Roivant Sciences Ltd. Q3 FY2025 Earnings Call

Good day, and thank you for standing by. Welcome to the Roivant Third Quarter 2025 Earnings Conference Call. 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 and 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. 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, Steph, and thanks to everyone for joining us this morning. I'll begin our presentation on Slide 5. About a week ago, I discussed a draft of this morning's presentation with the team and thought it could be a rather dull 10-Q. After our Investor Day in December and the JPMorgan conference, we ended up with a very busy week. We have some exciting updates, especially the Phase II data in brepo and cutaneous sarcoidosis, which Ben will present shortly. The truth is we executed exceptionally well and made significant progress this quarter. The data is certainly a highlight, but we can also announce that the NDA for brepo is for dermatomyositis, the Phase IIb study for 1402 D2T RA has fully enrolled, and the Phase II study for primarily PH-ILD is also fully enrolled. Additionally, all our updates, including the Immunovant offering, have positioned us well for the upcoming Graves' launch. Overall, it's been a fantastic quarter with numerous updates since our last gathering in early January. On Slide 6, we see that 2026 is shaping up to be another very busy year for us, with major events later this year surrounding the brepo NIU Phase III trials and pivotal results expected in the second half. We will also be initiating a Phase III study in brepo for cutaneous sarcoidosis this year. Ben will provide more details on this soon. The Phase IIb data for primarily is anticipated in the second half as well since the study is fully enrolled. The same goes for the D2T RA data, with both open-label and randomized withdrawal periods concluding in the latter half of this year. We expect to gather proof-of-concept data in 1402 and CLE, and we remain on schedule for the jury trial against Moderna beginning March 9, which is just weeks away. This year promises to be extremely active for us at Roivant. Looking at Slide 7, our pipeline continues to impress us and deliver on multiple fronts. Brepo is now involved in three pivotal registrational programs, and there are multiple registrational programs for the FcRn franchise. We eagerly anticipate top-line data arriving in the second half of this year. I'm genuinely excited about our position as a business and our pipeline as we move into 2026. It's off to a strong start. Now, let's turn to the Phase II data for brepo and cutaneous sarcoidosis on Slide 9. I'll quickly go over a few highlights before handing it over to Ben for a detailed analysis. I'm thrilled to say that this drug has performed exceptionally well in this study. We achieved a statistically significant result; we previously indicated that a 5-point improvement on the CSAMI was clinically meaningful, and we now have a placebo-adjusted delta of almost 22 points, specifically 21.6, with a p-value indicating strong results, even though the study was not specifically powered for this efficacy endpoint. Every patient on brepo 45—equivalent to 14 on placebo—experienced at least a 10-point improvement, which is significant since the clinically meaningful improvement was defined as 5 points. All patients on our higher dose also saw at least a 10-point improvement, marking an exceptional outcome across the board. We're seeing strong supportive data on other endpoints as well, and safety and tolerability remain consistent with our prior observations of the compound. This outcome is particularly meaningful given that there has never been a positive placebo-controlled study in an industry-sponsored context for this disease. It’s a momentous day for these patients. With that, I'll hand it over to Ben to discuss cutaneous sarcoidosis and the study data. Ben, please take it from here.

