Title

Presentation

Roivant Sciences Ltd. beats earnings expectations. Reported EPS is $-0.00038, expectations were $-0.27.

Operator: Good day, and thank you for standing by. Welcome to the Roivant Third Quarter 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

Stephanie Lee Griffin: Good morning, and thanks for joining today’s call to review positive Phase II results for brepocitinib and cutaneous sarcoidosis and Roivant’s financial results for the third quarter ended December 31, 2025. The I’m Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant; and Ben Zimmer, CEO of Priovant. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.investors.roivant.com. We’ll 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 filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. With that, I’ll turn it over to Matt.

Matthew Gline: Thanks, Steph, and thanks, everyone, for dialing in and listening this morning. I’m going to start our presentation on Slide 5. I was sitting and talked to the team, it was about a week ago today, looking at a draft of this morning’s presentation and thinking it was going to be a pretty boring 10-Q. We had gotten together in December for the Investor Day, we had we’ve spoken a JPMorgan conference, and it turned out a really busy week. So we have some great updates, obviously, most notably, the Phase II data in brepo and CS, which Ben is going to present on momentarily. But truth is terrific execution and progress across the board for us this quarter. Obviously, that data is a highlight. But we also can announce today that the NDA for brepo was in dermatomyositis that the Phase IIb study for 1402 D2T RA has fully enrolled that the Phase II study for mostly in PH-ILD has fully enrolled, and obviously, all of the updates that we’re known for, including the Immunovant offering earlier that gets us now financed to Graves’ launch all behind us.

So just a terrific quarter and a terrific set of updates even since early January when we last got together. On Slide 6, 2026 is, again, a very busy year for us ahead. Obviously, some major events later in the year on the brepo NIU Phase III, the pivotal readout in the second half. We’re now going to be starting this year a Phase III study in brepo and cutaneous sarcoidosis. Ben will talk a little bit more about that. It’s early days and getting that going, but that will be this year. The Phase IIb data for mostly is expected firmly in the second half of this year. We now know that because the study is fully enrolled, obviously. Same thing with the D2t RA data where all of that, both the open-label period and the randomized withdrawal period will be done by the second half of this year.

We also are getting proof-of-concept data in 1402 and CLE. And finally, we are still on track for the jury trial against Moderna starting on March 9, so just a few weeks away now. So a really, really busy year ahead for Roivant. And really, if you look at Slide 7, before we get again to the data for CS, just a pipeline we’re really proud of that continues to deliver across multiple dimensions would be obviously brepo with now three indications in the pivotal registrational programs, multiple registrational programs for FcRn franchise made, which we’ve talked about and mostly with top line data coming in the second half. So really excited about where we are as a business, really excited about the pipeline. I couldn’t be more excited for the beginning of 2026 here.

Certainly, it’s off to a good start. And with that, what I’m going to do is turn to the Phase II data for brepo and sarcoidosis. So I’m just really briefly on Slide 9 of the presentation. I’m just going to walk through a couple of highlights, but mostly, I’m going to hand it over to Ben to take you through the data in detail. And the short answer, and we keep saying this, it’s a tremendous fortunate, I think to be able to say that, this drug has done everything we could have asked for us for it in this — of it in this study. We had a significant statistically sign. Remember, we had said before the bar for clinical success here, we thought was sort of 5 points of CSAMI was clinically meaningful. We got a placebo-adjusted almost 22 points, 21.6% point delta with a p-value, and again, the study was not powered for efficacy in this endpoint.

100% of patients on brepo 45 equivalent to 14 on placebo had a 10-point improvement. Again, clinically meaningful was 5 points. 100% of patients on our high dose had at least a 10-point improvement. So just a tremendous outcome across the board. There’s some great supportive data on some of the other endpoints as well. And with safety and tolerability completely consistent with what we’ve seen for the compound in the past. So a really terrific outcome and in a disease that needs it, where there’s never been a positive placebo-controlled study in an industry-sponsored study to our knowledge. So really a terrific day for those patients. So with that, I’m going to hand it over to Ben to walk you through a little bit about cutaneous sarcoidosis as a reminder.

And then on to the study data as well. Ben, take it away.

Benjamin Zimmer: Great. Thanks so much. Great to be here with everyone. Starting on Slide 10, I just wanted to bring back to what the disease is, walked through this at the Investor Day in December. But cutaneous sarcoidosis is a really debilitating skin disease. And among skin diseases stands out for its rapid progression towards permanent scarring and destruction of tissue as well as its disfiguring nature given the particular prevalence on the face and scalp of the disease. Turning to Slide 11. I would note that there is no approved therapies, not only for cutaneous sarcoidosis, but for any form of sarcoidosis. And so as we think about our development program in really a great opportunity for brepo to meet this overall unmet need and become the therapy of choice if we’re going to be successful in Phase III as we hope and expect we would be on the basis data to really be a promising option for all patients with skin involvement in their sarcoidosis.

