Roivant Q3 2025 Earnings Call - Brepocitinib posts striking Phase 2 cutaneous sarcoidosis results, 45 mg arm 100% responders on key measures

Matt Gline, CEO, Roivant: Good day, and thank you for standing by. Welcome to the Roivant Third Quarter 2025 Earnings Conference 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 the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

Stephanie Lee, Investor Relations, Roivant: Good morning, and thanks for joining today’s call to review positive phase 2 results for dermatomyositis and cutaneous sarcoidosis, and Roivant financial results for the third quarter ended December 31, 2025. 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.investor.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.

Ben Zimmer, CEO, Priovant2: 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 talking to the team (it was about a week ago today) looking at a draft of this morning’s presentation and thinking that it was going to be a pretty boring 10-Q. We had gotten together in December for the Investor Day. We had spoken at the JPMorgan conference, and it turned out to have been a really busy week. So we have some great updates, obviously most notably the phase 2 data in brepocitinib 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 brepocitinib is in dermatomyositis, that the phase 2b study for 1402 in D2T-RA has fully enrolled, that the phase 2 study for mosliciguat in PH-ILD has fully enrolled, and obviously all of the updates that were known before, 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: the brepocitinib NIU phase 3 that’s the pivotal readout in the second half. We’re now going to be starting this year a phase 3 study in brepocitinib and cutaneous sarcoidosis.

Ben will talk a little bit more about that. It’s early days and getting that going, but that’ll be this year. The phase 2b data for mosliciguat is expected firmly in the second half of this year. We now know that because the study’s 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 in CLE. And finally, we are still on track for the jury trial against Moderna starting on March 9th, so just a few weeks away now. So a really, really busy year ahead for Roivant.

And really, if you look at slide seven before we get again to the data for CS, just a pipeline we’re really proud of that continues to deliver across multiple dimensions, obviously brepocitinib with now three indications in pivotal registrational programs, multiple registrational programs for the FcRn franchise, 1402, which we’ve talked about, and mosliciguat with top-line data coming in the second half. So really excited about where we are as a business, really excited about the pipeline. Couldn’t be more excited for the beginning of 2026 here. Certainly off to a good start. And with that, what I’m going to do is turn to the phase 2 data for brepocitinib and sarcoidosis. So I’m just really briefly on slide nine 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. The short answer, and we keep saying this, it’s a tremendous fortune, I think, to be able to say, but this drug has done everything we could have asked for it in this study. We had a statistically significant, 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. Again, this study was not powered for efficacy in this endpoint. 100% of patients on brepocitinib 45 versus 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 onto the study data as well. Ben, take it away.

Ben Zimmer, CEO, Priovant: Great. Thanks so much. Great to be here with everyone. Starting on slide 10, I just wanted to bring back to what this disease is, walk through this at the Investor Day in December. Cutaneous sarcoidosis is a really debilitating skin disease. And among skin diseases, it stands out for its rapid progression toward 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’s no approved therapies not only for cutaneous sarcoidosis but for any form of sarcoidosis.

As we think about our development program in CS, really a great opportunity for brepocitinib to meet this overall unmet need and become the therapy of choice if we’re going to be successful in phase 3, as we hope and expect we would be on the basis of this 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. 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. I think in a small study, the data is very, very compelling.

It’s hard to argue 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. brepocitinib 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. 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 to brepocitinib 45 milligrams, 15 milligrams, and placebo. A 16-week study evaluated several different efficacy endpoints 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, brepocitinib 45 milligrams and placebo are very well balanced between those two arms, but 15 milligrams are actually quite a bit lighter on duration of disease and damage, which would mean really a higher bar for both brepocitinib 45 and placebo. 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. You see this plaque-predominant morphology most pronounced and most common in the brepocitinib 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 brepocitinib 45 mg to demonstrate efficacy, both compared to placebo and as compared to brepocitinib 15 mg. In spite of that, as I’ll walk through, we really see exceptional data from the brepocitinib 45 mg dose arm. Turning to slide 15 to get into the efficacy results. On the left hand of the slide, you see the mean 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. Then on the right here, we see the achievement of Investigator’s Global Assessment 0/1 and a two-point reduction. As a reminder, the IGAs are a standard FDA-supported endpoint for cutaneous disease.

