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

Well, good afternoon, everybody, and thanks once again for joining us for the 45th Annual TD Cowen Healthcare Conference. I'm Yaron Werber from the Biotech team, and it's a real great pleasure to have with us today, Matt Gline, CEO of Roivant. Matt, great to see you as always.

Thanks for having me. It's fun to be here.

I think the first thing I want to ask you is that your new show on biotech TV, when is that going to be on so we can watch.

We have not recorded the next episode yet, but I'll let you know when...

Is it the same time every week?

No, no. It's like every now and then thing.

It's a special feature.

That's right. It's a special future.

Got it. Both Matt and I sometimes do the biotech.

We do hangouts, it's fun.

Yes. All right. So lots to talk about, and by the way, for the audience, if you have any questions, just raise your hand and more than happy to take it as it comes. There's a lot of data coming up from Immunovant this month, we're in March now. When you're thinking about the 2, obviously data sets that come to mind is the CIDP data and GMG with beta. CIDP you ended up over and rolling just given some of the initial sort of the way things worked out with 40% of patients kind of relapsed quickly. And then in GMG, the enrollment just took a little bit longer. You've said the bar is fairly high to continue to commercialize beta. And no matter what you're going to learn from these studies to design future 1402 studies. Kind of what should we expect from -- what should we look for from this data?

Yes. So first of all, just to acknowledge the truth, we have not successfully controlled the narrative for Immunovant that -- look, I think there's been a lot of speculation and discussion around what the bar should be and there's a vocal community of you all that have had a lot of influence over that perception. Look, I think from our perspective, there's a few things we've said consistently over a period of time. One is, I think the study is like interesting for informing development plans in MG. I think it's interesting for continuing to underscore the possibility of a dose response that shows our best-in-class profile. I probably think it's less interesting than other people think it is because I'm really excited about Graves' disease. I'm really excited about other indications where we do close to first-in-class or first-in-class indications where I think it would be easier to show a dose response than even in MG, for example. And so -- now the headline is going to be Matt talking down the Immunovant data. Look, I think this is a really exciting data set. I think it has a lot of potential. But I think it's sort of earned the life of its own. What I really want to see in this data set is a clear dose response. What I really want to see is 680 sort of conclusively looking better across a variety of factors than 340, among them, certainly absolute improvement in MG-ADL, but also a responder rate analysis also QMG also other scores. And I think all of that's helpful. And I think the bigger the magnitude of that delta, the better. Obviously, our view is 340 is actually a pretty good proxy for our competition that is it suppresses IgG in the mid-60s. And so I think looking at 680 relative to 340 is probably, in my view, the best way to get a picture of how we would look relative to other drugs in a head-to-head study, for example. Obviously, there's been a lot of discussion of placebo and what the placebo adjusted delta does or does not need to be. I don't know what it's going to look like. But my honest view is that the efgartigimod studies, in particular, will run at a different era in MG drug development and especially in FcRn drug development, and that we have seen a significant increase in placebo arms performance across a variety of studies, including obviously the Nipocalimab study also the UPLIZNA study, which had a mandatory steroid taper and still had a mid-2s placebo. I think it's just realistically, reasonably likely that placebo will be higher in our study than it was in the efgart study and that there will be some compression as a result. My view is that's to be expected and is not really a referendum. But again, I think that's been a part of the discussion.

So when you're thinking about GMG that's becoming so competitive or the UPLIZNA obviously going to be the next entrance, so to speak, and I know Wall Street even there was kind of concerned about the delta to your point. But when you talk to KOLs, and we're doing our panel here today and let's see what they say, but when you talk to KOLs, they actually look at that dosing to be very, very attractive. So I know Wall Street is obsessed about any delta, but that's not always what happens in the community. As you said, the bar is very high and there's multiple other indications to go into. So how do you prioritize?

