Good day, and thank you for standing by. Welcome to the Roy Vant Third Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

Good morning, and thanks for joining today's call to review positive Phase 2 results for breakfast whitnip and cutaneous sarcoidosis, and Roy Vance financial results for the third quarter ended December 31, 2025. I'm Stephanie Lee with Roy Vance. Presenting today, we have Matt Lyons, CEO of Roy Vance, and Ben Zimmer, CEO of Roy Vance. 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.royvant.com. We'll also be providing the current slide numbers as we present to help you follow them up. 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 everyone for dialing in and listening this morning. I'm going to start our presentation on slide five. You know, I was sitting, talking to the team, it was about a week ago today, looking at a draft of this morning's presentation and thinking that it was going to be a pretty boring 10Q. We had gotten together in December for the Investor Day. We had spoken at the David Morgan conference, and it turned out to have been a really busy So we have some great updates, obviously, most notably the phase two data in BREPO and CS, which Ben is going to present on momentarily. But truth is, terrific execution of progress across the board for us this quarter. Obviously, that data is a highlight, but we also can announce today that the NDA for GREPO is in endermatomyositis, that the Phase 2b study for 1402 in DGTRA has fully enrolled, that the Phase 2 study for Moseley in PHLD has fully enrolled, and obviously all of the updates that were known before, including the Immunivan offering earlier, that gets us now financed to Graves launch, all behind us. So, just a terrific quarter and a terrific set of updates even since early January when we last got together. You know, on slide six, 2026 is, again, a very busy year for us ahead. Obviously, some major events later in the year, the BREPO-NIU Phase III, the Pivotal Redoubt in the second half, we're now going to be starting this year a Phase III study in BREPO and Janus sarcoidosis. Ben will talk a little bit more about that. It's early days. I'm getting that going. But that will be this year. The Phase IIb data for Moseley 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 DTGRE data, where all of that, both the open-label period and the randomized withdrawal period will be done by the second half of this year. We also are getting proof-of-concept data in 1402 in CLE, and finally, we are still on track for the jury trial against Moderna starting on March 9th, so just a few weeks So, a really, really busy year ahead for Reuven. And really, if you look at slide seven, before we get, again, to the data for CS, you know, just a pipeline we're really proud of that continues to deliver across multiple dimensions with the, obviously, PREPO with now three indications in the Pivotal Registrational Programs, multiple registrational programs for FCR and FranchiseMate, which we've talked about, and mostly with top-line data coming in the second half. So, really excited about where we are as a business, really excited about the pipeline. I couldn't be 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 two data for BREPO and sarcoidosis. So I'm just really briefly on slide nine of the presentation. I'm just going to walk through a couple of highlights, but mostly I'm going to hand it over to Ben to take you through the data in detail. And the short answer, and we keep saying this, and it's a tremendous fortune I think to be able to say, but this drug has done everything we could have asked for us for it in this or of it in this study. You know, we had a significant, remember, we had said before the bar for clinical success here we thought was sort of five points of CSAMI was clinically meaningful. You know, we got a placebo-adjusted almost 22 points, 21.6 point delta with a p-value. And again, the study was 100% of patients on Brepo 45 for middle of 14 on placebo had a 10-point improvement. Again, clinically meaningful was five points. 100% of patients on our high dose had at least a 10-point improvement. So, you know, just a tremendous outcome across the board. There's some great supportive data on some of the other endpoints as well, and with safety and tolerability completely consistent with what we've seen for the compound in the past. So a really terrific outcome, and in a disease that needs it, where there's never been a positive placebo-controlled study in an industry-sponsored study to our knowledge. So really a terrific day for those patients. So with that, I'm going to hand it over to Ben to walk you through a little bit about cutaneous sarcoidosis as a reminder, and then on to the study data as well. Ben, take it away.

