Good day and thank you for standing by. Welcome to the Roivant Second Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

Good morning, and thanks for joining today's call to review Roivant's financial results for the second quarter ended September 30, 2024. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant; and Ben Zimmer, CEO of Priovant. For those dialing in via conference call, you can find the slides being presented today, as well as a press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. With that, I'll turn it over to Matt.

Thank you, Stephanie. Thank you to the operator, and thank you everyone for dialing in this morning. We actually have a relatively full update. So I'm excited to share and there's at least one major new thing we're going to talk about, which is the 52-week data from our NIU study, which I'm pretty excited about. So starting on slide five, look, I think there's really two major areas of focus for us right now. And the first is clinical trial execution. We have a lot of ongoing trials, all of which are important and are going to generate interesting data coming in the near future here. Obviously, today, we're talking about the 52-week data for brepocitinib in NIU in the Phase 2 study, where also the Phase 3 study is ongoing with the first patients enrolled and with fast-track designations having been granted. We presented this quarter batoclimab in Graves' disease. We are now getting our programs up and running for IMVT-1402 in both Graves' disease and with difficult-to-treat rheumatoid arthritis as well as a number of other programs to be starting soon. We have initiated our Phase 2 study of mosli in PH-ILD. And then we have clinical data coming, including namilumab in sarcoidosis by the end of this quarter, batoclimab data coming next year in MG, CIDP, and TED, and brepocitinib in dermatomyositis top line data coming in the middle of next year as well. So that should be all exciting updates in the near future, all focused on clinical execution. On Slide 6, the evolution of the business continues in some other ways as well with the Dermavant deal having closed just a week or so ago, now allowing us to refocus on clinical execution as I just mentioned, while maintaining a large share of potential…

Great. Thanks, Matt. Before going into the 52-week data, I just wanted to briefly highlight two tailwinds in I&I that we are really excited about as it relates to the brepo Phase 3 programs in NIU, as well as in dermatomyositis, and these are outlined on slide 11. The first on the left-hand side is you can see that as a category, JAK inhibitors have roughly doubled since 2020 in terms of both treated patients and revenue. And I think this really speaks to the fact that the benefit-risk profile of these agents and physicians and patients’ comfort with that benefit-risk profile is quite established at this point and that even includes in indications with significantly less morbidity than those in which Priovant is operating. And then in terms of those indications where Priovant is operating these orphan diseases with high morbidity, we've also seen over the last few years several launches in those, including the one played out on the right-hand side of this slide that have really validated this category of indication as a source not only of blockbuster revenue, but blockbuster revenue that can be achieved in a very quick timeframe given the prevalence of the disease, high morbidity, high unmet need, and concentrated prescriber base with orphan pricing. And so if you turn to slide 12, you see that NIU really fits this phenotype quite on the money around 70,000 to 100,000 patients in terms of prevalence, very high morbidity, fourth leading cause of blindness in the developed world among the working age population, very little available for patients and concentrated prescriber base. Most of these patients are seen at dedicated uveitis specialty centers. And turning to slide 13, you see really supporting this -- a new claims analysis that we did with IQVIA, which reconfirms…

Thank you, Ben. And as I said, really excited about that data as well. So I appreciate all the work Priovant team has done there and looking forward to what's coming. So I'm going to now read through a couple of other updates that are rehashing some things that have happened over the past couple of months that we are excited about, starting with a reminder of what's going on in our anti-FcRn franchise. On slide 25, I know everyone's familiar with this data, but we're really thrilled with it. We've put out some really, really good proof-of-concept data in Graves' disease, which we think positions IMVT-1402 to be a potentially best-in-class and a first-in-class program in that indication. As you'll remember, we had an over 75% response rate in patients who were uncontrolled on ATDs with over 50% of patients becoming ATD-free being able to completely titrate their ATD dose and getting too normal T3 and T4 levels by 12 weeks. We continue to support our premise that deeper IgG reduction is important with our sort of 680 milligram dose with deeper IgG reductions driving meaningfully higher response rates, which gives us a position for IMVT-1402 be potentially best-in-class. And that's against the backdrop of a very high unmet need with 25% to 30% of Graves’ patients uncontrolled or intolerant ATDs and really with no pharmacologic options. And now let’s move into the announced IMVT-1402 IND has been cleared by FDA, enabling a straight to pivotal transition. Now, I won't go through the data again in great detail, but on '26 and '27 and '28, we'll repeat that data. It's just -- it's really exciting data for a disease with really no other options for this portion of the population. The other announcement from Immunovant on slide 29 is…

Thank you. [Operator Instructions] Our first question is going to come from the line of Louise Chen with Cantor. Your line is open. Please go ahead.

