Ladies and gentlemen, thank you for standing by. Welcome to a Roivant Sciences Ltd. second quarter 2024 earnings call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during this session, you would need to press star one one on your telephone. You would then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Stephanie Lee. Miss Lee, please go ahead.

Hi. Thanks. Good morning. We are actually reviewing the third quarter ended December 31, 2024, for Roivant Sciences Ltd. I am Stephanie Lee, and presenting today, we have Matt Gline, CEO. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at investors.roivant.com. We will also be providing the current slide numbers as we present to help you follow along. I would like to remind you that we will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. So with that, I will turn it over to Matt.

Thank you, Stephanie, and thank you everybody for listening. Good morning. I am going to start on slide five, and thank you again for joining our third quarter results call. So, look, I wanted to just start by setting the stage. This is our first quarterly call in 2025. It is obviously, we talked a little bit about this at the conference in January. But we think 2025 is just a pretty incredible year for us in terms of the setup and the opportunity. Obviously, that starts this quarter with an opportunity to validate our API CRM franchise as a potentially best-in-class franchise with data coming in MG and CIDP in the coming weeks. It continues in the middle of this year with a registrational readout in dermatomyositis, which would set the stage if we see approval for commercial launch of brepasitinib. And so we are really excited about that program and excited also to talk today about a new indication for brepasitinib in which we will be starting a trial this year as well. And it is also a big year for our LNP litigation with Moderna and Pfizer BioNTech with a jury trial currently scheduled for September and the summary judgment phase to take place in the second to third quarter of this year. So just a big year with a lot of important milestones, many of which we planted the seeds for years ago at this point. And so we are excited to see those results. Look, all of this ultimately on slide six comes down to our pipeline, which we think is one of the most exciting pipelines in late-stage biotech. Obviously, anchored by FCRN and brepasitinib, both with a number of other programs including monthly ciguat, which we unveiled last year. And also ongoing BD…

Thank you. Star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. And our first question will come from David Risinger with Leerink Partners. Your line is open.

Great. Thanks very much. So congrats on all the progress, Matt. I have two questions, please. First, could you review the bateclimab efficacy bars for success ahead of the release of results in coming weeks. And then second, could you also discuss the additional bateclimab GD data, the six-month treatment-free remission results that are coming this summer, including what you are hoping to see? Thanks so much.

Thanks, Dave. I appreciate the question. I confess we anticipated that it would be among the earlier questions asked this morning. Look, we have had a lot to say on this over the past month. And obviously, in so far as all of these questions get to sort of pre-data positioning, I think we finished our pre-data positioning with the $330 million stock that we bought in January. So I do not have a ton to add. Obviously, our view is that deeper is better has been pretty well established. In our own Graves' trial and our own head study, in J&J's Sjogren study and I UCB's ITP study and even at the individual patient level in our own and other people's MMG studies. So, you know, I have said over and over again, in some ways, I think this data is a little bit less interesting to us than it seems to be to other people because it mostly is a referendum in my mind than what an MG study is able to show. That said, I think what we are looking for is a nice clear dose response between the two doses. I think if we saw that it would give us confidence that an MG study is able to differentiate in a way that sets us up well for best in class. I think we are looking across the evidence for other things that can help us structure our fourteen o two mg program for maximal success. I am glad you asked about the six-month remission data. For Nunavut. Obviously, Engraves coming later this year. Look, we are excited about the great data we generated in phase two. I think it already offers a completely novel option with significant potential efficacy for a patient population that has had nothing. Obviously, the dream here is that not only can we get these patients under control, but that we can get at least some of the patients who are under control to stay controlled off therapy. And so my hope is that we see I do not know exactly what the number is, but some reasonable rate some percentage of the patients who got controlled in the initial study. Stay controlled off drug for a period of time after the study ended. And that is something that we think will be helpful, well, for patients who want to know that there is a path off therapy. Then also, obviously, for payers and others who I think will look at that data with interest. Thanks, Dave.

And the next question will come from Dennis Ding with Jefferies. Your line is open.

Hi. Good morning. Thanks for taking our question. We had a question around the LNP litigation and the upcoming summary judgment. Can you help us understand the range of outcomes as it relates to fourteen ninety-eight? Meaning, will the judge rule that, you know, either Moderna or the US government will be liable for all the patent infringement liabilities or could there be a middle scenario based on terms within the contract where Moderna would only be liable for damages for I do not know, like, twenty-five, fifty, seventy-five percent of the doses. Thank you.

