Prepared remarks
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 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 Roivant. 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, everyone, for joining us this morning. I'll begin our presentation on Slide 5. About a week ago, while discussing the draft of this morning's presentation with the team, I realized it could be quite a dull 10-Q. We got together in December for Investor Day, spoke at the JPMorgan conference, and it turned out to be a really busy week. We have some great updates, particularly the Phase II data for brepo in CS, which Ben will discuss shortly. This quarter has been marked by excellent execution and progress overall. The data is certainly a highlight, and we can also announce that the NDA for brepo in dermatomyositis has been submitted, the Phase IIb study for 1402 in D2T RA is fully enrolled, and the Phase II study for mosliciguat in PH-ILD is also fully enrolled. Additionally, we have successfully completed the Immunovant offering that has positioned us well for our upcoming launch.
It has been a fantastic quarter with numerous updates since our last meeting in early January. On Slide 6, 2026 is shaping up to be another very busy year for us, with significant events planned, such as the brepo NIU Phase III readout in the second half of the year. This year, we will be starting a Phase III study in brepo for cutaneous sarcoidosis, which Ben will elaborate on. The Phase IIb data for mosli is expected in the second half of this year, and we know this because the study is fully enrolled. We anticipate the D2T RA data, including both the open-label and randomized withdrawal periods, to be ready by the second half as well. We are also expecting proof-of-concept data for 1402 in CLE. Additionally, we are on track for the jury trial against Moderna starting on March 9, which is just a few weeks away. It’s looking to be an incredibly busy year for Roivant. As shown on Slide 7, we are proud of our pipeline, which continues to deliver across multiple fronts, with brepo now in pivotal registrational programs for three indications, multiple registrational programs for our FcRn franchise, and mosli's top-line data coming in the second half.
I'm truly excited about our business's current state and the progress of our pipeline, and I couldn't be more enthusiastic about the start of 2026. Now, I'll turn to the Phase II data for brepo in sarcoidosis. I'm going to briefly highlight a couple of points from Slide 9 of the presentation before passing it over to Ben for a detailed look at the data. The key takeaway is that this drug has performed exceptionally well in the study. We achieved a statistically significant result, exceeding our expectation of a 5-point improvement in CSAMI with a placebo-adjusted delta of nearly 22 points, specifically 21.6, along with a strong P-value. It's important to note that the study wasn't specifically designed to measure efficacy for this endpoint. Every patient on our high-dose treatment saw at least a 10-point improvement, which is significantly above the clinically meaningful threshold of 5 points.
The results across all metrics are outstanding, with additional supportive data on other endpoints. Safety and tolerability remained consistent with previous findings for this compound, leading to an excellent overall outcome in a disease area where we believe this is the first positive placebo-controlled study in an industry-sponsored context. This is a significant advancement for patients. Now, I'll let Ben remind you about cutaneous sarcoidosis before diving into the study data.
Great to be here with everyone. Starting on Slide 10, I want to discuss cutaneous sarcoidosis, which is a debilitating skin disease known for its rapid progression towards permanent scarring and tissue destruction, particularly affecting the face and scalp. Moving to Slide 11, I would like to emphasize that there are no approved therapies for cutaneous sarcoidosis or any type of sarcoidosis. This presents a significant opportunity for brepo to address this unmet need and potentially become the preferred treatment if we are successful in Phase III as we anticipate based on our promising data. This represents a valuable option for all patients with skin involvement in their sarcoidosis, including those with skin-only involvement and those with other organ involvement. On Slide 12, I want to briefly touch on the connection between the disease’s pathobiology and the treatment mechanism. This connection is crucial, as we have compelling data that we are very excited about.