Great. Thanks so much. Great to be here with everyone. Starting on slide 10, I just wanted to, you know, bring back to what this disease is, walk 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 towards permanent scarring and destruction of tissue, as well as its disfiguring nature, given the particular prevalence on the face and scalp of the disease. Turning to slide 11, I would note that there's no approved therapies, not only for cutaneous sarcoidosis, but for any form of sarcoidosis. And so as we think about our development program in CS, really a great opportunity for BREPO to meet this overall unmet need and become the therapy of choice if we're going to be successful in phase three as we hope and expect we would be on the basis of this data to really be a promising option for all patients with skin involvement in their sarcoidosis. That would include patients both with only skin involvement as well as those with other organ involvement as well. Turning to slide 12, really just briefly here on the alignment between the pathobiology of the disease and the mechanism, and I think this is important because, you know, as Matt alluded to, and I'll walk through in a bit more detail, we really have great data here that we're very excited about, and I think, you know, in a small study, you know, the data is very compelling. It's hard to argue on its own, but it also really aligns with what you would expect to see given the mechanism of this drug. sarcoidosis, all of the forms of sarcoidosis, including cutaneous disease, are driven by the polarization and recruitment of a factor T-cells, and particularly TH1 polarized cells. And BREPO really distinctively inhibits TH1-related pathways by hitting both IL-12 through TIC2 and interferon gamma through JAK1. So, really, an opportunity here mechanistically to see the benefits of JAK1, TIK2 inhibitions specifically, and I think that's really part of what's flowing through to our clinical data that I'll walk through now. Slide 13, study design, very straightforward, 31 patients in the United States, randomized 3 to 2 to 2 to Brepo, 45 milligrams, 15 milligrams in placebo, a 16-week study evaluated several different efficacy endpoints. On the baseline demographics and disease activity, slide 14, I do want to highlight a few things. First, if you look at the duration of disease and background damage of patients, REPO 45 milligrams and placebo are very well balanced between those two arms, but 15 milligrams actually quite a bit lighter on duration of disease and damage, which you know, it would mean really a higher bar for both BREP-O45 and placebo. And then I would also call attention to the plaque-predominant morphology. You know, cutaneous sarcoidosis can present through both plaques and papules. In general, the plaques are viewed as more treatment-resistant, and you see this plaque-predominant morphology most pronounced and most common in the BREP-O45 milligram enzyme, followed by 15 milligrams, followed by placebo. So, you know, sort of punchline of this is, you know, there were some imbalances. Those imbalances actually made it harder for BREPO 45 milligrams to demonstrate efficacy, both as compared to placebo and as compared to BREPO 15 milligrams. And in spite of that, as I walk through, we really see exceptional data from the BREPO 45 milligram DOSARM. So, turning to slide 15 to get into the efficacy results on the left hand of this slide, you see the mean to SAMI activity score change from baseline, you know, both doses, statistically significant separation from placebo as early as week four, the first time point evaluated and then sustained at every visit out to week 16 at the end of the trial. And then on the right here, we see the achievement of the Investigator's Global Assessment 0-1 and a two-point reduction. So as a reminder, the IGAs are a standard FDA-supported endpoint for cutaneous disease. This is similar to the IGAs used in other skin indications with scores from 0 to 4, clear, almost clear, mild, moderate, and severe. So, to achieve both a two-point reduction and an end at a zero or one is a very high bar and, you know, notably it's a high enough bar that zero placebo patients cleared it. So, you may be confused where the placebo line, the placebo line and the x-axis line are the same thing on this chart. And you see here, again, some early progress for both dose arms at week four, really significant or substantial improvement at week 8, and then STAT-SIG improvement at week 12 and 16, and then here on this higher bar endpoint, you do start to see Brepo 45 milligrams begin to separate some from the 15-milligram DOSARM. Slide 16 has the Sasami 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 five 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 achieve twice that, twice the minimum clinically important difference. So, you know, 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 SESAMI less than Notably, it's 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 two-point improvement to 01 that I walked through before. So, again, seeing pretty consistent data here across multiple endpoints. Turning now to the patient-reported outcomes, slide 17 has the Skindex 16. This is, again, a pretty established standard metric in inflammatory skin disease trials. You see excellent data here with the placebo group worsening, Brepo 45 mg and 15 mg, both improving substantially, well above the minimum clinically important difference. Again, here with Brepo 45 mg outperforming 15 modestly, and both doses really far better than the placebo. So, slide 18, we have the KSQ skin domain, so this is the King Sarcoidosis Questionnaire. It's a PRO for sarcoidosis overall, not just limited to skin disease. What we focused on in our initial TLR was the skin-specific domains, and you see here very in line with the Skindex and in terms of the data, so just yet another data point. Finally, on the efficacy side, I alluded to this before, but on slide 19 would call it the patient's global impression of change. So this is a single question where patients are asked since they started taking the study medication, how would they describe the overall change in their sarcoidosis symptoms, and they can answer no change or some degree of improvement or some degree of worsening. I think this is a powerful endpoint for simplicity, and notably 100% of BREPO 45 milligram patients reported that they improved, again, consistent with the SESAMI data where we saw 100% response rate. So, very compelling here. BREPO 15 milligrams, also very considerable improvement for most patients, although two patients in the BREPO 15 milligram group did not, not only did not report improvement, but actually reported worsening. And then in the placebo group, very little improvement, and most patients reported either worsening or... Turning to slide 20, safety data, you know, I think the study and all adverse events were graded mild or moderate against the backdrop of this efficacy data. In particular, certainly, you know, the safety, you know, would tee up a potentially very favorable benefit-risk profile for brevisitinib for these patients. Obviously, we have over 1,500 patients of data in brepacitinib, and so the overall safety database is characterized by much more than just these results. But, you know, certainly here, you know, 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, you know, 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 Brevco 45 milligrams arm, and a rapid onset of action sustained over time. So, you know, really exciting results. We're really excited to move this ahead to Phase 3 and potentially have the first approved therapy for sarcoidosis. So I look forward to discussing any questions later, and I'll hand it back to Matt.

