Royvant Sciences at Jefferies Conference: Strategic Focus on Biopharma

On Thursday, 05 June 2025, Royvant Sciences (NASDAQ:ROIV) presented its strategic vision at the Jefferies Global Healthcare Conference 2025. The discussion highlighted the company’s robust cash position and ambitious pipeline, while also addressing challenges such as patent litigation and market uncertainties. CEO Mac Glein emphasized both the potential for growth and the hurdles the company faces in its biopharmaceutical endeavors.

Key Takeaways

• Royvant Sciences holds nearly $5 billion in cash, bolstered by a significant asset sale.
• The company is focusing on late-stage programs, particularly brepocitinib for dermatomyositis.
• Strategic partnerships with transitioning big pharma companies are a priority.
• Ongoing patent litigation with Pfizer and Moderna over COVID-19 vaccine technology.
• Emphasis on expanding indications for existing assets like FcRn and JAK1/TYK2 inhibitors.

Financial Results

• Royvant Sciences has a strong cash position of just under $5 billion.
• This capital was primarily generated from the sale of an anti-TL1A antibody from Pfizer to Roche.
• Funds are being allocated towards pipeline development, acquisitions, and stock buybacks.
• Pricing expectations for dermatomyositis treatments are competitive, with comparisons to IVIG and Argenx FcRn therapies.

Operational Updates

• A Phase III data readout for brepocitinib in dermatomyositis is anticipated in the latter half of this year.
• Future data releases are expected for Immunovant programs and the PHLD program.
• The company’s regulatory strategy focuses on efficient approval processes with a single trial requirement if Phase III results are positive.
• Royvant is targeting a variety of therapeutic areas, including immunology and rare diseases.

Future Outlook

• Royvant plans to launch brepocitinib for dermatomyositis, targeting specialty centers.
• The company is preparing for potential litigation outcomes with Pfizer and Moderna, which could proceed to trial this fall.
• Continued focus on business development through strategic acquisitions and partnerships.
• Efforts to mitigate placebo effects in clinical trials are a priority to ensure robust study results.

Q&A Highlights

• "Good" data in trials is defined by statistically significant results on primary endpoints.
• Strategies for placebo mitigation include a mandatory steroid taper in study protocols.
• Commercial strategies involve focusing on a concentrated prescriber base and pricing brepocitinib at a rare/orphan price point.
• Royvant is committed to deeper IgG suppression for enhanced clinical outcomes.

In conclusion, Royvant Sciences remains optimistic about its strategic direction and commercial potential. For a detailed understanding, refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Dennis Ding, Biotech Analyst, Jefferies: Good afternoon. Welcome to day two of the Jefferies Healthcare Conference. My name is Dennis Ding, biotech analyst here at Jefferies. I have the great pleasure of having, CEO Mac Glein of Royvant Sciences here with me. Welcome.

Mac Glein, CEO, Royvant Sciences: Thanks for having me. It’s great to be here.

Dennis Ding, Biotech Analyst, Jefferies: So I usually like to kick things off with just a very broad sort of topic, just like an intro of where the company is today, some of the progress that you guys have made over the last couple of years, and maybe you mentioned TL1A, and then just your outlook going through the rest of the year in 2026.

Mac Glein, CEO, Royvant Sciences: Yeah, great. Thank you. Look, that is a super broad question. We are for those who don’t know us, I think most of you do we are a clinical stage biopharma company focused on we’re ultimately focused on the same thing everybody else is, developing medicines that matter in ways that we hope add a bunch of value. We have built at this point a portfolio of late stage programs that we are really excited about.

There are probably three that we’ll at least touch on in conversation today. One is our anti FcRn franchise, which is at our subsidiary Immunovant. Another is a JAK1TYK2 inhibitor that we’re developing for dermatomyositis, non infectious uveitis, and cutaneous sarcoid. And then the third is a PHLD program called Mosley Siguat. But we have a handful of other things we’ve worked on over time, as well as a couple other aspects of the story, like we’re in patent litigation with Pfizer and Moderna over their use of RIP and their COVID-nineteen vaccine.

