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

Welcome back, everybody. So this is [indiscernible] an analyst here at Guggenheim. And it's my pleasure to introduce to you Roivant company as next -- for our next fireside chat. And it's my pleasure to introduce Richard Pulik, the CFO of the company, who is with us. Welcome, Richard.

So to start, why don't you give us an overview of the company and tell us what are the upcoming milestones that we should be interested and focusing on?

Great. Thanks again for having us and sticking with us for the last panel of the day. Hopefully, you guys stay awake. So look, Roivant is about 10 years old. We IPO-ed roughly 3 years ago. We have about $6 billion in cash. We have multiple late-stage programs in development, largely with a focus on I&I. And we own 55% of Immunovant, which is the anti-FcRn franchise, which you may be familiar with. And then have a JAK1/TYK2 inhibitor called brepocitinib that is underway for -- in a Phase III for dermatomyositis that reads out in the second half of 2025. And we just started a study Phase III in NIU, noninfectious uveitis. And then, of course, our thinking about additional indications for that franchise. At the end of this year, we have a study reading out in sarcoidosis with namilumab, but that's a Phase IIb. And then as you might be aware, we have ongoing litigation around our LNP patents with Moderna and Pfizer. The Markman hearing is scheduled for December for Pfizer. We've already had the Moderna Markman hearing and the trial for that is in September of 2025. That's certainly something that many investors have been focused on. And I'm sure we'll get into some of these pipeline products in a little bit more detail. And you probably also saw that Vtama, we ended up doing -- announcing closing of that deal in October earlier this year.

And that's actually why don't we start from there because that was an interesting deal. And we would like to get your opinion about like what went into the decision of selling Vtama and how are you considering the opportunity overall? Because we considered like the upfront payment seems a little bit lower than our expectations. So how are you thinking about the royalties coming up and the overall opportunity?

Look, I would say, at Roivant, we're constantly thinking about how to prioritize the portfolio about risk and what's the best way to use our capital. Organon is a very strong established partner. They have -- they don't have currently a derm franchise in the U.S. So they essentially took that entire sales force on. They also took on the debt, which was over $300 million. And when we announced the deal, when you looked at my SG&A, that was roughly on a stock-based comp adjusted basis, roughly 50% of my SG&A burn. So very meaningful [indiscernible] write-outs paying for the DTC, the sales force. And as AD was approaching, I would have to pay more there. And look, on the surface of it, the $175 million may be for a product which could be very meaningful for -- in the derm space for psoriasis and AD may seem small, but you have to remember that we received $175 million plus we'll get $175 million, plus we'll get another $75 million upon AD approval, which is now expected in the first quarter of 2025. Plus we have $950 million in milestones that are up to $1 billion in sales. And then if this ends up being a blockbuster, we get 30% royalties. And as we start getting those milestones, we get low to mid-single-digit royalties starting in 2027. So look, obviously, we don't need capital, so this is a great deal to make sure that Organon was comfortable and that we would have a real opportunity on the upside and have a great partner here.

Yes, got it. And since they are taking over the -- for the development of the drug, what's your expectation in terms of cost savings?

So roughly, if you look it by costs and spend on SG&A, it was about 50%. So take out the stock-based comp, roughly 50%, sometimes it's a little bit more, sometimes a little bit less. It would have -- in your models, you probably included a ramp after AD launch. So whatever you included for that. And then if you look at the R&D line, a lot of those Phase III trials were running off. So I think it's like a little bit less than $10 million last quarter, and then you had the MSL savings again, you didn't need MSLs for AD launch. So whatever you build out for that, but again, very meaningful. And plus the debt service went way, right? So you had debt service on $300 million of debt that, of course, left the balance sheet and also left the P&L.

Thank you for all those details. And just curious, was it the competitive bidding, can you give us any color on that?

Yes. Look, I would say, at a deal like this and given where we're landed, you can imagine, it was very competitive. And we really liked Organon, given their partnership and also the fact that we still get a lot of back-end opportunity on Vtama.