Although this is from a small study, the findings are significant and align with what we expect based on the drug's mechanism. Sarcoidosis, like all forms of sarcoidosis, including cutaneous disease, is driven by the polarization and recruitment of effector T cells, particularly Th1 polarized cells. Brepo specifically inhibits Th1-related pathways by targeting both IL-12 through TYK2 and interferon gamma through JAK1. This provides a mechanistic opportunity to see the benefits of JAK1 and TYK2 inhibition. Now, moving on to the clinical data on Slide 13, the study design included 31 patients in the United States, randomized in a 3 to 2 to 2 ratio to receive brepo at doses of 45 milligrams, 15 milligrams, or placebo, over a 16-week period, evaluating several efficacy endpoints. On the baseline demographics and disease activity, I want to highlight a few things. First, the duration of disease and background damage of patients was very well balanced between the brepo 45 milligrams and placebo groups, while the 15 milligrams group showed noticeably lighter duration of disease and damage, which sets a higher bar for both brepo 45 and placebo.
I also want to point out the plaque predominant morphology; cutaneous sarcoidosis can manifest through both plaques and papules, with plaques generally being viewed as more resistant to treatment. This plaque predominant morphology was most pronounced and common in the brepo 45 milligrams group, followed by 15 milligrams and then placebo. The key takeaway is that there were some imbalances that made it more challenging for brepo 45 milligrams to demonstrate efficacy compared to both placebo and brepo 15 milligrams. Despite those challenges, we are seeing exceptional data from the brepo 45-milligram dose arm. Moving on to the efficacy results, on the left side of the slide, we can see the mean change in the CSAMI activity score from baseline, with both doses showing statistically significant separation from placebo as early as week 4, and this was sustained at every visit up to week 16 at the end of the trial.
On the right side, we observe the achievement of a 2-point reduction in the investigator global assessment. As a reminder, the IGAs are an FDA-supported endpoint for cutaneous disease, similar to those used in other skin conditions, with scores ranging from 0 to 4, indicating clear, almost clear, mild, moderate, and severe. Achieving both a 2-point reduction and scoring 0 or 1 is a significant challenge, particularly since no placebo patients achieved this. The placebo line and the x-axis line are the same in this chart, which might cause confusion. Again, we see early progress for both dose arms at week 4, substantial improvement at week 8, and then static improvement at weeks 12 and 16. At this higher bar endpoint, we begin to see brepo 45 milligrams separating from the 15-milligram dose arm. Slide 16 has the CSAMI responder data. Again, really compelling data. I think this chart on the left, quite remarkable.
As Matt alluded to, we were hoping to see a mean improvement of 5 points. And what we saw was not only a mean far in excess of that, but we saw 100% of patients in the brepo 45-milligram arm achieved twice that, twice the minimum clinically important difference. So really every brepo 45-milligram patient a responder in this trial. And as I'll walk through momentarily, that's really corroborated by an independent patient-reported outcome as well. And then you see on the right-hand side of this chart, achievement of a CSAMI less than 5. Notably, this is not an improvement by less than 5. This means that the absolute score by the end of the trial is 5 or less, which is a standard for functional remission. And you see 62% of brepo 45-milligram patients achieving that compared to no placebo patients. So again, this data quite in line with the IGA 2-point improvement to 0, 1 that I walked through before.
So again, seeing pretty consistent data here across multiple endpoints. Turning now to the patient-reported outcomes. Slide 17 shows the Skindex-16, which is a well-established standard metric in inflammatory skin disease trials. We have excellent data here with the placebo group showing worsening, while both the 45-milligram and 15-milligram doses of brepo show substantial improvement, exceeding the minimum clinically important difference. The 45-milligram dose slightly outperformed the 15-milligram dose, with both doses performing significantly better than placebo. On Slide 18, we have the KSQ skin domain from the King's sarcoidosis questionnaire, which assesses overall sarcoidosis, not limited to skin disease. In our initial TLR, we concentrated on the skin-specific domains, and the data aligns well with the Skindex findings, providing compelling evidence of benefit. Lastly, on Slide 19, we address the patient's global impression of change.
