Prepared remarks
Good day, and thank you for standing by. Welcome to the Roivant Third Quarter 2025 Earnings Conference Call. Operator instructions were provided. 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 II results for brepocitinib in cutaneous sarcoidosis and Roivant's 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 Therapeutics. 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. And with that, I'll turn it over to Matt.
Thanks, Steph, and thanks, everyone, for dialing in and listening this morning. I'm going to start our presentation on Slide 5. I was sitting and talking to the team 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've gotten together in December for the Investor Day. We've spoken at the JPMorgan conference, and it turned out to have been a really busy period. So we have some great updates, obviously, most notably the Phase II data in brepocitinib in cutaneous sarcoidosis, which Ben is going to present on momentarily. But the 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 in dermatomyositis is submitted, that the Phase IIb study for IMVT-1402 in difficult-to-treat rheumatoid arthritis (D2T RA) has fully enrolled, that the Phase II study for mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) has fully enrolled. And obviously, all of the updates that we're known for, including Immunovant offering earlier that gets us now financed to greater launch, are 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 non-infectious uveitis (NIU) Phase III pivotal readout in the second half. We're now going to be starting this year a Phase III study in brepocitinib in cutaneous sarcoidosis. Ben will talk a little bit more about that. It's early days and getting that going, but that will be this year. The Phase IIb data for mosliciguat is expected firmly in the second half of this year. We now know that because the study is fully enrolled, obviously. Same thing with the D2T RA data where both the open-label period and the randomized withdrawal period will be done by the second half of this year. We are also getting proof-of-concept data in IMVT-1402 in cutaneous lupus erythematosus (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 cutaneous sarcoidosis, just a pipeline we're really proud of that continues to deliver across multiple dimensions with, obviously, brepocitinib with now three indications in pivotal registrational programs, multiple registrational programs for the FcRn franchise, many of 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. I 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 II data for brepocitinib in sarcoidosis. So just very briefly on Slide 9 of the presentation, I'm just going to walk through a couple of highlights, but mostly, I'm going to hand it over to Ben to take you through the data in detail. And the short answer, and we keep saying this, is it's a tremendous fortunate, I think, to be able to say that this drug has done everything we could have asked for in this study. We had a statistically significant result. 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, a 21.6-point delta with a highly significant P-value. And again, the study was not powered for efficacy on this endpoint. One hundred percent of patients on brepocitinib 45 milligrams achieved a 10-point improvement; zero on placebo had a 10-point improvement. Again, clinically meaningful was 5 points. One hundred percent 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 options—there's never been a positive placebo-controlled study in an industry-sponsored study to our knowledge. So really a terrific day for those patients. So with that, I'm going to hand it over to Ben to walk you through a little bit about cutaneous sarcoidosis as a reminder and then on to the study data as well. Ben, take away.