That would include patients, both with only skin involvement as well as those with other organ involvement as well. Turning to Slide 12 really just briefly here on the alignment between the pathobiology of the disease and the mechanism. And I think this is important because as Matt alluded to, and I’ll walk through in a bit more detail. We really have great data here that we’re very excited about. And I think in a small study, the data is very compelling. It’s hard to argue it on its own, but it also really aligns with what you would expect to see given the mechanism of this drug, sarcoidosis, all of the forms of sarcoidosis, including cutaneous disease are driven by the polarization and recruitment of effector T cells and particularly Th1 polarized cells and brepo really distinctively inhibits Th1-related pathways by hitting both IL-12 through TYK2 and interferon gamma through JAK1.

So really an opportunity here mechanistically to see the benefits of JAK1, TYK2 inhibition specifically. And I think that’s really part of what’s flowing through to our clinical data that I’ll walk through now. Slide 13, study design, very straightforward, 31 patients in the United States, randomized 3:2:2, the brepo 45 milligrams, 15 milligrams in placebo, a 16-week study evaluated several different efficacy end points that I will walk through. On the baseline demographics and disease activity, Slide 14. I do want to highlight a few things. First, if you look at the duration of disease and background damage of patients brepo 45 milligrams and placebo are very well balanced between those two arms. But 15 milligrams actually quite a bit lighter on duration of disease and damage, which would mean really a higher bar for both brepo 45 and placebo.

And then I would also call attention to the plaque predominant morphology, cutaneous sarcoidosis can present through both plaques and papules. In general, the plaques are viewed as more treatment-resistant. And you see this plaque predominant morphology most pronounced and most common in the brepo 45-milligrams arm followed by 15 milligrams followed by placebo. So sort of punchline of this is there were some imbalances. Those imbalances actually made it harder for brepo 45 milligrams to demonstrate efficacy, both as compared to placebo and as compared to brepo 15 milligrams, and in spite of that, as I walk through, we really see exceptional data from the brepo 45-milligram dose arm. So turning to Slide 15 to get into the efficacy results. On the left hand of the slide, you see the mean to CSAMI activity score change from baseline, both doses statistically significant separation from placebo as early as week 4, the first time point evaluated and then sustained at every visit out to week 16 at the end of the trial.

And then on the right here, we see the achievement of investigator global assessment 01 and a 2-point reduction. So as a reminder, this is — the IGA are a standard FDA supported endpoint for cutaneous disease. This is similar to the is used in other skin indications with from 0 to 4, clear, almost clear, mild, moderate and severe. So to achieve both the 2-point reduction and at 0 or 1 is a very high bar — and notably, it’s a high enough for that 0 placebo patients clear it. So you may be confused where the placebo line, the placebo line and the x-axis line are the same thing on this chart. And you see here, again, some early progress for both of dose arm at week 4, really significant or substantial improvement at week 8 and then static improvement at week 12 and 16.

And then here on this higher bar endpoint, you do start to see brepo 15 milligrams begin to — sorry, brepo 45 milligrams, begin to separate from the 15-milligram dose arm. Slide 16 has the CSAMI responder data. Again, really compelling data. I think this chart on the left quite remarkable as Matt alluded to, we were hoping to see a mean improvement of 5 points and what we saw was as not only a mean far in excess of that, but we saw 100% of patients in the brepo 45-milligram arm achieve twice that, twice the minimum clinically important difference. Really every brepo 45-milligram patient, a responder in this trial and does all walk through momentarily, that that’s really corroborated by an independent patient reported outcome as well. And then you see on the right-hand side of this chart, achievement of CSAMI less than 5, notable there’s not an improvement by less than 5.

This means that the absolute score end of the trial is 5% or less, which is a standard for functional remission. And you see 62% of brepo 45-milligram patients achieving that compared to no placebo patients. So again, this data are quite in line with the IGA 2-point improvement to 0/1 that I walked through before. So again, seeing pretty consistent data here across multiple endpoints. Turning now to the patient reported outcomes. Slide 17 has the Skindex-16. This is, again, a pretty established standard metric in inflammatory skin disease trials. You see excellent data here with the placebo group worsening brepo 45 milligrams and 15 milligrams, both improving substantially well above the minimum clinically important difference. Again, here with brepo 45 milligrams outperforming 15 modestly and both doses really far better than placebo.

Slide 18, we have the KSQ skin domain. So this is the King’s Sarcoidosis Questionnaire. It’s a PRO for sarcoidosis overall map, just limited to skin disease. What we focused on in our initial [ TLR ] was skin-specific domains, and you see here very in line with the Skindex in terms of in terms of the data. So just yet another data point, a very compelling evidence of benefit. And finally, on the efficacy side, I alluded to this before, but on Slide 19, we call it the patient’s global impression of change. So this is a single question where patients are asked since they started taking the study medication, how would they describe the overall change in the sarcoidosis symptoms and they can answer no change or some degree of improvement or some degree of worsening I think this is a powerful endpoint for simplicity and notably, 100% of brepo 45-milligram patients reported that they improved, again, consistent with the CSAMI data where we saw 100% response rate.