Yes. One more comment about MG by the way, because I think it's an important point. Look, I think actually, there is an opportunity for a category leader to emerge in MG on absolute performance that has not happened yet, many, many MG programs have landed in that kind of mid-4s territory in terms of absolute MG-ADL improvement. And I do think it's not to be underestimated. If we can actually generate a delta above that, we will be in pretty rare air, right? There have been like a couple of one-off open-label studies that have been in the 5s or maybe have touched 6, but it's actually like pretty uncommon. And so I do think there is an opportunity to show convincingly better efficacy here if not on a sort of placebo-adjusted basis than at least in terms of absolute performance. And I think the market needs that. Like I think to your point about back looking at a variety of things, I think there have been a lot of these studies are sort of clustered in terms of what their efficacy looks like. And I think that's one of the reasons only that people are a little bit nervous about our data is that a lot of studies have clustered in that kind of mid 4s territory. So I think we're going to have to see how that shakes out. In terms of how we prioritize, look, I started this by saying, and I mean it, I think here's a prediction. 24 months from now at this conference, I think there's going to be a lot of people talking about Graves' Disease not just for Immunovant, but like as an indication. I'd just like here, because we are out in front in Graves' we hear from everybody that is working on Graves'. And I know for a fact, there are big pharma companies working on programs in Graves' disease. There are biotech companies working on programs in Graves' Disease. I think the world has sort of figured out that this is like a meaningful market. And we are definitely in Graves' disease what Argenx was in MG. We are out in front. We are in pivotal studies. It is a big market with a huge prevalent population, a lot of unmet need. And I think we're going to get to define that market. We're going to get to meet those docs, meet those patients where they are first. And so I'm really excited about that. There are other indications in my mind that we are working on some that we've talked about, but mostly that we haven't yet that are of a similar character where we can be really close to the front of the market where -- or at the front of the market where we can define the market together with our peers or alone. Those are obviously the most exciting opportunities in the same way that argenx has been tremendously successful in MG. And so I think that's certainly -- if we're talking about resource prioritization, the first thing is like find those indications and develop there. Look, I think MG is an interesting place. It's a big market, but obviously, it's got to be a little bit lower on the priority list just because we're competing against a really successful drug.

Yes. You've said you've had 6 INDs open, right, the 1402. You've only talked about when the definition of an IND being opened, it's filed allowed and you may have not started enrollment. Is that the definition of...

These are all studies that we are clear to run according to FDA. And therefore, all of these studies are in the process of either enrolling patients or standing up sites, like the studies are moving.

Yes. And your disclosure practices is when you started sort of enrolling is when you announce it or shortly thereafter.

Roughly.

Whenever -- it's based on strategy and what makes sense.

Look, I think the truth is in a competitive field where other people have FcRns in development, we're looking to maximize head starts.

And you said you're going to announce -- so far, I mean we know about 3 indications right now, 1402.

Yes. I think you can infer from Pete's public commentary MG, probably CIDP, RA, AM claims 4 of the 6 cleared in INDs.

And 2 are open and enrolling.

I think you can infer something like that from Pete's public commentary as well. There's a couple that are already on clinicaltrials.gov, for example. Although that is also relatively set up.

I mean the other one that comes to mind, obviously, is Ted. The other one -- well...

We have Ted data coming later this year for etokimab.

Exactly. The other one that comes to mind, obviously, Sjogren's. Right now, it's an open horse race.

Yes, I think Sjogren's is a great example of an indication where anyone's Phase II study is everyone's Phase II study. And so where if we are aggressive, we can be very near the front of the pack in Sjogren's. And I think it's indication where -- if you look at the nipocalimab data, for example, there's a very nice dose response, and it does not look like it has plateaued. So I think Sjogren's is exactly the kind of place conceptually where I would be excited for us to allocate resources.

And another one that would make a lot of sense. And by the way, we've already had discussed this in 2 different panels here is myositis, which will lead me to the Brepo question in a minute. Does it make sense to have -- I mean, if you listen to what physicians are saying about IQVIA, right, we know argenx went ahead with all 3 subtypes of myositis, including mado does it make sense for you to run 2 different strategies in their mado one and more broader myositis with another drug.

