Roivant Sciences Ltd. (ROIV) Q1 2027 Earnings Call Transcript

Good day and thank you for standing by. Welcome to Roy Van First Quarter 2026 Earnings Conference Call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1 and 1 on your telephone. Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today. Definitely. Thank you. Please go ahead.

Good morning, and thanks for joining today's call to review RoyBan's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with RoyBan. Presenting today, we have MacLine, CEO of RoyBan. 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.royban.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have 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.

Thank you, Steph, and good morning, everybody, and thank you for joining. This is a little bit of a calm-before-the-storm moment for us, and so a pretty quiet quarter and maybe not the most interesting of our earnings calls in recent memory, but nonetheless, a lot of great progress in the business, and certainly we're expecting a gem-packed second half, as I'll get to in a moment. So I'll be relatively brief in my remarks, and then we'll go to Q&A. I just want to start on slide four. This is a slide we took from our own prior deck. This is from the investor day that we did in December of last year, and this was a list of our priorities for the year. And we're sitting here a little bit more than halfway through the year, First, I just wanted to highlight that it's gone well for us, that we feel really good about the setup. And so on slide five, you know, looking across the list here, we've got Brevisit NIV expected to launch by the end of September. Obviously, we've got a priority review, and our PDUFA date, as we said, is this quarter. We had great data from 1402 in the DTCRA study that we presented on our last quarterly call. Probably the most notable update for today on the top center of this slide is that we've now enrolled patients in the phase three study in cutaneous sarcoidosis for brepsitinib, which follows on the positive result that we had in our phase two data, which I think we announced on our first quarterly call this year, earlier in the calendar year. We've now received the initial payment from Moderna in the settlement, and the second part of that, the 1498 part of that case is progressing, and we filed international proceedings against Pfizer and BioNTech in that case. And finally, earlier this year, we added LPP as a fourth prep signal indication. And as I'll remind people later today, that study is continuing to enroll really well. As I mentioned at the top of the call here on slide six, I'll just say this is a quiet quarter and this is a quiet day. I don't know exactly how the following statement could be true, but I think it is. The next six to 12 months are in many ways busier than the prior six to 12 months for us. And so we just have an enormous amount coming up, starting, as I mentioned, with the upcoming potential brepcitinib launch in DM, which should happen imminently, assuming everything goes as we hope and expect it will with FDA. We've got top-line data in BREPO from the NIU study, an indication that could easily be as large as dermatomyositis. That data is coming in the second half of this year. We also have top-line data coming shortly in the second half from Moseley, the phase study in PHLD. I know that's being closely watched, and we're looking forward to getting that data and presenting it. We will provide updates, further updates, on the D2TRA program at Immunivant in the second half of this year, including hopefully a download on a conversation we hope to have with FDA about that program, as well as the results from the second part of the study and a little bit more about our plans going forward. And then finally, probably the smallest of these, we're expecting top-line data from the POC study in CLE also in the second half this year. I'm looking forward to finding out what we've got there when that comes in as well. So just a jam-packed second half and even more coming in 2027 with the greatest data and beyond. So just a lot in the promise here. I'll just hit a couple of highlights in terms of the pipeline updates in a little more detail here before going to Q&A. Starting on slide eight with a reminder because it's been a few months since we've talked about it. You know, the initiation of this cutaneous sarcoidosis phase three study is a pretty exciting event. It's a little bit ahead of schedule in terms of what we've been able to do here. And this is a disease that we're just privileged to be able to work in here. It's a high morbidity, very difficult disease with a high urgency to treat. You can see on slide eight some of the photos we've shared before, but these are patients who are really sick and have very few treatment options. You know, on slide nine, as a reminder of the data that we generated in our phase two study, we had set for ourselves a goal of a sort of five-point benefit on this CSAMI scale for clinical meaningfulness, and in the study on the top left of this chart, we showed a greater than 20-point benefit compared to roughly nothing on placebo, so just a huge benefit to those patients in the phase two study, and really excited to carry that forward into the PIVOTAL program. You know, as a reminder on slide 10, we think this is a pretty decent-sized indication, again, with high M that need probably about 40,000 patients in the U.S., and reasonable overlap with some other organ systems, including optical sarcoidosis or eye sarcoidosis, where that overlaps with NIU. That is one of the types of NIU that we're studying, as well as pulmonary sarcoidosis, which is a big potential indication as well, and where we hope to be able to treat some of those patients via either their ocular sarcoidosis or CS. The phase three study that we've now begun, the design is laid out on slide 11. I know there were some questions after the phase two about what exactly this study would look like. It is designed to take all of the learnings from the phase two study that was successful. It is a 16-week study with the primary endpoint of CSAMI greater than equal to 50% response rate. It's 140 patient study across about 70 sites, three to two randomized with patients either on 45 milligrams of repcitinib or placebo, and with a mandatory staper, sorry, a mandatory steroid taper going from week two to week eight down to zero, which is consistent with, roughly consistent with what we did in the phase two, and generally consistent with what we think is appropriate for patients in this indication. So that study, as I said, has already begun enrolling patients, and we expect top-line data in 2028, which just adds to the list of registrational, potential registrational indications for brevacitinib coming up. I'll reiterate on slide 12, the other ongoing registrational program is the brevacitinib study in Lichenclanopilaris LPP that we announced earlier this year. That study is enrolling, I'll say, extremely well. There's a lot of enthusiasm from physicians and patients for that. Speaks to the high-end need on the indications, speaks to the quality the work being done by Ben and the private team. I'm looking forward to sharing more about that as soon as