Okay. So as you rightfully pointed out, you have a very strong balance sheet. And that is a conversation we have with investors all the time, how are you considering like deploying this cash. So previously, you have disclosed that ideally, you are thinking about 1:1:1 between internal R&D allocation and external licensing and buyback -- cash buyback. Are you still thinking in that direction? Or have you revised your view?

Yes. I would say that's still broadly accurate. Look, we announced a $1.5 billion buyback program at the beginning of the year. You saw that we ended up buying the Sumitomo shares. So that was a little bit under $650 million. So I still have quite a bit of capacity left there. And we're being very opportunistic as the stock price has remained, I would say, pretty anemic to deploy that. At the same time, we have a lot of great things to invest in. Look, when the FcRn, you saw that Immunovant announced last week, they had 5 INDs approved now. They expect 5 more the following year. So by March of 2026, that's -- these are all largely registrational or Phase IIb studies. So that require a lot of capital, and we're very happy to fund that given the IgG suppression we've seen there in 80%, which is unprecedented compared to the competitors, and also a real true subcu. So we've been happily investing behind them there. And then as brepo, as the data reads out, if that's positive, of course, I'm going to go -- we're going to fund the launch of that and to expand that franchise to other indications depending on how that data reads out. Similarly, a sarcoidosis reads out at the end of this year. Look, that certainly is still high risk, given how difficult that disease is. It's only a Phase II trial, but depending on what that looks like, we would be very happy to fund additional Phase III trial, if that makes sense. And then we are -- look, JPMorgan's coming up. So of course, we've been -- we have a road map for -- with the things we like in big pharma that we think are stalled there. And I think we are the only company that has the capital that is pretty much agnostic in terms of indication and is flexible in structure to get deals done and accomplish what big pharma needs and why we've been so successful here.

Got it. So we'll go back later into Immunovant and the other programs and dig more into that. But I would just get more color, if possible, on the possible areas where you're thinking of expanding? Like do you have any preferential type of area or assets that you're looking for? And any budget indication?

So I would say the strength of Roivant is that we haven't put a stake in the ground in terms of the indication. So we've remained open minded. And I think that's pretty much -- our pretty broad and look at everything and are opportunistic. I would say a lot of the deals we've done, typically, if you look at the most recent deal we did with Pulmovant, with Bayer that was a $14 million upfront payment. We then invested little bit in usually a POC trial, so sort of a Phase II trial to validate our hypothesis before going into a larger Phase III. Look, that means there's very little capital at risk. If it doesn't go our way, then we move on and reprioritize in something else. But we can -- with the amount of capital we have, we can do that again and again. And it's the right thing for patients, and it also is a way to really move these assets forward that unfortunately lost support in some of these other companies. But actually have a data package usually that's delivered. The Bayer asset over 100 patients of data across the Phase I studies, really a robust dose ranging and a very strong profile from what we showed in the Phase I studies, which we are happy to talk about later. But that's really been the focus, sort of these smaller trials where we have a unique hypothesis and then we spend behind it and validate. And if it works, we spend more.

Yes, that makes a lot of sense. And looking specifically at Pulmovant. So as you mentioned, the Phase Ib data were very promising. But can you contextualize them in relationship to the competitive landscape? Especially because you are -- so the Phase Ib was in PAH, but then you are thinking of moving into PH for further development. So if you can clarify what's the strategy behind and your view about the commercial opportunity, that would be helpful.

Yes. So we had 30 patients of data, the PVR is 30%. This is with 1 single dose with a simple device. That's the best data we've seen in PAH so far. United therapeutics that has Tyvaso, they had also data in PAH with not quite as robust PVR data and they're approved in PH-ILD, that's been a fantastic product. There's really only Tyvaso right now approved in PH-ILD. This is an indication that impacts almost 200,000 people. It's a very severe disease, higher morbidity. And unfortunately, many of these people have nothing. And so to be able to have a 40-hour half-life, 1 puff drug to address these patients, I think, would be very compelling, which is why we started the Phase II.

