Good afternoon. Thanks for joining us for another session at the 42nd J.P. Morgan Healthcare Conference. I'm Brian Cheng, I'm one of the senior biotech analysts here at the firm. I'm joined by my associate, Sean Kim, who is in the audience today. On stage, we have Roivant's CEO, Matt Gline. I'll pass the mic to Matt shortly for a presentation, followed by a live audience Q&A. If you're joining us live here, in the audience today, you can submit the questions for the team through our conference portal, or you can, hold your hands up during the Q&A session. I'll pass this to Matt. Matt, the stage is yours.
Thank you. Hi, good afternoon. Thanks for coming today. It's good to see some familiar faces, some new ones. It's a pleasure to be here. So I'm gonna go through just a brief presentation, and then, as Brian said, we'll hang out and answer some questions. Should be fun. So I'm gonna be making some forward-looking statements. There's disclaimers available here, and this presentation is available on our website. Cool. So I'm gonna start with a short but important to me, victory lap for 2023, which was just a phenomenal, phenomenal year for Roivant. I was reflecting back when we came up on this conference stage last year, I talked about the fact that 2023 was gonna be Roivant's best year. And it was an amazing year.
On our commercial program on VTAMA, we obviously spent a lot of the year expanding insurance coverage, but also we had, which feels like ancient history to the extent that no one's talking about it anymore, two phase III readouts in the first part of the year in atopic dermatitis, which we'll come back to because they're gonna be important for 2024. Probably the main event of 2023 was the journey of our anti-TL1A antibody, which at this conference last year, we had just put out the data from our phase IIb induction period.
And over the course of last year, we put out the 52-week maintenance data, and we actually ultimately sold that program to Roche, a transaction that closed just last month, and netted us about a little more than $5 billion in cash. We also have put out some astonishing data for IMVT-1402, Immunovant's next-generation anti-FcRn antibody, which we've now shown to suppress IgG, we think in a category-leading degree without an attendant impact on albumin and LDL, something that we had wanted to achieve. And staying within our FcRn franchise for a moment, we also showed just a couple of weeks ago data from our phase II study in Graves' disease.
We haven't said a lot about it, but it's data that's cleared the bar that we set and makes us very excited about the opportunity in Graves'. So more coming there. We weren't able to have a perfect year, so we also put out data from Brepocitinib, our TYK2/JAK1 pivotal trial in SLE. We knew SLE was a tough indication. We're excited. Our partner, Pfizer, generated that data set. We're excited to have put it out, but obviously it was not successful, and so we will not be progressing Brepocitinib in SLE.
But overall, a tremendous year with a ton of really important clinical data, some important transactions, and leaving Roivant in a transformed position with an extraordinary capital base that will be the subject of, I'm sure, some of my presentation and many of Brian's questions of how we're gonna manage that capital from here. One of the things that I'm proud of, and this has been something that Roivant's been after for a long time, is just the R&D productivity underlying this output. So this is the top 15 global pharma companies plus Roivant. Number of phase II and phase III readouts. We focus specifically on the non-oncology readouts, because obviously, oncology tends to produce a larger number of readouts.
Suffice to say, we're not the most of any company, but we are right there in the mix, and the number that stands out on this page is the highlighted number. Most of these other companies have R&D budgets that are much larger than ours. And so we are incredibly proud to be able to produce this level of clinical data and this amount of important clinical data in a manner that is this capital efficient. So it's something we've always prided ourselves on. It's something Roivant set out to do at our inception, and something we really feel like we showed in 2023, that we can continue to execute on, generating clinical data, which is what this industry is all about in a capital-efficient manner.
We are now and again, this will be the subject of much of today's presentation, set up in a truly unique position. We have immense financial strength, $7 billion in consolidated cash, given rise to the proceeds from Telavant transaction, really not dependent on capital raises. I've been asked a couple times, it says here we're funded through profitability. What does that mean? And I think if I couldn't stand up on this stage and say that with $7 billion, we're funded through profitability, that would be embarrassing. So I think this is enough cash to get us where we need to go, and just a really powerful position. We also have married that with quite a lot of development expertise at this point.
