Good afternoon and welcome back to our Guggenheim SMid Cap Biotech Conference. I am Delma Caiati , one of the analysts here, and it's my pleasure to introduce the next company, Roivant. And here on stage, we have Richard Pulik, the Chief Financial Officer from the company. Welcome, Richard.
Thanks so much for having me.
Before we go into the Q&A session, why don't you tell us, give us a little bit of an overview of the company and the key milestones that we should expect in the upcoming months?
Great. So we celebrated our 10-year anniversary last year. We have roughly a little bit over $8 billion market cap, over $5 billion in cash. We own over 50% of Immunovant, which is a publicly traded company. And we have a JAK1/TYK2 in the clinic brepocitinib for dermatomyositis and non-infectious uveitis. We're obviously considering other indications there as well. And then we did a deal with Bayer in PH-ILD for mosliciguat. And then we historically have been very acquisitive, obviously, as we generally get our programs from big pharma and have pretty strong relationships across the board with those companies.
Thank you for that. And as you were saying, this is a big year for Immunovant for sure. We have a series of upcoming catalysts this quarter. And before we jump into the specifics of the programs, so I'm thinking about the two key catalysts of this quarter, MG and CIDP. Previously, Immunovant has guided for the MG data to come first, but we don't know if CIDP data will be released at the same time or later. Any update on that? And it would be helpful also to understand your reasoning behind that timeline.
So look, we said the data should come through by the end of March of this year for both studies. In terms of the exact timing, I can't really say specifically, but that's obviously around the corner since today is the 5th of February. And then as soon as the data comes through, we will disclose it as appropriate.
Got it. And let's start from the trial in MG. So this is a program with batoclimab, which is the first asset Immunovant developed in anti-FcRn. But my understanding is that you are not planning to commercialize batoclimab in MG. But this will be an important readout, mainly to somehow set the expectation for the pivotal program of IMVT-1402, which is the next generation anti-FcRn. So how should we frame expectation in that regard? What's your internal bar of success for the MG trial?
Yeah, so obviously, Vyvgart is approved in MG and also CIDP. So minimum bar is always to at least be at where Vyvgart is. We have two different doses in the first period of the MG trial. So you have a 680 and 340 dose. That's for 12 weeks. The idea is really to see if there's an efficacy delta. And if at the 680 dose, which generally is a little bit over 80% IgG suppression, whether we get better efficacy. Look, when we look at other individual patient data from other FcRNs, we've seen those signals. And this is actually a very large, meaningful Phase III study where we can finally address that question. And of course, we've developed SubQ from the beginning with a standard autoinjector. So there's a convenience factor here as well based on what's available in the market.
That makes sense, and thinking about the two assets, when you consider the PK/PD of the asset, the pharmacological properties, is there any expectation that 1402 can even show superior efficacy than batoclimab, or would be in line according to what we know so far?
Yeah, we would anticipate similar efficacy. I think given in 1402, we didn't see any impact on albumin or LDL. You can stay on the higher dose longer since the batoclimab trials were designed so that you dose reduce to the 340 dose given the LDL liability, so as the data emerges and we think about how long we keep patients on the high dose, then that certainly could tease out some more efficacy. When we designed the Graves' study, you can see that's actually at the 600 mg dose, and that's the only dose in that study, and we keep patients on that high dose throughout because of the safety, much better safety profile we've seen in the second generation of the lead asset, the 1402 antibody, but otherwise, I think that's being able to do the maintenance therapy at the high dose could drive better efficacy.
Got it. And in terms of how we are going to design the pivotal trial for 1402, can we expect the same trial design as this Phase III? And when are you planning to start that trial?
So we've said that we anticipate to start that as soon as that reads out. Obviously, given the breadth of that data set, let's look at it and see if we'd want to make some tweaks there. But I largely expect that to be similar. And then we can obviously reflect on it and see whether we want to do something different there.
Got it. And so just to sum up the MG readout, how are you seeing the commercial positioning of the asset? Let's say you show similar efficacy as Vyvgart, that I guess is your expectation. And how do you see navigating the commercial landscape?
Yeah, so look, I think there's a couple of different scenarios here. At the low dose, we have similar IgG suppression to Vyvgart. So that should translate to similar efficacy. I think the opportunity is really at the high dose where we could potentially show better efficacy. And that certainly would create a best-in-class profile and also the most convenient profile given the SubQ. So that would really be the opportunity to come up with a best-in-class product.
Yeah, I see. OK, so moving to the CIDP program. Here, it's even more complicated to benchmark possible outcomes. We like to compare and try to analyze. But there is an issue. You have adopted a few changes in your trial design compared to Vyvgart. So can you summarize for us those changes, these differences? And how do you expect those differences to affect possible efficacy outcome there?
Yeah, look, it's a heterogeneous disease, and so I think when Argenx first had that data, I think Argenx market cap went up by $10 billion. Pretty remarkable. The launch has been going very well. We have four different cohorts in that trial. There's a washout period, and a lot of it is driven by sort of steroid use and also IVIG and sort of prior therapy and following that through. We'll look at all of those different cohorts pretty closely as we think about designing the 1402 study. Obviously, this is also around the corner, so we can look at that and think through how we can win in that indication as well and be best in class.