We’ve had a busy couple of years building this portfolio. I think part of what Dennis was alluding to was we have just under $5,000,000,000 in cash. And the main reason for that is because a couple of years ago we bought and then sold an anti T1 antibody from Pfizer to Roche in a way that resulted in quite a lot of proceeds to us. And so we’ve been sort of deploying that cash cautiously and thoughtfully towards our existing pipeline, towards some new things that we’re looking at, and then towards buying back stock, which we’ve been doing over the past couple of years as well. And you asked about the outlook from here.

Look, I’m super excited about what our next couple of years look like. The first major event here, at least on the portfolio side, is we have a phase three readout for what we think will be registrational data in dermatomyositis at brepcitinib, which if successful will put us back into the sort of commercial hot seat, launching a program that we think could be very important to patients in what we think is big and interesting market. And that data will come in the second half of this year pretty soon. And then on top of that, we have so portfolio development wise, after that, we then have a bunch of data coming both for additional programs at prapacitinib. We have NIU data coming about a year and a half after that.

We have data coming in Immunovant and a whole bunch of indications and data coming in the second half of next year in the PHLD program. So a lot of clinical data in programs that advance significantly or become commercial really in the next couple of years. And then on top of that, we have a Moderna trial that we believe should be in the second half of this year, knock wood, assuming everything progresses according to plan. And that’ll be meaningful as well.

Dennis Ding, Biotech Analyst, Jefferies: Sure. That’s a great overview. Before we kind of go into some of the pipeline, would love to ask you more broadly just around BD and some of your strategy. You’ve been talking about how the environment has been very ripe, very conducive to deal making for the last twelve to eighteen months. But I feel like now with so many companies trading under cash, etcetera, like how do you view the BD landscape right now?

Mac Glein, CEO, Royvant Sciences: What are the really good companies trading under cash?

Dennis Ding, Biotech Analyst, Jefferies: Look,

Mac Glein, CEO, Royvant Sciences: we’re pretty excited about the stuff we see in the world. So we’ve always been drug hunters. It’s a big part of the history of our business. Most of our partnerships, but by no means all, have been with big pharma companies that are in a moment of transition. And we have a lot of interesting things on the racket in conversations with various big pharma companies that we like a lot.

And some of them I hope will get done and will be awesome to talk about. The biotech market has had a rough four or five months. That’s tough for everybody, but an opportunity for us as valuations get cheaper, expectations change. Stuff that was competitive last year is not competitive this year. So I think that’s all been constructive as well.

We are long term owners of things we buy. So I think we’re pretty choosy and have taken our time. And I think we’re going to continue to be pretty choosy and take our time. But there are definitely multiple things I’m excited about that could get done within probably months is the right time frame to articulate there, maybe a little sooner, depending on what comes together. Some really good stuff on the BD side.

Dennis Ding, Biotech Analyst, Jefferies: Okay. And maybe also talk about, given just some of the uncertainties

Mac Glein, CEO, Royvant Sciences: One more comment on BD, which is I just think we’re increasingly excited about both the FCRN and JAK1TIC2 sort of opportunities. And one kind of BD that we have done a fair amount of just indication expansion for those businesses. And I think you will also see more of that from a capital deployment perspective.

Dennis Ding, Biotech Analyst, Jefferies: What do you mean by that? Like organically or you mean

Mac Glein, CEO, Royvant Sciences: Yeah, organically. Like we’ve added cutaneous sarcoidosis, which exactly. Which we view in a very similar context to BD. It’s spending more money on things we care about.

Dennis Ding, Biotech Analyst, Jefferies: Okay. And on tariffs, right, that has been definitely a point of uncertainty and pharma is going through. I’m sure there’s scenario planning, worrying about margins and EPS, etcetera. How has the tone in these discussions with pharma changed or maybe not changed over the last couple of months during this period of transition?

