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Leerink Global Healthcare Conference 2026

Mar 11, 2026

David Risinger
Senior Managing Director, Leerink Partners

Everybody.

Matthew Gline
CEO, Roivant Sciences

Thank you, Claire.

David Risinger
Senior Managing Director, Leerink Partners

My name is David Risinger. On behalf of Leerink Partners, just wanted to thank you for joining our conference. It's very much my pleasure to introduce Matt Gline, the CEO of Roivant. He's just putting a little sugar in his coffee.

Matthew Gline
CEO, Roivant Sciences

Sorry.

David Risinger
Senior Managing Director, Leerink Partners

We'll get started. Really appreciate you being here, and his team members, Richard and Kay are in the audience as well. I thought it would be great for you to just maybe kick off, Matt, with some opening comments on you know, on the business prospects. You've had a tremendous run of good news and hoping for good, you know, for more good news ahead. Would love you to start with some opening comments.

Matthew Gline
CEO, Roivant Sciences

Yeah, thanks, David. Thanks for having us. It's obviously a great venue for a conference. I think the best in Miami at present. Thanks again for having us. Look, I don't know. It's hard looking out over the room to know exactly who's got what level of familiarity, but it's been a really transformative period for us. I think in some ways we've been built for a long time to find drugs that matter and develop them in creative ways. I think we've done a phenomenal job at indication selection and at sort of building a pipeline. At this point, I feel like the fruits of that labor have, like, finally come together.

As many of you may know, mid last year, we got data in a registrational program in dermatomyositis that sets us up now. Our NDA was just accepted last week with priority review, so we'll now be knock wood, launching that product in this year by the end of September. That sets us up for this incredible period ahead with this stacked series of data and commercial launches, starting with that dermatomyositis launch, but also with data coming in multiple other registrational programs in NIU later this year, in Graves' disease for our FcRn next year. On top of that, we have phase II-B data for mosliciguat in PH-ILD.

I'm sure we'll talk about all these different programs, but it's just a period of true business transformation for us, where we're standing at the cusp of becoming, as daunting as it sounds, a real company. The kind of business that has to generate sales and make quarters and be profitable and all that good stuff. I think it's just an exciting moment to stand at the doorstep of that, and I'm excited to talk more about everything that's going on.

David Risinger
Senior Managing Director, Leerink Partners

Phenomenal. Before we go into the details, maybe you could step back. Obviously, you had an analyst meeting in December, in New York, but just highlight sort of your vision and where you wanna take the company.

Matthew Gline
CEO, Roivant Sciences

Yeah. Look, I think it's sort of funny in biotech. When I first got started, I had all these friends in tech, and I was, like, new to biotech. Someone, I cannot remember who, gave me this piece of advice and they said, "Oh, the difference between tech and biotech is that in tech, all the ideas sound stupid, and some of them turn out to be really good. In biotech, every idea sounds amazing, and most of them don't work." I just, like, have thought a lot about that as our business has matured, but one of the things about it is, like you said, what do you wanna be? The answer is, like, "I wanna be what everybody else wants to be.

I wanna be a successful therapeutics company that deliver drugs that matter to patients that need them." That's sort of like from a vision perspective, it's not more complicated at some level than that. I think what we are really good at, in particular, obviously, is we don't do a lot of basic bench science, so most of our pipeline is in-licensed partnered, et cetera. I think we're good at finding real value in the world and in particular in seeing creative ways to build partnerships around drug development, indication selection, good clinical execution.

I hope that as we become a commercial pharma company, first of all, we can bring some of that energy to launching our dermatomyositis, our orphan JAK/TYK franchise that I think should be a really important franchise, and then into the FcRn programs. We can bring some of that energy to the commercial field. I hope that it serves us well in. You know, I think I think, whatever, one of the things about biotech is, every marathon ends with another marathon, and I think our next marathon is both about commercial success, but also.

I mean, how many quarters into our launch are you gonna turn to me and ask me what's next? It's not gonna be very many. I think one of the great things about the business we're building is I hope that we're capable of continuing to deliver on an R&D base layer that allows us to stack and compound. I think that is a big part of what we're building from here.

David Risinger
Senior Managing Director, Leerink Partners

Yeah. Well, you've certainly demonstrated to date that the ROI in your business model with your leadership team and the structure of the company is extremely high. Just, you know, provide a little bit more color on that. What makes Roivant so special?

