Roivant Sciences Ltd. (ROIV) September 10, 2026 Conference Transcript

Sam Semenko, one of the senior biotech analysts here at Citi, and it is my pleasure to be hosting Roy Vant at Citi's 2026 Biopharma Back to School Summit. I'm joined by Richard Paluk, CFO of Roy Vant. Richard, welcome and thank you so much for being here.

Thank you so much. And it's officially, I think, also the first day of school in York School, so perfect timing with the conference.

Yes, it is. It is. And we will go to school today on Roy Vant. So why don't we just start off a high, high level, Richard? Yeah, obviously you've made a lot of progress on the pipeline, lots of great data that you shared with us this year, and you've had your first FDA approval for brepacitinib. Maybe just, you know, level set, all of that, and what we can expect throughout the rest of the year, where Roivant stands and where Roivant aims to be in the next several years.

Look, we've had an incredible year so far. As we think about Roivant, look, we're approaching 30 billion market cap here we have 3.9 billion in cash which doesn't include the 700 plus that we received in july on the moderna settlement and um we have now i would say with the mosley data that read out a couple days ago really affirmed the third leg of the stool um into a place where that can be another big pillar for the company adding to brepositinib, which you mentioned just had our first approval for Lysriah is the drug name, and dermatomyositis, which, look, I think if you look at the label, it's pretty incredible in terms of the indication statement, and, you know, no restrictions on concomitant use, and then also covering the skin and muscle manifestations and breath of the disease of the study that we had in the phase three data, which was, you know, a disease that's been largely ignored, and it was the largest DM study, the Severan, and so to kick off and going into this patient population that's ignored for a long time, I think, is a very roidant move, right? We, as we formed the company and thought about areas where to go, it was really to think about disease areas where there's high limit need that have been ignored for a long time that are severe in scope and also where we had a bit of validation right where where certainly there was either data that was driven by investigators or that we had seen from other jacks that worked here so look it's very exciting time for brepo we certainly have three other indications that are late stage there um with niu reading out this year and a phase three study and then uh cs and lpp ongoing and then the third leg of the stool is really immune event 1402 where we also had some exciting data and i think data that surprised a lot of the investment community especially in difficulty to ra uh certainly uh you know nipo paved the way a little bit with uh in ra certainly but in a much earlier population but we saw that fcrns had activity there and then we again thought in the roi bent way where do we go here where's the underserved population and that was in um patients who are very late line where um you know jacks and tns it failed uh and uh where we can deliver strong efficacy so we saw uh very strong efficacy rates there with um acr 70 50 and 20 and that was period one and period two is reading out later this year and then um along with uh we have cle data right which is again another roevent uh type indication where we could potentially be first. Certainly, I think that's a flyer, right? We're really trying to see if this is an area where we hit a bar that makes sense from a commercial perspective. And I think there's a little bit more competition there. But we had seen a little bit of data in some patients in UC that sort of helped validate this. And we'll see what that looks like. And then we have four other indications with MG and Graves, you know, potential approvable data sets next year and other indications that we can go into. But that's really the third leg of the stool here. Certainly, we're very active as well on BD, given our cash balance and the breadth of resources we have.

That's a great overview. Lots to dig into. So maybe we do start with the Mosley data that you shared earlier this week excellent data clear proof of concept i think it exceeded the expectations you've set for the street by far and and even the expectations i had in like a bull case scenario so maybe just talk a little bit about that data set what the reaction has been from kols in the few days since you presented it at ers and just frame the market opportunity for us for phild so maybe you know to back up a little bit so we uh mosley is an sdc activator that we did this deal with Bayer.

