Roivant Sciences Ltd. (ROIV) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by, and welcome to Immunovant corporate update call. [Operator Instructions] Please be advised that today's conference is being recorded. I would like now to turn the conference over to Stephanie Lee. Please go ahead.

Good morning, and thanks for joining today's call to review the Immunovant corporate update. I am Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant; and Eric Venker, CEO of Immunovant and Roivant President. 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.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we 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.

Thanks, Steph, and thanks, everyone, for joining this morning. It's pleasure to be back in front of you all. I wanted to spend some time today on a couple of topics, and I'm going to start on Slide 3 of the materials that are posted. It's a series of pretty big update here for Immunovant. First of all, on the management side, Pete Salzmann is retiring as CEO. I want to personally thank Pete for all of his hard work. His record at Immunovant is, at this point, unimpeachable, having seen the company from pre-IPO, really just an idea [ to prove ] the batoclimab, LDL and albumin questions and through the invention and development of 1402. So we're super appreciative of all the work that Pete and Renee have done to get us where we are. And I want to say thank you to them. In his place, we are appointing Eric Venker, who is sitting next to me, President of Roivant, who will be CEO of Immunovant. And Tiago Girao will be joining as Immunovant CFO. This is part of an intentional strategic realignment that we're taking this moment, with Pete's retirement and with the MG and CIDP data behind us, to make an Immunovant where, first of all, we're planning to be laser, laser focused on clinical execution, on the potential registrational studies of 1402, on commercial planning, on the upcoming 1402 launches and on careful allocation of resources and capital as we enter this just head down execution forward period of Immunovant's life. We're also making an intentional decision to run Immunovant more closely to Roivant than we have historically, hence, the overlap between the Roivant and the Immunovant management team, given the importance of the program to us and given where we're at this next leg. So not an overall strategic shift for Roivant, but definitely a shift in how we're thinking about Roivant and Immunovant together. And then look, lastly, we're taking this opportunity to provide what I think are two pretty exciting updates on the pipeline. One, which I don't think will come as much of a surprise is the addition of Sjögren’s disease, where we've said all along that we can get to a pivotal program using data generated by our competitors and using biology and disease understanding. And we're here to announce a potentially registrational program that will start imminently on Sjögren’s disease with, we think, a potential best-in-class profile. And then we're also announcing a proof-of-concept program, much smaller, in CLE, cutaneous lupus, with a potential first-in-class profile. This is new biology for an FcRn. And one of the things that I'm particularly excited about around the CLE announcement is we're also going to take the opportunity today to present data from the first 2 patients with actual data from IMVT-1402. These patients were dosed as part of an overseas proof-of-concept program, and the results are pretty exciting and confirm everything we're excited about with 1402. And then finally, look, we're here to announce that we're making a slight tweak to the way that we talk about how Immunovant works going forward and the way we run the business, which is that previously we collectively committed to 10 programs by the end of this year. We're withdrawing that commitment. We're super focused on the 6 indications currently underway, including the ones we're announcing today. We're continuing to evaluate new opportunities. There are some first-in-class opportunities, we're discussing internally that I'm really excited about. But we're particularly focused on these 6 and on advancing the program, as I said, with a focus on execution. So I'll talk about all of those updates, including continued guidance on cash runway, where we expect to have cash certainly through the Grave's readout expected in 2027 and more. But before I do that, I just want to give Eric a chance to say a few words. His bio is on Slide 4, although many of you know him from his Roivant role. But I want to give him an opportunity to introduce himself.

Yes. Thanks, Matt. Well, I'll keep it very brief. I'm super excited to get more involved at Immunovant. Obviously been very closely involved already both in my role as Roivant's President and COO, but also more directly as member of the Board of Immunovant since early 2020. The team, as Matt said, has made enormous progress in the last couple of years bringing 1402 forward into so many clinical trials in parallel, most of them being pivotal. As I take the helm, Matt used the phrase I'll reiterate, I'm going to be laser, laser focused on clinical execution to ensure that we position 1402 best to realize the massive value potential that it has. I think most of you out there appreciate this, but it's a pretty rare thing to have a drug that is this high-quality across efficacy, tolerability, form factor, breadth of indication space, where it has either already worked or is likely to work. It is once-in-a-generation opportunity that deserves world-class execution. And that is going to be my primary focus as we prepare to take 1402 commercial in the coming years. And look, Matt alluded to this already too, but I want to say it again myself. One big perk of the Roivant model that we've designed over the years is that we offer our Vant leaders the ability to turn to Roivant and the apparatus that we have at Roivant to help offload various activities if and when that Vant leader feels it would benefit their business, help them move faster, et cetera. I'm going to leverage that feature immediately and have Matt and the Roivant team essentially handle all Investor Relations for Immunovant. This way, I can spend 98%, 99% of my time on the core substance of advancing our programs at Immunovant. But again, I couldn't be more excited about joining the team as CEO. It's in a prime position to dominate, and I'm confident I can steer it to success. So with that, back to you, Matt.