Matthew Gline
CEO, Roivant Sciences

Yeah. I mean, look, I think there's a few things. One is we've just always been of the belief that bringing people together of different backgrounds and phenotypes can make a difference in how drugs are developed in the industry. We have a leadership team that comprises career drug developers, but also frankly a lot of former buy side people who think about the world like investors do. I actually think that's just been a very potent combination for us in designing an R&D portfolio and in thinking about ROI and thinking about the ways of investing to generate maximum value from the next data set. You know, I think sometimes we've made decisions that have initially, because I think they don't necessarily rhyme with the decisions of other biotech companies, been a little bit head scratchers.

I think it's always been in service of sort of ruthlessly economic thinking about R&D. That is, like, how do you drive value by making every dollar and every inch count in a clinical trial? You know, I'm proud of where we are right now on the back of that, but it wasn't always easy.

David Risinger
Senior Managing Director, Leerink Partners

Yeah. Excellent. Why don't we turn to brepocitinib.

Matthew Gline
CEO, Roivant Sciences

Great

David Risinger
Senior Managing Director, Leerink Partners

with the launch plan for the end of the third quarter. How do you expect brepocitinib to be taken up? Could you just, you know, contextualize the opportunity and describe your launch plans?

Matthew Gline
CEO, Roivant Sciences

My handlers are in the room, and I'm talking to a sell-side analyst, so the answer is slow and steady, David. Effectively launched it slow and steady. Look, the truth is there has not been a modern therapy developed in dermatomyositis basically ever. I mean, IVIG is approved, but has been used off-label for a long time. It's a physician and patient community that on the one hand is desperate for new options. These are very sick patients, and if you talk to the doc community, I think you'll find a lot of enthusiasm for our drug. But on the other hand, it's steeped in unknowns. It's very hard to tell exactly how early adoption will work. It's very hard to tell exactly which patients will come on.

We have theories about all of these things, and I'm excited about the work that we're doing to identify these patients ahead of time, to work with the referral centers that treat a lot of them, to make sure the docs are familiar with our data and how to think about what our drug might be capable of. Ultimately, we won't know about what the next step looks like until we reach the next step. We're doing all the prep work that we can. We're building our patient support org so that we're gonna be able to get patients on drug and covered. We're building a field force of incredibly qualified, sort of high degree of medical expertise, a lot of advanced degrees, to make sure that...

Again, it's a pretty academic treating physician community, so to make sure we're sort of steeped in that community and working with all the right people. Ultimately, it's gonna come down to execution, and we're gonna have to see when we see.

David Risinger
Senior Managing Director, Leerink Partners

Excellent. The KOLs with whom we've spoken, you know, are obviously quite excited about brepocitinib, given the oral administration.

Matthew Gline
CEO, Roivant Sciences

Yeah

David Risinger
Senior Managing Director, Leerink Partners

And the efficacy and safety profile you detailed, particularly relative to IVIG.

Matthew Gline
CEO, Roivant Sciences

Yeah

David Risinger
Senior Managing Director, Leerink Partners

For those patients that are not in, you know, a crisis at this very moment. Could you just talk about the 40,000 U.S. patient opportunity, including what percentage have both skin and dise-

Matthew Gline
CEO, Roivant Sciences

Yeah

David Risinger
Senior Managing Director, Leerink Partners

Skin and muscle involvement?

Matthew Gline
CEO, Roivant Sciences

Perfect. Taking a tiny step back, dermatomyositis is the whole idea behind our development plan for brepocitinib is to take the most potent and anti-inflammatory mechanisms we've ever developed in JAK and TYK inhibition, especially JAK1 and TYK2 inhibition and turn them on orphan inflammatory disease with high unmet need. Brepocitinib is like a perfect sort of center of the bull's eye indication for us. These are very sick patients. It's in part an interferon-driven disease. We know the signaling pathways we hit should matter. There's a lot of needs. You talked about the number 40,000. There's probably. Epidemiologically, some of our competitors have found sort of 70,000 patients in literature searches in terms of total U.S. population.