Got it. And how translatable are the data in PAH to PH-ILD. What's the risk there?

Look, certainly, it's group -- it's a slightly different disease. So I don't want to downplay that. But look, if you look at the Tyvaso data, you can see that they were successful to translate that. And there's some risk around it, but we'll see how that plays out.

And do you expect to see any differentiation? Like, can you get even higher efficacy than Tyvaso based on the profile of the drug?

Yes. Look, given the half-life we have, also the fact that the safety profile, the fact that it's puff, I do -- and also the fact that we've shown the best PVR we've seen in the space, I do think that there's real ability here to potentially win on efficacy, if not only on convenience as well. And there's a huge amount. If you look at PAH, I mean there's 6 or 7 different competitors there, that's a $6 billion, $7 billion growing area. So there's certainly room for 2. But I do think given what we've shown so far, there's a real ability here to differentiate on efficacy and also on the safety and convenience profile.

Nice. Okay. And moving on to Immunovant. As you were saying, a lot of exciting news. Recently, they got the 5 IND approved for -- cleared for potential 5 registrational programs, and they disclosed the IRA as first indication. But we just spoke with Pete and he was saying that was our fourth disclosing indication, not necessarily the ones we are prioritizing. So I am curious to hear from you, like what's the Roivant perspective, what's your view on that?

In terms of...

In terms of prioritization between different indication, different programs for 1402?

So look, the data that they showed in Graves was, I think, unprecedented. This is a really large patient population. If you look at the unmet need here, and the inability to control a lot of patients on ATDs, I think it's super exciting. I think it's one of those underappreciated indications that we haven't seen for a long time. If you talk to the KOLs and you look at our data and being completely ATD free, I'm super excited about that, and that's obviously going to start in the Phase III study with 1402. Look, we're going to see the batoclimab data in short order in the first quarter of 2025 calendar year. So we'll see exactly what that looks like. And if the 80% IgG hypothesis plays out in those diseases as well, and we can make a call on the excitement around that, I think the data is still pending. But given what we've seen from not just our own data, that IgG matters in TED, in Graves, from J&J., we've seen Sjogren's from UCB, we've seen ITP. There's a lot of data that's been generated by us and competitors to show that this is IgG suppression matters, and that we have a real shot at winning on efficacy here, and also on having a real subcu.

And for Graves, you showed a very robust data from the Phase II, but it seems like there is a disconnect from -- with investors in terms of commercial opportunity. So it's like an undervalued opportunity in your view? And why -- where is the disconnect there? Why is it underappreciated?

Look, I think every -- whenever you don't have -- I mean I can think of countless examples, for example, having had the debate in TED or a lot of these new sort of disease areas where people thought there was a real opportunity. I think the data actually that Immunovant showed with surveys, we're looking -- they looked through all of the claims data that -- I mean, it was really impressive, like deep dive across 4 different data sources. And like even if you just get a portion of that, right, for the uncontrolled patients, then it's still an enormous opportunity...

Because of the large [indiscernible].

Yes. So I do think that people just haven't done the work. And I think KOLs are excited and we will -- we have some pretty incredible data for these patients to actually manage that disease without ablation or without being on ATDs for the rest of your life. And of course, this is a disease that many times also moves into TED. And so having seen also some of that TED data in the Phase II, where we saw that IgG matters is another, I think exciting portion to the whole story here.

And if you can disclose it, what's your internal bar for proceeding, let's say, with batoclimab in indication like MG and CIDP or switching to 1402 for those indications. And by a regulatory perspective, how are you thinking about the transition? What will be the time lines there?

So look, I think you have a -- Vyvgart obviously is launched. So that's certainly a very clear commercial bar from an efficacy perspective that you probably would want to beat. And for launch, I would say, a lot of those batoclimab studies are really just to sort of inform and help us think through the broader 1402 portfolio, which indications do we really want to develop and what kind of label do we want to have ultimately for 1402. Look, there certainly is upside if you can meaningfully beat the standard of care right now, Vyvgart, the anti-FcRn that's -- I mean it's done pretty incredibly. But certainly a high bar. And I would say it goes back to what I was talking about is we are very careful about even though we have almost $6 billion in cash, we are very careful about how we deploy our capital and what we ultimately end up if we end up spending for a launch.