Makes sense. And just logistically, so I guess you're having already patients from part one of the trial moving into part two. And this is with batoclimab. As you close, let's say, the batoclimab program, will you show data also from the patients that are already enrolled in part two? Or how are you thinking about that? Or will you just close the trial?
So we've said that the CIDP really would be focused on the Phase I data by March.
Like thinking ahead.
Yeah. And then we can certainly think about what we want to do with the later period and when we show that. And how we approach it. But right now, the commitment is to show the period one data by March.
I guess it depends also how it turns out. Makes sense and how are you thinking about the trial design for the pivotal program? I guess it will depend on the data you get, but we were discussing with Pete about the possibility of removing the withdrawal period, doing some adjustment like the washout. Have you considered?
Yeah, I mean, look, I think Argenx. It's a pretty long washout period. That is always stressful for patients, and we stretched the trial a little bit for that given the dropout. Argenx had the same issue, so I think it's something we always have to think about as we design what's best for patients and have to be attuned to, sensitive to what happens there. Certainly, you can just make a bigger trial and correct for that, but that is something to think through as a potential change.
OK, got it, and Vyvgart had a stellar launch in CIDP, which clearly shows that despite having IVIG approved in this indication, there is an unmet need, but you have also new competitors coming up, like from complement, you have Sanofi and Argenx that are emerging. How are you thinking about positioning of another anti-FcRn in the CIDP space?
So first, it's potentially best in class given the IgG suppression. I think the first question we want to sort of think through is, in this disease, does better IgG suppression for longer matter and drive better efficacy? And so then you have an opportunity to be best in class, at least in the FcRns. I think, look, at the same time, we're going to be first and best in class in Graves. We were the first to also start the TED study. And that's a Phase III that's reading out for batoclimab in the second half of this year. For rheumatoid arthritis, difficult to treat, we have a unique study design and a unique study population compared to what others are doing. And again, you have the autoinjector, which I think is going to be important for the breadth of patients.
So I think there's a mixture of indications here where we're clearly being first and where we'll soon get answers whether we may be best on the CIDP side, for example. Look, we get a lot of questions about other mechanisms that are coming through, either from the degraders side, et cetera. Look, I want to be humble there. And some of those are early. I think some exciting and interesting approaches, but we haven't seen a lot of clinical data yet. So let's see how that comes through.
Got it. And you were mentioning Graves'. Graves' data there from the Phase II. And there will be an update also this summer. What can we expect from that new data set?
Yeah, so I think we're looking at six-month treatment-free remission. So essentially seeing what happens, how well controlled the disease is once you go off the drug, which will be another very exciting thing for these patients.
Got it. OK, and related to Graves, there is the possibility of expanding that study, including TED. That's something that Immunovant has been discussing about. What's your bar for doing that? You have the readout in the second half with the two TED studies. So what are you expecting to see even if you are not continuing the batoclimab program there? And how will you integrate a possible sub-study with TED inside the Graves program?
Yeah, so the first Phase III study is up and running, and there's two studies there. There's an opportunity here to really think, given the overlap with Graves' and TED, to think about how we include those patients and get sort of a broader label as we design the second study. We haven't released the study design specifically yet, but certainly, you can imagine that's something we're thinking through and how we could sort of elegantly include with 1402 also some of that TED subset. Obviously, we'll see what the Phase III batoclimab data looks like. That's a viable study in the second half, and can make a decision on that separately as that data emerges.
OK, got it. OK, so before moving to the other programs, one last question on Immunovant. So to sum up, there are five INDs that have been cleared. I guess Immunovant will disclose also soon the fifth new indication. How are you thinking about priorities among these different indications? You have array programs that we didn't discuss, but it's also a huge opportunity there. By Roivant's point of view, what are the priorities there?
So look, I think we have a very high bar for investment. You saw that right before JPMorgan, we invested $450 million with two other investors, Intermune Event at $20. We're very closely aligned, and I think these studies really are not that we said we'll start 10 studies by March of 2026. Usually, they're placebo-controlled, so we're not talking huge amounts of dollars, but it's still 10 studies, and we look at those indications all very closely, and I think we're excited that where we're not first, we can still potentially win on efficacy, so very happy to support those studies, and then places where certainly, there's a lot of other FcRNs, so we're, of course, watching closely. There's a lot to learn from other programs and data to think about how we can be better, so there's some POC reading out as well.
I just want to poke there a little bit more because we receive this question a lot from investors. If you can rank in your priority list, where would you put MG and CIDP?
So look, I think Graves in my mind, look, when I just look at the number of patients who are not controlled on ATDs, the prevalence there is over 300,000. There hasn't been really. There's been no real development for these patients for decades. I think that's a, and also given the overlap with TED, that's just such a large market opportunity. No one's gone there. That I thought was a very unique. We obviously developed a proof of concept there. We showed pretty incredible data across the two different doses. I find that very exciting. I think it's very much underappreciated. Look, in TED itself, we did a show. We showed almost doubling of response rates with batoclimab as we went to the high dose. Again, there's a clear comp here that's sort of approaching multi-blockbuster. That has its own limitations.
