Roivant Sciences at BofA Securities: Strategic Shifts and Litigation Focus

On Wednesday, 14 May 2025, Roivant Sciences (NASDAQ:ROIV) presented at the BofA Securities 2025 Healthcare Conference, offering insights into its strategic priorities. The company highlighted its focus on innovative treatments for Graves’ disease while acknowledging challenges in the Myasthenia Gravis market. Additionally, Roivant addressed ongoing patent litigation with Moderna and Pfizer over COVID-19 vaccine technology.

Key Takeaways

• Roivant is prioritizing the development of IVD fourteen o two for Graves’ disease, aiming for a leadership position in this market.
• The company is cautious about competing in the crowded Myasthenia Gravis market, dominated by Argenx.
• Roivant is actively engaged in litigation against Moderna and Pfizer regarding lipid nanoparticle technology used in COVID-19 vaccines.
• Operational changes include Eric Vanker’s new role as President of Roivant and CEO of Immunovant.
• The VALOR trial for Brepocitinib in dermatomyositis is progressing, with a regulatory submission expected in early 2027.

Operational Updates

• Immunovant Management Change: Eric Vanker has transitioned to President of Roivant and CEO of Immunovant, reflecting a strategic leadership shift.
• Graves’ Disease Trials: The company is heavily investing in clinical trial infrastructure, particularly in community endocrinologist offices, to enroll patients effectively.
• Brepocitinib (VALOR Trial): The Phase 3 trial for dermatomyositis is underway, with plans for regulatory submission in early 2027.
• PHR RD Program: The Phase 2b study for PHLD patients is expected to yield data in the second half of next year.

Future Outlook

• Graves’ Disease: Roivant aims to secure a first-to-market position, with remission data anticipated mid-year.
• Myasthenia Gravis: The company recognizes competitive challenges but seeks to differentiate through deeper remission endpoints.
• Broader R&D Strategy: Roivant is evaluating new opportunities, preferring to announce investments as they commence.
• Brepocitinib Approval: Targeting regulatory approval for dermatomyositis by early 2027.

Q&A Highlights

• Graves’ Disease Market: Approximately 350,000 refractory patients in the US present a significant opportunity, despite enrollment challenges.
• Myasthenia Gravis Competition: Roivant acknowledges Argenx’s market dominance, focusing on unique endpoints to stand out.
• Dermatomyositis Trial: Confidence in Brepocitinib’s efficacy, with dosing set at 30 mg for dermatomyositis and 45 mg for NIU.
• RNP Litigation: The outcome of the patent case against Moderna and Pfizer could have significant financial implications, depending on trial results and government liability.

Roivant’s strategic focus and ongoing legal battles highlight its commitment to innovation and market leadership. For further details, refer to the full transcript provided below.

Full transcript - BofA Securities 2025 Healthcare Conference:

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: We’re going with our next company presenter at the BofA Annual Healthcare Conference. I am pleased to be introducing Royvant and Chief Executive Officer, Matt Glein. My name is Jason Gerberry. I cover SMIDCAP Biotech and Specialty Pharma, and I’m joined by my colleague, Chi Fong, as well. Both of us collectively cover ImmunoVent and Roivant.

And so this is a great opportunity, I think, to have a discussion around a lot of the key assets that funnel up into the Roivant umbrella. Awesome. So great.

Matt Glein, Chief Executive Officer, Royvant: Thanks so much for having me.

Chi Fong, Colleague of Jason Gerberry, BofA: It’s great

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: to be here.

Matt Glein, Chief Executive Officer, Royvant: I appreciate it.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Yeah. So maybe we can start with just some of the recent changes as it pertains to the Immunovant and what that ultimately means from a development perspective, hyper focus within certain assets within Immunovant within the portfolio, and then we’ll we’ll we’ll we’ll dig down a little deeper from there.

Matt Glein, Chief Executive Officer, Royvant: Sure. Yeah. Perfect. Look. I think the change you’re referring to, you know, we’ve had a portfolio of anti FcRn antibodies in development of Imbuvant for a little while, betoclimab and IMG fourteen o two.