Mac Glein, CEO, Royvant Sciences: Yeah, it’s been a really interesting mean,

Dennis Ding, Biotech Analyst, Jefferies: been

Mac Glein, CEO, Royvant Sciences: an interesting eighteen months, but also especially an interesting few months on big pharma conversations, especially around M and A, which is the rhetoric is busy. The rhetoric is like teams working on things, looking at things, spending a lot of time, engaging actively. But the pace isn’t matching that. And I think there’s a bunch of reasons for that. Look, I think, first of all, we’ve seen more China deals out of big pharma.

We’ve seen more value buying out of big pharma. And I think that’s had an impact on how they think about deploying their time and capital. But also, I was meeting with a big pharma CEO a few weeks ago, and his comment was this was before the MFN noise. And his comment was, I’ve spent 85% or 90% of my time the last month on tariffs. So that means everything else involved in running a, whatever, multi hundred billion dollar pharma company has been squeezed into 10 or 15% of this big pharma CEO’s time.

And I think you can imagine then why big deals have been sometimes hard to get done. You can imagine why some of the stuff in general has been slower. That’s probably been the main impact for us in terms of sentiment in these conversations. It’s just been a real time suck trying to figure out which way is up. And I’m sure the MFN stuff has made that even more complicated.

And so I’m sure there’s just like a lot of I hope everybody’s Okay. A lot of trying to figure things out.

Dennis Ding, Biotech Analyst, Jefferies: So do you feel like pharma needs to get clarity and visibility on both tariffs and MFNs before doing BD deals? Or do you think they’re okay with kind of, you know, running with it?

Mac Glein, CEO, Royvant Sciences: I think what we’ve learned this week is that the answer to that question is evidently not, which is great.

Dennis Ding, Biotech Analyst, Jefferies: Okay. And then therapeutic areas in terms of BD and like new assets?

Mac Glein, CEO, Royvant Sciences: Yeah, so what we’ve always said is that we are opportunistic, that we’ll go anywhere, that there are certain things that lend themselves better to our portfolio construction than others, that like Onc has always been a little bit harder for us because of the competitive dynamics, that gene therapy and cell therapy has always been a little bit harder for us because we don’t have the concentrated expertise on manufacturing. But everything else is on the table. And there’s stuff that we like right now in immunology, respiratory, pulmonary, cardiometabolic, mostly outside of obesity, rare disease, and a little bit of what I would call like spec pharma.

Dennis Ding, Biotech Analyst, Jefferies: Okay. Spec pharma, what do you mean by that exactly? Just

Mac Glein, CEO, Royvant Sciences: Yeah, like, I mean the stuff we’ve done before in this area has been like women’s health, urology. Patama. Sorry? PETER Like Patama? PETER Yeah, but also Religolix and vibegron or like yeah.

Dennis Ding, Biotech Analyst, Jefferies: PETER Okay.

Mac Glein, CEO, Royvant Sciences: PETER That sort of stuff.

Dennis Ding, Biotech Analyst, Jefferies: PETER All right. That’s helpful. Now kind of going to the pipeline and the most near term, I think, data card flip is the Phase III dermatomyositis data in the second half of this year. Maybe you can frame that opportunity, the indication, the commercial opportunity, etcetera, for people.

Mac Glein, CEO, Royvant Sciences: Yeah, dermatomyositis is a very severe, rare inflammatory condition that presents with both muscle wasting and very severe skin symptoms, like a very severe rash. It is often fatal and very difficult to live with. There are basically no good therapeutic options. These patients are on sort of the standard, the sort of cadre of steroids and methotrexate and stuff like that. IVIG, one IVIG is approved for use in DM and works Okay, but has all the liabilities associated with IVIG.

And other than that, there’s really nothing else. We will be, if successful, the first oral sort of novel medication in DM and the first next generation therapy. There’s a variety of other things in development, including Argenx’s FcRn and so on. We think the patient population in DM is the number we’ve given is around forty thousand patients. Competitors give numbers up to seventy.