Yes. Thanks, Dennis. Appreciate the question. A couple of things. First of all, it is obviously a little bit difficult to comment on ongoing litigation, so my answers will be couched in that or with that predicate. Second of all, just as a reminder for those who are a little bit less close to it on fourteen ninety-eight, what fourteen ninety-eight represents is a World War one era section of the US patent code that is designed for government contractors who have been asked by the government to manufacture an infringing product for the government to allow the government to take on infringement liability. But just for example, if you were manufacturing, like, patented jet engines for US air force planes in World War two or something like that, so Moderna has asked for the court to acknowledge that they can use that defense for at least some of the vaccine that they have sold. They have attempted twice to get claims removed on that basis. First, in an initial motion to dismiss, and then, the US government filed a statement of interest in the case early in 2023. And in both cases, the court declined their request. So I think that is one piece of evidence. In the statement of interest moment, one thing that happened is so fourteen ninety-eight has two prongs to it. There is a the government prong and there is a with authorization and consent of the government prong. And in the statement of interest from the DOJ in early 2023, the government pointed out that of the two contracts they had signed with Moderna, only one of them included express reference to fourteen ninety-eight. And therefore, it seemed to them that perhaps that one was not made with authorization consent. Anyway, we will learn more about that in the summary judgment phase. But suffice it to say, therefore, the answer is there could be a range of outcomes on that point.

Great. Thank you so much.

And our next question will come from Yaron Werber with TD Cohen. Your line is open.

Great. Good morning. Thanks for taking. Matt, I got a couple of questions. Maybe just the first one on cutaneous sarcoidosis. This looks like a really interesting opportunity. So if you are thanks for that slide showing us the beacon trial design.

So this is a study that has got three to three to two randomization you give us a little bit of a sense sort of how do you power it? What do you want to see in terms of delta over placebo? And then secondly, just for the Graves' disease in terms of remitted ability, what would be good data from your payroll checks in terms of remissions at six months? Thank you.

Yes. Thanks, Yaron. Those are both great questions. I appreciate them both. On cutaneous sarcoid, you know what? I think the short answer is this is a proof of concept study. This is less about sort of powering for some specific stat sig outcome. And more of what we again, there has not been and there have been some studies run-in Zarcoid where CSAMI was measured there has not been a lot of some research into indication we are really trying to get a sense for what the placebo bar looks like what dose response looks like, how these patients respond to therapy, obviously, the sort of hundred percent meaningful improvement rate in the IIT study was encouraging. But there was no placebo in that study. And so I think we are trying to get a sense for what these response rates look like overall. And I think the benefit of the placebo arm here is to give us something to shoot for in a larger phase three study later once we understand kind of what that patient population looks like. So I think that is really what it is. And the reason we are so heavily randomized in favor of drug of all, is we have two doses, but second of all is because we are looking for the study to enroll pretty quickly. That we can get this information and get on with a bigger later stage study. On Graves, you know, look, we have had quite a lot of conversations with KOLs about Graves' disease, and we think there is a lot of enthusiasm for a new treatment option. The truth is there is a lot of enthusiasm for a new treatment option among prescribers even if it does not bring about remission. But I think patients would be excited to see, you know, a little bit of benefit. Look. I think you know, therefore, any meaningful amount of permission, I think, would be encouraging to see here would set us up well to detect the signal in the phase three study that we have got designed a similar outcome in mind. I do not know if we have set a numeric bar at this point. Maybe we will talk a little bit more about that as we get closer, but my guess is even if a couple of patients who got off therapy managed to stay in remission, we would be pretty happy with that. Thank you.

And our next question will come from Brian Cheng with JP Morgan. Your line is open.

Hey, guys. Thanks for taking my questions this morning. We have two. First on ImmunoVAN. There are certainly a lot of investor questions on how the high dose at tokamap is going to look compared to the low dose. But just curious, you know, if you can tell us the level of your commitment you are you have today to advance fourteen o two specifically into MG and CICP, regardless of what the data show, will you still proceed in both indication with both pivotal studies?

For the question. I appreciate it. Look. I think like any reasonable people gonna look at that data and take signal from it in terms of what we think of MG and CIDB and how to develop there. MG and CIDP are huge markets. Where there is a lot of unmet need. And we bring unique things to the table literally no matter what data shows in terms of form factor, in terms of dosing schedule relative to some of the other trials. So I do not think this data alone is gonna inform that question. But, obviously, in terms of how we think we will play in MG and what we think our share will look like, that will depend on how likely we think we are to be able to differentiate in these studies on efficacy. One reminder, Josh, we think three forty and six eighty are pretty much exactly the same from an IgG suppression perspective as three hundred and six hundred fourteen o two. And we think three forty will suppress IgG you know, in the mid-sixties. And if it does, that will be pretty similar to what our competitors do. So we think the study will give us a relatively decent read on what an MG study is capable of showing, for example.