We've generated, through our portfolio, six FDA approved products, one of which commercialized by us. Just in 2023 alone, as I mentioned, seven phase II and phase III readouts. We have five significant readouts and one registrational filing expected this year, and four ongoing pivotal programs with data coming in the near future. And just a ton of flexibility to fund our pipeline, to be the partner of choice for a next generation of programs, which we'll spend some time talking about later in this presentation, and to be ruthlessly economic, as we always have been with our deployment of capital, in order to be, to be maximally efficient. You know, 2024 for us is really... It's a year of expansion. It's not like last year.
Last year was about harvesting the seeds that we had planted over a long period of time. This year is about growing. It's about growing into the position that we've built for ourselves. So we have a lot of clinical data coming. We have clinical data coming in particular in our anti-FcRn franchise, where we will deliver data in CIDP, in an MG, and Batoclimab, as well as announce and cement plans for our next-generation antibody, IMVT-1402. We have further clinical data coming in a range of pipeline opportunities that I think I can safely call underappreciated, including Brepocitinib, our TYK2/JAK1, with data coming imminently in NIU, as well as readouts coming in namilumab and sarcoidosis, and in RVT-2001, in transfusion-dependent anemia in low-risk MDS patients.
We will file an sNDA this year for VTAMA and AD, which we hope and expect will lead to an approval later this year, and we'll continue to grow our revenues in psoriasis and to grow that commercial business. We're also, this is the subject of a lot of interest and a lot of questions we're getting, we're very focused on expanding our pipeline, on taking our capital position and turning it into a number of programs, hopefully programs just as exciting as the FcRn and the TL1A franchise, that we had last year. So a lot of opportunity there. And frankly, it is an unbelievable environment for us to build those partnerships right now, we'll come back to.
And finally, it's a year where we're gonna spend a lot of time and attention on our capital allocation strategy to maximize the best value creation opportunities across our existing pipeline, across our new pipeline, and so on... So I'm gonna talk about each of those chevrons to varying degrees in turn. But I wanna start just by this is actually a mirror image of a slide that we had a year ago around where we are. And I think a lot of people will say, "Hey, look what's left?" And I think the thing that strikes me is we still, in my opinion, have one of the most exciting, even just focusing on INI, one of the most exciting INI portfolios of any biotech company. We have a commercial product in psoriasis and atopic dermatitis.
We have products in three of the six biggest INI markets, including psoriasis, soon-to-be AD, and myasthenia gravis. Then we have a number of programs on the right-hand side of this screen, in markets that we think of as growth markets. Markets where we feel like we can pave the way and do something different, and show a really big opportunity. A number of markets like this have been the basis for very, very large drugs across the industry. So we're really excited about our development programs in those markets. So, you know, we think across this portfolio we should get multiple approvals, as well as six or more phase II or III readouts over the next several years, with a wave of potential approvals coming in the latter half of this decade.
And we think it's not very difficult, if you look across analyst coverage, et cetera, to believe this is a portfolio with $10 billion or more in peak sales potential, as we convert some of these programs into approved products. And I'll just highlight, because we talked about on slide 8, the sort of growth market opportunity. We think some of the markets we're in, like Graves' Disease, like Non-Infectious Uveitis, like Dermatomyositis, these are markets that we think we will define new categories that matter in a similar way to some of the therapies listed at the bottom of this slide. Our next chapter here is truly anchored then by this pipeline. We have a pipeline that we are incredibly proud of.
I've talked about a number of these drugs, and we think there's a lot to do in advancing this set of programs. We are generating a lot of clinical data this year. For a year that is about building, we nonetheless have a lot of data coming. That includes top-line data from brepocitinib in non-infectious uveitis. It includes data from RVT-2001 in the first half in our trial in low-risk MDS. It includes data from batoclimab in both CIDP and our phase III program in myasthenia gravis. It includes top-line data from namilumab in sarcoidosis coming in the second half of this year. And then, as mentioned, we also expect to file our sNDA for VTAMA and AD coming in the first quarter here.
So I want to pivot and talk for just a minute, specifically about the FcRn program, and Pete at Immunovant is presenting at this conference tomorrow, so he'll say much more. But one of the things that we're excited about is now that we have IMVT-1402, 1402 in pole position, we're excited about advancing that franchise. We think it's just an incredibly large opportunity. And at the base of it, the thing about that franchise that has us excited, the thing about 1402 that has us excited is 1402 suppresses IgG as deeply as any other anti-FcRn antibody and more deeply than our best-established competitor in argenx.