So very compelling here. Brepo 15 milligrams also very considerable improvement for most patients, although two patients in the brepo 15-milligram group, did not — not only do not report improvement, but actually reported worsening. And then in the placebo group, a very little improvement and most patients reported either worsening or no change. Turning to Slide 20. Safety data. I think very well, brepo was very well tolerated during the study when no SAEs in the study and all adverse events were graded mild or moderate in severity. So against the backdrop of this efficacy data, in particular, certainly, the safety data we see would tee up a potentially very favorable benefit risk profile for brepocitinib for these patients. Obviously, we have over 1,500 patients of data in brepocitinib, and so the overall safety database is characterized by much more than just these results.

But certainly here, nothing that would really add anything to what’s already known about the drug from that perspective. And I think, again, starting to dose it now in this particular patient population, I think we see the early signs of a very indication-specific compelling benefit risk profile. So just to wrap up very quickly, before handing it back to Matt, really compelling evidence of benefit. The effect sizes we see here are extremely large we see them very consistently across multiple different endpoints, including independent patient reported and physician-reported assessments, very high response rates, including the 100% response rate for the brepo 45-milligrams arm and the rapid onset of action sustained over time. So really exciting results.

We’re really excited to move this ahead to Phase III and potentially have the first approved therapy for sarcoidosis. So I look forward to discussing any questions later, and I’ll hand it back to Matt.

Matthew Gline: Thanks, Ben. Yes, look, we’re just terrifically excited about the data about what it means for us and what it means for these patients. On Slide 22, just sort of as a reminder of what the picture for brepocitinib now looks like. People pass around the phrase pipeline and a product for a lot of different products I feel at this point, looking across the indication set for brepo, even with what we’ve talked about already with CS, DM and NIU, where we get to a very large addressable patient population. These are patients who — in every one of these indications lacks efficacious therapies and is in need of options, and we continue to add legs of the stool or opportunities that grow into these sort of first-in-class orphan inflammatory diseases that are high unmet needs, important areas.

And I think we’ve got more to come there. So stay tuned. But just starting to feel it brepocitinib is a really important medicine for us and hopefully for patients, so looking forward to continuing that journey. I’m going to brief through a couple of other highlights or updates across the portfolio, quick financial update, and then we’ll do Q&A at the end. Super quickly on Slide ’24. As a reminder, IMVT-1402 remains a huge focus for us at Immunovant. We think we’ve got an FcRn with potential best-in-class efficacy with a safety profile that looks favorably within the class. Obviously, convenient administration with a subcu auto-injector. And we [indiscernible] pipeline and product potential, again, with Graves’ among our lead indications where we’re expecting pivotal data in 2027.

We’re now, as I mentioned earlier, expecting the DTRA data later this year, and that study is fully enrolled. We actually enrolled 170 patients in that study up from the anticipated 120 originally, and that was in part just due to speed of enrollment and the level of enthusiasm from the patient in that community. Moving over to mosli on ’25, and we’ll definitely spend some time later this year talking more about PH-ILD and mostly in setting the stage for what we expect there. But that study is fully enrolled. With thanks those patients investigators in the Priovant team PH-ILD remains an exciting opportunity for us, where targeted delivery gets at a disease where lung is the primary site of disease activity. I think we have a convenient once-daily dosing regimen in a disease where existing therapies mostly have multiple daily inhalations there aren’t very many existing therapies bluntly.

We expect or hope for tolerability benefits. And then as I think you know, we showed really the best ever PVR reductions in the PAH population if that translates we’ll be able to get some best in class efficacy as well. So really excited about what we could do there later this year. I think it will be a really important part of our story in the coming months. And then finally, and as I said before, I’m not going to spend a ton of time talking about this today because we’re so close in here, but with the jury trial in the Moderna case is scheduled for March 9. We continue to make progress there and the sort of major update there in the recent weeks is that we got earlier this week, we got the first of the summary judgment decisions, which covered a few things and hand some puts and takes in it.

But one thing we were quite happy with is a favorable decision on Section 1498 which sets us up for the case that we were sort of hoping for in this trial, where almost all of the doses that we had asserted are going to be covered in this jury trial. So looking forward to that and obviously, more to come there. Finally, just a really brief financial update on Slide 28. R&D expense of $165 million adjusted non-GAAP of $147 million for the quarter. G&A of $175 million, adjusted non-GAAP of $71 million, for total non-GAAP net loss of $167 million. Cash remains very strong, $4.5 billion of consolidated cash in the business. So plenty of capital to get us to profitability with dry powder to do other things as well. As a reminder, we still have share buyback authorization and are happy to have that sort of capability.

On Slide 30, as discussed just a really catalyst-rich period ahead of us. A couple of these things checked off now. Obviously, the beginning of the summary judgment also make progress and just feeling good across the board with a lot more updates to come this year. It should be a big year for us. And a big few years on Slide 31 before I go to Q&A, multiple commercial launches potential in the coming years, obviously, brepo and DM would be first with that NDA now in multiple NDA and BLA filings. We continue to have even sort of more future POC study reads even among the ones we’ve already announced and now 9 or more pivotal study readouts, including cutaneous sarcoidosis coming over this time line, which is just a really exciting slate for us to build on.

So with that, thank you again for listening. I’m going to stop talking and open up the line for Q&A. Thank you. Operator?

