Q2 2025 Roivant Sciences Ltd Earnings Call & Business Update
Good day. Thank you for standing by. Welcome to the Roivant second quarter 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press *1, 1 on your telephone. You will then hear an automated message advising that 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 Griffin. You may begin.
Good morning, and thank you for joining today's call to review Roivant's financial results for the second quarter ended September 30, 2025. I'm Stephanie Lee, and presenting today we have Matthew Gline, CEO of Roivant. For those dialing in via conference call, you can find the slides being presented today, as well as a press release announcing these updates, on our IR website at www.investor.gov. 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 will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we've filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties.
And with that, I'll turn it over to Matt.
Thank you, Steph and good morning everybody and thank you for listening.
I appreciate all your dialing in, um, say not at all a quiet quarter for us and that we put out, uh, both the graves data and obviously the phase 3 data for for brexit nib and DM. So just a tremendous moment of transformation for the business, but a relatively quiet earnings call. As we're looking forward to getting everybody together. Uh, in December, for a more wholesome telling of where we are as a business more about the future uh, on our investor day on December 11th, that registration link is live on our website to look forward to seeing you all there today, we'll be more of a review of what's happened in the recent quarter and then we'll talk much more about the future, uh, when we get together in December. So we're looking forward to that.
Um, I want to start out on slide 5 just by taking a short victory lap because it's been a pretty wild year for us.
Obviously, starting with, uh, and probably most notably the valor data, perhaps shouldn't have been DM, uh, which hit, uh, on all 10 ranked endpoints and just a phenomenal data set that we think is going to transform the lives of DM patients. So that NBA filing remains on track, plans for the first half of next year. Uh, and it'll be the first novel oral therapeutic in DM. Uh, if approved, uh, we also put out data in this quarter, uh, from the uh, durable remission sort of portion of the Graves disease trial for PTO mab, uh, which sets us up, uh, for the future there, in our, in our.
1402 Graves program, I you know that demonstrated disease, modifying potential for 1402 and then we think earlier this year uh we put out some data in mgnc IDP that we can do a pretty nice job of validating. The the deeper is better uh idea for fcrn uh from an IG expression perspective. Uh we also have initiated an immune event this year potentially registrational trials in Graves me gravis cidp, Dental Tri ra and Shoguns as well as a PC trial, and cl. So some really exciting progress there with Ivy 1402, which we hope will take us to a, a first, and last. In many cases in best-in-class, and we hope all in all indications potential. Uh, we got a favorable Mark in ruling this quarter for Gen of ant in the fiser case. And just overall continued progress in the LMP litigation, uh, with the jury trial and the minority case, scheduled for March of 2026, and our Capital position remains very strong with 4.4 billion dollars of cash cash equivalents, uh, which will get our current pipeline to profitability and support pipeline expansion.
A potential additional capital return, including the $500 million that we have currently authorized.
Uh, you know, on slide 6 and we've been showing this slide for a while, but it just, it feels realer and realer. Uh, with each passing quarter, just a play stage pipeline, that we are really excited about with 11 potentially registration trials, and indications, with Blockbuster potential. Obviously the first of those demanded by situs now behind us. But but, but many more to come setting us up for a slide that we've been showing since June on slide 7, which is just a stacked. 36 months ahead of us between multiple registration data sets first, DM, and NIU, and Breo. And then the beginnings of a, of a long list of them and 1402 lining up for a series of launches again, first, DM and breto, uh, and then NIU, and prepo and then and then very shortly thereafter at 1402 across multiple Blockbuster indications including Graves
So look, it's as I said, a moment of real change and transformation for the business. I 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 its excitement that I hear from investigators certainly and and patience and docks in the great in the, in the DM landscape and from investors as well. So so looking forward to the next leg of our journey here.
I'm going to do just a brief recap of the 2, major data sets from the quarter. So I want to spend a ton of time on either of these because we've talked about all of them in this setting before, but but they bear we mentioned, just because of how how exciting both of them are starting with the the representative Valor data you know, on page 9. Again, we've gotten through this all before but but but Valerie 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 mg to be the optimal dose here, uh, responses were rapid deep broad, clinically meaningful, uh, you know, across the board of statistically meaningful, and clinically important Delta to, to Placebo on mean tests, uh, with uh, deep responses, uh, occurring quickly, uh, and across a range of endpoints including muscle and skin.
