Roivant Sciences Q2 2027 Earnings Call Transcript

Roivant Sciences (NASDAQ:ROIV) reported second-quarter financial results on Monday. The transcript from the company’s second-quarter earnings call has been provided below.

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Summary

Roivant Sciences reported strong financial performance with $31 million in net revenue from the initial commercial launch of Lysraya, reflecting high demand.

Significant clinical advancements were noted, including positive data in RA, cutaneous sarcoidosis, and PH-ILD, with successful trial completions and strong data outcomes.

Future outlook remains positive with plans for new indications, ongoing FDA discussions, and an Investor Day in December to share more strategic insights.

Operational highlights include the commercial launch of Lysraya and strong execution by the Pryvant team in addressing unmet medical needs.

Management expressed optimism about the company’s trajectory, highlighting robust clinical data and the transformative impact of recent developments.

Full Transcript

OPERATOR

Ladies and gentlemen, thank you for standing by. Welcome to the Roivant Sciences second quarter 2026 earnings call. At this time all participants are in a listen-only mode. After the speaker’s presentation there will be a question-and-answer session. To ask a question during the session you would need to press Star 11 on your telephone, and you will then hear an automated message advising your hand is raised. To withdraw your question, please press Star 11 again.

And as a reminder, we ask that you please limit to one question. Please be advised that today’s conference is being recorded. I would like now to turn the conference over to Stephanie Lee. Please go ahead.

Stephanie Lee (Investor Relations)

Good morning and thanks for joining today’s call to review Roivant Sciences’ second quarter ended September 30, 2026. I’m Stephanie Lee with Roivant. Presenting today we have Matt Gline, CEO of Roivant Sciences. For those dialing in via conference, you can find the slides being presented today as well as a press release announcing these updates on our IR website at investors.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 have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I’ll turn it over to Matt.

Eric Venker (President and CEO)

Thanks, Steph, and thank you all for joining this morning. I’m glad you’re all here. I’m going to go through the deck and I’ll announce the slide numbers as I hit them. I’ll start with the agenda on three. There’s a lot to hit today, between stuff that we’ve already talked about on calls and some pretty exciting new updates, so I’m not going to be able to go through it all in detail, but I just want to say what a tremendous quarter it’s been for us and, obviously, transformational with the commercial launch of Lysraya as well as some other items.

I’ll start on page four with just hitting, because this is our last quarterly update in 2026. It’s been a phenomenal year for us, right? Starting out with our calendar Q1 last February with the positive data in cutaneous sarcoidosis, and then the fact that we got a trial started in LPP and NCS. We got Lysraya approved, we got the NIU data, so the Brepo franchise, the Pryvant team executing, incredible quality for 1402. Obviously, the RA data was a really tremendous surprise.

And today we’re putting out the period 2 data, which is also surprising in that we hit the primary endpoint there, which feels really, really good as far as where that drug is headed. Obviously, earlier this quarter we also announced that we hadn’t succeeded in CLE, and we’re announcing today—I can talk a little more about it—that we’re not going to wind up progressing, in all likelihood, in Sjogren’s based on various updates in the field. We’re going to run that study out and learn what we can from it.

And then an amazing year for Mosely as well with, obviously, the phenomenal data earlier this quarter in PH-ILD, as well as the starting of the phase three study there and the ongoing combo study with Tyvaso. So just an incredible year with a lot of really, really great updates. It’s going to be tough to top in 2027, but we have lots of plans for that as well. I will start briefly, although I know there will be a lot of questions about it, with the commercial quarter. Obviously, in August we got Lysraya approved. It’s a really exciting moment for us, for the dermatomyositis community, for patients, prescribers. We’re really proud that it’s out on the market. So this quarter reflects, on slide 7, really five weeks on the market from approval. So, you know, there’s only so much you can take away from it.

Obviously, $31 million of net revenue reflects strong initial demand—lots of unmet medical need, lots of physician and patient enthusiasm. Feeling really, really great about that. There were hundreds of patients on paid drug at the end of the quarter. There are many hundreds of patients on paid drug now. We have a broad initial prescriber base, and the early payer dynamics have supported good uptake, though it’s a little too early to extrapolate exactly what’s going to happen from here.

I’m sure we’ll get some questions about exactly how to think about this. We’re not providing a ton of information now because it’s early, but we feel great about what we’re learning from the field. The initial patient and prescriber feedback is strong, although, again, it’s early in the launch. One question I’m sure we’ll get is on stocking or inventory dynamics. Again, we record revenue when the specialty pharmacies buy the drug from us. So there was a meaningful amount of undispensed drug as of 9/30. That drug has all been dispensed following the end of the quarter, and we continue to see strong uptake—I think really as a reflection of the pharmacies trying to get ahead of demand. There’s probably a tailwind from those dynamics in the September quarter.

