Sam Semenkow, one of the senior biotech analysts here at Citi, and it is my pleasure to be hosting Roivant at Citi's 2026 Biopharma Back to School Summit. I am joined by Richard Pulik, CFO of Roivant. Richard, welcome, and thank you so much for being here. Thank you so much. It is officially, I think, also the first day of school in New York schools, so perfect timing with the conference. Yes, it is. We will go to school today on Roivant. Why do not we just start off high level, Richard? Obviously, you have made a lot of progress on the pipeline, lots of great data that you have shared with us this year, and you have had your first FDA approval for brepocitinib. Maybe just 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 have had an incredible year so far. As we think about Roivant, look, we are approaching $30 billion market cap here. We have $3.9 billion in cash, which does not include the $700 million plus that we received in July on the Moderna settlement. We have now, I would say, with the mosliciguat data that read out a couple of days ago, really affirmed the third leg of the stool into a place where that can be another big pillar for the company, adding to brepocitinib, which you mentioned just had our first approval for LISRAYA, is the drug name in dermatomyositis, which, look, I think if you look at the label, it is pretty incredible in terms of the indication statement, and no restrictions on concomitant use. And then also covering the skin and muscle manifestations and breadth of the disease of the study that we had in the phase III data, which was a disease that's been largely ignored and was the largest DM study that's ever run. To kick off and going into this patient population that was ignored for a long time, I think is a very Roivant move, right? As we formed the company and thought about areas where to go, it was really to think about disease areas where there's high unmet 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 certainly there was either data that was driven by investigators or that we had seen from other JAKs that worked here. Look, it's a very exciting time for brepocitinib. We certainly have three other indications that are late stage there, with NIU reading out this year in a phase III study, and then CS and LPP ongoing. The third leg of the stool is really IMVT-1402, where we also had some exciting data, and I think data that surprised a lot of the investment community, especially in D2T RA. Certainly, nipocalimab paved the way a little bit with an RA, certainly, but in a much earlier population. But we saw that FcRn had activity there. Then we again thought in the Roivant way, where do we go here? Where's the underserved population? That was in patients who are very late line, where JAKs and TNFs have failed, and where we can deliver strong efficacy. We saw very strong efficacy rates there with ACR20, ACR50, and ACR70 and that was period one, and period two is reading out later this year. Then along with we have CLE data, right, which is again another Roivant-type indication where we could potentially be first. Certainly, I think that's a flyer. 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 ulcerative colitis that sort of helped validate this, and we'll see what that looks like. Then we have four other indications with MG and Graves' disease 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. It was a great overview. Lots to dig into. Maybe we do start with the mosliciguat data that you shared earlier this week. Excellent data, clear proof of concept. I think it exceeded the expectations you set for the Street by far, and even the expectations I had in a bull case scenario. 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 PH-ILD. Maybe to back up a little bit. Mosliciguat is an sGC activator that we did this deal with Bayer. We paid, I think roughly $15 million or so was the upfront, and then there is milestone payments under $300 million, and then high single-digit royalties. This is an area where sGC activators have been looked at systemically for quite some time in pulmonary hypertension. Then we showed data about a couple of years ago at ERS that showed the highest PVR reductions we have seen in PAH. PAH was a market that had what? Six or seven therapies, I think, at the time when we showed the data. Lots of breadth of available therapies. mosliciguat was a once-a-day inhaled DPI, and then with a differentiated mechanism, with the long half-life, and we delivered in PH. As we were thinking about where do we want to go, going back to what I said before, to a place that does not have a lot of addressable and really a lot of scientific development. Obviously we have TYVASO, and we saw the great data, and I would say innovation there for PH-ILD patients. We ran the study, and then what happened, and happened a couple of days ago, we saw the highest PVR reductions we have seen in PH-ILD. We surprised people because we did not power for the six-minute walk test, but we delivered with 35, and then this is at week 16, and we saw continued improvement at over 50 placebo-adjusted. If you look at across all of the key measures we had, we saw that they continued to improve. These are very smooth curves where you actually continue to improve after week 16 and as you are dose escalating. On the safety, we had very good safety data. I would say that the prostanoids obviously have cough as an on-target effect. Again, an easy to use once-a-day molecule that has delivered really the best efficacy markers we have seen so far, and even on six-minute walk, which we were powered for. I think that is really opened up a lot of excitement for these patients. That data was presented at ERS a couple of 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 people really have trouble just walking across the small room. The morbidity is very high with a lot of people dying within a couple of years and have a terrible quality of life. To deliver