Q1 2026 Immunovant Inc Earnings Call
Speaker #1: 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.
Speaker #1: Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today, Stephanie Lee.
Speaker #1: Thank you. Please go ahead.
Speaker #2: Good morning, and thanks for joining today's call to review Roy Van's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with Roy Van, presenting today.
Speaker #2: Gline, CEO of Roy Van. 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.royvan.com.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: And with that, I'll turn it over to Matt.
Speaker #3: 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 I am pretty quiet quarter and maybe not the most interesting of our earnings calls in recent memory.
Speaker #3: But nonetheless, a lot of great progress in the business, and certainly we're expecting a jam-packed second half, as I'll get to in a moment.
Speaker #3: So I'll be relatively brief in my remarks, and then we'll go to Q&A. I just want to start on slide 4. This is a slide we took from our own prior deck.
Speaker #3: 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.
Speaker #3: And we're sitting here a little bit more than halfway through the year, so just wanted to highlight that it's gone well for us and that we feel really good about the setup.
Speaker #3: And so on slide 5, looking across the list here, we've got Brexit and have expected to. Obviously, we've got priority review, and our PDUFA date, as we said, is this quarter.
Speaker #3: We launch by the end of September. had great data from 14.02 in the D2CRA 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 3 study and continuous sarcoidosis for Brexit.
Speaker #3: on the positive results that we had in our Phase 2 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 that sort of second part of that, the 1498 part of that case is progressing, and we filed international proceedings against Pfizer and BioNTech in that case.
Speaker #3: And finally, earlier this year, we added LPP as a fourth brexit of indication, and, as I'll remind people later today, that study is continuing to enroll really well.
Speaker #3: As I mentioned at the top of the call here on slide 6, I'll just say this is a quiet quarter, and this is a quiet day.
Speaker #3: I don't know exactly how the following statement could be true, but I think it is. The next 6 to 12 months or in many ways busier than the prior 6 to 12 months for Which follows us.
Speaker #3: And so, we just have an enormous amount coming up, starting, as I mentioned, with the upcoming potential Brexit and launch in DM, which should happen imminently, assuming everything goes as we hope and expect it will with the FDA.
Speaker #3: 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.
Speaker #3: We also have top-line data coming shortly in the second half from Mosley, the Phase 2 study in PHLD. I know that's being closely watched, and we're looking forward to getting that data and presenting it.
Speaker #3: We will provide updates further updates on the D2TRA program at Immunovant, and 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.
Speaker #3: 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.
Speaker #3: 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 GRAVES data and beyond.
Speaker #3: So just a lot, a lot in the front of us here. I'll just hit a couple of highlights in terms of the pipeline updates, and a little more detail here before again, before going to Q&A.
Speaker #3: Starting on slide 8 with a reminder because it's been a few months since we've talked about it. The initiation of this continuous sarcoidosis Phase 3 study is a pretty exciting event.
Speaker #3: 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.
Speaker #3: It's a high morbidity, very difficult disease with a high urgency to treat. You can see on slide 8 some of the photos we've shared before, but these are patients who are really sick and have very few treatment options.
Speaker #3: On slide 9, as a reminder of the data that we generated in our Phase 2 study, we had set for ourselves a goal of a 5-point benefit on this Sesame scale for clinical meaningfulness.
Speaker #3: And in the study, on the top left of this chart, we showed a greater than 20-point benefit compared to a roughly nothing on placebo.
Speaker #3: So just a huge benefit to those patients in the Phase 2 study. And really excited to carry that forward into the pivotal program. As a reminder on slide 10, we think this is a pretty decent-sized indication.
Speaker #3: Again, with high MME, probably about 40,000 patients in the US. And reasonable overlap with some other organ systems including optical sarcoidosis or eye sarcoidosis, where that overlaps with NIU.
Speaker #3: 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.
Speaker #3: The Phase 3 study that we've now begun—the design is laid out on slide 11. I know there were some questions after Phase 2 about what exactly this study would look like.
Speaker #3: It is designed to take all of the learnings from the Phase 2 study that was successful. That is one of the types 16-week study with the primary endpoint of Sesame greater than or equal to 50% response rate.