I wanted to remind people, there's a lot of evidence across the field and a growing base of it, across multiple programs, that suggests that deeper IgG suppression leads to greater efficacy. At this point, we have that data in multiple places. We have it from argenx and J&J, who have showed in various different ways that at the patient level, deeper IgG suppression has led to better improvements in MG-ADL. We have it in Immunovant data in thyroid eye disease, probably one of the clearest data sets.
We've shown it multiple times before, where we show that our high dose, we delivered apoptosis response rates that were in the 40s, and got a majority of patients to normal autoantibody levels, whereas our low dose, that is more comparable to what argenx can deliver, we showed a significantly lower apoptosis response rate. We've now shown it in our own Graves' Disease data. This was really just a small comment in the press release from Pete, but in the press release, we mentioned... Remember, the Graves' study had two pieces to it. It had a 12-week period at 680, sort of maximal IgG suppression, and then a 12-week period at 340, lower IgG suppression. And we showed a real dose response.
We were significantly better able to control patients' thyroid hormone levels at our high dose than our low dose. UCB has shown it in ITP, for example, where greater IgG reduction led to greater platelet responses. And J&J, in their recent RA data, showed that patients with deeper IgG suppression had a correlation with better autoantibody reduction, and that was a correlation with greater clinical response. So a lot of evidence to suggest that we should be in a best-in-class position with IMVT-1402 across multiple indications, given the depth of IgG suppression that we can deliver.
And so, 1402, which is now, although it is not literally the lead asset, is probably the most important asset of our FcRn franchise, really does have potential best-in-class attributes with deep IgG lowering, a clean profile from an albumin and LDL perspective, which is something we're really shooting for this year. As a reminder, convenient administration with a simple subQ injection, should enable self-administration at home and long patent protection out to 2043. So an opportunity to build a durable, important franchise from an FcRn perspective. I'll come back to just briefly now, having talked about FcRn, just a couple of other things in the portfolio, including notably, VTAMA, which is a commercial program. You wouldn't know it from all the conversations we have.
It's not top of people's minds, but it's a program we're really proud of. It's continued to do well, script volume growing nicely, even up through the very end of last year. And that's just in psoriasis, where we, we've been pleased with our ability to really saturate and convert a group of high-prescribing docs and have now been growing more slowly but steadily into a group of of community physicians and folks who are used to prescribing steroids, who are getting used to the new world order with non-steroidal medicine. So we continue to be the top-selling branded topical in psoriasis. We have been since the eighth week of our launch, and we hope and expect that's gonna continue, and we're excited to watch this grow. We're particularly excited because what 2024 is really about for us is atopic dermatitis.
So, now that we've put out the great data at the beginning of last year, we'll be filing our sNDA in the first quarter of this year. And as a reminder, atopic dermatitis is truly a much, much, much larger market. You know, there's about 100,000 topical prescriptions written a week in psoriasis. We're currently about 5,000 scripts a week, so plenty of room to grow in psoriasis. But there are close to 350,000 topical prescriptions written every week in atopic dermatitis. Just a huge opportunity. And our clinical trial was designed to maximize the breadth of our experience. We're studying patients down to the age of—we have studied patients all the way down to the age of 2. Atopic dermatitis is a heavily pediatric market.
We'll be one of the few novel topical agents to have a label all the way down to 2 at launch, assuming everything goes according to plan. So really excited about that opportunity, and excited to deliver a nonsteroidal option to patients who need one, especially one with a clean safety profile. We don't expect anything like a black box warning, which some of our competitors have, et cetera, so a really big opportunity. More to come on that, over the course of this year as we get closer to the approval. But excited to show what we can there and think it should be a big addition to our portfolio once we get the AD approval.
So, the last thing I want to do is talk a little bit about pipeline expansion, which is something that's been on a lot of people's minds. I've gotten a lot of questions about it, and I want to talk a little bit about how we think about that, and what we expect it to look like this year. First of all, we have a track record. We've been doing this since literally 2014, and we believe we have become really a partner of choice for all manner of potential partners, from pharmaceutical companies to biotech companies to academic institutions. We've done a number of deals.