we've got it. So that's also moving along nicely. Look, finally, and I'm sure there will be questions about this in Q&A and lots of opportunity to talk about it, hopefully with a potential approval and beyond. Obviously, one of the major events in the near term here is the potential launch of brebcitinib in dermatomyositis. Obviously, I think we're in a a phenomenal position here in terms of what we've got and in terms of what we hope to be able to do, starting with the quality of our clinical data, which, as you know, from the multiple times we've talked about it from the publications, including in the New England Journal and so on, just phenomenal data, stats data across all 10 endpoints, big clinical benefit, a lot of enthusiasm from the doc community. This is a really tough disease, a large addressable population, most of them on sort of polypharmacy trying a lot of different things and frankly most of them still dissatisfied with the available treatments so we feel like we have an opportunity to do something big and different for this patient population our team has been out spending a lot of time with the physician and the patient communities on overall education and I think the enthusiasm for a new therapy is coming out loud and clear including with all the academic presentations that have been done and so on commercial launches there's not much to say today other than that it's on track we're ready to launch on time having received prior review the sort of commercial and patient support teams are built out trained ready to deploy we feel really great about the hires we've made they're really great about the organizations we've built there we think we're doing this in a way that is both capitalizing on all the learnings from successful launches at other companies in recent years and doing it in a in a relevant private way there's there's no nobody in the world I'd be more excited to oversee this than the team we've got at Privant with Ben and Daniel and others. And I think we're going to be fully ready. Everything's on schedule. So, you know, we'll have much more to say about that with the potential approval and after, but looking forward to it. I'll say one more thing about the commercial franchise overall at PrepSitNib on slide 14. You know, we get a lot of enthusiastic questions from investors around pace of launch. And we've been pretty consistent that our answer to that question is sort of slow and steady, is what we're looking to build there. And I think there's a bunch of reasons for that. Obviously, some of them are DM is a new indication, and no one's launched a novel therapy basically ever, or at least a targeted therapy basically ever. And so it's hard to know exactly what work will need to be done to get everyone comfortable and excited and on drug, although I think we're fully prepared. But also, to me, it's because preposyptinib is a lot more than just dermatomyositis. And to me, what we're really doing here is not just trying to make that launch as fast as possible. We're trying to lay the groundwork for the overall opportunity, which goes beyond DM into first NIU and then CS and LPP with the data coming thereafter. And I think as you think about that layering, to me, it's much less about what week one or month one or quarter one look like and much more about making sure that the foundation around access, the foundation around patient support, the foundation around the institutional activities, the foundation around our communication with the scientific and physician community, and our communication with patients are all set up to deliver the maximum opportunity for representive across all of these indications. And so I think, you know, I think slow and steady isn't just about sort of guidance. Slow and steady is about the approach that we're taking with the program to make sure we have maximum reach across everything that we're doing there, including and indications that we're excited about beyond the ones we've already announced. So a lot to come, as I said, on track for that launch. You all here are the same thing we do, which is a ton of enthusiasm from the patient and physician community for new options and all of these indications, and looking forward to sharing more when we know about it. But our guidance is going to continue to be slow and steady because that's what we think we're building. You know, final business update here is we got the upfront payment in the settlement with Moderna, of that $950 million has come in, 770-ish of it, to Genevieve and to the rest to Arbutus. So that's done. There'll be progress in terms of, you know, return of capital, et cetera, of that by Arbutus and so on. The 1498 sort of appellate ruling is that that process is ongoing at the Federal Circuit. That'd be another $1.3 billion if we got a favorable outcome there. and then we continue to advance our litigation against Pfizer and BioNTech. We filed three international lawsuits, notably in Canada and the UPC, in July, so just last month, and continue to progress that case as fast as we can. Obviously, not all of it in our control, but equally enthusiastic about the potential there in terms of what we could get. I'll wrap up just with our usual financial update on slide 17. Look, I think overall, most importantly, we are spending in areas that we're excited to be spending. We're excited about all of our R&D programs, about $200 million of R&D expense for the quarter, just under $100 million of non-GAAP-adjusted G&A or 166 of GAAP G&A expense, and cash just under $4 billion, and that's before the receipt of the 772. Notably, pretty significant share repurchase activity, about $200 million in the quarter, a bit more than that when you include March. Obviously, what we did there was we accelerated our share repurchase program upon the announcement of the Moderna settlement so that we could get those shares in. And the shares that we bought by kind of the first round of this, the billion and a half that we had bought back sort of up through mid last year, we bought back at around $10 a share. I think the average price at which we've been able to buy back stock since we kicked off the second round of this in earnest in March has been in the high 20s. So, you know, feeling good overall about retiring those shares and getting that capital back to shareholders. I'm going to continue doing that according to our authorizations for now and all of it ahead of on slide 19 a really rich catalyst calendar ahead with a lot coming so looking forward to all of that with a just just an incredibly busy incredibly busy stretch ahead you know on slide 20 again a little bit incredulous for the people around relevant who are doing all of this work are incredible people have to do this work but but by the end of calendar 2028 will have had hopefully three or more commercial lunches nine full more study readouts, four-plus NDA or BLA filings, a number of proof-of-concept studies, just a ton coming up in the near term. So with that, I'm going to wrap up my prepared remarks for the day, and I will hand it back over to the operator for Q&A in just a moment. Thank you again for listening this morning and looking forward to taking your questions. Operator, over to you. Certainly.