Speaker #3: It's 140 patient study across about 70 sites, 3 to 2 randomized, with patients either on 45 milligrams of Brexit or placebo. And with a mandatory staper sorry, a mandatory steroid taper going from week 2 to week 8 down to 0, which is consistent with roughly consistent with what we did in the Phase 2.
Speaker #3: 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 Brexit and coming up.
Speaker #3: I'll reiterate on slide 12, the other ongoing registrational program is the Brexit and study in like in clinical RSLPP that we announced earlier this year.
Speaker #3: That study is enrolling, I'll just say, extremely well. There's a lot of enthusiasm from physicians and patients for that. It speaks to the high MME and the indication, speaks to the quality of the work being done by Ben and the private van team.
Speaker #3: And 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.
Speaker #3: Hopefully with a potential approval and beyond. Obviously, one of the major events in the near term here is the launch potential launch of Brexit in dermatomyositis.
Speaker #3: I'll just say I think we're in a phenomenal position here in terms of what we've got and in terms of what we hope to be able to do.
Speaker #3: data, which as you know from the multiple times we've talked about it from the Starting with the quality of our clinical publications, including in the New England Journal and so on, just phenomenal data stats across all 10 endpoints.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: Including with all of 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.
Speaker #3: 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.
Speaker #3: We feel really great about the hires we've made there, really great about the organizations we've built there. We think we're doing this in a way that is both capitalizing on all of the learnings from successful launches at other companies in recent years and doing it in a rodent private way.
Speaker #3: There's nobody in the world I'd be more excited to see oversee this than the team we've got at private van with Ben and Daniel and others.
Speaker #3: And I think we're going to be fully ready everything's on schedule. So we'll have much more to say about that with the potential approval and after.
Speaker #3: But looking forward to it. I'll say one more thing about the commercial franchise overall at Brexit and on slide 14. We get a lot of enthusiastic questions from investors around pace of launch.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: And so it's just 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.
Speaker #3: But also, to me, it's because Brexit 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, but 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.
Speaker #3: 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.
Speaker #3: And much more about making sure that the foundation on access, the foundation on 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 Brexit and across all of these indications.
Speaker #3: And so 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 indications that we're excited about beyond the ones we've already announced.
Speaker #3: So a lot to come. As I said, on track for that launch. You all hear the same thing we do, which is a ton of enthusiasm from the patients and physician community for new options in all of these indications.
Speaker #3: 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.
Speaker #3: Final business update here is we got the upfront payment in the settlement with Moderna, that $950 million, has come in $770-ish of it to Genevent and the rest to Arbutus.
Speaker #3: So that's done. There'll be progress in terms of return of capital, etc., of that Arbutus, and so on. The 1498 sort of appellate ruling, that process is ongoing.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: Just under $100 million of non-GAAP adjusted GNA or 166 of GAAP GNA expense. And cash just under $4 billion. And that's before the receipt of the $772.
Speaker #3: 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.
Speaker #3: And the shares that a reminder, 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.
Speaker #3: 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.
Speaker #3: So 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.
Speaker #3: 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.
Speaker #3: With just an incredibly busy stretch ahead. On slide 20, again, a little bit incredulous for the people around Rodman who are doing all of this work.
Speaker #3: Incredible for the people around Rodman who have to do this work. But by the end of calendar 2028, we'll have had hopefully three or more commercial launches, nine or more physical study readouts for plus MDA or BLA filings, and a number of proof of concept studies.
Speaker #3: 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.
Speaker #3: Thank you again for listening this morning and looking forward to taking your questions.
Speaker #1: Thank you.
Speaker #2: Operator, over to you.
Speaker #1: Certainly. We will now begin the question and answer session. As a reminder to ask questions, please press star one and one on your telephone.
Speaker #1: If you'd like to cancel requests, you can also press star one and one again. Our first questions comes from July O'Brien Ching of JP Morgan.
Speaker #1: Your line is open. Please go ahead.