Thanks, Ben. Yeah, look, we're just terrifically excited about this data and about what it means for us and what it means for these patients. You know, on Slide 22, just sort of as a reminder of what the picture for brevisitinib now looks like you know people toss around the phrase pipeline in a product for a lot of different products I feel at this point looking across the indications that for Brepo even with what we've talked about already with CSDM and NIU where we get to a very large addressable patient population these are patients who in every one of these indications 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 important areas and I think we've got we've got more to come there so stay tuned but just starting to feel like brevacitinib is a really important medicine for us and then hopefully for patients so looking forward to continuing that that journey I'm going to breathe through a couple of other highlights or updates across the portfolio real quick financial updates and then we'll do, we'll do Q&A at the end. You know, super quickly on slide 24, as a reminder, IMD-4202 remains a huge focus for us at Immunivan. We think we've got an FCRN with potential best-in-class efficacy with a safety profile that looks, you know, favorable even within the class, obviously convenient administration with a sub-Q auto-injector, and we've raised again here 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 DTRA data later this year, and that study is fully enrolled. We actually enrolled 170 patients in that study, up from the anticipated 120 originally, and that was in part just due to speed of enrollment and the level of enthusiasm from the patient and doc community. Moving over to Moseley on 25, and we'll definitely spend some time later this year talking more about PHLD and Moseley and setting the stage for what we expect there. But that study is fully enrolled with thanks to those patients' investigators and the Pulmovant team. PHLD remains an exciting opportunity for us where, you know, targeted delivery gets at a disease where lung is the primary site of disease activity. We think we have a convenient once-daily dosing regimen in a disease where existing therapies mostly have multiple daily inhalations, and where there aren't very many existing therapies bluntly. We expect or hope for tolerability benefits, and then, you know, as I think you know, we showed really the best-ever PVR reductions in the PAH population, and if that translates, we may be able to get some best-in-class efficacy as well, so really excited about what we could do there later this year. I think it will be a really important part of our story in the coming months. And then finally, and as before, I'm not going to spend a ton of time talking about this today because we're so close in here with the jury trial and the Moderna case is scheduled for March 9th. We continue to make progress there. And the sort of major update there in the recent weeks is that we got the, for earlier this week, we got the first of the summary judgment decisions, which covered a few things and had to put some takes generally. But one thing we were quite happy with is the favorable decision on Section 1498, which sets us up for the case that we were sort of quote-unquote hoping for in this trial where almost all of the doses that we had asserted are going to be covered in this jury trial. So, you know, looking forward to that and obviously more to come there. Finally, just a really brief financial update on slide 28. You know, R&D expense of 165, adjusted non-GAAP of 147 for the quarter, G&A of 175, adjusted non-GAAP of 71 for a total total non-GAAP net loss of 167. Cash remains very strong, four and a half billion dollars of consolidated cash in the business, so plenty of capital to get us, you know, to profitability with dry powder to do other things as well. As a reminder, we still have shared buyback authorization and are happy to have that sort of capability. You know, 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, PREPO 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 nine or more pivotal study readouts, including continuous sarcoidosis, coming over this timeline, which is just a really exciting slate for us to build on. So with that, thank you again for listening. I'm going to stop talking and open up the line for Q&A. Thank you, operator.

