All right. So we're going to get started here. Our apologies for the delay in getting started. It is not Matt's fault. It's my fault.
Not your fault either.
But Anyway, it's very much my pleasure to welcome Matt Gline, the CEO of Roivant.
And I guess, maybe it would be great to just start off with your vision for the company and how you see it coming to fruition in coming years. I think that many investors are a little bit lost in terms of how to think about the company, yet I think you do have a pretty clear vision on where you want to take it. So if we could start off there, that would be great.
Yes. Thanks, Dave. Appreciate it. Thanks for having me. And look, part of my vision for the company is we're going to show up 5 minutes late to every formal presentation so that everyone thinks we're really busy. I -- look, I do understand why I get this question a lot. But ultimately, our vision for the company, I think, is very straightforward. Which is we think we have an opportunity to build a great biopharma company developing medicines that matter and delivering them to patients. And we think today, we have a pipeline sufficient to fuel that between the anti-FcRn franchise at Immunovant, brepocitinib, mostly and earlier things behind that.
The only thing really that is different about our company versus any other biopharma company is most of our pipeline is assembled through selective in-licensing and careful acquisition of programs at the development stage because what we think we are world class at. The thing that we think we are best in the world at is finding those opportunities and developing them in creative ways that matter to patients that maybe their prior owners thought of or maybe they didn't.
Excellent. Excellent. And management incentives are 100% tied to -- or virtually 100% tied to shareholders. Could you talk about that?
Yes, sure. I mean, look, our whole management team are big shareholders in the company, and we have since -- sorry, I don't want to mess with the microphones, since before we went public. And as of last year, which may be part of what you're referring to, we put in place a package for the senior most team at Roivant that is one of the sort of latter deals where we don't get much of it unless the stock is 2.5 to 3x what it is now.
And I think the reason our Board did that is because they agree with what I started with here, that we have a pipeline that can carry us to whatever that would imply, a $25 billion, $30 billion, $35 billion market cap. And I think we've got a pipeline that can carry us there, and they wanted us to be betting for the same thing as the shareholders.
Excellent. And could you talk a little bit about the sort of the durability of those incentives, meaning the actual holding period, such that the incentives that are not let's say, valeant flash in the pan type of incentives?
Yes, sure. So we have about 5 years to hit those goals, a little bit less now. And once we hit them, we have to hold the stock basically for 3 years after hitting them. So this is not like we're going to hit some goal and then dump on stock. This is a -- we have a chance to appreciate a lot of value, but it has to be durable a little bit it this way. Every public shareholder will be able to sell any stock at those prices long before we can. And I think that was the goal, right, is to make us long-term aligned with the business.
Excellent. Excellent. So let's turn to the pending Immunovant news. I think many in the investment community are basically are hesitating or hitting the pause button on purchasing Immunovant or Roivant stock ahead of the batoclimab readouts ahead. Could you just sort of frame the readouts and then we'll go from there?
That is perhaps the most polite way anyone has described the current sentiment around Immunovant to me. So I appreciate that. Yes. Look, so mechanically, this month, we have 2 data sets coming. One is our Phase III program in myasthenia gravis and the other is our Phase IIb program in CIDP, both for batoclimab, the first-generation antibody at Immunovant. My opinion of these data sets is there being overanalyzed and over considered on the Street.
And the reason I think that is because there are basically 2 things that -- let's start with the MG data set, 2 things it could tell us. One is it could be some kind of referendum on the overall strategy of deeper IgG suppression mattering, which for those who aren't paying that close tension, our view has always been we in all of our compounds, batoclimab and 1402, suppress IgG more deeply than we think our competition other FcRn antibodies will in practice. And frankly, the biology of this is not that complicated, right?
These are diseases caused by pathogenic IgG autoantibodies. In our view, the deeper you reduce the level of those autoantibodies, the more you will treat patients. And my view is that has largely borne out at this point in our own data in Graves' disease and our own data in TED, in J&J's data and Sjogren's disease, in UCB's data and ITP. And it was a benefit of our competitor programs that they advertised up until the point where somebody wound up with deeper IgG expression than they had at the individual patient level in MG studies.
And so as our pretty clearly held view is that is true. And it is largely true, in our view, irrespective of what the specific data shows. So in that sense, what this data really tells us is how easy is it going to be to show a dose response and generate competitively important data in myasthenia gravis, which is an important question. Myasthenia gravis is a big market. But First of all, we are -- even with great data, if 1402 was the drug of choice ultimately years behind Argenx. And Argenx has done a beautiful, beautiful job making that market. So I think it's a high hill to climb.