We have really a 10-year track record of doing this, dating all the way back to, you know, Intepirdine from GSK, and Relugolix from Takeda and others, all the way through to the TL1A partnership with Pfizer just last year. The main thing for us is this has to be a win for both us and our partners, and we think we've repeatedly demonstrated an ability to execute well on these programs and deliver clinical data that matters in ways that generate value for our partners, in addition to for ourselves.
And we have never been in a better position to do this as a company than we are now, both because of the execution track record we now have across multiple therapeutic areas, and because our balance sheet enables us to work on all kinds of things, large and small, that very few other people can say they can work on with the same confidence. We have an execution track record that we are very proud of. You know, IMVT-1402, who does this? We had a problem with one of our programs, and within 2.5 years, we had generated human clinical data for a replacement program that did not have the LDL and albumin impact that the first-generation program did.
We were basically ready to start a phase 3 study within 12 months, very close to ready within 12 months for TL1A. Unfortunately, I don't get a chance to prove that because Roche bought the program, but really proud of the progress we have made there. Then on the products that have been approved, we've initiated a clinical study at Myavant within 6 weeks of closing the transaction, ran multiple phase 3 programs very quickly, and that led to an FDA approval following the sale of that program to Sumitomo. Something similar in terms of speed with Gemtesa at Urovant, and obviously really pleased with our execution at VTAMA as well, which has led to our own commercial franchise. What do our deals look like generally? Just mostly historical information.
First of all, in general, we're stingy. Our upfronts have been low. The vast majority of our deals have been less than $30 million upfront. 70% of them have had less than $10 million upfront payments. This is still the kind of deal we like to do. We like to risk share with our partners. We like to give them back-end exposure and spend fewer of our dollars on upfront payments and more of our dollars on clinical development. Our deals tend to split about 50/50 between mid- to late-stage deals, which is still a big part of what we're focused on right now, and earlier stage, so proof of concept kind of opportunities where we can flip a card for fewer dollars.
And I'll just say, on the things we have exited, which is a small percentage of our overall portfolio, and it's never our goal to exit the things we work on, our capital efficiency has been good, ranging from fantastic as it was last year with the Televant transaction, which is obviously an unusual situation, and was not our goal going into that partnership, to very, very good across the Sumitomo and Immunovant situations. So really proud of our ROI and, you know, focused on doing deals that probably loosely mirror what we've done historically in terms of capital efficiency and stage of development. And the last thing I'll say is, there has never been a better environment for what we do.
The overall environment in pharma has led to seismic shifts in the way that pharma companies think about their portfolios. There's EPS pressure, driven from a variety of sources. There's a series of looming patent expiries, with billions of dollars in sales at risk across large pharma, and I think they are acutely aware of this problem and working aggressively, including through M&A, to solve it. And it's something that I'm sure they'll do an impressive job of turning over their pipelines, but it leads to an opportunity for reprioritization. And then there's the backdrop of the IRA, which has led to portfolio strategy changes, right?
People who thought maybe they were gonna develop six drugs at once, one indication at a time, are now thinking maybe they need to develop two drugs at once, three indications at a time, and that also leads to reprioritization, at least to rethinking which programs they're gonna focus on. What that means in aggregate is a bunch of promising drug candidates are gonna become available, and we feel pretty uniquely positioned to take advantage of that market. There's very few people, to be honest, who can show up, incredibly say: "We're gonna execute on a mid-nine-figure development program.
We're gonna do it successfully, we're gonna do it quickly, and we're gonna share with you on the back end." And so I think when it comes to some of those really important late-stage programs that our, our would-be pharma partners care about, we feel like we really can be a, a partner of choice in a, in a unique environment. So, you know, we, we feel like we're in an extraordinary position for 2024. We, we have the capital, as I said, to, to fund the business to profitability. We think we have the setup, both outside and inside, to expand our pipeline and to be a partner of choice.
We have the possibility to be efficient with our capital and to think creatively about how much we need for these various purposes, and to return some capital to shareholders, including potentially in a way that reduces our existing shareholder concentration, something that's been a topic of interest for many of our shareholders, including the large ones, over the past 12 months. Looking forward to that as well. With that, I'm gonna wrap up. I'm gonna have a seat and chat with Brian. Thank you.