Receive real-time insider trading and news alerts

Operator: Our first question comes from the line of Corinne Johnson with Goldman Sachs.

Corinne Jenkins: I think you’ve mentioned today and previously that you consider further development expansion opportunities for brepocitinib. And I’m curious how these data kind of inform the direction you’d like to go. Maybe you could also help us kind of size the opportunity set, particularly with respect to like what percent of the patient population you think are great candidates for this relative to NIO and dermatomyositis.

Matthew Gline: Thanks. It’s a great question. Look, I think the first thing is we are absolutely enthusiastic about further development in brepo. We have other indications that Ben and the team are hard at work at. I don’t — I think the — but I would say the main thing about this data is just that it continues to underscore how strong an agent brepo can be in these patient populations that need it. and sort of drives enthusiasm, but I don’t know that it reveals anything specific or new. Other than we’re continuing to think about other forms of sarcoidosis, et cetera. CS is another indication where we will be first and only drug approved if we’re successful from here. And then on patient population, look, I think this is right in the sweet spot of what we’ve been trying to do, not just bluntly for brepo, but across the different drugs we’re developing, where we’re in this kind of large orphan market.

And again, we might do things outside of this category, but it’s been a really good space for us and for others with tens of thousands of patients, a big opportunity, high unmet need. And we think it will be the kind of thing that we can attractively launch and that we can that we can make a successful franchise around. So it feels great from an ability to benefit these patients perspective and from a commercial perspective as well. Ben, anything you’d add there?

Benjamin Zimmer: I would just add that I think — and this is something we’ve felt already, but this data really enforces that the alignment of TYK2, JAK1 inhibition to T cell polarization both as we see here, predominantly Th1 driven, but also Th17 driven. And the mechanism of TYK2, JAK1 inhibition really does aligned to that through IL-12 and interferon gamma for TH1, IL-6 and IL-23 for Th17. And I think that’s really one of the mechanistic hypotheses around the distinctive benefits of TYK2, JAK1 inhibition, others are obviously the type 1 interferon suppression that’s very important in dermatomyositis, in addition to the T cell polarization. But I would kind of highlight that this data really enforces that NIU has some overlapping mechanism as well, where obviously, we had really strong Phase II data, excited to see that Phase III result.

But I think just as we think about not just kind of the unmet need of indications, as Matt articulated, but also diseases where TYK2, JAK1 inhibition is going to really be, in our view, potentially better than any other form of immunosuppression. I think this data kind of reinforces some of our hypotheses there.

Operator: Our next question comes from the line of Dave Risinger with Leerink Partners.

David Risinger: Let me add my congrats as well, Matt and team. So obviously, the data was phenomenal. I had a couple of questions. First, with respect to the headline CSAMI numbers, they were similar between the two arms. The press release, obviously, you mentioned different baseline characteristics. Could you just add a little more color on that? Second, with respect to the FDA timeline, obviously, Octagam is approved for dermatomyositis. But is there a chance for the FDA to elect to grant priority review? Could you talk about that a little bit? In DM, I’m talking about.

Matthew Gline: Thanks, David. Both great questions. On CSAMI point, I think Ben hit on this well in his presentation as well. Look, I think if you look at the table, I can pull up the slides in a second, but if you look at the table in the presentation, on baseline characteristics, I’d say there are some relatively — it’s a small proof-of-concept study, it’s a relatively small in each arm. And so you can see some relatively significant differences on some aspects, including duration of disease. As well as morphology of disease with more a plaque predominant patients, which are those more recalcitrant patients on our 45 arm than on our 15 arm. And I think that’s probably in part what’s responsible for the sort of headline numbers looking similar.

And you can see that they separate more, again, as Ben hit pretty well in the presentation on the more stringent endpoints like the proportion of patients hitting a 10 or more point season benefit. So we feel pretty good about that translating into Phase II. And then on the FDA time line, look, I think the answer to that question is DM is a severe disease with not a lot of options. And so there’s certainly a chance, but that ultimately is up to FDA. Thank you.

Operator: Our next question comes from the line of Yaron Werber with TD Cowen.

Yaron Werber: Great, really nice to see this data. I got a couple of questions. One is price. The IVIG is around $180, but the concomitant sort of price for Vyvgart for these indications around $870 gross. So maybe help us understand how you’re thinking about pricing of brepo. And then secondly, as you — and I know this might be a little premature, but from Pfizer owns 25% of the JV, you’ll obviously consolidate all sales of brepo. How do we handle their 25% ownership because you’re not going to be paying a dividend, but I imagine you’ll have to sort of give them their 25% of the profits. What is that going to hit the P&L?

Matthew Gline: Yes. Thanks, Yaron. Those are both good questions. Look, I think on price, we obviously have not decided on the price yet, it’s too early to have an answer to that question. What we’ve said before is taking bookends that are not so different from the ones you quoted there. I think our view is IVIG is probably a little bit more expensive than that in practice. Those bookends are a reasonable place to think about in terms of the pricing envelope for these indications is what we said before, and I think that continues to stand. And I think it gives us a lot of room. So I think stay tuned, but this will be an orphan price drug. And then on the — what I think is really sort of an accounting math question, so we’ll fully consolidate all of the results, losses, sales of everything, and then there’ll be a below-the-line minority interest that attributes a portion of Pfizer’s earnings.

