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

Good afternoon. Thank you for joining us for another session at the 44th JPMorgan Healthcare Conference. I'm Brian Cheng. I'm one of the senior biotech analysts here at the firm. On stage, we have the CEO of Roivant joining us. I'll now pass the mic to their CEO, Matt Gline, for a short presentation, followed by a live audience Q&A. Matt, the stage is yours.

Thanks, Brian. Thanks, everyone, for being here. We did quite a long Investor Day in December. So this is going to be in part a recapitulation of that and in part just an opportunity for me to test some stand up material because I don't actually have that many announcements. But look, it was a really fun year for us last year. And 2026 is a really exciting year, and so it will be good to go through some of that as well as just some thematic stuff that's affecting us in a mostly positive way. I will be making forward-looking statements, and you're all not going to read this right now, but it's here. Cool. So look, where is Roivant as a business. I think there's a couple of sort of level-setting facts for us as we come into this new era. The first is, look, I think it's just true for us that our next decade is going to look a lot different from our last. We are a significantly simplified company, focused on a smaller subset of products which we're going to be talking a little bit about today and which we've talked a lot about in this Investor Day. And I think we've been really laser-focused on that clinical execution. We've moved a number of top line readouts earlier. We have a pipeline that I think really matters. I'm sure some of my presentation, a lot of Brian's questions will come down to some of those programs, and they positioned us to shape our own destiny. And our highest priority by far is making sure that we do right by those programs because we think they have a lot of potential for us. 2025 was a banner year for us, and it sets us up for an incredible moment going forward. We got positive data for brepocitinib in dermatomyositis. I'm sure that will be subject of a number of things we talk about later. But we showed statistically significant benefit across all of our 10 end points, a remarkable data set. We expect to file our NDA by early this year. It will be the first novel oral therapeutic in DM. I think it's a really big opportunity. We showed that we could deliver durable disease -- drug-free remission in Graves' disease, which sets us up for a disease-modifying benefit for IMVT-1402 now in multiple pivotal Graves' disease studies. We progressed registrational studies across a whole bunch of indications at Immunovant, Graves', MG, CIDP, difficult to treat RA, Sjogren's as well as a proof-of-concept trial in CLE. We now expect -- thanks to clinical execution, we expect to get that full RA data set, both the open-label run-in period and then the randomized withdrawal period in 2026 as well as CLE proof-of-concept data. We have this ongoing litigation with Moderna. We're not talking that much about it in this context. But we've got a favorable market ruling in the Pfizer case, and we have that jury trial scheduled for March. We have an incredibly strong capital position. We have $4.4 billion in cash as of our last filing, with a pipeline that's capitalized to profitability. We don't need to raise money. We are basically at what I think will be our peak share count for the future potentially. 2026 is an amazing year for us. We will get, obviously, our NDA filing for brepo in DM, which sets us up for commercial launch there. We have top line data coming for a registrational program for brepocitinib in NIU. Another indication that is every bit as large potentially as dermatomyositis, and that data will be in the second half of this year. We have Phase IIb data for mosliciguat, which is our inhaled sGC activator for PH-ILD. That data is coming in the second half. That's another huge opportunity. PH-ILD has proven to be in United Therapeutics hands, an enormous commercial market. Obviously, people are excited about some of the other prostacyclins. We will be among the first, if not the first non-prostacyclin novel mechanisms in PH-ILD and again, that data later this year. One of the first ever studies for potentially registrational data in difficult to treat sort of fourth-line rheumatoid arthritis, these are for patients that have failed at least 2 of JAK IL-6s and TNFs. So these are sick refractory RA patients who have no options right now. That trial has moved very quickly, and we'll be getting that data this year. We have proof concept data coming in cutaneous sarcoidosis and in CLE, respectively, in brepocitinib in the first half and in IMVT-1402 in the second half. So additional data that could drive future value. And then as I said, we have our jury trial scheduled for March. So honestly, sitting here a few months ago, looking forward to '26, we weren't exactly sure how we were going to match 2025, and then we pulled some things forward and put it altogether, and it's just going to be a wild year. So it feels crazy to be at the start of it. At this point, we have a 10-year track record of execution and value creation. We have, as I said, significant financial strength, the cash balance that should be the envy of many. I think is the envy of many and gets us everything we need from a capital perspective. We have 12 positive Phase III studies behind us, 3 commercial launches coming in the next 3 years. We generated 8 FDA approvals. We've had more than $10 billion in exits. So just a strong pipeline and a lot of performance in the rearview mirror. And then a ruthless focus on capital efficiency. We bought back $1.5 billion of stock at an average of $10 a share. So a really strong position from a capital efficiency perspective and an additional $500 million authorized. I'm not going to spend a ton of time on this, we never do in these meetings, but a number of things that make us unique. One, which I will definitely spend a lot of time on is just our talent model has been unique. We combine people from within the industry, people from outside the industry. I myself, for example, came to biopharma 10 years ago from physics and finance and other places. We have a bunch of people from every background. I think that's been a major driver of success for us in our programs. I think we are -- a thing that I'm proud of is I think we're among the best in the world at creative clinical development. We've thought creatively about indication strategy. We've thought -- we found dermatomyositis as an indication and others have followed us into -- obviously, patients have been sick with it for a long time. But as a beach front or beachhead for novel therapeutic development, same thing with Graves' disease. With mosli, we pivoted into PH-ILD. I think we've been really thoughtful around how we develop these medicines. And then we've been ruthlessly focused on execution and getting patients into studies, on getting good outcomes from studies, on designing studies for maximum benefit. And I'm really proud of that as well. And look, I talked about 2026. Our next 36 months is just transformative for us. We have 3 commercial launches or more. We have 8 or more pivotal study readouts across 6 indications. We will have 4 NDA or BLA filings across indications and multiple proof-of-concept study readouts. The truth is we will have far more clinical data in the next 36 months than could be represented on this slide, much of which hasn't been announced yet, but we're working on all kinds of things. And so it's just -- we're going to look like a very different company a few years from now. I want to talk a little bit more about that in the sense that I think we are -- with good fortune, riding a little bit of a wave in this moment in time where 7 or 8 years ago, we definitely would have been a short to launch story now. We have a commercial drug or a peri commercial drug that's awaiting an FDA decision. And biotech companies were not doing great at launching products, and it was really sort of a show-me dynamic. But thanks to argenx and Insmed and Alnylam and Bridge and Madrigal and Verona and Horizon, we get to watch these commercial launches, learn from them. And these companies have done an enormous job at showing that biotech companies can, in fact, in the right markets, under the right pricing dynamics, launch products successfully. And I feel like after what has been a relative drought of graduates from biotech, we went through a period, and I can talk a little bit more about this, where the fate of all biotech companies was to be bought or struggle. And I feel like we finally entered an era now where companies like us have a shot of graduating from the sort of small-cap biotech arena into the real company profitable sort of high leverage biopharma business. And I'm excited that I feel like we are at the doorstep of that transformation that we get to look ahead towards companies like Insmed and argenx have done this recently, and aspire to be more like them, aspire to learn from their commercialization and do that for our own product. So it feels really great. Actually, it's been sort of annoying being a public biotech CEO for the past handful of years because up until this moment, up until you had this like opportunity for companies to graduate, what it felt like to be a public biopharma CEO was either -- there was like this sort of Lord of the Rings, Eye of Sauron thing happening where either you were in the M&A basket, and public market investors thought you were going to get bought by big pharma and your stock traded well or you weren't and everybody asked you how you could look more like those companies. And my team actually made a little video on what it is like to be public biopharma CEO in that environment. And -- it's -- well, anyway, you'll see. [Presentation]