Yes, look, I think when you talk about Brepo in a second. I think Brepo is to dermatomyositis in some sense, again, what argenx is to MG in the sense that we are the first novel therapy other than Octagam really the first novel therapy that ought to come to market in DM. And so again, we get to be really active in defining that market and one of the great things about a market like DM, and this is for about almost all the FcRn markets is it's going to sustain a high price point. So it really is like down to the level of like you can pre-identify the individual patients who are candidates for therapy and like make sure that you know the doctors who treat them and make sure that you're sort of work in that. Obviously, there are certain things you can't do before you have an approved product, you've be careful about that. But from a medical positioning perspective, many of the most important DM treatment centers are already in our brepocitinib study. So we like myositis as an indication. One of the things that's been nice for us is we've been saying that we think DM is a great indication for Brepo for 2 years, and we got a lot of drugs. And then argenx announced that they were progressing in biosites, and then people came up us. They were like, hey, DM sounds like a big indication. So that's been helpful. Look, I think Argenx gets a lot of credibility on their decision-making. And I'm happy to draft off it, especially when we're ahead of them. So that's been good. So look, I like myositis, I like it as an indication space. I like the breadth of it. We obviously have I would say we know as much about dermatomyositis at this point is anybody else in the world developing drugs. So I think that's certainly helpful in thinking about programs in other mechanisms and so on.

Let's maybe before we leave beta. Just the CIDP study, we talked about GMG. CIDP, again, it was a little bit of a complicated situation because, unfortunately, you had a lot of relapses early on, totally not of anybody's fault had just random luck, right? So we ended up having to enroll more patients, and they will be valuable data. This is Part 1 Phase IIb.

And just to be precise, I think there's 2 things. One is, look, in general, in my view, obviously, relapses and dropouts are not good for any study at some level. But here, where so much of the game is won or lost on patient selection, you want a sick patient population, right? That's the point. You want patients coming in on drug who when you watch them out, they feel bad. That's like how you know they have active CIDP. So I'm not sure that's like necessarily a bad thing in terms of patients selection and then the other reason -- and Pete said this at the time that we ramped up enrollment on the CIDP study that we continue to enroll in the CIDP study for longer is because once we knew what we had with 1402, we sort of had to make a choice on sort of prioritization. And my view was learning about dose response in the Bato study was going to be a really useful tool for helping us understand how to study and how to think about CIDP. And frankly, what our opportunity set is in CIDP. And the truth of the matter is when you were focused on Bato alone in CIDP, we had multiple doses, but the study was really powered to focus on period 2 and not to focus on showing a delta between 340 and 680 in period 1, and so I think once we sort of thought about, okay, like how many patients is it going to take for us to really be able to tell between those 2 doses. At that point, we were like think it probably makes sense to have some more patients in period 1, so that was the other sort of benefit to continuing to enroll there.

Okay. for again, that's going to be a thesis validating a data gathering sounds like study that's going to then pave the road for 1402.

Yes, I think that's right. Look, again, we're not making any final final decisions about launching Bato until we actually see the data sets. And certainly, if we're hearing clamoring commercial demand, we'll revisit. But in general, I think the point of the CIDP study is to set us up for a Phase III program for 1402.

Yes. Okay. So let's go to the dermatomyositis as a Brepo Phase III, which is 2 different doses against placebo, study was fully enrolled sort of late Q3 or so last year. It's a 1-year study. That's right. So data is -- you kind of do the math, it's probably early Q I think you said second half.

I think last patient first visit was in July. So last patient, last visit will be in July, and the data will come after that.

Maybe late Q3. The nice thing and this is a JAK1/TYK2. We know JAK1's work, they're just not approved.

Yes, there's case studies and the tofacitinib study.

The TYK2 signature kind of rounds it out. It doesn't really add more talks from what we've seen a lot of data right? We know interferon beta is on the pathway of JAK1 unquestionably, that's related to DM, it's a interferon beta signature. So physicians are really encouraged by the profile, and I'm expecting positive data in Q4. I mean, I think it's the chance for failure knock on wood, should not be high. And we've been talking about this for a year now in our calls yes, and in our deep dives. It's been overlooked by the market because I think it's been "far" but now it's within the 12-month orbit. What are you doing ahead of the data? Or kind of what's the plan after the data? Is this something you're going to commercialize?

Look, I think we're ready to go there. And so look, we just had a long discussion at our Board meeting last month about commercial prep about understanding the patient landscape, understanding where these patients are. I think -- I don't even need to speculate about price point at this point. Argenx is going forward in DM we know what FcRns cost. So that market is clearly going to be able to sustain pretty high-priced therapy. And I think it's exactly the kind of market bluntly where biotech companies have been winning with launches lately. So I think we feel really good about that. And I think our plan as soon we get that data, if it's positive, as we hope and expect it will be, is to sprint towards commercialization. And I think Brepo is setting up behind that is a nice franchise. So there's other indications that will pair nicely with it from a price point and market perspective. So look, I think we're really excited.