Speaker #3: Hey guys, good morning. Thanks for taking our questions. Maybe just thinking through the DM launch mat, can you give us a quick sense of what metrics we could be receiving right out of the gate to help us better track the initial launch?
Speaker #3: And then secondly, on THLD, as we think about the baseline characteristics here in focus, it seems that more patients are on metadonip. We're curious if there's any implication in terms of the fibrosis versus emphysema ratio in the populations.
Speaker #3: And then further down the line, whether there's any implication towards the bar for success for both six-minute walk and also PVR. Thank you.
Speaker #2: 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 observe our guidance, which isn't quite fair.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: But I don't have a lot to say right now about metrics. I'll say 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.
Speaker #2: For practical purposes—but we'll provide more guidance on that as it gets closer and is here. On PH-ILD, I guess first of all, we've obviously been watching, for example, the treprostinil data in IPF and trying to understand a little bit better what's been going on with these PH-ILD patients, in treatment of PH-ILD for fibrosis and for lung disease.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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 the triprostinal has anti-fibrotic benefit.
Speaker #2: Look, I think our view is, if you treat PHLD patients well for their pulmonary hypertension, you may well deliver a benefit overall on their lung disease.
Speaker #2: 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 famosely.
Speaker #2: Overall, on six-minute walk and PVR, and I'm sure I'll get versions of this question. More today. Look, I think it's consistent with what we said before.
Speaker #2: We're hoping to see a clear 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.
Speaker #2: 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.
Speaker #2: And we'll know what we've got once we get a closer look at it, including the full balance of that data. Thanks, Brian.
Speaker #3: Thank you, Matt.
Speaker #1: Thank you for the questions. Next questions comes from the line of Dave Risinger from Leering Partners. Your line is open. Please go ahead.
Speaker #4: 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.
Speaker #4: 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?
Speaker #4: I.e., what would be relevant to the clinicians and to the patients? So, that's my first question.
Speaker #2: 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.
Speaker #2: The truth is that PHLD 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.
Speaker #2: And second of all, most importantly, the actual not from a clinical trial perspective, but from a real-world evidence perspective, survival and mortality rates go down as new classes of drugs are introduced in PAH over time.
Speaker #2: And I think it's less about a number on six-minute walk and more about having an approvable therapy. Remember, these are patients that are trying to walk to the car.
Speaker #2: They're trying to walk to the bathroom. They're trying to live their daily lives. So I don't know that I think it's correct scientifically to describe a specific numerical bar that matters.
Speaker #2: 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 a little bit difficult to translate into daily lives, whereas if these drugs really effectively vasodilate and improve lung function and improve PVR, I think you wind up seeing a lot of benefit for these patients.
Speaker #2: So 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.
Speaker #2: 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.
Speaker #2: Thanks, Dave.
Speaker #4: 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.
Speaker #2: Yeah, 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 payer community.
Speaker #2: That you'd expect us to have at this stage. And also, and I think this is a critical point about all of these launches, we are super focused on making sure that the physicians you want to write this drug and patients who want to get on this drug are going to have access.
Speaker #2: I think that's going to be really important for our engagement with the community, for access generally. I think, in terms of the literal formulary, it's probably not so different.
Speaker #2: It's not like there's a separate committee for different kinds of diseases, but there are lots of medical exception procedures and other things that you can do to get patients covered.
Speaker #2: And we have a whole team of people built out at 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.
Speaker #2: As they're deciding how to use the drug.
Speaker #4: Excellent. That's really helpful
Speaker #1: 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 announce initiation of new studies , , for over the next year or so ?
Speaker #2: 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 is not yet aware of in our pipeline in all of those cases , we could announce new trials , new indications , , in the next year .
Speaker #2: I think it's every one of those are eligible . And all of our molecules , could be put into , , indications beyond the ones we've talked about .
Speaker #2: 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 in fact , preparing to initiate programs .
Speaker #2: , to varying degrees , depending on how busy those teams are today versus next month or the month after . But , but , but real progress .
Speaker #2: I think the answer is we are actively working on that . And all of our products are , as you've called them , pipeline and products and , , that we're excited to share more indications , , as we start those studies .
Speaker #1: Excellent . Thanks so much .