We paid, I think, roughly $15 million or so was the upfront, and then there's milestone payments under $300 million and then high single-digit royalties. This is an area where, look, sgc activators have been looked at systemically for quite some time in pulmonary hypertension and then we showed data about a couple years ago at ers that showed the highest pbr reductions we've seen in ph ph was a market that you know had what six or seven therapies i think at the time when we showed the data so lots of breath available therapies mostly was a once a day inhaled dpi and and then so it doesn't and then with a differentiated mechanism with the long half-life and we delivered in ph then as we were thinking about where do you want to go going back to what i said before um uh to a place that that doesn't have a lot of um addressable and really a lot of scientific uh development uh is right you obviously we have a tyvaso and we saw um you know the great data and i would say innovation there for phild patients uh and so we ran the study and then what happened and happened a couple days ago we saw the highest pbr reductions we've seen in phild we we surprised people because we look we didn't power for the six minute walk test but we delivered with 35 and then we saw this at week 16 and we saw continued improvement at over 50 placebo adjusted so and and then if you look at across all of the key measures we had we saw that they continue to improve um so these are very smooth curves where you actually continue to improve after week 16 and as your dose escalating and then uh on the safety uh right we had a very good safety data no um uh you know i would say that the prostitutes obviously have cough um is an on target effect so um again an easy to use once a day molecule that has delivered really the best efficacy markers we've seen so far and even on six minute walk which is when which we were powered for so i think that's really um opened up a lot of excitement for these patients and then that data was presented at ERS a couple days ago on short notice I think the room as I was told was very full there was a lot of excitement from KOLs and this is a really severe disease where you know people really have trouble just walking across the small room um the you know the uh the the morbidity is is very high with a lot of people um you know dying within a couple of years and uh and have a terrible quality of life so this is to deliver this kind of data is very exciting for the field yeah absolutely and and you you know maybe anticipated some of this in some sense because you started the phase three at risk already so is well underway um the only major difference you know might be just and correct me if it's wrong

but background um is permitted here and but you have a phase two combo study ongoing so you're going to learn a little bit more about that um in the coming um you know going forward so i could you speak to you know how that data will inform how you're thinking about you know how much background to personal to um enroll and just overall you know if you replicate the phase two data that you have today would that be you know more than sufficient for you to you know take this to fda and then be quite competitive i think the answer is probably yes so uh in in the phase three study that's ongoing yeah uh so look i think uh we we did take a flyer here right moving directly into

phase three and i think that's another place where we surprise people um certainly we obviously didn't really know the breadth of this data and, you know, took a little bit of risk on there. But look, I think the other thing that's been at the core of the company is to really get to get like, look, we knew the pH data, we knew how powerful and how unique this drug was, and to be able to get this out to patients quickly, that seemed like a risk that we should be taking and um and then in terms of the study uh look i think uh the the titration is a little bit faster uh it also allows um to personal as as we're you know we have another study that's ongoing uh that you mentioned which is pretty small that was really driven for safety so that'll kind of help us inform um the cap we want to have there on uh to possibly use i think one consideration There's obviously, you know, given Tavasa not approved XUS, that certainly is something we need to think through as well as we're thinking about that. But it'll help us as we go to the FDA here to help validate the phase three thinking. And then also, look, as you see the data, you see this data on top of other therapies, right? So this is an indication, just like we've seen in pH, that could be used on top of other therapies. It can be potentially additive. We'll see what that looks like on the combo. And then, you know, this could be one of those diseases that's treated multifactorily.

And then when we think beyond pH-ILD into expansion opportunities, You know, you mentioned a few of the obvious ones that are on the table for you, but maybe just, you know, talk about those and how you're thinking about prioritizing what the next indications for Mosley are. How many can you maybe go forward with at once to maximize this opportunity, or is it more, you know, one at a time as you triage through them?

Look, I think certainly what I said is in our initial thinking, we thought pH was potentially too competitive, but we now really have proven with this data set that we have developed, you know, really delivered the best PBR reductions we've seen across, you know, pulmonary hypertension. mention, and maybe that gets us back to thinking around whether we go there. I also think as we look at these data a little bit more fully, there's certain subtypes of patients here that can help us inform where we want to go. But look, I think the data came out a couple days ago. I think this is really, like I said, created and firmed up the leg of the stool here. And it's really all hands on deck now to think very broadly about developing this just like we did with Brepo and with, you know, 1402. And I would say the beauty of our setup is that we really think, you know, given the man structure, we can really move quickly here and and do this in multiple ways of course right now the the the you know we're gonna go to FDA we're gonna talk about the page all the data and really push that forward and I think simultaneously the team will be doing quite a lot of work to think through where does it makes most sense and working with a big sim back on patients across some of these other disease areas across pulmonary hypertension the great data has created a lot more work for you So looking forward to hearing more about that in the future.

Maybe just switching over to DM then and talking about the approval of Lysriah. Maybe, can you speak to any of the early engagement that you're seeing from physicians since the approval?

