Immunovant - Earnings Call - Q2 2026

Executive Summary

• Q2 FY2026 was execution-heavy: R&D spend rose on IMVT-1402 registrational programs; net loss widened modestly YoY, while cash remains sufficient to fund announced indications through the Graves’ disease (GD) readout expected in 2027.
• Clinical timing pivot in TED: while the first of two batoclimab Phase 3 TED studies remains on track to conclude in 2025, management now plans to disclose topline from both studies together in H1 2026 given the evolving competitive landscape—an important narrative shift for the stock.
• GD durability data: six-month off-treatment remission data in uncontrolled GD (batoclimab) showed ~80% (17/21) maintained normal T3/T4 at Week 48 and ~50% (8/17) were ATD-free—supporting potential disease-modification and strengthening the case for IMVT-1402 in GD.
• Upcoming catalysts: Dec 11 investor day, 2026 readouts in D2T RA (open-label) and CLE (PoC), and 2027 registrational readouts in GD/MG/D2T RA; these events anchor the medium-term setup.

What Went Well and What Went Wrong

What Went Well

• Disease-modifying signal in GD: six-month off-treatment remission data from batoclimab showed ~80% maintained normal thyroid function; ~50% achieved ATD‑free remission, reinforcing FcRn’s potential and 1402’s positioning in GD.
• Pipeline breadth and execution: 1402 in six indications (potentially registrational in GD, MG, CIDP, D2T RA, SjD; PoC in CLE) remained on track; management reiterated multiple 2026/2027 data milestones.
• Management tone/confidence: “A tremendous moment of transformation for the business,” with excitement to detail the future at investor day; the team emphasized the strength and depth of the late-stage pipeline.

Selected quotes:

• “Valor succeeded with really highly significant, robust, and consistent data across the primary and all key secondary endpoints…”.
• “This is a very large patient population with a significant unmet need… we showed real disease-modifying benefit” (GD).

What Went Wrong

• TED disclosure timing shifted: topline for the first Phase 3 TED study will be held to report concurrently with the second study in H1 2026 due to competitive dynamics; this defers a potential 2025 data catalyst.
• Operating intensity rose: R&D expenses increased to $114.2M vs $97.3M YoY on 1402 clinical/CMC and personnel costs, driving a higher quarterly net loss ($126.5M).
• Competitive overhang: Management acknowledged intensifying competition in GD and TED (e.g., FcRn entrants and other mechanisms), reinforcing the need to demonstrate best-in-class depth/durability and safety.

Transcript

Operator (participant)

Good day, and thank you for standing by. Welcome to Immunovant's second quarter 2025 earnings 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 will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your first speaker, Stephanie Lee. You may begin.

Stephanie Lee (COO)

Good morning, and thanks for joining today's call to review Immunovant's financial results for the second quarter ended September 30, 2025. I'm Stephanie Lee with Immunovant. Presenting today, we have Matt Gline, CEO of Immunovant. 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.immunovant.com. We will also be providing the current slide numbers as we present to help you follow along. I would like to remind you that we will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we file with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. With that, I'll turn it over to Matt.

Matt Gline (CEO)

Thank you, Steph, and good morning, everybody, and thank you for listening. I appreciate all your dialing in. Not at all a quiet quarter for us in that we put out both the Graves' data and obviously the phase three data for BREPO and MNDM. Just a tremendous moment of transformation for the business, but a relatively quiet earnings call as we are looking forward to getting everybody together in December for a more fulsome telling of where we are as a business, more about the future on our investor day on December 11. That registration link is live on our website, so look forward to seeing you all there. Today will be more of a review of what has happened in the recent quarter, and then we will talk much more about the future when we get together in December. Looking forward to that.

I want to start out on slide five just by taking a short victory lap because it's been a pretty wild year for us. Obviously, starting with, and probably most notably, the Valor data for BREPO in DM, which hit on all 10 ranked endpoints and just a phenomenal data set that we think is going to transform the lives of DM patients. That NDA filing remains on track, planned for the first half of next year, and it'll be the first novel oral therapeutic in DM if approved. We also put out data in this quarter from the durable remission sort of portion of the Graves' disease trial for batoclimab, which sets us up for the future there in our 1402 Graves program. You know, that demonstrated disease-modifying potential for 1402.

Earlier this year, we put out some data in MG and CIDP, and we think did a pretty nice job of validating the deeper is better idea for FcRNs from an IgG suppression perspective. We also have initiated at Immunovant this year potentially registrational trials in Graves, myasthenia gravis, CIDP, dental tree RA, and Sjogren's, as well as a POC trial in CLE. Some really exciting progress there with IMVT-1402, which we hope will take us to a first-in-class in many cases and best-in-class, and we hope all in all indications potential. We got a favorable marketing ruling this quarter for Genevant in the Pfizer case and just overall continued progress in the LNP litigation with the jury trial in the Moderna case scheduled for March of 2026.

Our capital position remains very strong with $4.4 billion of cash and cash equivalents, which will get our current pipeline to profitability and support pipeline expansion and potential additional capital return, including the $500 million that we have currently authorized. You know, on slide six, and we've been showing this slide for a while, but it just feels realer and realer with each passing quarter, just a late-stage pipeline that we are really excited about with 11 potentially registration trials and indications with blockbuster potential. Obviously, the first of those, dermatomyositis, now behind us, but many more to come.