We think about it in terms of treated patients now. When in claims dataset, there's about 40,000 patients who show up as an active therapy for dermatomyositis. And it looks very similar to some of the other great orphan indications that people have launched into, like myasthenia gravis. Today, the vast majority of those patients, about 75% of them, are on what I would call sort of "first-line therapy," right? Older meds, steroids, immunosuppressants, methotrexate, DMARDs, things like that. And then about 25% of the patient population is on later line meds. About half of that 25% are on IVIG, and the other half are on a sort of zoo of other anti-inflammatory stuff, Remicade and rituximab and off-label JAK inhibitors.

Basically everything in that bucket has failed the dermatomyositis studies, but these patients are desperate, and these are anti-inflammatory medicines, and so people are trying them. That's kinda what the treatment landscape looks like today. Notably, you mentioned the oral administration. Those 75% of patients that are on corticosteroids or that are on methotrexate, obviously, those patients are all on oral regimens now.

David Risinger
Senior Managing Director, Leerink Partners

Mm-hmm.

Matthew Gline
CEO, Roivant Sciences

The idea of someone coming in and offering for that patient population, the sort of uncontrolled patients on, in many cases, like very difficult, like, regimens, right? Being on high-dose oral prednisone is terrible, and yet these patients are consistently on high-dose oral prednisone because nothing else is really working for them. Being able to offer them something that is gonna be a real alternative with an improvement in efficacy, being able to reduce that steroid burden, I think it's gonna be a really exciting opportunity.

David Risinger
Senior Managing Director, Leerink Partners

Excellent. What is the process to be able to garner access? Obviously these are pretty desperate patients, so payers should, you know, allow access quickly. How do you think about that?

Matthew Gline
CEO, Roivant Sciences

Yeah, I mean, it's a good question. One of the beautiful things about the current moment in the biotech industry is we would like to be commercial innovators along certain dimensions, but we don't really have to be commercial innovators. That is, Horizon and argenx and BridgeBio and Insmed and Madrigal and Verona and a number of other companies have demonstrated what a biotech company can do in a modern commercial launch, especially in sort of orphan-ish indications. I think the first thing is we've learned a lot from that playbook. Part of what's been shown is, if you have a patient community, if you have high unmet need and an important medicine, that you can get patients and docs to work with payers, and you can get patients on drug.

You wind up building these patient support hubs where the patients and the physicians agree in exchange for a bridge program to really work with you to convince the payers that it's the right thing. Again, in recent memory, that's worked pretty well for biotech companies, and we're working on that endeavor, and we're building a team out of people who have done that on some of the very same launches I just mentioned.

David Risinger
Senior Managing Director, Leerink Partners

That's great. Let's transition to CSU. Congrats on those recent compelling results. How quickly can you get phase three up and running, and how long will it take to generate phase three results?

Matthew Gline
CEO, Roivant Sciences

Yeah, perfect. Dave's talking about, we had another indication for brepocitinib. We were running a small but interesting proof of concept study, a disease called cutaneous sarcoidosis or CS, which is another devastating orphan inflammatory disease. It's a subcomponent of sarcoidosis generally, which affects multiple organs. Actually, one other form of it is ocular sarcoidosis, which is a subset of non-infectious uveitis, yet another brepocitinib indication. Anyway, you asked about cutaneous sarcoidosis. It's a devastating inflammatory skin disease. It can be permanently disfiguring if left untreated. There's a high desire to treat the symptoms, and it's very uncomfortable. We ran a phase II study that demonstrated, so our assessment of the bar for clinical, the endpoint, the scale of disease activity is called CSAMI.

It's one of these skin scales like CDASI in dermatomyositis or PASI in psoriasis or EASI in atopic dermatitis. Our view was a five-point improvement in CSAMI was clinically meaningful. In the study we ran, placebo patients were flat to slightly worse, and drug patients on brepocitinib had been improved by about 20 points. Just blew our own bar for clinical meaningfulness out of the water. To give you a sense, the baseline CSAMI scores were in the 30s, and we were delivering a 20-point improvement, so just huge benefit to these patients in the phase II. There's a lot of excitement for the pivotal program that we're now about to begin. We've said we're gonna start the study this year.

Basically the only significant gating item is a discussion with FDA about the phase II data, and you can imagine we put that data out a few weeks ago. We've been preparing for and lining up for that conversation as quickly as possible. I think once we're done with that and we've answered a couple of relatively minor in the grand scheme of things questions about how the protocol should be set up for the phase III, we should be off to the races, and I think this trial will be pretty easy to enroll because the phase II data was very good, and there's not a lot of other options for these patients. I think we're excited to see that through. You know, I think it's, you know, it'll be. We haven't given specific guidance on the timeline. That's the short answer, but a couple of years.