There’ll probably be a modest headwind from those dynamics in the December quarter. And I expect inventory and stocking to be completely irrelevant as we round the corner into next year. So overall, again, just tremendously pleased—what this means in terms of patient and physician demand, in terms of execution from the Pryvant team. I think it’s really just a signal of how highly unmet need has been in dermatomyositis that so many patients and so many prescribers are working with us.

The payer dynamics have been clean so far. I expect we’ll start to see more of these policies coming into effect that will sort of shape that from here on out. So we’ll have to watch that and learn more about it as it comes. And I’d say those plans have been—some have been quite good, some have been a little bit more challenging. But I think we’re going to be able to work through all of that again, given the amount of patient and physician demand for the drug.

Happy to take questions on it. Not going to talk much more about this today, but obviously we’ll continue to provide updates on the commercial uptake as we go. I want to jump now to another update that I wasn’t totally expecting to provide today, but it’s a great update, which is that period two of the 1402 RA study has now—and as a reminder on slide nine of the way the study worked, this was a randomized withdrawal trial in which, in period one, all patients were on 600 milligrams—that’s the high dose of 1402. And we reported that data. As a reminder, we had, you know, 70-plus percent ACR20 responses, 50-plus percent—kind of mid-50s—ACR50 responses, and around 35% ACR70 responses at the end of that period one.

In period two, those patients who had achieved an ACR20 response were then put into a randomized withdrawal portion where they were either kept on 600 or randomized down to 300 or placebo. And then the primary endpoint was ACR20 at the end of that 12-week period, which you can sort of think of as an ACR20 maintenance endpoint in that, you know, 100% of those patients roughly started—or were randomized into this—had ACR20 responses. So, you know, if you look at slide 10, it was 118 patients had that ACR20 response, and 117 of them were effectively re-randomized for the efficacy analysis in period 2—or 118 were re-randomized, 117 were analyzed.

And, you know, the disposition was pretty straightforward in terms of balance across the arms. And, you know, as a reminder, before we get to the actual data on slide 11, this is a big unmet medical need, right? These patients have all failed multiple lines of therapy. Many of them have failed TNFs and JAK inhibitors; some of them have also failed IL-6s, et cetera. We think there’s, you know, about 85,000 patients in the U.S. We’ll talk more about the commercial opportunity here at our upcoming Investor Day in December. But this is a large number of patients who struggle to get adequately treated.

And we know that autoantibody pathology matters, at least in some of these patients. It’s increasingly clear that we have found a subset of patients for whom it matters quite a lot. These patients, on slide 12, have significant morbidity and quality-of-life impairment. A significant portion of them are fully work disabled for over a decade. They have many consultations with their physicians. A large number of them are dependent on external help to live.

A lot of them require surgery. A lot of them cannot walk or report walking disabilities. These are really struggling patients with late-line RA. The trial on 13 enrolled a difficult-to-treat population. These were fourth-line-plus patients, having failed conventional therapy and, again, two-plus mechanisms of advanced therapy. You can see a little bit about—this is all from the previously reported data on slide 13. The arms on slide 14 were reasonably well balanced once you got into the randomized withdrawal period—similar disease severity, similar balance of prior meds, et cetera.

So, you know, a pretty well-balanced study. And I think what we saw on slide 15 was just phenomenal across a couple of dimensions. So remember, 100% of these patients approximately had an ACR20 response at the beginning of this period. Almost all of them—92.5%—still had an ACR20 response at the end of 28 weeks, whereas only 75%-ish had an ACR20 response on placebo, notably. That got a P value for the 600 milligram arm. Notably—and I think this is an important finding—300 milligrams was not enough to preserve the response.

Three hundred milligrams looked pretty similar to placebo, which I think is just a further reinforcement of something we’ve believed all along, which is that depth of IgG suppression really matters across FcRn indications, and that it took a higher dose with deeper IgG suppression to deliver the sustained clinical benefit in this patient population. You can see on slide 16 similarly great data on ACR50 and ACR70. You start to run into N issues when you get to ACR70, but we hit a P value on ACR50 as well—80% of patients at 600 milligrams, I think a nominal P value.

Stats worked: 80% on ACR50 had an ACR50 response at week 28 versus 56% on placebo, and again, nice separation without a nominal P value on ACR70 at week 28. So consistent data across depth of response. And I really like slide 17. You can just see over time that these patients are just—it looks like they’re significantly benefiting. So this is the cohort of patients who were on 600 for the full period, and you can see already some meaningful ACR50 and ACR70 responses as early as week four.

And those responses really continue to get and are well preserved through the end of the study, even though after week 16 there starts to be a quote unquote placebo effect where the patients thought they might have been taken off drug at that point. So this data looks great and, in my opinion, supports a clinically meaningful profile for these patients that is pretty exciting. You can see on slide 18 just a little bit more data here on separation from placebo on CDAI and SDAI, which reflects widely used scales in clinical practice for assessing sustained response. And you can see these placebo patients really worsened, whereas the drug patients were able to preserve their response through week 28, which is pretty exciting. The other thing I’ll just add on slide 19 is looking at the JAK-experienced subset. The JAK-experienced subset did just about as well as the overall population.