Thanks, Eric. So in keeping with the comment Eric just made, despite the fact that it might be normal in the situation that Eric do some of the following, I'm going to pick it up and do my best to represent what's going on here. And Eric remains just next to me if we need to call him for Q&A. So look, one of the things we haven't done before on Slide 5 is lay out our best estimate of timing for all the programs we're running with the focus on execution that Eric and I have both alluded to. And you can see on Slide 5, look, I do think this is a very exciting setup for us, for Roivant, for Immunovant, where we have, including this year, but especially starting in 2026, a series of really, really exciting data coming our way from first-in-class data, from the proof-of-concept we're announcing in CLE as well as early data from the RA program reading out next year; to 2027, where we get our first potentially registrational top line data in Grave's and in myasthenia gravis; and then 2028, where we add two more of the potentially registrational data sets in Sjögren's and in CIDP. So feeling really, really good about the catalyst flow from here. And again, as I said on the previous slide, we feel comfortably capitalized through that Grave's data into 2027. And so we think we're in a really strong position to turn over a bunch of those cards and show the world what we've really got with 1402. So on Slide 6, this is me repeating myself for things that we've said a bunch of times before, but it bears mentioning. We think 1402 is just an amazing potential drug with the opportunity to be both first and best-in-class across multiple indications. We think we have certainly among the deepest, if not the deepest practical IgG lowering of any of these agents, which we think we have validated with our own data now across Grave's, MG, CIDP as well as data from many of our competitors including, for example, Sjögren’s disease, that suggests that deeper IgG is ultimately going to lead to better clinical benefit in patients. We have convenient administration with a user-friendly standard, straightforward small volume auto-injector that will be available as a part of the IMVT-1402 launch. We have just a really strong program here with patent protection out to 2043, which is extraordinary life for a program like this. We have a ton of ongoing clinical progress with multiple ongoing potentially registrational studies. And so we're very excited of putting all of that together, and we think 1402 is going to be an important medicine if we succeed in our goals. As a reminder, on Slide 7, the other thing -- and we made this analogy, it was a little bit less than a year ago, we also believe strongly that the FcRn class is just a really big opportunity in and of itself. But we're excited about where we're placed within it, but also just excited about the breadth of what it could be with a number of indications. There are actually more than 20 indications now being studied across the field, and we're studying a decent number ourselves, and with the launch at this point that has gone faster, bluntly, than even the launch of the TNF class. So we feel really good about the breadth, the size of the overall pie. One of the things that I've been a little frustrated by is what I perceive as a bit of a myopic discussion about slicing up small pieces of the pie among different competitors. When in fact, what I feel is this is just a big tent with a lot of important biology and a lot of diseases that have previously been unaddressable now within our grasp. And so I'm really excited to watch and participate as Eric and the team continue to explore those options. On indication strategy overall on Slide 8, really, we break this down into three buckets for ourselves. There are the indications where we can be -- in all cases, to be clear, and you can see this on the left side of the page, we think we have a drug that has the ability to be best-in-class. Deep IgG suppression, potentially best overall efficacy driven by deep IgG suppression and really great route of administration. Then there are sort of three buckets on timing. There are the truly first-in-class indications, indications like Grave's, potentially difficult to treat fourth-line RA and potentially CLE, where this is true white space. There's no other FcRn in the same position that we are. We think we have the ability to get to market ahead of the pack with potentially best-in-class data. Then there's a middle category. Sjögren’s is the only announced indication in this category so far, where we believe we can be nearly first-in-class in that lead wave of potential approvals within, call it, 6 to 12 months of any of our competitors, and so a best-in-class drug that doesn't have a significant time lag in terms of access to the market and access to patients. And then finally, we have indications like MG and CIDP, where our competitors have undeniably paved the way for us. They are ahead of us. They have well-established programs that are well loved by patients and docs. And what we think we bring to the table is best-in-class efficacy and route of administration based on our data around deeper IgG suppression, and that includes MG and CIDP. So we think we have a truly differentiated profile over a range of development opportunities. And we're continuing to look at white space across this picture, including new indications in each of these buckets, but with a particular focus on executing in our lead programs, especially Graves' disease. So on Slide 9, and I'm going to spend a little bit of time today on Sjögren's and CLE, and then we're going to have lots more opportunities to talk about them as these programs progress. These are two great indications for FcRn that we are excited to be adding to our portfolio. First, in Sjögren’s, where we think we can be again nearly first-in-class, neck and neck with our competitors. This program is starting sort of within 6 months of any of our competitor programs, and we think we can keep up and potentially catch up. This is a disease with high unmet need. Again, both of these diseases are alike and having close to 100,000 potential addressable patients with a clear rationale for IgG autoantibodies with IgG autoantibodies measured in significant fractions of patients in both indications and with in-class proof-of-concept data, frankly, in both of these now in Sjögren’s and our competitor programs and in CLE with our own case study that we'll talk about today and with both of these programs now underway with the CLE study already enrolling patients and the Sjögren’s study soon to be up and running. So I'll start with Sjögren’s on Slide 11. For those not familiar with Sjögren’s disease, so this is an autoimmune disease with a bunch of different clinical manifestations. It has in common with some of the other diseases we're studying that it's a little bit of a challenge because of its heterogeneity, frankly, with a lot of difficult symptoms including severe dryness of the eyes and mouth, difficulty swallowing, potentially tooth decay, gum disease, impaired quality of life. It can occur either on its own or in association with a variety of other autoimmune diseases such as RA, and we're focused here on primary Sjögren’s where it occurs on its own. But a really tough disease. We know, on Slide 12, biologically that autoantibodies play crucial roles in both diagnosis and the prognosis for Sjögren patients. So you can detect autoantibodies in a high proportion of Sjögren patients, somewhere between 50% to 70%. The disease precipitating antibodies were first discovered many, many years ago and are well understood and tested for as part of Sjögren’s diagnosis. And then on Slide 13, we also know that FcRns deliver benefit to Sjögren’s patients. So this is competitor data from nipocalimab that showed significant improvements in clinESSDAI