So the other drug that's very relevant and you know well, is the dazukibart, Pfizer, your original partner, so to speak, that they decided to keep that interferon beta antibody because that's obviously novel and ultimately, to deal with you for Brepo presumably because there's JAK1, they have other JAK1s, they'll specialize with the antibody. The Phase II looked pretty good on the dermatological scores it still hit on polymyositis or on the real the muscle score not quite as robustly, so to speak, and their data, I think, is coming potentially right before yours later this year.

I don't -- that based on clincaltrials.gov our impression of that study, and this is really a better question from Pfizer is that it's been and enrollment challenge. So I don't know for sure whether we're expecting that data around the same time as ours or not to be totally honest. .

SP1 And what's been the issue there?

I don't know. That's a question for Pfizer. It's just been a little slow. Look, I think that's a reasonable mechanism. Obviously, they have the Phase II data. I agree that the data looked promising, but not sort of category ending as it were. And the truth is my view is that DM is a big enough market to sustain multiple programs across multiple different mechanisms. So we'll see. There's a couple of other studies ongoing. There's nanafrolumab study that's a few years out. There's obviously the Argenx study. So I think there will be more mechanisms coming in DM. But I suspect we will be the first to launch.

Okay. Maybe just to go back to Brepo. Because Brepo is really going to be your next real Phase III, right? That's potentially commercialize -- that allows you to commercialize. Have you thought about -- do you want to be a commercial company? Are you still -- are you looking to monetize value as it comes earlier?

Again, I think base case plan here that we're really excited about is that we want to launch Brepo and DM. We think it's a great drug and a great market. And again, we think it's the kind of thing. We learned a lot from the Dermavant experience. And I think 1 of the things we learned is that DM is exactly the kind of market that we are excited about. Look, I think it's -- so I think we're -- I think we would -- look, I also think -- why is Immunovant a $3.5 billion company and Argenx a $40 billion company, I think because they want the product. And so I think we're excited to build some real value around the commercial business. And I started talking about this before, but I think Brepo is the kind of drug where every morning, we wake up and come up with 2 more things we might like to study with it. So we just added cutaneous sarcoid a few weeks ago now instead. We obviously have the NIU Phase III is now running. So I think we're excited about the reach of what that could be. I mean if you take a step back, first of all, I think it's a little bit wild that Roivant owns brepocitinib, right? This is probably one of the 2 or 3 best JAK inhibitors in the world just based on clinical data. And we were able to buy it from Pfizer for $14 million upfront that included like $10 million of clinical material or something. It was a -- because in the summer of 2021, I think it was when we actually signed the license agreement, I think that's right. It was like 6 months after the Enbrel study had shown -- had not shown noninferiority to TNFs on cardiotovascular side effects. And you looked at RINVOQ and it was like a $3 billion drug that I think the consensus view was with the black box. It was going to flat line, and people are going to prefer other mechanisms. And now you fast-forward 3 or 4 years and RINVOQ is a $7 billion drug that I think could be a $15 billion drug. And just like so much baby was thrown out with the bathwater on JAK inhibitor development. I mean like how many JAK inhibitor script reports were going out weekly from the sell side in 2019. It was like 80% of the e-mail traffic, and now we are like in pole position with one of the best JAK inhibitors with late-stage development in multiple completely open space indications and the only companies doing novel development in like true JAK inhibitor development -- JAK inhibitor space at this point like us and Incyte. And then there's a couple of TYK2 companies, like it's a relatively open field. So I think it's a great, great place to be.

Yes. Can we -- I want to maybe spend any questions from the audience, by the way. I want to spend maybe just a couple of minutes also on IP, LNP IP specifically related to COVID. So we're waiting for the Markman decision with Pfizer. That hearing was December 18. Yes. was exactly right. So we're expecting that, I think, fairly imminently. The Moderna jury case is late September.

September 25 is the scheduled date for the start of the trial.

So usually, it's a 2-week trial roughly?

Yes. What we've said -- I've said I think it will take about 3 weeks in total. There's a lot to cover. Obviously, the jury will have to deliberate. So I think sort of within the span of 3 weeks, is my best guess.