Anyway, it feels good to be past that and it really felt like a moment in time that was really annoying, to be honest. So it's great to be in an environment where we have another path forward as a business, not that M&A isn't great, and we've benefited from it historically. Look, I think we have a real confluence of both internal and external factors that create opportunity for us from here. Obviously, and this is changing by the day. But in an environment where M&A has been, let's at least call it sporadic or idiosyncratic. We have launches and pivotal readouts that support value creation that go beyond M&A. In an environment where the capital markets have been up and down, we have a cash balance that support runway into profitability. In an environment where China and other dynamics in early-stage discovery have affected what adds value. I think we are really good at late stage global clinical development, which is something that continues to matter, irrespective of the way the sector has evolved. And then -- this is a sector theme is really -- this was a long debate on how to write policy without writing policy. But it's been a choppy environment from a policy perspective. And I think the fact that we just have differentiated first-in-class products has allowed us to look at a lot of that from the outside, which feels good because it's been a tough environment for a lot of people. Recent launches of the kind that I think we are going to embark on in the near future have been very successful, in a couple of different ways. They've been successful in that they have driven shareholder value and they've been successful in that they have open therapeutic categories and delivered outcomes beyond what was originally expected for them. And so they've been in markets like MG, like in amyloidosis, like in bronchiectomy, where new therapeutic options have grown the market, where there's been unmet need supporting access and more adoption has been rapid, and I feel like we have an opportunity to do something similar. We are, as I've said a few times, capitalized profitability. We have a $4.4 billion cash balance. That will give us enough money to invest in our current pipeline, to invest in new opportunities and to continue to return excess capital to shareholders. So it just feels like a great place to be. And I'll just reiterate in terms of what we're focused on for the next 12 months, we want to be ready to nail the launch of brepocitinib in DM. We want to progress 1402 across multiple pivotal studies. We want to convert our proof-of-concept programs into pivotal programs. We want to successfully execute on this LNP litigation, and we want to add to our pipeline. Because we think we have an incredible decade ahead. We think we have the possibility for a large, potentially $15-plus billion portfolio of products across the indications that are currently identified and others. I think that's about where I'm going to end this. I think Brian will take us through some of the specific products, but I'll just say we have an incredibly busy 36 months ahead. We can't even fit all of it on a slide. But I couldn't be more excited for what's coming and excited to talk more about the business in Q&A. So I'll leave it to Brian to take us through that. Thanks, everybody.

