, which excludes the $75,000,000 milestone from the approval of atopic dermatitis from January, as well as $113,000,000 of external capital, which was raised alongside Rodent's investment in the January private placement there. And no debt on our balance sheet following the close of the Organon transaction. And so that that's about that on the finance side. Looking 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 and A. Thank you again for listening.

Operator

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

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

Great. Thanks very much. So congrats on all the progress, Matt. I have two questions, please. First, could you review the betoklamab efficacy bars for success ahead of the release of results in coming weeks?

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

And then second, could you also discuss the additional betoklamab GD data, the six month treatment free remission results that are coming this summer, including what you're hoping to see? Thanks so much.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Thanks, Dave. I appreciate the question. I confess we anticipated that it would be among the earlier questions asked this morning.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 pre data positioning with the $330,000,000 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 GRADE's trial and our own TED study, in J and J's Sjogren study, in UCB's ITP study, and even at the individual patient level in our own and other people's 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 fourteen oh two MG program for maximal success. I'm glad you asked about the six month remission data for Nunavant. Obviously, ENGRAVE's coming later this year.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

We are excited about the GRADE's data we generated in Phase II. I think it already offers a completely novel option with significant potential efficacy for 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 interests.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Thanks, Dave.

David Risinger
Senior Managing Director & Senior Research Analyst at Leerink Partners

Thank you.

Operator

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

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Hi, good morning. Thanks for taking our question. We had a question around the LMP 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 U.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

S. Government would 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%, fifty %, seventy five %

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

of the doses? Thank you.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Yes. Thanks, Dennis. Appreciate the question.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

A couple of 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 fourteen ninety eight. What fourteen ninety eight represents is a World War I era section of The U.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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. Just for example, if you were manufacturing like patented jet engines for U. S. Air Force planes in World War II or something like that.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 twenty twenty three, 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

But suffice it to say, therefore, the answer is there could be a range of outcomes on that point.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Great. Thank you so much.

Operator

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

Yaron Werber
Yaron Werber
Analyst at Cowen

Great. Good morning. Thanks for taking. Matt, I got a couple of questions. Maybe just the first one on cutaneous sarcoidosis.

Yaron Werber
Yaron Werber
Analyst at Cowen

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:three: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?

Yaron Werber
Yaron Werber
Analyst at Cowen

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 remissions at six months? Thank you.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

This is less about sort of powering for some specific stat sig outcome and more bluntly again, there has not been and there have been some studies run-in Zarkoid where SESAMI 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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, 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 remitiv benefit.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Look, I think, 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.

Operator

And our next question will come from Brian Ching with JPMorgan. Your line is open.

Brian Cheng
Brian Cheng
Biotech Analyst at J.P. Morgan

Hey guys, thanks for taking our questions this morning. We have two. First on ImmunoVent, there are certainly a lot of investor questions on how the high dose at ocumab 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 fourteen oh two specifically into MG and CIDP regardless of what the data show. Will you still proceed in both indication with both pivotal studies?

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 three forty and six eighty are pretty much exactly the same from an IgG suppression perspective as three hundred and six hundred and fourteen oh two. And we think three forty will suppress IgG 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
Brian Cheng
Biotech Analyst at J.P. Morgan

Okay. And then on the neocyclosis 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 CSAAMI score? How do you assume the placebo will perform in a target indication in a target population? And just wondering if the choice of cyclo doses here for preble here today has anything to do with this infrastructure they already built with Kennevent?

Brian Cheng
Brian Cheng
Biotech Analyst at J.P. Morgan

Thanks.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Yes, perfect, Brian. Thanks for that question. We are really excited about kidney sarcoid. Look, the study 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

This is not I said this, we're not really about like powering for stats saying on Csami, 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. I think there's not a lot of studies done historically on CSAMI, so there's not a ton of information, but docs mostly believe placebo responses 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 in the study obviously.

Brian Cheng
Brian Cheng
Biotech Analyst at J.P. Morgan

Okay. Thank you.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Thanks, Brian.

Operator

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

Yatin Suneja
Biotechnology Research Analyst at Guggenheim Partners

Hey guys, thank you for taking my question. So the question is on the recent investment you made in ImmunoMine. 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 in house and sort of take advantage of the dislocation in pricing?

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Yes. Thank you, Gaten. It's a great set of questions. Obviously, we made the investment because we thought it was attractive. We thought the opportunity was attractive.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

We thought there was a good possibility that it would be validated with 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 ImmunoVent 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's there was a lot attractive to us about the timing and the setup of that investment.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 it back.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

So I think steps in a direction that we care about and continue to be incredibly enthusiastic about what our FCR franchise could be.

Yatin Suneja
Biotechnology Research Analyst at Guggenheim Partners

Got it. One more question, if I may. And this is regarding the data, the ImmunoN data that's coming up. I think there is increasing focus in terms of the relative better efficacy or 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.

Yatin Suneja
Biotechnology Research Analyst at Guggenheim Partners

So do you really need to produce more efficacy than other FcRn player? I'm just curious like how you are benchmarking the data relative to the others?

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Yes. Look, 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 expression, the form factor. I don't think this data is a referendum on the commercial viability of fourteen oh two at all.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 efgartigimod and are still expecting to launch those drugs. Those companies will expect 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 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 sub Q auto injector, we bring chronic dosing in our study.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 going to 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 don't need that.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 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 that. Thank you.

Yatin Suneja
Biotechnology Research Analyst at Guggenheim Partners

Thank you.

Operator

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

Analyst

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 twenty twenty five with potential registration on the table and with also argenx as a recent success in DM, I guess what are your expectations for the Brepo Phase three readout and the future just competitive landscape if argenx successfully completes its Phase three?

Analyst

Thank you.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Yes, thanks. It's a great question and we're obviously really excited for dermatomycinetitis. We are with the exception of IVIG, which already approved the 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 four 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. But I think the trial really needs to do is just succeed.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 your especially JAK inhibition combined with TIK2 inhibition has the potential to be a best overall mechanism, at least among things currently being studied. But obviously, we won't know the answer to that for years and years as those other mechanisms data.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Thank you.

Analyst

Great. Appreciate the results.

Operator

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

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

Hi, good morning. Thanks for taking the questions. And Matt, I guess just maybe starting with bracosid nodes 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 bracositinib 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.

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

And I have a follow-up.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Yes, clear. No, that's a great question. Thank you. Look, we're obviously excited about continued 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 BRAVO.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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.

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

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 Breville could ultimately be relevant in?

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Yes, look, I think the answer is there is probably a very long list of opportunities that Breppo could I mean, you can ask Cat CPT with deep reasoning for a list of inflammatory orphan indications with tens to 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 mode 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 in Priovant, so 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.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

So look, I think there are a lot of possible places to go. I'm not sort of giving a number today, but I think we're choosing our spots and even at Raymond's pace, which is to say, hopefully.

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

Okay, great. Thank you.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

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 Mac Klein for closing remarks.

Matthew Gline
Matthew Gline
Chief Executive Officer at Roivant Sciences

Great. Well, thank you everybody for listening this morning. Thank you to the Roivent team, the ImmuneVent team, the Priovant team, all of the Vant teams at Roivent 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.

Operator

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

Executives
    • Stephanie Lee Griffin
      Stephanie Lee Griffin
      Vice President of Special Projects
    • Matthew Gline
      Matthew Gline
      Chief Executive Officer
Analysts
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Earnings Conference Call
Roivant Sciences Q3 2025
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