this kind of data is very exciting for the field. Yeah, absolutely. You maybe anticipated some of this in some sense because you started the phase III at risk already, so that is well underway. The only major difference might be just, and correct me if this is wrong, but background treprostinil is permitted here, but you have a phase II combo study ongoing, so you are going to learn a little bit more about that going forward. Could you speak to how that data will inform how you are thinking about how much background treprostinil to enroll? Just overall, if you replicate the phase II data that you have today, would that be more than sufficient for you to take this to FDA and then be quite competitive? I think the answer is probably yes. In the phase III study that is ongoing. Correct. Yeah. Look, I think we did take a flyer here, moving directly into phase III, and I think that is another place where we surprised people. Certainly, we obviously didn't really know the breadth of this data and took a little bit of risk on there. Look, I think the other thing that has been at the core of the company is to really get these patients. 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. In terms of the study, look, I think the titration is a little bit faster. It also allows treprostinil as we have another study that is ongoing that you mentioned, which is pretty small. That was really driven for safety, so that will help us inform the cap we want to have there on treprostinil use. I think one consideration, there is obviously, given TYVASO not approved ex-U.S., that certainly is something we need to think through as well as we are thinking about that. But it will help us as we go to the FDA here to help validate the phase III thinking. 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 have seen in PH, that could be used on top of other therapies, that can be potentially additive. We will see what that looks like on the combo. Then this could be one of those diseases that is treated multifactorially. When we think beyond PH-ILD into expansion opportunities, you mentioned a few of the obvious ones that are on the table for you. Maybe just talk about those and how you are thinking about prioritizing what the next indications for mosliciguat are. How many can you maybe go forward with at once to maximize this opportunity, or is it more 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 really delivered the best PVR reductions we have seen across Pulmonary Hypertension, 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 are certain subtypes of patients here that could help us inform where we want to go. But look, I think with the data that came out a couple of days ago, I think this has really, like I said, created and firmed up the leg of the stool here, and it is really all hands on deck now to think very broadly about developing this, just like we did with brepocitinib and with IMVT-1402. I would say the beauty of our setup is that we really think, given the man structure, we can really move quickly here and do this in multiple ways. Of course, right now we are going to go to FDA, we are going to talk about the PH-ILD data and really push that forward. I think simultaneously, the team will be doing quite a lot of work to think through where does it make most sense and where can we make the biggest impact on patients across some of these other disease areas, across Pulmonary Hypertension. The great data has created a lot more work for you. Looking forward to hearing more about that in the future. Maybe just switching over to DM then, and talking about the approval of LISRAYA. Can you speak to any of the early engagement that you're seeing from physicians since the approval? First of all, this is the biggest DM study that we've seen. These patients are treated on very high-dose steroids, and then also IVIG. This is a disease that has muscle and skin involvement. We deliver data across all of these different areas, I think that got physicians excited. Then we have, like I said, captured a lot of that data on label. Certainly, we anticipated a black box given it's a JAK, and I think that was always in our hypothesis here. It hasn't really stopped much of the broader indications that JAKs are going after either. Given the severity of the disease, I think that's all, again, very manageable. But I think the physicians are very excited here. The reality check is that we're going into a disease area that's been ignored for a long time. To change behavior, look, there's the sort of ivory tower that we all sit in, and then there's the reality of the physicians and changing behavior. I think that's the work we have to do now. I think we're well set up with LISRAYA My Compass Support. We thought through the dynamics here, and then there's a lot of breadth here for brepocitinib, 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 brepocitinib 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 JAKs, others don't have any, so perhaps there's an off-label JAK switching market, or physicians have even said first-line to us. When you think about what that initial addressable population is in DM, how should we be thinking about that? I would think all of them. You can use it with IVIG. Look, I think the reality is these are kind of younger patients who, if you are on IVIG, you have to go into a fusion center four or five days a week, obviously, in a month. That is a pretty big burden for someone of working age. But look, if they are doing well on that, they can obviously also go on brepocitinib. I would not think about this as exclusively across these different segments. I think the data that we certainly delivered was also, you can think about as first-line in some of the KOL discussions. Also, some of these patients are on off-label JAKs. To have actually real data in hand with the breadth we have, I think we are very well-positioned, and you can think through it across all of those