And as a reminder on slide 10, this is a patient population with very significant unmet need. And 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, uh, are on only either steroids or ists and are are struggling to get well controlled. Uh, and, uh, you know, many of them are requiring high doses of oral pnone, uh, in order to be to sort of be treated appropriately and are all looking for for options or make them. We're looking for options, only a relatively small percentage, only a quarter of the market is currently on other
Other therapies at all and 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. So we're getting a a predictably enthusiastic response from all of the Physicians we've engaged with on this data already and are obviously looking forward to continuing that as we go through the registration process in the coming year.
Um, you know, looking at slide 11 again, uh, a recap from before, but, but but this is the primary endpoint. This is mean tests. Uh, and you know, this is a, a textbook picture from my perspective of positive clinical data statistically significant at the high dose. Starting at the earliest time Point, uh, nice clear separation, uh nice clear, dose response and 1 thing that 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 a clear benefit from the drug against the background of it. Not really Placebo, but actively actively, but actually actively managed, the background therapy and we did that. But the other thing we were able to show is a real dose response on steroid reduction that as we were able to get a significantly greater portion of patients to lower steroid doses or off steroids on high dose preventive. Then 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 by do steroids.
On the combination of endpoints, you know, on slide 12 again, without going through the mold just a a, a statistically robust data set. I'll say with, with with really low P values across every secondary we tested uh benefit on muscle benefit on skin benefit on patient reported outcomes like the the hacky questionnaire on on disability. Just a a, a terrific across the board uh, outcome here.
Uh, in terms of what's next here. I think everyone's clear. You know, the NDA submission were moving as fast as we can. The only real gating item here was Drafting and it's ongoing right now. We expect to get it filed, uh, in the first half, um, data readout from that proof concept study in CS that we have, ongoing will be next year, uh, in the NIU study. Uh, which is enrolling, very nicely, uh, is currently anticipated to read out, uh, or or say guided to the first half, 27 around the same time as potential registration of Breo and and launching DM. Uh and then you know we submit the snda for NIU shortly thereafter with potential further indications and so on to come. So that's for uh I'm sure we'll get some questions about it and like I said, we'll talk more about that program and what it could represent commercially uh,
On the 11th, but suffice it to say, uh, a tremendous quarter and something we're we're really excited to carry forward from here. Uh, next up, I'll just recap the Grave Disease, remission data, uh, that we put out. Uh, earlier this quarter as well, starting on slide, 16 would just a reminder, this is a uh very large patient population uh, with a significant unmet need. And
And they're saying, I think this is an important point as people are doing their work here: a shift away from ablation over time, as patients don't want to go through the surgical procedure or the radioactive iodine. But really, there is a lack of new medical therapies that's left.
Something like a quarter to 30% of graves. These patients, who are relapsed, uncontrolled on or intolerant to ATDs, represent 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, 4 times, higher risk, of of of free clamps and a 7 times higher risk of thyroid cancer than the general population. So these patients are are really sick or at a high risk of developing severe. Comorbidities, uh, they often go on, to develop thyroid identities, about 40% of patients. Uh, go on to develop these eye symptoms, some of which get, uh, optic, neuropathy and other issues, that that can be pretty significant for vision. Uh, and then there's a bunch of other complications here. Uh, you know, 16% are diagnosed with thyroid thyroid storm, which has a impatient with, with hospitalized. For rare disease, 16% are diagnosed with thyroid storm, which has a 20% mortality rate. So, again, potentially sort of very sick patients, and uh, again a relatively high risk of thyroid cancer, including a high risk of progressive, thyroid cancer. So disease, that makes people makes people quite sick again, more more to come on the 11th. But but just wanted to highlight that fact. And then, you know, on page 18
In addition to being a severe disease, it's a disease affecting a lot of people. And so you've got, 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. And then there's 880,000 diagnosed us patience. So what's 330,000 in the prevalent population are walking around in that, uh, intolerant or unable to get well controlled buckets. So just just a, a huge patient population with a significant unmet medical need what we showed earlier this year. Uh, in the PTO map study, uh, is a pretty interesting result. We showed real disease modifying benefits, uh, in these patients, you know, of the 25 patients who came in at Baseline as a reminder, the way to study work. Patients were treated for 12 weeks. So the high do lab followed by another 12 weeks of low dose, pmab, and we're Then followed, uh, for another 24 weeks off drug entirely. And what we saw is, you know, after that first 12 weeks, 20 out of 25 of those patients were responders to therapy. Uh,
After dropping to low dose after another 12 weeks, 18 out of 25 of those patients, uh, were responders a and truly remarkably after being off drugs for a further 6 months 17, out of the 21 patients. We were able to follow up with, at least 48, uh, were responders to therapy. So these are patients who were uncontrolled on, 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 remain respondents to therapy having good off drugs, for 6 months. So so,
This was underscored on slide 21, not just by the sort of clinical data on T384 and so on, which is obviously always most important to the patients.