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

Good morning, guys, and thanks for the question. You know, I think you've mentioned today and previously that you consider further development expansion opportunities for represent them, 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 person of the patient population you think are great candidates for this relative to NIEO and dermatobiocytis.

Yeah, perfect, Corinne. It's a great question. Look, I think the first thing is we are absolutely enthusiastic about further development in We have other indications that Ben and the team are hard at work at. I don't, I think the, but I would say the main thing about this data is just that it continues to underscore how strong an agent REPO can be in these patient populations that need it and sort of drives enthusiasm, but I don't know that it reveals anything specific or new other than, you know, we're continuing to think about, you know, other forms of sarcoidosis, et cetera. CS is another indication where we will be the first and only drug approved if we're successful from here. And then on patient population, look, I think this is right in the sweet spot of what we've been trying to do, not just bluntly for Brepo, but across the different drugs we're developing, where, you know, we're in this kind of large orphan market. And again, we might do things outside of this category, but it's been a really good space for us and for others with tens of thousands of patients, a big opportunity, high unmet need. And we think it'll be the kind of thing that we can tractably launch and that we can make a successful franchise around. So it feels great from an ability to benefit these patients' perspective and from a commercial perspective as well. Ben, anything you'd add there?

I would just add that, you know, I think, and this is something we've felt already, but this data really enforces that, of the alignment of TIC2-JAC1 inhibition to T-cell polarization, both, as we see here, predominantly Th1-driven, but also Th17-driven. And, you know, the mechanism of TIC2-JAC1 inhibition really does align to that through IL-12 and interferon gamma for Th1, IL-6, 17. And I think, you know, that's really one of the mechanistic hypotheses around the distinctive benefits of TIC2-JAC1 inhibition. And, you know, others are obviously the type 1 interferon suppression that's isitis in addition to the T-cell polarization. But I would kind of highlight that this data really enforces that NIU, you know, has some overlapping mechanism as well, where obviously we had really strong Phase II data, excited to see that Phase III result. But I think just as we think about not just kind of the unmet need of indications, as Matt articulated, but also diseases where TIC2, JAK1 inhibition is going to really be, in our view, potentially better than any other form of immunosuppression. I think this data kind of reinforces some of our hypotheses there.

Thanks, Jen. Congrats on the data.

Thanks, Trent.

Thank you. Our next question comes from the line of Dave Reisinger with Lea Rink Partners. Your line is now open.

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

Yeah. Thanks, Dave, those are both great questions. You know, on the point, I think Ben hit on this well in his presentation as well. You know, look, I think if you look at the table, if I can pull up the slides on a second, but if you look at the table in the presentation on baseline characteristics, you know, I'd say there are some relatively, remember this is small proof of concept studies, a relatively small NCHRM, and so you can see some relatively significant differences on some aspects, including, you know, duration of disease, as well as morphology of disease with more plaque-predominant patients, which are those more recalcitrant patients on our 45 arm than on our 15 arm, and I think that's probably in part what's responsible for the sort of headline numbers looking similar, and you can see that they separate more, again, as Ben hit pretty well in the presentation, on the more stringent endpoints, like the proportion of patients hitting a 10 or more point CSAMI benefit. So we feel pretty good about that translating into Phase 3. And then on the FDA timeline, look, I think the answer to that question is DM is a severe disease with not a lot of options, and so there's certainly a chance, but that ultimately is up to FDA. Thank you. Thanks, David.

Our next question comes from the line of Jeroen Werber with T.D. Cowan. Your line is now open.

Great. Thanks so much, and congrats. really nice to see this data. I got a couple of questions. One is price. The IVIG is around $180, but the concomitant sort of price for VivGuard for these indications around $870 gross. So maybe help us understand how you're thinking about pricing of Brepo. And then secondly, as you, and I know this might be a little premature, but from Pfizer owns 25% of the JV, you'll obviously consolidate all sales of Brepo. How do we handle their 25% ownership? Because you're not going to be paying a dividend, but I imagine you'll have to sort of, you know, give them their 25% of the profits. Where is that going to hit the P&L? Thank you.

