I think we can go ahead and get started with our next session. So my name is Allison Bratzel. I'm one of the senior analysts here at Piper Sandler, and it's my pleasure to introduce Matt Gline, CEO of Roivant.
Thank you for having me.
Yeah. So thanks for joining us. And also just for the audience, if anyone has any questions, feel free to either, you know, just raise your hand or shoot me an email, and I'll be sure to ask it. But yeah, I have a bunch of questions, so I'm going to go ahead and get us started off. So Matt, maybe starting off, you know, high level, it's fair to say that the Roivant of today looks a lot different than, you know, even than it did this time last year across advances. The Telavant transaction, proof of concept data for 1402, the successful Phase III AD readouts at Dermavant, which, you know, all are arguably transformative developments crammed into 12 months.
So can you just kind of help us understand, you know, what you envision for Roivant and the Vant family, you know, over the next 12, 24, 36 months? You know, was 2023 an anomaly, or is that par for the course in terms of transformative events, you know, for Roivant?
Yeah, look, 2023 was a very busy year for us. You listed a good portion of things that happened. It was like a year ago, maybe like today or something like that, that we announced that we were in licensing the anti-TL1A antibody. And a month and a half ago that we announced we were selling it. So it's been a busy year. You know, not every year is going to be that. But we have some really exciting ideas for things to do in 2024.
We've obviously got an extraordinary position in terms of being fortunate from a capital perspective at a time when very few have been. And so we feel great about all that. And then there's a whole bunch of data coming in our pipeline between a bunch of stuff at Immunovant, who I know is going to be on, I think, this stage in half an hour, and some more data from brepocitinib at NIU and some progress on some of our other projects. And so it is a pretty exciting year next year, even sort of absent secret unannounced plans.
Yeah, a little bit of an unfair question, but, maybe another kind of, you know, high-level question before we get into some of the specifics is just, in terms of your therapeutic focus, you know, I think you built a really broad immunology pipeline. Doesn't necessarily mean you need to be siloed in immunology. So I guess, you know, thinking now, you know, what are your thoughts on that? You know, what therapeutic areas do you find most compelling or do you see as having the most opportunities?
Yeah, I mean, I guess sitting here this morning, I wish we were an ADC company. No. Look, I, we've been really pleased with what we've been able to build in immunology. We obviously have worked over the past 12 months on two of the most important immunology targets in FcRn and TL1A, and FcRn, we think is, yeah, just an unbelievable opportunity, the extent of which I think we as a field are even, like, just scratching the surface, to be honest. So, we're excited about our positioning there, and we see things in immunology that we continue to like.
We've always been intentionally agnostic on therapeutic area because so much of our opportunity comes from other people having firm views on what they want to do, that if we said we're only going to do immunology or we're only going to do whatever, whatever area, we would miss out on opportunities that we think are really great. So we're generally flexible. We're looking to chase chase the opportunities where they are, chase the biology and science where we can find it, and that's always kind of been our approach. There are a couple of things that I think are probably slightly further from top of mind for us, and it's probably easier to state what those are.
F irst of all, and both of these are never say never kinds of things, but, like, I think capital O, oncology, like sort of heart of oncology, the problem there is so much of our sort of BD pipeline construction strategy involves kind of finding things where they are. And because a lot of oncology involves combination therapy and development of a portfolio, it's just hard to imagine stumbling on four or five different building blocks all at once. It could happen, maybe there's a whole portfolio for sale, but, like, not the kind of thing that's, that is as close to top of mind for us. And then we've experimented in the past with, let's say, difficult to manufacture modalities, and I think our conclusion has been, that's hard.
and that if we're going to do stuff like that, it's got to come with a clear answer as to how those challenges are being addressed, because we don't have... We're not a gene therapy company, we're not even an mRNA company. And so, like, some of these modalities where manufacturing expertise really matters, you know, I think we'd like to only work on those programs if we have a partner or a manufacturing partner who is really solid, because I'm not sure we're going to build that sort of bolus of expertise in-house.
Okay. Excellent. Maybe pivoting to, you know, just the, the Telavant deal. And I think that has to go down as one of the highest ROI deals maybe we'll ever see in, in biotech. And I guess my question is not, you know, can you do that again?