Speaker #2: Thanks . Thank you .
Speaker #3: Thank you for the questions . The next question comes from the line . Of Samantha Salmon from city . Please go ahead
Speaker #4: Hi . Good morning . Thanks very much for taking the questions . I also have two , one on Mosley , one on Brito for Mosley .
Speaker #4: I'm wondering if you could just talk about the translatability of PBR reductions in patients with PAH to those with the pH ILD population that you enrolled in focus .
Speaker #4: 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.
Speaker #2: , yeah . So look , I think , , thanks for the question . I appreciate it . I think the translation from PAH to ILD is the fundamental question being answered by our study .
Speaker #2: And so the first unfortunate answer to that question is we're just going to have to see what we see . , and it is the .
Speaker #2: It is the risk of the , the program at some level that we find something again , the phase one data , including in PAH patients looked very good on a PVR basis .
Speaker #2: So one of the main quote unquote risks of this program is that there's something I would call it unexpected . , in the field translation , obviously , I use the word unexpected because I think scientifically it seems relatively straightforward that inhaled vasodilation is an effective mechanism in filed , but we'll find out .
Speaker #2: Obviously , the lungs of PPH , patients are different . Than the lungs of PAH patients . And so you might expect some difference in sort of the pharmacodynamics of the drug .
Speaker #2: In those patients . But overall it seems pretty clear that , , when you take in inhaled vasodilator , , in a flood patient , you get drug to the healthy lung tissue and it matters .
Speaker #2: So that's, that's, that's what I'd say.
Speaker #4: Got it . Thank you . That's , that's very helpful . And then just on , on DM in your conversations that you've been having with physicians for education , I'm wondering if you just talk about the reception to given the Jack class safety concerns , obviously , the safety profile and 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 .
Speaker #4: Thanks very much .
Speaker #2: Yeah , we've said a few times that , , that , , you know , when we first In-licensed Brepocitinib , 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 .
Speaker #2: I think dermatomyositis is a poster child for this, in that JAK inhibitors are at this point extremely widely used in, you know, diseases with much less morbidity.
Speaker #2: , many more alternative therapies , , you know , in dermatomyositis , , there's , there's really no other options available . And I don't think physicians therefore are going to be particularly focused on this question .
Speaker #2: , remember these patients are often , first of all , I think you sort of alluded to the profile in the trial , the randomised patients are inherently at risk of many of these concerns .
Speaker #2: Malignancies , , cardiometabolic 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 dermatomyositis are things like high dose steroids .
Speaker #2: , which themselves add meaningfully . In fact , in many cases much worse than Jak inhibitors to those very same risks . So , you know , 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 .
Speaker #2: , anyway . And it's clear from our conversations with docs across different prescriber bases , they're just very comfortable using these agents , including prescribing bases , as we said , for patients with significantly less severe disease .
Speaker #2: You know , as a reminder , we fully expect that our label is going to look like the labels for other Hdac inhibitors , that it's going to have the black box warnings , it's going to talk about experience with Jak inhibitors and other indications .
Speaker #2: , and like I said , I think docs expect that , , and , , and I think are not , are not going to be too concerned about it because these patients are a very sick and be on other drugs .
Speaker #2: , in many cases , significantly worse safety concerns .
Speaker #4: Thanks , Matt . Very helpful
Speaker #3: Questions . Our next question will come from the line of Prakash Aggarwal from Cantor Fitzgerald . Your line is now open .
Speaker #5: Hi . , 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 .
Speaker #5: Firstly , on Bravo and DM , could you remind us what percentage of DM patients are on off label Jaks based on your latest primary or secondary research ?
Speaker #5: And would you expect rapid switches from these patients who are on off label to . If not , why is that the case ?
Speaker #5: And secondly , for Bravo and Niou trial , what do you see as the biggest risks for phase three , given the phase two was really strong and is geographic variation , which is been , , a key risk for this trial , which could drive some of the baseline variability .
Speaker #5: This has been flagged as one of the risk factors by some of the checks that we have done . thank you . Really appreciate it .