different segments of the market. I think slow and steady has been your guidance for some time now. You reiterated on the approval call. Revenue is really the main metric you are going to provide to The Street. This is perhaps maybe a little unfair, but as we go to 3Q earnings, you have already had some, I think you mentioned some engagement on even day one post-approval. How should we be thinking about that? Is that something that is a couple single-digit million? Or any guidance you could really like, not guidance, any framework you could share? Look, I just think it is so early that, it is what, August 27th, where our call was when we had the approval. Look, it is super early days. I think ultimately you can think about various different, because it is a specialty pharmacy, it is going to be hard to see script date, et cetera, right? This is like a typical rare disease launch. As a CFO, what matters is net revenue ultimately, and I think that just takes quite a bit of time to build 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. Then, given the breadth of data that we have, the revenues will come, and I am confident of that since, given the data set. Even 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. On the side of competition, I think it's picking up in DM. I think people have looked at your success, looked at the market. There's a lot more interest that we're seeing from a range of companies and a range of mechanisms. How should we think about the longer-term opportunity for LISRAYA as the DM market matures with multiple novel therapeutic options, particularly given this is a polypharmacy market currently? I just like to remind people, there were many failures in this disease area. Six or seven of them with very smart, very large, different trials. We are very uniquely positioned here because it's a TYK2/JAK1. When we looked at the data when we did this deal, we had roughly 1,500 patients of data across, and we compared that to different JAKs alone or TYK2s alone and outperformed across all of those different data sets. This is for a much broader disease, right? But there is 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, sGC activator, sGC stimulator, there's sort of stories we say to try to think through, but the data that really matters is the patient data. 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. Also given our mechanism, and it's a once-a-day oral. So being able to really replace. Most of these patients are really on high steroids. That's sort of 70%, I think, of the market. So switching those patients and getting them off of a pretty bad. 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 phase III, although we have some IMVT-1402 data to talk about as well. But the unmet need is clear in NIU. But can you just talk overall how you're thinking about that market opportunity? Non-infectious uveitis, that is one of the leading causes of blindness in the U.S. Again, you have steroids, and then you have HUMIRA. We had a phase II data set, fairly small, that was not placebo-controlled, where we saw compelling data not just on this multifactorial time to failure endpoint, but also on edema, resolution of edema, and also keeping patients from getting edema and resolving it. That was. We have not seen really across any of the available therapies. These are also, if you think about the HUMIRA patient pool, that is probably 50,000 at this point. So delivering a once-a-day oral with such strong data, I think is very compelling. The reality is the phase III, it is placebo control. We know in these studies that placebo is always difficult. As we designed the study and thought about the mandatory steroid taper, which again, we had in the phase II study, right, where it was much faster than HUMIRA. 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 brepocitinib arms. Look, this is a commercial opportunity that is, I would say, even larger than DM. So it is very exciting for us, and we will see the data in short order this year. Looking forward to it. I have a pricing question for you. You have set the price for LISRAYA, and as we think about the upcoming phase III NIU data potentially being positive and pricing in that setting, particularly because the brepocitinib dose that you are testing is higher for NIU, it is about 45 mg versus 30 mg, which is on label for LISRAYA. So how should we think about 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 provide some framework there? Look, I think the first thing is what do you deliver to these patients, right? So once we see the data, and if we can deliver what we saw, then that will help command price. Then certainly because the DM indication is 30 mg, there is some flexibility there potentially, right, since that would be a 45 mg dose. Look, once the data reads out and if it is positive, we will have a lot of feedback on the current price, and we can think through those dynamics. There is certainly flexibility then to do what is right given the data set and where we land. Then, of course, we have the CS and LPP indications as well as we are thinking through that, which are also at 45 mg dose. Which is a good segue. Maybe let's talk about those. You are running pivotal trials in both, and I think these get less airtime, perhaps because there is not any more data from either of them this year. Maybe just walk through both diseases, how they fit into your broader dermatology franchise that you are building for brepocitinib, 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 we quickly were able to then enroll and start this phase III study. That patient population is sort of similar size to the 350,000. Then LPP is maybe twice that size. There is really no approved therapies. It can be very disfiguring. Particularly drives hair loss and pretty terrible disfiguration on the scalp. So this is a disease area where there really is not much, and so we have another phase III there. But look, I think both