But you can also see it in the Trap, reductions on slide 21. And as you can see, as you'd expect for fcr and therapy, uh, these patients showed a rapid decline, both in general IGG and in treb levels, especially in high dose. The, the IG levels came back a little bit as you'd expect during the lower dose period. And then what is maybe unique to Graves disease or at least unusual among fcr? And indications is well, IGG, bounces right back. When you come off therapy and the only time points on this graph are League, 24 and weak 48. But by week 48, these patients were effectively back at Baseline for IGG the vast majority of these patients still had
Basically, sort of reduced or not to grabs.
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 uh, dtra and C next year. Uh, the second part of the dtra study as well as Graves and mg uh, in 2027, uh, and then show within cidp after 1, small update just to flag for today. Uh, the the Ted study remains on track to conclude uh, this year last patient. Last visit is uh
Very close to today. Uh, but, uh, we're going to hold off reporting the Topline data from that first, study in all likelihood until we see, uh, the Topline data for the second study in the first half of next year, the evolving competitive landscape in Ted, and especially in Graves disease. Uh, has led us to to take a more prudent path there. And so we're going to collect that data together and report it when we have it all
Um, moving on to the, uh, to briefly to just a reminder of where we are on the LMP litigation which I know some people are following, uh, in the madna case. Uh, we are in a pre-trial process around the narrow and claims and defenses, and around summary judgement, which is uh,
Which is happening. Now the judge is reviewing summary judgement briefings uh in the sort of a calendar on the docket that we're hoping will take us through trial on March. The trial is scheduled for March and the first International proceedings are also expected in the first half 2026. The fiser case is ongoing in Discovery and there was a favorable Mark in the ruling issued uh in September. That certainly sets us up nicely for what we think that we need to do from there.
Um, so I'll conclude before we go to Q&A uh, with a brief Financial update, uh you know, overall a straightforward quarter, from a financial perspective uh lost continuing operations that attacks of of 166. Uh and uh, you know, cash cash flow is a 4.4 billion with no debt on the balance sheet and obviously a Share account reflective of the significant share of BuyBacks. We've done over the last 18 months
So a strong position overall that, as I said, is expected to carry us through profitability. Uh, we've got more of our financials in here and the Catalyst sort of roadmap on slide 28. But, but but again, just a, a really exciting 6 months or 12 months behind us and a really exciting. 12 months to 36 months ahead of us. So feeling great about where the business is feeling great about the just the, the significant transformation in our profile that we've been through in the, in the recent months. And, and looking forward to carrying that forward from here. Once again, as a reminder, uh, uh, we have an investor day, uh, in New York City, for those that can make it in person on December 11th, 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 uh, many of you there to round out the year and talk about the future. So with that, I'll say thank you again for listening. Again, a relatively quiet earnings call, but not at all a quiet quarter and I will pass it back over to the operator for Q. And I thank you everybody.
Ladies and gentlemen, as a reminder to ask a question, you will need to press star 1 1 1 on your touchtone, telephone and wait for your name to be announced. So we try your questions simply press star, 1 1 1, again please, stand by. While we compile the career master,
Now, first question, coming from the line of Dave for singer with luring Partners, your line is now open.
Thanks very much. Uh, congrats on all the progress. Matt, and looking forward to the event on the uh, on the 11th. So my question is, could you please comment on what we should be watching next with respect to fiser litigation so specifically in international uh,
An international markets and then in the US, thanks very much.
Yeah. Thanks, Dave. I appreciate the question. Uh, and 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.
Together and progressing from here.
Thanks, Dave. Great question. Got it. Thank you.
Thank you.
Our next question comes from the
Brian Cheng with JP Morgan yon is now open.