I think, yes.
Yes. So I guess what gives you confidence, you know, that, that those kind of opportunities are out there, that you, your team at Roivant can, can locate and find and act on those opportunities, you know, repeatably in the future?
Yeah, look, yes was a glib answer to that question in the sense that the thing that I think will have proven unusual about TL1A is the rapidity of the turnaround of it. The thing that is not unusual in our history and will not be unusual in our future is our ability to access that sort of kind of opportunity, important late-stage programs with with with with potentially broad sort of therapeutic implications. I think that stuff we have, at this point, a a long track record of finding and frankly, I've never been more excited than at the present moment for what that opportunity space looks like. A a big slice of that, certainly there's lots of places to look for things right now. And look, Immunovant came from a South Korean biotech company.
TL1A came from Pfizer, brepocitinib came from Pfizer, some of our earlier programs came from Merck or from Takeda or whatever. Like, we've done a wide variety of things. Big pharma right now looks like a rich opportunity set for us because so many big pharma companies have a problem to solve, a challenge ahead of them that we can help with. And that is they are going through these seismic shifts in portfolio construction. They're facing LOEs in many cases that are going to dramatically reshape their sort of growth picture. And what are they trying to do? They're trying to acquire programs that meet their needs, that match their therapeutic focus, that match the stage that they're looking for. And in parallel, they're trying to trim their budgets and manage their earnings.
And there aren't that many tools that a big pharma company has to manage R&D expense. And the biggest by far is to take a look at their late-stage portfolio, where they have expensive phase III programs coming, and to pick the things that are the odd men out, not necessarily 'cause they're not good programs, but because they don't fit with their commercial apparatus or whatever. And so we are here to help them solve that problem. We are here to look at those programs and to bring them in and to develop them and to share back end, as we did with Pfizer, in a way that we think can really be of benefit. And the truth is, first of all, by and large, these big pharma companies don't have capital problems.
It's not like they're trying to solve for a cash need, so a big upfront check is not, is not what they're solving for. And there are not that many other people at this point who can show up, partner on a program, and be trusted to spend the dollars and do the work to run a successful late-stage development program, which is something we've done many times. And so I think that unique ability puts us in a great position right now, and I think there's a ton we're excited about in the portfolios of large and mid-sized pharma companies.
Excellent. I think, the next question is one you've, I think, been asked every which way. I'm gonna ask it again anyway. Just, you know, about plans for the proceeds from the Telavant sale. Can you talk... Just talk about your priorities and, and how you, how you weigh, you know, your, your path to deploying this, you know, what options are on the table, and how do some of the, the other recent, you know, data events, like in the last week, the SLE data for Brepo, the 1402 success, you know, how does that factor into your thinking, on, on deploying that?
Yeah, look, I'll say a few things. One is a perennially unpopular answer, which is, we are in an extraordinary position, which is that we have the ability to be flexible, to be thoughtful, and to go after the opportunity where we find it. And I appreciate that "we're gonna be patient" is not what people want to hear, but it is, it is actually a tremendous source of value for us that we can give that answer and mean it. And so again, that's sort of the unpopular part of the answer. I guess, like, to the more popular part, first of all, I think this question is actually not that complicated. There are fundamentally three buckets. There's the existing pipeline, obviously FcRn largest among it, but with brepocitinib and the other programs also important, and some of those programs are thirsty.
We are now capitalized, way more than sufficiently capitalized to sprint at those opportunities and to win in a big way where we have the best program. There's the BD question, which we've hinted at already in this conversation, which is obviously bucket two. And then there's a question of what excess looks like, how much capital we have beyond those two buckets, and what we're gonna do with it. And I think, you know, there's some competing priorities. There's a question about exactly how much we want to continue to deploy on Telavant, which I'm sure we'll come to later in this conversation. And then there's the truth that we look to be incredibly efficient stewards of capital generally, and we would certainly actively consider returning capital to shareholders. And bluntly, look, I think it, it...
We're trading below the aggregate value of our cash in our Telavant stake. That is moderately offensive, but it creates an opportunity for us in that if we want to be out in the market returning capital, there's a clear path, which is to go buy stock at this, stupid price. And so at some point, that's on the table.