And what are your expectations in terms of commercial positioning for rheumatoid arthritis that was recently announced?

So look, we've seen the data from J&J with nipo, right? Certainly, there is a high unmet need here for difficult to treat rheumatoid arthritis. You also, I think, look, some people thought some of that data was lackluster, given the response rates we saw. But bear in mind, they don't have an IgG that has an 80% IgG reduction. So I do think we have an ability here to have a monotherapy, auto-injector that will potentially have better efficacy given what we've seen so far, particularly for these -- for difficult to treat rheumatoid these patients.

Got it. And how robust is the evidence that higher IgG suppression would lead to stronger efficacy? And if there is an indication in this specific subtype of patients?

Yes. I would say the evidence we've seen so far is really just from nipo. So certainly, look, they'll have another readout with the doublet, I think towards the end of the year. So we'll certainly look at that. But you do see that -- a correlation between the IgG suppression across those patients and efficacy, it was a fairly small data set, but I think that was convinced us to move forward with this trial, and we're excited about it.

Makes sense. And moving to brepo now. So you are -- you have completed enrollment in dermatomyositis. And I think you have guided for data for the second half of next year. So is that still your guidance, first of all? And like tofacitinib as highly derisked, I would say, this indication. So is there any possibility for brepo to show even higher efficacy than what tofacitinib has shown before?

Yes, I think there is. You have -- this is the one -- just to remind folks is JAK1/TYK 2, we haven't -- it's a first of its kind. If you look at all of the different disease areas that Pfizer studied with this drug, it would be JAKs and TYK2s pretty hardly across most of those diseases. And because this is -- look, we'll probably have JAK liabilities, I don't think that's going to be an issue in this disease given the severity and also lack of treatment. So I do think we're a real shot to deliver better efficacy given the dual mechanism.

Got it. IVIG are approved in this indication, right? So how are you thinking about positioning?

So it's an oral. So much easier for patients. You don't have to go to an infusion clinic. Certainly, I think if you talk to some of these patients, IVIG is not necessarily the easiest and then look it also, I think there's some efficacy on the table here. We can see that the skin manifestations and improvement that we've seen with TYK2s are pretty meaningful. A lot of these patients have very severe rashes all over their body. So I think that's another component which will differentiate as we look at the composite scores across the clinical trial.

Got it. And for the study design, how is it powered? Have you disclosed that?

We have not, no.

Okay. I see.

But we think, given the amount of patients that we have plenty of -- we're very comfortable with the design and where we landed.

Okay. And what have you guided for NIU for the readout?

So we haven't -- the trial started. We haven't -- we're going to watch to see how that enrolls and then make a update everybody on when we anticipate it to read out.

Okay. And switching to namilumab now as additional program. So you are expecting to read out this quarter, the sarcoidosis data. So it's a very risky indication and what are the internal expectation for that?

So risky, high risk, I would say very little has worked for these patients. There's roughly 200,000 patients. Again, nothing works, and we're excited to see that data and see if we can deliver something meaningful. So high risk, but high reward.

And can you remind us the scientific rationale there?

So essentially, if you look at the [indiscernible], that impacts the granulomas. So the mechanism, it's like there wasn't a ton of -- I mean we didn't generate own data, but it was really the impact on the granulomas from the mechanism of the drug to alleviate pulmonary sarcoidosis. And the steroid tapering, obviously, is meaningful. And so to make sure that as you taper those steroids that you can have stable -- you don't need to go back on steroids and you can taper them down without needing rescue therapy.

Okay. Thank you. That's helpful. I think we are out of time. So I appreciate it. Thank you so much for being here.

Great. Thank you so much. Thanks for having us.