The truth is a little bit hard to know. But my guess is this is a market that is similar in overall size to something like myasthenia gravis and similar in support of overall price point to something like myasthenia gravis. That the main difference between them is that we’re just earlier as an industry in terms of our understanding of what the commercial landscape looks like here. And that makes me really excited about the position that I think we get to play as kind of the first novel therapy other than IVIG to market.

Dennis Ding, Biotech Analyst, Jefferies: Okay. So then when the data reads out, like what do you consider to be good data?

Mac Glein, CEO, Royvant Sciences: The great news for us about this space, first of all, is that the mechanism that our mechanism, JAK one, TYK two inhibition, and especially JAK inhibition generally, DM patients are mostly treated by rheumatologists. They have a tremendous amount of familiarity with JAK inhibition and a strong belief based on case studies and investigator initiated studies and so on that JAK inhibitors will work to treat dermatomyositis patients. So if they have there are no unlabeled JAK inhibitors. If they have an unlabeled JAK inhibitor, we think they will reach for it. And what that means to us is the bar for success here is mostly just a statistically significant trial.

We need to hit a p value on the primary, which in our case is mean TIS, and that’s it. That’s what we’re looking for.

Dennis Ding, Biotech Analyst, Jefferies: Okay. And, you know, when you talk to doctors and you mentioned that, you know, many of them or some of them use off label JAK inhibitors, can you kind of quantify that? Is that very common? Is that kind of a

Mac Glein, CEO, Royvant Sciences: It’s not like commercially common because JAK inhibitors are really expensive, so there’s just like no good way to do it. There are hundreds at this point. I think we’re aware of about 600 published case studies of JAK use in dermatomyositis. So you can imagine that’s certainly not every patient treated is getting a case study published on them. So you can imagine it’s some multiple of that in terms of treated patients, but still like a very small percentage of the overall treatment landscape.

Dennis Ding, Biotech Analyst, Jefferies: Okay. And when you think about the phase three, placebo is kind of, you know, very difficult to predict and handicap here. So can you just help investors frame what placebo would do? Because, you know, the whole goal is to show a delta over TIS. And just what are some of the mitigation strategies around placebo?

Mac Glein, CEO, Royvant Sciences: Doctor. Yeah, first of say and look, I am the first to agree that placebo is if you were going be nervous about something in this study, the thing you’d be nervous about is placebo. Some of that’s just a function of TIS. TIS is like not a great endpoint from a placebo perspective. It starts at zero and can only go up.

And so that’s just like mathematically not great. That having been said, these are like slightly object to the characterization that it is unpredictable, in the sense that we have a handful of studies. We have a fifty two week Corbus study that failed. We have the argenx data that was just put out. We have all the IVIG studies, some of which have been successful and some haven’t.

And I’d say at six months, if you had to try and dimension it out, like placebo, TIS ranges from, I don’t know, 25 to 40, which is like a real range. It’s not like in that sense, there’s some real unpredictability there. But it is what it is. I think, look, we are doing the things that you would want terms of managing placebo. We are the first certainly first phase three study to have a mandatory steroid taper in the protocol, which tapers down to at a minimum at a maximum of five milligrams of oral prednisone by thirty six weeks.

So I think that should be helpful. That said, I was also just encouraged. Argenx is in this different patient populations, pan myositis data. But I felt like relatively high placebo. Think they had like a close to 40 test

Dennis Ding, Biotech Analyst, Jefferies: Yeah, around

Mac Glein, CEO, Royvant Sciences: different patient population. But nice separation from the drug effect and very low p value in a way that like made TISS feel reasonable. In their study, TISS was reasonably well behaved as an endpoint. So I would hope for the same for us.

Dennis Ding, Biotech Analyst, Jefferies: Okay. Knock on wood, yes. And then This isn’t real wood,

Mac Glein, CEO, Royvant Sciences: which is making me a little nervous.