Great. Thanks for having me here. Starting on Slide 10, I want to revisit what cutaneous sarcoidosis is. I discussed this at Investor Day last December. Cutaneous sarcoidosis is a debilitating skin disease known for its rapid progression, leading to permanent scarring, tissue destruction, and disfigurement, particularly on the face and scalp. Moving to Slide 11, it's important to note that there are currently no approved treatments for cutaneous sarcoidosis or any form of sarcoidosis. This highlights a significant opportunity for brepocitinib to fulfill this unmet need and ideally become the preferred therapy as we aim for success in Phase III trials based on positive data, presenting a promising option for patients with skin involvement in their sarcoidosis, whether they have only skin issues or other organs involved as well. On Slide 12, let's briefly address the alignment between the disease's pathobiology and the drug's mechanism. This is crucial because, as Matt mentioned, we have compelling data that excites us. Though it comes from a small study, the results are hard to dispute and align well with the expected effects of the drug. Sarcoidosis, including cutaneous forms, involves the polarization and recruitment of effector T cells, especially Th1 polarized cells. Brepocitinib uniquely inhibits Th1-related pathways by targeting both IL-12 via TYK2 and interferon gamma through JAK1, offering a mechanistic opportunity to demonstrate the advantages of JAK1 and TYK2 inhibition. Now, let's move to Slide 13, which outlines the study design. We had 31 patients in the United States, randomized in a 3:2:2 ratio for brepo 45 mg, 15 mg, and placebo over a 16-week period, assessing various efficacy endpoints. On Slide 14, regarding baseline demographics and disease activity, I want to point out that the duration of disease and baseline damage were well balanced between the brepo 45 mg and placebo groups. However, the 15 mg group had a notably shorter duration of disease and baseline damage, making it a more challenging benchmark for brepo 45 mg and placebo. Additionally, cutaneous sarcoidosis can present as plaques or papules, with plaques generally being more resistant to treatment. The plaque-predominant morphology was most pronounced in the brepo 45 mg group, followed by 15 mg, and then placebo. This illustrates that the imbalances made it harder for brepo 45 mg to show efficacy compared to both placebo and brepo 15 mg, yet we still observed exceptional data from the brepo 45 mg group. On Slide 15, looking at the efficacy results, the left side shows the mean change in CSAMI activity score from baseline. Both doses displayed statistically significant separation from placebo as early as week 4, maintained through week 16. On the right side, we see achievement of the investigator global assessment with a 2-point reduction. This endpoint is an established FDA standard for cutaneous disease, rated from 0 to 4, where achieving a 2-point reduction to 0 or 1 is a very high bar, especially since no placebo patients reached that level. The chart shows early progress for both dosage arms at week 4, with noteworthy improvements by week 8, and consistent results at weeks 12 and 16. At the higher bar endpoint, brepo 45 mg starts to show separation from the 15 mg arm. Slide 16 presents CSAMI responder data, which is compelling. The left chart illustrates that while we anticipated a mean improvement of 5 points, we exceeded that expectation, with every patient in the brepo 45 mg group achieving twice the minimum clinically important difference. This remarkable outcome is further supported by independent patient-reported outcomes. On the right side, the achievement of CSAMI less than 5 indicates that 62% of brepo 45 mg patients reached functional remission, compared to none in the placebo group. This data aligns well with the previously discussed IGA 2-point improvement to 0/1, showing consistent results across various endpoints. Moving to patient-reported outcomes on Slide 17, the Skindex-16 results, an established measure in inflammatory skin disease trials, show that while the placebo group worsened, both brepo 45 mg and 15 mg improved significantly above the minimum clinically important difference, with brepo 45 mg performing slightly better. Slide 18 presents the KSQ skin domain results, emphasizing skin-specific metrics in sarcoidosis, which parallel the findings from Skindex, reinforcing the evidence of benefit. Finally, on Slide 19, we discuss the patient's global impression of change. This single-question assessment reveals that 100% of patients on brepo 45 mg reported improvement, consistent with the exceptional CSAMI responder data. The brepo 15 mg group also saw considerable improvements, though two patients did not report any progress and reported worsening, while most patients in the placebo group noted minimal improvement or worsening. On Slide 20, regarding safety data, brepocitinib was well tolerated, with no serious adverse events, and all adverse events were mild to moderate. This safety profile combined with the efficacy data suggests a promising benefit-risk profile for brepocitinib in this patient population. Given our extensive safety database following over 1,500 patients treated with brepocitinib, we have a comprehensive understanding of the drug's safety profile. In this specific patient population, we see early indications of a favorable benefit-risk profile. To conclude, we have strong evidence of benefit here with large effect sizes across multiple endpoints, including independent patient- and physician-reported assessments. The 100% response rate in the brepo 45 mg group and the quick onset of action are very encouraging. We are excited to advance this to Phase III and potentially position brepocitinib as the first approved therapy for sarcoidosis. I look forward to discussing any questions later, and now I'll hand it back to Matt.

