Roivant Sciences Ltd. (ROIV) May 13, 2026 Conference Transcript

Let's get started. Good morning, everyone. Thanks for joining the BFA Healthcare Conferences. My name is Chi Fong. I have Medina Ramadane with me today. We are both from the U.S. Biopharmaceutical Healthcare team here at Bank of America. I cover Roy Van. She covers ImmunoVan. And we are glad to be co-hosting CEO of Roy Van Magline today. Thanks for joining us, matt i'm so happy to be here thank you um okay great uh maybe start with some high level question if we may before we dive into some of the deeper product level questions and so as you know roi has gone through several distinct eras you have the initial my family days through the value realizing exits like tl1a to now you're building franchises that like bradpole and i am immunovan and 14.02 as multi-indication franchises. So curious, which parts of the original Roy Venn model have proven durable? And what have you potentially want to move away from us to company matures?

Yeah, look, it's a great question. Good to be here. Thank you for having me. I can't see that well because the lights are, but I think thanks for being in the room. And thank you for your great coverage of Amunavant. and you know um so uh uh sorry i have to tell the joke because the u.s fold rated um it's okay man yeah uh richard makes me uh do that uh thanks richard yeah so um you know revitz actually we celebrated our 12-year anniversary last week um and uh we've done a lot of things in our history and i think like it's hard biotech is such a path-dependent industry It's hard to say that like any of it was wrong, but we've built a successive, a group of successive pipelines. First, a sort of more spec-formy pipeline you referred to in women's health and urology. And then, you know, we had the T1A briefly as a short era. And then now with this immunology pipeline, immunology-pomenology pipeline that I think is the best we've ever had. You know, I think one of the things that's always been core to our model is I think we're pretty thoughtful about how we bring drugs in. And one thing that's become more and more true about us, I think we're pretty thoughtful about how we develop them. I think we've become quite good at indication selection and aggressive clinical development. I think that's something we've developed as a core competence over the past handful of years, gotten better and better at. And I think it's enabled some of the multi-indication franchises you've referred to. I think it's enabled some of the clinical data we've been able to generate. So that's been sort of a new add. You know, BD remains core to the model. We're always out looking for new programs. Obviously, at our current scale, the things we need to do to matter are different than some of the things that could have worked for us as a smaller company. So I think that's shifted over time. But in general, we remain opportunistic. we remain uh we remain you know aggressive i was talking to someone yesterday i feel like there are ceos who are sort of whatever they're very like long-term narrative driven ceos they have like a big vision and i feel like royvan's more of a markov chain it's about like what what the next thing we can build is on the thing that we've got now and sort of keep continuing to add that on over time i think it served us well and i'm excited to see where it takes us next Mm-hmm.

Is the business model still primarily optimizing for optionality where, say, if you have a great asset, potentially, if you can find an extra strategy for it, you know, contemplate that? Or are you starting to think about underwriting Royvon as more of a standalone commercial biotech company?

Yeah, look, we're not dogmatic. And so I think we remain open and flexible in the literal sense of that word i think we are acutely aware and have been since the very beginning of the company that the way you build at this scale the way that you deliver shareholder value the way that you grow as a business the way that you become a 50 60 80 100 billion dollar company over time there are no 100 billion dollar like like bc companies or whatever like in our industry the way you build a company that size is you commercialize products and you generate revenues and you become profitable. And I think that's always been sort of our expectation for where we would land eventually. And I think it's been true that with each successive exit, from a capital and portfolio perspective, we wound up in a stronger position the next time to do it again.

I think you would be hard pressed to describe a pipeline or portfolio of drugs more exciting to commercialize than the one we have now, nor a pipeline or portfolio of drugs more aligned with where biotech has been successful at commercializing drugs than the one we have now and so i think it's highly likely we're going to commercialize this portfolio of drugs great great um curious on the capital allocation um after the tier 1a divestiture you were able to balance between reinvesting in the company as well as returning capital to shareholders you know um if additional lmp proceeds were to materialize um how would you rank about