This is a simple question where patients report their overall change in sarcoidosis symptoms since starting the study medication, with options for no change or varying degrees of improvement or worsening. This endpoint is powerful in its simplicity. Notably, 100% of patients on the 45-milligram dose reported improvement, consistent with the CSAMI data showing a 100% response rate, which is very compelling. The 15-milligram dose also showed considerable improvement for most patients, although two in that group reported worsening. In the placebo group, improvements were minimal, with many patients reporting either worsening or no change. Turning to Slide 20, safety data. I think very well, brepo was very well tolerated during the study. We had no SAEs in the study and all adverse events were graded mild or moderate in severity. So against the backdrop of this efficacy data, in particular, certainly, the safety data we see would tee up a potentially very favorable benefit-risk profile for brepocitinib for these patients.
Obviously, we have over 1,500 patients of data in brepocitinib. 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 a rapid onset of action sustained over time. So really exciting results.
We're really excited to move this ahead to Phase III and potentially have the first approved therapy for sarcoidosis. So I look forward to discussing any questions later, and I'll hand it back to Matt.
Thanks, Ben. Yes, look, we're just terrifically excited about this data and about what it means for us and what it means for these patients. On Slide 22, just sort of as a reminder of what the picture for brepocitinib now looks like, people toss around the phrase pipeline and a product for a lot of different products. I feel at this point, looking across the indication set for brepo, even with what we've talked about already with CS, DM and NIU, where we get to a very large addressable patient population, these are patients who in every one of these indications lacks efficacious therapies and is in need of options, and we continue to add legs of the stool or opportunities that grow into these sort of first-in-class orphan inflammatory diseases that are high unmet need in important areas. And I think we've got more to come there. So stay tuned. But just starting to feel like brevcitinib is a really important medicine for us and hopefully for patients.
So looking forward to continuing that journey. I'm going to brief through a couple of other highlights or updates across the portfolio, little quick financial updates, and then we'll do Q&A at the end. Super quickly on Slide 24, as a reminder, IMVT-1402 remains a huge focus for us at Immunovant. We think we've got an FcRn with potential best-in-class efficacy with a safety profile that looks favorable even within the class, obviously, convenient administration with a subcu auto-injector and we use the phrase again here, pipeline and product potential, again, with Graves' among our lead indications where we're expecting pivotal data in 2027. We're now, as I mentioned earlier, expecting the D2T RA data later this year, and that study is fully enrolled. We actually enrolled 170 patients in that study, up from the anticipated 120 originally, 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, we will definitely spend some time later this year discussing PH-ILD and mosli and preparing for what we expect there. That study is fully enrolled thanks to the patients, investigators, and the Pulmovant team. PH-ILD remains an exciting opportunity for us because targeted delivery addresses a disease where the lungs are the primary site of activity. We believe we have a convenient once-daily dosing regimen, especially in a disease where existing therapies typically require multiple daily inhalations, and there are not many existing therapies available. We anticipate potential tolerability benefits. Additionally, as you may know, we demonstrated the best PVR reductions ever in the PAH population. If that translates well, we may achieve best-in-class efficacy. We are really excited about the potential developments later this year, and I believe it will be a significant part of our story in the upcoming months.
Finally, I won’t spend too much time on this today since we are close to the date, but the jury trial in the Moderna case is scheduled for March 9. We are making progress, and a major recent update is that we received the first summary judgment decisions earlier this week, which addressed a few issues with some favorable and less favorable points. One aspect we were pleased about is the favorable decision on Section 1498, which positions us well for the case we are hoping for in this trial, where nearly all the doses we asserted will be covered. We look forward to that, and there will be more updates to come. Finally, just a really brief financial update on Slide 28. R&D expense of $165 million, adjusted non-GAAP of $147 million for the quarter, G&A of $175 million, adjusted non-GAAP of $71 million for a total non-GAAP net loss of $167 million. Cash remains very strong, $4.5 billion of consolidated cash in the business.