This is similar to the IGAs used in other skin indications with scores from 0 to 4, clear, almost clear, mild, moderate, and severe. So to achieve both a 2-point reduction and at a 0 or 1 is a very high bar. And notably, it’s a high enough bar that 0 placebo patients cleared it. So you may be confused, where’s 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 dose arms at week 4, really significant or substantial improvement at week 8, and then stat-sig improvement at week 12 and 16. And here on this higher bar endpoint, you do start to see brepocitinib 15 mg begin to—sorry, brepocitinib 45 mg begin to separate some from the 15 mg 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. What we saw was not only a mean, far in excess of that, but we saw 100% of patients in the Brepa 45 milligram arm achieve twice that, twice the minimum clinically important difference. So really, every Brepa 45 milligram patient, a responder in this trial, and as I’ll walk through momentarily, that’s really corroborated by an independent patient-reported outcome as well. Then you see on the right-hand side of this chart, achievement of a CSAMI less than 5. Notably, this is not an improvement by less than 5. This means that the absolute score by the end of the trial is 5 or less, which is a standard for functional remission.

You see 62% of BREPA 45 milligram patients achieving that compared to no placebo patients. So again, this data is quite in line with the IGA two-point improvement to 01 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, BREPA 45 milligrams and 15 milligrams, both improving substantially, well above the minimum clinically important difference. Again, here with BREPA 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 Sarcoidosis Questionnaire. It’s a PRO for sarcoidosis overall, not just limited to skin disease.

What we focused on in our initial TLR was the skin-specific domains. And you see here, very in line with the Skindex in terms of the data. So just yet another data point of very compelling evidence of benefit. And finally, on the efficacy side, I alluded to this before, but on slide 19, we would 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 their 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 its simplicity. And notably, 100% of brepocitinib 45 mg patients reported that they improved, again, consistent with the CSAMI data where we saw a 100% response rate. So very compelling here.

Brepocitinib 15 mg, also very considerable improvement for most patients, although two patients in the brepocitinib 15 mg group not only did not report improvement but actually reported worsening. Then in the placebo group, very little improvement. Most patients reported either worsening or no change. Turning to slide 20, safety data. I think very well, brepocitinib was very well tolerated during this study. We had 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. 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 brepocitinib 45 mg arm, and a rapid onset of action sustained over time. So really exciting results. We’re really excited to move this ahead to phase 3 and potentially have the first approved therapy for sarcoidosis.

I look forward to discussing any questions later, and I’ll hand it back to Matt.

Matt Gline, CEO, Roivant: Thanks, Ben. Yeah, look, we’re just terrifically excited about this 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 toss around the phrase pipeline and a product for a lot of different products. I feel at this point, looking across the indication set for BREPA, even with what we’ve talked about already with CSDM and NIU, where we get to a very large addressable patient population, these are patients who, in every one of these indications, lack efficacious therapies and are 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 need, important areas. And I think we’ve got more to come there, so stay tuned.

But just starting to feel like brepocitinib is a really important medicine for us and hopefully for patients. So looking forward to continuing that journey. I’m going to breeze through a couple of other highlights or updates across the portfolio, a little 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 favorable even within the class, obviously convenient administration with a subQ autoinjector. And we use the phrase again here, 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 D2T-RA data later this year. And that study is fully enrolled.