Dennis Ding, Biotech Analyst, Jefferies: Going beyond twenty four weeks because your primary endpoint is fifty two weeks, how does placebo typically behave beyond the twenty four week period?

Mac Glein, CEO, Royvant Sciences: Well, think there’s only one study that went beyond twenty four weeks. I think it was the Corbus study. So I don’t really think there is atypical. And this is definitely a question that no one knows the answer to. I think you would hope, first of all, that it would level off

And second of all, that like some patients, especially with the taper, will worsen or have to discontinue, and that that will be net helpful from a mean test perspective. Is

Dennis Ding, Biotech Analyst, Jefferies: there any data that you can point to, you know, from investors that could quantify, I guess, the placebo mitigation on tests?

Mac Glein, CEO, Royvant Sciences: Male From the steroid taper?

Dennis Ding, Biotech Analyst, Jefferies: It’s just anything that you can point people to. Because I feel like, you know, like you said to your point, like the placebo is kind of the biggest, you know, point of variability here. And if people feel a little bit more comfortable around how that could behave, and if there’s any kind of incremental data they could point people to, then I feel like people could be a little bit more confident and feel better going to this data set.

Mac Glein, CEO, Royvant Sciences: I’m not 100% sure that my job is to convince people not to worry about placebo before the data set reads out. It’s a real risk. People can worry about it. The thing that I’m most focused on is if and when the study reads out positively and we’re happy with the outcome, people should understand that it’s a big commercial market, that it’s an exciting opportunity, that we’ve delivered a clinically meaningful benefit. So I guess like look, I think we are appropriately focused on placebo mitigation because it’s one of the important things about running a study well in immunology.

But to people who came to me and said, I’m worried about placebo for tests, I’d probably say, me too. I’m also worried about placebo for tests. But I think the thing that is encouraging is, at this point, several other drugs have been able to produce statistically significant deltas versus tests in a way that suggests it’s a viable endpoint that works in clinical trials. And there’s a lot of evidence to suggest that JAK inhibitors and brepcitinib in specific should work in this indication. And so I feel cautiously optimistic that we’re going to be able to work through that.

Dennis Ding, Biotech Analyst, Jefferies: Okay. Can you comment on the small phase two study that’s on clinicaltrials.gov around DM and, you know, flipped to complete it just a couple months ago. So just comment on like, you know, what the purpose of that study was and Yeah,

Mac Glein, CEO, Royvant Sciences: the purpose of that study was to achieve orphan drug designation with FDA, which requires certain specific clinical there’s like, you need some clinical data in mechanism to do. And so we ran a small skin focused study in DM. We haven’t said what the results were. They were good. But whether we put that data out or not is an open question still.

But anyway, the purpose was to get orphan drug designation, which has some real benefits for us. It gets us better user fee situation, better engagement with FDA, etcetera. So it’s been a good trade.

Dennis Ding, Biotech Analyst, Jefferies: Okay. And you guys will be hosting an investor event with Preovant around So talk a little bit about that and just what kind of things will you be disclosing and sharing.

Mac Glein, CEO, Royvant Sciences: Yeah, I want to set the stage correctly for that. I don’t think this is like a I don’t think the investor event ought to be like a stock catalyst. This is not like we’re trying to put out some surprise data and get people to move. I think this is about making sure that people understand the trial design, some of the placebo stuff that we’re doing and why and what it like, a little bit about baseline characteristics. And then just like disease state education, making sure people understand what dermatomyositis is, why we care about it, why we’re focused on it, why we think the opportunity is big.

I also think part of that is TIS is a pretty coarse grained measure. And so we want people to understand what TIS is, all the different components of it, and then also what some of the other endpoints we’re measuring are, which I think is the less look, obviously, we miss on TIS, it’s done. But some of these other endpoints will actually be the commercially relevant endpoints. Things like CDASI, the talk around skin presentation, DMOMs, which is a dramatic but TIS is not even specific to dermatomyositis. It is the same for all flavors of myositis.