scores at week 24, especially at their high dose of 15 mgs per kg every other week. And you can see two things that encourage us on the chart at right. One is it looks like these improvements are continuing over time. And the other is it looks like there's a pretty clear dose response here, where the lower dose did much less for these patients than the higher dose did. And there's certainly nothing in this data, including based on the time course of improvement, that suggests that we've hit a trough in terms of our ability to deliver benefit based on IgG suppression. So we think we have a shot with deeper IgG suppression to yield pretty meaningful benefit in Sjögren’s disease. On Slide 14, this is a big patient population. There are probably 300,000 -- close to 300,000 prevalent patients in the U.S. with primary Sjögren’s. And moderate to severe patients with identified autoantibodies is probably 30% of that number. So there's about 90,000 addressable patients in the U.S., which makes this a market every bit as large or maybe even potentially larger than something like myasthenia gravis, where the FcRns are pretty well established. And there's significant opportunities to expand beyond even primary Sjögren’s with secondary Sjögren’ with glandular disease and potentially on different levels of disease severity other than the moderate to severe population. But even just where we're starting here in this primary Sjögren’ population, it's large and interesting. On Slide 15, look, this is a competitive area in the sense that both other FcRns and other mechanisms are in Sjögren’s. But notably, nothing is currently approved for the treatment of primary Sjögren’s. These patients are managed, as with many of these diseases, using steroids and using methotrexate and ISTs and things like that. And so we're still sort of in the wave of modern therapy trying to help these patients with very high unmet need. There's good pathophysiology for us, well understood autoantibody involvement. We are -- this is a potentially registration-enabling study. We have a plan to get registration for the drug in a competitive time line to our peers that we think we'll be able to be successful at. We believe that this study will successfully test the impact of deeper IgG suppression mattering, and we have an active IND with study start in just a couple of months. So last of all, I want to talk briefly about CLE, which is another white space first- and potentially best-in-class opportunity for us. So CLE, this is a rare chronic skin disease, affects about 230,000 people in the U.S. It's a lot of skin-specific disease activity, again, heterogeneous like many forms of lupus and many of these other diseases. It seems likely that IgG autoantibodies and immune complexes play a key role. And about half of the patient population are not well controlled on a combination of topical broad-spectrum therapies. There's some use of IVIg or off-label biologics. It's a very uncomfortable skin disease with psoriasis-like scaling. You can get these papulosquamous lesions that are very painful. It's a tough, tough disease. 1402 should disrupt CLE pathophysiology by downregulating the autoantibodies that we think are potentially causal in the disease. And dermatologists are really looking for a targeted biologic to matter here. And there are a few other mechanisms in development, but we think FcRn could very much have a role to play, particularly if we can get something that is safe and well tolerated, as we know that FcRns are; that has the ability to get quick control of symptoms, and FcRn certainly deliver that in other diseases; and sustained remission which, again, we and others have shown an ability to do in other diseases. So about 75,000 addressable patients based on how we're looking at this population now who are nonresponders to antimalarials or topicals and have the kind of CLE we're actively studying. Now one of the things I'm actually most excited about, which really isn't super specific to CLE although it gives us a good leg up, on Slide 20, is we've dosed 3 patients with IMVT-1402, with our sort of core-of-the-pipeline, next-generation agent in -- as part of an overseas proof-of-concept program where we've been dosing patients in a variety of contexts and have seen very impressive disease response in these patients, first of all, notably. And we've got the most data here from one patient in this program and then a little bit of data from a second patient. And the third patient is still in therapy. But yes -- but first of all, the first patient for whom we have all the data at this point had close to 80% IgG reduction from baseline achieved by week 12. So that's exactly what we are hoping to achieve with 1402 across indications, and it's nice to see that reaffirmed in this N of 1 in CLE. And then this patient had a greater than 60% reduction in CLASI-A with -- a 5-point reduction is considered clinically meaningful. This patient saw a 23-point improvement by week 12. So -- and this was a patient who had tried lots of things, had been on hydroxychloroquine, had been on methotrexate, had been on a number of other medicines and had not seen anything close to this kind of improvement. And this patient was on 600 milligrams weekly open label of IMVT-1402 for 12 weeks. We had a second patient dosed, too. It's still in process of generating all the lab data and so on. That patient had a greater than 50% improvement in CLASI-A, had a CLASI-A score that went from 18 to 8, so a 10-point improvement by week 12, which is also a very clinically meaningful benefit. And we look forward to sharing data from that patient as well as any others that we dose, third patient, et cetera, in the future. But exciting both to see some early proof of principle data specific to CLE as well as early evidence that 1402 does what we want in a clinical setting with patients. So again, on CLE, large unmet -- untapped market opportunity, high unmet need for patients, a disease that is IgG and immune complex driven as best of our understanding with the potential to target upstream. We are actively enrolling this study. And by the way, the study is being run with self-administration with our auto-injector which is, again, pretty great validation of that platform. This is a proof-of-concept study. So this is earlier biology than the other, and this is not designed to be registrational. And our approximate expectation of the cost of the program from here is about $15 million, but we're excited to generate this data and to produce it next year as part of our overall package. So I'm going to wrap up on Slide 22, just again highlighting we are -- just could not be more excited about the breadth of indications that we're going after here and the breadth of biology that we think FcRns in general and IMVT-1402 in specific are going to be able to deliver on. I think we view Grave's as our lead indication. It's got a large prevalent population. That study is underway and enrolling, and excited for Eric and the team to really continue to pound the table, making that work as well as we possibly can in terms of speed of enrollment. And then the rest of the indications, some of which we've talked about new today, some of which you're all very familiar with, are all indications with at least some real proof of mechanistic activity where we think we can be best-in-class across the board with some luck, potentially best-in-class and first-in-class in many cases with some execution. And so just excited to see all of this through for sure. With that, in just a moment, I'll turn it over to Q&A. But first, I just want to say again thanks to Pete and the Immunovant team for getting us to where we are, and congratulations to Eric, and no pressure, but it's an important one. So with that, I'm going to hand it over to the operator to go to Q&A. Thank you, everybody.