Speaker #2: Great . Thank you . , so , you know , I , , in terms of your first question on DM around who's on off label jaks and what is that ?
Speaker #2: What does that look like ? Look , I think first of all , there's just like variability in physician practice and some physicians use more .
Speaker #2: Jax—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.
Speaker #2: I think what we said publicly is a low single digit percentage or mid-single digit percentage of myositis patients have experience with these things .
Speaker #2: You know , I some of the docs who were involved . , who do use some of that , some docs don't use off label drugs , full stop .
Speaker #2: I think some of the docs who use off label Jax have said they expect to switch patients over . And you know , I hope I hope they do .
Speaker #2: And obviously we'll be working to help them where that's appropriate . , facilitate those switches . Yeah , I think it's just , , it's just going to be down to the preference and practice of each individual doc .
Speaker #2: I think one of the things that our team is finding and 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 .
Speaker #2: 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 .
Speaker #2: But , , but I think , medically , we'll see a wide variety of different phenotypes , , , any , you know , what is the biggest risk in phase three ?
Speaker #2: It feels funny to call placebo a risk in these trials . And that that's not quite exactly what I mean . But I think the , you know , variability in placebo response rates in immunology trials is significant .
Speaker #2: And if you're asking me what keeps me up at night , it's that we don't know exactly what placebo response rates will be in that study .
Speaker #2: And , , you know , that that just makes it hard to know exactly what the trial is going to look like on outcome .
Speaker #2: , obviously the phase two data was quite compelling and the level of drug activity seemed good . And so I'm pretty optimistic about the study .
Speaker #2: But , but , you know , there's certainly this is biotech . So you can lose sleep over anything . , is geography a risk ?
Speaker #2: , 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 I don't know that it's a risk in the sense that it's like unanticipated or whatever .
Speaker #2: It's just a feature of running immunology studies . But overall , I think the team is doing a great job with the study .
Speaker #2: And I hope , I hope it's going to come out well . Thank you .
Speaker #5: you
Speaker #3: The questions Our next question Thank comes from the line of Andy Chen of Wolfe Research . Your line is now open .
Speaker #6: Hey , thank you for taking the question . I don't think this has been talked about yet , but for the launch , can you maybe talk about a few launch analogs that you're assessing right now , either patient curve or market share curve ?
Speaker #6: What are the historical products with the most resemblance to in DM ? Thank you .
Speaker #2: Well , , thanks . It's a , it's a good question . , the truth is , , there has never been a launch of a targeted therapy in Dermatomyositis before .
Speaker #2: And so there is no good . Quote unquote analog in the sense that you can point to lots of other launches of lots of other kinds .
Speaker #2: 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 .
Speaker #2: And I think it's hard to say . And there have been successful products with all kinds of different launch faces . So I think the short answer is I don't have a specific analog for another drug that we're watching as evidence of our own penetration .
Speaker #2: I think what we're really focused on here is the dermatomyositis opportunity itself . These docs or these patients , , and you know , the , the benefit and the cost of being a pioneer in an indication is that you don't get to look at others .
Speaker #2: You have to chart your own course . I don't have an analog to point to . Thanks , Andy
Speaker #3: Thank you for the questions . One moment for our next question . Our next question comes from Yatin Suneja from Guggenheim . Please go ahead .
Speaker #7: Hey , guys . , thank you for taking my question . , just a quick one on difficult to treat RA . Could maybe talk about the strategy there ?
Speaker #7: 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?
Speaker #7: Thank you .
Speaker #2: Yeah . Thanks . Great question . Look on . , study designs . So , you know , we're going to come back .
Speaker #2: , later this year with a full update on that program . And that includes we don't yet have the randomized withdrawal period data yet .
Speaker #2: So I can't speak to what's in it or how it will or will not inform , , strategy from here . And I think at some level , the results of that study may inform whether it is usable or not .
Speaker #2: As a , as one of our pivotal studies , etc. . I think we , we designed it to serve potentially as one of two , , but obviously it's got to hit for that to , for that to work .
Speaker #2: , and as we said , when we announced the data , , the , the quality of the response rates in the open label period have set a somewhat higher bar for hitting a p value on the randomized withdrawal section .