David Risinger
Senior Managing Director, Leerink Partners

Okay, great. Before we go on, I just thought it would be helpful for those that aren't familiar for you to just briefly touch on why this is such a safe drug, i.e., and how it will be perceived to be safe.

Matthew Gline
CEO, Roivant Sciences

Yeah.

David Risinger
Senior Managing Director, Leerink Partners

in the wake of JAK adoption

Matthew Gline
CEO, Roivant Sciences

Yeah.

David Risinger
Senior Managing Director, Leerink Partners

Particularly Rinvoq, despite its label warnings.

Matthew Gline
CEO, Roivant Sciences

I hate to undercut my own truth or but undercut my own messaging. Look, brepocitinib is a JAK inhibitor. It hits JAK1 and it hits TYK2, and it has had in its clinical data the kinds of safety issues that people talk about with JAK inhibitors, slightly elevated risk of infection, slightly elevated risk of MACE events, et cetera. And that's just a fact of life for these drugs. Now, we in-licensed brepocitinib from Pfizer in 2021, right around the time that black box warnings were known to be becoming a thing for the class.

At the time, you know, Rinvoq was a $3 billion drug in inflammatory bowel disease and some skin conditions, and I think, like, the presupposition was that in sort of "mass market indications" in places like psoriasis and AD and in inflammatory bowel disease, that docs would go elsewhere because of these safety concerns. Our view at the time was, okay, we're gonna go after severe orphan disease with high unmet need where the cost-benefit trade-off is just different, where people would more comfortably tolerate the kinds of things that JAK inhibitors introduce. For example, in dermatomyositis, first of all, dermatomyositis causes elevated risk of MACE events. It causes malignancies. Steroids and methotrexate cause elevated risks of these things.

Getting patients properly treated and off steroids is gonna provide benefit along the exact same axis that people otherwise worry about with JAK inhibitors, so it felt like the kind of thing where we wouldn't face the same cost-risk trade-offs as people might be wondering about in something like IBD. Now, fast-forward to 2026, the truth is docs don't seem all that worried about these things in IBD relative to the benefit of a Rinvoq, and very few other drugs, if any, have come close to Rinvoq-like benefit in these inflammatory markets. Rinvoq's probably gonna be a $15+ billion drug, and rheumatologists and other sort of immunologists are very happy to prescribe it. I do think that the specific concern that we were engineering around may wind up being a little bit different.

Anyway, in these inflammatory diseases, the orphan diseases that we're going after, the feedback we get from physicians is an option that works is gonna be incredibly important, and people will look past, for the most part, with education, any of the JAK-class sort of safety liabilities that these drugs will have. I think brepocitinib was a very good JAK inhibitor. It's very sort of specific to JAK1 and TYK2, and I think overall its safety and tolerability looks to be kind of on the benign end of what you see for the class. Make no mistake, we will have the kinds of things that people see with JAK inhibition.

David Risinger
Senior Managing Director, Leerink Partners

All right. Very good. That's very helpful context. Let's transition to NIU. Can you talk about those results and-

Matthew Gline
CEO, Roivant Sciences

Sure.

David Risinger
Senior Managing Director, Leerink Partners

The timing for the phase III readout?

Matthew Gline
CEO, Roivant Sciences

Yeah. This is our next pivotal indication. CSU will just start a pivotal program, but dermatomyositis will launch in, by the end of September, and then, in the second half of this year, we will get data for our pivotal program in non-infectious uveitis. This is a sort of umbrella diagnosis for inflammation of the eye, and in particular in our case, inflammation of the sort of back or sort of back of the eye structures, where these patients generally can't be treated with locally administered steroids, which is the sort of first-line therapy for front of the eye inflammation. Standard of care is a combination of high-dose anti-inflammatory drugs, steroids, DMARDs. Humira is approved in the indication, although it doesn't. It leaves room for improvement from an efficacy perspective.

We ran a phase II that read out a couple of years ago at this point that showed really sort of transformatively better data for NIU patients, right? The Humira data, for example, the clinical endpoint is time to treatment failure. In the Humira study, it was about 3.5 months on placebo and just a hair shy of six months on drug. Our phase II study at the high dose, it was greater than 12 months. We stopped evaluating patients after a year, basically, or at least the study concluded at 12 months. The median time to treatment failure, most of the patients were still appropriately treated at 12 months. Really, really great data.