Setting us up for a slide that we've been showing since June on slide seven, which is just a stacked 36 months ahead of us between multiple registrational data sets, first DM and NIU and BREPO, and then the beginnings of a long list of them in 1402, lining up for a series of launches, again, first DM and BREPO, and then NIU and BREPO, and then very shortly thereafter 1402 across multiple blockbuster indications, including Graves. Look, as I said, a moment of real change and transformation for the business. I think we recognize that. We're excited to talk more about it when we get together in December. It's something that the team internally is excited about. It's exciting that I hear from investigators, certainly, and patients and docs in the DM landscape and from investors as well.

Looking forward to the next leg of our journey here. I'm going to do just a brief recap of the two major data sets from the quarter. I won't spend a ton of time on either of these because we've talked about all of them in this setting before, but they bear re-mentioning just because of how exciting both of them are. Starting with the BREPO and Valor data, you know, on page nine, again, we've gone through this all before, but Valor succeeded with really highly significant, robust, and consistent data across the primary and all key secondary endpoints with a nice clear dose response that sets us up for 30 milligrams to be the optimal dose here.

Responses were rapid, deep, broad, and clinically meaningful, you know, across the board, a statistically meaningful and clinically important delta to placebo on mean TIFS with deep responses occurring quickly and across a range of endpoints, including muscle and skin. As a reminder, on slide 10, this is a patient population with very significant unmet need. This is a story that has been underscored over and over again as our team has been out talking to physicians in the field after this data. This is a patient population that is significantly underserved by therapeutic options. 75% of these patients are on only either steroids or ISTs and are struggling to get well controlled. You know, many of them are requiring high doses of oral prednisone in order to sort of be treated appropriately and are all looking for options or many of them are looking for options.

Only a relatively small percentage, only a quarter of the market is currently on other therapies at all. Of the ones that are, some of them are on very demanding IVIG regimens, multiple days a month spent entirely in the infusion centers, and others are on a series of off-label therapies, many or most of which have failed DM programs before, but are used simply because there are no better options. We are getting a predictably enthusiastic response from all of the physicians we have engaged with on this data already. We are obviously looking forward to continuing that as we go through the registration process in the coming year. You know, looking at slide 11, again, a recap from before, but this is the primary endpoint. This is mean TIFS.

You know, this is a textbook picture from my perspective of positive clinical data, statistically significant at the high dose starting at the earliest time point. Nice clear separation, nice clear dose response. One thing it bears mentioning, and we said this with the data originally, you know, we had originally been focused on the steroid taper as a risk mitigant in order to make sure we saw a clear benefit from the drug against a background of not really placebo, but actually actively managed background therapy. We did that, but the other thing we were able to show is a real dose response on steroid reduction. We were able to get a significantly greater portion of patients to lower steroid doses or off steroids on high-dose batoclimab than on placebo. I think that actually with the doc community has been an enormously resonant finding.

It's something that the docs are really, really focused on in DM, getting these patients off high-dose steroids. We are very excited that we were able to show this in the study, including as a part of at least one of the key secondary endpoints. You know, on slide 12, more than a third, and this is the key secondary where we were able to really hit both the TIFS improvement, or the TIFS, I should say, and a minimal or no steroid burden. More than a third of BREPO 30 patients were able to get to both major TIFS responses and minimal or no steroid burden at week 52. That's just a really exciting finding across the board. More than half of patients were able to achieve a TIFS 40, a moderate TIFS response with very low dose of oral steroids at the same time.

Just a phenomenal outcome there on the combination of endpoints. You know, on slide 12, again, without going through them all, just a statistically robust data set, I'll say, with really low P-values across every secondary we tested, benefit on muscle, benefit on skin, benefit on patient-reported outcomes like the HACD questionnaire on disability. Just a terrific across-the-board outcome here. In terms of what's next here, I think everyone's clear. You know, the NDA submission, we're moving as fast as we can. The only rotating item here was drafting, and it's ongoing right now. We expect to get a file in the first half. Data readout from that proof of concept study in CLE that we have ongoing will be next year.

The NIU study, which is enrolling very nicely, is currently anticipated to read out or, say, guide into the first half of 2027, around the same time as potential registration of BREPO and launch in DM. You know, we'd submit the SNDA for NIU shortly thereafter with potential further indications and so on to come. That's Prevacid. I'm sure we'll get some questions about it. Like I said, we'll talk more about that program and what it could represent commercially on the 11th. Suffice it to say, a tremendous quarter and something we're really excited to carry forward from here. Next up, I'll just recap the Graves' disease remission data that we put out earlier this quarter as well. Starting on slide 16, but just a reminder, this is a very large patient population with a significant unmet need.

