Roivant Sciences Ltd. (ROIV) Earnings Call Transcript & Summary

Welcome, everybody. We'll kick things off. I'm Doug Tsao, senior analyst at H.C. Wainwright. We are thrilled to have with us Roivant up next, represented by the company's CFO, Richard Pulik. I've known Richard for almost a decade. There was a little break in there from when I knew you at Novartis. So a lot going on at Roivant. And maybe we'll start with the Immunovant business because I think you recently had some additional data in Grave's. And you recently showed an update in terms of remission and durability of the effect, which I think enhanced investors' confidence. I guess maybe just what were some of your takeaways from that incremental data? And in the past, Immunovant was focused on thyroid eye disease and then the company sort of shifted to Grave's because they thought it was a better opportunity. What makes you as a company sort of think that Grave's is a better opportunity, even though others right, like Argenx is still pursuing TED?

So thanks very much, Doug, for having us. Look, I think a very exciting time to be at the conference. Like you said, we did an update last week on Grave's, just to put everything in perspective, this was a disease where we had Phase II data last year that I think Immunovant has really been sort of at the forefront of finding places to go and indications we go to be first-in-class. They had data in TED and we're the first ones to move there from the anti-FcRns. And then as we thought about other places to go, Grave's obviously seemed like a clear place just given the mechanism and the biology. Then we validated that with the Phase II study. And I think the exciting data that you mentioned was where we saw really potential disease-modifying benefit. So patients were on drug at 680 milligrams for 12 weeks and stepped down to 340 milligrams. And then we followed them for 6 months and 80% of those patients were controlled and then 50% of those were controlled off ATDs, which I think is pretty incredible. If you looked at the curves there, it was essentially a flat curve even though you stepped down on the drug. When we thought about the population, there's, what, 330,000 uncontrolled Grave's disease patients that people should keep in mind, these are -- this is a disease that's usually diagnosed for women between the ages 20, 40. They're working age, they're motivated. It is a disease that has significant impact on just your daily living, your moods, your appetite, you have palpitations. So a lot and then a significant impact on additional risk. And so to be uncontrolled here is actually pretty terrible in uncontrolled IDs. There really hasn't been a lot of research in this area for any novel therapy for at least 2 decades. And so this was very exciting for the field. And I think this is going to help with the Phase III studies that we started. We started a Phase III study back in December, where we already started thinking about the potential upside here for disease modification because we had -- we designed it so that you had Group 1, Group 2 and Group 3 and the Group 2 patients actually have the ability for responders to step down to placebo after 24 weeks. So potentially, we'll even have better data, right, because you'll be on the high dose for much longer and maybe there's a potential to get that on label. So I think that's sort of driven a lot of excitement. At the same time, if you recall, we did show data in Grave's where we followed some of the more sort of traditional TED eye symptom measurements. And those were, again, very -- there's a 40% overlap with TED and Grave's. And so we certainly are going to continue to follow those. I think it gives us an opportunity to think about this disease more broadly and earlier, and we're excited about both.

Do you think that there's any opportunity or the potential for you to show the prevention of development of thyroid eye disease?

I think, look, we're certainly looking at some important measurements there in secondary characteristics and the ones we've shown. So certainly, that's something we thought about. And so I think potentially impact on Grave's and TED as well.

The gray space is becoming more competitive, right? It was sort of interesting a few years ago before Immunovant and if you talk to KOLs, that just antithyroid drugs are sort of our mainstay of treatment, a lot of patients respond. Some patients are somewhat intolerable. We've now seen, obviously, Immunovant sort of take a lead to sort of be a bit of a pioneer in Grave's. We're also seeing now Biohaven with their IgG degrader. We've seen Prinetics talk about a TSHR receptor antagonist as well as some other companies with taking sort of different approaches to address the specific autoantibody. So in the scheme of the competitive landscape, especially when we think about maybe a small molecule potentially being having some cost advantages, how do you see the competitive landscape evolving in Grave's?

So look, having been in this industry for over 20 years, I think data is what rules. And we're the only company that has meaningful data for lots of patients that has now started 2 Phase III studies and that is firmly had and has shown potentially disease-modifying benefit and control of ATDs for a lot of patients. All of the -- and look, I think it's awesome that others have finally woken up and are in Grave's. There's a lot of patients here that need our help as an industry. And so I think awesome that others are coming in. I think we're just so firmly ahead here and the profile of IMVT-1402 is -- looks very good from a safety perspective and efficacy perspective that I think will be firmly in place. Look, there's always been an interesting place for orals to. I don't think we've seen any data there yet. So looking forward to seeing them and very much welcoming to have more therapies, just way too early to really speak to that right now.