And conversely, in every other indication, for example, in Graves' disease, we will be first-in-class. And basically, every other indication other than MG and CIDP, we can be neck and neck with any competitor because all of these drugs are effectively just starting Phase III studies within the last 6 or the next 6 months in these indications.
So my view of the MG readout is it is mostly a referendum on how likely we are to develop competitively winning data in MG. And I think that is a meaningful but not sort of transformative impact to the business. Obviously, the Street has traded it differently.
And then I want to come back just to talk about that a little bit more. But just looking ahead to 1402. So could you just talk about expectations for efficacy and safety of 1402 relative to whatever we see in coming weeks for batoclimab?
Yes, perfect. So what we believe, based on the Phase I work we've done for 1402 is that it is slightly more potent than batoclimab, which is to say whatever we see from an IgG suppression perspective here, I think we will see that or higher for 1402 and [indiscernible] normal variability. And our opinion is that will translate well to efficacy. On safety, battle and 1402 are fundamentally pretty different molecules. The truth is, in terms of on-target safety, FcRn at least up to a level of sort of 80-ish percent IgG suppression where the field has tested it, has been pretty safe. There have not been a lot of on-target sequelae of suppressing IgG.
And these are antibodies. So I would not expect a lot of "off-target" tax. The one notable exception to that is some anti-FcRn antibodies also interfere with the binding of albumin to FcRn to the receptor. And that results in a lowering of blood albumin levels. And that has had -- it turns out sequelae, most notably in our data, it caused an elevation of LDL as the body goes and produces the LDL in order to increase oncotic pressure once albumin drops. And our expectation based on the Phase I data is that 1402 does not have that impact, that is it does not interfere without binding. And so my expectation is that 1402 will show quite comparable efficacy to batoclimab without any LDL or albumin associated safety issues.
Excellent. And so obviously, the longer-term vision is for multibillion dollars in sales from 1402. But it's years from market. So maybe you could just create a road map for 1402 at a high level for us?
Yes, sure. I mean 1402 now, what we said publicly is that 6 INDs have been cleared. And a significant majority of those INDs are in indications where the path is straight to pivotal. So we are effectively in multiple registrational programs of 1402 now. The ones we've effectively confirmed publicly in different forums or MG, CIDP, Graves' and then a first of 2 studies in RA for difficult-to-treat fourth-line patients. So that RA study has the potential to show data in the next 18 to 24 months.
And if that data looks good, obviously, it puts us on a really interesting path in terms of access to that market. And then shortly after that, we will start to accumulate data in these various registrational studies that will then lead to first approvals a few years from now.
In between now and 18 months from now, I'd say like the 2 major events at Immunovant. One is to see this MG, CIDP and then later this year, TED data from batoclimab, which I think should frame up what we think we can do with deep IgG suppression. And there's some upside outcomes where the data looks good enough that we would consider launching batoclimab in one of those indications. And then also, we've been pretty coy so far about our indication road map, which is part of the reason I can't give a very precise answer to the question you're asking. And I think that will all be clarified in the relatively near future. And I think once we are through this particular couple of data sets, will put us in an incredibly clean place that is funded as we now are through Graves' disease if we want to run the business that way with a very sort of catalyst-rich period coming only a few years from now that we think could lead to frankly one of the largest drugs in I&I.
Excellent. Excellent. Well, since you discussed the batoclimab data on recent calls, I won't go into that again and make you repeat yourself again and again.
Everybody else at the conference is going to do exactly that also.
So maybe what we could do is turn to brepocitinib. So brepocitinib is a very unique asset that you have with its breadth of Phase II data and the validation to date but not specifically in dermatomyositis. And so if you could paint the picture for brepocitinib, and then I'll have a follow on.
Yes. Look, I think first of all, before getting to dermatomyositis, it is like weird and interesting and exciting to me, fact of history that Roivant owns brepocitinib. This is one of the best JAK inhibitors ever developed. We know that from many clinical studies run by Pfizer and big indications. We acquired it from them for -- was $14 million, including a whole bunch of inventory in the summer of 2021, when JAK inhibitors were at their nadir, right? That was right around the time where the Enbrel study is showing -- not showing noninferiority and cardiometabolic outcomes had come out around -- I forget what JAK it was, tofacitinib and all of the class got slapped with black box labels. And at the time, RINVOQ was a $3 billion drug that I think people expected to flatline, honestly, or even decline.