Great. Thanks so much. Great to be here with everyone. Starting on Slide 10, I just wanted to bring back what this disease is. I walked through this at the Investor Day in December, but cutaneous sarcoidosis is a really debilitating skin disease and among skin diseases stands out for its rapid progression toward permanent scarring and destruction of tissue as well as its disfiguring nature given the particular prevalence on the face and scalp. Turning to Slide 11, I would note that there are no approved therapies not only for cutaneous sarcoidosis, but for any form of sarcoidosis. And so as we think about our development program in cutaneous sarcoidosis, it's really a great opportunity for brepocitinib to meet this overall unmet need and become the therapy of choice if we're successful in Phase III 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, briefly 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. 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 forms, including cutaneous disease—are driven by the polarization and recruitment of effector T cells and particularly Th1-polarized cells. Brepocitinib distinctively inhibits Th1-related pathways by hitting both IL-12 through TYK2 and interferon gamma through JAK1. So it's an opportunity 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 to 2 to 2 to brepocitinib 45 milligrams, 15 milligrams and placebo, a 16-week study evaluated several different efficacy endpoints that I will walk through. On 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 were very well balanced between those two arms, but 15 milligrams actually had quite a bit lighter duration of disease and damage, which would mean really a higher bar for both brepocitinib 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. You see this plaque-predominant morphology most pronounced and most common in the brepocitinib 45-milligram arm, followed by 15 milligrams followed by placebo. So the punchline here is there were some imbalances. Those imbalances actually made it harder for brepocitinib 45 milligrams to demonstrate efficacy, both as compared to placebo and as compared to brepocitinib 15 milligrams. And in spite of that, as I walk through, we really see exceptional data from the brepocitinib 45-milligram dose arm. Turning to Slide 15 to get into the efficacy results. On the left-hand side of the slide, you see the mean change in CSAMI activity score from baseline: both doses showed 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. On the right here, we see the achievement of Investigator Global Assessment (IGA) 0/1 and a 2-point reduction. As a reminder, 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. To achieve both a 2-point reduction and a 0 or 1 is a very high bar. Notably, it's a high enough bar that zero placebo patients cleared it. So you may be confused where the placebo line and the x-axis line are the same thing on this chart. You see, again, early progress for both dose arms at week 4, really substantial improvement at week 8, and then sustained improvement at weeks 12 and 16. On this higher-bar endpoint, you do start to see brepocitinib 45 milligrams begin to separate from the 15-milligram dose arm. Slide 16 has the CSAMI responder data—again, really compelling. That chart on the left is 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 100% of patients in the brepocitinib 45-milligram arm achieved twice that minimum clinically important difference. So every brepocitinib 45-milligram patient was a responder in this trial. And as I'll walk through momentarily, that's corroborated by an independent patient-reported outcome as well. 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 brepocitinib 45-milligram patients achieving that compared to no placebo patients. So again, this data is in line with the IGA 2-point improvement to 0/1 that I walked through before. So again, pretty consistent data across multiple endpoints. Turning now to patient-reported outcomes. Slide 17 has the Skindex-16, an established metric in inflammatory skin disease trials. We see excellent data here with the placebo group worsening, brepocitinib 45 milligrams and 15 milligrams both improving substantially, well above the minimum clinically important difference. Again, brepocitinib 45 milligrams outperformed 15 modestly and both doses far better than placebo. Slide 18 shows the King's Sarcoidosis Questionnaire (KSQ) skin domain, a PRO for sarcoidosis overall. We focused on the skin-specific domains and you see data very in line with the Skindex in terms of improvement. So just another data point of compelling benefit. Finally, on Slide 19, we have the Patient's Global Impression of Change (PGIC): 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. They can answer no change or some degree of improvement or some degree of worsening. This is a powerful, simple endpoint. Notably, 100% of brepocitinib 45-milligram patients reported that they had improved, again consistent with the CSAMI data where we saw a 100% response rate. Brepocitinib 15 milligrams also showed considerable improvement for most patients, although two patients in the brepocitinib 15-milligram group reported worsening. In the placebo group, very little improvement; most patients reported either worsening or no change. Turning to Slide 20, safety data: brepocitinib was very well tolerated during the study. We had no serious adverse events in the study and all adverse events were graded mild or moderate in severity. Against the backdrop of this efficacy data, the safety data here 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 much larger than just these results. But certainly here, nothing that would add anything unexpected to what's already known about the drug. I think, again, starting to dose it now in this particular patient population, we see the early signs of a very indication-specific compelling benefit-risk profile. 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 and consistent 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 milligrams arm, and a rapid onset of action sustained over time. So really exciting results. We're excited to move this ahead to Phase III 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.