We will now begin the question and answer session.

As a reminder, to ask question, please press star one and one on your telephone if you would like to cancel your request you can also press star one and one again our first questions comes from the line of brian ching of jp morgan your line is open please go ahead hey guys good morning um thanks for taking our questions um maybe just thinking through the dm launch mat can you give us a quick sense of um you know what what metrics we could be receiving uh right out of the gate um to help us better track the initial launch. And then secondly, on PHLG, as we think about the baseline characteristics here in focus, it seems that more patients are on the tantamib. We're curious if there's any implication in terms of the fibrosis versus epithema ratio in the population. And then further down the line, whether there's any implication towards the bar for success for for both extended log and also PVR.

Yeah, perfect, thanks. I appreciate both questions. Look, on DM, a thing I've gotten fond of saying as I've watched other companies with commercial launches is that you all don't deserve our guidance, which isn't quite fair. But look, I think other than sort of a slow and steady launch and obviously the sort of top-line metrics will be plainly visible in our financials each quarter. I don't know that we're going to provide a ton of detail in the early days. I think it's important for us mostly to spend our time focused on understanding those dynamics ourselves, getting out, talking to patients, talking to physicians, doing the work we need to do. We'll give a little more color on what that's going to look like on a call with potential approval, and then we'll start to flesh out the package that we share with each successive quarter. but I don't have a lot to say right now about metrics. I'll say, you know, I think typical with these launches, I'm not sure a ton is going to be visible in the early days, just given how the commercial apparatus is set up for actual purposes, but, you know, we'll provide more guidance on that as it gets closer and is here. On PHLD, I guess, first of all, we've obviously been watching, for example, the tropopinol data in IPF, and trying to understand a little bit better what's been going on with these PHLD patients in treatment of PHLD for fibrosis and for lung disease. It's been a view of ours for a while that one of the things to look out for in treatment of PHLD with vasodilators is emphysema, and so the study was designed with care around the amount of emphysema allowed in the study overall, and that was an important part of the guiding philosophy of the study to make sure that we could serve the patient population broadly, but also we're maximizing the potential benefit of the therapy. So that was considered from the beginning. So those are, I think, things we're keeping an eye on. I know there is a local cohort that believes that tropopinol has any fibrotic benefit. Look, I think our view is if you treat PHLV patients well for their pulmonary hypertension, you may well deliver a benefit overall on their lung disease. And I think our view is probably that vasodilation is driving a lot of the activity there. but we also have some evidence from non-clinical models of anti-fibrotic activity for Moseley. Overall, on six-minute walk and PVR, I'm sure I'll get versions of this question more today. Look, I think it's consistent with what we said before. We're hoping to see a clearer signal on PVR. We expect if the drug is at all active, we will. We don't expect to see very much with clarity on six-minute walk. The study is not powered for six-minute walk. It would be nice to see some separation, but I don't think that's essential for our sort of go-no-go decision from here. And we'll know what we've got once we get a closer look at it, including the full balance of that data. Thanks, Brad.

Thank you, Matt.

Thank you for the questions. Next question comes from the line of Dave Riesinger from Leering Partners. Your line is open. Please go ahead.

Thanks very much, and thanks for all the updates, Matt. So I have three questions, but rather than rattling them all off right now, maybe if it's okay, I'll go one by one. So first, on Moseley, you commented just now on six-minute walk distance. But if you were to run a large trial, what type of six-minute walk distance would you be hoping for, i.e. what would be relevant to the clinicians and to the patients? So that's my first question.