priorities on capital allocation strategy yeah one of the things that has been always true about roivind and particularly true about us since the tl1a is we've been spoiled from a capitalization perspective we're a well-capitalized business we always have been uh and uh you know i think on the back of the tl1a we sort of said at the time we had roughly six billion dollars in cash and we sort of said we're going to return a third of it to shareholders roughly. We're going to sort of save a third of it for like new stuff and we're going to spend a third of it making sure we do right by the existing pipeline. I think we've been executing along that plan. If we are taking in money from this Moderna settlement as soon as this summer, we've already accelerated our share buyback on the basis of that cash coming in. The truth is it's hard to look at our pipeline and opportunity set and say if someone handed me another billion or $2 billion tomorrow that we would do anything materially different from what we're doing now. And so I think up to a point, I think we'd be pretty aggressive about continuing to return capital to shareholders. But we are constantly evaluating the opportunity set and looking at bigger things, different things, different opportunities. Obviously, we'll have a better sense of what our own commercial P&L looks like as we get launched, hopefully later this year. And so I think, you know, all of those things will factor into capital allocation systems. I think the base case thought here is we have the cash to do the things we need to do. And if we have more, we'll be thoughtful about returning it. And share buybacks are judged in hindsight, which always makes them nerve-wracking to do as a company. But we bought back a billion and a half dollars of stock at 10 bucks a share, which looks pretty good now.

All right, great. I guess on business development, where do you feel externally sourced assets could add the most value versus, say, what you're already developing internally?

Yeah, again, we're spoiled not to have to choose between those things and that we have plenty of capital to add indications for our existing programs. I think it is clear that both BREPO and 1402 are phenomenal drugs that work well at impacting important systems that have a lot of biology associated with them. And I think we have lots of ideas beyond what we are currently doing in both of those spaces and for the moment are not capital constrained on those ideas. It's just about making sure the execution remains at high quality. And I think we will continue to add indications to both programs.

You talk about you're not capital constraint, but you have frequently described revenue and R&D culture as ruthlessly economic. Repeatedly. So I'm curious, as the company scales and begins to generate revenue, improving cash flow, does that standard loosen up, allowing for bigger and longer data investments?

I don't think being ruthlessly economic precludes bigger or longer-dated investments. I just think it stipulates a standard for the quality of those investments that I hope we never stop holding ourselves to. Look, I think one of the reasons—this is like a philosophical comment—I think one of the reasons Roivant exists as a company is because the investor landscape as pertains large pharma companies forces large pharma companies to do unnatural things to try and make choppy businesses with highs and lows related to patent cliffs and R&D cycles look more like NVIDIA or Google because the marginal investor in Pfizer or Eli Lilly right now isn't deciding mostly between Pfizer and Eli Lilly. They're deciding between Pfizer and NVIDIA. And I think the truth of the physics of our industry is the return on capital can be amazing, but it's fixed life and these programs have ebbs and flows, and the unnatural things you have to do to make yourself look different than you are are costly. And so my hope, at least for the foreseeable future, is that we can avoid those pitfalls and we can run ourselves in a ruthlessly economic way, making decisions about capital based on what is right for the capital and not based on trying to attract the attention of a specific investor.

Great. Maybe we'll jump to Bradpole. It's your next truck coming up that has a Biduva in 3Q and launch follow after. And so it's for initial indication is for dermatomyositis. And so you've talked about building a targeted and specialized field force focusing on academic testing physician community. So I'm curious how concentrated is the DM patient population among physicians that you are targeting and what proportion of that patients represent out of the 40,000 treated patients right now?