And, we’re at this pretty natural moment of transition where we read out, our late stage studies in betoclimab, in MG and CIDP, And, we’re sort of transitioning our focus more or less fully at this point to IVD fourteen o two, our next generation program. And, we’re really excited about the data that we put out there. We think it sets us up really well for success with the with the sort of main program. But we also took the opportunity. Pete was ready to retire, and so we took the opportunity for a management change.

And Eric Vanker, had been president and CEO of Roivant, is now president of Roivant and CEO of Immunovant. And he took the reins from Pete with a laser focus on what is the most important thing of the next leg of a Butavent’s journey, which is clinical execution. I told Eric on his first day on the job, priorities one through six is patient enrollment in Graves’ disease and seven beyond is everything else. And so he’s really sort of setting up to focus on those clinical trials and make sure we’re gonna win where we have the natural lead and the right to do so. Okay.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: And does it seems like for at least for the indications that you’ve publicly stated, nothing’s really changed in terms of the prioritization or what you’re working on. Maybe in terms of what’s behind the scenes, has anything really changed in terms of the prioritization of FCRM programs?

Matt Glein, Chief Executive Officer, Royvant: Nothing super significant. Look, I think my view has been for a while that Graves’ is a really unique opportunity for us. It’s a first to class location. It’s one of these wide open spaces. It’s got a enormous prevalent patient population with, we think, pretty pretty high unmet need.

Mhmm. And so we get to be for Graves what Argenx is in Mysenia gravis or what what Horizon was in TED, and it feels really good to sort of have that space.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Yeah.

Matt Glein, Chief Executive Officer, Royvant: But it also feels like a burden to win that that you’re you sort of set yourself up and now you wanna you wanna pull it through. You know, I think that’s as opposed to something like Myasthenia gravis where the Univut team has been focused for a while on execution because Yeah. It’s sort of the the classic FcRn indication at this point. But my view has been, look, that’s more of an uphill battle in terms of commercial success in MG precisely because Argenx has such a commanding presence there and such a popular drug. Yeah.

But even with what I what I think is best in class data, we’re sort of coming from coming from that position. So I think we’re really focused on the indications where we can be first. We’re really focused on the indications where we can be very close to the front of the pack. And I think something like MG, look, I think there’s sort of almost an obligation to be an MG as an FCRN. I think there’s, like, a real opportunity to do something there, and we could talk a little bit about how I see that market evolving.

But I think in some ways, that’s, a little bit of a lower priority relative to making sure we win in the spaces where we’re ahead.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Yeah. I suppose, like, if you were working on TNFs back at the we get the get go and you were behind you were behind AbbVie, you may still develop RA, but maybe you were trying to make your hay in in another setting.

Matt Glein, Chief Executive Officer, Royvant: We are AbbVie in this situation. We’re behind Enbrel, which was the first TNF with the worst form factor. And so we’re playing to win in all of the indications that

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: that you have. I analogy. But so you you ultimately have a mix, right, of some fast follower stuff, some some areas where you’re first and perhaps you’re interrogating the biology. And and so there’s a little bit of a different clinical risk profile.

Matt Glein, Chief Executive Officer, Royvant: And Yep.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: You know, hopefully, that’s gonna net out with a really big, you know, swath of opportunities

Chi Fong, Colleague of Jason Gerberry, BofA: in front of

Matt Glein, Chief Executive Officer, Royvant: you. There’s no wood on stage, but I hope so too. Got it.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Okay. And Graves, I mean, you know, we’ve done some work on on Graves and, you know, it’s it’s an interesting category. I think investors maybe struggle a little bit to understand the market and maybe because they just haven’t seen anything. Right? You know, other than methimazole, which is generic and has a has a nice amount of volume.

Matt Glein, Chief Executive Officer, Royvant: Yeah. Right?

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: And I imagine that that’s a decent proxy for starting to think about maybe the the number of patients who become this doesn’t work for them Yeah. Know, at some point in time. And that’s ultimately sort of becomes the opportunity set for an FcRn. And so, I guess, as you think

Chi Fong, Colleague of Jason Gerberry, BofA: about

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: that opportunity, do you feel like you’ve got a good handle on how many patients are out there and how easy it’s gonna be to enroll a trial. Right? Could you say that that’s going to be the push is to enroll this trial faster, but there are also criteria that are strict to get these patients in the study?