Yeah, thanks, Dave. Look, I think, obviously, we'll have a slightly better answer to these questions overall once we have a sense of what we saw in phase two. The truth is that PHLV patients are really sick. There are not a lot of options for these patients. And as we saw in group one in PAH when you have more treatment options. First of all, patients go on multiple options, multiple lines of therapy. And second of all, most importantly, like the actual, not from a clinical trial perspective, from like a real-world evidence perspective, like survival and mortality rates go down as new classes of drugs are introduced in PAH over time. And I think it's like less about, you know, a number on six-minute walk and more about having an approvable therapy remember these are paced they're trying to walk to the car they're trying to walk to the bathroom they're trying to like live their live their daily lives so i don't i don't know that i think it's like correct scientifically to describe a specific numerical bar that matters versus just being able to get a new therapy and some of that's frankly because six minute walk in clinical settings is an artifice that is complicated and noisy and like a little bit difficult to translate into daily lives whereas if these drugs really effectively vasodilate and improve lung function, improve PVR, I think you wind up seeing a lot of benefit for these patients. I don't know that we're going to articulate or have a specific numerical bar versus a successful study. Obviously, we will be judged, especially by the investor community, based on competitor data, but I don't think we even need to be per se better than any other mechanism in order to have a big benefit to patients.

Thanks, Dave. Great. That's very helpful. And then regarding the forthcoming BREPO DM launch, could you discuss the cadence of formulary reviews for rare disease drugs? I ask because for mass market drugs, P&T committees often wait until six months after launch before putting drugs on formulary.

Yes, thanks. Look, I don't have a ton to say about that right now other than we're having all of the normal engagement with the para-community that you'd expect us to have at this stage and also I think this is a critical point about all of these launches we are super focused on making sure that patients the physicians who want to write this drug and patients who want to get on this drug are going to have access I think that's going to be really important for our engagement with the community for access generally I think in terms of like literal formulary it's probably like not so different. It's not like there's a separate committee for different kinds of diseases, but there's lots of medical exception procedures and other things that you can do to get patients covered. And we have a whole team of people built out of Privant that's dedicated to making sure whether the formulary work has happened yet, whether the P&T committee has happened yet, is not something that our patients and physicians have to spend a lot of time thinking about as they're deciding how to use the drug.

Excellent. That's really helpful context. And then finally, beyond the list of programs on slide 19, could you remind us about pipeline and a product opportunities for your portfolio, including specific products that you could announce initiation of new studies for over the next year or so?

I think every single one of the programs that the world is aware of in our pipeline, as well as potentially ones that the world does not get aware of in our pipeline, in all of those cases we could announce new trials, new indications in the next year. I think every one of those are eligible and all of our molecules could be put into indications beyond the ones we've talked about and I think it's fair to say in each case we have specific ideas of indications we're excited about. We've done active work and are, in fact, preparing to initiate programs to varying degrees, depending on how busy those teams are today versus next month or the month after, but real progress. So I think the answer is we are actively working on that, that all of our products are, as you called them, pipeline into products, and that we're excited to share more indications as we start those studies. Excellent. Thanks so much.

Thanks.

Thank you.

Thank you for the questions. The next question comes from the line of Samantha Semenkau from Citi. Please go ahead.

Hi, good morning. Thanks very much for taking the questions. I also have two, one on Mosley, one on Brepo. For Mosley, I'm wondering if you could just talk about the translatability of PBR reductions in patients with PAH to those with the PHILD population that you enrolled in focus.

Are there any aspects of either disease that could influence the magnitude of PBR that you could see in the Mosley data and I have a follow-up yeah so look I think thanks for the question I appreciate it I think the translation from pH to pH I'll be is the fundamental question being answered by our study and so that the first unfortunate answer to that question is we're just gonna have to see what we see and it is the is the risk of the program at some level that we find The phase one data, including in PAH patients, looked very good on a PVR basis. So one of the main quote-unquote risks of this program is that there's something, I would call it, unexpected in the PHLV translation. Obviously, I use the word unexpected because I think scientifically it seems relatively straightforward that inhaled vasodilation is an effective mechanism in PHLV, but we'll find out. Obviously, the lungs of PHLV patients are different than the lungs of PAH patients. And so you might expect some difference in sort of the pharmacodynamics of the drug in those patients. But overall, it seems pretty clear that when you take an inhaled vasodilator in a PHLD patient, you get drug to the healthy lung tissue and it matters. So that's what I'd say.

Got it. That's very helpful. And then just on Brepo and DM, in your conversations that you've been having with physicians for education, I'm wondering if you could just talk about the reception to Brepo given the JAK class safety concerns. Obviously, the safety profile in Valor was quite favorable, but from a class perspective, it would just be helpful to hear how the physicians are thinking about safety, particularly since DM patients already tend to have a higher underlying risk for cancer. Thanks very much.