That kicked off a pair of pivotal studies that are reading out later this year, and you know, an indication that is frankly similar in size and scope to dermatomyositis, about 70,000 to even more potentially patients in claims data sets with non-anterior uveitis who could be good candidates for a good systemic drug, and about 47,000-ish uveitis patients on TNF inhibition, many of whom, just given the data I just shared, will fail and need a later line option.

David Risinger
Senior Managing Director, Leerink Partners

Phenomenal. That's great. Let's then turn to potential other indications for Brepo.

Matthew Gline
CEO, Roivant Sciences

Sure. Yeah. Lots of great ideas, some indications that'll be proof of concept, some indications that may be straight to pivotal. Some of those studies ready to start in the relatively near future and looking forward to talk about them as they get up and running. Look, our view at this point is. Look, we're in the sort of pinch me position. We have one of the best sort of JAK class drugs ever developed, which is itself one of the best classes ever so far discovered for anti-inflammatory use, and we have carved out, with a significant lead, orphan inflammatory disease as a swim lane for us. It's an amazing position of privilege to be in, and there are many, many places you could imagine going, right? There's a whole host of inflammatory skin conditions that are orphan and quite severe.

You know, now that we have good data in cutaneous sarcoidosis and are working on ocular sarcoidosis, you can imagine thought going into pulmonary sarcoidosis. We get a lot of investor ideas that are good ideas. People suggest, you know, systemic sclerosis and things like that. There's a lot of good places to imagine taking the drug, and I think at the moment we're focused on expanding indication opportunity, doing a good job with it, but making sure that we're focused on the right number of things such that we can win and continue to grow the franchise without diluting our efforts, and I think we're spoiled for choice.

David Risinger
Senior Managing Director, Leerink Partners

Excellent. Is there a way for you to contextualize, you know, those incremental opportunities for brepocitinib relative to, you know, the indications that are currently modeled by the street, whether they're modeled right or wrong, right? When you think about the size of the first three potential indications-

Matthew Gline
CEO, Roivant Sciences

Yeah.

David Risinger
Senior Managing Director, Leerink Partners

You consider those incremental opportunities that you're gonna start to disclose this year. Any way to contextualize that? Are we talking about 50% greater potential, double the potential, 25% more?

Matthew Gline
CEO, Roivant Sciences

Well, yeah, I think of the three indications that we've now talked about, I think NIU and DM are, you know, roughly similar in size. You can imagine puts and takes as the market evolves in terms of which one winds up being bigger than the other, but they're both about the same size. Cutaneous sarcoidosis is very large. There's about 30,000 or 40,000 patients with cutaneous sarcoidosis as well, which is probably like a little smaller than a DM or an NIU, but maybe only a little, to be honest.

I think the other indications that we're looking at range in size from sort of CS-ish on the small end to bigger than DM and NIU on the big end by at least a bit. I think we're looking at indications that are right in the same range and add legs to the stool that are every bit as large as the other ones that are currently in place.

David Risinger
Senior Managing Director, Leerink Partners

Excellent. That's great. We'll look forward to those updates.

Matthew Gline
CEO, Roivant Sciences

Yeah.

David Risinger
Senior Managing Director, Leerink Partners

So, um-

Matthew Gline
CEO, Roivant Sciences

Sure.

David Risinger
Senior Managing Director, Leerink Partners

Let's turn to mosliciguat.

Matthew Gline
CEO, Roivant Sciences

Yeah.

David Risinger
Senior Managing Director, Leerink Partners

Would love to hear you talk about, you know, how translatable you think the proof of concept data from Group 1 PAH will be to and also group four PH to the Group 3 PH-ILD setting.

Matthew Gline
CEO, Roivant Sciences

Yeah. Mosliciguat, again, for those not familiar, it's a drug we had licensed from Bayer. It is an inhaled activator of SGC. That's a target that's been used successfully in pulmonary hypertension before as a systemic therapy. It's a drug called Adempas. It was Adempas that was a Merck-Bayer collaboration that did about $2 billion, close to $2 billion in sales in pulmonary arterial hypertension. But in general, systemic vasodilation, which was partly the name of the game in PAH, has not been efficacious or safe in PH-ILD because of this V/Q mismatch issue. Basically, because if you have a lung that is healthy in parts and diseased in other parts, that when you systemically vasodilate, as much oxygenation benefit as you get in the healthy lung tissue, you give it right back again in the diseased lung tissue.

