Roivant Sciences Ltd (ROIV) 2025 Q3 法說會逐字稿

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.

Good morning, and thanks for joining today's call to review positive Phase 2 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.

Thanks, Stephanie, 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've got 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 2 data in brepo and CS, which Ben is going to present on momentarily. But truth is terrific execution of 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 and Dermatomyositis that the Phase 2b study for 1402 D2T RA has fully enrolled that the Phase 2 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 3, the pivotal readout in the second half. We're now going to be starting this year a Phase 3 study in brepo and cutaneous sarcoidosis then we'll talk a little bit more about that. It's early days. I get that going, but that will be this year.

The Phase 2b data for mostly is expected firmly in the second half of this year. We now know that 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 working for the beginning of 2026 year. certainly stood off to a good start. And with that, what I'm going to do is turn to the Phase 2 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 most thing I'm going to hand 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 thing to be able to say, this drug has done everything we could have asked for us for it in this -- or if it in this study. We had a significant (inaudible). Remember, we had said before the bar for clinical success here, we thought was sort of 5 points of C-sam 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 for 149 placebo had a 10 point improvement, again, clinically meaningful with 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 then it isn't us that need 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 as well.

Ben take it away.

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 continuous 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 3 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, sarcoid sets, all of the forms of sarcoidosis, including cutaneous are driven by the polarization and recruitment of effector T-cells and particularly Th1 polarized cells and brepo really distinctively inhibits TH1related 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 to 2 to 2, the brepo 45-milligrams, 15-milligrams and 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 solid by placebo.

So sort of punch line of this is there were some imbalances. Those amounts 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 [Mentesami] 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 1, 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 DISARM at week 4, really significant or substantial improvement at week 8 and then that big 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 some from the 15-milligram dose arm.

Slide 16 has the Sesame 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 Sesame 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 M201 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 and 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 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 Sesame 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 3 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.

Thanks, Ben. Yeah, 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 CSP and MINU, 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 free through a couple of other highlights or updates across the portfolio, [blue quick] financial update, and then we'll do Q&A at the end. Super quickly on Slide '24. As a reminder, [42] remains a huge focus for us at Roivant. 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 phrase you again here pipeline and product potential, again, with grains 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 long as 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 investment cost 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 before, I'm not going to spend a ton of time talking about this today because we're so close in hearing 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 puts and takes generally.

And one doing 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 mystery 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, at the beginning of the summer does but also make progress and just feeling good across the board with a lot more updates to come this year to be a big year for us.

And a big few years on Slide 31 before I go to DNA 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?

Thank you, operator. (Operator Instructions)

Corinne Johnson, Goldman Sachs.

Good morning guys, and thanks for the question. I think you've mentioned today and previously that you consider further development extension opportunities for brepocitinib. And I'm curious how these data can 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.

Thanks.

Yeah. Perfect trend. 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 continuing to think about other forms of targets, 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 globally 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?

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 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 as some of our hypotheses there.

Dave Risinger, 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 Sesame 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? Thanks so much.

In DM, I'm talking about. Thank you.

Yeah. Thanks, David. Both great questions. On the same 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 a slide to 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 energy 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, I've been 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 3. 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.

Yaron Werber, TD Cowen.

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 VIVGard 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 given there 25% of the profits. Where is that going to hit the P&L?

Thank you.

Yeah. 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 bookings that are not so different from the ones you quoted there.

I think our view is IDH 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 private and fit really the need to match their portion of our spend or will be diluted and we'll wind up owning more.

Brian Cheng, JPMorgan

Hi, madam then, 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 take. 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 destem clinically meaningful. How should we think about deterioration, and I have one quick follow-up as a housekeeping question. Thank you.

Yeah. 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 local super response. Ben, do you want to talk a little bit about that and about whatever we can share at this point on Phase 3 design?

Yeah, sure. I mean, first, just on erosion, obviously, would be hard to do any better than this. But I think that the minimum clinical (inaudible) differences, as we've discussed the slide 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 US-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 3 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 3 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 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.

Got it. Thanks, Ben. 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 and all? Is there any read-through to how we should think about the setup for the tech data readout later this year?

Thank you.

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 have to make a decision around how to work together within all our next steps there. So that's really nothing to say.

Dennis Ding, Jefferies

Good morning. 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?

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 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-prostanol 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.

Yasmeen Rahimi, Piper Sandler.

Good morning team. Thank you so much for all the color. As an immune event, 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 2 registrational study to be shared? And then I'll jump back in the queue.

Thanks.

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.

Prakhar Agrawal, Cantor.

Hi, good morning and thanks for all my questions and 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 3 design. Would the time point of the endpoint the 16-week similar to your Phase 2, 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?

Yeah. 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 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 with 70,000-plus 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. And obviously, to the extent that we can match parameters on which we're confident we'll do that.

Samantha Semenkow, Citi

Hi, good morning. Thanks very much for taking the question and congrats on this very good safe data. I'm wondering what percentage of patients in the [BEGIN] 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?

Thank you.

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 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 patients with organ involvement and what we can learn from it,

Ben, anything you'd share about that?

Yeah. 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.

Yatin Suneja, Guggenheim.

Hey guys, thank you for taking my question. 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 understand from you how should we think about further -- do you expect further deepening for the 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 side. 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.

Yeah. I mean, just to reiterate on Phase 3, 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 recounting 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 funny, 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, Well, it's very 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 3 program, it would be a huge win. So I think we should be offset there.

Douglas Tsao, H.C. Wainwright.

Hi, good morning. Thanks for taking the 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 -- [yesterday], 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 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.

Could you, yeah, how broad are you thinking about the [reup] opportunity? Thank you. Great question. Thank you. Great question.

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 much of people retinas 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?

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 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.

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

Thank you, [Dollars] go to the best opportunity wherever they are, the sort of answer to that question. Look, we're funded through profitability on our existing portfolio obviously, things like running the Phase 3 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.

Derek Archila, Wells Fargo.

Hey, good morning, and, 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?

Thanks.

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 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 physiological 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.

Thanks, Derek.

Ash Verma, UBS

Hi, thanks for your questions. So for [Barrow's], just upcoming the TED results, the data that you're expecting. Just curious how you're thinking about that in the light of recently got set back in TED. In your case, how confident are you that a positive grade disease readout would translate to success in Thyroid Eye Disease?

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 2 study in TED as well as from our own Phase 2 work in grade 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 organic case 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 2 data in Graves and the diseases are pretty different. Like the TED study enrolled mostly thyroid patients.

So they're pretty different fundamentally through the boohoo was in the studies. So I feel like we are confident in the efficacy or potential efficacy of FcRns and 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 grades 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.

Thomas Smith, Leerink Partners.

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 3 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?

Thanks so much.

Thanks. 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 draw 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 and 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 use we go the exact time under those studies, we'll be able to provide more guidance on specific launch time lines.

Alex Thompson, Stifel.

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. 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.

Thanks.

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 we do may depend a little bit on what the competitive competition does. But this is also one of those -- whatever one or 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 2 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.

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

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, including particularly with the cutaneous sarcoidosis data, the patients and investigators involved in that program.

As well as the private team or our execution there, but also everybody at Roivant, all the patient 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.

This concludes today's conference. Thank you for your participation. You may now disconnect