Okay. Maybe now, you know, touching on, you mentioned FcRn, you know, going to that. I know you've talked about your ruthlessly economic framework that you're operating from here. I guess, walk us through the rationale then, for continued, you know, investment in batoclimab. You know, just given the profile you've seen for 1402 at this point, and then I guess more broadly, you know, like, how do you maximize the value of that FcRn franchise?
Yeah.
Can it be maximized with the current ownership structure?
Yes. So, you're gonna have an opportunity to ask Pete that question in 15 minutes now.
Okay.
He's a good person to answer that question. Look, I think there are certainly arguments to be made that having a franchise of these programs and being able to take them into the best indications for each drug, to be able to go after rarer, more acute disease with batoclimab, and to go after kind of everything else with 1402 is an attractive concept. The profile of 1402 is just coming into relief over the past couple of months. It is a phenomenal profile. Certainly, the better 1402 looks, the narrower the aperture for batoclimab necessarily, in terms of like where you would take that program.
Right.
And so I think, you know, that is an ongoing discussion. Again, I'm sure Pete will have an opinion on it. I think there are probably good places for both, but certainly 1402 is gonna get the lion's share of the investment as a, as a potentially best-in-class program. So I think that's sort of the main answer to that question. In terms of like, better in our hands or somebody else's hands, I guess I'd go back to the ruthlessly economic comment, and I'll say two things. One is. Certainly, we felt like we were getting a great value for the TL1A program when we sold it, but capital was a consideration for us, right? We had two thirsty programs between that and the FcRn, and we needed to make sure we were adequately set up.
Now, with Roivant's balance sheet, we certainly have the capital to pursue FcRn to the maximal extent. So, you know, I think we will never sell Immunovant out of a position of weakness. But ruthlessly economic, everything has a price is a little bit of a. It's an ethos that we find it hard to get away from. It's just a function of, like, getting real value. So, that's part of that question. I guess the one thing I'll say as a plug for Pete and the Immunovant team and for Roivant as a family of companies, more generally, from an execution perspective, there's a lot of clinical work to do in FcRn. There's many studies to run, and certainly, like, you can imagine breadth being helpful.
That said, I would hold our clinical capabilities at this point up against almost anybody else's in the world in terms of our ability to do things, do things quickly, do things comprehensively. And I think, look, I think the Immunovant team has done something that almost no one ever does, which is that we had a program, it was a great program, it had a problem, and we fixed it. And so I think that's just a testament to what that team is capable of.
Yeah. No, absolutely. And maybe just kind of one more along those same lines. You know, just, just thinking about the FcRn opportunity longer term, you know, what-- I guess, what other modalities do you think might complement that? You know, I know we've been hearing about IgG degraders, CAR-T, and some of these immunology indications.
Yeah.
Just talk about your appetite for other maybe novel mechanisms, or what do you see out there that could, maybe augment or change your, your FcRn strategy?
So, look, this is kind of a wonky point, but I think it's worth making. FcRn is sort of unique in immunology right now in that it's... So much of immunology historically has been in the category of, like, broad-spectrum anti-inflammatory activity, JAKs or TL1As or TNFs or IL-17s or whatever it is. And those are all great programs, and many of them have become large, multi-blockbuster opportunities 'cause many immunology diseases are marked by inflammation. FcRn is not really the same thing, right? FcRn cuts across a swath of diseases, sort of first tier of which are mediated by pathogenic IgG autoantibodies.
And one of the neat things about that is, it is a uniquely shaped competitive picture, and with the exception of IVIG, which is fundamentally going after the same biology, there's really nothing that cuts across all of it with the possible asterisk of the Biohaven IgG degrader program has obviously gotten a lot of attention. But in my opinion, it is early, and there's a lot of interesting questions about it. Other than that, yeah, sure. I think some of the... This week's FDA news aside, some of the CAR-T approaches in immunology will be interesting in some subset of the areas where FcRn is also interesting. Anti-inflammatories will be interesting in some subset of the areas where FcRn is interesting.