Let's start off with the Q&A. For those of you who are in the audience, if you have any questions, you can raise your hands. There are runners on the floor. For those joining us virtually, you can submit questions on the conference portal. I'll kick off with a question that I always get, and I think you always get the same question as well, but what is the latest on your search for assets? You know, given where the market is today, do you feel the urgency to execute on something? And are you also looking for—I mean, on the slide, you said that half of it is gonna be proof of concept, half of it is mid to late stage.
What exactly are you leaning on when you try to identify an asset?
It's a, that's a great question. I'm looking out in the middle of the audience at my colleague, our President, Chief Investment Officer, Mayukh, who is, principally responsible within Roivant for that activity, and I do think he feels a sense of urgency. But, look, I think— So I laid out some of the ways in which this environment is unique, and I think when I think about why I feel a sense of urgency, on the one hand, we're in a tremendous position. We have the capital we need to run our business, and, that's a rare thing. Very few businesses wind up with this kind of capital opportunity.
So I think we're intent, and we've said this in multiple different ways, in multiple different forums, to take our time and to invest in the right things and to find the right opportunities, to work with our existing relationships, and to find things that will really benefit from our hand and will really benefit us and our shareholders and patients when we take them on. And so I think we're intent on getting it right. And in that sense, I think we're acting with urgency, but that doesn't mean it's gonna be tomorrow. It doesn't mean it's gonna be next month. It's gonna be when the right opportunities, when the stars align in the right way.
I think where I do feel a sense of urgency is the unique features that I described about the current moment. I don't know exactly how long those features are gonna last in the marketplace. I don't know exactly how long large pharma companies are gonna be in exactly this position. We don't know what the biotech capital markets are gonna do in the next months and years that may erode some of the advantages that are unique to us right now. So I think we feel urgency to act because we wanna capitalize on this moment in time, where the need is there, and the internal opportunity and the capabilities have come together. So I think that creates some real urgency. In terms of what it's gonna look like, I showed the historical statistics.
I showed that about half our deals historically have been earlier stage, half have been later stage. To be honest, I think what the Street is most focused on right now is some of those later-stage meteor opportunities. We're gonna do both. In fact, if you read our 10-Q closely in November, we've already done one program that you can imagine to be earlier stage that we have not talked much about publicly or at all about publicly yet. So we're gonna continue to do things in both categories, but what I think we're most focused on is finding the next sort of diamond-in-the-rough TL1A kind of opportunity, and we see a bunch of things we like that meet that broad description out there. So it's just a function of finding the right one for us and getting our hands on it.
Okay. If you have to allocate your $7 billion cash today?
I would-
You have to.
put it in U.S. government money market funds earning just over 5%.
That's not an option.
That's-
Unfortunately, that's not an option.
That's what we've done.
So if you have to... I mean, we talked about this many times, right? I think the last time we—I think every time—
You don't think the people at J.P. Morgan who market those money market funds would be disappointed with you saying it's not an option? Anyway, look, I think the-
I can't comment.
I think the real question you're asking is: How are these dollars gonna go? Look, I think, like, we talked a little bit in the presentation, we have three categories of things to spend money on, writ broadly. We have the existing pipeline. Obviously, some of those programs, the FcRn in particular, are thirsty programs, right? Competing there with some very well-funded competition in J&J and argenx, and maintaining our potential best-in-class and achieving first-in-class in indications that matter is gonna take capital. So that's obviously a piece of the dollars that are spoken for.
You know, in terms of how much we're gonna spend on new business development, look, I think it is relatively unlikely, given our history, that we're gonna go out and, like, pay big premiums to acquire expensive, high EV biotech companies and things like that. Never say never. We could find something we really love at a price that we like, but that's just not been how we've historically connected with opportunities. So I think the dollars in the, quote-unquote, business development bucket, probably, in my mind, mostly go to development. They go to running clinical studies through to completion across multiple programs, which will be spent over a period of time, but when we're going in to work on a program, we wanna feel confident that we're able to tell our partner we're gonna fund this thing the whole way through.
And to me, like, the third bucket, the sort of capital return bucket, is a product of how the other two shake out. It's a product of what we see in the world, how we feel about it, how it comes together, and it's a function of opportunistic, you know, when there are specific opportunities to bring back shares at prices that we think are attractive, obviously, we'll look at them. So I don't know. I think, like, very rough numbers, if you thought of the capital, is divided in thirds across those three buckets, it'd be reasonable, but I think there's a lot of-
Variables, depending on-
Slush between them, and it depends on how things play out.