So even in these patients who have failed really the most effective anti-inflammatory mechanisms available in RA, we had really nice continued preserved responses, which feels good as well. And same thing on slide 20 in the deeper response levels—ACR50 and ACR70 data looked good even among JAK failures. Safety on slide 21 was entirely consistent with what we’ve shared before. Consistent with the mechanism, event rates comparable to placebo, everything sort of looked reasonable.

No new safety signals. 1402 continues to look safe and well tolerated as a drug, which is great for all of the ongoing programs that we’ve got. We had hoped, on slide 22, to be able to share—together with this update—that we were sort of through the FDA discussions and had a path forward. Those discussions are ongoing. Frankly, we had to disclose this data at this point because we hit a P value unexpectedly. And so we’ll come back to you once we’ve finished our FDA discussions, probably later this year or early next year, with an update on our trial plans.

But we think, based on this data, we have a really exciting set of opportunities here to treat a patient population with a high unmet need, where the period 2 data really support deep therapeutic responses in a population that has failed multiple mechanisms, multiple advanced therapies. So excited to come back and think this is going to be one of the important pillars for 1402, potentially as a product. I am not going to go through the next two sections in great detail, but because they are both transformative updates for us, even though we’ve gotten on a call before, I wanted to remind everybody of what we’ve seen both in NIU and in PH-ILD. It was just a few weeks ago we got on the phone together to talk about our NIU data. Again, just tremendously proud of what this has meant for us clinically, in terms of Brepo continues to do basically everything that we could ask for as an agent.

And NIU is a highly morbid disease—on slide 24 it’s a poorly served indication. It’s the third leading cause of blindness. There are hundreds of thousands of patients with anterior uveitis and then potentially hundreds of thousands of patients, or at least we thought 70 to 190,000 patients with posterior, intermediate, or pan-uveitis. That’s obviously a specific target population here. And the data from Clarity, as a reminder on slide 25, really suggests we can achieve a new standard of care here.

As compared with placebo, patients who failed therapy in around 12 weeks across the two studies, we did not see median treatment failure in this patient population in over 48 weeks, which is phenomenal. I think it’s the largest benefit ever seen for a non-steroidal therapy in NIU. And it met the primary endpoint and all secondary endpoints in both of our studies, with almost two-thirds of patients achieving steroid-free quiescence, which is a major treatment goal for physicians.

Consistent across all subgroups, statistically and clinically meaningful, generally well tolerated. So, look, this data has been incredibly well received by the DAC community as we’ve been out talking about it. I think it’s going to be an important new treatment option for NIU patients. We’re going to spend a fair amount of time on our Investor Day in December talking about the marketplace for NIU and the commercial opportunity here, so I won’t belabor the point here, but really looking forward to talking about that as I think NIU is going to be another pillar—hopefully as exciting as DM, which, given the earnings results today, is a high bar to clear. So really exciting. I’m not going to go through the data slide by slide, but we’ve reproduced it here because we’re quite proud of it.

Same thing with Mosely Ciguat, jumping to slide 31. As a reminder, PH-ILD is a really tough disease with few current treatment options. These patients have 1.5 to 2 years median survival despite best available standard-of-care therapy. We said about up to 200,000 patients across the U.S. and Europe. It’s likely an underreported disease. You see the market growing as new therapies like Tyvaso are on the market, and there are no non-prostanoid approved therapies for these patients.

So there’s a big opportunity to deliver something new. Again, don’t need to belabor the data, but on slide 32 we were just tremendously proud of what Mosely Ciguat was able to do for these patients. On the primary endpoint of PVR, we saw a 56% placebo-adjusted PVR reduction at week 16. That is, we think, the deepest PVR ever shown, certainly in a PH-ILD study. We showed a 35-meter statistically significant improvement in the key secondary six-minute walk at week 16.

On multiple week 24 exploratory analyses we saw tremendous outcomes, including a meaningful benefit on NT-proBNP and a phenomenal benefit on six-minute walk at week 24. Cardiac measures—the sort of hemodynamics—looked phenomenal, and 98% of patients achieved the high dose, which is a good signal of safety and tolerability. And notably, given the tolerability profile of treprostinil, we saw well tolerated, and cough rates that were lower than placebo, which is something that’s important for these patients with lung disease.

Not going to go through it slide by slide here, but we reproduce the data again because we’re just tremendously proud of what Mosely Ciguat’s been able to demonstrate in this patient population—just phenomenal. On slide 37, as a reminder, that phase three study is underway, actively screening and enrolling patients. Excited to continue to provide updates on that, including—based on the quality of this data—we’ve said multiple times, and we really mean it: this is a drug that we think is going to work in a lot of places.