We actually enrolled 170 patients in that study up from the anticipated 120 originally. That was in part just due to speed of enrollment and the level of enthusiasm from the patient and doc community. Moving over to mosliciguat on 25, and we’ll definitely spend some time later this year talking more about PHLD and mosliciguat and setting the stage for what we expect there. That study is fully enrolled with thanks to those patients, investigators, and to the Pulmovant team. PHLD remains an exciting opportunity for us where targeted delivery gets at a disease where lung is the primary site of disease activity. We think we have a convenient once-daily dosing regimen in a disease where existing therapies mostly have multiple daily inhalations and where 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. And if that translates, we may 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’ll be a really important part of our story in the coming months. And then finally, and as before, I’m not going to spend a ton of time talking about this today because we’re so close in here, but the jury trial in the Moderna case is scheduled for March 9th. We continue to make progress there.

The sort of major update there in the recent weeks is that we got the first of the summary judgment decisions, which covered a few things and had to put some takes generally in it. But one thing we were quite happy with is the 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. 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 a 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 beginnings of the summary judgment also make progress. And just feeling good across the board with a lot more updates to come this year 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, Brepa and DM would be first with that NDA now in. Multiple NDA and BLA filings.

We continue to have either sort of more future POC study readouts, even among the ones we’ve already announced, and now nine or more pivotal study readouts, including Cutaneous Sarcoidosis, coming over this timeline, 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.

Stephanie Lee, Investor Relations, Roivant: Thank you. As a reminder, to ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Corinne Johnson with Goldman Sachs. Your line is now open.

Ben Zimmer, CEO, Priovant2: Good morning, guys, and thanks for the question. 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 opportunities set, particularly with respect to what portion of the patient population you think are great candidates for this relative to NIU and dermatomyositis. Thanks.

Matt Gline, CEO, Roivant: Yeah, perfect, Corinne. Thanks. It’s a great question. Look, I think the first thing is we are absolutely enthusiastic about further development of brepocitinib. We have other indications that Ben and the team are hard at work at. I think what I would say the main thing about this data is just that it continues to underscore how strong an agent brepocitinib 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 continuing to think about other forms of sarcoidosis, etc. CS is another indication where we will be the first and only drug-approved if we’re successful from here.

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 brepocitinib, 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’ll be the kind of thing that we can tractably launch and that we can make a successful franchise around. So it feels great from an ability to benefit these patients’ perspective and from a commercial company perspective as well. Ben, anything you’d add there?

Ben Zimmer, CEO, Priovant: I would just add that I think and this is something we’ve felt already, but this data really enforces that of 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 align 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 2 data. Excited to see that phase 3 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.

Ben Zimmer, CEO, Priovant2: Thanks. Thanks for congrats on the data.

Matt Gline, CEO, Roivant: Thanks, Corinne.

Stephanie Lee, Investor Relations, Roivant: Thank you. Our next question comes from the line of David Risinger with Leerink Partners. Your line is now open.

David Risinger, Analyst, Leerink Partners: Thanks very much. And 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 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? Thanks so much. In DM, I’m talking about. Thank you.

Matt Gline, CEO, Roivant: Thanks, Dave. Thanks, Dave. Those are both great questions. On the CSAMI report, 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 now in a second. But if you look at the table and the presentation on baseline characteristics, I’d say there are some relatively small. This is 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 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.

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 CSAMI benefit. So we feel pretty good about that translating into phase 3. And then on the FDA timeline, 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.

Ben Zimmer, CEO, Priovant: Thank you.

Matt Gline, CEO, Roivant: Thanks, Dave.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Yaron Werber with TD Cowen. Your line is now open.

Ben Zimmer, CEO, Priovant0: Great. Thanks so much and congrats. 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 is around $870 gross. So maybe help us understand how you’re thinking about pricing of brepocitinib. 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 brepocitinib. 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. Where is that going to hit the P&L? Thank you.

Matt Gline, CEO, Roivant: Yeah. Thanks, Yaron. Those are both good questions. Look, I think on price, we obviously have not decided on a 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. That those bookends are a reasonable place to think about in terms of the pricing envelope for these indications is what we’ve 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-priced drug. And then on what I think is really sort of an accounting math question, so we’ll fully consolidate all of the results, losses, sales, everything.

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

Stephanie Lee, Investor Relations, Roivant: Thank you.