I think this is an important point as people are doing their work here, a shift away from ablation over time as patients do not want to go through the surgical procedure or the radioactive iodine, but really a lack of new medical therapies that has left something like a quarter to 30% of Graves' disease patients who are relapse, uncontrolled on or intolerant to ATDs. Just a very high proportion of patients who are unable to get well controlled. As a reminder, on slide 17, this is a bad disease. These patients are at much higher risk of cardiovascular events, much higher risk of preeclampsia, four times higher risk of preeclampsia, and a seven times higher risk of thyroid cancer than the general population. These patients are really sick or at a high risk of developing severe comorbidities. They often go on to develop thyroid eye disease.

About 40% of patients go on to develop these eye symptoms, some of which get optic neuropathy and other issues that can be pretty significant for vision. Then there's a bunch of other complications here. You know, 16% are diagnosed with thyroid storm, which has a, in particular, with hospitalized for Graves' disease. 16% are diagnosed with thyroid storm, which has a 20% mortality rate. Again, potentially sort of very sick patients and, again, a relatively high risk of thyroid cancer, including a high risk of progressive thyroid cancer. A disease that makes people quite sick. Again, more to come on the 11th, but just wanted to highlight that fact. Then, you know, on page 18, in addition to being a severe disease, it's a disease affecting a lot of people.

You have, you know, every year, call it 65,000 newly diagnosed patients, of which, you know, 20,000 of those wind up in that sort of refractory bucket. There are 880,000 diagnosed U.S. patients, of which 330,000 in the prevalent population are walking around in that intolerant or unable to get well-controlled bucket. They are just a huge patient population with a significant unmet medical need. What we showed earlier this year in the batoclimab study is a pretty interesting result. We showed real disease-modifying benefit in these patients. You know, of the 25 patients who came in at baseline, as a reminder, the way the study worked, patients were treated for 12 weeks of high-dose batoclimab, followed by another 12 weeks of low-dose batoclimab, and were then followed for another 24 weeks off drug entirely.

What we saw is, you know, after that first 12 weeks, 20 out of 25 of those patients were responders to therapy. After dropping to low dose, after another 12 weeks, 18 out of 25 of those patients were responders. Truly remarkably, after being off drug for a further six months, 17 out of the 21 patients we were able to follow up with at week 48 were responders to therapy. These are patients who were uncontrolled on standard of care at the beginning of the study, and 17 out of the 21 of them that we were able to follow up with remained responders to therapy, having been off drug for six months. A pretty remarkable disease-modifying benefit.

Of the off-drug responders on page, on the off-drug responders on slide 20, nearly half of them were fully off ATDs, and over 75% of them were on only the lowest doses of ATDs or off ATDs. Not only were we able to deliver disease-modifying benefit for patients who were uncontrolled on ATDs before, we were able to significantly reduce or eliminate ATD need for those patients. This was underscored on slide 21, not just by the sort of clinical data on T3 and T4 and so on, which is obviously the most important to the patients, but you can also see it in the TRAb reductions on slide 21. As you can see, as you'd expect for FcRn therapy, these patients showed a rapid decline both in general IgG and in TRAb levels, especially on high dose.

The IgG levels came back a little bit, as you'd expect, during the lower dose period. What is maybe unique to Graves' disease, or at least unusual among FcRn indications, is while IgG bounces right back when you come off therapy, and the only time points on this graph are week 24 and week 48, by week 48, these patients were effectively back at baseline from IgG. The vast majority of these patients still had basically sort of reduced or no TRAb, and that is a pretty remarkable finding around the durability of the benefit here. You know, on slide 22, the next period is absolutely stacked for us in 1402, with data coming in a variety of indications, DGTRA and CLE next year, the second part of the DGTRA study, as well as Graves and MG in 2027, and then Sjogren's and CIDP after.

One small update just to flag for today, the TED study remains on track to conclude this year. Last patient, last visit is very close to today. We are going to hold off reporting the top-line data from that first study in all likelihood until we see the top-line data for the second study in the first half of next year. The evolving competitive landscape in TED and especially in Graves' disease has led us to take a more prudent path there. We are going to collect that data together and report it when we have it all. Moving on briefly to just a reminder of where we are on the LNP litigation, which I know some people are following. In the Moderna case, we are in a pretrial process around the narrowing claims and defenses and around summary judgment, which is happening now.

The judge is reviewing summary judgment briefings and there's sort of a calendar on the docket that we're hoping will take us through trial in March. The trial is scheduled for March, and the first international proceedings are also expected in the first half of 2026. The Pfizer case is ongoing in discovery, and there was a favorable marketing ruling issued in September that certainly sets us up nicely for what we think we need to do from there. I'll conclude before we go to Q&A with a brief financial update. You know, overall, a straightforward quarter from a financial perspective, loss from continuing operations, net of tax of $166 million, and, you know, cash and cash equivalents of $4.4 billion with no debt on the balance sheet, and obviously a share count reflective of the significant share buybacks we've done over the last 18 months.

A strong position overall that, as I said, is expected to carry us through profitability. We've got more of our financials in here and the catalyst sort of roadmap on slide 28. Again, just a really exciting six months or 12 months behind us and a really exciting 12 months or 36 months ahead of us. Feeling great about where the business is, feeling great about the significant transformation in our profile that we've been through in the recent months and looking forward to carrying that forward from here. Once again, as a reminder, we have an investor day in New York City for those that can make it in person on December 11, 2025. That registration link is live. It's in the presentation we'll put up as well as on our website.