Okay. And then on the neo cyclodosis indication, for Prebo, the phase two b can seem to be a relatively small study. So can you give us a sense of the trials powering on the CSA MI score? How do you assume the placebo will perform in a target indication a target population. And just wondering if the choice of psycho doses here for Preval here today has anything to do with you know, this infrastructure they already built with Canavan.

Yeah. Perfect, Brian. Thanks for that question. We are really excited. Changing our code. Look, to say small here, I think for starters, again, the IIT study had a very large effect size. And so I think if it is gonna look anything like that, powering is not gonna be a question. This is like, I said this, we are not really about, like, powering for stats saved on CCI. I am like, I do not believe it obviously. This is really about signal finding. It is really about understanding the sort of range of parameters and giving us some information about those ranging that we can use to design a phase three that serves for registration purposes. So you know, I think there is not a lot of studies done historically on CCMIs, so there is not a ton of information. But docs mostly believe placebo response is gonna be pretty low. Sort of makes sense when you think about what the disease looks like and how it presents. So, you know, I think that is best both, but we will see in the study, obviously.

Okay. Thank you. Thanks, Brian.

And our next question will come from Yatin Suneja with Guggenheim. Your line is open.

Hey, guys. Thank you for taking my question. So the question is on the recent investment you made in ImmunoGen. Could you just talk about why that investment was made or what was your thought process to make it before the data versus after the data? And then if part of the question is that the evaluation is attractive, you made the investment now, why not bring the whole asset in house and sort of take advantage of the dislocation in pricing.

Thank you, Yatin. It is a great set of questions. Obviously, we made the investment because we thought it was attractive. We thought the opportunity was attractive. We thought there was a good possibility that it we validated with data that we are gonna generate, and so we were excited to be able to put that in place. You know, I think we also felt that in the hopeful event that the MG data is clean and successful, that we would like for ImmunoVet to be able to message to the market that the company is funded through Graves' data if we choose to run it that way, and we think that is a pretty powerful statement to be able to make, especially given just how excited we are about Graves. What we think that could mean as an opportunity. So I think there was a lot attractive to us about the timing and the setup of that investment. In terms of why not bring the whole asset in house, look, we participated super pro rata in the financing because we like the opportunity and wanted to own more of it. I think that is clear. It would be a large investment for us to own the entire thing now. It would require either billions of dollars of cash or billions of dollars of stock, and our stock is not currently valued at a place where excited the issue a ton of it. We have been buying it back. So I think, you know, steps in a direction that we care about and continue to be incredibly enthusiastic about what our FCR franchise could be.

Got it. One more question, if I may. And this is regarding the data, the ImmunoVent data that is coming up. I think there is increasing focus in terms of you know, the relative better efficacy or a little bit more efficacy that you have to show versus other FCRN. It is our understanding that in many different classes, a drug with similar efficacy and maybe some differentiation can still get significant share. So do you really need to produce more efficacy than other FCRM pair? I am just curious, like, how you are benchmarking the data relative to the others.

Yeah. Well, thanks. I appreciate that question. I think, first of all, to be clear, your question is what is the bar for Immunavant to have a commercially valuable important therapy across indications, I think there is basically nothing that could come out of this MG study that could take us off that trajectory given the quality of the molecule we have, the depth of IgG expression, the form factor. I do not think this data is a referendum on the commercial viability of fourteen o two at all. In MG, where it is more of a referendum, I completely agree with what you just said. I think that if this if the if the drug look, we have other competitors in the FCRN space, but have showed likely less good data than Efra Hijimod and are still expecting to launch those drugs. Those companies are expected to launch those drugs. I think those drugs are expected to be commercial successes with pretty meaningful sales. Either because they bring a form factor benefit or dosing regimen benefit or just because MG is a large market with a lot of different entrants and there is an opportunity for multiple therapies, we bring a lot to the table that has nothing to do generating an efficacy differential. We bring we talked about the auto injector. We bring a simple subcu auto injector. We bring chronic dosing in our study. So there is a whole bunch of things that I think we bring to the table. Mean that we do not, in my opinion, for commercial viability, need to show a delta. Obviously, the bigger delta we show an efficacy, the more share I expect we will ultimately take in the class. That is sort of total logical, and I hope we show a meaningful delta that everyone can understand. And I hope that means we are gonna be a leader in the class in MG. But I completely agree with the point that you made that in order to be commercially successful, we do not need that. My impression to be blunt when everybody has been asking me about the bar for the MD data it has not been that they were asking me what do you think the bar is for a commercially successful drug. The question that I think they have been asking me is what do I think the bar is for near-term market reaction? And my answer mostly has been that but I think the people asking me that question are supposed to be better at it than I am. So anyway but but but totally agree with the point. You are asking what I got. Thank you.