So, you know, there are other subsets of TIS and other endpoints that the DM community is more focused on, and we want to help the investor community understand better a little bit how we think docs will view the data set before we put it out, and a little more of just like what does good look like.

Dennis Ding, Biotech Analyst, Jefferies: Okay. That’s very helpful. So in terms of the regulatory path forward, if the Phase III were positive, and, you know, like you say, just need to hit stat sig on TIS, you only need one trial for approval? Okay. Then how should you know, assuming the data is positive, how should we think about the launch?

Do you think there would be a bolus of demand? Do you think it’d be kind of a more steady you know, slow and steady type of trajectory? Like, how should you know, how are you guys thinking about it?

Mac Glein, CEO, Royvant Sciences: These are also tough questions to answer because I feel like the right thing to do is to say it’s going to be slow and crappy and then to beat every quarter. Look, I think DM is a big patient population. I think the nice thing about launching in DM is the prescriber base in The U. S. Is concentrated.

Many of these patients are treated at specialty myositis centers. Those patients have hundreds of DM patients. Those centers have hundreds of DM patients. So you can address, like, lots of patients in contrary way, including in many sites that are already trial sites, who are familiar with the program, who are excited about it. So I think it has a lot of ingredients that make it feel tractable as a launch, that make it feel like we can get it done.

And as a further benefit, look, this is not like VITAMA. This is a drug that will have a rare and orphan price point. And there’s like you don’t need that many patients to have a successful early launch. And I think we have a good beat on where to find those patients now. And so I feel like it’s a launch that we are excited to take on.

Dennis Ding, Biotech Analyst, Jefferies: Okay. And historically on pricing, guys have always kind of pointed to what Pfizer said three or four years ago around being $150,000 net. Has that changed at all? Do you still feel

Mac Glein, CEO, Royvant Sciences: That price has gotten a little more expensive over time. Look, I think the bookends are clear at this point. On the bottom end of the range is IVIG, which is pushing $200,000 these days. And at the top end of the range, you’ve got argenx coming in, albeit after us, but they’re going to come at an FcRn price point, which will be probably 607 hundred thousand dollars when all is said and done for a full year of therapy, if it’s similar to CIDP in terms of usage. And so I think that sets a pretty wide bookend.

I expect us to come in within those bookends.

Dennis Ding, Biotech Analyst, Jefferies: Okay. Okay, that’s very helpful. And that’s list price, is that right? Or is that?

Mac Glein, CEO, Royvant Sciences: Yeah. Although it’s way too early to be talking about rebating and gross to nets and all that stuff. And I think modern launches have a wide variety of approaches to that question. Okay.

Dennis Ding, Biotech Analyst, Jefferies: Perfect. And then how do you you know, how are you guys thinking about product positioning once approved relative to IVIG?

Mac Glein, CEO, Royvant Sciences: I don’t guess I think the answer to that question is ahead of or after. I don’t think it’s like I expect there to be a clear treatment paradigm that every patient who gets off of steroids immediately goes on to repo and then IVIG or vice versa. I think it will be a viable alternative option. I guess my view is, assuming our data supports this, many patients would prefer a once daily oral to going on to IVIG. And so I think we have a really attractive form factor.

But I don’t the answer is like I don’t expect there to be like a clear algorithm of like one than the other. I think we were happy to exist ahead of IVIG in many patient treatment journeys and happy to exist after IVIG and others.

Dennis Ding, Biotech Analyst, Jefferies: Okay. And you mentioned earlier around, you know, when you talk about BD, it’s not necessarily inorganic Yeah. Indication expansion. That’s something that you guys have been kind of doing around prepo. So assuming if, you know, if the DM data were positive, that you would take another hard look and maybe be a little bit more enthusiastic about that and announce multiple indications.

True

Mac Glein, CEO, Royvant Sciences: to the irrespective of the DM data, there are other indications for that we are excited about now that we are doing active work to explore.

Dennis Ding, Biotech Analyst, Jefferies: Okay, perfect. So we just spent about twenty minutes on DM. That’s great. I love it. So maybe we could talk about ImmunoVAN.