[Operator Instructions] And our first question will come from Derek Archila with Wells Fargo.

So just two quick ones for us. I guess maybe to Matt and Eric, I just wanted to understand some of the changes that might be employed now with kind of more alignment with Roivant in terms of the execution. I know you hinted at some of that, but just trying to understand how that might impact some of the time lines that you guys laid out here. And then just on CLE which, again, I find very interesting. Probably very hard to compare now, but just kind of curious how you're thinking about 1402's profile here relative to some of the other agents in development, particularly ones targeting pDCs and type I interferon, and whether you're seeing any correlation between the reduction in type I interferon and IgG reduction.

Yes. Thanks, Derek. Appreciate it. Thanks for listening, and thanks for the good questions. Look, on the first point, I think the one thing that's clear is this is a slightly different era for Immunovant than the prior era that a ton of really complicated work around regulatory strategy, around trial design, around auto-injector design all had to take place under Pete. And I think the team was really focused on getting these programs stood up. I think reflective both of sort of Eric's specific leadership and what we know that he is awesome at and also the stage of business, I think, first of all, we have learned a lot across the Roivant portfolio about this stage, around clinical execution, around driving patients into trials. We've been working on it at Priovant with our DM study and with our NIU program. We've been working on it Pulmovant with mosli. We feel like we can translate a lot of those learnings to a rapid execution at Immunovant around enrollment in Grave's and other indications. And so I think part of Eric's job here is to bring those learnings over sort of maximally efficiently. And so I think that on execution is probably the big thing. And then the other is, in the world we're in, there's a lot of really, really important decisions to make around indication expansion, around what else we're going to do here, around sort of how to think about the program and how to think capital. And I think it was just really important to us in the context of Pete's retirement and sort of moving to this new chapter to be very, very closely aligned with the Immunovant on all of those decisions. And there was no human being in the world that I expect to be more closely aligned with than Eric on this stuff. So it felt like a good moment for this change. On the CLE questions, look, this is exactly the kind of stuff we're trying to learn in this proof-of-concept program. So it's a 56-patient planned study. It's a moderately sized proof of concept. And I think we're sort of looking at what we want to do from a pivotal design perspective and so on and sort of how we would progress the program. And that includes measuring exactly some of the things you're describing around those relationships. And this is what I say like one of the reasons we're running this as a proof of concept instead of trying to have some faster path to approval is precisely that we know it's a competitive landscape, but we think the biology of FcRn makes a lot of sense, but also a lot of the other work happening across the industry is compelling. And so we want to make sure we understand the role that we have to play. Thanks, Derek.

And our next question will come from Dave Risinger with Leerink Partners.

So I have two questions. First, could you provide some more color on the decision to develop 6 indications rather than 10, maybe just comment on what you decided to subtract and why? And then second, on Slide 27, I see the design for the proof-of-concept study in CLE. But I guess, could you just explain why you have an open-label period at all? Why not just do period 1 and go into period 3 with the two different doses?

Yes. Thanks, Dave. On the first question, first of all, to be clear, we're not saying we're done at 6, we're not going to explore other indications. And in fact, as I think I alluded to on the call, we have ideas for white space first-in-class indications that we may still pursue. I think the main signal here is we want people to know that we're super focused on value and super focused on getting to the starting line with the sort of best possible position. And so I think our value, even in the 6 that we're publicly talking about here, we think is many, many billions of dollars, frankly, multiples of where Immunovant is valued today. And so we just see an enormous opportunity if you really get those right and sort of execute excellent. And we think these are among the highest ROI opportunities that we've identified especially, frankly, things like Grave's, where every day matters to the NPD there. And so we really, really want to make sure we get that right. But again, not saying we're done or that our view is that the opportunity is any less broad overall, just trying to signal a shift in focus and not arbitrarily commit ourselves to a broader program when we think executing very carefully on a narrower one may be the better strategy for today. On the design in CLE, look, we put the design out there. We're not going to comment on exactly all of the specifics. But often, these decisions are related to exposures that FDA wants to see as programs head to pivotal and sort of understanding exactly what those exposures look like. And then we're just trying to learn as much as we can when people are on drug, especially on high dose, in terms of what the performance of the agent is.

And our next question will come from Sam Slutsky with LifeSci Capital.

I guess two for me. One, can you discuss more broadly the open-label case study program where the CLE patients were evaluated? How many CLE patients do you plan to enroll here? And then are there other indications where you also have data from this program? And then just second, just a reminder on when the second Grave's disease study might be started. And is that also expected to read out in 2027?