Great. Well, let's start the Q&A. Matt, thank you so much for joining us. For those who are in the audience today. If you have any questions, please feel free to raise your hand. We do have runner on the floor. And for those joining us virtually, you can submit the questions on the portal. Over the past couple of years, I definitely have witnessed how Roivant has evolved in a very good way, right? I think it's also going in parallel as my coverage grows and it's just been an incredible story. I think maybe just start off with some higher-level questions. I think when you look at Roivant, there are not a lot of biotech models that function, that operate like this. And to me, there's always -- it's always a challenge to explain some of the parts of Roivant. And can you talk about just where are you taking this model in the long haul? And what worked and what didn't work and do you think it's going to work continuously moving forward?

Yes, there's a lot there. First of all, I'd say, thank you for the positive comments on the evolution of the business. It's felt like -- look, I think it always feels like a journey in this industry. I think one of the things that's been humbling is that biotech is a business where the how is eaten by the what. But it actually doesn't matter how creative you are, how thoughtful you are, how sophisticated your business is. What matters is whether you can successfully generate medicines that deliver good data and matter to patients. And ultimately, we've spent a lot of time in our history talking about and optimizing the how. And I think we're finally at a moment where the what speaks for itself, for where we have a portfolio of products that are going to matter the first of them, we have all the data we need. And I think that's at a moment in time, sort of simplifies that whole question actually in terms of like people get lost in the Vant model and the way we organize the team and what's sits where. And actually, I think mostly that doesn't matter. What matters is the same thing for us as for Insmed or any other company. What matters is that we have a portfolio of products that are going to deliver a lot of value to the patients that are sick with these diseases and that we've been thoughtful and aggressive in developing medicines for those patients. So I think a lot of that has kind of fallen away from our story in a way that I feel proud of that we no longer have to get up here and talk about the portfolio of Vants and who's funded where and which says which CEO, that stuff doesn't really drive the story. We are much simpler than we have been in moments in our past. We have fewer programs. They are programs of higher value. And I think that's a function of maturity and a function of realizing that it's much better to do a few things well than a lot of things not as well. And I think we've just learned a lot of those lessons. It is -- we do not have enough time here to talk about all the things that haven't worked for us. It's a long list. Look, I think ultimately, I think, where we're at now, creative aggressive clinical development is something that is always going to matter. Sometimes I get asked about market moments. There's just no bad time to deliver good clinical data. I think that's really been where a lot of our focus has landed.