So, look, I think, so first of all, this is the biggest DM study that we've seen. uh this these patients are treated on very high dose steroids and then also ivig and and this is a disease where that has muscle and skin involvement if i think about uh and so we deliver data across all of these different areas i think that got physicians excited and then we have like I said captured a lot of that data on label certainly we anticipated a black box given it's a jack and I think that's that was always in our hypothesis here and it hasn't really stopped much of the broader indications that jacks are going after either and so given the series of the disease I think that's all again very manageable but I think the physicians are very excited here we you know the reality check is that we're going into disease here that's been ignored for a long time and so to change behavior look there's the there's the sort of ivory tower that we all sit in and then there's the reality of the physicians and changing behavior. And so I think that's the work we have to do now. I think we're well set up with MyCompass. We thought through the dynamics here. And then we have, you know, the real, there's a lot of breadth here for BREPO. So it's sort of a long haul to make sure that we're maximizing the value across these other indications as well. But look, I think there's a lot of excitement from patients and also physicians. but certainly we think this will be a slow and steady launch as we really develop this molecule broadly.

Maybe we can dive a little deeper on the breadth of where Brevo can be used. We've heard physicians say they're excited to switch their patients off IVIG if they're not fully controlled. Some physicians are heavily using off-label jacks, others don't have any, so perhaps there's an off-label jack switching market. Or physicians have even said first line to us. So, you know, when you think about, you know, what that initial addressable population is in DM, like how, how should we be thinking about that?

I would think all of the, I mean, you can use it with IVHG. I mean, so if you, so look, I think the reality is these are, you know, kind of younger patients who, you know, if you're an IVHG, you have to go in a fusion center four or five days a week uh obviously uh in a month that's that's a pretty big burden uh for someone of working age and um uh but look if they're doing well on that they can go obviously obviously also go on brepo so i think that there is a um i would not think about this as exclusively uh you know across these different segments i think the data that we certainly delivered was also, you know, you can think about his first line in some of the KOL discussions. Also, some of these patients are on off-label jacks. So to have actually real data in hand with the breadth we have, I think we're very well positioned, and you can think through it across all of those different segments of the market.

And I think slow and steady has been, you know, your guidance for some time now. You reiterated on the approval call. um and and revenue is really the metric main metric you're going to to provide to the street um this is perhaps maybe a little unfair but you know as we go to 3q earnings um you know you've already had some i think you mentioned like some engagement on on even day one uh post approval what is how should we be thinking about that you know like is that something that's like a couple single digits million like or any guidance you can really like not guidance any framework you could share look i just think it's so early that um and i mean you know i'm not this is not to sort of it's it's what august 27th very call was when we had the approval so uh uh look it's super early

days um i think like ultimately you can think about various different because it's especially pharmacy it's going to be hard to sort of see scripted etc right i mean this is this is like a typical rare disease launch and so it you know as a CFO what matters is net revenue ultimately and I think that just takes quite a bit of time to build and and do well especially as we focus on making sure we get the medicine to patients we have the bridge program in place and we have a good patient and physician experience here and then given the breadth of data that we have the revenues will come and I'm confident of that since given the data set and then even you know as potential competition comes that really helps with new approved therapies and awareness for the disease to get these patients on much better drugs.

Got it and on the side of competition you know I think it's picking up in indium I think people have looked at your success looked at the market you know there's a lot more interest that we're seeing from a range of companies and a range of mechanisms. You know, how should we think about the longer term opportunity for Lysraya as the DM market, you know, matures with multiple novel therapeutic options, particularly given this is a polypharmacy market currently?

So, you know, I just like to remind people there were many failures in this disease area, six or seven of them with, you know, very smart, very large uh different trials and uh we are very uniquely positioned here because it's the tick to jack one uh when we looked at the data when we um did this deal we had roughly 1500 dissipations of data across and we compared that to to different jacks alone or tick twos alone and outperformed across all of those different data sets i mean this is for for um this is for a much broader disease right? But there's a unique mechanism here where we're first, and then we also have the data in hand. Look, I think as you're thinking about where you go, and as you're thinking about mechanisms, I mean, SGC activator, SGC stimulator, you know, there's a sort of stories we say to try to think through, but the data that really matters is the patient data. And given that this is the largest DM study we've had, and the breadth of data and endpoints, I think we're very firmly positioned here. And also, given our mechanism, and it's a once-a-day oral. So, you know, being able to really replace, most of these patients are really on high steroids. I mean, that's sort of 70%, I think, of the market. And so switching those patients and getting them off of a pretty bad, you know, being on these high steroids is pretty bad, not just from a lifestyle perspective, but also from a side effect profile perspective, as we had seen in the DM data. So I think we're very firmly positioned, and it'll be great to have other mechanisms come here to help these patients.