Hi Matt. Um, thanks for taking a question this morning. Um, just 2 quick ones from us. Um, how do you feel about our Gen X stepping into Graves and whether that has any impact on your strategy of 1402?
And that we have a quick follow-up.
Thanks. Thanks, Brian. It's a great question. And look, uh, I think you, you heard my comment on the, the timing of the intended, sort of production of the the token web T data. Obviously, we're acutely aware of the competitive landscape in Graves disease. Uh, and uh, look, I think, um,
To make a gentle comment, uh, whatever imitation is the finest form of flattery. Uh, I think, uh, it's it's great to see others, recognizing the importance of graves as a disease, uh, it's great to see, uh, more people working out treatment options for these patients. Obviously, in our Phase 2 study, we studied both high and low dose, uh, low document. And we saw, uh, a, a great benefit to the higher dose ptop, uh, in the study. And then also we reported in the past data, breaking out the patients between that 70%, cut off below and above and below 70%, IGG, reduction and we had 3 times as many patients getting off atds at the above 70% group and then the below 70% group. So we think we should
Quite a competitive profile there. But most importantly, to be honest, it's a big patient population. There's a lot of sick people, and I think, uh, a rising tide there will lift all boats. And like I said, uh, our Genex is an affordable company with a wide following and has done a great job of execution. And I know there's at least some people out there who find it, uh, all those might be frustrating to us, validating of our strategy that they're following in our footsteps. And, uh, we'll always take it. Thanks. Bye.
Okay, and and just 1 quick 1. So on, um, on the investor day next month, um, just curious, if you can talk about, you know, what, what do you want investors to get out of the investor day? Um, is this more of um, broader recap of, um, your current strategy or or do you think that there will be some unveiling of completely new data or new strategic direction that Roy vans?
Yeah, look, uh, it wouldn't be a fun investor day if I, if I revealed uh, all of it now but I I think most importantly, this is just it's a moment of huge transformation for our business. I think the type of investors who are now along for the ride are different. Uh, and obviously a lot of other things about the business are different. So 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 certain nature of the Blockbuster opportunity. You know, there might be some other new things we're able to share by then.
Terms of updates or other things, but, but we'll see where we're at uh, in a few weeks here in a month. But I think it'll be, 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.
Thank you, man.
Thanks B, really appreciate the questions.
Thank you. Our next question.
Coming from the line of Samantha semenov.
We align us now, open.
Hey, good morning. Thanks very much for taking the question, just for grave. When thinking about the remission data is there any way to tease out the impact of starting on the high dose for Toca mob and that study and and how much that actually contributed to the remission rates, you saw just wondering if there's anything that you could share, that you were able to, uh, T down from the data when you analyzed it. So, if we think about the competitive landscape. Thanks, very much. Yeah. Uh, look, thanks that's a, uh, it's a great question, uh, and I do think we're going to, like I said, be a little bit careful with that some of what we say here, because of the evolving competitive landscape and we're going to learn more about this from hypothyroid, Ted patients and so on, in in that study as well. But look, I think in general, remission is about t-rex getting normal for longer a and our viewers that deeper edgy, reductions are going to drive towards exactly that outcome. And so both in terms of the speed of of responses that we saw in the Battle of trial and the depth of responses that we saw in the battle trial, in terms of 2 out, lowering, I think that's going to be
Uh, that's going to be a significant driver for us. So I think we we feel good to put this way about our level of IGG suppression in in that program, at high dose. Thanks, it's a great question.
Thank you. Our next question, coming from the line of around, wherever with TD Cohen, is now open.
Maderna with respect to the US government involvement in the uh, the eup in the I'm sorry eua and what is the government, every 2, quote, unquote control of of the vaccine for distribution and whether that made them a commercial party and whether that impacts their involvement, and as a result would potentially provide Moana some um, some some venue to to to make an argument. Any thoughts about that? If you can comment at all the great. Thank you. Yes, thanks. Thank you. And again as you voice, it's difficult to come in in depth about an ongoing litigation and and it's ultimately going to be the judge's decision on the 1498 question. I'll point out that the 2 things that are just like worth keeping in mind. 1 is the madna case in the US uh madna sales of Co vaccines. In the US in total is a bit less than half of Mna total global global Co vaccine sales and Mna totals over that total.