Speaker #2: So I think we've got to sort of see all that taken in aggregate . Look at the patient level data , understand what's going on .
Speaker #2: 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 .
Speaker #2: I don't have a specific , , guidance to give on exactly what those studies are going to look like now because we don't know , but I'll say the team is working on it hard .
Speaker #2: The data was , was obviously exciting . It has it has gotten noticed . We've gotten a lot of enthusiasm , enthusiastic reception , including from the community on it .
Speaker #2: And we're excited to finalize those plans and bring them back to you later this year Thank you
Speaker #3: Thank you for the questions . Our next question comes from Yaron Werber from TD Cohen . Your line is now open .
Speaker #8: Great , 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 ?
Speaker #8: And then secondly , for CS , the trial design is super interesting and makes obviously a lot of sense . The primary endpoint is Sammy , more than a 50% response .
Speaker #8: , can you maybe translate the phase two data into the same context ? Because I think the phase two looked at Sammy over ten points and the change from baseline .
Speaker #8: So I'm just trying to get a sense of apples to apples , kind of what to expect . Thank you
Speaker #2: , great . , so on Mosley , I think the short answer to your question is we will not release the monotherapy data in the combo data at the same time , because the combo study started much later and is enrolling now , whereas the monotherapy study obviously will read out , , pretty soon in the second half .
Speaker #2: So , 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 the combo study .
Speaker #2: 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 won't provide that much incremental .
Speaker #2: 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 .
Speaker #2: , but , but I'm not sure it's going to be like a super , super informative , , outcome , you know ? Yes .
Speaker #2: So that's what I'll say . I'm mostly , I think data are going to come at separate times . , CS , I don't have to give right now .
Speaker #2: , the exact delta , but I'll say , , we saw meaningfully higher rates of greater than 50% . See Sammy in the treatment arm than in the , , in placebo .
Speaker #2: , so the delta was wide , , and , , you know , I think , , 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 treatment arm of the phase two , , had a response rate greater than 50% compared to , I think it was zero .
Speaker #2: On placebo . So it should be a , it should be a good , a good bar to set for us in terms of the endpoint .
Speaker #2: I don't think we're going to replicate exactly what we saw in the phase two . But but I think the point is it's well powered .
Speaker #2: , for , for , for probability of success , given what we saw in the phase two .
Speaker #8: Right . And if I could , maybe just sneak in the phase three Niu , do you have a sense is the percent Humira experience going to be the same as the phase two , given that the data looked pretty good overall ?
Speaker #8: So it must have been pretty good in that segment too . Thank you .
Speaker #2: I don't think we've said , , thank you . What the percentage of patients in the phase three , , have Humira experience .
Speaker #2: I don't have that number off 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.
Speaker #2: , very different than what we've seen . There are a meaningful number of experienced patients in phase three , which matters in terms of ability to go into all those patients .
Speaker #2: But I think the short answer to your question is , I , 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 .
Speaker #2: Thank you , Your Honor
Speaker #3: Since our next question comes from Thomas Smith from Living Partners, your line is now open.
Speaker #9: Hey , good morning . Thanks so much for the updates and for taking our questions . , on the 1402 difficult to treat RA program , I just wanted to clarify how you're approaching the disclosure in the second half of the year .
Speaker #9: Should we expect to see the part two randomized withdrawal data prior to your meeting with FDA ? Or are you planning to share the data and the regulatory feedback and next steps ?
Speaker #9: Simultaneously ? And then on graves , I just wanted to get your thoughts on the competitive landscape . Obviously , you're the first advanced therapy there with really stellar phase two data , and you'll have the first pivotal readout next year with 1402 .
Speaker #9: 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.
Speaker #9: 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 .
Speaker #9: And Grace , thanks so much .
Speaker #2: Yeah , perfect . Those are both really great questions . On the first one , I think what we said , we put the data out still holds .
Speaker #2: 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 .
Speaker #2: 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 .
Speaker #2: 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 .
Speaker #2: , tra , 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 graves , disease was like the 1950s or 1960s .
Speaker #2: 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 .