And now you -- there was an announcement earlier this week with Arbutus kind of changing the strategy a little bit and then concomitantly yesterday or the day before now you submitted some filings in other territories around the world against Moderna. Yes. I guess where I'm going with this, it's a tough question because the case is almost bifurcated, right? U.S. and even in the U.S., it's U.S. government involvement versus commercial sales versus noncommercial sales, and that historically going back to World War I. And then obviously, rest of the world, which is going to play it on timelines. So when you're thinking about the case with Moderna, it's going to end up being -- is there a case to just end up wrapping it all in a global -- in one way that handles all the commercial sales around the world, this is going to up being piecemeal.

Look, I think the literal scientists who today work at Arbutus and Genevant have been working on this technology for 20 years and -- or more. And believe that we are owed or due. I don't think we are particularly focused on one way or another of getting it. And in some ways, the question you just asked is in part a question for Moderna, which you should feel free to ask them. My view is if what it takes is to win cases on infringement in 30 or 35 jurisdictions across many tens of billions of dollars in sales to get our due, then we have winning cases. And I'll tell you this, litigating on IP is expensive, but it is a lot cheaper than running a Phase III clinical trial. And we're set up to do it, and we're ready. And again, we just filed cases in what cover 30 countries on Monday. Certainly, if Moderna at some point in this process, wants to come to the table and have a conversation about putting this behind us, we're happy to have that conversation.

The -- checking again, any questions from the audience?

Are you -- obviously, you have a huge task force, what -- and historically, your biz dev deals have been earlier stage, not a lot of upfront. Is that with this -- but at the same time, you have forecast probably [indiscernible] . So is that philosophy going to change going forward?

Yes, sure. The question was we have a significant cash balance. We have about $5.2 billion in cash as Historically, our BD plans have been mostly focused on lower upfront deals, early stage. I think they've been often late stage, but low upfront, but relatively low upfront deals. And the question was with our current cash balance that can change. Look, I think for us, a low 9-figure upfront feels pretty spendy but I think you could see us do a deal with a low 9-figure upfront, the truth is that we are preternaturally stingy. And so if the question is like, are we going to do public company biotech M&A, like big upfront acquisition kind of deals. I never say never, but it's just not really in our DNA. I think it's extremely unlikely we're going to wake up tomorrow and see us buying a $1 billion public buyer to come in or something. It's just not who we are. Conversely -- and look, the other thing I'll say is, and obviously the markets are choppy. But I'll say bluntly, like even with everything that's going on in the public markets in the last 12 months, compared to what we find when we talk to big pharma companies, biotech is somewhat competitive, right? Like other people are around the table. Those companies want cash to do other things. And so I think our strongest hands are often in our relationships with big pharma companies, where I think we can be a pretty unique partner of choice and where they're solving for something different that works well for what we do. So I think the short answer to that question is we're going to keep doing the kinds of deals we've always done. That said, we are opportunistic and we're hunting around the world, and we're looking in a lot of the same places that other people are looking at some different places. And we see some things we really like. So I think there's a diversity of deals to do I think we will continue to focus a lot of our effort on late stage, low upfront or low-ish upfront deals from big pharma with a lot of back-end sharing. And if other things come our way, we'll look at them as well.

And I guess it's related to what I asked. I mean there's a lot of thought recently of how many small biotechs you have that are trading for a lot less than the holding cash, it's not making -- anything in any way or...

Yes. The question was there's a lot about the companies trading for discounts to cash. Does that make us think about anything in any way? It does. Look, I think there's some really interesting opportunities in biotech. A thing that we found is even companies trading under cash have high expectations for what they want in order to be bought. And I think it's very different to talk to a company trading at our cash acquiring them for twice their cash balance, they talk to them about acquiring them for their cash balance. I think it depends a lot on the actual realities of the situation. I think we just look at it economically, right? If there's a company with $300 million of cash, and you can buy a $400 million. You're paying $100 million upfront from the asset roughly. And so I think like it's just a math question at some level. I think it's been interesting to watch other people play in and around that space and focus on some of these liquidations and some of these sales. And I find a lot of those opportunities interesting, but I think some of it comes down to not just how much the company's market cap is or where their cash is, but like how the Board is thinking about the future of the business. And to be honest, it's often hard to tell that from the outside. So we have to kind of take and figure it out.