And when you look at your name, Roivant itself, ROI is part of the name. And it took me -- it actually took me a few years to actually recognize that. Do you feel a difference in terms of your level of execution or just the way how you executed in the past, has it changed? Because there are a couple of dynamics that you have marked, right? The way you think about operating the Vant model today or even, let's say, let's say when we talk -- have the same discussion in 2028, do you think there's going to be a difference in terms of expectation for ROI? And how are you going to get there?

I think if we are successful at becoming a $30 billion, $40 billion, $50 billion, $60 billion company, yes, look, I think, it's one thing to grow from $1 billion to $2 billion. Another thing to go from $2 billion to $4 billion. Another thing to grow from $4 billion to $8 billion and from $8 billion to 16 billion, hopefully, and from $16 billion to $32 billion, even more hopefully. And I think each of those journeys is different. And ultimately, your clients, if you call investors your clients are a fickle bunch, and they will happily ask maybe what's next, no matter how well last year went. It's just the nature of the beast. I think we are well positioned for the next leg of value creation and that I think executing on what we have will take us pretty far. But I think from here, look, if we succeed at launching these products and they become multibillion-dollar products, and we are of the size of some of our larger peers and growing up, I think, we'll need to then answer the question of what's next from there. So I think we're looking at expanding the pipeline now, focusing on opportunities that can drive value not from $5 billion to $10 billion of market cap, but from $30 billion to $50 billion and from $50 billion to $75 billion. And I think that's probably a little bit of a difference for us. That's I think one of the core founding innovations of Roivant from the beginning is -- and we frame this a lot of different ways over time. But look, the truth is our business is a capital-hungry business that relies on the not goodwill, but the return hunger of the investor community to fuel itself, and we have to feed that to be successful for patients. And I think many of our peers, some companies that are very successful are born on a scientific dogma and pursue that dogma sort of irrespective of the business merits and succeed or fail sometimes. Whereas I think we were born on the idea that if we focus on creating value that the good outcomes for patients will follow from that. And I think that's always been in our DNA. It's -- I didn't name the company, but I think it's why ROI is in the name is because our belief is that -- with that as the horse the cart of patient benefit will follow.

The transaction of the TL1A, I still remember those days to Roche, really gave...

So long ago...

I still have the newspaper on my desk. And what I remember was it really gave you the cash runway that you need to really showcase such a robust catalyst timetable, right? Has that changed your way about thinking, about going for strategic, is any of these assets open for strategic discussions. How do you think about that? Because you have talked about the fact that you see a role towards profitability, right? So how do you kind of balance that?

Yes. It's a question are we for sale? I -- we answer that question always, because we are fueled by the investor community, the answer to that question, to be clear, is always yes. I know that one. Look, I -- first of all, for those that weren't around or don't remember or haven't paid attention, the transaction that Brian is referring to is we partnered on a drug with Pfizer for inflammatory bowel disease and it turned out to be a very good drug and a lot of good things happened, some of them driven by us, some of them outside of us. And we sold it a year later for $7 billion to Roche and capitalized ourselves for the foreseeable future, which was great and allowed us to do all kinds of things that are unique. And I think, look, being funded through profitability is an incredible privilege in biotech. It is not a privilege that most companies have. And sometimes, I'll talk to an investor and the investor would be like, oh, your stock trades funny, like something is different about it. It reacts differently to data, it moves in different ways. And I think part of the answer to that is like everybody else is doing financing. Everybody else is raising money when they put out good data, and I think like that just like affects the patterns of institutional investing activity in a way that we don't have. And so I think we are a different beast from that perspective. And I think there's very few other development-stage biotech companies that have that. I think what it means is we are afforded the privilege of being ruthlessly economic in our decision-making, of having high standards for ourselves in terms of what deals we will take, high standards for ourselves in terms of what deals we will do and the ability where we have conviction, for example, that brepocitinib in dermatomyositis should be a multibillion-dollar drug. Or that our FcRn franchise is a best-in-class franchise that will matter in indications like Graves' disease. No one can take away from us the opportunity to test that thesis. And so if we do any kind of partnership, if we do any kind of transaction, we're doing it because the value is right, the moment is right and we want to, not because we have to, to survive. And I think that's mostly been great for us.