Speaker #2: It's about changing doc behavior in an indication that that badly needs new options . You know , 1402 , will have been studied in lots of patients is a safe and well tolerated drug .
Speaker #2: 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 lots of different approaches .
Speaker #2: And those patients may be appropriate for those drugs, may be appropriate for later-line patients, or a different subset of the patient population.
Speaker #2: And over time , I'm sure that segmenting will occur . But first of all , we're going to be first out in the marketplace .
Speaker #2: Their long before anybody else . And so we're going to get to have some influence over the treatment paradigms . And also just get an option out to patients , physicians before some of those other choices are available .
Speaker #2: , second of all , I think it's mostly about building the market , not about not about any , any specific alternative and so on .
Speaker #2: 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 .
Speaker #2: The only other thing I will say is you learn a lot running these studies . You learn a lot , engaging with this physician community .
Speaker #2: 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 US .
Speaker #2: 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 .
Speaker #2: And I think that will be a big benefit to us in being here in the first place. Thank you.
Speaker #3: Our next question comes from Yasmeen Rahimi of Piper Sandler , your line is now .
Speaker #10: Hi , this is Shannon on for Rami . Congrats on the great quarter . , maybe just one more from us about clarity with the readout in second half 26 .
Speaker #10: , 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 .
Speaker #10: , and then timing post data , , would you expect to file an NDA and sort of what would be the cadence on that ?
Speaker #10: Thanks .
Speaker #2: Thanks . Look , I think , , I doubt that we're going to provide more specific timing guidance at this point than we have .
Speaker #2: , you know , we announced , I think when the study was fully enrolled , you , I think we're just going to read the study out when it's , when it's done and we have the data clean .
Speaker #2: , you know , , the truth is Niu is another one of these diseases where there's a lot of unmet need . Humira leaves a lot of room on the table .
Speaker #2: 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 .
Speaker #2: Studies that would support registration . And I think if we get that , , we will have a big opportunity to help lots of patients who need it .
Speaker #2: So I don't think there's like a numerical bar , obviously better data is better . And the more we look like phase two , the happier I'll be about that .
Speaker #2: Our phase two was really , really great data . But but overall , I think as long as we have a successful clinical trial , a successful outcome , we're going to get , we're going to get what we need .
Speaker #2: And we have a lot of patients we can reach . , and I don't , , want to put Ben on the spot right now on exactly when that snda goes in .
Speaker #2: But we got the DM one in , , nice and quickly . And I know the team is enthusiastic for , , for you as an indication of that studies positive .
Speaker #2: You got to believe that team is going to be working really quickly to get that snda in as fast as possible . Thank you
Speaker #3: Our next question comes from Douglas Chow from HHC . Ryan , please go ahead Douglas , your line is open . You can unmute locally And in that case , we will move on to our next questions .
Speaker #3: One moment please The next question comes from Sam Slutsky from Lifesci Capital . Please go ahead .
Speaker #11: Hey , thanks for taking the questions . , two quick ones for me , I guess for the proof of concept readout in CLL .
Speaker #11: 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 and the concentration of patients at those clinics .
Speaker #11: Thanks .
Speaker #2: Yeah . Thanks . , the on CLI and again , I think we've said this before in other settings , but it bears mentioning , I think , you know , seal is an interesting indication .
Speaker #2: This is a small study . It's really a fact finding proof of concept study . , we've been watching the competitive landscape in CLL closely .
Speaker #2: 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 .
Speaker #2: 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 .
Speaker #2: And I think that will all be super informative to what we do from here and whether we , whether we go forward , , you know , I think the primary is a , is , , is , , is 12 weeks , , 600 versus placebo .
Speaker #2: , and then in period two , all patients go out 600 at 52 weeks . But the thing that we'll be reporting first is that 12 weeks , , for 600 versus placebo .
Speaker #2: , so that's , that's what we'll see . , and then 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 US patient population .
Speaker #2: And so obviously those , those clinics are those docs , those centers are an important part of the overall picture . But there are other important physicians as well .