Thanks, Ben. We're incredibly enthusiastic about the data and its implications for us and the patients. On Slide 22, we can see what the current landscape for brepocitinib looks like. Many refer to the term pipeline in relation to various products, but right now, across the diverse indications for brepo, including CS, DM, and NIU, we are looking at a sizable potential patient population. These patients lack effective therapies and are in desperate need of options. We continue to explore opportunities that cater to these first-in-class orphan inflammatory diseases, which have significant unmet needs. There's more to come, so stay tuned. We believe brepocitinib is a vital medicine for us and hopefully for patients as well, and we are excited to continue this journey. Now, I'll quickly highlight some updates across the portfolio, provide a brief financial overview, and then we’ll move to the Q&A at the end. On Slide 24, remember that IMVT-1402 is a major focus for us at Immunovant. We believe we've developed an FcRn with potential best-in-class efficacy and a favorable safety profile within its class, along with convenient subcutaneous auto-injector administration. Our pipeline and product potential is promising, particularly with Graves' disease among our lead indications, where we expect pivotal data in 2027. As I mentioned, we anticipate the DTRA data to be released later this year, and it's worth noting that the study is fully enrolled with 170 patients compared to the original target of 120, primarily due to swift enrollment and enthusiasm from the patient community. Moving on to mosli on Slide 25, we will discuss PH-ILD in more detail later this year as we set the stage for what we expect. The study is fully enrolled, thanks to the patients, investigators, and the Priovant team. PH-ILD is an exciting opportunity for us, focusing on targeted delivery for a disease where lung activity is primary. We believe our once-daily dosing regimen is advantageous, especially since existing therapies often require multiple daily inhalations, and there aren’t many treatments available. We anticipate tolerability benefits and have shown significant PVR reductions in the PAH population. If this continues, we may achieve best-in-class efficacy, which is very exciting for what we can accomplish this year. It will be a crucial part of our narrative moving forward. Lastly, although I won't dwell on the Moderna case today since the trial is approaching, it's scheduled for March 9. We have made progress there, and a significant recent update is that we received the first summary judgment decisions earlier this week. This covered several issues and had a mix of outcomes, but we were pleased with a favorable decision concerning Section 1498, which aligns with our expectations for the trial, where nearly all of the doses asserted will be included. We look forward to that and will provide further updates soon. Now for a brief financial update on Slide 28. Our R&D expense is $165 million, adjusted non-GAAP is $147 million for the quarter. G&A stands at $175 million, adjusted non-GAAP is $71 million, resulting in a total non-GAAP net loss of $167 million. Our cash position remains strong, with $4.5 billion on hand, giving us ample capital to reach profitability and explore other opportunities. We still have share buyback authorization available. As discussed on Slide 30, we anticipate a series of exciting catalysts ahead. A few of these items have already progressed, including the initial summary judgment, and we are optimistic about the updates we will be sharing this year—it should be a significant year for us. On Slide 31, before I move to Q&A, there are multiple commercial launch possibilities in the coming years, with brepo and DM leading the way with several NDA filings. We also expect future POC study readouts among those already announced, along with nine or more pivotal study updates, including cutaneous sarcoidosis, which presents a thrilling slate for us. Thank you once more for your attention. I'll stop talking now and open the floor for Q&A. Thank you.

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

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

Thanks for the question. First, we are very excited about further development opportunities for brepo. Ben and the team are diligently working on other indications. The main takeaway from this data is that it highlights the effectiveness of brepo in the patient populations that need it, which is encouraging, but it doesn’t present anything particularly new. We are still considering other forms of sarcoidosis, among other indications. If we succeed, we will be the first and only drug approved for CS. Regarding the patient population, this aligns perfectly with our strategy, not just for brepo but across all the drugs we are developing, as we are targeting a significant orphan market. We could explore areas outside of this category, but this space offers a substantial opportunity with high unmet medical needs and tens of thousands of patients. We believe it sets us up well for a successful launch and a strong franchise. Overall, we have a great opportunity to benefit these patients and we are optimistic commercially as well. Ben, do you have anything to add?