Okay. So one more before I open the floor for some questions. On your last slide, your last sentence was, "You're prioritizing reducing shareholder concentration." That has always been one of the questions that we get. What is the option here to execute on this goal?
Yeah, look, that's a hard question to answer in the abstract. I guess, like, the first thing is, when I say that, part of what I mean is, it would be a shame if we did all of this, return capital to shareholders, transformed the business into the next era of Roivant's growth, and didn't. Insofar as accessing liquidity has been an important goal of our existing pre-IPO shareholders, and insofar as the pathway through which they've accessed that liquidity has been complicated for us in our public market experience. I think it would be a shame if we didn't at least take a shot at cleaning that up as a part of this sort of transition of eras for us.
Look, I think some of our shareholders have publicly indicated an intention to hold the stock for a really long time, and we're excited about that. We welcome it. We're pleased to have them for the long run, and some of our shareholders have indicated that they are not in a position to do that, and I think we'd like to take this moment to work with them and to figure out how to get them the liquidity that they need as a part of whatever we're doing here.
Okay. I'll open up the floor for any questions... We have one from the portal, actually. So I think this can actually pile on. I can also add on to this as well. So, the question is, you know, are you continuing focus on I and I space? I mean, let's say two years when we come back to the same table, do you think Roivant will be known as an I and I company? And then the $10 billion peak sales that you kind of laid out, how do you think that $10 billion peak is gonna split across? You know, you have Priovant , you have Immunovant and Dermavants . How do you see that?
Yeah.
peak sales split across the buckets?
So I'll start with the first of those questions, which is, are we going to continue to be an I and I company? Look, I think it is not lost on us that, through 2023 there was a pleasing coherence to our portfolio, that the programs sort of fit together and were of a piece. That's never been an antecedent goal of ours. And if you think about how I described the opportunity, right, it's really about what our partners need as much as it's about what we need. It's about finding the mix between programs that we really like and needs that our partners have to adjust their portfolios. So a lot of what we've always wound up doing is a little bit what I'd call contrarian, right?
We were sort of intentionally on the side of the boat that other people had left, because that's where the programs were available that were most exciting to us. 2023 was definitely a year where I&I was front and center for at least some big pharma companies. And so, you know, against that backdrop, it's not obvious to me that the most exciting opportunities we'll find in 2024 will be I&I opportunities, and we're on the lookout across therapeutic areas. We have shown our ability to execute across dermatology, women's health, especially pharma, urology, a little bit of oncology, a lot of I&I in our history, and I think we continue to be confident in our ability to execute across a range of broad therapeutic areas.
So I think we are agnostic, as long as it's a great program that's going to matter. The other thing I'll say is the unique moment in time that we're in, if you are a big pharma company rationalizing R&D spend, a lot of what their focus is on is late stage programs, because that's how you move the needle as a pharma company. And often those late stage programs, the ones that are going to be available are the ones that are a little bit off piece, the ones that don't quite fit in strategy. And so I think that sort of lends itself towards certain therapeutic areas as you think about where pharma is organized, and you probably are as well equipped as I am to sort of think about what those areas might be.
In terms of the $10 billion peak sales number, I think you have a model that shows some numbers in there. I think it's going to vary across scenarios. Obviously, FcRn will be a big piece of of our peak sales potential. We're still very excited about VTAMA and what it can deliver, and think it has the potential to be a blockbuster product, especially once we layer in atopic dermatitis. Brepocitinib in DM, we've said we think is a blockbuster opportunity in and of itself. And then some of the earlier stage programs, like sarcoidosis, obviously there's a lot of risk and uncertainty in our ability to deliver. GM-CSF has been a target in search of an indication, sarcoidosis has been an indication in search of a therapy.
If we find the right fit, if that program is successful, that also, in our view, has potential to be a blockbuster indication. So I think it'll be spread relatively broadly, but obviously, FcRn, sitting where we sit today, looks to be the biggest piece of it.
Any questions from the audience? Last, you know, last 12 months, we've seen a lot of changes. Every time I look at the press release, there's always a lot of changes, right? TL1A, Immunovant, and then, SLE. But you have proven the VANT model to be really successful. And I think, you know, when you look at the space, your model is very unique in the sense that it's relatively incredibly capital efficient, right? So how confident that you can build on this momentum, is it still easy for you to go out there to, you know, to pharma shelf and say, "Hey, we want that asset?" Is it still easy to do that kind of function?