Yes. Thanks, Sam. Appreciate the questions, and thanks for listening. So on the first one, look, we haven't said a lot about this work we've been doing overseas. I'm not going to say a lot about it now. We have several other nondisclosed indications that are being studied in this way, and we think it's enormously valuable to be able to generate a little bit of data with 1402 away from prying eyes such as it is. So we're excited to keep doing that. We are mostly done enrolling CLE patients in that program with the 3 that are enrolled. Because we now have this IND for a sort of global POC study, and I think it will be more important to push patients into that program. But we continue to like that framing. We haven't disclosed the time line for the second Grave's study. But obviously, the thing that's important to us around Grave's is getting to approval as quickly as we can. And I'll just say, Eric is laser-focused on that program in totality, and we'll share more updates as we've got them. And I think we've got a lot of really great ideas for what that study looks like, commercial positioning around that study, the inclusion of patients with eye symptoms sort of pre-TED or TED patients or whatever in that program, all as opportunities to make sure we get the best possible arrangement and, hopefully, the best possible label for a program with Graves' disease. Thanks, Sam.

And our next question will come from Brian Cheng from JPM.

Maybe just on Sjögren’s. Compared to nipocalimab Phase III, we know that there are some differences in terms of the Phase III design, like having primary endpoint at week 24 and dividing the treatment period to two periods. First, can you provide a bit more color on the differences? And then second, Matt, you talked about how Sjögren’s, you can potentially catch up to nipocalimab's program. What are some of the potential levers that you're considering to close the gap?

Yes. Thanks, Brian. I appreciate the questions, and thanks for listening this morning. Look, I think on design, I think the main thing is we've had a close and productive dialogue with FDA on what they want to see in our Sjögren’s program. We feel confident about the design and think it sets us up well. Again, our program in total is obviously a little bit different from the nipo program in that they ran a complete Phase II followed by a pivotal program, whereas we're taking advantage of their data to sort of mush those things together into a more sort of closely correlated or closely collaborated set of programs. So I think that just leads to a slightly different trial design. But we think highly of the program we're running, obviously, and we think it's going to produce commercially helpful and important sort of clinical data for FDA on the program. So I think it's mostly sort of driven by that close dialogue with FDA. On catching up, look, I think there's a few things. One is although -- and you mentioned nipo specifically. I'll say our competitors broadly here are fierce and not to be underestimated. I think we are just excited about executing hard as a means to close that gap. And I think we feel like with some focus, for example, as part of the decision to focus on these indications, that we can do some work there. We also just feel very confident about our profile. We get lower IgG, which we think is going to matter and we think that will matter to patients as well. Patients like auto-injectors better, including patients in clinical trials. So we think knowing that we have a really good format is going to be helpful in our trial. And look, I think patients who have trials to choose from are going to want to pick the programs that they are most excited about. So we think we have a lot to offer from that perspective as well.

And our next question will come from Yasmeen Rahimi with Piper Sandler.

This is [ Dominic ] on for Yas. Our first one was what are you looking to -- or what do you need to see in the proof-of-concept studies for these two indications? I know you touched on it a little bit, but if you could just provide some more details there. And what is the mechanistic rationale that is supporting the deeper IgG reductions lead to deeper responses across these two indications?

Yes. Thanks. Those are both good questions. In terms of what do we need to see in proof of concept, I'll point out, the CLE study is a proof of concept. And there, I think we need to see meaningful, frankly, competitive clinical benefit. We're both going to learn more from the field during the next 18 months, and we're going to learn more from our program. And I think we need to see data that is generally supportive of moving forward against that competitive landscape. And if it works well, we'll win. In terms of mechanistic rationale for deeper is better. Look, I think in both of these diseases, autoantibodies are known to play a role. They are measurable. They're observed. And pathophysiologically, you would expect if there are autoantibodies, they are contributing to severity of disease. They are not necessarily sort of sole contributors to disease activity in each of these settings, but we know they're important. In the case of CLE, those autoantibodies are specifically nameable and, even in Sjögren’s, they're well understood. So I think it's clear that autoantibodies play a role. And if autoantibodies play a role, I think deeper IgG expression should matter. I'll point out as a matter of practice, we have seen deeper IgG suppression matter in every indication where we've tested that theory at this point. Through the MG study from last month which, again, putting competitive dynamics aside, we clearly saw a benefit between our low and high dose from an IgG suppression perspective in that study. The same thing when we cut the patients on IgG suppression in CIDP, the same thing in our Grave's data. And basically across the board for our competitors, whenever they have seriously studied the relationship between IgG suppression and disease benefit, they have seen it as well. So it is not just about sort of clinical rationale or scientific rationale. At this point, I think we feel pretty good about the actual data in support of that idea.

And the next question will come from Yaron Werber with TD Cowen.

Great. Appreciate it. This is super useful. So I have a couple of questions. One is just nitty-gritty, a little bit about Sjögren’s. I noticed that you're going to do your study in moderate to severe systemic disease, which is comparable to the other two companies. What about symptomatic? Because one would think that this mechanism would lend itself to work in symptomatic patients as well. And then secondly, just kind of a broader question. I mean, this is obviously a fairly big shift. Historically, I think we used to get a lot of questions whether the goal is to sell Immunovant and then maybe even to sell brepocitinib, just like you did with Telavant. But I think that the compensation of the management team has now changed to be very much aligned with sort of the stock price, which I think would potentially lead one to believe that you're thinking and you're planning on actually commercializing brepocitinib and 1402. Can you comment on that? And are we sort of thinking about this correctly, maybe from a broader strategic viewpoint?