But again, it will be below the net income line. And then in terms of how cash comes out, obviously, if we distribute cash out, Pfizer, we’ll get their portion of that cash, and we’ll get out a portion of that cash. The only other comment I’ll make there is — and we said this elsewhere, the early portion of the relationship with Pfizer had dilution protection for their ownership stake. That’s been exhausted now. And so for any further capital into Priovant, Pfizer will either need to match their portion of our spend or will be diluted and we’ll wind up owning more.

Operator: Our next question comes from the line of Brian Cheng with JPMorgan.

Lut Ming Cheng: Congrats on the data here. Two questions from us. As we think about the Phase III, what’s your latest thinking about the size and the dose that you have picked?. And just curious if you have any thoughts about how we should think about the stability of efficacy going from a Phase II to Phase III for this indication, it seems that you have a pretty large gap going from 22 to the 5-point Delta that seems clinically meaningful. How should we think about deterioration, and I have one quick follow-up as a housekeeping question.

Matthew Gline: Yes. Thanks, Brian. Look, I’m also going to hand over to Ben for these questions, but I’ll just say it feels like we’ve got a fair amount of cushion in the quality of this data. And also, a, this was a relatively small study. You either aren’t a lot of other studies to go on in CS. So we kind of got to take our guidance from here. But it was nice to see a low placebo response. Ben, do you want to talk a little bit about that and about whatever we can share at this point on Phase III design.

Benjamin Zimmer: Yes, sure. I mean, first, just on erosion, obviously, would be hard to do any better than this. But I think that the minimum clinically important differences, as we’ve discussed, is 5 points here, we have over 20 points we could have significant erosion and still have a very compelling data set and a very compelling product profile for patients and physicians. That said, I would also note this was — it was the U.S.-only study, but 15 sites for the 31 patients. So this was a multicenter, multidose, placebo-controlled trial, very rigorous for a smaller proof-of-concept study. So while I think that there’s always some risk of erosion in particular, while the very low placebo rate is consistent with natural disease course, you can never be sure of the behavior of placebo and these inflammatory disease trials, particularly when you move to larger global trials.

But broadly speaking, I think this data gives us an incredible cushion to still have an effect size in Phase III that maybe is large or maybe is not quite as large, but still would be extremely compelling. As far as the design of the Phase III in terms of size, I think we would probably be looking at a sort of similar size per arms to the DM trial roughly, but we need to kind of take this data into consideration and think more about the powering and have final discussions with FDA on it, including as related to the in indication safety set that they would want to see to support approval. So we’ll have more to share on that after we engage with FDA. And the same is true on dose, I would say that I think our incoming hypothesis to this trial is that 45 milligrams based on the totality of the 1,500 patient data we have, a very compelling potential option for these patients balancing benefit and risk.

And certainly, I would say, in totality, this data reinforces that, you see really excellent efficacy results from the 45-milligram arm, including on some of these higher bar, more stringent endpoints, starting to see real separation with 15 milligrams. And then certainly, in terms of the safety data, nothing that would suggest the overall safety profile of 45 milligrams that we’ve seen across all of the different indications in which it’s been studied, that nothing in this data to suggest there’s anything specific to cutaneous sarcoidosis separate from those. So I think broadly speaking, I would say we’re very excited about 45 milligrams coming into the study. We’re even more excited about it coming out of the study. 15 milligrams also performed very well, and that’s great to see.

It really just speaks to the overall efficacy potential of the product. And so we’ll kind of have a final update on that after we engage with the agency.

Operator: Got it. And maybe just one quick one on the housekeeping side. So looking at the 10-Q from Immunovant, can you give us a little bit more color on the return for certain rights around batoclimab back to HanAll? Is there any read-through to how we should think about the setup for the tech data readout later this year?

Matthew Gline: No, it was the short answer to that question. meaning there’s no read-through anything. It’s just as we get closer to that data, depending on what we decide to do with batoclimab, if we decide to further development, we’ll have to make a decision around how to work together with HanAll next steps there. So that’s really nothing to say.

Operator: Our next question comes from the line of Dennis Ding with Jefferies.

Unknown Analyst: This is Anthea on for Dennis. And congratulations on the data. I wanted to ask two questions on upcoming catalysts. First on Daubert, can you explain how important Dr. Mitchell’s testimony is to the case improving direct infringement and whether or not there’s any risk to that being taken out, so to speak, ahead of trial? And then on PH-ILD, thoughts on the competitive landscape and if sotatercept could work in the disease as well?

Matthew Gline: Both great questions. Look, on Daubert, as we said, we really can’t talk too much about an ongoing litigation. There are a variety of Daubert motions in front of the court, what they are or visible and the judge will make a decision on all of them and anything within the range as possible. Obviously, we’re hoping for favorable test outcomes in case. On PH-ILD question, look, I think the answer is, in theory, any drug that improves PVR could work in PH-ILD, systemic vasodilation has not, in and of itself, a been a great approach in PH-ILD but sotatercept certainly could work in PH-ILD. Right now, we are slated, I believe, to be the first non-prostacyclin, non-treprostinil in PH-ILD. I suspect given the amount of unmet patient need, there will be others behind us, but I think we have a really favorable profile as we enter that space.