Again, there's been a lot of [indiscernible].

Yes. So the question was, with all the speculation around Immunovant and around deeper IgG suppression mattering, why do we feel confident in MG or otherwise. Look, more broadly, setting the MG study aside for a second, I feel confident about this for 2 reasons. One is that biologically, I think you have to twist pretty hard to convince yourself that it isn't obviously true. That is like these are diseases driven by autoantibodies and the mechanism of the drug is to reduce the level of circulating autoantibody. And so if you reduce level of auto antibody, you should get a better treatment benefit. And I think you have to think really hard. Biology is humbling, weird things happen all the time but you have to think pretty hard to convince yourself of reasons why it wouldn't work that way. So I think that's sort of -- again, biology is humbling, but that's thing one. thing too, we have shown it. We've shown it in Graves' Disease with the study with multiple doses. We've shown it in our own TED study, J&J has shown it in their Sjogren's study. UCB showed it in an ITP study. And up until we came along with deeper IgG suppression, both Momenta and argenx had these charts and their decks that showed how clear the correlation was between IgG suppression and clinical benefit. So I think across MG studies and studies and other indications, this has been like consistently true, as I think you would expect with the obvious interpretation on the biology. So okay, now having said that, I understand the noise around MG. First of all, MG-ADL is a tough endpoint. It just is there's subjectivity to it. And not only is it like a tough endpoint, just like to look at it as an end point, but also the data is tough, right? Like it's -- there have been some smaller studies that included high-dose deeper IgG suppression that have so far failed to show a clean picture. And that's just a true fact. And honestly, therefore, is there some chance that we're like saturating some subcomponent of MG-ADL and to get deeper requires a urophysical therapy or something like maybe that's certainly a possibility. But I guess my view is this is a big study I think it will have been a well-run study. It is the biggest study that includes this sort of dose ranging activity. And I think the biology is clear. It's clear across all of these other indications. And so I feel pretty optimistic about what we're going to be able to show. To say it again, I think our placebo rate is reasonably likely to be high because of the changing environment relative to when I say high. I think it's likely to be normal. But I think normal for placebo rates now in MG is different than what was normal for placebo rates in 2021. And I think that's just a fact that we're going to have to deal with. But in terms of showing a dose response, I guess I think the biology is ought to be on our side.

[indiscernible]

Sure. In MG, it does. It doesn't mean we won't -- it doesn't change my view of what we should do with 1402 Graves' because we have data on Graves'. So -- but in MG, I think if we don't show a great dose response in MG with Vyvgart as a well-entrenched and well-loved competitor, it will be hard to take a ton of share in MG. And so I think we will focus our indication efforts elsewhere. That's not to say we won't run some kind of MG program. But I think our internal expectations for how large it will be as an indication will be different if our dose response is good than if it isn't. And to be honest, I think there is nothing to take off the table. If we show a nice clear dose response, you're running a head-to-head study versus some of our competitors based on this data so that we can prove to the world that we have a better drug. And I was talking about this in the hallway earlier. I'm not one of these CEOs that has any problem with short sellers, squeezing it was fun from time to time. But having said that, I think it would be an interesting experiment to the world to see who felt comfortable shortening a head-to-head study between us and our competitors on the back of having shown a clear dose response in this study. That feels like a pretty compelling design to me. But we'll see.

[indiscernible]

I'm talking about a dose response on MG-ADL. That's right. And on clinical benefit, generally, on responder rates on MGL and QMG, et cetera. That's really where I think the attention ought to be focused. I've said elsewhere, but I'll say it again here. We will show a dose response on IgG lowering or I will eat a shoe, what is a dose response for MG-ADL?

[indiscernible]

Deeper MG-ADL responses at higher doses, constitutes a dose response.

[indiscernible]

Yes. I think Immunovant used this sort of 10% number to describe a bar. And I think what he meant by that is like, whatever, roughly 0.5 point to 4.5 points or something, I don't know. I think it mostly doesn't matter what I say now today, I think, looks like a dose response. I think we're all going to have to look at the data and make that judgment together.

All right. Well, terrific, Matt, thank you so much. You didn't quantify the size of the show.

I like your shoes.

I like my shoes, too. Terrific, Matt. Thanks for joining us. Really appreciate it.

Thank you.