Matt Gline, CEO, Roivant: Thanks, Jeroen.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Brian Chang with JPMorgan. Your line is now open.

Brian Chang, Analyst, JPMorgan: Hi, Matt and Ben. Congrats on the data here. Two questions from us. As we think about the phase 3, 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 2 to phase 3 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. Thank you.

Matt Gline, CEO, Roivant: Yeah, thanks, Brian. Look, I’m mostly 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. There 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 local super response. Ben, you want to talk a little bit about that and about whatever we can share at this point on phase 3 design?

Ben Zimmer, CEO, Priovant: Yeah, sure. I mean, first, just on erosion, obviously, it would be hard to do any better than this. But I think that the minimum clinically important difference, as we’ve discussed this 5 points here, we have over 20 points. We could have significant erosion and still have a very compelling dataset and a very compelling product profile for patients and physicians. That said, I would also note this was a US-only study, but 15 sites for the 31 patients. So this was a multi-center, multi-dose 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 in 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 3 that maybe is as large or maybe is not quite as large but still would be extremely compelling. As far as the design of the phase 3, in terms of size, I think we would probably be looking at 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 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 is 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, 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. That’s great to see. It really just speaks to the overall efficacy potential of the product. So we’ll kind of have a final update on that after we engage with the agency.

Brian Chang, Analyst, JPMorgan: Got it. Thanks, Ben. Maybe just one quick one on the housekeeping side. Looking at the 10-Q from Immunovant, can you give us a little bit more color on the return of certain rights around batoclimab, HanAll? Is there any read-through to how we should think about the setup for the TED data readout later this year? Thank you.

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

Brian Chang, Analyst, JPMorgan: Great. Thank you, Matt.

Matt Gline, CEO, Roivant: Thanks, Brian.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Dennis Ding with Jefferies. Your line is now open.

Ben Zimmer, CEO, Priovant2: Good morning. This is Anthea on for Dennis. Thanks for taking our questions 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? Thank you.

Matt Gline, CEO, Roivant: Thanks. 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 are visible. And the judge will make a decision on all of them. And anything within the range is possible. Obviously, we’re hoping for favorable test outcomes in each case. On the 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 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-prostanoid 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. Thanks, Anthea.

Ben Zimmer, CEO, Priovant2: Thank you.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.

Ben Zimmer, CEO, Priovant2: Good morning, team. Thank you so much for all the color. As an Immunovant covering analyst, we’d love to spend time on 1402 and get some color around the here and near-term RA readout. Obviously, the study’s upside. Help us understand, as the study’s coming to an end, reading out, what do 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 3 registrational study to be shared. And then I’ll jump back in the queue.

Matt Gline, CEO, Roivant: Thanks. 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 I’d say 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 a better answer to that question. Thanks, Yasmeen.

Ben Zimmer, CEO, Priovant2: Okay. Thanks.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Prakhar Agrawal with Cantor. Your line is now open.

Prakhar Agrawal, Analyst, Cantor: Hi. Good morning. Thanks for taking my questions. Congrats on these amazing results. So maybe on Brepo in CS, just wanting 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? If that’s the case, do you think this is a similar size opportunity as dermatomyositis? Maybe just one follow-up on the phase 3 design. Would the time point of the endpoint be 16-week, similar to your phase 2, given 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? Thank you so much.

Matt Gline, CEO, Roivant: Yeah, thanks. Thanks, Parker. Great questions. Look, I think the short answer on market opportunity is this is a patient population that’s sick with high unmet need. And assuming our phase 3 data looks similar to our phase 2 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, but 70+ 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 3 data. And then I think the short answer on phase 3 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 2 study. Obviously, to the extent that we can match parameters on which we’re confident, we’ll do that. Thanks for the questions.

Prakhar Agrawal, Analyst, Cantor: Thank you.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Samantha Semenkow with City. Your line is now open.