And we’re excited to share updates in the coming months on initiation of other trials with Mosely Ciguat and other indications where we are now hard at work. I will wrap up here with just a quick financial update on slide 39. You know, relatively consistent with expectations in terms of expenses for the quarter—net of tax loss, continuing operations of 153 million, or, you know, non-GAAP of $133,000. Cash is back at 4.2 as of 9/30, reflecting in part the receipts from the Moderna litigation that we got over the summer. And in the six months ended 9/30 we had repurchased about $280 million worth of stock, about 9.4 million shares.

Look, on slide 41, 2026 has been a tough year to beat for us just in terms of the phenomenal quantum of clinical data, the meaningfulness of that clinical data, and now with the Lysraya launch off to a start that we’re pretty excited about. But 2027 is a very busy year. In addition to getting the sNDA filed for NIU and hopefully adding another indication in relatively short order for Brepo, we have some very important top-line data coming for 1402 in Graves, some data in MG.

We expect multiple program indication expansion. Just a lot of other things coming, including some hopeful surprises over that time. So looking forward to next year, looking forward to seeing many of you in New York for our Investor Day next month. And yeah, I think we’ve got a lot to come. So with that I will pause and just remind everybody our Investor Day is on December 9th. Please register—the link is in the presentation from today—and I will hand it back to the operator to start Q&A. Thank you again, everybody. I want to, just before I do that, say thank you again to everybody who makes this happen: the Roivant Sciences employees, the Vant employees, updates from all those teams, and then obviously again to the patients and investigators who trust us with their care.

It’s been a phenomenal year. Thanks, operator. Please go to Q&A.

OPERATOR

Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. And as a reminder, we ask to please limit to one question. And our first question is going to come from Dave Risinger with Leerink Partners. Your line is now open.

Dave Risinger (Analyst at Leerink Partners)

Thanks very much. So congrats, Matt, to you and the team on a phenomenal quarter. So my question is on Lysria, could you talk about the evolution of paid RX, just to help us understand what percentage of RXs were paid for in the September quarter, and as of early November, what percentage are paid for today? And then regarding the scripts, what are you seeing in terms of the mix of RX that are switches from off-label JAKs versus switches from IVIG?

Thanks so much.

Matt Klein (Chief Executive Officer)

Yeah, perfect. Great question, Dave. Thank you. First of all, just as a reminder on the way that we do reporting, our bridge program is not reported as sales in any way, and so it’s really everything in that number is quote, unquote, paid, although obviously it’s paid at the time it’s purchased pharmacy. I’ll say without giving specific numbers, we’re still in the early innings of payer coverage. And the early innings of payer coverage have been straightforward, and so we’re getting very good conversion rates at this point with relatively straightforward access from a sort of payer dynamics.

Obviously the concern, or the question, is as the payers get their act together, we’ll start to see plans in place, and we’ve seen some of those programs in place, or access controls in place, and we’ve seen some of that. And I’ll say it’s ranged from, you know, there are significant national plans whose only restriction is that you have to have tried a systemic immunosuppressant, and then there are plans that are trying more significant restrictions than that.

And I think it will be a variety, and I think we are prepared to help every patient get access to drug. The hundreds that I indicated as of 9/30 and the many hundreds that I indicated as of now are all on paid drug having made it through that process. That’s sort of how we’re thinking about those numbers. So I think feeling good, and I’d say there has not so far been a significant change in access relative to early in the launch. Maybe, like reading tea leaves, small changes up or down at different times, but really nothing significant so far. Access continues to be pretty straightforward for the moment.

I don’t have a lot of specific things to report in terms of sort of who is coming on drug other than to say we had originally indicated that we thought it was going to be quite a broad patient population. I think we are in fact seeing a broad patient population. It continues to be prescriber-specific which patients are coming on. There are prescribers who are moving patients from off-label JAKs or from IVIG. There are prescribers who are moving patients from steroids and immunosuppressants.

Look, it’s a great option for patients and a lot of patients and physicians are enthusiastic about it. There were even some newly diagnosed patients coming onto drug. So I think we’re seeing a pretty broad variety of uptake and it really is sort of varying by practice and is hitting the whole spectrum in terms of who we might get. Thanks, Dave. Those are both great questions.

Dave Risinger (Analyst at Leerink Partners)

Thank you.

OPERATOR

Thank you. And the next question will come from Sam Slusky with LifeSci Capital. Your line’s open.

Sam Slusky (Analyst at LifeSci Capital)

Hey, good morning. Thanks for taking the questions, and congrats on the great updates. I guess on just the RA study, could you remind us on the IgG reduction differences between 600 and 300 mg you saw there? And then I realize it’s early, but any sensitivity analysis you’re able to do, even within the 600 mg cohort, for those who had deeper versus less?