Operator: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler.

Yasmeen Rahimi: Thank you so much for all the color. As an Immunovant covering analysts would love to spend time on 1402 and get some color around here near term or a readout. Obviously, the study is upsized. Help us understand as the studies coming to end reading out what you hope to see and how you’re sort of preparing for filing and how soon you could actually get ready for that first Phase II registrational study to be shared? And then I’ll jump back in the queue.

Matthew Gline: Thanks. I appreciate the question. Look, I think in terms of expectations for RA, I think the short answer to that question is, on the one hand, these are patients with high unmet need. And so in some sense, the bar for efficacy is relatively low compared to what we may be used to seeing in RA. On the other hand, there’s just very little precedent data for drugs in late-stage RA with sort of this level of pretreatment. And so it’s hard to know. I think we’re doing some work on that very question now, and we will share some guidance on what would cause us to run the second study before we put out that data. So it’s a stay tuned for that. Remember, these are burned out patients with pretty tough disease at this point.

So obviously, if we’re excited about the data, there’s a potential for it to be a big product. Obviously, we will engage with the agency once we’ve got the data and think about what a plan looks like. I think the base case expectation should be that this is one of a couple of studies that we’ll have to run just because this is a relatively smaller randomized withdrawal trial, but we’ll see the data, and then we’ll have better answer that question.

Operator: Our next question comes from the line of Prakhar Agrawal with Cantor.

Prakhar Agrawal: Congrats on these main results. So maybe on brepo and CS, just wanted to better understand the market opportunity here. You’ve talked about 40,000 eligible patients. would all of these be eligible for brepo therapy and meet the inclusion/exclusion criteria for the trial. And if that’s the case, do you think this is a similar size opportunity as dermatomyositis? And maybe just one follow-up on the Phase III design. Would the time point of the endpoint the 16-week similar to your Phase II, given your — you already have the safety database. Or would you have to test longer, just trying to figure out if there’s any ways to accelerate development here?

Matthew Gline: Yes. Thanks, Prakhar. Great questions. Look, I think the short answer of our market opportunity is this is a patient population that’s sick with high unmet need. And assuming our Phase III data looks similar to our Phase II data, I think a lot of these patients are going to be enthusiastic about a better treatment option. It’s probably a modestly smaller indication than dermatomyositis just in terms of total end. I mean, obviously, DM is 40,000 patients in treatment with 70-plus thousand total patients. So I’d probably think of this as an exciting opportunity, but a little bit smaller than the DM opportunity, although, again, depends on the Phase III data. And then I think the short answer on Phase III design is let’s just wait until we’ve had the conversation with FDA before we sort of talk about final outcomes, but we’re going to be looking to leverage as much as we can of what we’ve learned from the Phase II study.

And obviously, to the extent that we can match parameters on which we’re confident we’ll do that. Thanks for the question.

Operator: Our next question comes from the line of Samantha Semenkow with Citi.

Samantha Semenkow: Congrats on this very good safe data. I’m wondering what percentage of patients in the BEACON study had organ involvement if you have that? And were you able to collect any data that would allow you to assess whether brepocitinib impacted organ-specific manifestations? And then just as a follow-up there, do you see a path to expand into other forms of sarcoidosis with brepocitinib?

Matthew Gline: Yes. Thanks. Look, I’ll take the second of those questions, which is certainly something we will evaluate in terms of further places to study brepo. And we — as I said before, we have ideas inside and outside sarcoidosis that are exciting. So stay tuned we’ll be back with it. On the first question, in terms of pace of organ involvement and what we can learn from it, Ben, anything you’d share about that?

Benjamin Zimmer: Yes. Around 60% of the patients had some pulmonary involvement and around 30% inclusive of that 60% had some other organ involvement, mostly ocular involvement we did take some exploratory endpoints related to those in the trial. We haven’t analyzed that yet. Ultimately, the study was not designed or set up to evaluate benefit in those other organ systems. So I don’t expect us to learn anything too meaningful from that, but it’s certainly something we will take. I look at it, and I think the important point to note is this is a real-world cutaneous sarcoidosis population, given these — many of these patients do have multiple organs and involved.

Operator: Our next question comes from the line of Yatin Suneja with Guggenheim.

Yatin Suneja: A quick one for me on brepo on the data that you provided. Like if you look at the curves, they continue to deepen over 16 weeks. So I’m just curious to understand from you how should we think about further — do you expect further deepening, further separation. Just talk about if somebody gets treated for a year, how should we think about it? And then if you can just talk about the scope and the size. I don’t know if you touched on that already of the Phase III study, should it be similar to what you did in DM .