Matt Glein, Chief Executive Officer, Royvant: Yeah. Perfect. Yeah. Look. So Graves, for those who are not super familiar with it is an autoantibody mediated disease where you develop antibodies to various parts of your thyroid function.

And so these patients untreated have out of whack thyroid hormone levels, and there’s millions of Graves’ patients in The US, but as a disease, it’s mostly treated with anti thyroid drugs, principally methimazole. Was approved, I think, in the nineteen fifties, so it’s been around a really long time. And basically, what doctors have said for many decades at this point is either you can get controlled on methimazole or you’re kind of screwed. We can take the thyroid out and treat it with Synthroid. But those are kind of the options basically.

And so I think that the sort of system around Graves patients has grown up around that idea. Methimazole, as you pointed out, is very widely used again. There’s millions of patients on Methimazole. We think there’s about three fifty, like combination of like talking to docs, looking at claims data and sort of literature surveys. We think it’s probably about three hundred and fifty thousand Graves patients in The US who are effectively refractory to all available treatment options.

That is they cannot get properly controlled on methimazole, either they’ve explored high doses and don’t tolerate them, They’ve been on high dose with them as all for a long time and still have out of like thyroid hormone levels, or they’ve been on and off with them as all, but the disease just keeps coming back. They can’t leave for a quote unquote rare disease. So it’s a big population. I think there’s a little bit of heterogeneity in the doc base here. There are docs who and a lot of Grace patients are treated at roughly community endocrinologists.

Right? They’re treated sort of in their in their local communities by regular treating physicians. Mhmm. I think some of those docs, ninety percent of their patients are well controlled on methimazole, and you call them they shrug. And they’re like, okay.

But but then once you start talking to, like, the specialty centers, the people that treat the harder cases, I think they see a need in this, like, large refractory patient population. I think we feel really good about the size of that population, what we need to do to access it. The problem from a clinical trial perspective is many, many There hasn’t been a novel drug in Graves’ disease in, again, seventy years. Most of these docs offices have not been involved in a trial in a long time. So it’s not like onc or even like rheumatology or whatever, where the big practices all have site coordinators and they’ve all got study, like study people on staff.

These are like, you’re going in there and you are paving the way for execution. Yeah. And you’re like the first in there, which is a huge opportunity like it was for Argenx and MG. But I think it like clouds the enrollment picture a little bit because I think the docs on the one hand in the study are super enthusiastic about patient flow. And we’ve got docs like Tahili who ran the the phase two, who I think has tens of patients in theory eligible for this study.

And can in Kailey’s case, he’s obviously got the infrastructure. But for a lot of these practices, even though they have a lot of patient demand, they don’t yet have the tools as a as a practice to get the patients onto the study and to monitor them. And so I think that’s the operational challenge that we’re working on. I see. I see.

Excuse me.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Yeah. So I guess, like, when we think about obviously, there’s a little bit of heavy lifting that goes into that in terms of getting good quality trial sites that can have a high high volume up up and operationalized. Maybe just the value proposition of the therapy in Graves. We hear surgery, radiation, not great, maybe even trending down. Yeah.

That might even be why we’re seeing an uptick in methimazole. We hear anecdotally people stay on methimazole way beyond, like, when it’s gonna help them anymore.

Matt Glein, Chief Executive Officer, Royvant: Yep. I totally I totally agree with all of that. And I think that result in 2020, was just looking at these data that were like ninety three thousand thyroidectomies or something. Those numbers have actually come down a lot post COVID. Yeah.

What I think that really means is those numbers are twenty or thirty thousand now, there’s seventy thousand patients who should be treated in some way, but have decided that and if you talk to patients who had thyroidectomies, it’s not that great. Right? They’re on lifelong Synthroid. They’re still managing to fluctuations at hormone levels via by by Synthroid and other things. And so there’s just, like, all of these patients who, like, just have this pent up demand.