Yeah. I'll say a few things. The first is, it may look easy from the outside, but, but thinking about the long arc of Roivant's history, and you talked about the amount of change, I think, a willingness to embrace chaos and just working really hard have been important ingredients to our success, and I think they will continue to matter. And I'm deeply appreciative of the entire Roivant team, past and present, who have contributed to that. So I think that's a piece of it, is it's just... It's going to continue to be a slog in the best possible sense, is, I think, part of the answer to that question.
In terms of how confident are we that we can continue, you know, we used to go out and say we thought the Vant model was the future of pharma. I am less sure that that's true now than I was a few years ago, but it is definitely the future of Roivant. That is, like, it works well for us, and we do our best when we stay our closest to those roots. We've experimented with different versions of it, and I'd say, like, enabling great management teams to develop therapies in a focused way is something that has always produced the best, most capital-efficient outcomes for us. So I think we're proud of that model.
And then on the pharma side, since months after Roivant was formed as a company, we've been getting asked the question: Are you going to be able to do this twice? And then, are you going to be able to do it a third time? Then, are you going to be able to do it a fourth time, and a fifth time, and a sixth time? And I think the answer is, we believe we found a product, a partnership style, a philosophy that works for pharma companies and being able to partner... and biotech companies and academic institutions, which is-...
The ability to partner with someone who's dynamic, who can pick something up quickly, who can be very flexible on deal structure, very flexible on how we work with them, and can deliver, can execute on the program, can generate the data, can, when necessary, convert it to an approved product. I think there's just, like, not that many people who bring that combination of flexibility and execution capability to the table. There are some, but there are not that many. And it, it has just turned out to be a formidable set of capabilities that I think will continue to work. And I think almost without exception, every single one of our former partners is actively talking to us about new opportunities.
And I think the fact that we have been a repeat partner with so many people is further evidence, in my view, of our ability to keep doing it.
Turning to NIU data later this quarter, how should we think about NIU as an indication for brepocitinib?
We've gone from broad to very specific. Look, when we brought in brepocitinib, the core of our thesis about the program was that... And we brought it in, in some ways, at a local nadir for JAK inhibition, right? It was sort of right at the moment where people were least certain around where the target was going to go. And I think our view was, all of that having been said, these targets, both JAK1 and TYK2, are important targets for inflammation, that they matter for severe inflammatory disease, and that we were not going to compete head-to-head with AbbVie in broad market inflammatory disease, that we were even were not necessarily capable of doing that effectively.
But what we could do is to find areas with high levels of unmet need, where other therapies weren't cutting it, where there was a real opportunity, and where, especially the biology of both JAK1 and TYK2 inhibition combined, were going to make a difference. And so we've really been focused on orphan rheumatology, right? Clearly, like the quote-unquote, lead program in our hands for brepocitinib has always been dermatomyositis, and then we, we've got this NIU program, we have HS as a possibility. We've got some other things we've been looking at. You know, I think NIU fits squarely in that area. It's a, it's a disease where the biology conceptually fits well with the mechanism, where the unmet need is enormous, and where nothing else has worked all that well. So I think that's kind of how we think about the program.
Now, having said that, unlike dermatomyositis, where there was investigator-sponsored study already demonstrating JAK inhibition in the disease, where there have been a number of case reports, NIU, there was less human clinical data to go on, and so we did what we think is the right thing, which is we ran a small, focused, capital-efficient proof of concept study to better understand the behavior of the drug in NIU patient populations. I wish I could say, and we've, we've talked about this bar of, you know, 70% treatment failure and so on. I wish I could say, I expect we're going to, like, hit F9 at the end of the study.
It's going to pop up on the screen, and there's going to be, like, a green thumbs up or a red thumbs down, and, like, that's just never been how the proof of concept drug development has worked for us. So what I expect for sure is that we're going to learn a lot about what kinds of NIU patients maybe respond to therapy, around what the different correlations are, and we're going to make a decision based on the totality of that data around how to progress the program.