I hope to see many of you there to round up the year and talk about the future. With that, I'll say thank you again for listening. Again, a relatively quiet earnings call, but not at all a quiet quarter. I will pass it back over to the operator for Q&A. Thank you, everybody.

Operator (participant)

Thank you. Please find John. As a reminder, to ask a question, you will need to press star 11 on your touch-tone telephone and wait for your name to be announced. To withdraw your question, simply press star 11 again. Please stand by while we compile the Q&A roster. Now, first question coming from the lineup, Dave Frisinger with Leerink Partners, Yolanda Snowbin.

Dave Risinger (Analyst)

Thanks very much. Congrats on all the progress, Matt, and looking forward to the event on the 11th.

My question is, could you please comment on what we should be watching next with respect to Pfizer litigation? Specifically in international markets and then in the U.S. Thanks very much.

Matt Gline (CEO)

Yeah, thanks, Dave. Appreciate the question. Obviously something that a number of people are watching. It's tough, as always, to comment on ongoing litigation. I have nothing to say about any potential timing of any kind of international cases. You know, look, it's a busier moment coming up. I think there should be a sort of scheduling process for the Pfizer case underway, and we should learn more about the exact timeline, including hopefully a trial date in the near future. I think that's probably what I would be most watching out for in terms of what's public at this point, just getting that schedule together and progressing from here. Thanks, Dave. Great question.

Dave Risinger (Analyst)

Got it. Thank you.

Operator (participant)

Thank you. Next question coming from the lineup, Brian Chang with JP Morgan, Yolanda Snowbin.

Brian Cheng (Analyst)

Hi, Matt. Thanks for taking our question this morning. Just two quick ones from us. How do you feel about Argenx stepping into Graves and whether that has any impact on your strategy of 1402? We have a quick follow-up.

Matt Gline (CEO)

Thanks, Brian. It's a great question. I think you heard my comment on the timing of the intended sort of production of the brotelcomab TED data. Obviously, we're acutely aware of the competitive landscape in Graves' disease. I think, to make a gentle comment, whatever, imitation is the finest form of flattery. I think it's great to see others recognizing the importance of Graves' as a disease. It's great to see more people working on treatment options for these patients.

Obviously, in our phase two study, we studied both high and low-dose batoclimab, and we saw a great benefit to the higher dose batoclimab in the study. We reported in the past data breaking out the patients between that 70% cutoff below and above and below 70% IgG reduction. We had three times as many patients getting off ATDs at the above 70% group as in the below 70% group. We think we should have quite a competitive profile there. Most importantly, to be honest, it is a big patient population. There are a lot of sick people. I think a rising tide there will lift all boats. Like I said, Argenx is a formidable company with a wide following and has done a great job of execution.

I know there are at least some people out there who find it, although it might be frustrating to us, validating of our strategy, but they are following in our footsteps. We will always take it. Thanks, Brian.

Brian Cheng (Analyst)

Okay. Just one quick one. On the investor day next month, just curious if you can talk about, you know, what do you want investors to get out of the investor day? Is this more of a broader recap of your current strategy, or do you think that there will be some unveiling of completely new data or a new strategic direction at Immunovant?

Matt Gline (CEO)

Yeah, look, it would not be a fun investor day if I revealed all of it now. I think most importantly, this is just, it is a moment of huge transformation for our business.

I think the type of investors who are now along for the ride are different, and obviously a lot of other things about the business are different. I think we want to make sure we're telling that story fully, that we're helping people see the course from a commercial perspective, from a patient need perspective, and these indications so they can see, you know, at least the reasons why we are so excited about these indications, about the sort of nature of the blockbuster opportunity. You know, there might be some other new things we're able to share by then in terms of updates or other things, but we'll see where we're at in a few weeks here or in a month.

I think it'll be an exciting opportunity to get together and take stock of the business and to talk a lot about the future and the opportunities in front of us.

Brian Cheng (Analyst)

Thank you, Matt.

Matt Gline (CEO)

Thanks, Brian. Really appreciate the questions.

Operator (participant)

Thank you. Our next question coming from the lineup, Samantha Semenkov with Citi, Yolanda Snowbin.

Samantha Semenkow (Analyst)

Hi, good morning. Thanks very much for taking the question. Just for Graves', when thinking about the remission data, is there any way to tease out the impact of starting on the high-dose batoclimab in that study and how much that actually contributed to the remission rates you saw? I'm just wondering if there's anything that you could share that you were able to tease out from the data when you analyzed it so as we think about the competitive landscape. Thanks very much.

Matt Gline (CEO)

Yeah. Look, thanks. That's a great question.

I do think we're going to, like I said, be a little bit careful about some of what we say here because of the evolving competitive landscape. We're going to learn more about this from the hyperthyroid TED patients and so on in that study as well. Look, I think in general, remission is about TRAb getting normal for longer. Our view is that deeper IgG reductions are going to drive towards exactly that outcome. Both in terms of the speed of responses that we saw in the BATO trial and the depth of responses that we saw in the BATO trial in terms of TRAb lowering, I think that's going to be a significant driver for us.