Yeah. I think roughly speaking, there are three important value three to four important value props in GRAVE. One is just these patients feel crappy all the time. They’re they’re sick. They’re they’re not controlled along withimazole.

They can’t control their weight. They can’t control their energy level. It’s just pretty unpleasant. The second is being on lifelong withimazole. These are patients who are refractory, you can’t get into remission, is its own trouble.

And withimazole at high doses is pretty unpleasant and it contributes to weight gain and other things the patients don’t like. And so I think in addition to just like getting patients feeling better, getting patients off methimazole And we had over fifty percent of patients on our high dose get off methimazole in twelve weeks, which was pretty great. Then I think the third value prop for us is if we can show real and we have some remission data coming out midyear this year. If we can show off drug remission, I think that’s like another level of benefit.

If we could say to patients, hey, for some decent percentage of patients who get controlled on our drug, you don’t even have to be on our drug for life. You can get off our drug and you can remain clear of any medication potentially much. I think that’s like a potential value proposition that we’re gonna be able to talk more about later this year. And then the last piece, which is really the focus of the second GRAVE study is now getting up and running, is as many of you will know from TEPEZZA, TED is a big market that is effectively a presentation of late stage or refractory Graves disease. And we think we’re gonna be able to show that in hyperthyroid patients with proptosis that we can reduce the onset of TED, that we can improve proptosis in those patients.

We see a little bit of that evidence in our existing phase two data, and so we’re we’re running the second phase three for Graves in a way that’s designed to, like, include a bunch of proptosis patients and show that we can benefit there too. And I think that will also be an important part of the value proposition.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: How is the trial? It seems like there’s a question that has to be answered as to how long, how much therapy do I need to drive a remission? Right? Do I need six months? Do I need a year?

Do I need eighteen months? If I listen to the Biohaven view of the world, they think it’s a chronic therapy for Graves and I know they wanna fast follow you in the setting. So as you think about the trial and how clinicians will get answers to the question of how long do I need to incorporate FcRn therapy to get the patient to remission? Or do I just keep it on board indefinitely? How do you think the trial answers those questions?

Matt Glein, Chief Executive Officer, Royvant: Yeah. Mean, main for the first GRAVE study, the main answer to that question is we put a line in the sand and we said we’re gonna treat for six months and then we randomize. And so the hope is that we can get a reasonable number of patients after twenty four weeks of therapy into remission. We’ll find out. We will titrate that a little bit based on what we see in the midyear remission data this year, but I

Chi Fong, Colleague of Jason Gerberry, BofA: think our hope is that we will see a reasonable rate of remission. I do think Define is, like, you go six months post

Matt Glein, Chief Executive Officer, Royvant: Six months post treatment without drug and still have pleurthyroid hormone levels and are euthyroid. I think in practice, it will vary a lot by patient. And I think there will be patients who are not who are either not in remission, is like they’re euthyroid at six months, but their disease recurs if they go off therapy. But if they were on therapy for eight or ten or twelve months, they might go into remission. And I also think there are likely to be some patients who just like aren’t yet euthyroid by six months, but on continued therapy get there at eight months or ten months or twelve months.

I think it’s gonna be a little bit about disease severity, about levels of autoantibodies. And also, I think TSH in particular is kind of a complicated piece of this puzzle. What seems to happen in general with methimazole as well is you dose these patients and T3 and T4 get controlled pretty quickly. But TSH is something that the body sort of regulates as a secondary phenomenon over time. And literature suggests that six months is about enough time to do that, but no one really knows.

And so I think, like, we’re gonna learn a little bit about that in the study. And I think for patients who take ten months for their TSH to get normal, I think what you might find is if you pull them off drug, we wouldn’t in this study pull them off drug if their TSH was abnormal. What if TSH is abnormal, T3 and T4 started to climb back up. But I think you can get these sort of negative we believe you can get these sort of negative feedback cycles in these patients where the TRAB levels come back up, the antibody levels come back up, and they are sick again. Whereas if you can get everything normal and sitting pretty for a few months, then sort of you’ve had a sort of homeostatic benefit where all of a sudden you don’t have to worry as much about continued therapy.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Okay. And so just to round out the Graves discussion. So you had some of the phase two data. I think it was either fifty or seventy percent of patients got to kind of T3, T4 normalization.