So plenty of capital to get us to profitability with dry powder to do other things as well. As a reminder, we still have share buyback authorization and are happy to have that sort of capability. On Slide 30, as discussed, just a really catalyst-rich period ahead of us. A couple of these things checked off now. Obviously, the beginnings of the summary judgment also make progress and just feeling good across the board with a lot more updates to come this year. It should be a big year for us. And a big few years on Slide 31 before I go to Q&A, multiple commercial launches potential in the coming years. Obviously, brepo and DM would be first with that NDA now in, multiple NDA and BLA filings. We continue to have even sort of more future POC study readouts even among the ones we've already announced and now 9 or more pivotal study readouts, including cutaneous sarcoidosis coming over this timeline, which is just a really exciting slate for us to build on. So with that, thank you again for listening. I'm going to stop talking and open up the line for Q&A.
Questions and answers
Thank you, operator. Our first question comes from Corinne Johnson with Goldman Sachs.
I think you've mentioned today and previously that you'd 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 percentage of the patient population you think are great candidates for this relative to NIU and dermatomyositis.
Yes, thank you, Corinne. That's a great question. First and foremost, we are genuinely excited about the further development of brepo. Ben and the team are diligently working on other indications as well. The key takeaway from this data is that it emphasizes the effectiveness of brepo in patient populations that need it, which fuels our enthusiasm. However, it doesn't necessarily unveil anything new, apart from our ongoing considerations for other forms of sarcoidosis. CS is another indication where, if we are successful, we will be the first and only drug approved. As for the patient population, this aligns perfectly with our goals. We aim to operate in this large orphan market, which has been a fruitful area for us and others, encompassing tens of thousands of patients with significant unmet needs. We believe this is an attractive opportunity that we can successfully launch and build a franchise around. It feels promising in terms of benefiting these patients and also from a commercial standpoint. Ben, do you have anything to add?
I would just add that we have already felt this, but the data strongly supports the alignment of TYK2/JAK1 inhibition to T cell polarization, primarily driven by Th1 and also by Th17. The mechanism of TYK2/JAK1 inhibition corresponds with this through IL-12 and interferon gamma for Th1, and IL-6 and now IL-23 for Th17. This is one of the mechanistic hypotheses behind the unique advantages of TYK2 and JAK1 inhibition. Additionally, the suppression of type 1 interferon is crucial in dermatomyositis, along with T cell polarization. I want to emphasize that this data shows that NIU has some overlapping mechanisms as well, where we already saw strong Phase II results and are looking forward to the Phase III outcome. As we consider not only the unmet needs in indications, but also diseases where we believe TYK2/JAK1 inhibition may be more effective than other forms of immunosuppression, this data reinforces some of 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 2 arms. The press release obviously mentioned different baseline characteristics. Could you just add a little more color on that? Second, with respect to the FDA time line, 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.
Thank you, Dave. Those are both excellent questions. Regarding the CSAMI point, Ben addressed this well in his presentation. If you look at the table in the presentation on baseline characteristics, you’ll notice that since this is a small proof-of-concept study, the sample size in each arm is relatively small. Consequently, there are some notable differences in aspects such as disease duration and morphology. For instance, we have more plaque predominant patients in our 45 arm than in our 15 arm, which likely contributes to the similar headline numbers. As Ben mentioned, the data diverges more significantly when examining more stringent endpoints like the proportion of patients achieving a 10 or more point CSAMI benefit. We’re optimistic that this will carry over into Phase III. As for the FDA timeline, DM is a severe disease with limited options. Therefore, there is certainly a possibility, but it ultimately depends on the FDA's decision.
Our next question comes from the line of Yaron Werber with TD Cowen.
Congratulations. It's great to see this data. I have a couple of questions. First, regarding pricing, IVIg is around $180, while the price for VYVGART for these indications is approximately $870 gross. Could you help us understand your pricing strategy for brepo? Secondly, I know this may be a bit early, but since Pfizer owns 25% of the joint venture, you'll likely consolidate all sales of brepo. How will you address their 25% ownership? Although you won't be paying a dividend, I assume you'll need to distribute 25% of the profits to them. How will this impact the profit and loss statement?