I think we feel good, let's put it this way, about our level of IgG suppression in that program at high dose. Thanks. It's a great question.

Operator (participant)

Thank you. Now, our next question coming from the lineup, John Weber with TD Cowen, Yolanda Snowbin.

Yaron Werber (Analyst)

Great. Thanks so much, Matt. Maybe a quick question. We've been getting a few questions about the ongoing preliminary, the summary judgment against Moderna with respect to the U.S. government involvement in the EUA, and whether the government ever took "control" of the vaccines for distribution and whether that made them a commercial party and whether that impacts their involvement and as a result would potentially provide Moderna some venue to make an argument. Any thoughts about that? If you can comment at all, it'd be great. Thank you.

Matt Gline (CEO)

Yes, thanks. Thank you, Your Honor.

Again, as usual, it's difficult to comment in depth about an ongoing litigation, and it's ultimately going to be the judge's decision on the 1498 question. I'll point out that the two things that are just worth keeping in mind. One is the Moderna case in the U.S. Moderna sales of COVID vaccines in the U.S. in total is a bit less than half of Moderna's total global COVID vaccine sales. Moderna's total global COVID vaccine sales are a bit less than half of the total inclusive of Pfizer. What Moderna has claimed in their own briefings is, we asked for about $5 billion in damages in the U.S. case, and Moderna has claimed that a little bit less than half of those damages would be subject to 1498 in Moderna's view.

I think you're talking about a little bit less than half of a little bit less than half of a little bit less than half of the total is the issue in summary judgment on 1498. Our position is pretty clearly laid out in our motions, and frankly, Moderna's position is also laid out in their motions. You know, obviously, we feel like we have a strong case to make here, but it's ultimately going to be up to the judge to determine. I just wanted to sort of scope out the magnitude of the question as well. Thanks, Your Honor.

Yaron Werber (Analyst)

Thank you.

Operator (participant)

Thank you. Our next question coming from the lineup, Brooke Haueggerle with Cancer Fiscal, Yolanda Snowbin.

Prakhar Agrawal (Analyst)

Hi. Thanks for taking my questions and congrats on the progress in the quarter.

Maybe firstly on Sjogren's disease, recently there has been a lot of excitement around Sjogren's market opportunity, especially with the recent data from Novartis' BAF drug and Elumab. Maybe can you contextualize how FcRNs can differentiate on ESSDAI scores or other specific endpoints? Do you think you could be first in class in this indication? Secondly, just quickly on BREPO and DM, do you plan to apply for FDA's national priority voucher for BREPO? Thank you.

Matt Gline (CEO)

Thank you. Those are both great questions. Look, I think on Sjogren's, we are also excited about the market opportunity. It's a large patient population with a very significant unmet need. Just a lot of people kind of going through it, as it were. There have been a variety of therapeutic classes that have shown some benefit.

Obviously, the in-class data was positive, and the J&J data in particular showed that lower is better. We think we have a real shot at best in class. We are working to launch as close to first in class as possible. I do not think we are here to commit that we will beat our competitors, who obviously got a little bit of a head start on us, but I think we are trying to be kind of within a window small enough such that it should not matter who comes first, and we can differentiate based on our profile. I will just say, I think, you know, I think first of all, I think the Novartis data was positive, but probably left room for even better, as I think have all of the Sjogren's data produced to date.

You know, I think the FcRn data to date has sort of been competitive with other classes of drugs. If our deeper IgG suppression yields a better benefit than the other FcRns, I think we should have a truly important opportunity in the space. There is a lot of excitement about new therapies from KOLs and from our investigators. The unmet need is significant. The overall market is a significant number of patients. It is a great place for us to be in our view. Sorry, you asked about the CMPG program for BREPO. We have not said, look, this is an orphan population with high unmet needs. I think we are thinking through all of the different ways we can get through FDA and out to patients as quickly as possible and thinking about the puts and takes of them all. Stay tuned.

Prakhar Agrawal (Analyst)

Thank you.

Matt Gline (CEO)

Thank you.

Operator (participant)

Now, our next question coming from the lineup, Corinne Johnson with Goldman Sachs, Yolanda Snowbin.

Corinne Jenkins (Analyst)

Good morning. Maybe following up on an earlier question about competitive intensity in Graves' disease, I think it goes beyond Argenx in terms of number of companies that have announced plans there. How are you thinking about the kind of competitive clinical landscape that is evolving, and what do you expect to inform sequencing decisions in that space over time? Maybe separately, just on business development, curious if you could give an update on what you are seeing on that front. Thanks.

Matt Gline (CEO)

Yes, thanks, Corinne. Look, I think the first question, and obviously, we see the competitive landscape. Similarly, there is a number of people trying different things, which is exciting. It is exciting for Graves' space. It is exciting to be there.

One comment about that is, look, I think we've watched the myasthenia gravis landscape play out, and there's a lot of competitive intensity and a lot of new mechanisms. Also, that FcRn has been, A, a pretty undisputed king so far, and B, that the first FcRn to launch with the quality of that data has been a tremendous head start. We think we've built something similar in Graves' disease, which is a market, obviously, you know, a multiple of the potential size of the MG market. We feel great about our position, both from a timing perspective as well as the mechanism. It's a well-understood mechanism, FcRn, and it's pretty exquisitely well-suited to treating the biology of Graves' disease.