Global COVID vaccine sales are a bit less than half of the total, inclusive of Pfizer.
Uh, a and so, and then 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.
Could be subject to 1498 in Maderna view.
And so, 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, Madna's decision is also laid out in their motions.
Uh, 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, but but I just wanted to sort of scope out the magnitude of the question as well.
Thank you. Thank you.
Thank you.
None. Next question, coming from the line of Broel with Cancer Christ. Child, the line is now open.
Hi. Uh, thanks for being my questions and congrats on the progress, on the quarter, maybe firstly on uh, shogun's disease. Uh, recently, there has been a lot of excitement around sugar and smoking opportunities, especially with the recent data from novartis's background in animal lab, we again context, uh, contextualize how fcrs can differentiate on fsds scores of the specific endpoints? And do you think that you could be first in class in this indication and secondly, uh, just quickly on breath and DM. Uh, do you plan to apply for fds National priorities out there for repos? Thank you. Thank you. Those are both both great questions. Look, I think on shor's. We are also excited about the market opportunity. Uh, it's a, it's a large patient population with a very significant unmet need, uh, and
And just a lot of people kind of going through it as it were. Uh 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. So if we think we have a, a real shot at at Best in Class, uh, we are working to launch as close to First in class as possible. I don't think we're, we're here to commit that, we'll, we'll beat our competitors. Who obviously got a little bit of a head start on us, but I think we're trying to be kind of within a window, small enough such that it shouldn't matter who comes first and we can differentiate based on our profile. And I'll just say, I think, you know,
I think, first of all, I think the Envy artist data was was positive but probably left room for even better. Uh, as I think have all of the shogun's data produced today, uh, and you know, I think the the the fcm data to date has sort of been competitive with other classes of drugs, uh, and so if our deeper IG expression yields a better benefit than the other other fcrn, I think we should have a truly important opportunity in the space. A lot of excitement about about new therapies from kol's and from our investigators, uh, the end that need to significant the overall Market is a significant number of patients. So so it's, it's a great place for us to be uh, in our view.
Um, and then sorry you asked about the, the CMT program for repo. Uh, we we haven't said, uh, look, this is a, uh, orphan population with high in that need. So I think we're thinking through all of the different ways we can get through, uh, through FDA and out to patients as quickly as possible and thinking about the puts and takes of them all. But, uh,
But but, but stay tuned.
Thank you.
Thank you.
No, next question. Coming from the lineup, Corin Johnson with Goldman Sachs, your line is now open.
Good morning and maybe you following up on an earlier question about competitive, intensity in Graves disease, they didn't get it. You know, it goes beyond our Gen X. In terms of number of companies that have announced plans. There are so, how are you thinking about the kind of competitive clinical landscape? The and what do you expect to inform sequencing the decisions?
Agents and Business Development, curious. If you can give an update on what you're seeing on that front, thanks.
Yes, thanks, Karen. Um, look, I think the first question, uh, and...
Obviously, uh, we we see the competitive landscape. Similarly, there's a number of people, trying different things. Uh, which is exciting. It's exciting for race based exciting to be there. What 1 comment about that is, well, I think we've watched the mice in your gravis landscape, play out, uh, and there's a lot of competitive intensity and a lot of new mechanisms. And also uh, that fcrn has been a, a a pretty Undisputed King so far and B that the first fcrm to launch with the quality of that data has been a, a tremendous, uh, Head Start. And we, we built something similar, uh, in Graves disease, which is a market. Obviously, you know, a multiple of the potential size of the mg market. So we feel great about our position, both from a timing perspective, as well as as a mechanism. It's a Well understood mechanism fcrn, uh, and it's pretty exquisitely. Well, suited to treating the biology of graves disease. So, you know, you think about some of the other mechanisms
outside of fcrn.
I have something in common with ATDs, which is that at high doses, they will cause patients to go hypothyroid, which is...