Hi. Congratulations on all the progress and the data today. Thanks for taking my questions. So I had two on brepocitinib. I wanted to ask you what set of efficacy you'd like to see in your Phase 3 NIU trial? And then also for brepo and HS, where do you stand and what's the latest update there? Thank you.

Yes, so I'll let Ben take both those questions other than I'll say what I hope I will say is we're very happy with the efficacy we've seen in Phase 2, and I think it gives us a pretty wide margin relative to the competitor programs like Humira, but Ben take it away.

Yes, I would agree with that. I think anything that even approximates the Phase 2 would be terrific. And I think even if there's standard drop off in efficacy that one often sees between Phase 2 and Phase 3, this is a space where there's very little available for patients. TNF inhibitors are widely used in spite of their quite limited efficacy. And so I think anything that gets the drug approved would support widespread adoption and certainly, anything that supports a potential better product profile than Humira would support widespread adoption potentially even in the first line setting.

Yes. And then on HS and Ben, you can jump in if you have any comments as well. But I guess what I'd say is, I can say this from the outside, I've been really happy with the work that the Priovant team has done on indication expansion, and we have some other ideas. HS is a great indication. We have very good Phase 2 data in it. It's a competitive field with a lot of other mechanisms, and there are some great places to take brepocitinib that may be less competitive, but we're continuing to consider a wide variety of indications and certainly, HS remains on our radar.

Yes, don't really have much to add to that.

Thank you, Louis. Thanks for the questions. Really appreciate it.

Thank you. [Operator Instructions] Our next question comes from the line of Brian Cheng with JPMorgan. Your line is open. Please go ahead.

Hey, guys. Thanks for taking our question this morning. Maybe just a question on CLARITY design. Are you requiring patients to have a certain steroid dose for entry? And are there any certification strategy that we should make note of? And also on the sub-studies between CLARITY 1 and 2, what is the difference here? Is there a geographical location difference?

Great. I'll let Ben take all of those.

Yes. So in terms of steroids, there's no specific requirement. Patients are allowed on any background steroid dose of up to 40 milligrams per day or no steroids at all. And again, with the notion that because there's the two-week burst at the start of the study, that kind of neutralizes whatever the background regimen was before. In terms of stratification, no particular stratification of material note. And in terms of the two sub-studies, sites will be assigned to one or the other in some geographies like the United States and certain other larger geographies will have sites in both sub-studies and then there are certain countries that will only be in one or the other.

Thanks for that. Appreciate it.

Absolutely.

Thank you. [Operator Instructions] Our next question is going to come from the line of Yaron Werber with TD Cowen. Your line is open. Please go ahead.

Hey, good morning, guys. This is Joyce on for Yaron. Thanks for taking our question. Can you talk about your thoughts around pricing for brepocitinib, of course, orphan price point here, but how should we think about pricing by indication? Thank you.

Thanks. Look, appreciate the question. Thank you for asking. Look, it's obviously premature to have a firm view on pricing for a program at this stage. We're focused on orphan disease with high unmet need. So we think a pretty wide range of prices is supportable. What I would say, and I'll give it to Ben to answer as well, is that the only thing I'd say is other competitors in dermatomyositis have talked about net pricing in current sort of the high $100,000 range. And I think that's a useful benchmark for us as we think about the range of possibilities in that indication. But other than that, I think a pretty wide range if possible.

Yes. I know -- just to echo what Matt said, I think if you look at benchmarks for recent orphan launches, including both biologics and small molecules that have been at similar price points, that's obviously the kind of band and range we'll be looking at, but we don't have any sort of firm decisions or plans at this point in time.

Thank you.

Thank you.

Thank you. [Operator Instructions] Our next question is going to come from the line of Andy Chen with Wolfe Research. Your line is open. Please go ahead.