Matthew Gline: Yes. I mean, just to reiterate on Phase III, and I think Ben shared a thought about that. But I think in general, we talked to FDA, it’s like it’s hard to commit to a specific study design. So I think like let us get through that, and then we’ll be back with a full accounting of the study design. But I think we’re prepared to run and enroll a nice sizable study, if that’s what we need to do. I think we feel good about what we need there. And then in terms of — look, in terms of continued deepening, we’re just looking at the data for the first time this week. So I think we’re continuing to explore all the various features. I think it’s fun, one of the KOLs was also involved with the study gave a quote to some journalists.

When I think his comment was if the data had been half as good and there have been twice as many side effects still would have been a great outcome. Look, obviously, long story short, there are certainly potential ways for this data to be even better with long with therapy with other parameters, but I think the answer is if we can come close to replicating this in a Phase III program, it would be a huge win. So I think we should be all set there.

Operator: Our next question comes from the line of Douglas Tsao with H.C. Wainwright.

Douglas Tsao: I guess, Matt, I’m just curious with brepo, how broad are you now thinking about the opportunity, right? I mean I think we’ve seen great results, obviously, in CS today DM as well as there is obviously a lot of data with JAK inhibitors in various indications, but not necessarily full randomized trials or proof of concept. I mean is that the breadth of universe? Or is there other white space that you’re also thinking about where JAK hasn’t been explored at all but perhaps it’s worth exploration just given the magnitude of effect that you’re starting to see. Thank you.

Matthew Gline: So could you just — yes, how broad we think about the rep opportunity. Thanks, Doug. Great question. Look, I think the short answer is, I think you can see from our indication selection already that we’ve been creative and thoughtful in going after indications with high unmet need, including lots of places where JAKs have not been explored. And I think there’s a lot of opportunity here. I’ll just reiterate something Ben said. And Ben, if you want to do it again as well, I think it’s a really good point to hit. Look, I think anywhere that TYK and JAK are both important is a particular area of focus for it because it gets the uniqueness of our mechanism, but I think we’ve done a really nice job, again, thanks to Ben and a bunch of people in his team as well. The private team on exploring that biology. I think we have more ideas in that category. Ben, anything to add there mechanistically or otherwise?

Benjamin Zimmer: No. I mean, I think I covered it earlier. I would say that the answer is both. I think there are some indications where there’s maybe some IITs or clinical reports from off-label use of other JAK inhibitors, where we think TYK2, JAK1 inhibition is really optimally suited for it. And I think those are indications we’re evaluating that would obviously be highly derisked. I also think as we — to your point, as we continue to see more and more excellent data here, I think we’re definitely looking into some obviously, higher risk but also exciting potential opportunities where there’s less proof of concept, and we would see what we end up with there.

Douglas Tsao: And Matt, if I can one follow-up, just obviously, business development has always been such a big part of the Roivant story. But just given the sort of expanding horizons for both brepo as well as IMP-1402, how are you thinking about capital allocation in terms of external versus sort of just internal R&D investment?

Matthew Gline: Dollars go to the best opportunity wherever they are, the short answer to that question. Look, we’re funded through profitability on our existing portfolio obviously, things like running the Phase III program in cutaneous sarcoidosis are no-brainers at this point. We were definitely going to do it. And adding additional indications, brepo or 1402 or for mostly are attractive options because those mechanisms are strong, and we’ll work in other places. That said, and I’m sitting across the table from a right now, the world is full of attractive opportunities, and we look at all of them. So I think we’ve absolutely got opportunities to deploy sort of externally as well, and it continues to be a core part of what we believe we are good at.

Operator: Our next question comes from the line of Derek Archila with Wells Fargo.

Derek Archila: Congrats on the data. So just quickly on Immunovant in terms of — we saw positive data for nipocalimab in systemic lupus. So curious about how you think about the read-through to cutaneous? And then second question, just in terms of commercial synergy between brepo and 1402, Obviously, we’re Immunovant covering analysts. So just curious how you think about fielding a sales force in the most cost-effective manner to leverage both brepo and 1402 between the two companies?

Matthew Gline: Yes. Thanks. Look, these are both really good questions and important areas for us. On SLE, first of all, I was on record long before the brepo study in SLE saying that anybody who isn’t afraid of a lupus study, I think the word I used in it. And so I’ll say congrats to J&J on the positive data in SLE, it’s always impressive when people were able to deliver those kind of results. It certainly supports the use of FcRns in diseases with a lot of complicated immune activity going on at the same time. There’s probably some read-through to CLE in the sense that in the sense that there’s some pathophysiological overlap there. But every lupus study of any kind is its own special flower and we’ll have to be successful in CLE on our own.

We like cutaneous lupus in part because we know that forms are pretty good at reading those kinds of endpoints. And so we feel good about that. Again, CLE is a different competitive landscape in SLE and we’re watching that bar as well. On the commercial question, look, the first thing I’ll say is even bluntly within a big pharma company these days, the truth is that for de novo launches, mostly you deploy a field apparatus that is specific to the program because you want to engage with those very specific physicians because you want sort of full voice share of your field force on the product. And so I’m not sure I think of like sales force as the most important commercial synergy, but we are definitely thinking about things like contracting expansively to make sure that we can get maximum benefit from commercial scale across the portfolio, and there definitely are areas where that is top of mind for us, but I think will translate to benefit both for the commercial performance of brepo and for the commercial performance of 1402 as those launches progress.