Matt Glein, Chief Executive Officer, Royvant: Yeah. Yeah. Seventy but on high dose, it was like seventy six percent or something of patients got to T3 and T4 normalization, and then about fifty six percent got off ATDs. Okay.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: And so then is more the purpose of this upcoming update just to see how well they do and kind of their off therapy?

Matt Glein, Chief Executive Officer, Royvant: That’s exactly right. Yeah. It’s for the for the patients who were clear at the end of that twenty four weeks of treatment to follow them for six months off therapy and to see how many of them stayed clear off drug for six months.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Yeah, I

Matt Glein, Chief Executive Officer, Royvant: see. Which is a pretty interesting dataset because again, these were all refractory patients. And I think what docs would say if you talk to them is like, these are not patients who spontaneously remit. That is like, these were not patients who absent our intervention were likely to go into remission. So it would be a pretty interesting outcome.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Yeah, okay. And then just it is novel territory here. So just, I guess I gotta ask the obligatory question around FDA interaction and kind of alignment on the right pathway forward for phase three design. FDA has been super constructive around the indication.

Matt Glein, Chief Executive Officer, Royvant: I think they’re eager to see a new therapy approved. Again, there’s been nothing for a long time, so there’s a lot of enthusiasm for the indication. And the thing that’s really nice for a pharma company in Graves’ disease is the disease is managed to thyroid hormone levels. That is how these patients are treated. And so FDA was pretty clear that that as long as we were including sort of the the conventional components of euthyroid in our study, that it was gonna be what they needed.

Okay.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Alright. Maybe shifting gears to just MG and CIDP as you’ve had more time to reflect. You know, you mentioned just the sort of the challenge, right, of a of a late mover, I guess, going up against Argenx and the popularity. And it seems like is part of the maybe tone shift a little bit, the fact that, like, they’re making progress on their sub q deliveries? I know that, like, simple sub q was always kind of an angle with fourteen o one and 14 o two.

I just wonder if maybe kind of Argenx has been able to kinda negate that aspect of the advantage.

Matt Glein, Chief Executive Officer, Royvant: And I don’t that that to me is not a big piece of it. Look. I think we are gonna have a better form factor than FGARD. And I think one thing to remember is three hundred of fourteen o two is in our view a pretty equivalent drug to the standard dose of FGARD. And so, like, for example, a study that I think is interesting is, like, we could potentially run, let’s just say, in healthy volunteers, like a study where you put patients on whatever four weeks of FGART and then transition them to steady state 300 to 1402 and show that IgG stays flattish so that you can continue to manage these patients.

I think most patients will prefer our 2CC auto injector with 300 to fourteen oh two over the current PFS or over a Halozyme auto injector or whatever argenx gets. I think it is not yet clear to us exactly what patient experience with the PFS will be, and I think that’ll be informative. But the short answer to your question is that’s not really what’s driving my view. What’s driving my view honestly is on the one hand, I think we have a potentially better drug. That is, I think, in my opinion, our data shows that deeper IgG expression yields better clinical benefit.

But on the other hand, Argenx is a very good drug. FGard is a good drug. It’s safe. It’s well tolerated. Docs are familiar with it.

And I think they’ve done a pretty good job already getting into the prevalent patient population. And I think like five years late, which is what we will be in MG. It’s like that is a tough hill to overcome.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Yeah. For sure.

Matt Glein, Chief Executive Officer, Royvant: Sure. And none of that’s to say that I don’t think we can be a big drug in MG. I just especially in forums like this, I just, like, wanna come out and say that I think we are eyes wide open about that challenge Yeah. And therefore are more excited about some of the indications where we don’t face those headwinds. I do think, though, having said that, I think there is an interesting opportunity in MG, which is I think the MG market by rights should go the way of many other autoimmune markets, which is to say people should stop talking about remission.