So about half of the in-treatment dermatomyositis patients in the U.S. right now are treated at specialty myositis referral centers, mostly academic in nature. And there are about 200 of those referral centers. Only because those referral centers are not single physicians. It's like Mayo Rochester is a referral center, Cleveland Clinic, Johns Hopkins. And so there are, excuse me, often multiple physicians involved, but we will target all 200 of those centers and most of the doc at those 200 centers at launch and more docs, community rheumatologists, community dermatologists who treat a larger number of dermatomyositis patients, but aren't like at an academic referral center. And the truth of the matter is when you're talking about 200 centers or even 2000 physicians, it's like not that difficult to build a field force to cover that size of operation. And so I think, to be honest, our principal focus right now, we want to make sure we have a large enough operation. We want to make sure we're able to cover those docs, able to cover them often, get in those offices and make sure they're getting what they need from a support perspective, getting what they need from a touchpoint perspective. But also, we're very focused on field force quality and on making sure that the people we're sending into these academic referral centers can go toe-to-toe with the highly experienced academic physician to treat these myositis patients. So like one of our field medical person, one of our, exactly a sales rep, like one of our field commercial personnel when she's out in the field is a myositis KOL who spent her career treating myositis patients and then decided she really liked our drug and wanted to do something different and came in-house. And I think if we could fill our field force with people like that, it would be enormously impactful. You've described the expectation for the repel launch as slow and steady. so i'm curious what do you think is the biggest unknown when it comes to the space of the early adoption or the kinetics of the launch curve yeah i mean there hasn't been a drug launched in dermatomyositis ever at some level the only like dermatomyositis specific approval of like a quote-unquote branded therapy is an ivig and so i think the truth is like at some level everything is unknown uh i think how these practice these practices treat other patients but like how these individual myositis referral centers embrace a new drug how they decide which patients to put on how we work with them to get used to the coverage dynamics of drugs like this which are complicated and well sorted at this point obviously argenics and magical and verona and horizon and a bunch of other companies have like figured this out but like working with the physicians to make sure we're getting what we need there is important and getting getting sites up and running and building a repeatable process. I think like all of that is specific to the physician, specific to the patient, specific to the patient. It's like stuff to declare itself. And it's the uncertainty around every single one of those elements that makes it harder to call ramp than peak. There's a huge opportunity here. There's no question, but how you get there and how long it takes is, you know, it's just a question. I'll also say you watch companies launching drugs very successfully and it's not it's not clear to me that anybody is really benefiting from giving guidance these days fair fair fair so so i'm not sure we're going to fair fair fair i won't ask that question no it's fine i just like i don't think will be sitting around thinking i wish i had given more guidance in terms of payments uh patient segmentation in the early phase where which one do you think is the early adopters you think is going to be treatment naive patients who are looking to roll off steroids or patients looking to formalize from an off-label jack to an on-label treatment my honest view is it's going to vary by physician and by patient experience and there will be some patients who hate ivig and use it because the only thing that works and they'll be eager to get off ivig and some patients who are at practices that have like off-label jack use is like not that common in dm and it's like pretty concentrated and so like there's some docs who use a lot of tofacitinib and those docs tell us they want to get patients on a better branded drug that has better access and better patient support and all those things so like those physicians i think will like potentially reach relatively quickly to those patients as they come in i think it will depend on the center it will depend on the patient and i think it's going to be a little bit of a mixture

of all of the above okay great i want to give it to dina to ask about immunovain questions dina go Thanks, Chi.

So we could talk for hours on just the 14.02 pipeline. You know, you guys have over 10 potentially registrational trials ongoing for across five to six or more indications. um maybe can you level set investors on where you think fcrn has the most value across these programs where you're prioritizing capital what you're most excited about and how do you kind of think about balancing these higher risk white spaces with large tams right versus this follow-on approach in certain indications that um you know are a little bit crowded or that there's first to market fcrns already approved yeah i mean look i think uh fcrns have declared themselves to be a