Yeah, thanks, Jerome. Those are both good questions. Look, I think on price, we obviously have not decided on a price yet. It's too early to have an answer to that question. And what we've said before is taking bookends that are not so different from the ones you quoted there. I think our view is IVIG is probably a little bit more expensive than that in practice. Those bookends are a reasonable place to think about in terms of the pricing envelope for these indications is what we've said before. And I think that continues to stand. I think it gives us a lot of room. So, you know, I think, you know, stay tuned, but this will be an orphan price drug. And then, you know, what I think is really sort of an accounting math question, so we'll fully consolidate all of the results, losses, sales, everything, and then there'll be a below-the-line minority interest that attributes the portion of Pfizer's earnings. But again, it'll be below the net income line. And then in terms of how cash comes out, obviously, if we distribute cash out, Pfizer will get their portion of that cash, and we'll get our portion of that. Another comment I'll make there is, and we said this elsewhere, the early portion of the relationship with Pfizer had dilution protection for their ownership's sake. That's been exhausted now, and so for any further capital enterprise, Pfizer will either need to match their portion of our spend, or we'll be diluted and we'll wind up owning Thank you.

Our next question comes from the line of Brian Chang with J.P. Morgan. Your line is now open.

Hi, Matt, and Ben. Congrats on the data. here. Two questions from us. As we think about the phase three, 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 two to phase three for this indication. It seems that, you know, you have a pretty large gap, you know, going from 22 to the five point delta that seems clinically meaningful. How should do you think about deterioration? And I have one quick follow-up as a housekeeping question.

Yeah, thanks, Brian. Look, I'm mostly going to hand over to Ben for these questions, but I'll just say it feels like we've got a fair amount of cushion in the quality of this data. And also, you know, A, this was a relatively small study, but there aren't a lot of other studies to go on in CS, so we kind of got to take our guidance from here, but it was nice to see a local super response. Ben, you want to talk a little bit about that and then about whatever we can share at this point on phase three design?

Yeah, sure. I mean, first, just on erosion, you know, obviously it would be hard to do any better than this, but I think that, you know, the minimum clinically important difference is we've discussed the five points. Here we have over 20 points. We could have significant erosion and still have a data set and patients and physicians. You know, that said, I would also note this was a U.S. only study, but, you know, 15 sites for the 31 patients. So, you know, this was a multi-center, multi-dose, placebo-controlled trial, very rigorous for a, you know, for a smaller proof-of-concept study. So, you know, some risk of erosion, in particular, while the very low placebo rate is consistent with natural disease course, you know, you can never be sure of the behavior of placebo in these inflammatory disease trials, particularly when you move to larger global trials. But, you know, broadly speaking, an incredible cushion to still have, you know, maybe is not quite as large, but still would be. As far as the design of the Phase III, in terms of probably be looking at roughly, but we need to, you know, kind of duration and, you know, have an 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, you know, the same is true on dose, you know, the 1,500 patient data we have, you know, in total to see results from the 45 milligram arm, including on some of these more stringent endpoints, starting to see real separation with 15 milligrams. And then certainly in terms of the, in terms of the safety data, nothing that would suggest the deep profile of 45 milligrams that we've seen across all of the different indications in which it's been studied, that, you know, nothing in this data to suggest there's anything specific to cutaneous sarcoidosis separate from those. So I think, you know, 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.

You know, 50 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 have a final update on that after we engage with the agency got it thanks thanks ben and and maybe just one quick one um on the housekeeping side so um looking at the 10q from email event can you give us a little bit more color on the return for certain rights around the token map back to n hall um is there any read through to how we should think about the setup for the that data read out later this year?

No, it was the short answer to that question. Meaning there's no read through or anything. It's just, you know, as we get closer to that data, depending on what we decide to do with the TOCEL MAP and if we decide to further develop it, we'll have to make a decision around how to work together with HANAL on next steps there. So that's really it. Nothing to say. Thanks, Brian.