Hey, good morning. Thank you for taking the question. On uveitis Phase 3, can you talk about what placebo response you're assuming? So in the Humira trial, I think they saw 13 weeks or three months. But in your trial, you have a more stringent tapering. So your tapering is eight weeks versus the Humira trial, which was, I think, 15 weeks. So in other words, are you assuming 13 weeks? Is that going to be the placebo response on the primary endpoint? Is it going to be less than 13 weeks? Or should we be assuming that's going to be less than 13 weeks? Thank you.

That's a great question. Ben?

Yes. I mean, I think as the base case, our assumption was a similar placebo rate to what was seen in VISUAL I. We think there is opportunity potentially for it to be even higher for the reasons you said with the taper, but we didn't want to assume that. In general, the study is actually overpowered. So even if the placebo rate ends up being significantly higher or the failure rate significantly lower in the placebo group than we expected and we saw in VISUAL 1, we'd still have an opportunity to detect a difference just being humble about the fact that this is an area where there's really just one precedent study, we wanted to err on the side of being conservative, and that's why we're running as large a program as we are.

And one thing that's patient-friendly about the study as a reminder is that it's an event-driven study and as people fail, they'll move right over to brepo, which some of your patients will like about the study. Thanks, Andy. That was a great question.

Thank you. [Operator Instructions] Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open. Please go ahead.

Hi, good morning. Thanks for taking the questions. Matt, just on that last one, when -- do patients automatically switch to brepo if they have treatment dose or do they have the option to switch? And is there a sort of alternative protocol that they could pursue?

They automatically switch to brepo. Obviously, they can drop out of the study if they wish and do not have to take brepocitinib. But if they want to stay in the study, the -- I think the kind of first -- and obviously, we don't know whether patients are on placebo or drug or neither do the investigators. So the first rescue medication in the event of failure is brepocitinib along with some other different options that the investigators have to deploy along with that. And then if the patient then fails for a second time in the open-label period, then there is an even wider array of options that the physician has available and then at that point, the patient can choose whether or not they want to stay on drug and can still remain in the study.

Okay. Great. Thanks. And just as a follow-up for Matt. From a business development standpoint, obviously, with mosli and the creation of [namilumab] (ph), we have sort of gone beyond what has been a short-term focus on I&I. I'm just curious how you're thinking about Roivant from a therapeutic category standpoint right now? And does this move respiratory like a big focus for adding additional assets or you're just going to continue to be as you put a sort of the economics and pick out the best opportunities as you identify? Thank you.

Yes, thanks, Doug. It's a great question. It's one you've been focused on and rightly so. I think we are pretty ruthlessly focused on doing the best things we can. The analogy that I've been using that you might have heard lately is that we exist in the excess dough outside of other people's cookie cutters. And so we're not the snow man, we're not the Christmas tree. We're the dough in between the two, and that means we've kind of got to be flexible in terms of therapeutic area, but we think there's a lot of really great cookie to bake out of that dough as well.

Okay, great. Thank you.

Thank you. [Operator Instructions] Our next question comes from the line of Dennis Ding with Jefferies. Your line is open. Please go ahead.

Good morning. This is Anthea on for Dennis. Thanks for taking our questions. Two on DM. Could you talk about your plan to share the full lupus data and if you see any overlaps between lupus and DM? And then also, what's the willingness from doctors to prescribe JAKs in DM and how much off-label use is there currently, if any? Thank you.

Yes, thanks. That's -- it's a great question. I'll take a part of it and then hand it over to Ben. Look, on lupus, my only reminder is about two things. One is a reminder; Pfizer designed and ran the DM study. It was -- sorry, the lupus study. Thank you. It was one of the last ones from their original brepocitinib program. And I guess on the overlap point, and I'm sure Ben will say something similar, we have so much data in brepocitinib across such a breadth of indications at this point in any one study in any one indication is really not as informative as the overall bolus of data on how efficacious the drug is. So I'm not sure we see a lot of specific commonality between SLE and DM or any prediction from SLE related to DM. But Ben, you want to take that as well as the off-label JAKs question?