Stop talking about response and start talking about remission, about MSC, about the sort of deeper responses, the equivalent of a PASI 75 or PASI 90, a sort of seven point MG ADL response or something like that. Right. They start talking about durability of remission. I think if they do those things The super responder type of Super responders and and and, yeah, like, again, patients going into effectively clinical remission. I think if the field moves from a treatment guidelines and expectations perspective in that direction Mhmm.

We will have two advantages. One is, actually, those are endpoints on which our deep red IgG expression will just make it easier to win on a placebo adjusted basis where placebo is not gonna deliver a lot of, like, true clinical remission. And also bluntly, argenx didn’t generate most of that data. Right? They were treated in four week courses.

They don’t have durable remission data to show. And I think one thing that helps us is many of the other therapies in development for MG are focused on things whatever. So it’s things like T cell engagers and, like, like, bigger guns that are designed to produce deeper effects with corresponding safety liabilities. Yeah. And so I think we will have the support of the community in moving towards these deeper emission endpoints because those are the kinds of settings in which these other companies are also gonna wanna deliver benefit.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Okay. And then I guess lastly, just

Chi Fong, Colleague of Jason Gerberry, BofA: when when do we think we can

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: get a more fulsome update on the broader r and d strategy? You know, the opportunities beyond what we already kind of know and we’ve talked about because there are a few kind of opportunities that you guys are keeping Yeah.

Matt Glein, Chief Executive Officer, Royvant: Invest. Look. The thing we did before, and I take some responsibility for this, in indicating that we were gonna pursue 10 indications and we were gonna tell people what they were later, was we just, like, basically got the street out there modeling a bunch of burn and no benefit for a lot of indications. Uh-huh. And so I think our current view is like, we’re gonna evaluate opportunities as they come.

And when we decide we wanna invest in something, we’ll talk about it concurrent with the beginning of it and people can evaluate both the sort of capital burden of it as well as the potential benefit of it. We are right now very focused on execution of the indications we’ve already talked about. Yep. But it wouldn’t surprise me if we announce another indication at some point along the way. We’ve got certainly ideas on which we’re doing work, including some of these studies that we’ve been running overseas and things like that.

So we’ll we’ll see.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: For example, when you you drop the lupus update. Right? Exactly. Things like that, you know, where you’re kinda covertly evaluating. These aren’t things that we’ll see on ct.gov.

Matt Glein, Chief Executive Officer, Royvant: That’s right.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: But but but, you know, we’ll just appear when you have signal.

Matt Glein, Chief Executive Officer, Royvant: But we’ve got something that we wanna talk about. Exactly. Understood. And maybe Chi?

Chi Fong, Colleague of Jason Gerberry, BofA: Yeah, sure. Matt, nice to see you here. Likewise. Good to be a guest to our conference. I want to switch gear to representative.

I know FCR is very important, but know, we’re even out of the border pipeline as well. And I want to hone in on some of the others assets that you guys have at telestation So first, I guess I want to focus on BRADCO Phase three trial in dermatomyositis. It’s called a VALUS 30. You guys have a phase three later this year. And I’m curious your thoughts about what your expectation for the phase three, curious also about what do you see as a bar of success in terms of regulatory approval?

And then separately, what do you see as the bar of success in the context of competitive landscape including approved therapies such as IVIG and also pipeline developments such as FcRn?

Matt Glein, Chief Executive Officer, Royvant: Yeah, perfect. So dermatomyositis rare disease, We think about forty thousand patients in The US. I think Argenx says seventy thousand patients in The US. Sort of a perfect size market for this kind of therapy. JAK inhibition on its own, there’s some evidence to suggest efficacy in DM.

There was an open label study of TOFA. There’s a lot of off label case report data of docs using JAK inhibitors. It’s an interferonopathy, so tick two should also contribute meaningfully from a biologic perspective. Seems like a lot of good reasons to believe in the drug. Think the the only to be honest, I think the drug likely works in dermatomyositis.

I think the the sort of concern, if you were to articulate one, is that the endpoint in DM is not a great endpoint. It’s this thing called TIS, which is the total improvement. It’s called total improvement score. It starts at zero for every patient and it can only go up. It measures improvement from baseline over the course of the study, which means placebo on average will be positive because it can’t be negative.