Our next question comes from the line of Dennis Ding with Jeffries. your line is now open good morning this is anthea on for dennis thanks for taking our questions um and congratulations on the data i wanted to ask two questions on upcoming callus first on dalbert can you explain how important dr mitchell's testimony is to the case improving direct infringement um and whether or not there's any risk to that being taken out so to speak ahead of trial um and then on phild thoughts on the competitive landscape and if so tires that could

work in the disease as well thank you thanks uh both uh both great questions look on a downward as we said we really can't talk too much about an ongoing litigation uh there are a variety of motions in front of the court what they are are visible and the judge will make a decision on all of them and anything within the range is possible obviously we're hoping for over for favorable best outcomes in each case on on the PHILD question I look I think the answer is in theory any drug that improves PVR could work in PHILD systemic vasodilation has not in and of itself been a great approach in PHILD but staterocept certainly could work in PHILD Right now, we are slated, I believe, to be the first non-prostacyclin, non-tropropanol in PHILD. 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 Yasmine Rahimi with Piper Sandler. Your line is now open.

Good morning, team. thank you so much for all the color as an immune event covering analysts would love to spend time on 1402 and get some color around the here in your term or a readout obviously the studies upside help us understand you know 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 space to your registrational study to be shared and then I'll jump back in the queue thanks appreciate the question look I think in terms of expectations

for RA I think the short answer to that question is on the one hand these are patients with high unmet need and so in some sense the bar for efficacy is is relatively low compared to what we may be used to seeing an 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. You know, I think we're doing some work on that very question now, and we will share some guidance on what would cause us to run the second study before we put out that data, so I'd say stay tuned for that. Remember, these are burned out patients with with pretty tough disease at this point so you know you know obviously if we 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 basic expectation should be that this is this is one of a couple of studies that we'll have to run just because just because this is a relatively smaller randomized withdrawal trial, but, you know, we'll see the data, and then we'll have a better answer to that Thanks, Yasmeen.

Thanks.

Our next question comes from the line of Prakar Agrawal with Cantor. Your line is now open.

Hi. Good morning, and thanks for taking my questions, and congrats on these amazing results. So maybe on BREPO and NCS, just wanted to better understand the market opportunity here. You've talked about 40,000 eligible patients. would all of these be eligible for Brepo therapy and meet the inclusion exclusion criteria for the trial? And if that's the case, do you think this is a similar size opportunity as dermatomyositis?

And maybe just one follow-up on the phase redesign, would the time point of the endpoint be 16 week, similar to your phase two, given you already have the safety database, or would you have to test longer just trying to figure out if there is any ways to accelerate development here thank you so much yeah thanks thanks Parker great questions look I think the short answer on market opportunity is this is a patient population that's sick with high end that need and you know assuming our phase three data looks similar to our phase two 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 in the dermatomyositis, just in terms of total end. I mean, obviously DM is, you know, 40,000 patients in treatment, but 70-plus thousand total patients. So, you know, I'd 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, you know, 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 questions.

Thank you.

Our next question comes from the line of Samantha Semenko with Citi. Your line is now open.

Hi, good morning. Thanks very much for taking the question and congrats on this very good safe data. I'm wondering what percentage of patients in the Beacon study had organ involvement, if you have that, and were you able to collect any data that would allow you to assess whether prerequisites have 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 brepacitinib? Thank you.

Yeah, thanks. Look, I'll take the second of those questions, which is certainly something we will evaluate in terms of further places to study BREPO. And as I said before, we have ideas inside and outside sarcoidosis that are exciting, so stay tuned, and we'll be back with it. On the first question, in terms of patients with organ involvement and what we can learn from it. Ben, anything you'd share about that?

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

Thank you. Our next question comes from the line of Yatin Sineha with Guggenheim. Your line is now open.

Hey, guys. Thank you for taking my question. Quick one for me on BREPPO, on the data that you provided. Like if you look at the curves, they continue to deepen over 16 weeks. So I'm just curious to understand from you how should we think about, you know, do you expect further deepening, further separation? Just talk about, you know, if somebody gets treated for a year, how should we think about it? And then, you know, if you can just talk about the scope and the size. I don't know if you touched on that already, of the phase three study. Should it be similar to what you did in DM? Thank you so much.

Yes, thanks. I mean, just to reiterate on phase three, and I think Ben, you know, shared a thought about that, but I think in general, until we talk to FDA, it's like hard to commit to a specific study design. So I think, like, let us get through that, and then we'll be back with a full recounting of the study design. but I think we're prepared to run and enroll a nice sizable study if that's what we need to do I think we I think we feel we feel good about what we need there and then in terms of look in terms of continued deepening we're just looking at this data for the first time this week so I think we're continuing to explore all the various features I think you know it's funny one of the one of the KOLs who was was also involved with the study gave a quote to some some journalists, when he thinks his comment was, if the data had been half as good and there had been twice as many side effects, it still would have been a great outcome. Look, obviously, long story short, there are certainly potential ways for this data to be even better with longer therapy, with other parameters, but I think the answer is, if we can come close to replicating this in a Phase 3 program, it'd be a huge win. So, you know, I think we should be all set there.