Which is a miserable thing as well. And so I think 1 of the great things about fcr and biology is other than maybe for a short for a very short period of time. You know, because what you are really doing is getting at the root cause of the disease with these. With these other antibodies, you're not going to like cause the thyroid to, to, to react in the other direction. Uh, sort of directly. It's not like a tshr targeted mechanism or something like that. And so, you know, I think that will be a big benefit to fcrn. The other thing that I think is, is, maybe underappreciated in some communities about fcrn is just how safe and well, tolerated, they are and I think in a great patient population that is going to be an important fact, uh, that I think will be will be, uh, will be great for fcrn as a mechanism. So, you know, I think, um,
I I think, uh, that that those will all be sort of good guides towards fcrn, being important, and early line therapy for these patients, uh, who, who can't manage it with with, with standard of care today. Um, you know, in general, as I said, I think lots of activity in space, is actually going to be good for everybody. These are docs who haven't run a lot of clinical trials. These are uh, docs who haven't had a lot of new treatment options and I think the more voices there are out there talking about this stuff, uh, the better we'll be able to get out to the patient population. So, thanks, it's a, it's a great question and then you ask for BD update. Look, we remain extremely well, capitalized. We remain very excited about the opportunities for pipeline expansion.
Uh, we we are incredibly excited about the things we currently have in our Pipeline. And obviously, you hear that in our voice. You see that in 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. And, uh, I think we've got some exciting ideas.
Thank you.
Thanks Karen.
Thank you.
For next question, coming from the lineup, Dennis staying with Jeffrey your line is now open.
Hi, good morning, thanks for taking the questions we have to. If we met, uh, number 1's on Poland, so you guys will have Phase. 2 pH. I will be data in the second half of next year. I guess how confident are you about? The translatability from, Paw to pH, ilv it helps me think about that update and what the positive uh, positive Delta on PVR.
Um, and secondly on the LMP litigation, I'm curious if you've done any work on what percentage of the US doses were given to actual federal government employees. As we think about a, a middle scenario for, for somebody judgement. Thank you. Thanks, Dennis. I appreciate it. Both great questions. Uh, thanks for the questions about following up. We're obviously super excited about Mosley. Look, I think, uh,
Opportunities especially with the overall growth in the process of cycling in in PH Al the uh leaving playing a room for additional mechanisms. The other thing, I'll point out is just the 38% PV reduction. We saw on pulmonary hypertension even if PVR reductions, are for some reason. A little bit lower in PH, alv obviously, there's still a lot of room for a very significant amount of benefits for these patients. Uh, your second question, what percent of doses given to federal employees? I don't think our best estimates of that are in any of our motions. Uh, but uh, I think you can imagine as you think about the number of federal employees that it's a relatively small percentage.
Got it and if I can and and if I can speak 1 more in about the LMP location maybe from minus, what's the status in terms of the O us trials? We're not that familiar with the OS process so I guess, can you remind us? How many cases you filed, which 1 is the farthest along and can you get an initial decision in 2026? Thank you. Yeah. So, uh, thanks it's a great question and we are, and with the case in Verno we filed a number of O us actions, including, uh, in the UPC in Europe as well as in Canada and Japan and a couple other places. Um, those litigations are all ongoing. Uh, there are important, uh, important hearings uh, in 2026. And the nice thing about some of these European jurisdictions is they can move quickly. So it is possible that we would get uh, outcomes of various kinds within 2026 in some of those jurisdictions. And obviously look forward to seeing more uh, when there's more to say
Perfect, thank you so much.
Thanks.
The next question, coming from the line of Jasmine Rahimi with Piper Sandler, you let us know often.
Hey, congrats on a great quarter. This is Dominic on for Yasmine Raimi. Uh so we just had a question going into the the Ted data. Um could you help us understand what you're thinking about with the expectations for the the studies that are reading out here soon? And what do you hope to see to consider development considering the competitive landscape? Thank you.
Yes, thank you.
It's a great question. Uh, we're looking forward to having that data relatively shortly for sharing it. Uh, next year. Look, I think the competitive bar in Ted is relatively high with with igf1 RS being pretty efficacious. That said they certainly leave room for a safety perspective Etc. And so I think, you know, we'll look into see data that that makes sense in the context of the competitive landscape there. Uh, the other thing that I think 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 hypothyroid. Graves patients from this study, uh, as well as uh, you know, the the possible ways in which Graves and Ted might interact with 1 another and so I think we're looking forward to the data from from that perspective as well. We'll obviously make a final decision on a launch in May, uh, once we've got the Ted data in hand and a consultation with, with our partner,
Thanks, it's a great question. Thank you.
Thank you. And our next question comes from the lineup with HC. When you're ready, your line is now open.