Speaker #2: And , you know , I think the team has done a really great job overall engaging with the physician community . So I'm excited about , , excited about what we've done there , excited about the sort of medical , , medical publication strategy , obviously doing a journal publication was a great outcome .
Speaker #2: 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 .
Speaker #2: So thank you . Great questions
Speaker #3: For the questions , we will now take the last questions from Alex Thompson of Stifel . Please go ahead .
Speaker #12: Hey , great . Thanks for taking our question . Maybe maybe two more on 1402 . , you know , going back to the questions around , around placebo responses , , you know , how are you thinking about managing placebo response in the grade studies , particularly in the backdrop of at down tritration and the potential for waxing and waning of disease in that context , over longer periods of time .
Speaker #12: And then secondly , you know , what's your current thinking on sort of where 1402 could fit within MG and Cidp as that landscape evolve ?
Speaker #12: Thanks .
Speaker #2: Yeah . , thank you . Great , great questions . Appreciate it . Look on graves . , I , 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 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 .
Speaker #2: , without saying much more about exactly how the titration works and so on and different of the studies being run by different companies are taking slightly different approaches there .
Speaker #2: 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 .
Speaker #2: , 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 .
Speaker #2: , where you can run a clinical trial and be just like very confident that the trial is going to work . , you know , Fcrn have been studied many times in MG at this point , you know , 1402 really should work in Milligrams .
Speaker #2: The data that we generated in battle , although I know there was plenty of debate over the deeper , better question , , we think showed a real treatment benefit , especially on things like MSD and of clinical remission that other fcrn , in our view , have not been quite as compelling on .
Speaker #2: So I think we have an opportunity to deliver , , really great data . And I think that data will translate to adoption .
Speaker #2: I'll say two other things . One is that the EMG market has just shown itself to be extremely large . There's room for lots of different classes .
Speaker #2: There's room for multiple fcrn . 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 chair , we take even a relatively modest share of a market , that size is a big opportunity .
Speaker #2: I think Argenx has done a really great job establishing that market, establishing themselves in that market, becoming the drug of choice that people reach to for a next-generation therapy.
Speaker #2: I think they may very well remain the class leader . They're , , 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 .
Speaker #2: And just with another option with different route administration and so on . So I think an EMG will be out there . I think we'll have a big opportunity just given the size of the overall market .
Speaker #2: 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 , by the end , on other indications , I think Cidp , you know , class leadership has been less concretely established at this point .
Speaker #2: It's a more recent launch , , and , you know , I think there's , , probably a little bit more room for improvement on treatment paradigm .
Speaker #2: And so , you know , I think what we showed with battle in Cidp study was pretty encouraging . And I hope we're able to do something similar with 1402 .
Speaker #2: And I think there will be a lot of enthusiasm if we can , for , for our role there . So I think we have an opportunity to be , you know , major driver in that market .
Speaker #2: Overall , I think the level of success that Argenx has had with things like MG and Cidp make me tremendously excited . About , , about graves and about a and the other indications where we are first in that the first mover advantage that our genetics is able to develop .
Speaker #2: And their indications are significant . And I expect to build a similar moat for ourselves . Look , I think ultimately these docs are going to be sensitive to clinical data focused on clinical data .
Speaker #2: 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 .
Speaker #2: Docs are going to follow the quality of the evidence. Thank you for that question.
Speaker #3: Thank you for the questions. With that, I'd like to hand the call back to management for closing.
Speaker #2: Great . Okay . Well , look , thank you everybody . Again , thank you for the thoughtful questions . I appreciate how much work it is to come up with a good questions and a quiet quarter .
Speaker #2: I promise there'll be lots coming in the coming weeks and months to to give you , , more substrate in the future . But in the meantime , we appreciate it .
Speaker #2: We appreciate everyone for listening . As always , I'm super appreciative of everybody who works for our events who are working super hard on all of these programs to move them forward .
Speaker #2: I've been very proud of our execution and pleased the quality progress we've made . And I want to thank the physicians and investigators and patients , , in our studies who trust us with their care and , , couldn't be more excited for the 12 months ahead .
Speaker #2: 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 .
Speaker #2: Thank you . Everybody . Have a good day .