Excellent, guys.

Thank you. Our next question comes from the line of Douglas Tassel with H.C. Wainwright. Your line is now open.

Thanks for taking the questions. I guess, Matt, I'm just curious, with BREPO, how broad are you now thinking about the opportunity, right? I mean, I think, you know, we've seen great results, obviously, in CS today, on DM, as well as NIU. You know, there is obviously a lot of data with, you know, with JAK inhibitors in various indications, but not necessarily, you know, 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.

Sorry, could you, yeah, how broad are we thinking about the breadth of opportunity? Great question. Look, I, look, I think the short answer is I think you can see from our indication selection already that we've been creative and thoughtful in going after indications with high unmet need, including lots of places where JAX have not been explored. And, you know, I think there's a lot of opportunity here. I'll just reiterate something Ben said, and Ben, if you want to do it again as well. I think it's a really good point to hit. Look, I think anywhere that TIC and JAK are both important is a particular area of focus for it because it gets at the uniqueness of our mechanism. And I think we've done a really nice job, again, thanks to Ben and a bunch of people at Reuven as well, the private team, on exploring that biology. I think we have more ideas in that category. Ben, anything you could sort of add there mechanistically or otherwise?

No, I mean, I think I covered it earlier. I would say that the answer is both, you know, indications where there's maybe some clinical reports from off-label use of other JAK inhibitors where we think TIC2, JAK1 inhibition is really optimally suited for it. And I think those are indications we're evaluating that would obviously be continue to see more and more excellent data here. I think we're definitely looking into some, you know, to some obviously opportunities where there's less proof to see what we end up with there.

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

Thank you. dollars go to the best opportunity wherever they are the short answer to that question look we're funded through profitability on our existing portfolio you know obviously things like running the phase three program cutaneous sarcoidosis are no-brainers at this point and we're definitely going to do it and adding additional indications prepper or 1402 or for mostly our attractive options because those mechanisms are strong the work in other places that said and I'm sitting across the table from my youth right now the world full of attractive opportunities and we look at all of them. So I think, you know, 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. Thank you, Doug.

Thank you. Our next question comes from the line of Derek Archula with Wells Fargo. Your line is now open.

Hey, good morning and congrats on the data. Thanks for taking the questions.

So just quickly on Immunivant in terms of, you know, we saw positive data for nipocalumab in systemic lupus, so curious about how you think about the read-through to cutaneous. And then second question, just in terms of, you know, commercial synergy between Brepo and 1402, obviously we're Immunivant covering analysts, so just curious how you think about fielding a sales force in the most cost-effective manner to leverage both, you know, BREPO and 14.02 between the two companies? Thanks.

Yeah, thanks. Look, these are both really good questions and important areas for us. You know, on SLE, first of all, I was on record long before the BREPO study in SLE as saying that anybody who isn't afraid of a lupus study is, I think the word I use is an idiot. And so I'll say congrats to Jane Jay 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 there's some pathophysiological overlap there. But, you know, 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 firms are pretty good at reading those kinds of endpoints, and so we feel good about that. Again, CLE is a different competitive landscape than SLE, and we're watching that far as well. On the sort of commercial question, look, the first thing I'll say is even bluntly within a big pharma company these days, the truth is that for de novo launches mostly you deploy a field a field apparatus that is specific to the program because you want to engage with those very specific positions because you want you want sort of full voice share of your field force on the product and so I'm not sure I think of like quote-unquote Salesforce as the most important commercial synergy but we are definitely thinking about things like contracting expansively to make sure that we can get maximal benefit from commercial scale across the portfolio and there definitely are areas where that is top of mind for us but I think will translate to benefit both for the commercial performance of brepo and for the commercial performance of 1402 as those launches progress thanks Derek our next question comes from the line of ash firma with UBS your line is now Oh, hi, thanks for taking your questions.