So let's start to talk about some of the assets in your portfolio. Let's start with brepocitinib first. When you look at where the JAK class is today, doctor feedback has told us that there's about 20%, 30% of the patients are currently using JAK. How confident that you can grow this JAK class in DM today? Do you think that brepo has the ability to grow it?

Yes. So brepo for those who aren't familiar with it, is a dual inhibitor JAK1 and TYK2. It's a drug that we acquired from Pfizer back in 2021 when they were pursuing a more common kind of JAK or TYK2 strategy of looking at larger market indications. They've studied it in psoriasis, in psoriatic arthritis, in UC and Crohn's. And at the time, it wasn't exactly clear where the JAK class was headed across indications. There was a sort of safety question around Black Box warnings. And we decided to focus on orphan immunology as an area where there's enormous unmet need where JAK inhibitors and TYK2 inhibitors are some of the most effective anti-inflammatory drugs, we as a field, we as a species have ever discovered. And we decided there was a real opportunity there. So we went into dermatomyositis. Now dermatomyositis is a terrible disease. It's an orphan inflammatory disease. It affects probably 70,000 people in America, of which 40,000 are in active therapy and claims data sets. Actually, practically the number of those patients that know JAK and the only approved medicines for dermatomyositis are either like steroids and immunosuppressants like methotrexate or high-dose prednisone or IVIG is approved. Other than that, everything, including what off-label use of JAK inhibitor is all off-label. It's all without sort of FDA approval. And indeed, I think, if you look at the claims data, it's a low single-digit percentage of patients are on JAK inhibitors now. And I think why is it so small? First of all, the JAK inhibitors available are not dual inhibitors of JAK1 and TYK2. They are pure JAK inhibitors. They are probably not as efficacious in DM as brepocitinib, and they're off-label. So access sucks and it's about the individual ability of a physician to navigate the universe to be able to get these patients on drug, and it's hard. And so for all those reasons, it is like not very widely used. And these patients are suffering. These patients are on very high doses of prednisone a significant portion of the time. Even the approved commercial dose of IVIG, if you follow the like letter of the treatment paradigm, these patients are on like 4 or 5 consecutive days of -hour a day infusions every month. It's like a full work week a month spent in infusion clinic, and these patients are so sick that many patients are doing this. It's about whatever, 12%, 13% of the market is on IVIG for days out of the month. It's like a whole thing. And I think there's just hunger for a new treatment option. So I think we have a huge opportunity. We've worked very closely with the DM document. In fact, one of the things I love about talking to investors about dermatomyositis, because I feel like I mostly don't need to pitch it. I think investors who do doc calls with dermatomyositis physicians, hear enthusiasm for our drug because the docs are legitimately enthusiastic for a new treatment option, specifically for a combo of JAK1 and TYK2. And just based on the incredible clinical data that the team generated back in September that we put out, I think all of that has carried a lot of enthusiasm. I think that enthusiasm will serve us well assuming we're successful with FDA. I think we have an opportunity to take share from off-label therapies. I think we have an opportunity to take share from IVIG, which is obviously, again, an onerous paradigm. But also, I think, among the biggest opportunities the 75% of patients were just like on high-dose prednisone or methotrexate or some combination and I think it's like a lousy existence. It's miserable. It's unpleasant, it's not treating the disease effectively. And we have an opportunity not only to afford those people better disease control, but better disease control on a lower burden of steroids. And I think that will allow us a lot of enthusiastic patients who will benefit from the drug. So absolutely, I think, we can grow significantly.

So you're interestingly in FcRn with 1402, and you're also in DM with brepo, we get this question a lot. People are looking into the incoming FcRn data in DM. What's your take of ultimately where brepocitinib is going to place in the DM space?