Obviously, the bar that we set is one tool for doing that, but there will be others, and I think it's a small enough study, and it's open label, that it's really going to be about understanding the data and understanding the patient's journey on the drug that's going to help us position it for the next step.
So maybe lastly, to Immunovant, we have ITP data, we have MG data laid out across 2024. Maybe let's focus on the phase 3 MG data set in the back half. Do you think batoclimab need to show superiority over Vyvgart in, in some functional measures to be commercially viable? And-
In MG, specifically?
In MG, specifically. How do you, how do you define success? Not just from a clinical trial perspective, right? How do you define-
Sure.
What do you want to see so that Batoclimab is, in your view, commercially successful?
So, I'm speaking here as Roivant again. Pete will be at the conference tomorrow.
Yeah.
People can ask him his version of this question. You know, FcRn is such wonderful broad biology that cuts across so many different indications, and it's such a unique access, right? It's a relatively uncompetitive domain in the sense of, like, unlike some of the inflammatory targets, it's really, quote-unquote, only IVIG and the other FcRns that are competing for the same slice of things. That, that, there's so many uncrowded areas of that biology, like TED, like Graves', where we can be first, where we can be best, where we have white space. You know, a lot of our focus is on quietly, because it's a competitive area, identifying those areas of biology and getting there first and cementing in that position. You know, MG is a big opportunity. There's a lot of unmet patient need.
Vyvgart has launched extremely well, and I think that's just like a demonstration, A, of how well FcRns are working there, and B, of how much need there is. Even with batoclimab, we will be years behind, and argenx is, by all measures, doing a phenomenal job of commercial execution. And if we decided to put together some kind of follow-on program with 1402, it will be even further behind. So I think coming in that set of dynamics, yeah, I think the commercial enthusiasm for that program has a high bar attached to it, right? We've got to, we've got to do something to be differentiated. The drug is differentiated on its face. We have a route of administration advantage. We have a clean, simple subQ administration, which is very helpful.
But I think ultimately, we have to deliver a clearly differentiated data set to have, like, a big commercial opportunity. But, you know, I think what that means, it'll depend a little bit what the data show. It'll depend a little bit how, how argenx evolves, especially now with the subQ on the market. So I think we've got to sort of watch the commercial landscape closely. Of all of the indications for which there is evidence that deeper IgG suppression yields better clinical benefit, I'd say, like, MG is probably not the cleanest place for that case, versus something like TED or something like ITP or something like the Graves' data that we now have. But I think there is suggestive evidence, supportive evidence, that it is possible to do better with deeper IgG suppression.
Also remember, argenx, who have been extraordinarily capable at clinical execution, had the first-mover disadvantage in MG and ran a relatively short duration study. Our study is long duration with induction and maintenance and rescue therapy, which meets these docs and these patients a little bit closer to where we think they wanna be from a treatment perspective. So I think there is an opportunity to show something really exciting in that MG data set, but I think the bar is relatively high.
Maybe just in the last two minutes that we have, you know, there are multiple moving parts in Roivant. I think the story has also grown mature over the last, I think, a year and a half now, since I started covering you. What, what's the lever that you think is not, you know, clearly defined today? I mean, you also have that, the Genevant LNP litigation, Hemavant. There are also other vant parts that we don't really talk about, at least from the inbound-
Yeah
-that we get. So what, what do you think is... that investors need to look at today?
You know, there's a lot of good answers to that question, but actually, at the risk of being the CEO who talks about his stock price, I guess I feel like right now, if you take our cash balance and the value of our Immunovant stake, that is roughly the share price. And so to me, the answer is, like, it's one of the easiest moments to talk to investors in our history. It's all upside. Everything you just described, the ability to bring in new programs, the mRNA litigation, the rest of the portfolio, brepocitinib, the sarcoidosis program, RVT-2001, everything we've got going on in discovery and health tech and other places, all of that is upside relative to just, like, a relatively straightforward analysis of where we are.
So I think we're excited to be aggressive and thoughtful about capital deployment. I think we're excited to prove that we can do it again, as far as the sort of at least part of the arc of the TL1A transaction is concerned, and I think we're feeling like the market is setting us up well to overdeliver.
Great. We look forward to another year of great things happening at Roivant. We're at the end of our Q&A session. Matt, thank you for your time today.
Thank you.
Thanks for joining us.
This was fun. Thanks, Brian.