Thanks, Ben. Yes, look, we're terrifically excited about this data and what it means for us and for these patients. On Slide 22, just as a reminder of what the picture for brepocitinib now looks like, people toss around the phrase pipeline for many products. I feel at this point, looking across the indication set for brepocitinib, even with what we've talked about already with cutaneous sarcoidosis, dermatomyositis and NIU, 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 in important areas. I think we've got more to come there, so stay tuned. But it's starting to feel like brepocitinib is a really important medicine for us and hopefully for patients. Looking forward to continuing that journey. I'm going to brief through a couple of other highlights across the portfolio, give a 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, convenient administration with a subcutaneous auto-injector, and 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, and that was in part due to speed of enrollment and enthusiasm in the patient community. Moving to mosliciguat on Slide 25: we'll definitely spend more time later this year talking about PH-ILD and mosliciguat and setting the stage for what we expect. That study is fully enrolled with thanks to those patients, investigators and the Pulmovant team. PH-ILD remains an exciting opportunity where targeted delivery gets at a disease where the 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. There aren't many existing therapies. We expect tolerability benefits and, as you know, we showed very strong PVR reductions in the PAH population. 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 will be an important part of our story in the coming months. Finally, and I won't spend a ton of time talking about this today because we're so close, but the jury trial in the Moderna case is scheduled for March 9. We continue to make progress there. A recent update is that we received one of the summary judgment decisions, which covered a few things and had some puts and takes. One thing we were quite happy with is the favorable decision on Section 1498, which sets us up for the case we were hoping for in this trial where almost all of the doses that we have asserted are going to be covered in this jury trial. So looking forward to that and more to come. Finally, a 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. We still have share buyback authorization and are happy to have that capability. On Slide 30, as discussed, a catalyst-rich period ahead. A couple of items checked off now. Obviously, the summary judgment progress makes a difference and overall we're feeling good across the board with a lot more updates to come this year. It should be a big year for us. On Slide 31 before I go to Q&A: multiple potential commercial launches in the coming years. Obviously, brepocitinib in dermatomyositis would be first with that NDA now in, multiple NDA and BLA filings. We continue to have more future proof-of-concept study readouts even among the ones we've already announced and now nine or more pivotal study readouts, including cutaneous sarcoidosis coming over the timeline, which is an 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.
Questions and answers
Operator instructions were provided. Our first question comes from the line of Corinne Johnson with Goldman Sachs.
I think you've mentioned today and previously that you'd consider further development expansion opportunities for brepocitinib. I'm curious how these data inform the direction you'd like to go. Maybe you could also help us size the opportunity set, particularly with respect to what percentage of the patient population you think are great candidates for this relative to NIU and dermatomyositis.
Yes. Perfect, Corinne. Thanks. It's a great question. We are absolutely enthusiastic about further development of brepocitinib. We have other indications that Ben and the team are hard at work on. What I would say is that the main takeaway about this data is it continues to underscore how strong an agent brepocitinib can be in these patient populations that need it and drives enthusiasm, but it doesn't necessarily reveal anything specific or new other than we're continuing to think about other forms of sarcoidosis, etc. Cutaneous sarcoidosis is another indication where we would be the first and only drug approved if we're successful. On patient population, this fits well with what we've been trying to do across our portfolio: target large orphan markets with tens of thousands of patients, high unmet need, and attractive commercial potential. So it feels great from a patient benefit perspective and from a commercial perspective. Ben, anything you'd add there?
I would add that this data reinforces alignment of TYK2/JAK1 inhibition to T cell polarization, both Th1 and Th17 pathways. The mechanism of TYK2/JAK1 inhibition—affecting IL-12 and interferon-gamma for Th1 and IL-6/IL-23 for Th17—supports the distinctive benefits we observe. That mechanistic alignment is part of our hypothesis for why brepocitinib could be particularly effective and reinforces enthusiasm for NIU and other indications where overlapping mechanisms exist.
Our next question comes from the line of Dave Risinger with Leerink Partners.
Let me add my congrats as well, Matt and team. The data was phenomenal. I had a couple of questions. First, with respect to the headline CSAMI numbers, they were similar between the two brepocitinib arms. The press release mentioned different baseline characteristics. Could you add more color on that? Second, with respect to the FDA timeline in dermatomyositis, is there a chance the FDA could grant priority review?