So, for Bartos, just upcoming the TED results, the data that you're expecting, just curious how you're thinking about that in the light of recent we've got setback in TED. In your case, how confident are you that a positive Graves' disease readout would translate to success in thyroid eye disease?

Appreciate the question. Obviously, TED is out there, and that data's coming. when we have both studies in the first half of this year. I don't think there's like a ton to say about that at this point, those studies are gonna happen and we'll put the data out. Obviously we know from our own phase two study in TED as well as from our own phase two work in Graves that the drug is active in patients with hyperthyroidism. And I think that should translate in both indications to some degree of efficacy. And we don't think there's a lot of read through from TED either in Argenix's case, Artenix obviously also doesn't as well or in our own situation in Graves disease to Graves disease in the sense that we have look obviously both what we have all of our phase two data in Graves and the diseases are pretty different like the TED study enrolled mostly youth thyroid patients so they're pretty different fundamentally in terms of who was in the studies so I feel like we are confident in the efficacy or potential efficacy of FCRNs and Graves disease and not particularly focused on what information there is from TED. Obviously, once we get the TED data and can talk about it, there will be information there from patients who happen to be hyperthyroid at various points in that study and how those patients looked, and we'll take full advantage of that data in optimizing our greatest program. But beyond that, I'd say not much read-through between the programs, and looking forward to getting all that TED data together once we've got it. Thanks, Ash.

Our next question comes from the line of Thomas Smith with Lee Rink Partners. Your line is now open.

Hey, guys. Thanks so much for the updates and for taking our questions. Great to see the rapid enrollment and the over-enrollment for 1402 and D2CRA, and appreciate the update on the data timing. I just wanted to clarify, should we expect that you'll report both the open label and randomized data from this study together, or is there potential we could see some of that open label period one data first?

And then as a follow-up, we noticed on slide 31, the expectation for GRAVES launched by the end of 28 but not mg although you're expecting phase three data for both indications in 27 just wanted to ask if that's purely a function of data timing there or there's some other strategic considerations with respect to pricing or competitive landscape thanks so much thanks thanks I appreciate I appreciate both questions look I think on the data release timing for the RA study I don't think we've made a final decision on how exactly we'll put that data out and when But I think it's reasonably likely, now that we know both are coming this year, that we'll wait for the randomized withdrawal period before we talk about it. Obviously, that first period is open-labeled, so we'll get some information from it as we go on. And then I don't think there's much to read into the exclusion from MG in 2028. In fact, there's probably some possibility it actually does, in fact, also launch in 2028. And so, you know, I think stay tuned and once we get that data, once those studies are, once we go to the exact timeline of those studies, we'll be able to provide more guidance on specific launch timelines.

Thank you.

Our next question comes from the line of Alex Thompson with Stiefel. Your line is still open.

Hey, great. Thanks for taking my question. Maybe one on sort of the competitive landscape and grades. I guess with Argenix entering the area and maybe trying to follow their, you know, strategy of chasing fast follower indications here, like how confident are you that you can maintain your lead in grades if Argenix were to run maybe 26-week studies or even one instead of two studies?

Obviously, the extent of our lead time in graves will depend a little bit on Argenix's study design and what they decide to do. And until we know what that design is, it's going to be hard to say. Certainly, shorter studies will be faster than longer studies mechanically. I think we have a lead in graves that will be significant roughly no matter what design Argenix runs. We have great relationships with those KOLs and the doc community. We've been out there. One of our studies is also 26 weeks. As a reminder, the 2503 study is 26 weeks. So, look, I think the answer is we will have a significant lead in grave disease. How significant that lead is may depend a little bit on what the competitive competition does. But this is also one of those that we're going to need to outrun the bear situations or whatever. I think mostly our focus is just getting those studies done and out as quickly as we can and getting out into that population. And it's such a large and exciting population that it just doesn't really matter. The other thing I'll say is, as a reminder, we feel like we showed pretty conclusively in our Phase II data that the deeper IgG suppression that we expect to deliver will matter in this population, and I think especially on remission, and I think that will also be a significant factor in Graves' disease, so looking forward to getting all that data together. Thank you very much, Matt.

Thank you. And this concludes the Question and Answer session. I'd now like to turn the call back over to Matthew Glein 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 kidney sarcoidosis data, the patients and investigators involved in that program, as well as the private team for their execution there, but also everybody at Roivind and all of these 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.