Matt Klein (Chief Executive Officer)

Yeah, perfect. Thanks, Sam. It’s a great question. And again, this was tremendously exciting data. We have not shared IgG or autoantibody data in this study because what we’ve learned is this field is competitive and everything we do gets closely followed. And also, as you saw from our data, it’s clear to us that we have a competitive advantage by being able to more deeply suppress IgG and autoantibody levels, and we’re trying to preserve that advantage as best possible.

As a reminder, in the phase one study, we saw pushing high-70s IgG reductions at 600 milligrams. And you can see in this data that indeed the 600 milligram dose outperformed the 300 milligram dose on the primary and secondary endpoints, which is consistent with deeper IgG suppression of the kind we saw in the phase one study mattering here. So we’re feeling pretty good about that. And I think we have learned a lot of interesting things, both to your question, specifically from sensitivity analyses around IgG suppression among the data.

The data is certainly consistent with the thesis that deeper reduction leads to better outcomes. There’s a variety of other sensitivity analyses we’ve done that is also helpful in informing how we think the drug is working, what we think it’s doing. Remember, there’s 170 patients overall, 118 in period two. So. And this was consistent across multiple endpoints. I think that just about covers it.

Sam Slusky (Analyst at LifeSci Capital)

Makes sense. Thanks.

OPERATOR

Thank you. And the next question will come from Yaron Werber with TD Cowen, and your line’s open.

Yaron Werber (Analyst at TD Cowen)

Great. Thanks so much. Congrats on, really, a terrific, amazing quarter all around. Maybe just a quick couple. Is there inventory for Lysria this quarter? Can you quantify it? And then secondly, I know you’re obviously continuing your discussion with FDA on 1402. Any sense whether just one phase three will be sufficient for approval, and with the endpoint one would presume is going to be longer than 16 weeks? Thank you.

Matt Klein (Chief Executive Officer)

Yep, perfect. Thanks. So on the inventory question, I think the way to think about this, again, all of the sales that we book are sales to specialty pharmacy partners. As I think I mentioned, there were hundreds of patients on paid drug—that is, sort of dispensed fills—as of the 9/30 quarter. There was a meaningful amount of undispensed drug that specialty pharmacies were holding as of 9/30. All of what they were holding at that point has now been dispensed, and there continues to be sort of further ordering.

I think we saw a tailwind from those dynamics in the 9/30 quarter. I think there may be a very modest headwind from those dynamics in the 12/31 quarter. But mostly I don’t think this is going to be a significant contributor to variability going forward. And I think those inventory builds are largely driven by demand. And there’s no inventory requirements in our specialty pharmacy agreements, and we ship when people order. On the RA question, look, I think the honest answer to your question is we don’t know on either of those questions for sure—that is, whether one phase three will be sufficient, or what’s the endpoint. We think this is a population with high unmet need and not a lot of options, and so we’re going to talk to FDA about a relatively aggressive plan, and we’re hoping to meet a reasonable reaction just given A) the quality of this data set and B) the levels on the need, and frankly the fact that this study hit a p-value is certainly helpful as well as a part of that discussion.

This data is good. So I think overall we’re hopeful for a good reaction there, but there’s still some uncertainty until we’ve aligned with FDA, including on things like endpoint. So looking forward to a further discussion once we know that. Thanks, Yaron.

OPERATOR

Thank you. And the next question will come from Thomas Smith with Leerink Partners. Your line’s open.

Thomas Smith (Analyst at Leerink Partners)

Hey guys. Good morning. Congrats on the strong RA results, and thanks so much for taking our questions. A couple on 1402. Just wondering, given the strength of the results in this really difficult-to-treat patient population, any thoughts or plans to expand the development program beyond the 85,000 addressable refractory patients? And is that something that could perhaps be discussed within the context of the upcoming regulatory engagement? And also, just wondering, on the current period two data—I know there’s a four-week safety follow-up—just wondering if there’s any potential or opportunity to continue monitoring patients in that four-week follow-up to see how the response rates evolve with greater follow-up. Thanks so much.

Matt Klein (Chief Executive Officer)

Thanks. Appreciate it. Tom, those are both great questions. The first one, I confess, has a “what have you done for me lately” flavor. We’ve just reported great data focused on this patient population. Look, I think we are very focused on first and foremost getting this drug out to these patients. There are a lot of them. Their unmet need is high. They are patients who have a demonstrated willingness to try multiple therapies and have failed the ones they’ve tried.

So I think first and foremost we want to get out there. Obviously, as we continue to learn more about how FCRNs work in these immune complex diseases and diseases that have more complicated pathobiology, I think we’re thinking about places to go. That could include other subsets of RA patients; it could include other diseases. We have some good ideas. But again, first and foremost, we really want to get out to this population. And, you know, I think in terms of what we’re going to learn for evolution of responses from this continued data, I think we’ve already learned an enormous amount from this study. And, you know, I think we’ll continue to learn a little bit as we continue to see what’s going on in this study. But more importantly, I think we just want to get the phase three program up and running, because I think this is going to be a big benefit to patients and we got to get going.