Operator: Our next question comes from the line of Ash Verma with UBS.

Ashwani Verma: So for [ Barron’s ], just upcoming the TED results, the data that you’re expecting. Just curious how you’re thinking about that in the light of recent Vyvgart setback in TED. In your case, how confident are you that a positive Graves’ disease readout would translate to success in Thyroid Eye Disease?

Matthew Gline: Thanks. Look, I appreciate the question. Obviously, TED is out there, and that data is coming when we have both studies in the first half of this year. I don’t think there’s like a ton of — a ton to say about that at this point. Those studies are going to happen and will put the data out. Obviously, we know from our own Phase II study in TED as well as from our own Phase II work in Graves’ that the drug is active in patients with hyperthyroidism. And I think that should translate in both indications to some degree of efficacy. And we don’t think there’s a lot of read-through from TED either in Argenx’s case. And Argenx obviously also doesn’t as well. or in our own situation in Graves’ disease in the sense that we have — look, obviously, both where we have all of our Phase II data in Graves’ and the diseases are pretty different.

Like the TED study enrolled mostly thyroid patients. So they’re pretty different fundamentally in terms of who was in the studies. So I feel like we are confident in the efficacy or potential efficacy of FcRns in Graves’ disease and not particularly focused on what information there is from TED. Obviously, once we get the TED data and can talk about it, there will be information there from patients who happen to be hyperthyroid at various points in that study and how those patients look and we’ll take full advantage of that data in optimizing our Graves’ program. But beyond that, I’d say not much read-through between the programs and looking forward to getting all that data together once we’ve got it. Thanks, Ash.

Operator: Our next question comes from the line of Thomas Smith with Leerink Partners.

Thomas Smith: Hey guys, good morning. Thanks so much for the update. Great to see the rapid enrollment and the over enrollment for 1402 from D2T RA and I appreciate the update on the data timing I just wanted to clarify, should we expect that you’ll report both the open-label and randomized data from this study together? Or is there potential we could see some of that open-label period one data first? And then as a follow-up, we noticed on Slide 31, the expectation for Graves’ launched by the end of ’28, but not although you’re expecting Phase III data for both indications in ’27. I just wanted to ask if that’s purely a function of data timing there? Or if there’s some other strategic considerations with respect to pricing or competitive landscape?

Matthew Gline: I appreciate both questions. Look, I think on the data release timing for the RA study, I don’t think we’ve made a final decision on how exactly we’ll put that data out and when, but I think it’s reasonably likely now that we know both are coming this year. That we’ll wait for the randomized withdrawal period before we talk about it. Obviously, that first period is open label, so we’ll get some information from it as we go on. And then I don’t think there’s much to read into the exclusion from MG in 2028. In fact, there’s probably some possibility it actually does, in fact, also launch in 2028. And so I think stay tuned once we get that data once those studies are — once we know the exact timeline of those studies, we’ll be able to provide more guidance on specific launch time lines.

Operator: Our next question comes from the line of Alex Thompson with Stifel.

Alexander Thompson: Maybe one on sort of the competitive landscape in Graves. I guess with Argenx entering the area and maybe trying to follow their strategy of chasing fast follower indications here. Like how confident are you that you can maintain your lead in Graves’ if Argenx were to run maybe 26-week studies or even one instead of two studies.

Matthew Gline: Obviously, the extent of our leading — thank you for the question. The extent of our lead time in Graves’ will depend a little bit on organic study design and what they decide to do. And until we know what that design is, it’s going to be hard to say. Certainly, shorter studies will be faster than longer studies mechanically. I think we have a lead in Graves’ that will be significant, roughly no matter what design organic runs. We have great relationships with those KOLs that community. We’ve been out there. One of our studies is also 26 weeks. As a reminder, the 2503 study is 26 weeks. So look, I think the answer is we will have a significant lead in Graves’ disease. How significant that lead is may depend a little bit on what the competition does.

But this is also one of those — whatever may got to run the bar situations or whatever. I think mostly our focus is just getting those studies done and out as quickly as we can and getting out to that population, and it’s such a large and exciting population that it doesn’t really matter. The other thing I’ll say is, as a reminder, we showed pretty conclusively in our Phase II data at the deeper IgG suppression that we expect to deliver will matter in this population. And I think especially on remission. And I think that will also be a significant factor in Graves’ disease. So looking forward to getting all that data together.

Operator: And this concludes the question-and-answer session. I’d now like to turn the call back over to Matthew Gline for closing remarks.

Matthew Gline: Thank you, operator. Thank you, everybody, for the good questions. Thank you all for listening this morning. I want to once again thank everybody involved in all of this, including particularly with the cutaneous sarcoidosis data, the patients and investigators involved in that program. As well as the Priovant team for their execution there, but also everybody at Roivant, all the patient and investigators on all of our studies. And look, we’ve got a lot more to come this year. So I’m sure we’ll be back together soon, and I’m looking forward to continuing the discussion. Thank you, everybody, and have a great day.

Operator: This concludes today’s conference. Thank you for your participation. You may now disconnect.

Receive real-time insider trading and news alerts