Absolutely. Maybe we switch gears a bit and talk about NIU as well, because this is the next major data set for you before the end of the year in terms of like phase three, although we have some 1402 data to talk about as well. But I mean, the unmet need is clear in NIU, but can you just talk overall how you're thinking about that market opportunity?

So non-infectious UBI, that's one of the leading causes of blinders in the U.S. there is again you have steroids and then you have Humira we had a phase two data set fairly small that was not placebo controlled where we saw you know compelling data not just on sort of this multifactorial, you know, time to failure endpoint, but also on edema, resolution of edema, and also keeping patients from getting edema and resolving it. That was, we haven't seen really across any of the available therapies. These are also, if you think about the Humira patient pool, that's probably 50,000 at this point. So delivering a once-a-day oral with such strong data, I think it's very compelling. You know, the reality is the phase three, it's placebo control. We know in these studies that, you know, placebo is always difficult. But as we designed the study and thought about the mandatory stereotaper, which, again, we had in the phase two study, right, where it was much faster than Humira. And then we also think about the endpoint, which is essentially time-to-treatment failure over quite a long time. That should also ultimately show up on the placebo versus the Brepo arms.

But look, this is a commercial opportunity that's, I would say, even larger than DM. so it's very exciting for us and we'll see the data in short order this year I have a pricing question for you you've set the price for LIS RIA and as we think about the upcoming phase 3 NIU data potentially be positive and you know pricing in that setting particularly because the represent of dose that you're testing is higher for NIU it's about 45 milligrams versus 30 which is on label for LIS RIA so how should we think about you know pricing Is it going to be higher from a WAC perspective, or how should we think about net pricing to the extent that you can, you know, provide some framework there?

Look, I think the first thing is what do you deliver to these patients, right? And so once we see the data and if we can deliver what we saw, then that will help command price. And then certainly because the DM indication is 30, there's some flexibility there potentially, right, since that would be a 45 mg dose. But look, we have, once the data reads out, and if it's positive, we'll have a lot of feedback on the current price, and we can think through those dynamics, but there's certainly flexibility then to do what's right, given the data set and where we land. And then, of course, we have the CS and LPP indications as well, as we're thinking through that, which are also at 45 milligram dose.

Which is a good segue. Maybe let's talk about those. You're running pivotal trials in both, and I think these get less airtime, perhaps, because there's not any more data from either of them this year. But maybe just walk through both diseases, how they fit into your broader dermatology franchise that you're building for brepacitinib, and just a little bit on the opportunity for both there.

So, look, we delivered very compelling data with CS that I think got a lot of excitement where, you know, where we quickly were able to enroll and start this phase three study. That patient population is sort of similar size to the MRT50,000, and then, you know, LPP is maybe twice that size. there's really no approved therapies it can be very disfiguring particularly you know drives hair loss and and and pretty terrible disfiguration on the scalp so this is this is a disease area where there really isn't much and um and so we have another phase three there uh but look i think both very exciting in terms of um the potential and then on the ultimate need uh and then all of course given the data we delivered in cs um i think a lot of excitement there with lpp we did have a little bit of data as well that we showed um for i think it was less than 40 patients roughly that also helped validate the phase three study and that I think has gotten investigators excited. So there's certainly some meat there to go off of as well. But, you know, these are, you know, when we're set and done and assuming all these indications come through, I mean, BREPO could be addressing roughly over 250,000 patients in the U.S. in areas where there's really no real treatment options there has met a lot of um a lot you know innovative treatment options uh and there really isn't the ability of um of this type of once a day oral therapy and when you think about your strategy for indication selection for represent going forward i mean should we expect that the dermatology franchise continues to be something that that you're considering expanding or could we see

you branch out into other therapeutic spaces spaces kind of like you've done for niu i mean and you have a plethora of options here, I imagine.

Yeah, look, I think number one is scientific, right? Where does, given the uniqueness of the molecule, where can the science go that differentiates? And I think, you know, these are multi-factor diseases where, you know, you have cutaneous sarcoidosis, pulmonary sarcoidosis, like that, you know, you have overlap with a lot of different diseases. areas so uh you know you have skin and muscle manifestations and so i think you really have to think about this as where is where's the science uh and where does that make sense where's the patient need uh and then uh where can we make a big difference i think there are i think given the data we have i think there's a lot of interesting areas where you can go, so stay tuned. But I wouldn't necessarily think about, oh, well, because we have derm data, we need to stick to derm. I think it's where's the need and where the patients need us to go.