I’ll note that we were aware of one other program in late-stage studies in this sort of patient population from Artiva, and obviously that program was not able to proceed for safety reasons. So we think the unmet need looks even more urgent today than it did not very long ago. And it’s a reminder of just what FCRN is able to deliver in terms of the risk-benefit trade-off, and we hope that’s going to continue in this disease. Thank you, Tom.

OPERATOR

Thank you. And the next question will come from Dennis Dinges with Jefferies. Your line is open.

Dennis Dinges (Analyst at Jefferies)

Hey, good morning. Thanks for taking my questions, and congrats on a fantastic quarter. So I have a question on Lysria. So it’s tough to square the mathematics between the hundreds of patients on paid drug that you reported and the $31 million that’s booked. So, you know, I know you guys won’t disclose a specific inventory revenue number, but is it fair to say that the majority of the revenue booked came from inventory? And then remind me how many patients from your phase three were in the U.S. and who converted to commercial drug in the quarter, but also the pace of converting.

Thanks so much.

Matt Klein (Chief Executive Officer)

Yeah, thanks, Dennis. Look, I think the truth is we’re not going to break out the specifics of how these numbers add up right now, in part because, remember, Lesraya was approved in late August. And so you’re talking about five weeks in total. And frankly, the pace of conversion from Rx to paid Rx is such that one day difference or a few days’ difference in terms of when the quarter happened can make a big difference in how these numbers add up, which is obviously irrelevant to the long-term trajectory.

So I think it’s just not that meaningful to draw the line in the sand, other than to reiterate again, there was a meaningful amount of drug held by the pharmacies at the end of the quarter and it’s all been dispensed now and demand continues to be very good. There were tens of patients from the phase three in the U.S. Of those, there was no U.S. EAP. There was no sort of defined path to get on commercial drug. There’s no sort of EAP transition effect in this data. No sort of bolus of patients coming from the trial or anything like that. A meaningful percentage of those patients are on drug; some are not yet on drug. In many cases, there was a pretty significant gap between the end of the study and when the drug got approved.

This is, I think, clear from the numbers, that there’s an order of magnitude more patients on drug than the entire number of U.S. patients from the OLE. So it’s just not a meaningful driver of any of this. Thanks, Dennis.

OPERATOR

Thank you. And the next question is going to come from Brian Jung with J.P. Morgan. Your line’s open.

Brian Jung (Analyst at J.P. Morgan)

Hey guys, thanks for taking our questions. Matt, do you have any color in terms of the number of touchpoints you’ve had with the DM specialists and how many of them have been converted and actively prescribing Listeria? And then one more on RA: just given the slight difference in the baseline CDAI score between 600 and placebo, how should we think about the potential of it influencing the efficacy output? Thank you.

Matt Klein (Chief Executive Officer)

Yeah, thanks. So look, on the first, we have many hundreds of prescribers at this point, which is awesome. It’s just a phenomenal number in terms of the number of people who have written. And again, I think it’s a reflection of the level of enthusiasm we have. The team is excellent at many things. One of the things they are excellent at is pounding pavement. So I don’t have a number, but we’ve had lots of touchpoints for the DM specialists, and I think that’s been great.

I think it’s been an important moment for the field, and I think we’ve been out there from a medical affairs perspective, we’ve been out there from a commercial perspective. I think you see it, even this weekend at the conference, there’s just a lot of enthusiasm for Brepo, and we’re excited to be continuing to talk about the drug in every setting that we’re able. I don’t—that’s it. On 1402, I think the short answer to that is not much to read into on CDAI. Remember that because it’s a randomized withdrawal trial, it’s not exactly obvious which direction is better. A higher starting point could be better or easier, but it’s a little bit unclear. As a reminder, all of these scores are actually positively biased by the fact these patients were on drug for 16 weeks and were limited to the responders. So I think it’s a little bit difficult to read exactly into the meaning of that number.

But overall, I don’t think we’ve seen anything notable from that relatively small delta across the arms. The numbers are strong and consistent across the board, and I think it’s just about overall clinical benefit. Thanks, Brian.

OPERATOR

Thank you. And the next question is going to come from Alex Thompson with Stifel. Your line’s open.

Patrick (Analyst at Stifel)

Hey, guys, congrats on the quarter. This is Patrick on for Alex. Switching gears a little bit, could you guys just talk about, for Moseli, which additional phase 2 starts we should maybe expect next year, and how you’re thinking about prioritizing these other PH indications?