Samantha Semenkow, Analyst, City: Hi. Good morning. Thanks very much for taking the question. Congrats on this very good safety data. I’m wondering, what percentage of patients in the Beacon study had organ involvement, if you have that? Were you able to collect any data that would allow you to assess whether brepocitinib impacted organ-specific manifestations? Then just as a follow-up there, do you see a path to expand into other forms of sarcoidosis with brepocitinib? Thank you.

Matt Gline, CEO, Roivant: Yeah, 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 as I said before, we have ideas inside and outside sarcoidosis that are exciting. So stay tuned. And we’ll be back with it. On the first question, in terms of patients with organ involvement and what we can learn from it, Ben, anything you’d share about that?

Ben Zimmer, CEO, Priovant: Yeah. Around 60% of the patients had some pulmonary involvement. 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 a look at. I think the important point to note is this was a real-world cutaneous sarcoidosis population, given many of these patients do have multiple organs involved.

Stephanie Lee, Investor Relations, Roivant: Thank you.

Matt Gline, CEO, Roivant: Thanks, Sam.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is now open.

Ben Zimmer, CEO, Priovant1: Hey, guys. Thank you for taking my question. Quick one for me on Brepa, on the data that you provided. 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 deepening? Do you expect 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 3 study, should it be similar to what you did in DM? Thank you so much.

Matt Gline, CEO, Roivant: Yeah. Thanks. I mean, just to reiterate on phase 3. I think Ben shared a thought about that. But I think, in general, until we talk to FDA, it’s hard to commit to a specific study design. I think let us get through that. Then we’ll be back with a full recounting of the study design. 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. Then in terms of look, in terms of continued deepening, we’re just looking at this data for the first time this week. I think we’re continuing to explore all of the various features. I think it’s funny. One of the KOLs who was also involved with the study gave a quote to some journalists.

What he thinks his comment was, if the data had been half as good and there had been twice as many side effects, this 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 longer therapy, with other parameters. But I think the answer is if we can come close to replicating this in a phase 3 program, it’d be a huge win. So I think we should be all set there.

Ben Zimmer, CEO, Priovant1: Excellent, guys. Thank you.

Stephanie Lee, Investor Relations, Roivant: Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is now open.

Douglas Tsao, Analyst, H.C. Wainwright: Hi. Good morning. Thanks for taking my questions. 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, on DM, as well as NIU. 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 JAKs haven’t been explored at all? But perhaps it’s worth exploration, just given the magnitude of effects that you’re starting to see. Thank you.

Matt Gline, CEO, Roivant: Sorry. Yeah. How broad are we thinking about the Brepo 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 at the uniqueness of our mechanism. And I think we’ve done a really nice job, again, thanks to Ben and a bunch of people at Roivant as well, the Priovant team, on exploring that biology.

I think we have more ideas in that category. Ben, anything you’d like to add there, mechanistically or otherwise?

Ben Zimmer, CEO, Priovant: 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 de-risked. I also think, 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, Analyst, H.C. Wainwright: 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 IMVT-1402, how are you thinking about capital allocation in terms of external versus sort of just internal R&D investment? Thank you.

Matt Gline, CEO, Roivant: Dollars go to the best opportunity, wherever they are, is the short answer to that question. Look, we’re funded through profitability on our existing portfolio. Obviously, things like running the phase 3 program with cutaneous sarcoidosis are no-brainers at this point. We’re definitely going to do it. Adding additional indications for Brepo or for 1402 or for Moseley are attractive options because those mechanisms are strong. We’ll work in other places. That said, and I’m sitting across the table from Mayukh right now, the world’s full of attractive opportunities. We look at all of them. So I think we’ve absolutely got opportunities to deploy sort of externally as well. It continues to be a core part of what we believe we are good at. Thanks, Doug.

Stephanie Lee, Investor Relations, Roivant: Thank you. Our next question comes from the line of Derek Archila with Wells Fargo. Your line is now open.

Thomas Smith, Analyst, Leerink Partners: Hey. Good morning. Congrats on the data. Thanks for taking the questions. 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. Thanks.