The way the field has gone, obviously the leaders here have been United Therapeutics with Tyvaso, is you administer inhaled vasodilators that sort of only activate the healthy part of the lung, and so you get a more sort of targeted approach. In general, I'll first make broad statements that make the risk seem low. In general, the translatability of inhaled vasodilation has been good from PAH to PH-ILD, and the things that have worked well in PAH and have demonstrated good, for example, PVR reductions, and we have basically the best PVR reductions ever seen in Group 1, have translated to good clinical benefit in PH-ILD. Now, the words in general are doing a lot of work in that comment, and that we're talking about a very small n of clinical trials, almost all of them with prostacyclins.

That's sort of the unknown unknown here, is we know that sGC works and pattern matches really well to what has happened with the prostacyclins, with treprostinil as between group one and group three. I think we have good reason to believe that sGC as a mechanism should be sort of active in group three and PH-ILD. The risk that we're taking is the unknown unknowns as we see that through. There's phase II-B data, as you know, coming second half of this year. Look, I think if successful, PH-ILD is a market that looks every bit as exciting from an unmet need and opportunity perspective as Group 1 pulmonary arterial hypertension. Tyvaso has been on a rocket ship.

One of the terrible things about pulmonary hypertension, it's a very bad disease. These patients wind up using, in Group 1, for example, ultimately every option they can get their hands on. It's a polypharmacy market, the goal is not even to, like, beat Tyvaso. The goal is to deliver another therapeutic option for these patients, so that they can get used earlier in the patients that like our profile better later, and patients that like Tyvaso better, but sort of used in every combination with all the different prostacyclins and treprostinils and other things that will come. I think we should be the first, knock on wood, non-treprostinil mechanism if we're successful.

David Risinger
Senior Managing Director, Leerink Partners

Excellent. Okay. That's great. Could you talk about the primary endpoint, how you'd characterize your base case PVR efficacy expectations?

Matthew Gline
CEO, Roivant Sciences

Yeah. The primary endpoint is PVR, a right heart blood pressure. It's measured under anesthesia on an operating table with a catheterization, so it's not an easy thing to measure. But again, these are quite sick patients. In our phase I studies, both in healthies and in PAH patients, for example, we saw I think a peak around a 38-point PVR reduction, 38%. You know, I think what it generally seems to take in these indications to deliver a clinical benefit is sort of 20%+ PVR reductions. I think that's kind of the bar for the primary, which is this PVR. In the study, we'll also be measuring six-minute walk and other sort of clinical endpoints, which will ultimately be the registrational endpoints of the phase III program.

You know, I think it's hard to power for those things. For those that have followed this field for a long time, six-minute walk is a notoriously frustrating endpoint. I think what we're looking for is this, like I said, 20-point PVR benefit and evidence of separation and progress on things like six-minute walk that help us contextualize for a phase III.

David Risinger
Senior Managing Director, Leerink Partners

Excellent. All right. That's great. Just touch on safety and tolerability for mosliciguat, expectations there.

Matthew Gline
CEO, Roivant Sciences

Yeah. In the phase II program, it was a very well-tolerated drug. Not a lot to speak of. Mostly sort of on target related to vasodilation is the kinda stuff you see. And all of that is the same as any vasodilator, PDE5 inhibitors or prostanoids or whatever. One of the nice things about mosliciguat is it's a very well-formulated drug. It's a single puff of a DPI once a day is the formulation we're testing. It's got very long activity, so we have phase one data that shows enhanced cGMP production out like two days from a single administration. So we've got nice long sort of half-life, if you wanna call it that, which is super encouraging. And, you know, in general, I think we expect it to be a well-tolerated agent.

One of the challenges with these patients is inhaled drugs can cause cough. We don't see a lot of that, and in particular, cough is an on target, we believe, effect of treprostinil, and it shouldn't be an on target effect of SGC activators. We're hoping not to see significant cough, and cough is a meaningful safety side effect in these patients because if you're an IPF patient, you already have quite a bad cough, and adding on top of it is something people are generally trying to avoid. You know, I'm hopeful that that's gonna be good. The way the study is designed, it's a dose escalation study where patients start out on a low dose and then are escalated relatively quickly to the highest dose they can tolerate.