You’re just sort of up against the normal rare disease immunology placebo dynamics. We are managing this with steroid taper, which I think were the first dermatomyositis study ever to have a mandatory steroid taper in it. But I think that would be the concern. Docs are very familiar with JAK inhibition in the space. Again, it’s treated by specialty myositis referral centers, but rheumatologists generally at those centers, they use JAKs a lot in their practice.

They are super enthusiastic about the possibility of an unlabeled JAK. I think it’s something they’ve been looking for for a long time, and I think they believe in TYK2 as a part of the mechanism. So I don’t think the bar for either I think the

Chi Fong, Colleague of Jason Gerberry, BofA: bar for regulatory approval is a positive study from a

Matt Glein, Chief Executive Officer, Royvant: stat sync perspective. I think the bar for commercial success is a positive study from a stat sync perspective. I don’t think the treating physicians are gonna be super keyed in on any specific like TIS, delta, placebo, whatever. And in fact, I think the IVIG approvals were largely done on a responder analysis anyway. So I think docs will be pretty happy with just any stat sig improvement.

The other point that I’d make about this is TIS is actually not a DM specific endpoint. It is across all myositis. And so I think one of the things the docs will look to is some of the other endpoints. Like, there’s a score called CDASI. That’s a it’s a it’s a purely a measure of top collective dose connectivity.

There’s a score called relatively newer scale look to for signal, but I think the bar here is stat sync.

Chi Fong, Colleague of Jason Gerberry, BofA: Okay. Great. I to ask about there was a, if I remember correctly, the VAILED trial evaluate two doses, thirty milligram and a fifteen milligram, but with your other programs such as uveitis, you guys have pushed it to forty five milligram, which is some interesting data for uveitis. Yeah. I’m just curious why why pick thirty milligram, not forty five and are you worried about living efficacy on the table or you think the thirty milligram is good to go?

Matt Glein, Chief Executive Officer, Royvant: I think thirty is a good dose. Look, think fifteen is an efficacious dose of Brepo and many other indications, and thirty is a very efficacious dose of Brepo and a bunch of other indications in which it’s been studied. So I feel good about thirty. The study is powered for thirty. Fifteen is there, I’d say, largely for regulatory reasons to show a minimally efficacious dose.

But but I feel good about what we’re gonna be able to do with thirty. I think it is nice for us that NIU is at 45 and DM is at 30 because, bluntly, I think NIU can probably sustain or at least potentially sustain a slightly higher price point than DM. IVIG has a price point attached to it, etcetera. The entry of FcRn into my side is probably elevates a little bit the supportable pricing bands. But anyway, I think it’s nice for us that we’ll be able to price by milligram and sort of set slightly differential pricing for DM and for NIU.

Okay, interesting.

Chi Fong, Colleague of Jason Gerberry, BofA: So assuming phase three success for VALOR, can you remind us sort of what your expectation for timing for regulatory submission? Do you expect a relatively quick turnaround time or do you still have to approve certain safety exposure before you can submit regulatory?

Matt Glein, Chief Executive Officer, Royvant: We have basically everything we need from a data perspective, so it’s just as fast as we can file. It still takes some time. I think the probably the most likely thing is to, like, look in for an approval in very early twenty seven. So, like, call it five or six months to file and then a year review. I think it’s possible that can be pulled in in a variety of ways.

It’s possible we could file faster. It’s possible FDA gives us acceleration on their own. It’s possible we find ways to ask for it. I think probably the base case is a very early ’27 approval.

Chi Fong, Colleague of Jason Gerberry, BofA: Great. Great. Next, I want to talk about your PHR RD program that you’ve licensed from Bayer. Interesting program. Thank you.

Curious, you guys are in phase two development, some interesting phase one data. Can you give us some color on the enrollment progress and do you have a line of sight when we might be able to see the data from the Phase two Yeah, perfect.