I would just add that we feel strongly that the data reinforces the alignment of TYK2 and JAK1 inhibition with T cell polarization, primarily driven by Th1 and Th17. The mechanisms of TYK2 and JAK1 inhibition relate to IL-12 and interferon gamma for Th1, and IL-6 and IL-23 for Th17. This supports one of our key hypotheses regarding the unique benefits of TYK2 and JAK1 inhibition. Additionally, the suppression of type 1 interferon is crucial for conditions like dermatomyositis, along with T cell polarization. This data also highlights that NIU shares overlapping mechanisms, especially since we have strong Phase II data and are looking forward to the Phase III results. As we consider the unmet needs in various indications, we believe that TYK2 and JAK1 inhibition may be more effective than other forms of immunosuppression, and this data bolsters our hypotheses.

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

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

Thanks, David. Those are both great questions. Regarding the CSAMI point, Ben addressed this well in his presentation. If you take a look at the table in the slides, you'll notice that it’s a small proof-of-concept study with relatively small groups in each arm. This leads to some significant differences in certain aspects, including disease duration. We have more plaque predominant patients in our 45 arm compared to our 15 arm, which likely contributes to the headline numbers appearing similar. However, as Ben pointed out in the presentation, the results differentiate more clearly on stricter endpoints, such as the proportion of patients achieving a 10 or more point season benefit. We feel optimistic about this translating into Phase II. As for the FDA timeline, DM is a severe disease with limited treatment options, which means there's a possibility, but ultimately that decision rests with the FDA. Thank you.

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

It's great to see this data. I have a couple of questions. First, regarding pricing, the IVIG is around $180, while the price for Vyvgart for these indications is about $870 gross. Could you explain your approach to pricing brepo? Secondly, I realize this might be a bit early, but since Pfizer owns 25% of the joint venture, you will consolidate all sales of brepo. How will you handle their 25% ownership? You're not planning to pay a dividend, but I assume you'll need to allocate 25% of the profits to them. What impact will that have on the P&L?

Thank you, Yaron. Those are both great questions. Regarding pricing, we have not yet decided on the price, as it's still early to provide a definitive answer. We previously indicated that the price framework is somewhat aligned with what you mentioned. Our perspective is that IVIG will likely be slightly more expensive than what you've noted. Those price points remain a reasonable reference for the pricing strategy for these indications, and that view holds true. It allows for significant flexibility. So, stay tuned; this will be an orphan-priced drug. As for the accounting aspect, we will fully consolidate all results, including losses and sales, while there will be a line for minority interest that reflects part of Pfizer's earnings, which will appear below the net income line. When it comes to cash distribution, if we distribute cash, Pfizer will receive their share, and we will receive ours. Additionally, the initial phase of our partnership with Pfizer included dilution protection for their ownership stake, but that protection has now been utilized. Going forward, for any additional investment in Priovant, Pfizer will either need to match their investment or they will face dilution, resulting in us owning a larger share.