Now we're sitting here a few years later, RINVOQ is a $7 billion drug going on, I don't know, $10 billion, $12 billion, $15 billion, and we have one of the best JAK inhibitors in the world. We still -- to the point that you made about dermatomyositis, we still did not want to walk in front of the AbbVie commercial steam roller. And so we carved out room for ourselves in orphan rheumatology indication, orphan immunology indications like dermatomyositis. Now one of the unique properties of brepocitinib is it's a selective inhibitor, but selective inhibitor of 2 targets, JAK1 and TYK2. And we've also focused on indications where we think the addition of TYK2 on top of JAK1 is going to be helpful. But bluntly, also, we're a very, very good inhibitor of JAK1 from cytokine expression perspective. And we all know at the point that JAK1 is one of the most powerful anti-inflammatory targets identified by industry.
So all that is backdrop. This is an incredibly important year for brepocitinib as a drug. We have our first registrational data set coming in the sort of second half of the year in dermatomyositis. Dermatomyositis is a perfect example of the kind of indications I listed earlier. It is -- I'll talk about the size in a second, but it is an orphan immunology indication. It has very high unmet need. These patients are super sick. It causes both muscle wasting and a very bad skin rash, and it's got high mortality within sort of years from diagnosis in many cases, but not very many years. And the only approved kind of novel therapies IVIG, there's a Pfizer IVIG called Octagam approved for use there. But other than that, there's really nothing. The development pipeline, when we started was pretty thin on the ground. There's a little bit more activity now, but all pretty far behind us.
We've said we think there's about 40,000 patients. But one sort of funny factor about the world is we've been saying we think dermatomyositis is an interesting commercial market for a few years now, but it wasn't until Argenx progressed into Phase III with their own FcRn and myositis that investors started coming to me and saying, "Hey, did you realize DM is a big market." And Argenx, I think, has set up maybe up to 70,000 patients in DM. So tens of thousands of patients in the U.S. at, call it, FcRn price points now that we know Argenx is going to be present in the market is a really big opportunity. And as with Graves' for FcRn and we get to define the path for DM here, we get to be the first sort of novel approved therapy other than IVIG, which has a lot of liabilities that people are familiar with.
And we're really excited about that possibility in the second half. We don't have a Phase II study of our own in dermatomyositis. But actually JAK inhibition is relatively well known to dock-to-treat the disease. There are a good number of case reports. There's an investigator sponsor study of tofacitinib. And bluntly, I hear all the time that docs at either derm or room KOL panels are asking about brepo because it's a brand name drug, to be honest, like many rheumatologists know brepocitinib from his clinical data and DM is one of these indications where they just don't feel like they have enough to reach for.
Excellent. And so you had mentioned it's a disease of muscle wasting and skin rash. So obviously, there's no question about the drug's ability to treat the skin rash. But could you talk about the drugs ability to treat muscle wasting?
Well, it's a muscle wasting that's caused by inflammation, and it's understood to be an interferon-driven disease. And so scientifically, there's good reason to believe that, that inflammation should be treatable by JAK inhibition. The other thing I'll say is if you look at the tofacitinib study and you look at the case reports, the patients are getting better on symptoms of muscle development in those studies in ways that gives us encouragement. Look, the other thing that's clear is -- yes, so I think that's the way to think about it. Yes.
Okay. Excellent. Excellent. And so -- and then just taking the next step, how do you see broader potential for brepocitinib speak to NIU and then whether there's additional indications that you could pursue?
Yes. So we have 2 other indications ongoing already. One you mentioned is NIU. In NIU, we are now in 2 Phase III studies that are enrolling nicely. NIU is an inflammation of the eye. It is a very large population. It's probably 400,000 patients within NIU in America. About 70,000 of those have sort of posterior back of the eye inflammation that can't be readily addressed with sort of topical therapies, eye drops. And for those, there's not a lot of options, and it's a very severe disease. And bluntly, the main line of therapy is high doses of systemic steroids, which is always a tough proposition for patients.
HUMIRA is approved and some biologics are used off label. And in total, there's probably about 40,000 patients on advanced therapy for NIU, whether it's HUMIRA or something off-label. Our Phase II data was phenomenal. It -- in HUMIRA's data, for example, the main clinical endpoint, the primary endpoint for FDA is what's called time to clinical -- time to treatment failure. And in HUMIRA studies, they show a little bit less than 6 months treatment failure. At 12 months, when our study stopped, we still had a majority of our patients successfully being treated. So it's a transformative data set as far as what it means. And that means even if we wind up, for example, for FDA reasons in a HUMIRA refractory patient population, we have a really, really big opportunity.
And we're also running a Phase II study now in cutaneous sarcoidosis, which reads out next year. And that's another orphan indication with very, very few options for patients and with good data from an open-label study in tofacitinib that showed actually 100% treatment response rate in that study to JAK inhibition. And so we feel like we've got a pretty good case to make there.