Matt Klein (Chief Executive Officer)

Yeah, thanks, Alex. It’s a great question, and it’s one that I’m personally really excited about, given what Mosuli was able to show in that PH-ILD study. And frankly, we’re now reaping the benefit from having started that PH-ILD study ahead of time, in that the team has been able to start to turn focus to these other phase 3 study starts. I think what we’ve said in various settings before is that we were excited about IPF, that we’re worried about competitive dynamics in PAH.

I think our world sort of turned upside down in a great way once we saw the data. And so I think what we’ve said is that every form of pulmonary hypertension is exciting to us. Now we’re aggressively looking at PAH, we’re looking at the other forms of pulmonary hypertension to see where there might be good opportunities. We’re looking at IPF, we’re looking at PPF. Lots of good places to go. I can’t commit to any of those indications now. Some of them could be phase 3, some of them might be phase 2s, depending on the indication.

But I think we’re envisioning a pretty broad program, and we’re sprinting to the starting line on additional indications. So looking forward to talking about it as soon as we can.

Patrick (Analyst at Stifel)

Awesome. Thank you.

OPERATOR

Thank you. And our next question will come from Yasmeen Rahimi with Piper Sandler. Your line’s open.

Yasmeen Rahimi (Analyst at Piper Sandler)

Hey, team, thank you so much. Congrats—an amazing year and more to come for next year. I guess my question is: 2027 is right around the corner. It could be a very big year for Immunovant with Graves and MG data. Obviously, on clinicaltrials.gov these studies are still indicated as recruiting. They’re 26 weeks long. So just would love to get an idea: at what point over the next few months would you be in a position to fine-tune guidance, provide color, and maybe even in this call provide commentary on the enrollment to help us understand the timing of these two studies, specifically around Graves?

Appreciate it.

Matt Klein (Chief Executive Officer)

Thanks, Yasmeen. I appreciate it. I’ll say enrollment has been strong in Graves. I think we benefited from pioneering that field and being first. I don’t have an update to share today, but I expect to have one relatively soon on timing for next year and how everything goes. So looking forward to sharing that in the relatively near future.

Yasmeen Rahimi (Analyst at Piper Sandler)

Perfect. Thank you.

OPERATOR

Thank you. And the next question is going to come from Derek Carcillo with Wells Fargo. Your line’s open.

Jake Monfort (Analyst at Wells Fargo)

Good morning, this is Jake Monfort. Derek, thanks for taking our question and congrats on all the updates. Just one from us on RA. Could you comment on what you saw from degree of ACPA positivity or autoantibody levels relative to IgG? And then, given what you saw in the 2b, would you expect the same ACPA positivity criteria to get carried forward into the phase three? Thanks.

Matt Klein (Chief Executive Officer)

Thanks. On the autoantibody side, I’ll say I think we have learned interesting, exciting things that are highly competitively valuable, and so we’re going to say almost nothing about autoantibody reduction for that reason. What I’ll say is, based on what we’ve learned, I think we’ve got a good amount of confidence going into phase three. I don’t think we intend to make a significant change to our enrollment criteria. But again, we haven’t finished that conversation with FDA, and so we’re still working through the details of that, and there could be changes in one direction or another depending on how that goes.

But overall, feeling good about our plan going forward and feeling like—honestly, and kudos to the various teams here who’ve worked on it—I think we’ve really found a patient population that is well suited to this therapy, and we’re excited carrying forward in that patient population given what we’re seeing today.

Jake Monfort (Analyst at Wells Fargo)

Thank you. Thanks, guys.

OPERATOR

Thank you. And the next question will come from Samantha Simenco with Citi. Your line’s open.

Samantha Simenco (Analyst at Citi)

Hi, good morning. Thanks very much for taking the question, and let me add my congrats on your very strong quarter. Just a question on 1402. As you’ve highlighted in the RA data, it seems that the greater IgG suppression is necessary to drive that difference versus placebo, and this is just the latest data set where you’ve seen this pattern. So I’m wondering, how are you thinking about the Sjogren’s opportunity in this context, even given the recent competitor data?

Thanks very much.

Matt Klein (Chief Executive Officer)

Yeah, thanks. So it’s a great question. And obviously the J&J Sjogren’s study looked like there was a dose response as well. You know, we said today we’re probably not expecting to progress Sjogren’s. The truth is our genex’s futility analysis had a really low bar, and they failed in 500 patients, which is just a tough sign. The reason, among other reasons, one of the reasons providing an update today is, in order to meet the timelines we’d originally set for ourselves, our plan had either been to expand the existing phase two or to add a phase three on right about now, and I think it just doesn’t make sense to do that given what we know.

And so, look, we’re hoping to learn as much as we can from our phase two to finish the study. Obviously if there’s something surprising, we’ll reevaluate. But just given the experience of our competitors and what we’ve seen in different directions, including Novartis’s ongoing schedule with FDA, what we’ve seen from Amgen, et cetera, we’re just thinking it’s relatively unlikely at this point. But we’ll learn what we can from the phase two, and if there’s something interesting, we’ll come back.