Hi, good morning. Thanks for taking the questions I guess. Matt maybe is another follow-up on Grace, and Ted. Um, as we referenced, um, you know, the 2 disorder. It's very interrelated with interplay. I mean, I guess when we think about our genetics,
They will potentially come to market with this, uh, being both ways and to add hypothetically. Um, obviously, you have a big head start with 1402 in Braves. So, I'm just curious how you're thinking about potentially pursuing, um, Ted with Fortune 02 versus, as you just noted, potentially thinking about the token lab, um, and the sort of disadvantage of maybe sort of coming at those dual markets with two different molecules. Thank you.
Yeah, look, thanks. It's a, it's a great question. Um, I I I and a couple of comments about this.
1 is uh, you know, it's it's we've been speaking in the abstract now. We're going to know a lot more about uh, the Ted data that will inform the answer to this exact question and we will be in possession of more information than anybody else will have, uh, at this moment in time on the, on the sort of overall treatment landscape and on what fcrm can deliver, which I think that
Is Braves market dynamics. I'd say let's just wait and see what the Ted data looks like. Uh and then we can talk more about it. As a reminder, the grace population is meaningfully bigger and its Upstream of the Ted population. And so I think there's a reason that was our first Focus. Uh once we got into the clinic with 1402,
great question. Okay. Great.
Not if I can on a follow-up with brefo, um, obviously you know, incredibly impressive results in DM on. You know, I'm just curious if you have given thought just given sort of somebody alluded to sort of the competitiveness and so Grande. Have you ever thought of that as an indication? Because I think there is enough investigation now and obviously an oral option would be very attractive. Thank you.
Again, thanks. I appreciate the question. Look, I think the short answer is uh we have thought pretty exhaustively about possible indications for Breo. Uh 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. Uh,
They've been indications, where we can really chart a, uh, a market defining course. And I think there are maybe more to do in that in that story. But but the short answer is, there's an embarrassment of riches in terms of the indication set available for Breo. And we feel very privileged with the data we have in hand. Uh, for for what we've got is a reminder. It has worked almost everywhere. It has been tested. Uh, and so, you know, I think, I think we feel like it's a, it's a great molecule and with a lot of a lot of great places to go. Thanks for your question.
Thank you.
Thank you. Our next question, coming from the line of Derek Archilla with Wells Fargo. Your line is now open.
Uh, this is how calling in, for Derek Achila from West Fargo. Um, thank you so much for the question. Um, I guess we have a question on Breo. Um, we will add ACR so very positive, feedbacks on all the kls. Um, so question is about really the competitive landscape, I guess we've seen. We've got having data next year, and the C is also starting their pivotal trials. How do you see, you know, the, the, the comp, um, kind of the treatment Paradigm evolved, um, over the years and Breo? Um, do you have also planned to explore in other subtypes of mild studies, like, IM, mm, as thank you.
Yeah, perfect.
Now look I think uh the deal of competitive landscape, you know similar comment to frankly my comment in Graves which is that I think it's a great opportunity to be able to to get out in front of it. Uh you know and obviously first and foremost are the easiest and oral is always going to have a huge place. The majority of these patients are on oral therapy now. Uh, and so I think, you know, just like the overall profile that makes us unique. Um, you know, I'll say uh,
The the car keys. Uh that's not in my opinion, going to play for the same patients, mostly that that we are. That's obviously uh a much different sort of intervention and there's still plenty of open questions about about benefit there. Uh, you know, look, I think, um,
I think that's uh, that's that's all sort of a little bit about that landscape fcrn. Could be a compelling option. Obviously IVIG is used but I'd say, first of all, it's good to have what we think of, as a multi-year head start in DM. Uh, and uh, you know, we think we think the patient population that we have access to given the nature of our therapy is really, uh, really basically the entire DM patient population, uh, which gives us a lot of, a lot of room to go. So we think again, similar to similar, to what they've gotten mg, we think we get to Define that market and be the heart of it. And so, you know, I think, uh, I think that's all great. You know, we also suspect that the data we have in DM specifically. Uh, maybe just the best overall. Uh, and that's the biggest part of the, my site is Market. Obviously, our Gen X is studying in other subtypes of Isis as well. And some of those may be more directly appropriate for for an fcrn, you know, as to your question about other subtypes of my status for us, I'll just say again, we we thought about a whole bunch of different places to go. There's a lot of exciting places to go and we have an embarrassment.