Specific autoantibody targeted antibodies, like IGF-1R or whatever, will be interesting in some of the areas where FcRn is interesting, but very few of those modalities are going to cut across the entire spectrum of it. Now, as a practical matter then, what complements FcRn? Certainly, a franchise of anti-inflammatory, something like brepocitinib, complements FcRn in the sense that it is in an orthogonal, tangential part of immunology that will only overlap sort of circumstantially. And then we're interested in other approaches as they play out, that sort of cut across the same spectrum. So we're watching the Biohaven IgG program closely. It's a cool program. A lot more to come on it, obviously, before we really understand what happens there. But, you know, I think that's sort of unusual in cutting across the same spectrum.
Okay. You mentioned brepocitinib, so I have a couple questions on that if we'll go there. You know, I think we had the, the update this week on SLE, and I think that had been pretty widely viewed as a, you know, pretty high-risk, opportunity. And we were just talking before this, I think that was kind of a holdover from the Pfizer.
That's right.
Right.
Yep, that was a program that Pfizer had begun before we acquired the program from them, and they did all of the execution on that study and paid for the majority of it. You know, it's always disappointing when a trial doesn't work. The truth is, we're not going to pursue brepocitinib in SLE. I want to be very clear. The study failed. It was going to be one of the two pivotals if it had been successful. We're just not going to go there barring some significant change. That said, it's disappointing because, look, fundamentally, brepocitinib as a drug, even having failed that study, probably works in SLE, right? JAK inhibitors work and have been shown to work many times. Obviously, so TYK2 put out pretty good data. TYK2s clearly work in SLE.
There's nothing about brepocitinib, even after this study, it just doesn't work. But I said a year ago in an interview, that you have to be an idiot to not be afraid of an SLE study. And the truth is, SLE, it's a heterogeneous disease. It's very hard to study, and you know, we took our best shot. So that said, brepocitinib is a big gun. It's a very potent anti-inflammatory. It's produced extraordinary data now in six positive phase II studies, in alopecia, in psoriasis, in psoriatic arthritis, in UC, in HS, and in Crohn's disease most recently, where we have, I think, the deepest clinical remission ever seen in a Crohn's study. So you know, it is a very potent agent.
We, Roivant, are not necessarily equipped to go head-to-head with AbbVie everywhere that Rinvoq plays. I'm not sure that's our strategy. But it's a great drug, and our view all along had been, in orphan rheumatology and some of these, like, rare, highly inflammatory diseases, there's not a lot of options. And you want to bring a big gun, and you want to get the commercial model right, and brepocitinib is going to be a, in our view, a great tool in that specific toolkit. So that's what we're excited for. Our DM study reads out in 2025, a proof-of-concept study in NIU next year. We're still thinking about things like HS, where we'd have quite good phase II data. Just a big opportunity.
Yeah, and maybe kind of, can you just expand on that? I think NIU is where we're getting data next. You know, what's the opportunity there? What do you need to see? And then, yeah, on the DM trial, you know, what kind of enrollment dynamics you're seeing in the phase III? What does that tell you about that, the opportunity you have there?
Yeah. So, you know, NIU and DM have in common that they are sort of orphan rheumatology kind of diseases with high unmet need, not a lot of other options. These patients are in a tough spot. DM is a devastating disease for people that have it. The biology is relatively clear. In fact, in DM, JAK inhibitors are used off label as therapy, that there's at least one investigator-sponsored study, this third study of tofacitinib that looked interesting. So I think it should work. These are both diseases with significant patient populations, in the case of DM, tens of thousands, where we feel like we can make a difference. You know, in terms of the bar for the NIU study, I think we've said a few times, sort of where that is.
We're looking for a reasonable responder rate in these patients, just clear signs of activity. It's a proof of concept study, so it's not going to show us much more than that, but it'll hopefully guide us into a late-stage program if the data makes sense. In DM, it's a phase III study. The hope is that it's a single registrational study if it is successful. We think that's one of these great orphan markets, where if you get a new agent that offers a real opportunity to these patients, you have a huge opportunity to make a difference in their lives, and that always correlates with commercial success.
Excellent. Maybe now, I know we have a couple minutes left. I do want to touch on Dermavant. Seems like this always comes up as kind of an afterthought in these kinds of conversations, but you are a commercial company. So I guess maybe just first, do you still see VTAMA as having, you know, blockbuster potential in psoriasis, any topical derm? You know, is there room, and is there room for multiple blockbusters in those indications, you know, branded topicals?