You know, you think about some of the other mechanisms outside of FcRNs, they have something in common with ATDs, which is that at high doses, they will cause patients to go hyperthyroid, which is a miserable thing as well. I think one of the great things about FcRn biology is, other than maybe for a very short period of time, because what you are really doing is getting at the root cause of the disease with these autoantibodies, you're not going to cause the thyroid to react in the other direction sort of directly. It's not like a TSHR targeted mechanism or something like that. I think that will be a big benefit to FcRn. The other thing that I think is maybe underappreciated in some communities about FcRNs is just how safe and well-tolerated they are.

I think in a Graves' patient population, that is going to be an important fact that I think will be great for FcRNs as a mechanism. You know, I think that those will all be sort of good guides towards FcRNs being important and early line therapy for these patients who can't manage it with standard care today. In general, as I said, I think lots of activity in the space is actually going to be good for everybody. These are docs who haven't run a lot of clinical trials. These are docs who haven't had a lot of new treatment options. I think the more voices there are out there talking about this stuff, the better we'll be able to get out to the patient population. Thanks. It's a great question. You asked for BD update. Look, we remain extremely well-capitalized.

We remain very excited about the opportunities for pipeline expansion. We are incredibly excited about the things we currently have in our pipeline. Obviously, you hear that in our voice. You see that in the way that we're talking about our data. Obviously, we're thinking about indication expansion for those programs and then always looking in the world for programs, especially programs that are of a size and scale that can move the needle against the backdrop of our existing pipeline. I think we've got some exciting ideas.

Corinne Jenkins (Analyst)

Thank you.

Matt Gline (CEO)

Thanks, Corinne.

Operator (participant)

Thank you. Our next question coming from the lineup, Dennis Sting with Jefferies, Yolanda Snowbin.

Dennis Ding (Analyst)

Hi, good morning. Thanks for taking our questions. We have two, if we may. Number one, on POLMIVANT. You guys will have phase two PHILD data in the second half of next year, I guess.

How confident are you about the translatability from PAH to PHILD? It has me thinking about that update and what's a positive delta on PVR. And secondly, on the LNP litigation, I'm curious if you've done any work on what percentage of the U.S. doses were given to actual federal government employees as we think about a middle scenario for summary judgment. Thank you.

Matt Gline (CEO)

Thanks, Dennis. I appreciate it. Both great questions. Thanks for the question about POLMIVANT. We're obviously super excited about Mosley. Look, I think you have correctly identified the risk that exists in the Mosley data. That is, we don't have data in the PHILD patient population, and that's sort of the nature of this study. In general, PVRs have translated well. And so, I think that's an important backdrop fact between these indications.

Where they haven't, it's mostly been, for example, because of these VQ mismatch issues associated with vasodilation in lung disease patients. We think the format of Mosley addresses that issue. We are, I'd say, cautiously optimistic about that translation. Obviously, I'll feel a lot better when that phase two B data is in hand. My hope is that we see pretty significant PVR reductions and pretty significant clinical benefit in those patients. Looking forward to that data in the second half of next year. That's another area where there's quite a lot of enthusiasm for the program and for new opportunities, especially with the overall growth in the prostacyclines in PHILD, leaving plenty of room for additional mechanisms. The other thing I'll point out is just the 38% PVR reduction we saw in pulmonary hypertension.

Even if PVR reductions are for some reason a little bit lower in PHILD, obviously, there's still a lot of room for a very significant amount of benefit for these patients. Your second question, what % of doses given to federal employees? I don't think our best estimates of that are in any of our motions. I think you can imagine, as you think about the number of federal employees, that it's a relatively small %.

Dennis Ding (Analyst)

Got it. If I can think one more in about the LNP litigation, maybe remind us what's the status in terms of the OUS trials. We're not that familiar with the OUS process. I guess can you remind us how many cases you filed, which one to defer this along, and can you get an initial decision in 2026? Thank you.

Matt Gline (CEO)

Yeah, thanks. It's a great question.

In the case in Brno, we filed a number of OUS actions, including in the UPC in Europe, as well as in Canada and Japan and a couple of other places. Those litigations are all ongoing. There are important hearings in 2026. The nice thing about some of these European jurisdictions is they can move quickly. It is possible that we would get outcomes of various kinds within 2026 in some of those jurisdictions. I obviously look forward to saying more when there's more to say.

Dennis Ding (Analyst)

Perfect. Thank you so much.

Matt Gline (CEO)

Thanks.

Operator (participant)

Now, our next question coming from the lineup, Yasmeen Rahimi with Piper Sandler, Yolanda Snowbin.

Dominic Lorenzi (Analyst)

Congrats on a great quarter. This is Dominic on for Yasmeen Rahimi. We just had a question going into the TED data.

Could you help us understand what you're thinking about with the expectations for the studies that are reading out here soon? And what do you hope to see to consider development considering the competitive landscape? Thank you.