I mean, that’s another big topic discussion among investors. Can you just remind us you remind us of, you know, just the data updates that you got that you had this year? Yeah. And maybe, you know, how you’re thinking about the opportunity moving forward?

Mac Glein, CEO, Royvant Sciences: Yeah. So our lead drug in Immunovant is IMG1402. It’s an next generation anti FcRn that’s currently in pivotal trials in a bunch of indications Graves and MG and CIDP and Sjogren’s, and some exploratory studies and some earlier ones. We had previously a drug called betoclimab. We have a drug called betoclimab.

It’s an earlier generation FcRn that is also a very good drug. It suppresses IgG quite deeply. It’s a nice sub q, but it has the unfortunate effect of increasing, as you know, LDL cholesterol, and so it’s therefore been it’s certainly our second most exciting asset, as it were, of two. However, we had a set of phase three programs for that drug reading out, including in MG and CID it was phase 2B, but a set of programs reading out earlier this year that had a few purposes for us, probably the most important of which was to help us show that in an indication like MG we could continue to deliver a dose response for deeper IgG suppression that is, that deeper IgG suppression would yield clinical benefit for those patients. And I think everybody can agree across the entire investor community that we’ve just put that to bed, that everybody in the world is now totally convinced that deeper IgG suppression yields better clinical benefit.

Now, I don’t think that’s true. But look, we were really happy with the data we put out there. We showed a clear dose response. We ourselves are convinced that we have an opportunity to be a best in class drug in MG, especially when looking at more stringent measures like effectively clinical remission. And that data was important, therefore, for like painting a path forward for us in terms of how to focus on those endpoints for fourteen oh two, for example.

And then we had the CIDP data also looked really promising, especially when cut on high versus low IgG suppression patients.

Dennis Ding, Biotech Analyst, Jefferies: Okay. And the idea there and the strategy there is to redefine what is good in MG. Is that kind of fair to say? Because people have been kind of preoccupied with MG ADL, and you guys are coming out with this new minimal And

Mac Glein, CEO, Royvant Sciences: argenx has started talking about MSC, and docs have started talking about MSC. Look, I think MG is actually still pretty young as a commercial market. And I think what we expect to see happen, and what we would like to see happen, and what we would like to be a part of engineering for the field, is the same progression that many other immunology markets have followed, right? From, you know, IgA to PASI 75 PASI 50 to PASI 75 to PASI 90 to PASI 100, from ACR 20 to ACR 50 to ACR 70, from clinical response in UC to clinical remission in UC. And I think we see a similar trend in the future of MG going from not just like MG ADL improvement from baseline, but like deep MG ADL responders.

Not just like two point MG ADL responders, but five and seven point MG ADL responders. Not just MG ADL improvement, but these MSE sort of clinical remission kind of patients. And also durable MSC, patients who obtain clinical remission and then hang on to it for a long period of time. Think that’s a good first of all, I think that is where MG patients deserve to see the market go, and is where a whole bunch of people involved in MG, not just us, but people developing T cell engagers and people developing all kinds of other therapies are going to want to see the market go towards these truly patient desired outcomes. And I think we can help move the FcRn field there in a way that I think is like what the next generation of data is going look like anyway, and in a way that I think really highlights what we can deliver with cheaper IgG suppression than what some of our competitors will deliver with lesser IgG suppression.

So that’s how I think we see the market evolving. And I think we’d like to be a big part of carrying there. Now, having said that, look, the truth about MG is these are patients who had very few options before. Efgartigimod is a good drug for these patients. It works well.

They like it. Docs are happy prescribing it. The patients are happy being on it. And so we obviously need to offer a real value proposition in order to take meaningful share. And it’s why I put some of these other indications like Graves ahead of the value prop of MG.

It’s because in Graves, we get to be in Graves what argenx is We get to define that commercial market and be out in front of it. And so it’s why I think that is an easier battle versus the cage match that we’ll wind up being in MG. That said, I think there’s a lot of opportunity in MG, to be clear along the lines of what we were just talking about.