Thanks, Dave. Great questions. On the CSAMI point, Ben hit on this in the presentation. This was a small proof-of-concept study with relatively small numbers per arm, so you can see some meaningful differences on baseline characteristics including duration of disease and morphology, with more plaque-predominant patients—who are more treatment-resistant—in our 45-milligram arm relative to the 15-milligram arm. That likely contributed to the headline numbers looking similar, and you can see more separation on more stringent endpoints like the proportion of patients achieving a 10-point CSAMI improvement. We feel good about translating this into Phase III. On FDA timeline for dermatomyositis: it's a severe disease with limited options, so there's certainly a chance for priority review, but that decision is ultimately up to FDA.
Our next question comes from the line of Yaron Werber with TD Cowen.
Congrats. Nice to see this data. I have a couple of questions. One is pricing: IVIg is around $180,000, but VYVGART pricing for these indications is around $870,000 gross. How are you thinking about pricing of brepocitinib? Second, Pfizer owns 25% of the JV and you'll consolidate all sales of brepocitinib. How should we handle their 25% ownership from a P&L perspective—will it be below the line as minority interest?
Thanks, Yaron. On price, we haven't decided yet—it's too early. We've previously cited bookends similar to what you mentioned and expect this will be an orphan-priced drug; that pricing envelope continues to be reasonable and gives us room. On the Pfizer ownership question: we'll fully consolidate all results—sales, losses, everything—and then there will be a below-the-line minority interest attributing Pfizer's portion of earnings. In terms of cash, if we distribute cash, Pfizer will receive their portion. Also note that the early dilution protection for Pfizer's ownership has been exhausted; for any further capital into the JV, Pfizer would need to match or be diluted.
Our next question comes from the line of Brian Cheng with JPMorgan.
Congrats on the data. Two questions. For Phase III, what's your latest thinking about size and dose selection? Also, how should we think about stability of efficacy moving from Phase II to Phase III, given the large delta versus the minimum clinically meaningful difference? How should we think about potential erosion?
Thanks, Brian. I'll hand to Ben for more detail, but overall we feel there's a fair amount of cushion in this result. It was a relatively small study, and placebo rate was low. Ben?
On potential erosion: it's hard to do better than this, but the minimum clinically important difference is 5 points and we observed over 20 points, so there's room for some erosion and still have a compelling profile. This was a U.S.-only study across 15 sites for 31 patients—multicenter and rigorous for a proof-of-concept. Placebo behavior can vary in larger global trials, but broadly this data gives us a strong cushion. On Phase III size and dose: we'd likely look at similar per-arm sizes to the dermatomyositis trial, but we'll finalize powering and safety-set discussions with the FDA. Regarding dose, our incoming hypothesis is that 45 milligrams has a compelling benefit-risk profile across the 1,500-patient database; this data reinforces that. You see excellent efficacy at 45 milligrams and some separation from 15 milligrams on higher-bar endpoints. Safety was consistent with prior experience. We'll have final decisions after engaging the agency.
Our next question comes from the line of Dennis Ding with Jefferies.
This is Anthea on for Dennis. Congratulations on the data. Two questions on upcoming catalysts. First, on Daubert motions: how important is Dr. Mitchell's testimony to the case regarding direct infringement and is there risk of it being excluded ahead of trial? Second, on PH-ILD, thoughts on the competitive landscape and whether sotatercept could work in the disease as well?
Thanks. On the litigation, we can't discuss too much about ongoing litigation. There are Daubert motions before the court and the judge will decide. We're hoping for favorable outcomes. On PH-ILD, in theory any drug that improves pulmonary vascular resistance (PVR) could work in PH-ILD. Systemic vasodilation hasn't been ideal in PH-ILD historically, but sotatercept could work. We are slated to be among the first non-prostacyclin therapies in PH-ILD and believe we have a favorable profile as we enter that space.