Yeah, fair enough. Maybe we spend a little bit of time on 1402 as well. We're expecting that rheumatoid arthritis period 2 data, and I think, you know, you've guided to ideally wanting to share a bit of a more comprehensive update, which includes the period 2 data and perhaps some regulatory feedback if possible you know what are the potential scenarios we should be considering on the path forward for RA you know towards the end of the year when we see that data so look I think the data that we had in period one was surprising to people right given given the, you know, ACR 70, 50, and 20 response rates we had, in the period two portion of the study,

the real question is, can you get patients down to, in a 12-week period, really make a meaningful impact on ACR 20 when you've had such success, right? And so I think that will be answered soon. We said that's coming out this year. We'll go to the agency with that. I think what we have answered is that we have found a niche here in rheumatoid arthritis for patients where nothing worked, right, that were on JAX, TNFs, and we delivered incredible data that really, you know, as you looked at NIPO and some of the other things that are out there, like, you know, the reality is IMVT-14-02 degrades IgG to the 80% range, right? All of the other late-stage NTF-sirens and development are in the 60% range. And so we, this, I think, you know, this is the first data set, large data set we've had for IMVT-14-02 that's really proven out that IgG hypothesis that's carved out a, you know, these are very sick patients that are pretty desperate. And so we'll see what that looks like on period two is, you know, I think, do we hit it or not? I think it's really, how do we then incorporate that into a phase three study and talk to the agency about it? And where do we go with it?

And D2TRA, I think is the real question absolutely so i mean it's likely then phase three you'll need another study is that's yes i think i think that should be the base case of some basic assumption here and then just you know quickly on cle you alluded to this in your opening remarks that it's competitive space you want to make sure that this will be a competitive product you know can you help us frame what that bar looks like for what would be competitive versus just you know 1402 works from a group of concept perspective so look I think we got when the nipple lupus data came out I think we got quite a few questions like well does this have a read on CLE look I think that again

frames that potentially this could work I think the reality is this is a small fairly small study we need to really look at the data closely and then understand is it making an impact like you know who are these patients what kind of efficacy are we seeing and is the impact meaningful enough to to invest behind it and also you know to get investigators and patients excited So I'm going to disappoint you and I'll throw out a percent number for you. But, look, I think there's also other CLE trials reading out, right, around this time or in the next few months. So we'll kind of look at that closely and see what makes most patients for patients.

Fair enough. Well, we are nearly out of time.

So, Richard, I just want to turn it back to you for any closing remarks you have to share and just maybe recap. we've gone through 2026 and the expectations maybe recap what we can expect next year from you as well so uh look i think uh such a fun time for roivand um for our patients uh i think it's really validated a lot of um you know key areas of our strategy i think mostly now has been um uh is now a solid pillar of the stool and um and then we're really looking forward to uh to the mg and the graves data i mean we didn't even cover graves really i mean this is an area that again there hasn't been innovation for a long time uh these patients are very sick um these they're not responding to existing therapies and that'll be a very exciting launch for imet 1402 and then hopefully on MG as well we can deliver better efficacy data as we had seen earlier with BATO. So look we'll see what that looks like that'll give us you know our first launches hopefully for 1402 and then we have the other launches behind as we expand on BRETBO and I I think exciting pieces to announce for Mosey Siguat as we expand the breadth given the incredible data we had and then stay tuned as we look through other business development opportunities. But I think that we're in a really unique situation and place and then from a cash perspective, it's well-funded and we still have the ongoing litigation on the other LNP trial that goes. And so we'll see how that plays out. But we're just in a pretty incredible place here. And we returned a lot of capital shareholders, right? We had, I think at this point, returned over 1.7 billion. A lot of that was returned at $10 a share. And so really created a lot of value. and I think we're going to continue to be very disciplined and very thoughtful about capital allocation and making sure we're making the right choices across the portfolio.

Absolutely. You're in a privileged place where you have more going on than we can fit into 35 minutes. So, well, thank you, Richard. This has been wonderful. I really appreciate all of your insights and the time today. Thank you.

Thank you, Sam.