Yes. Thanks, Yaron. I'll take the bigger question first and then the specific question second. On the bigger question, first of all, obviously, I can't comment on any active strategic dialogue we might have right now. But I can say two things. One is for any major strategic path forward, whether it was a sale of the company, whether it was a partnership, whether it was anything else, those decisions would have to be made with hands tightly held with Immunovant in a way that, frankly, makes all of those paths, whether it's partnership or anything or a sale of the company or running to commercial, as you suggested, easier in terms of decision-making after these changes than before. And I'll just point out because there are conspiracy theorists in the world that if you think Pete leaving now has anything to do with that, I'll just point out that Pete's agreements have this economically covered as well, and you can see that where they're filed. So I don't think there's anything to read into any change in strategic path of possibility or vision from our perspective. On the Sjögren’s question, look, I think the main thing here is that the regulatory path for moderate to severe is well understood. And the most important thing for us, as I led with earlier, is being in that front of the pack and having a regulatory outcome that allows us to get there to patients without being significantly behind our peers, being in that sort of front wave of therapies. And so I think we're going to do what we can in a trial design with the agency first and foremost, to keep up and catch up. We certainly agree with the idea that there are other potential treatment benefits to Sjögren’s patients potentially -- potential categories of Sjögren’s patients that we could be helpful with. And I can imagine expanding beyond the moderate to severe population in the future. But right now, we're just laser-focused on getting there as early as possible in the race.

And just maybe if I could just follow up quickly. So on brepocitinib, is your goal as of now to commercialize brepocitinib? We're expecting positive Phase III data in dermatomyositis in September or October, I think you said second half. But are you thinking about commercializing it yourself?

Yes. I think the base case expectation here is that we will commercialize brepocitinib ourselves. We are super excited about dermatomyositis. We're super excited about that trial and looking forward to that data later this year and absolutely looking forward to that opportunity. It's a huge unmet need. So yes, absolutely. Yes. Thanks, Yaron.

And our next question will come from Thomas Smith with Leerink Partners.

Just coming back to Sjögren’s. Saw on Slide 25 that you're planning this as a 180-patient study which is smaller than the argenx and the J&J Phase III programs. Matt, I think you mentioned you've engaged in a lot of regulatory dialogue here. You have nice alignment on this program. I was wondering if you could just elaborate on that and your expectations about whether you think this could be registrational with a single study or whether there might be a need for a second study potentially down the line?

Yes. Thanks. I appreciate the question. This is -- in short, this is 1 of 2 studies that we will run in Sjögren’s. So this is the design for the first study. We're working out the second study right now. I don't have specific comments on the design, but you'll know it soon because we're planning to start it so that we can keep on this path.

And our next question will come from Jason Gerberry with Bank of America.

Just one question just in lieu of the changes today. I'm curious if there's any updated thoughts on monetizing this upcoming TED data for 1401. It would seem like you could have a carve-out single indication for 1401 and perhaps take it to market data depending, whereas pursuing all other opportunities with 1402. So just kind of curious if that's a reasonable expectation or if you would, I don't know, guide us differently. And then just from a capital financing perspective, just given how Immunovant stock has been trading of late. Just curious, appetite to be an even larger shareholder of Immunovant or maintaining current levels and just being -- or revisiting during financing opportunities?

Yes, thanks. Those are both, Jason, great questions. Appreciate them, and appreciate the question behind the question on [ what if ] it doesn't work. Look, on the first one, I'll reiterate something I said before. I can't comment on any active strategic discussions we may be having or what we see as specific or expected, to use your word, on expectation. What I can say is we continue to be excited about the potential value delivery that FcRns have in TED. Obviously, it relates to the work that we're doing in Grave's disease. And I think we would be excited about making sure that we reach the maximum number of patients, that we'd be open to great partnership deals if something came together and that we're going to be ruthlessly data-driven when we see the actual data in TED around what we do with batoclimab, either on our own or as a carve-out or partnership or whatever. So I think you can expect that we are still absolutely open to all of those possibilities and thinking about them. In terms of Roivant's appetite to be a larger Immunovant shareholder, I'll point to a few facts. One is as recently as January, we participated super proratably in the financing to increase our ownership. And we've produced only data that we have characterized as good as well as updates that we've characterized as positive since then. So I think you can believe that whatever went into that, we still feel that way. We obviously think Immunovant is attractively valued, to use a euphemism for chief. And we like the opportunity as we see it. And so look, I think we're absolutely excited about owning as much of it as we practically can. We are also focused on maximizing its value and focused, as we've said a few times on this call, on execution of the existing programs, which we think is a path to enormous value creation both for Roivant and Immunovant shareholders.

And the next question comes from Prakhar Agrawal with Cantor Fitzgerald.

So Matt, you have highlighted a few times that you wanted to execute hard in some of the high-value opportunities on hand versus going broader. So I guess that leads to my question on what was the status of the Grave's and RA trials that were ongoing? Were they running slower than what Roivant would have hoped for? And do you still have high conviction of being first-in-class in these indications? And the second question is, given this more active operational and strategic involvement in Immunovant, what's the latest on Roivant's BD strategy? You had set aside $2 billion or so for BD. So any updates there?

Thank you. Appreciate the great questions. First of all, I'll say, we still have a high conviction on being first-in-class in Grave's and RA population. And I'll let you in on a secret about being a biotech CEO, which is that every trial enrolls slower than you have hoped for. So in that narrow sense, I can say it's true. But I would say they are enrolling as expected. And we just put out our time lines today. And so I can reaffirm them 45 minutes later and just say I think we're feeling good about our ability to deliver this data on a good pace by 2027, again, with very high confidence of being first in Grave's, obviously, given both our execution there and the competitive landscape and where we're at. So I think we feel really good about all of that. I want to make a comment just because I think it gets to a possible misinterpretation of the indication comment as well as something on the BD side here. Look, I think we feel very, very good about expansion opportunities between these 6 indications for FcRn. And I feel virtually certain that we will add indications beyond these 6. We're just not committing to any specific number or time line for doing so while we are continuing to do work on that. And then even beyond Immunovant, it's just a great environment to be deploying capital and to be capital rich. And so I think we're looking at a veritable cornucopia of possible opportunities within Immunovant for indication expansion, beyond Immunovant for new programs elsewhere at Roivant as well as ways for these sort of two sets of programs to work better and better together. So I think overall, a great moment to have the capital and conviction to deploy. This is not a -- the decision to withdraw guidance on the 10 is not a capital-constrained decision. It's really an execution-focused decision. Thank you.