Our next question comes from the line of Yasmeen Rahimi with Piper Sandler.
As an Immunovant-covering analyst, I'd like color around IMVT-1402 and the near-term RA readout. The study was upsized—how are you thinking about expectations as the study finishes, how you're preparing for filing, and how soon you could be ready for a Phase III registrational study?
Thanks. On RA expectations: these are patients with high unmet need, so the bar for efficacy is lower compared to typical RA studies, but there's limited precedent data for late-stage RA in this heavily pretreated population, so it's hard to predict. We're working on that question now and will share guidance on what would lead us to run a second study. Base-case expectation is this will likely be one of a couple of studies needed because this was a relatively smaller randomized withdrawal trial, but we'll engage with the agency after the data to determine the path forward.
Our next question comes from the line of Prakhar Agrawal with Cantor.
Congrats on the results. On brepocitinib in cutaneous sarcoidosis: you've talked about 40,000 eligible patients. Would all of these eligible patients meet the trial inclusion/exclusion criteria and be candidates for brepocitinib? If so, is this a similar-sized opportunity as dermatomyositis? Also, for Phase III, would the endpoint time point be 16 weeks like Phase II or would you need longer given your safety database?
Thanks, Prakhar. On market opportunity: this is a patient population with high unmet need. If Phase III mirrors Phase II, many patients would likely be enthusiastic about a better treatment. I view this as a modestly smaller indication than dermatomyositis in total treated population, although it depends on Phase III data. On Phase III design and endpoint timing: we'll discuss specifics with FDA and aim to leverage what we can from Phase II. We'll provide final details after agency discussions.
Our next question comes from the line of Samantha Semenkow with Citi.
Congrats on the safe data. What percentage of patients in the BEACON study had organ involvement, and were you able to collect any data to assess whether brepocitinib impacted organ-specific manifestations? And as a follow-up, do you see a path to expand into other forms of sarcoidosis with brepocitinib?
Thanks, Samantha. On expansion: we will evaluate further places to study brepocitinib and have ideas inside and outside sarcoidosis. Ben, on organ involvement data?
About 60% of patients had some pulmonary involvement and around 30% had other organ involvement, mostly ocular involvement. We collected some exploratory endpoints related to those organs, but the study was not designed to evaluate benefit in other organ systems, so I don't expect meaningful conclusions, though we'll analyze the data. Importantly, this is a real-world cutaneous sarcoidosis population with many patients having multiple organ involvement.
Our next question comes from the line of Yatin Suneja with Guggenheim.
Looking at the data curves, efficacy seems to deepen over 16 weeks. Do you expect further deepening or separation with longer treatment—e.g., at one year? And also, thoughts on Phase III size—should it mirror dermatomyositis?
Thanks. On the long-term trajectory: we are still early in analyzing the data, but there are potential ways the effects could deepen with longer therapy. If we can come close to replicating this in Phase III, it would be a major win. On Phase III size: until we talk to FDA, it's hard to commit to specifics, though we are prepared to run and enroll a sizable study if needed. We'll provide more once we've engaged the agency and refined design.
Our next question comes from the line of Douglas Tsao with H.C. Wainwright.
With brepocitinib showing great results across CS, dermatomyositis and NIU, how broad are you thinking about the opportunity? Are you targeting indications where JAKs haven't been explored at all, based on the magnitude of effects you're seeing?
Great question. We've been thoughtful about indication selection and have pursued areas of high unmet need, including places where JAKs have not been explored. We focus especially where TYK2 and JAK1 are both important given our mechanism, and we have more ideas in that category. We also consider higher-risk opportunities with less prior proof of concept. Our approach is to pursue the best opportunities wherever they are.