Matt Gline (CEO)

Yeah, thanks. It's a great question. We're looking forward to having that data relatively shortly for sharing it next year. Look, I think the competitive ball in TED is relatively high with IGF-1Rs being pretty efficacious. That said, they certainly leave room from a safety perspective, etc. And so, I think, you know, we're looking to see data that makes sense in the context of the competitive landscape there.

The other thing that I think, and this is part of the reason why we're focused on the sort of competition in Graves' disease, I think we'll learn a lot about hyperthyroid Graves' patients from this study, as well as, you know, the possible ways in which Graves' and TED might interact with one another. I think we're looking forward to the data from that perspective as well. We'll obviously make a final decision on a launch in batoclimab once we've got the TED data in hand and in consultation with our partner. Thanks. It's a great question.

Dominic Lorenzi (Analyst)

Thank you.

Operator (participant)

Thank you. Now, our next question coming from the lineup, Doug Ossop with HC Wainwright, Yolanda Snowbin.

Douglas Tsao (Analyst)

Hi, good morning. Thanks for taking the question. I guess maybe as another follow-up on Graves' and TED, as you referenced, the two diseases are obviously sort of interrelated with interplay.

I mean, I guess when we think about Argenx, they will potentially come to market with VYVGART in both Graves' and TED, hypothetically. Obviously, you have a big head start with 1402 in Graves. I'm just curious how you're thinking about potentially pursuing TED with 1402 versus, as you just noted, potentially thinking about batoclimab and the sort of disadvantage of maybe sort of coming out very dual markets with two different molecules. Thank you.

Matt Gline (CEO)

Yeah, look, thanks. It's a great question. A couple of comments about this. One is, you know, we've been speaking in the abstract now. We're going to know a lot more about the TED data that will inform the answer to this exact question.

We will be in possession of more information than anybody else will have at this moment in time on the sort of overall treatment landscape and on what FcRNs can deliver. I think that will set us up really nicely to think about the possible options. You know, they're a totally different call point in terms of the physicians who treat these things. There are different stages of disease. I think, you know, they get treated at different times and different ways. I think being able to talk to endos who are treating Graves' patients about the benefit in forceful TED, for example, is an important potential thing to be able to discuss when we get to it.

You know, in terms of, you know, thinking about the sort of TED versus Graves' market dynamics, I'd say let's just wait and see what the TED data looks like. Then we can talk more about it. As a reminder, the Graves' population is meaningfully bigger, and it's upstream of the TED population. I think there's a reason that was our first focus once we got into the clinic with 1402. Great question.

Douglas Tsao (Analyst)

Okay, great. Matt, if I can, on a follow-up with BREPO, obviously, you know, incredibly impressive results in DM. I'm just curious if you've given thought, just given sort of as somebody alluded to, the competitiveness in Sjogren, have you ever thought of that as an indication? I think there is a mechanistic rationale and obviously an oral option would be very attractive. Thank you.

Matt Gline (CEO)

Yeah, thanks.

I appreciate the question. Look, I think the short answer is we have thought pretty exhaustively about possible indications for BREPO. We have a number that we think are exciting beyond what we've talked about. I think, you know, if you look at the indications we've chosen so far, they've been indications where we can really chart a market-defining course. I think there are maybe more to do in that story. The short answer is there's an embarrassment of riches in terms of the indication set available for BREPO. We feel very privileged with the data we have in hand for what we've got. As a reminder, it has worked almost everywhere it has been tested. You know, I think we feel like it's a great molecule and with a lot of great places to go. Thanks for the question.

Douglas Tsao (Analyst)

Thank you.

Operator (participant)

Thank you.

Next question coming from the lineup, Derek Arcilla with Wells Fargo, Yolanda Snowbin.

Morning. This is Hau calling in for Derek Arcilla from Wells Fargo. Thank you so much for the question. I guess we have a question on BREPO. We were at ACR, so very positive feedback on all the KOLs. The question is about really the competitive landscape. I guess we've seen Vyvgart having data next year and the CAR-T is also starting their pivotal trials. How do you see, you know, the kind of the treatment paradigm evolve over the years? And BREPO, do you have also planned to explore in other subtypes of myositis like IMNM, ASYS? Thank you.

Matt Gline (CEO)

Yeah, perfect.

You know, look, I think on the DM competitive landscape, similar comment to, frankly, my comment in Graves, which is that I think it's a great opportunity to be able to get out in front of it. You know, and obviously, first and foremost, it's going to be easiest. Oral is always going to have a huge place. The majority of these patients are on oral therapy now. I think, you know, just like the overall profile of it makes us unique. I'll say the CAR-Ts, that's not, in my opinion, going to play for the same patients mostly that we are. That's obviously a much different sort of intervention. There's still plenty of open questions about benefit there. You know, look, I think that's all sort of a little bit about that landscape. FcRn could be a compelling option.

Obviously, IVIG is used. I'd say, first of all, it's good to have what we think of as a multi-year head start in DM. You know, we think the patient population that we have access to, given the nature of our therapy, is really basically the entire DM patient population, which gives us a lot of room to go. We think, again, similar to Vyvgart in MG, we get to define that market and be the heart of it. You know, I think that's all great. We also suspect that the data we have in DM specifically may be just the best overall. That's the biggest part of the myositis market. Obviously, Argenx is studying in other subtypes of myositis as well, and some of those may be more directly appropriate for an FcRn.