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

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

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

Yes, sure. I mean, first, just on erosion, obviously, would be hard to do any better than this. But I think that the minimum clinically important differences, as we've discussed, is 5 points here, we have over 20 points we could have significant erosion and still have a very compelling data set and a very compelling product profile for patients and physicians. That said, I would also note this was a U.S.-only study, but 15 sites for the 31 patients. So this was a multicenter, multidose, placebo-controlled trial, very rigorous for a smaller proof-of-concept study. So while I think that there's always some risk of erosion in particular, while the very low placebo rate is consistent with the natural disease course, you can never be sure of the behavior of placebo and these inflammatory disease trials, particularly when you move to larger global trials. But broadly speaking, I think this data gives us an incredible cushion to still have an effect size in Phase III that maybe is large or maybe is not quite as large, but still would be extremely compelling. As far as the design of the Phase III in terms of size, I think we would probably be looking at a sort of similar size per arms to the DM trial roughly, but we need to kind of take this data into consideration and think more about the powering and have final discussions with FDA on it, including as related to the in indication safety set that they would want to see to support approval. So we'll have more to share on that after we engage with FDA. And the same is true on dose, I would say that I think our incoming hypothesis to this trial is that 45 milligrams based on the totality of the 1,500 patient data we have, a very compelling potential option for these patients balancing benefit and risk. And certainly, I would say in totality, this data reinforces that, you see really excellent efficacy results from the 45-milligram arm, including on some of these higher bar, more stringent endpoints, starting to see real separation with 15 milligrams. And then certainly, in terms of the safety data, nothing that would suggest the overall safety profile of 45 milligrams that we've seen across all of the different indications in which it's been studied, 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. And maybe just one quick one on the housekeeping side. So looking at the 10-Q from Immunovant, can you give us a little bit more color on the return for certain rights around batoclimab back to HanAll? Is there any read-through to how we should think about the setup for the tech data readout later this year?

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

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

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?

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 is possible. Obviously, we're hoping for favorable test outcomes in 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-treprostinil in PH-ILD. I suspect given the amount of unmet patient need, there will be others behind us, but I think we have a really favorable profile as we enter that space.

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

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

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 a better answer to that question.

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

Congratulations on the results. I have a question regarding brepo and CS to better understand the market opportunity. You mentioned there are 40,000 eligible patients. Would all of these patients qualify for brepo therapy and meet the trial's inclusion/exclusion criteria? If so, do you believe this represents a market opportunity similar in size to dermatomyositis? Additionally, concerning the Phase III design, will the endpoint duration of 16 weeks be the same as in Phase II, considering you already have a safety database? Or would you need to conduct a longer test? I'm trying to understand if there are any possibilities to expedite development in this area.

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

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

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

Yes, thank you. I will address the second question regarding the evaluation of additional places to study brepo. As I mentioned previously, we have some interesting ideas both within and outside of sarcoidosis, so stay tuned for updates. Ben, do you have anything to share about the pace of organ involvement and the insights we can gain from it?

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

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

I have a quick question about the data you provided on brepo. The curves you presented continue to deepen over 16 weeks, and I would like to understand how we should think about further deepening or separation. If someone is treated for a year, what should we anticipate? Additionally, could you discuss the scope and size of the Phase III study? Should it be similar to what was done in DM?

Yes, to reiterate on Phase III, I believe Ben mentioned something about it. In general, we've discussed with the FDA, and it's challenging to commit to a specific study design at this point. We should complete that process, after which we'll provide a complete overview of the study design. We're ready to conduct and enroll a substantial study if necessary, and we are optimistic about what we need to accomplish. Regarding continued deepening, we've just begun reviewing the data this week and are exploring its various aspects. One of the key opinion leaders involved in the study shared a comment with journalists saying that even if the data had been half as good and twice as many side effects, it would still be considered a great outcome. There are definitely potential ways for this data to improve further with extended therapy and other metrics. Ultimately, if we can closely replicate these results in a Phase III program, it would be a significant success. We should be well-prepared for that.

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

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

So could you just clarify how broad we think about the rep opportunity? Thanks, Doug. Great question. I think the short answer is that you can see from our indication selection that we've been creative and thoughtful in pursuing areas with high unmet needs, including many where JAKs have not been explored. I believe there is significant opportunity here. I'll reiterate something Ben mentioned, and Ben, if you want to add anything, that would be great. I think anywhere that TYK and JAK are both significant is a key focus area because it highlights the uniqueness of our mechanism. We've done a commendable job in this area, thanks to Ben and his team. The private team has also explored that biology well. I believe we have more ideas in that space. Ben, do you have anything to add, either mechanistically or otherwise?