Which is in terms of where we can take the molecule from here.
That's a great question.
Thank you.
Our next question.
Coming from the lineup.
Thomas Smith with Ling partner. CNN is now open.
Hey guys. Good morning. Congrats on the progress and thanks for taking our questions just um, with respect to the Ted program and
The competitive landscape.
Could you comment on some of the data we recently saw in the Aisle 6 class? Um, whether you think S was approvable with that data set and sort of your expectations for the total average relative to those results? And then, um,
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 beta from additional indications for that study, thanks so much.
I'll say uh obviously not our place to make comments on the approval of other mechanisms. There was a notably hyperbole response in the A6 study which is something we've we've paid attention to but overall, you know those specific comments on on where that program goes from here for competitive, landscape perspective. I think the competitive intensity. And Ted is real, as I said earlier, uh, and, uh, you know, the igf-1 RS are efficacious, although they have safety and tolerability concerns associated with them. And so I think we're sort of focused on where we could play in Ted, and then, as we said a minute ago, you know, uh thinking about Graves, uh, thinking about Graves and opportunity to impact the disease much earlier in his course. Uh, and that I think that's an important important thing to the way that we are approaching that uh, we have 1402. Um,
On the sort of second overseas study look, I think uh we uh obviously at this point, have a number of large registration programs running in 1402 that are big Global Studies. Uh we continue to like the option of small fast PC's overseas uh and uh and feeding that information into bigger studies. Uh if and when we have anything to share from those ongoing efforts, uh we'll share it but mostly it's being used to inform either indication selection or design decisions of the of the bigger studies.
Thanks for the questions.
Thank you. And our next question coming from the liner.
Brandon fit with wolf researcher and is now open.
Hey, this is Brandon known for Andy and thanks for taking the question. Um, have you provided any analogs for the DM launch? And I'm more curious to know what to expect for the the Cadence out out of the gates and longer term. Thank you.
Yep. Perfect. Um, look I think uh,
DM is an area with high unmet need, uh, but also not a lot of Novel therapies. Recently launched, first of all, there aren't great analogs, uh, to look at specifically in DM, uh, and second of all, uh, I think the appropriate course for any public company uh is uh is to guide cautiously on launch speed. Uh and to say that we're going to do everything we can to to, to get this drug out there, uh, and to get docs excited about it. And the thing that we're most confident in is that, uh, is that the overall Market opportunity is large that there is high on that patient need and that when we get to Peak penetration there's a really a really big and exciting opportunity. Exactly how long it takes us to get there. I think we're going to, we're going to save uh, is the answer. And we're going to do everything we can to make it uh, to make it, uh, as as successful as we can. Obviously, the the real value add is the stuff to get the long term trajectory here, right? Um so that's that's probably how I how I think about the launch.
All right. Thank you.
Thank you.
Our next question is coming from the lineup, Samsung with Lifestyle Capital. Your line is now open.
Hey, y'all. It's congrats on the quarter. This is Gorgon for Sam from lifesize. So, just a question on graves here. You know, based on all the market research done the date is you compare the uncontrolled Graves disease opportunity, versus what fcr ends have shown, you know, in in the mg Market, I guess, how do you size these up? You know, how are you thinking about the opportunity? Is it bigger or smaller similar? As we think about MG for for fcrs, thank you.
I mean, look, it's hard to
The mg Market has been, uh, tremendous. Uh, and uh, so I think, you know, it's, it's hard to call it uh, 1 way or another, but obviously there's a lot of uncontrolled Graves patients, uh, and it's an exciting place to be. And I think we have a real opportunity to build something big that there. There's just lots and lots and lots of uncontrolled patients is the answer. Uh, the other thing I'll say is we'll talk more about the commercial opportunity in grave disease, on December 11th. Uh, and I think we're, we're excited with what we see and I think we can, 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, different toe holds and places. And so, we're looking forward to all of that. We're also learning
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 and rolling patients. In the study, looking at what we're finding and 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. Thank you.
Thank you.
No, no further questions at this time. I will not turn the call back over to Mr. Matthew Gline for any closing remarks.
Importantly, I am looking forward to getting together on the 11th to talk about the future and address in further detail the very same questions we received on today’s call. So, 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.
Conference call. Thank you for your participation and you may now disconnect
goodbye.