Matt Gline, CEO, Roivant: Yeah. 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 as saying that anybody who isn’t afraid of a lupus study is I think the word I use is an idiot. And so I’ll say congrats to J&J on the positive data in SLE. It’s always impressive when people are 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 germs are pretty good at reading those kinds of endpoints. And so we feel good about that. Again, CLE is a different competitive landscape than SLE. And we’re watching that bar as well. On the sort of 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 "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 maximal benefit from commercial scale across the portfolio. And there definitely are areas where that is top of mind for us that I think will translate to benefit both for the commercial performance of Brepo and for the commercial performance of 1402 as those launches progress. Thanks, Derek.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Ash Verma with UBS. Your line is now open.

Ash Verma, Analyst, UBS: Oh, hi. Thanks for taking our questions. So for batoclimab, just upcoming the TED results, the data that you’re expecting, just curious how you’re thinking about that in the light of recent we’ve got setback in TED. In your case, how confident are you that a positive Graves’ disease readout would translate to success in thyroid eye disease? Thanks.

Matt Gline, CEO, Roivant: Thanks. Look, 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 a ton to say about that at this point. Those studies are going to happen. And we’ll put the data out. Obviously, we know from our own phase 2 study in TED, as well as from our own phase 2 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 to Graves’ disease in the sense that we have, obviously, we have all of our phase 2 data in Graves.

The diseases are pretty different. The TED study enrolled mostly euthyroid 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 looked. 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 of that TED data together once we’ve got it. Thanks, Ash.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Thomas Smith with Leerink Partners. Your line is now open.

Thomas Smith, Analyst, Leerink Partners: Hey, guys. Good morning. Thanks so much for the updates and for taking our questions. Great to see the rapid enrollment and the over-enrollment for 1402 and D2TRA. And 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’ launch by the end of 2028 but not MG, although you’re expecting Phase 3 data for both indications in 2027. 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. Thanks so much.

Matt Gline, CEO, Roivant: Thanks. Thanks, Doug. 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. And 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. And once we get that data, once we know the exact timeline of those studies, we’ll be able to provide more guidance on specific launch timelines.

Thomas Smith, Analyst, Leerink Partners: Got it. Thanks, Matt.

Matt Gline, CEO, Roivant: Thank you.

Stephanie Lee, Investor Relations, Roivant: Our next question comes from the line of Alex Thompson with Stifel. Your line is now open.

Ben Zimmer, CEO, Priovant: Hey. Great. Thanks for taking my question. 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, how confident are you that you could maintain your lead in Graves if argenx were to run maybe 26-week studies or even one instead of two studies? Thanks.

Matt Gline, CEO, Roivant: Obviously, the extent of our lead in Graves. Thank you for the question. The extent of our lead time in Graves will depend a little bit on argenx’s study design and what they decide to do. 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 argenx runs. We have great relationships with those KOLs and doc 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 competitive competition does.

But this is also one of those whatever, "Don’t even outrun the bear situations," or whatever. I think mostly, our focus is just getting those studies done and out as quickly as we can and getting out into that population. And it’s such a large and exciting population that it just doesn’t really matter. The other thing I’ll say is, as a reminder, we feel like we showed pretty conclusively in our phase 2 data that the deeper IgG suppression that we expect to deliver will matter in this population, 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. Thank you for the question.

Thomas Smith, Analyst, Leerink Partners: Great. Thanks, Matt.

Stephanie Lee, Investor Relations, Roivant: Thank you. This concludes the question-and-answer session. I’d now like to turn the call back over to Matthew Gline for closing remarks.

Thomas Smith, Analyst, Leerink Partners: Great. 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, particularly with the cutaneous sarcoidosis data, the patients and investigators involved in that program, as well as the Priovant team for the execution there, but also everybody at Roivant and all of the patients 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.

Stephanie Lee, Investor Relations, Roivant: This concludes today’s conference. Thank you for your participation. You may now disconnect.