Yeah, we've said a few times that when we first in-licensed brepacitinib, we didn't exactly know what the reception to JAK inhibitors was going to be following the addition of black box warnings, and our whole view was to choose indications where the safety profile of JAKs was going to be much less of a focus. I think dermatomyositis is a poster child for this in that while JAK inhibitors are at this point extremely widely used in, you know, diseases with much less morbidity, many more alternative therapies, you know, in dermatomyositis, there's really no other options available. And I don't think physicians, therefore, are going to be particularly focused on this question. Remember, these patients are often, first of all, I think you sort of alluded to the profile in the trial, dermatomyositis patients are inherently at risk of many of these concerns, malignancies, metabolic events, and treating them well makes them healthier and reduces those risks. And then on top of that, the therapies that they are currently on for dementia myositis are things like high-dose steroids, which themselves add meaningfully, in fact, in many cases, much worse than JAK inhibitors, to those very same risks. So I think in general, physicians are not going to spend a lot of time worrying about this, especially when reminded of the inherent risks of steroids and immunosuppressants that they're on anyway. And it's clear from our conversations with docs across different prescriber bases that they're just very comfortable using these agents, including across different prescriber bases, as we said, for patients with significantly less severe disease. You know, as a reminder, we fully expect that our label is going to look like the labels for other JAK inhibitors, that it's going to have the black box warnings, it's going to talk about of experience with JAK inhibitors and other indications, and like I said, I think docs expect that, and I think are not going to be too concerned about it because these patients are A, very sick, and B, on other drugs with, in many cases, significantly worse safety concerns.

Thanks, Matt. Very helpful.

Good questions. Our next questions will come from the line of Prakat Agarwal from Kento Fitzgerald. Your line is now open.

Thank you so much for taking my questions, and congrats on the continued execution. So maybe a couple of questions from my side as well. Firstly, on BREPO and DM, could you remind us what percentage of DM patients are on off-label JAX based on your latest primary or secondary research, and would you expect rapid switches from these patients who are on off-label JAX to BREPO? If not, why is that the case? And secondly, for BREPPO and NIU trial, what do you see as the biggest risk for phase three, given the phase two was really strong? And is this geographic variation, which has been a key risk for this trial, which could drive some of the baseline variability that has been flagged as one of the risk factors by some of the cable checks that we have done? Thank you. Really appreciate it.

So, you know, in terms of your first question on Brepo and DM around who's on off-label JAX and, you know, what does that look like? Look, I think, first of all, there's just, like, variability in physician practice, and some physicians use more JAX and some physicians use less JAX, and that has more to do, I think, with the docs in many cases than with any specific subcategory of patient. You know, I think what we've said publicly is a low single-digit percentage or mid-single-digit percentage of randomized status patients have experience with these things. You know, some of the docs who are involved who do use, and some of that, some docs don't use off-label drugs full stop. Yeah, I think some of the docs who use off-label DACs have said they expect to switch patients over, and, you know, I hope they do, and obviously we'll be working to help them, where that's appropriate, facilitate those switches. Yeah, I think it's just going to be down to the preference and practice of each individual doc. I think one of the things that our team is finding in talking to physicians is that, you know, different patients have, different docs have different sort of ideals in mind for who their sort of first patients might be. And I think it just varies based on the patient experience, the physician. And so, you know, obviously we'll be able to have much more of these conversations pending a potential approval. But I think, you know, medically, we'll see a wide variety of different phenotypes. On NIU, you know, what is the biggest risk in Phase III? It feels funny to call placebo a risk in these trials, and that's not quite exactly what I mean. But I think the, you know, variability in placebo response rates in immunology trials is significant. And if you're asking me what keeps me up at night, It's that we don't know exactly what single response rates will be in that study. And, you know, that just makes it hard to know exactly what the trial is going to look like on outcome. Obviously, the phase two data was quite compelling, and the level of drug activity seems good. And so, you know, I'm pretty optimistic about the study. But, you know, there's certainly – this is biotech, so you can lose sleep over anything. Is geography a risk? You know, I think there may be geographic variation, just as there is in many other indications, and some of that's literally driven by geography, and some of it's driven by physician practice, and some of it's just noise. You know, I don't know that it's a risk in the sense that it's, like, unanticipated or whatever. It's just a feature of running immunology studies. But overall, I think the team is doing a great job with the study, and I hope it's going to come out well. Thank you.

Thank you. Thank you for taking the question.

I don't think this has been talked about yet, but for the Brepo launch, can you maybe talk about a few launch analogs that you're assessing right now, either patient curve or market share curve? What are the historical products with the most resemblance to Brepo in the end?

Well, it's a good question. the truth is there has never been a launch of a targeted therapy in dermatomyositis before and so there is no good quote-unquote analog in the sense that you know you can point to lots of other launches of lots of other kinds and some have been faster and some have been slower and some have been slow and steady and some have been you know just like a different versions of different things and I think it's hard to say and there have been successful products with all kinds of different launch paces so I think the short answer is I don't have a specific analog for another drug that we're watching as like evidence of our own penetration I think what we're really focused on here is the dermatomyositis opportunity itself these docs these patients and you know the the benefit and the cost of being a pioneer in indication is that you don't get to look at others you have to try your own course I don't have an analog to point to thanks Andy thank you for the questions.