Thank you.

OPERATOR

Thank you. And the next question is going to come from Douglas Salwitt, HC Wainwright. Your line is open.

Douglas Salwitt (Analyst at HC Wainwright)

Hi, good morning. Thanks for taking the question, Matt. In terms of the RA, after the part one data, you sort of set an expectation or noted that it might be hard to see a difference in part two. I’m just curious, given the fact that we did see some nice separation, ultimately what was the key takeaway for you? Was it the rapidity that placebo patients declined, or was it that the treatment effect really continued to maintain itself? And what does that tell you about the opportunity for you from a commercial standpoint?

Thank you.

Matt Klein (Chief Executive Officer)

Yeah, it’s a great question. And part of what is interesting is, again, you’re thinking all these patients come in with an ACR20; three quarters of them—75%—on placebo have maintained an ACR20 response. So there appears to be some sort of durability of clinical benefit, which is interesting. I think against the backdrop of 75% of these ACR20 responders still having a response at the end, the fact that we were able to preserve north of 90% of those responders on drug is pretty exciting, again in a patient population that has really struggled across others.

So I think we’re pretty excited about both the durability off-drug effect as well as the durability continuing on-drug effect, and the fact that we saw a continued build in some of the responder rates, especially at ACR50 and ACR70 over time. And so I think it’s just pretty interesting data overall, and we think that translates to an exciting commercial opportunity. Again, I’m looking forward to—one of the things we’re going to do on our investor day is spend some time digging in on this and why we’re so excited about it.

So I’ll plant that as a flag for please come and listen. I think that’ll be a good session. But I think the data really, really did us a solid here.

Douglas Salwitt (Analyst at HC Wainwright)

Okay, great. Congrats, and we’ll see you in December.

OPERATOR

Thank you. And the next question is coming from Ash Burma with UBS. Your line is open.

Ash Burma (Analyst at UBS)

Hey. Yeah, thanks for taking my question. So, just on 1402 for difficult-to-treat RA. You mentioned the FDA interaction is the next step. Can you talk a little bit about the initial thoughts on what you think would be the right clinical trial design here? Is it likely a regimen that would be a combo with methotrexate or TNF? Or are you thinking of monotherapy? And just in terms of trial design, is it likely to be parallel or randomized withdrawal?

Eric Venker (President and CEO)

Yeah, look. Thanks, Ash. It’s a great question. The first thing I’ll say—sorry, there’s a little bit of an echo. Could someone just mute their line? Maybe. I’m not sure whose line it is, but… Okay, that sounds better. Look, I think the first thing is the right study design here is the one that gets the drug approved. And so that’s ultimately got to be a conversation together with FDA. And, you know, we think this population has a big effect and, you know, a lot of the particulars in terms of endpoint and so on are going to be discussions. I think it’s relatively unlikely this will be a randomized withdrawal study. I think it’s pretty likely, just given the division and the way other RA studies have worked, this will be a straightforward RCT.

And I think other than that, in terms of patient population, it will be quite similar to what we’ve done here in the Phase IIb in this study because it’s a good patient population. We expect a lot of collaboration from FDA and we think we’ll get to a path forward here. Again, I think the questions are N and specifics around endpoints and things like that. And I think we’re hoping for a reasonable dialogue with FDA on those points, but there’s a pretty broad range of potential outcomes depending on how FDA approaches the questions.

And we’re looking forward to sharing that once we’ve got it. Thanks, Ash.

OPERATOR

I am showing no further questions at this time. I will now turn the call back over to Matthew Glein for closing remarks.

Matt Klein (Chief Executive Officer)

Thanks. Thank you. Thank you again, everyone, for listening. Look, it’s been a really fun year for us. I think there’s no substitute in this business for generating clinical data that matters. And we’ve had a lot of opportunity to do that across multiple indications. And then it’s tremendously rewarding when something like the Lysria approval and launch happens, where you plan for something for a long time, you work really hard as a team on getting it there, you generate data that matters for patients, FDA agrees with you, then you get to actually see patients on drug using it, physicians excited to make it a part of their practice.

And it’s just a… it’s a really great moment and it feels amazing. And, you know, a huge kudos to, you know, to the Roivant Sciences team, to the private team, to the Polyvan team, the Immunovant team. These things are a ton of work. And, you know, even in the AI age, there is no substitute for hard work and pavement pounding. And it’s been a lot of that. And then, you know, again, just thank you to the patients in our studies who have made this possible, the investigators, and now to the patients and the physicians who are entrusting us with their care in neuronomyositis.

It’s a great moment for Roivant Sciences, and I’m looking forward to lots of good stuff coming. So thank you everybody, and looking forward to seeing many of you in just a few short weeks here for our investor day. Have a great day.

OPERATOR

This concludes today’s conference call. Thank you for participating, and you may now disconnect.

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