No, I believe I addressed that earlier. The answer is both. There are indications related to some IITs or clinical reports stemming from the off-label use of other JAK inhibitors, where we feel that TYK2 and JAK1 inhibition is particularly well-suited. These are indications we are currently evaluating, which would obviously be less risky. Additionally, as we continue to observe more excellent data, we are definitely considering some higher-risk but also exciting potential opportunities that lack proof of concept, and we'll see what results we achieve there.

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

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

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

Congratulations on the data. I wanted to ask about Immunovant regarding the positive results for nipocalimab in systemic lupus. How do you view the implications for cutaneous lupus? Additionally, I'm interested in the commercial synergy between brepo and 1402, especially with Immunovant covering analysts. How do you plan to establish a sales force in a cost-effective way to utilize both brepo and 1402 between the two companies?

Yes. Thanks. Look, these are both really good questions and important areas for us. On SLE, first of all, I was on record long before the brepo study in SLE saying that anybody who isn't afraid of a lupus study, I think the word I used in it. And so I'll say congrats to J&J on the positive data in SLE, it's always impressive when people 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 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 benefits both for the commercial performance of brepo and for the commercial performance of 1402 as those launches progress.

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

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

Thanks for the question. I appreciate it. TED is out there, and we expect the data from both studies in the first half of this year. At this point, there isn't much to say about that. Those studies will take place and the data will be released. Our own Phase II study in TED and Graves' has shown that the drug is effective in patients with hyperthyroidism, and I believe this should indicate some level of efficacy for both conditions. We don’t see significant implications from TED for Argenx, and the same applies to our situation with Graves' disease, as both of our Phase II data involve fairly different diseases. The TED study mainly included thyroid patients, making them quite different in terms of the participants involved. We are confident in the potential efficacy of FcRns in Graves' disease and are not particularly concerned with the data from TED. Once we receive the TED data, we will analyze it, particularly regarding hyperthyroid patients in that study, to enhance our Graves' program. However, I would say there is not much crossover between the two programs, and I look forward to compiling all that data once we have it.

Our next question comes from the line of Thomas Smith with 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 a potential we could see some of that open-label period one data first? And then as a follow-up, we noticed on Slide 31 the expectation for Graves' launched by the end of '28, but not although you're expecting Phase III data for both indications in '27. I just wanted to ask if that's purely a function of data timing there? Or if there's some other strategic considerations with respect to pricing or competitive landscape?

I appreciate both questions. Regarding the timing of the data release for the RA study, we have not made a final decision on when and how we will present that data. However, it seems likely that we will wait for the randomized withdrawal period before discussing it, especially as we expect both data sets to be available this year. The first period is open label, so we will gather some information as that progresses. As for the exclusion from MG in 2028, there is a chance it could still launch in that year. Therefore, once we have the data and a clearer timeline for the studies, we'll be able to give more specific guidance on launch timelines.

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

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?

Thank you for the question. The extent of our lead time in Graves' will depend on the organic study design and their decisions. Until we know that design, it’s hard to provide a specific answer. Generally, shorter studies will progress faster than longer ones. We believe we have a significant lead in Graves' disease, regardless of the organic runs. Our relationships with key opinion leaders in that community are strong, and we have conducted studies there. One of our studies is also 26 weeks long, specifically the 2503 study. Ultimately, we anticipate a significant lead in Graves' disease, although the exact degree of that lead could be influenced by the competition. Our main focus remains on completing those studies quickly and reaching this exciting population, which is substantial in size. Additionally, as a reminder from our Phase II data, we have shown that deeper IgG suppression, which we expect to achieve, will be important for this population, particularly regarding remission. This will also play a crucial role in Graves' disease. We look forward to compiling all the data.

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

Thank you, operator. Thank you, everybody, for the good questions. Thank you all for listening this morning. I want to once again thank everybody involved in all of this, including particularly with the cutaneous sarcoidosis data, the patients and investigators involved in that program. As well as the Priovant team for their execution there, but also everybody at Roivant, all the 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.

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