I feel like I'm supposed to say better, right? We're going to be better. Look, I'll say a few things. One is -- so for those -- again, don't follow this closely. So argenx is studying efgartigimod in myositis. The study they're running is about 150 patient study across 3 different types of myositis. DM is one of those types, but they're also in like polymyositis and IMNM. So it's a different kind of study in a broader patient population. And indeed, I think, the biological rationale for FcRns or IVIG for that matter, but we'll start with FcRns in myositis is probably stronger in some of the other myositis in like IMNM, which is more obviously driven by autoantibodies and less in dermatomyositis, which has significant inflammatory components. I think if you look at the data argenx generated, they didn't have a steroid taper. They generated against a backdrop of not having a steroid taper, like comparable benefit from a test perspective, which is to say, I think, like less overall clinical benefit to the patients because they were still on steroids at the time and a little bit slower. We generated moderate TIS responses in a median of, I think, about 60 days, and they were about twice that. So I think those are all benefits that we have. We're also an oral medication. They are either IV or subcu, depending on format, mostly subcu in this indication. So look, I think, we have attributes that should make us appealing in dermatomyositis that should give us, I think, a real leg up. That said, I also think this is just 1 of these opportunities where these patients have poor disease control. There's really nothing available right now. Multiple people out there talking about novel therapies, it's just going to be good for the field. They'll be better diagnosed. I was talking to somebody actually on the buy side at one point who has either DM or lupus and part of what they were saying is they were diagnosed and told like you probably have either DM or lupus, and they didn't get more specific than that. Even though they're in treatment for the disease because it turns out it's like relatively hard to diagnose the disease and there wasn't much of a reason because they weren't going on a therapy that was like specifically approved in either of those indications. And so I think like that will change in a world where both we and others are out there talking about the treatment of the disease in a way that I think will expand the pie. To be honest, I think, there's almost nothing that you could have said about myasthenia gravis as a commercial market 5 years ago that you couldn't say about DM today. The size is similar, the severity is similar, the dearth of options is similar. And certainly, the MG market is larger than anyone imagined it to be and growing all the time and definitely supporting multiple drugs in the same class, definitely supporting multiple classes of medicine. So I think the same thing will absolutely be true in DM.

So turning to, I guess, from the audience, any questions? Okay. Turning to 1402. How do you define the criteria for success in RA? I think to some, nipocalimab's history indication does raise some questions. Why do you think the setup here is different with 1402?

So as a reminder, we are running a study of IMVT-1402, which is our sort of next-generation anti-FcRn antibody in difficult to treat rheumatoid arthritis. So this is a study. Now you think about RA, you think about like 1,000 patient studies and a huge patient population. This is for patients who have failed, I think I said this earlier, at least 2 advanced therapies. So at least 2 basically of IL-6, TNF and JAK inhibitors. These are patients with very few options from a therapeutic perspective. And we are also explicitly only studying those patients that are autoantibody positive, They're ACPA-positive. And so it's a subset of the RA population that is severe late line and has disease that seems affected by autoantibodies. J&J has run a few studies, nipocalimab has a few studies under its belt. The most important one here is they studied in early line patients. They studied a monotherapy. And in that study, they saw a clear dose response that is deeper. Larger doses of nipocalimab drove better ACR20, better ACR50, better ACR70s and they showed better responses in ACPA-positive population autoantibody positive disease than in the sort of general population as a whole. And so I think we took that, we looked at it and we said, okay, this is a drug that is -- it appears active in the patient population. It's a mechanism that is orthogonal to most of the other anti-inflammatory drugs approved in RA. It's a patient population without very many options. We're going to focus on that patient population and design a study that gives us a quick answer. And so we're running this randomized withdrawal design where patients are open label on therapy for a period of time and then we rerandomize responders either to drug or to placebo. So that we'll see sort of who falls off as responders. You asked about the bar for success. I think -- so the first answer to that question is, I don't think we have a great answer to that question now. It is incumbent on us to have one before we generate this data, and we're working on it now. The problem is just like a very understudied population. There are basically no studies in late-line RA. And so I don't think any -- there's no like quantitative answer to like what we have to beat to be interesting. And so it's really a question for docs and patients of like what is the threshold ACR50 or ACR70 or even ACR20 that gets patients with no other options excited about trying a novel therapeutic. We are doing that work now. I expect we will produce our view of an answer to that question sometime in the first half of the year before we put out this data and that will inform our decision to run the second study, the sort of final pivotal study, depending on what we see in the study that we're running now. There's about 75,000 of these ACPA-positive late-line patients. This, again, is a patient and commercial opportunity that is wide open. Nobody else is really working in this field right now, and we feel like we have a huge opportunity if we're successful here to do something interesting.