Yes, I don't see a ton of read-through there. I mean, I think one lesson from these sort of rheumatic diseases in general and our lupus data was an example of that is you have to be very focused on managing placebo response, and that's something I can't say that in the DM study, where we've designed it and are running it ourselves, we've been extremely focused on that, including with the mandatory steroid taper in the study and a very high operational focus from our team on ensuring adherence to that taper among other kind of study execution related steps we're doing. As far as JAKs and DM, yes, they're used pretty extensively. There was a recent publication that was kind of a literature review of case reports and there were 600 published case reports roughly in that across DM and juvenile DM in that. And I think if you talk to KOLs and other prescribers and other DM treaters, you'll see that they do use JAK inhibitors. So I think it's certainly an area of a lot of comfort. Most of the treating physicians here will be rheumatologists and dermatologists, a few neurologists as well. But both rheum and derms are also obviously very comfortable with JAK inhibitors from other indications as well. And as I mentioned before, both rheumatic and derm indications with less morbidity than DM, JAK inhibitors that are on-label for those indications are widely prescribed at this point. And so I think there's a lot of excitement in the in the physician community about JAK inhibition, I think there's a lot of excitement about a TYK2/JAK1 inhibitor, in particular, given the alignment of that particular mechanism to the pathobiology of DM and really just the prospect of having a once-daily oral approved therapy that's efficacious and targets the underlying disease that would be a new and important development for the field.

Great. Thank you.

Thank you. [Operator Instructions] Our next question comes from the line of Corinne Johnson with Goldman Sachs. Your line is open. Please go ahead.

Hey, good morning. This is Craig on for Corinne. So the first question here is, given the emergence of Humira biosimilars, how do you expect brepo could be positioned if it potentially gains approval? And then from there, will you recruit or target patients that are refractory to anti-TNF type medicines within CLARITY?

Yes, Ben, you want to take first Craig at both of those?

Yes. So what was the…

So the first question was just how do we track to position brepo relative to Humira biosimilars?

Yes.

And then the second was will we recruit refractory patients.

So on the first one, look, I think our base case kind of view of the market here is to be used predominantly in the TNF refractory population. And I think we're going into this with a lot of excitement about brepo's potential in NIU, even if that is the only population into which we're launching, I think, as I mentioned before, Humira's failure rate is high and its use is high. And I think the biosimilar -- with biosimilars available, we'd expect the use to be at least as high and the failure rate to be at least as high. And so I think that will only lead to an expansion of the TNF refractory market. I also think that this is a rare disease, very high unmet need, one of the leading causes of blindness in the United States. If our data is actually differentiated from Humira, there is going to be a very significant outcry from patients and physicians to use this drug first line because people don't want to go blind and they want to use whatever the best available treatment is to prevent that.

And then does the study…

Okay. And then no. So there's no particular stratification or requirement in that regard, that's something we discussed with FDA. It's not something they are focused on in the study. I think our expectation is that we will be enrolling a number of patients who have been on prior TNF therapy, just given the extent to which these drugs are used and we'll be tracking that and be able to analyze those subgroups, but it's not something that we're in any way, stratifying for pre-specifying.

Yes. And I would just reiterate, tolerance for ocular inflammation is very low. And I think if brepocitinib improves as the Phase 2 data suggests may to be a best-in-class agent with a pretty wide margin, there's just going to be a lot of demand to use it in the earliest setting as people can get comfortable because that's how you treat this disease most effectively. So we'll see. It's going to be a conversation with FDA and so on, but we feel confident given the profile of Phase 2 data that we have a good shot at a bigger population, even than the refractory population, acknowledging also refractory population is very large. Great. Thank you very much.

Thank you. I would now like to hand the conference back over to Matthew Gline for any further remarks.

Great. Thank you, operator. Thanks, everyone, for listening this morning. Thanks, obviously, to Ben and the Priovant team for the Phase 2 study in NIU. We're getting the Phase 3 going, thanks to all the patients and investigators. Thanks to the entire Roivant team who gets these results together and then moves us forward every quarter. Looking forward to a little bit of a busy end of the year with the namilumab data coming and then a very busy 2025. So we'll talk to you all very soon. Thank you. Have a good day.

This concludes today's conference call. Thank you for participating. You may now disconnect.