One moment for our next question. Our next question comes from Yatin Suneza from Guggenheim. Please go ahead.

Hey guys, thank you for taking my questions. Just a quick one on difficult to treat RA. Could you maybe talk about the strategy there? Would you need one more study, two more studies? How are you thinking about that?

What should be our expectations for the randomized withdrawal phase that we're going to get data on thank you yeah thanks great question look on uh study designs so you know we're going to come back uh later this year with a full update on that program and that includes we don't yet have the randomized withdrawal period data yet so i can't speak to what's in it or how it will or will not inform uh strategy from and I think at some level the results of that study may inform whether it is usable or not as a as one of our pivotal studies etc you know I think we we designed it to serve potentially as one of two but obviously it's got a hit for that to for that to work and as we said when we announced the data the quality of the response rates in the open label period and have set a somewhat higher bar for hitting a p-value on the randomized withdrawal section so I I think we've got to sort of see all that, take it in aggregate, look at the patient level data, understand what's going on, and we are planning for an FDA conversation this fall that will inform both the exact design of that study as well as help us answer those questions. I don't have a specific guidance to give on exactly what those studies are gonna look like now because we don't know, but I'll say the team's working on it hard. The data was obviously exciting. It has gotten noticed. We've got a lot of enthusiastic reception, including from the doc community on it, And we're excited to finalize those plans and bring them back to you later this year.

Thank you for the questions. Our next question comes from Yaron Werber from PD COVID. Your line is now open.

Thanks so much. I have a couple of questions. The first one was mostly, once you release the data this year, would you release both the mono and the combo data at the same time? And then secondly, for CS, the trial design is super interesting and makes obviously a lot of sense. The primary endpoint is CSAMI more than a 50% response. Can you maybe translate the Phase 2 data into the same context? Because I think the Phase 2 looked at CSAMI over 10 points and the change from baseline. So I'm just trying to get a sense of apples to apples kind of what to expect.

Great. So on Mosley, I think the short answer to your question is we will not release the monotherapy data and the combo data at the same time because the combo study started much later and is rolling now whereas the monotherapy study obviously will read out pretty soon in the second half so I think the answer is they won't come out at the same time and we'll put out the combo data when we've got it the combo study remember it's an open-label study it was designed the truth is I think a lot of the information that we could want will come out of the monotherapy study anyway such that the combo study like won't provide that much incremental I think it was designed in part to give us really good safety experience in the combination as well as like a little bit of information about incremental efficacy just so that we could get a sense for like inclusion criteria and management in the in the phase three but but I'm not sure it's gonna be like a super super informative outcome you know yes so that's what I'll say I'm mostly I think they're gonna comment at separate times on CS I know I don't have to give right now the exact delta, but I'll say we saw meaningfully higher rates of greater than 50% CSAMI in the treatment arm than in placebo, so the delta was wide. And I think in the press release that may have gone out around the initiation of the CS study, it'll have said well north of 50% of the patients in the treatment arm of the phase two had a CSAM response rate greater than 50 percent compared to I think it was zero on placebo so it should be a it should be a good a good bar to set for us in terms of the end point I don't know we're going to replicate exactly what we saw in the phase two but but I think the point is it's well powered for for probability success given what we saw in the phase two right and if I can maybe just sneak in in the phase three NIU do you ever sense, is the percent Humira experience going to be the same as the Phase II, given that the data

looked pretty good overall? So it must have been pretty good in that segment, too. Thank you.

I don't think we've said, thank you, what the percentage of patients in the Phase III have Humira experience. I don't have that number on the top of my head, so I'll have to check into it. But I think the answer is there's no reason to expect it to be very different than what we've seen, there are a meaningful number of a few very experienced patients in the phase three, which matters in terms of ability to go into all of those patients. But I think the short answer to your question is I wouldn't expect it to be a major driver and I wouldn't expect anything markedly different about the patient population from the phase two. Thanks, Yaron.

And our next question comes from Thomas Smith from Leering Partners. Your line is now open.

Hey, good morning. Thanks so much for the updates and for taking our questions. On the 14.02 difficult-to-treat RA program, I just wanted to clarify how you're approaching the disclosure in the second half of the year. Should we expect to see the Part 2 randomized withdrawal data prior to your meeting with FDA? Are you planning to share the data and the regulatory feedback and next steps simultaneously? And then on Graves, just wanted to get your thoughts on the competitive landscape. Obviously, you're the first advanced therapy there with really stellar Phase II data, and you'll have the first pivotal readout next year with 14.02. but there are a number of different approaches targeting various segments of the Graves patient population. Just wondering if you could comment on the competitive landscape. And as you see some of the approaches some of these competitors are taking with respect to the patient population, wondering how you're thinking about potential future studies for 1402 in Graves. Thanks so much.