To add: there are indications with investigator-initiated trials or off-label reports of other JAK inhibitors where we think TYK2/JAK1 inhibition could be optimally suited—those are lower-risk. We are also exploring higher-risk, exciting opportunities where there's less proof-of-concept. The breadth of potential is large and we continue to evaluate each based on mechanism and unmet need.
One follow-up on capital allocation: how are you thinking about deploying capital between internal R&D and external business development?
Dollars go to the best opportunities wherever they are. We're funded through profitability on our existing portfolio. Running the Phase III program in cutaneous sarcoidosis is a no-brainer. Adding indications for brepocitinib, IMVT-1402 or mosliciguat are attractive. We will also pursue external opportunities that make sense—business development remains core to what we do.
Our next question comes from the line of Derek Archila with Wells Fargo.
Congrats on the data. On Immunovant: positive data for nipocalimab in systemic lupus—how do you view read-through to cutaneous lupus? And second, thinking of commercial synergies between brepocitinib and IMVT-1402, how would you field a sales force to leverage both products cost-effectively?
Thanks. On the SLE read-through: congrats to others on positive SLE data. There may be some read-through to cutaneous lupus erythematosus (CLE) because of pathophysiological overlap, but every lupus study is unique and CLE will need to be successful on its own. Derms are generally good at reading skin endpoints, which we view positively. On commercial synergies: for de novo launches, field forces tend to be product-specific to engage target physicians. The most important commercial synergies are in contracting and scale, not simply sharing reps. We'll focus on contracting and other ways to maximize commercial scale across the portfolio to benefit both brepocitinib and IMVT-1402.
Our next question comes from the line of Ash Verma with UBS.
For batoclimab (bato), upcoming TED results: given the recent Vyvgart setback in TED, how confident are you that a positive Graves' result would translate to success in thyroid eye disease?
Thanks. TED data is coming in the first half of this year. We have Phase II data in TED and Graves' showing activity in hyperthyroidism; that should translate to some efficacy in both indications. We don't see strong read-through from other companies' TED results to our Graves' program, as trial populations can differ significantly—e.g., TED trials often enroll euthyroid patients. We are confident in the potential efficacy of FcRns in Graves' disease based on our Phase II data and will optimize our program based on the TED readouts when they are available.
Our next question comes from the line of Thomas Smith with Leerink Partners.
Great to see rapid enrollment for IMVT-1402 in D2T RA. Should we expect you'll report both the open-label and randomized data together, or could the open-label period be reported first? Also, Slide 31 shows expectations for Graves' launch by the end of 2028 but not myasthenia gravis (MG), though Phase III data for both could be in 2027—does that reflect data timing or other strategic considerations?
Thanks, Thomas. On IMVT-1402 data release: we haven't finalized the release strategy, but now that we know both periods are completing this year, it's reasonably likely we'll wait for the randomized-withdrawal data before presenting the full dataset. The open-label period will, of course, yield information earlier. On the launch timing notation: there's no strong inference to be read in—it's possible MG could also launch in 2028 depending on data and regulatory timing. We'll provide more detailed guidance once we have the data and clearer timelines.
Our next question comes from the line of Alex Thompson with Stifel.
On the competitive landscape in Graves' disease: if argenx runs shorter 26-week or single-study designs to try to be a fast follower, how confident are you that you can maintain your lead with your program?
Great question. Our lead in Graves' will depend a bit on competitors' designs, but we believe we'll have a significant lead time regardless. We have strong relationships with KOLs and the community and have already run a 26-week study as a reminder (our 2503 study). We also believe deeper IgG suppression will matter for remission and that our data supports meaningful differentiation. Our focus is executing quickly on our studies and getting into the population; given the size of the opportunity, speed matters but there's ample runway.
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 and for listening this morning. I want to once again thank everyone involved in all of this, including particularly with the cutaneous sarcoidosis data, the patients and investigators involved in that program as well as the Priovant team for their execution, but also everybody at Roivant and all of the investigators on all of our studies. 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.