A lot of patients end up not responding after six months. I was quite excited about that as well. Depending on where we land with MG and CIDP, I can provide more excitement based on what that data looks like. We have pretty validated data that we see on an individual patient basis, at least for MG, that shows this should behave in a similar way to some of the indications I talked about where we could get best efficacy as well.
Got it, and another question is, at which point Roivant will bring completely new Immunovant asset? How are you thinking about that possible strategy?
So look, we like the setup that we have currently. Obviously, with the recent raise, we participated super pro rata. So we increased our ownership stake a little bit. We thought it was a great price. But I do. Look, there's a broad development plan here. And so I like having the current setup where other investors help support this R&D plan. And then obviously, the more success you get, you have to also then think about launch costs and supporting DTC. So I think the current setup makes a lot of sense for us. And very happy with that. If the market doesn't support it, certainly we can continue to increase our share.
OK, thank you for that. And moving to Brepo program.
Can I ask for a very quick clarification before we move on?
Sure.
So the upcoming readout, gMG, that's batoclimab. Is the same also for CIDP? Is it also batoclimab? Is that for?
Yes, yes, it is. It's the first generation. So it's batoclimab.
I guess moving to Brepo, this will offer you the opportunity to have the first commercial product this year if successful. First of all.
Data for the first commercial product.
Yes, and then.
This year.
Of course, yes. And so first, what are your expectations from that readout in the second half of this year? And we will discuss about commercial opportunity after that.
So look, this is a JAK1/TYK2. This is a very severe disease. We know that the skin is implicated. A lot of these patients have rashes all over their body. It's multi-organ. It has high morbidity. And we've also seen data from JAKs here in multiple studies that shows efficacy from obviously, none of them are approved. But that got us very comfortable to move into a Phase III study. And we're well ahead of other mechanisms here, so at least one to two years and as an oral. So I think that will be quite exciting. I mean, it's almost 50,000 patients, rare disease. Obviously, that'll help us with the price point as well and high morbidity. And that data will be coming out in the second half. So assuming that goes well, we can have a launch here in 2026.
Got it. And have you started already launch preparations?
You can imagine we're thinking about that, of course.
OK, got it, and so yeah, and what is interesting about brepocitinib is also the breadth of opportunities that you have because, as you said, it's a risk mechanism, so you can move into many indications. Are you considering any specific indication so far, and when are you planning to disclose that?
Very similar with almost the thinking very similar to the thinking we had with FcRn is we'll typically think through an indication and then do a POC study. For non-infectious uveitis, we had some data at the beginning of last year that showed Humira has obviously improved in the class. I think there's roughly in the U.S. 30,000 patients or so on that. Our data was if you look at edema and all of sort of the critical signs that could potentially lead to blindness. I mean, this leads to blindness in a large number of Americans. We had response rates that were sort of three times better than Humira. It's oral. Pretty incredible that obviously then we had maintenance data one year out. Again, this was very consistent. Of course, we immediately moved to a Phase III.
That'll be reading out in 2026. You have this cadence of you have DM, then you have NIU. Then you can imagine we're also thinking about other diseases, sort of orphan rare diseases that would have a similar profile for POC studies.
Got it. So in these last few minutes we have, I would like to make sure to check about your plan for business development. It's another of the recurring questions we get. You have a very strong balance sheet over $5 billion. And how are you thinking about to cash deployment? Any change in your previous strategy you have discussed before? Anything, any color you can provide there?
Yeah, so maybe just very briefly, we did a deal with Bayer on mosliciguat. So we're running a Phase II study there for PH-ILD. We had some of the best PVR data we've seen in PAH. So again, we want to validate that in PH-ILD. There's obviously one approved drug there, which is doing very well. And stay tuned to that as that enrolls and reads out. Look, even though we have over $5 billion of cash, we think it's really important to continue to have the same standards across these deals. And so J.P. Morgan was obviously very busy. And we engaged with a lot of companies. But generally, we kind of think about doing one to two deals per year. And so there's a lot of exciting stuff out there. And stay tuned.
So you're not targeting any specific type of asset or in any indication? What's your current thinking for that?
Yeah, look, I think the beauty about Roivant is we're agnostic here. So it really depends on the data. Generally, we look at things that have data. So we're not taking very meaningful biologic risk, and then we don't want to really go immediately into Phase III. We usually end up doing a small Phase II, and if that doesn't work, then it's not a ton of spend, right? Because Phase II, roughly $50 million or so, and then upfront is historically has been sort of $40 million for us. So you can kind of do this again and again, but look, it obviously takes a lot of time, and you have to go to the agency as we think through this. So the capacity is really sort of like one to two.
Got it. Makes sense. OK, thank you so much, Richard, for all the updates. And we'll stay tuned.
Great. Thank you so much.