You know, as to your question about other subtypes of myositis for us, I'll just say again, we've thought about a whole bunch of different places to go. There's a lot of exciting places to go. We have an embarrassment of riches in terms of where we can take the molecule from here. Thanks for the great question.

Operator (participant)

Thank you. Our next question coming from the lineup, Thomas Smith with Leerink Partners, Yolanda Snowbin.

Thomas Smith (Analyst)

Hey, guys. Good morning. Congrats on the progress. Thanks for taking our questions. Just with respect to the TED program and the competitive landscape, could you comment on some of the data we recently saw from the IL-6 class? Whether you think SATSA is approvable with that data set and sort of your expectations for batoclimab relative to those results.

And then secondly, is there any update you could provide from the overseas study that you're running with 1402 and any sort of timing guidance for when we might see data from additional indications from that study? Thanks so much.

Matt Gline (CEO)

Yeah, thanks. Those are, look, obviously great questions. I'll say, obviously not our place to make comments on the provability of other mechanisms. There was a notably high placebo response in the IL-6 study, which is something we've paid attention to. Overall, you know, no specific comments on where that program goes from here. From a competitive landscape perspective, I think the competitive intensity in TED is real, as I said earlier. The IGF-1Rs are efficacious, although they have safety and tolerability concerns associated with them. I think we're sort of focused on where we could play in TED.

As we said a minute ago, you know, thinking about Graves, thinking about Graves' opportunity to impact the disease much earlier in its course. I think that's an important thing to the way that we are approaching that with 1402. On the sort of second overseas study, look, I think we obviously at this point have a number of large registrational programs running in 1402 that are big global studies. We continue to like the option of small, fast POCs overseas and feeding that information into bigger studies. If and when we have anything to share from those ongoing efforts, we'll share it. Mostly, it's being used to inform either indication selection or design decisions of the bigger studies. Thanks for the questions.

Operator (participant)

Thank you. Our next question coming from the lineup, Brandon Frith with Wolf Research, Yolanda Snowbin.

Brandon Frith (Analyst)

Hey, this is Brandon for Andy.

Thanks for taking the question. Have you provided any analogs for the DM launch? We're curious to know what to expect for the cadence out of the gates and longer term. Thank you.

Matt Gline (CEO)

Yeah, perfect. Look, I think DM is an area with high unmet need, but also not a lot of novel therapies recently launched. First of all, there aren't great analogs to look at specifically in DM. Second of all, I think the appropriate course for any public company is to guide cautiously on launch speed and to say that we're going to do everything we can to get this drug out there and to get docs excited about it.

The thing that we're most confident in is that the overall market opportunity is large, that there is high unmet patient need, and that when we get to peak penetration, there's a really big and exciting opportunity. Exactly how long it takes us to get there, I think we're going to see is the answer. We're going to do everything we can to make it as successful as we can. Obviously, the real value add is the stuff to get the long-term trajectory here right. That's probably how I think about the launch.

Brandon Frith (Analyst)

Thank you.

Matt Gline (CEO)

Thanks.

Operator (participant)

Thank you. Our next question coming from the lineup, Sam Sliski with Lifestyle Capital, Yolanda Snowbin.

Hey, all. Congrats on the quarter. This is Gorgon for Sam from Lifestyle. Just a question on Graves here.

You know, based on all the market research done to date, as you compare the uncontrolled Graves disease opportunity versus what FcRNs have shown, you know, in the MG market, I guess, how do you size these up? You know, how are you thinking about the opportunity? Is it bigger, smaller, similar as we think about MG for FcRNs? Thank you.

Matt Gline (CEO)

I mean, look, it's hard to—the MG market has been tremendous. And so I think, you know, it's hard to call it one way or another. Obviously, there's a lot of uncontrolled Graves patients. It's an exciting place to be. I think we have a real opportunity to build something big. There's just lots and lots and lots of uncontrolled patients is the answer. The other thing I'll say is we'll talk more about the commercial opportunity in Graves disease on December 11th.

I think we're excited with what we see. I think we can make them—I think the most important thing is there are hundreds of thousands of patients for whom we could make a meaningful difference and a lot of different ways for us to get into that market and establish different toeholds and places. We are looking forward to all of that. We are also learning, and I want to highlight this as an important advantage that we have from being first, so much about the Graves opportunity by being out there with these docs enrolling patients in the study, looking out at what we're finding. I think that competitive benefit is going to set us up really well to make sure we've got the right product on the market as well.

Great. Thank you.

Thanks, Sam. Thank you.

Operator (participant)

Thank you.

Matt Gline (CEO)

There are no further questions at this time. I will now turn the call back over to Mr. Matt Gline for any closing remarks. Thank you. Thank you, everybody, for listening this morning. Once again, a phenomenal quarter for us in terms of the results we delivered. And super importantly, looking forward to getting together on the 11th to talk about the future and address in further detail some of the very same questions we got on today's call. I hope to see many of you there. I hope you all have a great end to your year apart from that. Thanks very much and have a good day.

Operator (participant)

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