Thank you.

And our next question will come from Emma Gutzine with Wolfe Research. Your line is open.

Hi. Good morning. This is Emma on for Andy Chen. Thanks for taking our question. Just one question from us. With the top-line DM readout, expected in the second half of 2025 with potential registration on the table and with also argenexx as the recent success in DM. I guess, what are your expectations for the BREPO Phase three readout and the future just competitive landscape if argenex successfully completes its Phase three. Thank you.

Yeah. Thanks. It is a great question, and we are obviously really excited for Ramon Visitis. You know what? We are the exception of IVIG was already approved sort of undisputed first in class new mechanism in DM. And we are if the data are successful and the drug is approved years ahead, of any competitor that we are aware of in dermatomyositis at this point. So I think we get to we get to describe that market, basically. In terms of how it comes together and how it gets positioned. Alright. There is obviously always a benefit at least some patients prefer orals versus injectors, and so regardless of the comparative efficacy, I think we have a four-factor differentiation that is gonna matter. There is tons of unmet need, and honestly, I think there is room for multiple additional new mechanisms in dermatomyositis if it comes to it. So, you know, I think from that perspective, it is all a good setup, but I think the trial really needs to do is just succeed. And I think with that, we will have a big opportunity. That said, because I cannot quite help myself, look, JAK inhibitors have been very, very good mechanisms for treating inflammatory disease. And I think we have a real shot of delivering meaningful efficacy for these patients, and the JAK inhibition has the potential to be your especially JAK inhibition combined with two inhibition has the potential to be a best overall mechanism least among the things currently being studied. But, obviously, we will not know the answer to that for years and years.

Great. Appreciate the response.

And our next question will come from Douglas Tsao with HCW. Your line is open.

Hi. Good morning. Thanks for taking the questions. And Matt, I guess, just maybe starting with represent notes and obviously we now have another indication. I am just curious if you have thoughts on sort of those the pace that you would potentially roll out additional indications with bracositinib given the fact that it seems to be an asset that could have fairly broad applicability across a range of orphan indications, which I know sort of has been your initial focus. You. Do I have a follow-up?

You too. No. That is a great question. Thank you. We are obviously excited about continuous start-up that we have unveiled today. And what I can say is that we are actively evaluating a number of other indications that we think would fit well into the paradigm for Prepo. And I think we are not unveiling them at some predetermined pace based on a goal or expectation. We are unveiling them as we get primed, ready, and good to go with each successive new indication. And so I think hope is that you can expect more in the period to come here, but let us see what we get.

I mean, I guess, Matt, as a follow-up, I mean, it is like, you know, ImmunoVent has talked about sort of ten studies over a certain amount of period. And I get you do not want to necessarily commit to that similar timing, but do you think that that is it their number of opportunities that that Provo could ultimately be relevant to?

Yeah. Look. Sure. I think the answer is there is probably a very long list of opportunities that Brevo could. You can ask chat CPT with deep reasoning for a list of inflammatory, orphan, and indications with tens to low hundreds of thousands of patients. There is a long list of them. And I think we are spoiled for choice in terms of places where patients might benefit. And so I think what we are doing is spending our time picking our spots figuring out which indications have the right set of competitive dynamics, the right sort of leaning into both jack one and tick two, which is something that creates a competitive mode for us. Things that have a patient population with a size for our competitive landscape and price point. And then, frankly, making sure that we scale operationally to match the sort of level of activity ongoing in private. That we continue to run good studies and generate good data. Obviously, we are really happy with the job that team has done is doing are excited to keep investing in them. So look, I think there are a lot of possible places to go. I am not sort of giving a number today. But I think we are choosing our spots and even at Robin's pace, which is to say, hopefully.

Okay. Great. Thank you.

Thanks, Doug.

I show no further questions in the queue. At this time. I would now like to turn the call back over to Matt Gline for closing remarks.

Great. Well, thank you everybody for listening this morning. Thank you to the enrollment team, the mid-event team, the private event team, all of the vent teams at Roivant Sciences Ltd. for their hard work, the patients and investigators who will help us progress. And looking forward to a big year in 2025. Excited to get back on the phone and talk about more updates probably pretty sure. So thanks, everybody. Have a good day.

This concludes today's conference call. Thank you for joining. Goodbye.