pretty great category and i think in some ways one of the most remarkable it's a new axis of biology it can treat a whole bunch of diseases that were like roughly unaddressable with modern therapies before but it's always i think one of the most exciting things about the fcrn class is that they've been able to do that while being like relatively easy to use safe well tolerated no like major complicated issues and that has meant just like a lot of doc enthusiasm uptake right like you talk to mg docs and they're like excited to use vivgard because it's a good drug for their patients and because it's like they put patients on it and the patients improve and don't complain which i think is like the dream for an indication like mg and so you know i think we're trying to lean into all of the great opportunities that are presented in the fcrn field i think it won't come as a huge surprise the thing that we are probably like most excited about is graves which has good in our view biological validation at this point with our own phase two work a relatively straightforward mechanistic rationale and just like an unfathomably large unmet medical need like so many patients who are walking around poorly treated on current therapy that it feels like uh and i'm immensely proud of our getting there first at some level like just like a huge opportunity to define that category in a way that is similar to what our gen x has been able to do with mg where they've defined a category that has been enormously successful except for a patient population that is three to six times larger than the mg patient population in total and so i think it's like a it's just an unfathomably large opportunity for us to get right you know i think like then we're doing and i look certainly there's like risk anytime you run the first phase three program in any indication so there's risk to the graze program it's not zero risk but like it's relatively lower risk compared with something like digital tra where the biological translation is more complicated where the evidence we have from docalumab is more mixed obviously also if you can get there in late late line ra a huge opportunity from patient population perspective but you've got to clear a scientific bar that i think is like relatively high i think that's kind of the book ends on the white space in terms of like do some things that are higher risk with big opportunity and like obviously any any time you're faced with an opportunity like graves where you can do something that is like relatively lower risk and that big it's going to be sort of top of mind then you get indications like mg where look the truth is are we going to take a ton of share in mg i believe that our drug will ultimately in the fullness of time be viewed as a more efficacious therapy than vivgard i think deeper agg suppression will matter for these patients and i think you look at the other fcrns on the market and even without a ton of obvious differentiation a little label differences things like that they're like doing okay like they're getting patients just like docs are using fcrns because they have them i think the mg study is obviously incredibly low risk mgs have invalidated fcrns over and over again it's not a very expensive study it will be a decent indication for us is it going to be a huge indication for us that's an uphill battle but it'll be a decent indication for us and it's obviously worth the effort given the risk great i want to dive a little bit deeper maybe into graves and d2 uh ra so um is maybe you top of mind here is the recent phase three data you guys presented last month maybe can you just outline what your takeaways were from this study how that maybe shapes your strategy for the graves indication yeah i mean first of all a lot of people have followed us into graves and that's great i think it will actually in the fullness of time be good for us to have a more robust set of companies out marketing because it's a lot of endocrinology it's not like my it's not like my status there's a lot of people treating graves patients the more mind share you can get the more these docs are used to new therapies, the more likely they are to reach for any of those. I think it's good. That said, we have learned an enormous amount by being years ahead of everybody in terms of actually treating Graves patients. And I think we're trying to stay relatively careful about how much of those learnings we share. But yeah, look, I think the hyperthyroid subset of patients in the TED study effectively doubled the number of hyperthyroid patients that we have treated with an FCRN, and that's informative. And they are different patients. They are less hyperthyroid. They are on higher doses of ATDs. They are kept on stable ATDs during the course of therapy instead of being titrated. And I think looking at that patient population and still seeing a very similar consistent treatment benefit is super encouraging in terms of what we think it means for the translation of the biology to the clinical benefit of FCRNs and Graves' disease.

Do you think there's opportunity to capture that overlapping patient population with both TED and Graves? Is there an opportunity to maybe kind of factor that into your current Graves study?

Yeah, I believe based on the data we've seen in the TED study, based on the data we saw in our own phase two study, based on the data we saw in our Graves study, that especially for like early onset of TED, FCRNs are benefiting these patients. They are slowing proptosis, they are resulting in proptosis improvements, the benefits are not as pronounced as you see with the best of the IGF-1R class, which makes sense biologically. And I think that makes TED in and of itself a relatively difficult commercial market. But I think for Graves patients, one of the many things that Graves patients struggle with, and you see it if you go to like Graves patient support groups on the internet or whatever, is like one of the most common posts in those groups is like someone takes a picture of their face and they're like, do I have bulging eyes? Do I have the beginning of ted do i need to get treated for this i think it's like you know it's something that like in an already stressful situation where you've been told you have a chronic illness that requires treatment you're also wondering how it's going to affect your appearance people get really really focused on that and i think being able to tell those patients we can slow this down we can catch it early you may never need to treat the ted because you're going to get the graves under control now i think is a super powerful message and i think we are gathering data in the phase three studies for graves that hopefully will allow us to tell that story great um so you're looking ahead to when we kind of see that pivotal data from the graves trial and i believe it's 2027 what's kind of giving you confidence you shared phase two data but what gives you confidence that you know

we'll be able to replicate that high 75 to 80 percent responder rate that we saw and what kind of degree of maybe potential data erosion would still be considered commercially compelling you You know, what would you consider to be a win to position FCRN as a potential, you know, replacement for ATD and avoidance of ablative therapy in this patient population?