Dennis Ding, Biotech Analyst, Jefferies: Sure. And then Graves?

Mac Glein, CEO, Royvant Sciences: Yeah. Graves is one of these fun markets where anyone trying to build a commercial model is going to result in a stupid number, because there are three hundred and thirty thousand Graves patients who are refractory to all pharmacological treatment options. They failed every drug available, and the only remaining options for them are to feel shitty sorry feel crappy, or to have their thyroid surgically removed and go on lifelong Synthroid and still feel crappy. And so look, I think that is a pretty special market in terms of what we can offer to patients, especially given the data that we showed in phase two. It’s a market where it’s really exciting to be first.

There will be a lot of other people showing up in Graves’ disease. Of that, I am confident. And I will get questions about all of them. And the fun thing I get to say to those questions that I could never say in MG is, well, we’re going to be ahead of them. So you can just watch us first, and then they can sort of figure out how to play from behind.

And that feels great.

Dennis Ding, Biotech Analyst, Jefferies: How do you think about the future of your relationship with ImmunoVAN? There has been a few changes, at least communication wise, over the last few months. But, you know, what’s the best case scenario for you? Where would you like that relationship going?

Mac Glein, CEO, Royvant Sciences: We’d like a good relationship with Immunovan. Look, we own 60% of the company, 58% of the company. That’s a little bit higher than it was a year ago. We like the program. We think it’s a really exciting place to be.

We think look, fourteen oh two is a drug that’s going to work in a variety of indications. It’s a well understood mechanism at this point. There’s broad biology. There’s many indications that people have not even begun to study, and many others that are being actively studied now. It’s the kind of indication the kind of mechanism that will stack commercially, where there’ll be a bunch of different indications that can get approved.

And there are error bars around all of them, but like many of those indications will certainly be 9 figure indications and could be blockbuster indications. And so being able to stack those together is a pretty unique opportunity. I love being involved in stories like that. I think it will stack nicely on top of brepacitinib and sort of be a part of a real and interesting commercial story. So in that sense, I guess, like, what I hope is that we can continue to be close to Immunovant, develop that drug, commercialize it successfully, to the extent that opportunities arise, that we can own more, and that we can be in that position.

The only thing I’ll say, which I think is clear and everyone knows that we feel this way, is we are not the only people in the world who have noticed that the commercial opportunity in FcRn is exciting. And so we get lots of inbound conversations and lots of ongoing dialogue with big pharma companies and others about the mechanism, and we take all those conversations seriously. And we are, as we showed with the TL1A, ruthlessly economic in how we think about our programs.

Dennis Ding, Biotech Analyst, Jefferies: Okay. Perfect. And then in the last thirty seconds, the LNP litigation? We

Mac Glein, CEO, Royvant Sciences: in thirty seconds. I believe that Moderna and Pfizer are infringing on our IP. I believe we will have our day in court in the relatively near future. My hope is that that day in court is this fall. And I think going to trial will be a good experience for us in terms of what it opens up.

Dennis Ding, Biotech Analyst, Jefferies: So there’s going to be a of a pretrial hearing summary judgmentdelbert motion next week. There you comment on that, or like just what expectations into that?

Mac Glein, CEO, Royvant Sciences: The thing that I am most interested in in that meeting is I hope that that meeting serves to put some additional timelines around the case, including potentially a time I think it almost certainly will come with a timeline for filing summary judgment motions. And I think it very well could, and I hope it does come with a timeline for the trial itself. And look, if we don’t like that timeline, we’ll talk to the judge about it. But I think having a timeline is important at this stage.

Dennis Ding, Biotech Analyst, Jefferies: Yes. Okay. Perfect. Well, thank you so much, Matt, for hanging out with us. Really excited about the path forward here.

It’s great to see you.

Mac Glein, CEO, Royvant Sciences: Thank you very much for having me. Appreciate it. Thank you, everybody.

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