And so when are you hoping to file an NIU?
I think we've said second half of '27 is sort of the over under for the data. And so I'd hope as soon after we get that data as we can, we'd file and then approval sort of 10 months after. So hopefully, we can file kind of within '27 and get approval in '28. So maybe a little bit less than 2 years after the approval on brepo and NDM.
Excellent. Okay. Great. Let me pause for a moment since Matt speaks quickly and efficiently. We're catching up on time. So anybody in the audience have any questions? All right. In terms of pivoting to LNP litigation, there's only so much you can say. Obviously, you're not going to be litigating on stage. But could you just paint the picture quickly for us? And what the key cards are that will be turning over, over the next 6 months or so?
Sure, yes. Again, I think most people are familiar with the basic backdrop here, but we have a team of scientists that were involved with the earliest invention of lipid nanoparticles. Which became -- which were relevant scientifically all along, it became commercially relevant with the approval of the COVID-19 vaccines from Moderna and Pfizer. And we believe those vaccines are infringing on inventions from those scientists, patented inventions to which we hold the IP. And so we've sued both Pfizer-BioNTech and Moderna for infringement. Obviously, there's $150 billion at this point of global COVID vaccine sales. So even a relatively modest royalty would be transformative for us as a business. And -- so it's a big deal in that sense. And look, the Moderna case is ahead of the 2 cases that was done on purpose for a variety of reasons.
And in that case, the main event this year is there is a jury trial scheduled for September in which infringement and damages will be effectively decided by a jury under a relatively short order, probably the soup to nuts 3 weeks maybe, starting in late September. Before that, there are some important pretrial motions, what are called summary judgment motions. That will go in as early as May and be adjudicated over the summer. And so those will help shape the dimensions of the case, but the truth is we won't have to wait very long for the ultimate outcome at this point. Now that's just the outcome of the main jury trial, there are appeals and things like that, but I think we will have a ton more information by October, November.
Got it. And I had talked to one consultant who had said that juries typically put meaningful weight on patents, i.e., they respect the U.S. patent and trademark office. And so they're more likely to favor patent holders in the majority of cases. Is that how you see it as well? Or have you heard that notion?
I believe Moderna is infringing on our patents. And I believe a jury will agree with us. Whether that is -- I don't -- I'm not a jury consultant, so I can't speak to the generalities of it, but I believe that to be true.
Great. And then if you could just talk about the Pfizer litigation as well?
Yes. So that one is about a year behind the Moderna case from a time line perspective. And basically, we had what's called the Markman hearing in that case in December and could get a ruling any time. It's up to the judge when he puts it out and it could be tomorrow or it could be June, but it's up to the judge. That will then set the stage on claim construction. We had a similar ruling -- a similar hearing in the Moderna case about a year ago. Hearing was in February and the decision came at the end of March, I think. And so I think we're kind of expecting a similar set of issues to be decided by the judge.
Therefore, would hope they go similarly because we were happy with how they went with Moderna case. That will then kick off discovery and get us a trial date. And I would expect that to be a year or so after the Moderna trial, but that depends on how all the calendaring goes.
Yes. Okay. Great.
And then we just filed last week, as you may have noticed, international litigations in the Moderna case, covering another $15 billion to $20 billion of sales between Europe and Canada and Japan. And those cases will go to trial a little bit faster, probably within 12 to 15 months for the first of those cases in overseas jurisdictions.
So they could potentially start to go to trial that quickly in 12 to 15 months?
In some of these other jurisdictions, the path to trial is much faster. These trials are often also separated into phases. There's an infringement trial and then a separate damages trial, which is not how it works in the U.S., but we could get infringement trials as soon as 12 to 15 months from now.
Excellent. Okay. And then maybe we could talk about other pipeline developments to watch. So if you could remind us about your other pipeline assets and what cards will be turning over when?
Yes, the furthest along of our other pipeline assets, the drug called mosliciguat. It is a inhaled once-daily sGC activator that we are developing for the treatment of PH-ILD, Group III pulmonary hypertension patients with interstitial lung disease. That, as you may remember, had a really, really strong kind of Phase Ib data showing really, the deepest PVR improvements shown across any mechanism of drug in Group I PAH patients and we're now running a large Phase IIb PH-ILD.
That is a plan to read out in the second half of next year. And so it sort of comes on the heels of 2025 being a very busy year for us. It's a major catalyst for 2026.
Excellent. Well, we are out of time. Thanks so much for being with us here, Matt. Sorry, again, to make you late.
No. I'm sorry, I was late.
But I appreciate it.
Thank you. Really appreciate it. All right. Thanks, David. Thanks again.