And one of the other indications where Immunovant has sort of taken a lead or sort of been out in front is in difficult-to-treat rheumatoid arthritis. J&J recently announced that they were discontinuing development of nipocalimab in RA based on what they saw in their Phase IIa study. What gives you confidence that you should continue to see positive results when J&J, obviously, who has sort of invested behind nipocalimab did not see necessarily a compelling opportunity after their initial IIa results?

So look, obviously, we looked at the J&J data closely. And just to remind people, there was -- if you looked at that data set, there was a very clear correlation between IgG lowering and efficacy. We know that 1402 delivers the lowest efficacy benefit, right, where we're lowering IgG to the 80s or high 70s. No one can match that. We know that the dosing that we saw in that study was probably going to the 60s and that they need to have a combination partner. I think that means it's wide open. Look, I still think that the initial hypothesis that lower is better with efficacy stays. There was actually a lot of disclosure in that PR. I think it's just as a doublet. It didn't add anything more. We certainly approached this to go into monotherapy, and we actually looked at different populations, so antibody positive and very late line here. So there is a high unmet need for these patients. This is third or fourth line. Nothing is really working for them. And we know that they're antibody positive. So excited to see that data. We'll see that readout in the first half or not in the first half rather next year is the period 1 of that study and then the following years of the period 2 of that study. So we'll see how that develops. Certainly another place where we can be first and potentially best-in-class knowing what the IgG benefit is that we delivered with 1402.

And then one of the other significant key catalysts for the company will be the Phase III data for brepocitinib and dermatomyositis, the Phase III VALOR study. Can you share your expectations for the data readout? DM is also an area, right, where there wasn't that much activity, but all of a sudden, we started to see a lot more activity, including FcRn as well as cell therapy. How do you see brepo sort of positioned in this market opportunity?

So look, when we did the JAK1/TYK2 deal, we got that drug delivered with 50 patients of data. We saw that brepo ended up beating JAKs or TYK2s alone across all the indications that Pfizer studied. We then also did our own Phase II study in the noninfectious uveitis, and we saw clear activity that was better than standard of care and where we had no edema. So we had essentially in hand, lots of data across multiple diseases that JAK1/TYK2 performs better. And we also have lots of safety data and showed that this is sort of in line with JAKs. When we developed it, we said, let's focus on rare disease indications that -- where there's a high unmet need. For those not familiar with dermatomyositis, a lot of these patients have painful rashes. They have inability to lift their hands above their head. There's muscle involvement. Some of them have trouble signing up. But this is, again, one of those diseases that's been ignored for a long time and where there's a high unmet need. And so we had the last patient last visit in July. When we looked at also some of the other JAKs and there's roughly 600 patients of data where you can see that JAKs have activity in this disease. So I think it's been exciting for us. And when you look at the powering of the study, you essentially need to see end point delta between the 30 mg dose and placebo for success here. So that -- we'll see what that looks like soon. And the other thing that we disclosed is that we had an aggressive sterotypering protocol here. We essentially wanted to get patients below 5 milligrams. We know that at the beginning of the study, there were 1,200 milligrams and we successfully got them down to 2.5 and that 98% of the patients adhere to that protocol. So these patients don't have a lot -- 80% of them are usually -- I mean these are patients that are actively treated, 80% of them on steroids, roughly 20% on IVIg and then some on antimalarials. I think the light just went out here for those who are listening to the audio, but I think we'll sort that out. So look, I think there is -- to be able to deliver for these patients with an oral, I think, is exciting for the field, and we'll see what that looks like in short order.

And then DM is not the only indication you're pursuing. And so just how are you thinking about brepo in the other markets, right, NIU as well as sarcoidosis?

So the other -- like I mentioned, so when we were doing this, we're doing this for rare diseases. And so CS, we essentially have another -- we have a Phase II study reading out next year. So that would be sort of -- if that is positive, there will be another pivotal place to go, we'll see what that looks like. And then the Phase III non-infectious uveitis study that is ongoing, that is going to read out in '27. And that will -- assuming that the DM is positive, that will be sort of reading out as the DM is launching. And that would be -- so there's 3 potential places to go here where we think there's not tons of competition and the high unmet need.