very exciting in terms of the potential and then the unmet need. Then of course, given the data we delivered in CS, I think a lot of excitement there. With LPP, we did have a little bit of data as well that we showed for, I think it was less than 40 patients roughly, that also helped validate the phase III study and that I think has gotten investigators excited. So there is certainly some meat there to go off of as well. But when we are said and done and assuming all these indications come through, I mean, brepocitinib could be addressing roughly over 250,000 patients in the U.S. in areas where there is really no real treatment options, and there has not been a lot innovative treatment options. And there really is an availability of this type of once-a-day oral therapy. When you think about your strategy for indication selection for brepocitinib going forward, should we expect that the dermatology franchise continues to be something that you are considering expanding, or could we see you branch out into other therapeutic spaces, kind of like you have done for NIU? You have a plethora of options here, I imagine. Yeah, look, I think number one is scientific, right? Given the uniqueness of the molecule, where can the science go that differentiates? I think these are multi-factor diseases where you have cutaneous sarcoidosis, pulmonary sarcoidosis, you have overlap with a lot of different diseases. So you have skin and muscle manifestations, I think you really have to think about this as where is the science and where does that make sense? Where is the patient need? Then where can we make a big difference? 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 do patients need us to go? Yeah. Fair enough. Maybe we spend a little bit of time on IMVT-1402 as well. We're expecting that rheumatoid arthritis Period 2 data, I think 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. What are the potential scenarios we should be considering on the path forward for RA towards the end of the year when we see that data? So look, I think the data that we had in Period 1 was surprising to people, right, given the ACR70, ACR50, and ACR20 response rates we had. In the Period 2 portion of the study, the real question is can you get patients down in a 12-week period really make a meaningful impact on ACR20 when you've had such success, right? 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 JAKs, TNFs, and we delivered incredible data that really, as you looked at nipocalimab and some of the other things that are out there, the reality is IMVT-1402 degrades IgG to the 80% range, right? All of the other late-stage anti-FcRn in development are in the 60% range. This is the first large data set we've had for IMVT-1402 that's really proven out that IgG hypothesis, that's carved out a These are very sick patients that are pretty desperate, so we'll see what that looks like on Period 2 is, I think, do we hit it or not? I think it's really how do we then incorporate that into a phase III study and talk to the agency about it, and where do we go with it in D2T RA, I think is the real question. Yeah. Absolutely. So, it's likely then phase III, you'll need another study. Is that Yes, I think that should be the- Yeah Best-case assumption here. Then just quickly on CLE, you alluded to this in your opening remarks that it's a competitive space. You want to make sure that this will be a competitive product. Can you help us frame what that bar looks like for what would be competitive versus just 1402 works from a proof of concept perspective? So look, I think when the nipocalimab lupus data came out, I think we got quite a few questions. Okay, 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 fairly small study. We need to really look at the data closely and then understand, is it making an impact? Who are these patients? What kind of efficacy are we seeing? Is the impact meaningful enough to invest behind it? Also to get investigators and patients excited. So I am going to disappoint you and not throw out a percent number for you. Look, I think there is also other CLE trials reading out, right? Around this time or in the next few months. So we will look at that closely and see what makes most patients our patients. Fair enough. Okay. 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 have gone through 2026 and the expectations. Maybe recap what we can expect next year from you as well. So look, I think such a fun time for Roivant, for our patients. I think it is really validated a lot of key areas of our strategy. I think mosliciguat now is now a solid pillar of the stool. Then we are really looking forward to the MG and the Graves' data. We did not even cover Graves', really. This is an area that, again, there has not been innovation for a long time. These patients are very sick. They are not responding to existing therapies, and that will be a very exciting launch for IMVT-1402. Then hopefully on MG as well, we can deliver better efficacy data as we had seen earlier with batoclimab. So look, we will see what that looks like. That will give us our first launches, hopefully, for IMVT-1402. Then we have the other launches behind as we expand on brepocitinib, and I think exciting pieces to announce for mosliciguat as we expand the breadth given the incredible data we had. Then stay tuned as we look through other business development opportunities. But I think that we are in a really unique situation and place. Then from a cash perspective, it is well-funded, and we still have the ongoing litigation on the other LNP trial that goes, and so we will see how that plays out. But we are just in a pretty incredible place here, and we returned a lot of capital to 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. 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. Well, thank you, Richard. This has been wonderful. I really appreciate all of your insights and the time today. Thank you. Thank you, Sam.