Thank you, Yaron, for the questions. Regarding pricing, we haven't made a decision yet as it's still early. Previously, we mentioned that the pricing of IVIG might be slightly higher than the figures you've referenced. We believe the range you mentioned is a reasonable reference point for pricing these indications, and that perspective remains unchanged. It provides us with considerable flexibility. So, stay tuned, but this will be a high-price drug. As for the accounting aspect, we will fully consolidate all results, including losses and sales, with a minority interest reflected below the net income line to account for Pfizer's share of earnings. Concerning cash distribution, Pfizer will receive their share of any distributed cash, while we will receive ours. Additionally, it's important to note that the initial aspect of our relationship with Pfizer included dilution protection for their ownership stake, but that protection has now expired. Therefore, for any additional capital needed by Priovant, Pfizer will either need to contribute according to their ownership stake, or they will face dilution, resulting in us having a larger ownership percentage.
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 mostly going to hand over to Ben for these questions, but I'll just say it feels like we've got a fair amount of cushion in the quality of this data. And also, a, this was a relatively small study. There aren't a lot of other studies to go on in CS. So we kind of got to take our guidance from here. But it was nice to see a 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, of course. Regarding erosion, it's already quite impressive, and the minimum clinically important difference we've discussed is 5 points. We have over 20 points here, so even with significant erosion, we still have a strong data set and product profile for patients and physicians. However, I would like to mention that this was a U.S.-only study, conducted at 15 sites with 31 patients. It was a multicenter, multi-dose placebo-controlled trial and very rigorous for a proof-of-concept study of this size. While there's always some risk of erosion, the very low placebo rate aligns with the natural course of the disease, but we can't be entirely certain about the placebo's role in these inflammatory trials, especially as we transition to larger global studies. Overall, I believe this data provides us a solid foundation for the Phase III trials, which might yield an effect size that is either similar or slightly different, but still very compelling. In terms of the Phase III design and size, we will likely aim for a similar size per arm as the DM trial, but we need to consider this data further and have final discussions with the FDA, particularly about the safety set they would require for approval. We will share more information after we connect with the FDA.
Got it. And maybe just one quick one on the housekeeping side.
So, looking at the 10-Q from Immunovant, can you provide more insight on the return for certain rights related to batoclimab? Is there any implication for how we should consider the setup for the TED data readout later this year? No is 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, we'll have to make a decision around how to work together with HanAll on 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. Congratulations on the data. I wanted to ask 2 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 good questions. Look, on Genevant, 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 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 best outcomes in each case. On the PH-ILD question, look, I think the answer is, in theory, any drug that improves PVR could work in PH-ILD. Systemic vasodilation has not in and of itself been a great approach in PH-ILD, but sotatercept certainly could work in PH-ILD. Right now, we are slated, I believe, to be the first non-prostacyclin non-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.
As an Immunovant covering analyst would love to spend time on 1402 and get some color around your near-term RA readout. Obviously, the study is upsized. Help us understand as the study is coming to an 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 III registrational study to be shared? And then I'll jump back in the queue.
Thank you for the question. Regarding expectations for RA, the short answer is that these patients have a high unmet need, which means the efficacy bar is relatively low compared to what we usually see in RA. However, there is limited precedent data for drugs in late-stage RA with this level of pretreatment, making it difficult to predict outcomes. We are currently working on this question and will provide guidance on the conditions that would prompt us to conduct a second study before we release that data. It’s important to remember that these are patients with advanced disease. If we are pleased with the data, it could represent a significant product opportunity. We will collaborate with the agency after reviewing the data and outline a plan moving forward. As of now, the expectation is that this will be one of several studies we'll need to conduct, given that this is a relatively smaller randomized withdrawal trial. We'll evaluate the data and provide a clearer answer then.
Our next question comes from the line of Prakhar Agrawal with Cantor.