I'll say a few things. One is, in terms of, like, what gives us biological confidence, the beautiful thing about Graves' disease is it's not that complicated, actually. Like, we know how the biology of Graves works, and FCRN seems to be able to treat it consistently. So I'm pretty confident in our ability to deliver a biological clinical benefit to these patients. the endpoints in the phase three are like a little bit different than the endpoints in the phase two and the truth is like we're exploring a whole bunch of different endpoints some of which will be more important for regulatory and scientific perspective some of which will be more important for commercial perspective and i think it's like very hard to say with the small group of phase two patients we have like which of those endpoints are going to matter most in the clinical setting i think remission is going to matter that is i think the ability to preserve off-drug effects is something that physicians will look to in the commercial data set you see it in Argenix's study, you see it in our study. I think that is something that will be important commercially. In terms of the numerical values of endpoints, my honesty, first of all, again, the definition of the primary in the phase three is actually a bit different than the definition of the primary in the phase two, and I would not expect an identical number. I think looking like for like to the phase two endpoint, I think we'll see high response rates, but I think there will be a variety of different data to show. And one of the important things here is we're going to generate that data. And not only is that going to matter for like the street's expectations around what Graves looks like, but more importantly, it will really be the first time a drug company is presenting data on the benefit of treating Graves patients with a novel therapy in decades. And so I think like even more than I'm focused on like, how did the data look relative to the phase two study or what is it going to mean for the street or how are they going to compare us to some other company? I'm focused on like, how do we present that data initially in a way that maximally sort of lands with the physician population who hasn't had a new drug for these patients in a long time. And that's really where our focus lies, not on, you know, the numerical benefit in phase two versus the numerical benefit in phase three. The other thing that I think we've learned that is just like an important thing to acknowledge is because in part there has been no novel development in grave disease for such a long time, the treatment of graves patients globally end in the United States is pretty heterogeneous. You could easily imagine the same patient biologically. If you took a patient off all drug and you watch them, their lab values would be the same, the extent to which they were sick, their symptoms would be the same, that that patient in two different physician's offices might be treated very differently today. In one physician's office, they might be on and off 25 milligrams of methamazole and relatively well treated for graves, but going through long periods of time where they were unhappy about the side effects with them with him is all and you can imagine another doctor's office for that patient is perpetually on five or seven and a half milligrams with him is all and like is fine with the the with him is all side of it but is like constantly complaining about symptoms of grave disease they are the same patient they're just being treated differently and once you add things like att titration to endpoints like the way those patients present in clinical trials looks pretty different so i think that's all the stuff that we have learned enormous amount about being out in the field and stuff that is driving how we run our study and how i expect we're gonna we're gonna present the data on the drug.

Great. And just mindful of time here, I wanted to ask on the RA program, we're going to see data in the second half of this year. Can you just speak to maybe general rationale for studying 1402 in RA? Some people may argue that J&J NEPO's data kind of raises some questions in regards to the sufficiency of an IgG lowering approach. What are you doing differently from NEPO's studies that will set you up for success?

I 100% agree that NEPO data raises questions about the sufficiency of an IgG approach, and I think we're going to learn that in our study. But I want to be clear. I think that is, especially the second NEPO study, the sort of TNF combo study, if that study had shown anything instead of basically nothing, I think you would feel differently about risk in our phase 2b. Look, the monotherapy NEPO study that they ran first, that study looked interesting. It showed dose dependence. It showed higher responses in ACPA positive patients. It seemed to preserve benefit in later lines of therapy, which are all things that like biologically you would expect from an FCRN, but like seeing it play out coherently in that data set, I think is what got us excited. And then our view was like, okay, how do you isolate a patient population where you were A, maximize the benefit you see, according to the data we've now seen from J&J, and B, like carve out a commercial opportunity in RA, which is obviously in the earlier lines of therapy complicated based on the number of great drugs approved. So we focused on those questions in the design of our study, and we're studying late-line patients who have experience with TNFs and JAKs and IL-6s in various proportions and who don't have other treatment options, really. And we enriched for a population that is highly autoantibody positive. And my hope is that those things combined will put us in a better position than either of the J&J studies were. The J&J combo study with Simzio was an interesting study. I think it is hard to study the effect of any drug together with a new onset TNF, because TNF just works so well in RA.

I think we're out of time, so just appreciate you taking the time to be here with us today, Matt, and thank you for the thoughtful discussion. Absolutely.

Thanks for having me. Thank you. Thanks.

Thanks, everybody.