Okay. And then turning to mosliciguat. PH-ILD historically has seen a lot of different competitors, many have failed. How do you think about the setup here? Maybe can you talk about what you saw in PAH that gave you the most comfort that this will be successful?

So mosliciguat, it is an inhaled drug. It's a dry powder inhaler for a mechanism, it's called an sGC activator. It's a vasodilatory mechanism. There was an approved drug with the same target an sGC stimulator it was called Adempas that did just under $2 billion in sales, mostly in PAH. And so now we're working on a next-generation drug here that's by dint of being an activator should be more efficacious. And by dint of being an inhaled drug should work in PH-ILD, where systemic vasodilation in PH-ILD doesn't work. Basically what happens is you end up vasodilating the healthy lung tissue, which is good and you get better oxygenation, but you also wind up vasodilating the unhealthy lung tissue, and you effectively bleed out oxygenation. And so you wind up like with -- in some cases, a net negative effect. Whereas what seems to work in these patients is local vasodilation in the healthy lung tissue, which you achieve through inhaled drugs. And so this is where, like, for example, systemic Treprostinil does not work well in PH-ILD, but Tyvaso was, an inhaled Treprostinil does work well. And now you've got TPIP from Insmed coming in quite a drug, all also inhaled Treprostinil. We are among the, if not the most advanced non-Teprostinil mechanism here in PH-ILD. The truth is the end of successful studies in PH-ILD remain small. And so it's hard to say for sure exactly how likely we are to succeed. But what we have is unbelievably good data in PAH. As an inhaled drug in PAH, we saw some of the deepest -- you look at this right hearted blood pressure, PVR, it's a very difficult thing to measure. You put these patients on an operating cable and put a cath in their artery. But we showed some of the deepest reductions in PVR ever shown, and PVR has generally correlated really well with clinical outcomes in PAH. It has also correlated well with clinical outcomes in PH-ILD, but it's hard to say really well because it's just such a small number of studies. But anyway, I think, the hope here is we are able to reproduce what Tyvaso has shown that is a drug with good PVRs and PAH will also generate good PVR reductions in PH-ILD and that is sufficient to then translate to clinical benefit in the form of 6-minute walk or time of clinical worsening or whatever else in the PH-ILD setting. And if that's true, I think we have a really big opportunity. PH-ILD as a market should be about as large as PAH and currently, Treprostinil is the only mechanism approved, and so it's a huge opportunity. And this will be one of these polypharmacy indications where patients are on everything all at once that works, because these patients are otherwise very sick and dying and so we expect to see drugs used on top of one other. In fact, we're running already a combo study with Tyvaso as a part of our program.

Okay. Turning to one of the big catalysts coming up in March. There's a Moderna LNPKs. Just heading into the litigation, into a trial, jury trial. Do you have an update on when we could get summary judgment?

It could come in an hour or it could come the day before trial. The truth is like we don't know and it's up to the judge. And in fact, the judge could decide not to rule, I think, basically on any of the issues in summary judgment and allow for the jury to rule on all of them. That's like a possibility in theory. I think either even then he would issue some kind of opinion. But the short answer is we don't know. This trial, again, for those that are not quite as close to it. So we have a team of scientists that have been working on lipid nanoparticle chemistry for literally decades. We are some of the originators of that field and developed the lipid nanoparticles that went on to be used in our view, in the COVID-19 vaccines. And so we're in IP litigation with both Moderna and with Pfizer-BioNTech to try and get our fair share of that, given our scientific contributions to the programs.

How should we think through the read through from this case to other litigations are ongoing in other jurisdictions?