Congratulations on the impressive results. I have a question regarding brepo in the context of customer success. I'm interested in understanding the market opportunity here. You've mentioned there are 40,000 eligible patients. Would all of these patients qualify for brepo therapy and meet the trial's inclusion and exclusion criteria? If so, do you believe this represents a market opportunity similar in size to dermatomyositis? Additionally, regarding the Phase III design, will the endpoint be evaluated at 16 weeks like in your Phase II trial, considering you already have the safety database, or will a longer testing period be necessary? I'm looking to see if there are any opportunities to expedite development.
Yes. Thanks, Prakhar. Great questions. Look, I think the short answer on market opportunity is this is a patient population that's sick with high unmet need. And assuming our Phase 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, but 70-plus thousand total patients. So I probably think of this as an exciting opportunity, but a little bit smaller than the DM opportunity, although, again, it 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 the 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.
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, thanks. Look, I'll take the second of those questions, which is certainly it's something we will evaluate in terms of further places to study brepo. And as I said before, we have ideas inside and outside sarcoidosis that are exciting. So stay tuned, and we'll be back with it. On the first question in terms of patients' organ involvement and what we can learn from it. Ben, anything you'd share about that?
Yes. About 60% of the patients experienced some pulmonary involvement, and approximately 30% of those, who are included in that 60%, had involvement in other organs, primarily ocular. We did consider some exploratory endpoints related to these factors in the trial, but we haven't analyzed that data yet. The study was not structured to assess any benefits in those other organ systems, so I don't anticipate gaining significant insights from it. However, we will certainly examine it. An important point to note is that this represents a real-world population of cutaneous sarcoidosis, where many patients have multiple organ involvement.
Our next question comes from the line of Yatin Suneja with Guggenheim.
I have a quick question about brepo based on the data you provided. Looking at the curves, they continue to deepen over 16 weeks. I’m curious how we should think about this going forward. Do you expect further deepening or separation? If someone is treated for a year, what should our expectations be? Also, could you discuss the scope and size of the Phase III study? Should it be similar to what you did in DM?
Thank you. To reiterate on Phase III, as Ben mentioned, until we have a conversation with the FDA, it's challenging to commit to a specific study design. We'll get through that discussion and then provide a complete overview of the study design. We are ready to conduct and enroll a substantial study if necessary, and we are optimistic about what we need to accomplish. Regarding the ongoing analysis, we just started examining the data this week, so we are still exploring all the different features. One of the key opinion leaders involved in the study shared with some journalists that even if the data had been only half as good, with twice the side effects, it would still represent a significant outcome. Long story short, there are certainly opportunities for this data to improve with longer therapy and other factors. However, if we can closely replicate these results in a Phase III program, it would be a major success. We should be well-positioned 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 on DM as well as NIU. There is obviously a lot of data with JAK inhibitors in various indications, but not necessarily full randomized trials or proof of concept. I mean is that the breadth of universe? Or is there other white space that you're also thinking about where JAKs haven't been explored at all, but perhaps it's worth exploration just given the magnitude of effects that you're starting to see?
Could you clarify how broadly we view the brepo opportunity? Thank you for the question. The short answer is that our selection of indications demonstrates our creativity and thoughtfulness in pursuing areas with significant unmet needs, particularly in places where JAKs have yet to be explored. There's substantial opportunity here. I'll reiterate a point that Ben made, which is important to emphasize. Areas where both TYK and JAK play a crucial role are of particular interest due to the uniqueness of our mechanism. We've done a commendable job in investigating that biology, thanks to Ben and the Priovant team. I believe we have additional ideas within that space. Ben, do you have anything to add about the mechanisms or anything else?
No, I think I covered it earlier. I would say that the answer is both. There are some indications where we see potential from off-label use of other JAK inhibitors, and we believe that TYK2 and JAK1 inhibition is optimally suited for those cases. We are evaluating these indications, which would obviously be less risky. Additionally, as we continue to observe excellent data, we are also considering some higher-risk but exciting potential opportunities with less proof of concept, and we will see what we come up with there.
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 Priovant team for their execution there, but also everybody at Roivant and all of the 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.