Yeah, perfect. Those are both really great questions. On the first one, you know, I think what we said when we put the data out still holds. I think, you know, my dream, our dream for the second half of this year is that we can come back with everything tied as nicely into a bow as possible, which is to say the period two data, the FDA conversation, maybe some further analysis of patient experience through both periods in the RA study, all shared at the same time. Obviously, until we have the part two data in hand, we can't sort of specifically know whether there's anything in there that requires earlier disclosure. But in general, I think the answer is our hope and expectation would be to give a fulsome update later this year on everything all at once for DGTRA. On Graves, look, I think, first of all, I cannot say enough times that discussion of competition in Graves' disease among therapeutic categories is just misplaced in the sense that you've got so many patients with unmet need that have had no option. The last time a novel therapy was developed in grave disease was like the 1950s or 1960s. There's so many patients who have need of novel therapy that it's not about outrunning the bear. It's not about beating some specific competitor. It's about changing doc behavior in an indication that badly needs new options. You know, 1402 will have been studied in lots of patients. It's a safe and well-tolerated drug. Graves is going to have room for lots of mechanisms and lots of products. Among the other mechanisms, some will have specific either safety liabilities or they'll mimic a thyroidectomy and they'll require treatment with Synthroid or, you know, there's just like lots of different approaches and those drugs may be appropriate for later line patients or a different subset of the patient population. And over time, I'm sure that segmenting will occur. But first of all, we're going to be first out in the marketplace there long before anybody else. And so we're going to get to have some influence over the truth and paradigms and also just get an option out to patients, physicians, before some of those other choices are available. And second of all, I think it's mostly about building the market, not about any specific alternative and so on. So, look, we're tremendously excited to be in our position in Graves to be first, to be able to offer, hopefully, a new option here. The only other thing I will say is you learn a lot running these studies. You learn a lot engaging with this physician community. And I do think there is nuance to the patient population, and I think there is nuance to the prescriber behavior. I think there's a lot of heterogeneity in terms of how these patients are managed around the world and around the U.S. And I think one of the things that we're going to be able to do is to take advantage of those learnings, you know, in future studies, in these studies, in commercial prep, and I think that will be a big benefit to us in being in the first place here.

Thank you. Next question comes from Yasmin Rahimi of Piper Sander. Your line is now open.

Hi, this is Shannon on for Yas Rahimi. Congrats on the great quarter. Maybe just one more from us about clarity. with the readout in second half 26. Could you give us just maybe what you might be thinking about narrowing guidance if you expect to do that and then sort of how you're thinking about the bar for success? And then timing post data, would you expect to file an SNDA and sort of what would be the cadence on that? Thanks.

Thanks. Look, I think I doubt that we're going to provide more specific timing guidance at this point than we have you know we announced I think when the study was fully enrolled and you know I think we're just going to read the study house when it's when it's done and we have the data clean you know the truth is and I knew is another one of these diseases where there's a lot of unmet need humoral leaves a lot of room on the table and frankly a lot of patients aren't even getting it and so I think the truth is that the bar for success is successful studies that would support registration And I think if we get that, we will have a big opportunity to help lots of patients who So I don't think there's like a numerical bar. Obviously, better data is better, and the more we look like on phase two, the happier I'll be about that. Our phase two was really, really great data. But overall, I think as long as we have a successful clinical trial, a successful outcome, we're going to get what we need and we have a lot of patients we can reach. Um, and, uh, I don't, uh, want to put Ben on the spot right now on exactly when that SNDA goes in, but we got the DM one in, uh, nice and quickly. Uh, and I know the team is enthusiastic for, uh, for any of his medications or if that study is positive, uh, you got to believe that team is going to be working really quickly to get that SNDA in as fast as possible. Thank you.

Our next question comes from Douglas Chow from H.C. Rainwright. Please go ahead. Douglas, your line is open. you can unmute locally. In that case, we'll move on to our next questions. One moment, please. The next question comes from Sam Slavsky from LifeSci Capital. Please go ahead.

Hey, thanks for taking the questions. Two quick ones for me. I guess for the proof-of-concept readout in CLE, there's a few parts to that study, so just remind me what we'll be getting in that initial release this year. And then for the initial launch in dermatomyositis, remind me how many clinics you're targeting being in the concentration of patients at those clinics? Yeah, thanks. On CLE, and again, I think we've said this before in other settings that Bear is mentioning. I think, you know, CLE is an interesting indication. This is a small study. It's really a fact-finding proof-of-concept study. We've been watching the competitive landscape in CLE closely. There's a lot of other exciting therapies in development as well, aren't really data from a couple of patients that we have dosed was encouraging. We're really sort of overall just looking to understand what our treatment benefit looks like, how we could conceptually stack up in the future treatment landscape, and I think that will all be super informative to what we do from here and whether we go forward. I think the primary is a reminder is 12 weeks, 600 versus placebo, and then in period two, all patients go out to 600 at 52 weeks. But the thing that we'll be reporting first is that 12 weeks for 600 versus placebo. So that's what we'll see. And then, you know, obviously a bunch of other data beyond just the specific primary endpoint. You know, on the DM launch, I'm not going to share today exactly what our sort of targeting strategy is. But as a reminder, there's about 200 myositis referral centers that treat approximately half of the U.S. patient population. And so obviously those clinics are, those docs, those centers are an important part of the overall picture, but there are other important physicians as well. And, you know, I think Ben and the team have done a really great job overall engaging with the physician community. So I'm excited about what we've done there, excited about the sort of medical publication strategy. Obviously doing a journal publication was a great outcome. So, you know, feeling good overall about that plan. And, you know, we're going to talk to as many docs and get out there as much as we can pending a potential approval. So thank you. Great questions.