And our next question comes from Alex Thompson with Stifel.

Maybe a follow-up on commentary related to capital allocation, et cetera. Could you talk a little bit about what this new cash runway guidance for Immunovant really encompasses and ways in which Roivant, with your balance sheet, can help potentially accelerate development here, particularly within this really competitive FcRn landscape, as you've mentioned several times?

Yes, perfect. Thanks. Those are great questions, Alex. Appreciate them. Look, I think on the cash runway guidance, I mean, I guess what I think it encompasses is we feel comfortable that we've got cash well into 2027 through the Grave's data. We actually also expect the MG top line data in '27. I don't have like an exact "prediction" on which of those data come first. But I think you can expect that we approximately have capital until that data set as well. And I think we're in a really strong position. I think in that time line, just to be clear about what we expect to get in addition to the MG and Grave's data, we expect to get data also in '27 from the ACPA-positive D2T RA top line outcome. We expect to get the CLE POC data in '26. We expect to get the open-label period from the RA data in '26, and then we expect to get remission data from our bato Grave's study midyear this year and Phase III data in TED from bato this year. So all of that data, I would say, is we didn't play for the current cash balance. Obviously, the exact sequencing of that data in '27, we can't know at this stage, and so it's a little bit hard to call. That's on the balance sheet. Look, I think that's kind of what we can say. I think this structure allows Eric to be 100% focused on the day job of executing and on delivering more value with the same cash. And I think that's an important opportunity for us as we think about the focus of the team. Obviously, given my comments on being open to owning more, Roivant's balance sheet is also an asset here. And if we see opportunities for expansion, opportunities to move faster that would require deploying more capital, I think we would have no qualms about doing so. But also, we see a ton of opportunity to create a ton of value with the cash that's currently on Immunovant's balance sheet without adding more.

And our next question will come from Leland Gershell with Oppenheimer.

I just want to ask, Matt, with all the indications for 1402, then the two new ones you're announcing, I'm just thinking about time lines and sequencing. I think in past conversations, even the Grave's had kind of come to the fore, it looked like MG might be the first indication to launch for 1402. Is that still the view? Or I just wanted to sort of see what your view is on kind of first indication for 1402 launch.

Look, I think -- thanks, Leland, for the question. I think the actual answer to that question in practice is we are running these studies as fast as we possibly can, and we will get approvals for these indications as early as we possibly can. I think it is possible that Grave's will launch before MG. It is possible that MG will launch before Grave's. And I welcome the internal competition between them if it means that both of them launch earlier. So look, I think we think this is a huge opportunity, and it would be great for us to have two great launches within close proximity to one another. So -- and I think there would be real synergistic benefit from those two launches being in close proximity to one another in terms of the work around building out Immunovant as a commercial organization, work on market access, et cetera. So I think we have, a, some flexibility on that relative timing; and b, we're just going to be running those programs as fast as we can.

Got it. And then in terms of additional potential indications for 1402, are those announcements we may hear in the near future? Or may those be dependent on data you may see from some of the trials you're doing now, which could then inform additional indications?

Yes. Look, I think part of what we're -- thanks for the question. I think part of what we're getting away from for the moment is providing explicit guidance on new indication announcements. So I think we're actively -- as you can see from the case study program with CLE, actively doing work in a variety of settings behind the scenes. And we'll announce new indications when we're ready, both from a competitive perspective, et cetera, including when we see breakthrough data in any indication will be driven by the biology. So I think the answer is no guidance on when you'll see those announcements, but trust us that we're doing work on it behind the scenes.

And our next question will come from Douglas Tsao with H.C. Wainwright.

Matt, maybe just in terms of the pursuit of CLE, I'm just curious because we've obviously seen Janssen pursue SLE. And I'm just curious what led you to sort of target CLE versus SLE with 1402. What was it about the disease that made you think that this was a better indication for FcRn?

Thanks, Doug. A few things. First of all, I don't mean to [indiscernible], but a minor correction which is that we inherited that SLE study from Pfizer. It was not something that we proactively necessarily decided to do, although we were happy for the program to be ongoing. And look, I think it was...

Matt, if I can, I was just referring to the fact Janssen is pursuing -- has an ongoing study with nipocalimab in SLE. So that sort of was the question why you were choosing CLE.

Fair enough. Look, I think there's a few answers to that question, too. One is that based on our own experience among others, SLE is a really challenging indication. And CLE is also uncertain but pathophysiology is better understood and a little bit more self-contained, certainly easier to do a POC. And to your point about Janssen, CLE is white space. So we get to run our own swim lane. And we just like overall the biologic rationale for IgG immune complexes in the skin.

The next question comes from Dennis Ding with Jefferies.