Yes. So first of all, it's hard to comment that much on an ongoing litigation with the trial that's this soon. But look, I think, in the Moderna case, our patent portfolio was a little bit different in the U.S. than in Europe. So they're not like perfectly analogous, but the product is pretty much the same in these different regions. And the patents are very similar. And so I would, absent some change in the patent portfolio or otherwise, expect some translatability from a U.S. outcome to another jurisdiction outcome, but it will be idiosyncratic and the different courts may look differently at different things. And again, like patent validity and things like that could be different from -- in different places. In theory, again, the patents are slightly different. In terms of read through to Pfizer, it's a different product and a different set of patents that have been asserted in the case. And so I think there's some read-through on what's allowed in court and the mechanisms and the analysis that we've done and so on, but I think mostly, they are different cases.

Got it. We have about 3 minutes left. So I want to go back to cutaneous sarcoidosis is one of the indications I've been getting a little bit more questions on. Maybe just on that indication. I know that you have worked on this indication in the past. So definitely some insights into what -- how to best design a trial. Can you talk about what you want to see out of the proof-of-concept trial in CS and what will give you the confidence to move this into a later stage study?

Yes. So sarcoidosis as a whole is a rare inflammatory disease. There's about 200,000 sarcoidosis patients in the U.S. That -- it can be multisystem in nature. Most sarcoidosis patients present with pulmonary sarcoidosis in the lung. Many present with skin symptoms, some present with ocular sarcoidosis in the eye, which actually is a subset of noninfectious uveitis that we're studying in our NIU program. And it's a terrible disease in every case. It can lead towards breathing problems. It can lead to cutaneous sarcoid, which is a question you asked about. Is a skin manifestation that leads to like terrible, terrible skin rashes and plaques that are debilitating and very, very uncomfortable. So that's the disease we're studying. Again, it's one of these orphan diseases with tens of thousands of patients with really no other options. The study you're referring to, where we have experience, we ran a pulmonary sarcoidosis trial with a different drug, an anti-GM-CSF antibody that failed. Pulmonary sarcoidosis is a very difficult disease to study. I think our hope is that cutaneous sarcoid is a little bit easier from a clinical development perspective that it's got the end point is a thing called CSAMI, which is one of these sort of skin scores. It's not so different from the skin scores used in other indications, CLE or even psoriasis or dermatomyositis. I think it's helpful that we have that kind of indication. And then obviously, JAK inhibitors historically have worked well in skin disease. And in fact, there is open label data for tofacitinib in cutaneous sarcoid that looked very good. So I think our hope is that we're running a program that's going to generate good data. It's a very small study. It's really a proof concept. It has a small placebo arm and then a drug arm. I think we'll see what we show. The answer is because it's a disease with really no other options, it's really just about -- it's just about delivering any kind of clinical benefit. And our view is like a 5-point change in the CSAMI end point is probably sufficient for doc and patient enthusiasm.

And just lastly, in our last minute here, there's a slide you talk about how you look forward to the $15 billion plus sales -- peak sales opportunity. How does each Vant stack up? And give us a sense of when we can see that?

When you can see $15 billion in sales. Eventually, look, I love all my children equally. Brepocitinib and FcRn for us, 1402 both are at this point already in clinical development in many indications, several of which in each case can and should be multi-blockbuster indications. So I think it's easier to chart the path towards $5 billion, $10 plus billion sales for either of those drugs. Which, again, it feels ridiculous to be sitting here and talking for a drug that hasn't launched about a $10 billion market opportunity. But on the other hand, they're really exciting drugs, and it's what we're supposed to do in these settings. So I think they're going to be really big drugs. I think -- you got to take it one foot in front of the other, though, right? We're going to launch in DM first. I think DM has the potential on its own to be a multibillion-dollar blockbuster opportunity. Then we're going to launch an NIU. I think that on its own has a chance to be a multibillion dollar opportunity. If we're successful in Graves', that will be the next one after that, probably, and then we'll start talking about PH-ILD and some of these other markets thereafter. So I think it's really about -- and this is one of the things that I love most about our situation right now. It's really about being able to stack these things on top of each other and build something that accumulates over time that makes me excited.

Right. Well, thank you so much for your time, and thanks for joining us.

Thank you.

Thank you.