For the questions, we will now take the last questions from Alex Thompson of Stifo. Please go ahead.

Hey, great. Thanks for taking our question. Maybe two more in 1402. You know, going back to the questions around placebo responses, you know, how are you thinking about managing placebo response in the GRADE studies, particularly in the backdrop of ATT down titration and the potential for, you know, waxing and waning of disease in that context over longer periods of time? And then secondly, you know, what's your current thinking on sort of where 1402 could fit within, you know, MG and CIDP as that landscape continues to evolve?

Yeah, thank you. Great questions. Appreciate it. Look, on graves, I think the short answer to this question is if you set the bar high enough on the endpoints, these are just not patients who are spontaneously remitting. And so if you're looking at patients who are getting to, you know, proper thyroid hormone levels and off ATDs, I think the simple truth is placebo should be pretty manageable here without saying much more about exactly how the ATD titration works and so on. And different of the studies being run by different companies are taking slightly different approaches there. So I'm not going to say too much about exactly what we're up to. But, you know, overall, I think this is something that is likely manageable. And then, you know, I think as far as MG and CIDP are concerned, and I'll say, first of all, it's pretty rare that you have a great drug where you can run a clinical trial and be just like very confident that the trial is going to work. You know, FDRNs have been studied many times in MG at this point. You know, 1402 really should work in MG. The data that we generated in battle, although I know there was plenty of debate over the deeper is a better question, we think showed a real treatment benefit, especially on things like MSE and sort of clinical remission that other FCRNs, in our view, have not been quite as compelling on. So I think we have an opportunity to deliver really great data, and I think that data will translate to adoption. I'll say two other things. One is that the MG market has just shown itself to be extremely large. There's room for lots of different classes. There's room for multiple FCRNs. There's a little bit of cycling going on. There's differences in dosing paradigm and so on. So I think, like, no matter what share we take, even a relatively modest share of a market that size is a big opportunity. I think Argenix has done a really great job establishing that market, establishing themselves in that market, becoming the drug of choice that people reach to for next-generation therapy. I think they may very well remain the class leader there. And, you know, I think we will find lots of operating room around them with hopefully incremental meaningful benefit to patients beyond what they can deliver and just with another option with different route of administration and so on. So I think an MG will be out there. I think we'll have a big opportunity just given the size of the overall market and then exactly what our share is and where we fit in will depend on the clinical data that we generate in the study. You know, CIDP, my one comment is, I think there is, I think the, I'll make it at the end on other indications. I think in CIDP, you know, class leadership has been less concretely established at this point. It's a more recent launch. And, you know, I think there's probably a little bit more room for improvement on, you know, truth and paradigm. And so, you know, I think what we showed with BATO in the CIDP study was pretty encouraging. And I hope we're able to do something similar with 1402. And I think there will be a lot of enthusiasm if we can for our role there. So I think we have an opportunity to be a major driver in that market. Overall, I think the level of success that Argenix has had with things like MG and CIDP make me tremendously excited about Graves and about digital CRA and the other indications where we are first, in that the first mover advantage that Argenics has been able to develop, and their indications are significant, and I expect to build a similar mode for ourselves. Look, I think ultimately these docs are going to be sensitive to clinical data, focused on clinical data, and, you know, I think if our data is phenomenal, we'll be able to lead in every indication where we have that kind of data. The docs are going to follow the quality of the evidence. Great, thanks, Matt. Appreciate the question.

Thank you for the questions. With that, I'd like to hand the call back to Management for closing.

Great. Well, look, thank you, everybody, again. Thank you for the thoughtful questions. I appreciate how much work it is to come up with good questions in a quiet quarter. I promise there'll be lots coming in the coming weeks and months to give you more substrate in the future. But in the meantime, we appreciate it. We appreciate everyone for listening. As always, I'm super appreciative of everybody who works for Roy Vance who are working just super hard on all of these programs to move them forward. I've been very proud of our execution and pleased with the quality progress we made. And then I want to thank the physicians and investigators and patients in our studies who trust us with their care. And I couldn't be more excited for the 12 months ahead. This is the last, one way or another, this is the last boring quarter we're going to have for a while. So looking forward to the more exciting ones ahead and losing sleep over them until we get there. Thank you, everybody. Have a good day.

That does conclude today's conference call. Thank you for your participation. You may now disconnect your lines.