I have one maybe for Eric. I'm just curious what new perspective will you bring to Immunovant as CEO and if there are any differences in how you approach capital allocation and the return on investment, or maybe it's not entirely up to you at all and it's up to Matt. But like, I guess, for Immunovant and Roivant, are you guys 100% committed today to finishing out the MG and CIDP studies? And then as a follow-up, I'm just curious, for Sjögren’s and CLE, what kind of design implementations will you make to minimize placebo?

Thanks, Dennis. I guess I can't protect Eric from literally every IR responsibility as far as if he's literally sitting next to me on a call and the question is directed at him. So Eric, why don't you...

Yes, I can take the first one. Look, I don't think it's that complicated. I think the thing I've done maybe the best at my -- in my 10 years at Roivant is working hard and excelling it, having the right people spend the right amount of time on the right things, so this sort of core resource allocation. And that includes capital of course within the Immunovant landscape. They've got $700 million in the balance sheet or whatever. Those dollars need to go toward those activities correctly in addition to the human resources aspect and with people being focused on the right stuff. So that, I think, I will do excellent at that, and that is the most important thing. And the ROI on those dollars and those hours will be very, very high under my leadership at Immunovant. On the point about Roivant's balance sheet and investing in Immunovant, that is Matt's domain, and so I'll let him speak to that. But from my perspective as CEO at Immunovant, that's how I will be leading the team from an ROI perspective there.

And look, on the question of Roivant's enthusiasm, first of all, honestly, I feel more, you can believe this or not, more enthusiastic every day about deploying capital at Immunovant, more enthusiastic now than I did in January because of the MG and CIDP data. I feel an enormous amount of trust in Eric and the leadership team to lead the company in this next era. And I think we're excited about allocating capital to these programs. I think your question about the MG and CIDP studies, I assume referred to 1402. Look, I think we think the opportunity in both of those indications for 1402 is large. In CIDP, in particular, our data from bato suggested a potentially meaningful efficacy benefit, at least in a cross-trial comparison relative to what we've seen from the field before. So I think that's a huge opportunity, and frankly, with less of a time lag. We've talked a fair amount in other settings about MG. Look, obviously, FcRns work there. 1402 is going to work there. I think the things that we are giving consideration to on the MG side and Eric is going to be giving consideration to on the MG side is -- relate to durable remission, relate to sort of endpoints that show some of the real benefits on deeper IgG suppression in a way that we can carve out some space for ourselves. I'll point to even relatively slow share in MG would be justified on an ROI basis relative to the risk and relative to the cost of those programs. For Sjögren’s and CLE, the question was sort of design considerations from the peer group, from competitors, et cetera. I think I don't have any sort of specific answer to that question today. But these studies were designed, especially the Sjögren’s study which is potentially registrational, in careful, close evaluation of every other study that we could find in Sjögren’s as well with discussions with FDA. And I think we're trying to learn everything we can from the field, a, about what makes a good approvable study; and b, about what's going to work for our data. So I think you can bet that we've incorporated many of those considerations. Obviously, CLE, where it's a smaller study is a little bit of a different setup where we're really trying to do some fact finding. But -- so it's less about the narrow specific design of the study and more about setting a program to generate as much information as we can. So that's that. Thank you, Dennis. Appreciate the questions.

And the next question comes from Ash Verma with UBS.

Congrats on all the progress. So just a quick one for me. Firstly, can you expand on like what is the time line that you're expecting on this readout, of this proof of concept, in the first half or second half next year? How quickly do you expect the enrollment to be?

Yes. I think the question was -- I'm sorry, it was a little bit hard to hear you on the line. But I think your question was time line on CLE, first half or second half of next year. The short answer to that question is it is early innings for that study. There's only a handful of patients enrolled so far, so give us a little bit more time before we provide a more concrete guidance on when that's going to come. Thanks, Ash.

I show no further questions at this time. I would now like to turn the call back to Matt for closing remarks.

Thanks, operator, and thank you again to everybody who listened today. Look, I want to reiterate our confidence here, both on the time lines we've laid out, our ability to deliver an enormous amount of valuable clinical data in the next 1, 2 and 3 years which we are just super excited about. I want to reiterate my confidence and enthusiasm for what I think Eric is going to be able to do here with his focus on execution and also execution and also execution on getting these programs enrolled and enrolled with high-quality patients that are going to generate data that's going to help us benefit the broader population. And then, look, you worry in situations like this as you change guidance and as you -- sort of leadership changes happen and so on about people questioning what's behind them. I just want to reiterate again, we are as excited or more about Immunovant's 1402 as we have ever been. This is a huge opportunity. This is lightning in a bottle. This is tiger by the tail. This is the kind of program that does not come along often in biotech. Our enthusiasm for the program is extremely high. You will see us over time making further capital investments unless something very unexpected happens along the way. And you'll see us deploying more. You'll see us investing resources. You'll see us investing manpower in making these programs successful. And look, we think this is a multibillion-dollar commercial opportunity that gets closer and closer every day. And at this point, looking ahead, I think the setup in the future here is I challenge you to find a more exciting one over the next few years than the one we've got on our hands. So I'm looking forward to seeing that all play through. I'm excited to continue to work with Eric in this new capacity. I'm super appreciative for Pete, super appreciative for the entire Immunovant team who has been working very, very hard for years to get us here and is about to work very, very hard again for the next handful of years to get us where we need and want to be. I'm thankful for the Roivant team who has been a close collaborator and will continue to be an even closer collaborator with Eric now in the role. And thank you to all of our stakeholders, patients, investigators and even the investors for your continued support. Thanks, everybody. Have a great day.

This concludes today's conference call. Thank you for participating. You may now disconnect.