Yeah. So look, to be clear, I still think it has the potential to be a blockbuster in those diseases. The fundamental dynamics have not changed, right? Topicals are very widely used, and they are imperfect. And the current generation of novel topicals, that includes us, that includes Opzelura, that includes Zoryve, that Arcutis, are better drugs than the sort of topical steroid standard of care in aggregate. And I think we have the best of that bunch taken with our full profile. Obviously, other people have different claims. You know, I think what we have... We have to be realistic about what we've seen, and it is clear that converting steroid prescribers and psoriasis to novel topicals takes time. We knew it was a challenge. We hoped to break through faster.
I'm still optimistic that we're going to be able to do that. I think we've got enough positive feedback and enough enthusiasm from docs and frankly, enough script volume at this point that it's clear, we can build a profitable franchise around the program. And so, you know, if the bear case is profitable and the bull case is multibillion dollars, that feels like a pretty good skew to us. That said, I think it's, it's important for us to be very thoughtful about capital deployment right now, because I think, look, I think there's a concern that if we have the money, we're just going to spend it. So I think we're being thoughtful about exactly how to deploy capital and maximize the opportunity set for government events.
Yeah, and that's—I was going to ask, it did seem like a bit of a maybe shift in tone on the last earnings call and willingness to, you know, advance the timeline to profitability. Maybe, I think you kind of covered that. I guess it—can you maximize value for VTAMA? You know, to do so, do you need to have, you know, maybe multiple product offerings in the sales rep's bag? Or how does that kind of factor in?
I think in the bear case scenarios that I described, where the product is not a multi-blockbuster product, I think at some point it's going to make sense for it to get paired with other products and to take advantage of commercial synergy. I don't think there's any rush to do that, but I think, you know, there are many companies in the world who make their business around, you know, nine-figure selling topicals, and those companies would undoubtedly get great synergy from a product like VTAMA. Many of them call us about it often because they see that opportunity. I think as we are deciding exactly what the picture looks like and whether we're shooting for that or how aggressively we're shooting for that multi-blockbuster opportunity, we'll continue to evaluate those conversations.
But at the moment, we're just pretty excited about this product.
Excellent. And I think we only have a couple minutes left, so maybe just kind of, you know, a broader question. I feel like we've only scratched the surface on, you know, the Roivant story. Lots of stuff going on we didn't even touch on. What else would you be highlighting, emphasizing to investors? You know, any new Vants, any other pipeline programs?
Yeah.
Tell us about it.
I mean, look, there's some data coming in earlier programs this year. We've got Hemavant data, and that's the MDS program. We've got maybe even a bigger opportunity, this GM-CSF that we're studying in sarcoid, which sarcoid has been a tough indication in search of a target. GM-CSF has been a target in search of an indication, so we'll see if the match is there or not. But I think that would be a big opportunity if it were successful. I put that in a similar bucket to lupus, but obviously small number of dollars with a big skew of successful. Astute readers of our 10-Q will note that there's been at least one other in-licensing transaction that we have not talked a lot about. So there's some stuff that we're excited about.
We've obviously got the LNP litigation ongoing, with some updates coming as soon as February with the claim construction hearing. All of that will sort of come soon.
Yeah, maybe. I think we, yeah, we have a couple seconds left, and I know this question is always left to last, but yeah. What is the latest on the LNP litigation? And, and also, how does that kind of play into your strategic thinking?
Yeah, the beauty of only having 30 seconds left is I can say, "Yeah, we're not going to comment that much on ongoing litigation.
Fair enough.
I think the claim construction hearing is an important event for us in understanding how the court views the patents. You know, like many other things, it's high stakes. We really believe that we have the scientific team that originated that technology, and we feel very strongly about both the science that is happening at Genevant, as well as about protecting the IP that we've developed, that team has developed over a 20-year period. I think we've got a real opportunity, and obviously, those products were important, are important, and have generated quite a lot of, quite a lot of value for their marketers. So, you know, I, I think, we see a big opportunity for us if we're successful.
Excellent. Well, I think we are about out of time, but, thanks for stopping by and telling us about the Roivant story.