Matt Glein, Chief Executive Officer, Royvant: So this is a inhaled SGC activator that we licensed from Bayer. It’s in a phase two b study, looking at PHLD patients for the first time. We have, phase one data in group one pulmonary arterial hypertension patients, but this is first time we looked at PHLD patients. And we’ve guided to second half of next year for data from that study. That’s when I think we’ll have it.

Chi Fong, Colleague of Jason Gerberry, BofA: Great, great, great. And last but not least, I wanna touch upon on RNP litigation. I’ll keep the question open ended and high level but to the extent you can, can you maybe walk us through the setup and expectation ahead of some of the update that you expect? I think you have a summary judgment phase in second to third quarter and jury trial scheduled for September for the case against Moderna.

Matt Glein, Chief Executive Officer, Royvant: Yeah. Look. So with this and again, there’s a lot of history here, too much to talk about in three and half minutes. But we have a team of scientists who’ve been working on lipid nanoparticles since the very beginning of that field in British Columbia. And we have IP associated with the work that those scientists have conducted.

And we believe that Moderna and Pfizer both are using that IP in their COVID vaccines to shoot for infringement. Where we are right now after years of preamble is the trial will be in 2025. It’s currently scheduled to start September 29. This will be a jury trial. In a courtroom, 12 people in a box, they will hear evidence from experts.

They will go into a room, and they will come back, and they will say, does it infringe? What are the damages, and was the infringement willful? Like, we will know all of that within weeks of the start of the trial. This is not like a protracted process anymore in that sense. That trial, again, will start in the fall.

Prior to that trial, there’s a series of what are called summary judgment motions where legal issues get dealt with before they ever make it to the jury. And some of those are important. One of them that’s up for that will be up for discussion is that Moderna has claimed that they can take advantage of a World War one era part of the patent code that allows for companies to offload some liability to the US government in the event that they were manufacturing something for the government, which I think is an open question legally in this instance. But that’s one issue that will be decided this summer in summary judgment. There are a few others, and then we’ll go to trial.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: Have you sized you know, if that goes your way versus doesn’t go your way and and what potential damages could be at all? Has that been, like, outlined in any of the the court documents?

Matt Glein, Chief Executive Officer, Royvant: There are places to see it. Look. I think the the short answer is there are a hundred and $50,000,000,000 worth of global COVID vaccine sales between Pfizer and Moderna. And what we said is that our other COVID collaborations, which are not necessarily presidential from a legal perspective, range from mid single digit to mid teens royalty rates. And so even at the bottom end of that split between Pfizer and Moderna, this is our market cap.

So the possible outcomes are obviously large. In The US Moderna case, Moderna is a little bit less than half of the global COVID vaccine sales. And then The US is, I think, a little bit less than half of Moderna’s sales. And so you’re talking about, like, a quarter of the total pie or a little bit less than a quarter of the total pie being adjudicated in this case. In terms of the range of outcomes from 1498, I think it’s, at maximum, probably 60 ish percent of The US case could conceivably be covered by US Government Contractors under 1498, and at minimum, none could.

And so I think the case ranges sort of Pretty massive expand. A pretty wide range. Yeah.

Jason Gerberry, Introducing Royvant and Chief Executive Officer, BofA: And so I guess the core issue is is there public disclosure of their what they have in their vaccine, which they have not, like, disclosed, but there’s some arguments that maybe it was disclosed in certain venues?

Matt Glein, Chief Executive Officer, Royvant: There is not public disclosure in The US of the molar ratios and their vaccines. What the case will ultimately come down to in part is testing. That is we were given samples of their vaccines, and we have run tests, and we will show the results of that testing to a jury. We haven’t published them yet. Okay.

And Moderna will if one presumes that we will show infringement in those results Yeah. Moderna will will then talk about why they believe our testing is inappropriate and so on. And that will be the back and forth with the jury, but, obviously, we we feel good about our case.

Chi Fong, Colleague of Jason Gerberry, BofA: Alright. Well, I guess we’re up against our time. Thanks so much, Matt, for joining us today.

Matt Glein, Chief Executive Officer, Royvant: Thanks for having me. This was really fun. Thank you. Thank you. Thanks, everybody.

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