From what we've seen so far, and obviously, we don't know who's on drug, who's on placebo, we don't know really anything about the performance of the drug. What we do know is that a lot of patients have been able to get to the high doses, which is encouraging in terms of tolerability.

David Risinger
Senior Managing Director, Leerink Partners

Excellent. Any opportunities to go beyond PH-ILD?

Matthew Gline
CEO, Roivant Sciences

Absolutely. Look, I think you could imagine other pulmonary hypertension indications, PAH. PH-COPD is, like, a little bit complicated because emphysematous lung has not generally been great for these mechanisms, but it's something we've thought about, and it's something that Merck has explored with a similar related drug that is in the middle of a study for. Obviously, we've watched with interest the Teton data that showed that treprostinil works in IPF, and that's definitely an area that we are actively focused on. But PH-ILD is such a big opportunity. We've been pretty head down there until we've gotten to this moment with the phase II-B and getting ready for the phase III. But there's a lot of places you could imagine going beyond PH-ILD, and I'm confident we will in time go broader.

David Risinger
Senior Managing Director, Leerink Partners

Excellent. What's the patent life for it?

Matthew Gline
CEO, Roivant Sciences

You know, I was literally answering the question I was just answering, and I was like, "Dave's gonna ask me the patent life for this drug.

David Risinger
Senior Managing Director, Leerink Partners

2042.

Matthew Gline
CEO, Roivant Sciences

2042.

David Risinger
Senior Managing Director, Leerink Partners

Okay.

Matthew Gline
CEO, Roivant Sciences

It's 2042, and I was like, "I don't remember sitting here right now." I felt like I was caught not having quite studied enough for the test. 2042. Thank you, Kay.

David Risinger
Senior Managing Director, Leerink Partners

Well, well, you have all the other answers, so.

Matthew Gline
CEO, Roivant Sciences

Yeah.

David Risinger
Senior Managing Director, Leerink Partners

Uh-

Matthew Gline
CEO, Roivant Sciences

Only to the questions you've asked so far.

David Risinger
Senior Managing Director, Leerink Partners

All right. Why don't we're running out of time here, but it'd be great for you to talk about the Immunovant readouts we should focus on this year.

Matthew Gline
CEO, Roivant Sciences

Right, that one. Yeah.

David Risinger
Senior Managing Director, Leerink Partners

Would love to hear about the Graves' disease opportunity.

Matthew Gline
CEO, Roivant Sciences

Yeah

David Risinger
Senior Managing Director, Leerink Partners

For next year.

Matthew Gline
CEO, Roivant Sciences

In a minute and 19 seconds, we'll talk about those things. Look, Immunovant is developing our franchise of FcRn inhibitors, which are a class that is, at this point, needs no introduction. argenx has done an amazing job with it. We've two datasets coming this year, a small proof of concept study in cutaneous lupus. Look, I think we have good evidence of disease activity there, and obviously, J&J's nipocalimab studies have been successful in an encouraging way. The bar there is to make sure we're able to outpace competitive programs that are also looking good in CLE, so we'll have a good look at that data when it comes later this year. Then the other readout coming this year is in treatment-refractory, difficult to treat rheumatoid arthritis. Look, the opportunity is huge. These patients are in bad need.

We're looking at patients that have failed, you know, some combination of TNF, IL-6s and JAK inhibitors. These are pretty sick patients and not a lot of options. That study has enrolled really nicely. Obviously, there's some data from nipocalimab there as well with mixed results, and we think we've done a nice job on patient selection. We're only looking at autoantibody positive late-line patients, so we'll know later this year what that looks like, but looking forward to that data as well. You alluded to Graves' disease. That reads out next year and is what I would call the lead indication for us. It's an enormous market of patients who are undertreated at present. No good options beyond very old antithyroid drugs, and I feel very proud.

I feel like we have pioneered modern Graves' disease drug development, which is an indication that, yeah, I think there's 330,000 fully treatment-refractory Graves patients in America. And if we can get to even a small percentage of those patients with a new option, we have a lot of opportunity ahead. That registrational program reads out next year, and would be probably the first indication, commercially for IMVT-1402.

David Risinger
Senior Managing Director, Leerink Partners

Phenomenal

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