Immunovant (IMVT) Q2 2027 Earnings Call Transcript

Image source: The Motley Fool.

DATE

Mon, Nov 9, 2026

CALL PARTICIPANTS

• Chief Executive Officer - Matthew Gline
• Investor Relations - Stephanie Lee Griffin
• Investor Relations - Keyur Parekh

TAKEAWAYS

• IMVT-1402 ACR20 Response (600 mg) -- 92.5% versus 75.6% for placebo at week 28 (p=0.0139), demonstrating maintenance of clinical response in patients with difficult-to-treat rheumatoid arthritis.
• IMVT-1402 ACR20 Response (300 mg) -- 75.0%, representing no statistically significant difference from the 75.6% placebo rate (p=0.9426).
• Exploratory ACR50 Response -- 80.0% for the 600 mg dose at week 28 compared to 56.1% for placebo (nominal p=0.0117).
• Exploratory ACR70 Response -- 52.5% for the 600 mg dose versus 36.6% for placebo at the week 28 analysis.
• CDAI Secondary Endpoint -- Showed a least squares mean change of -0.3 for the 600 mg dose versus a +3.1 increase for placebo (p=0.1096).
• SDAI Secondary Endpoint -- Showed a least squares mean change of +0.1 for the 600 mg dose compared to +3.5 for placebo (p=0.1299).
• Sjögren’s Disease Strategic Update -- Management stated it is unlikely to advance IMVT-1402 beyond the current Phase 2 trial due to the evolving landscape and recent competitor data.
• Graves’ Disease and Myasthenia Gravis Timing -- Topline data for potentially registrational trials are expected in calendar year 2027.
• CIDP Data Guidance -- Topline data for the potentially registrational trial in chronic inflammatory demyelinating polyneuropathy is anticipated in calendar year 2028.
• Cash Position -- $722.3 million as of Sept. 30, 2026, which the company expects will provide a runway to the potential commercial launch in Graves’ disease.
• Research and Development Expenses -- $85.0 million for the quarter, a decrease from $114.2 million reflecting the wind-down of batoclimab trials and timing of manufacturing costs.
• General and Administrative Expenses -- $19.1 million, an increase from $17.5 million driven by higher investments in pre-commercial activities.
• Net Loss -- $97.2 million, or $0.47 per share, compared to $126.5 million in the prior year's second fiscal quarter.
• Common Stock Outstanding -- 206,785,540 shares as of Sept. 30, 2026.
• LISRAYA Net Revenue -- $31.0 million recorded during the first five weeks of launch following its August approval.
• LISRAYA Patient Volume -- Hundreds of patients were on paid drug at the end of the quarter, with many hundreds currently receiving paid therapy.
• Mosliciguat PVR Reduction -- 56% placebo-adjusted reduction in pulmonary vascular resistance at week 16 in patients with PH-ILD.
• PH-ILD Clinical Outcomes -- 35-meter statistically significant improvement in six-minute walk distance observed at week 16.
• Brepocitinib NIU Quiescence -- Almost two-thirds of patients achieved steroid-free quiescence in clinical trials for non-infectious uveitis.
• Roivant Corporate Cash -- $4.2 billion as of Sept. 30, 2026, reflecting receipts from Moderna litigation.
• Roivant Share Repurchases -- $280 million worth of stock, totaling 9.4 million shares, repurchased during the six months ended Sept. 30, 2026.
• IgG Suppression Data -- Management reported high 70s% IgG reduction at the 600 mg dose in Phase 1 studies, which is consistent with the observed therapeutic benefit.

Need a quote from a Motley Fool analyst? Email pr@fool.com

RISKS

• Gline stated, "There'll probably be a modest headwind from those dynamics in the December quarter," referring to the impact of initial specialty pharmacy stocking on sequential revenue growth.
• Gline noted that "argenx's futility analysis had a really low bar, and they failed in 500 patients," as a reason for the company's caution regarding the Sjögren’s disease program.
• Gline indicated that for LISRAYA, "some plans are trying more significant restrictions" on patient access, which may impact future uptake despite early straightforward coverage.

SUMMARY

Immunovant, Inc. (NASDAQ:IMVT) reported that its lead candidate, IMVT-1402, met the primary endpoint in a Phase 2 trial for difficult-to-treat rheumatoid arthritis, with the 600 mg dose achieving a 92.5% ACR20 response at week 28. Management indicated a strategic decision to deprioritize further development in Sjögren’s disease, citing unfavorable clinical data from competitors and the evolving market landscape. Parent company Roivant Sciences reported a commercial launch for LISRAYA, yielding $31.0 million in initial revenue and broad early physician adoption. The company confirmed it is on track for major data readouts in Graves’ disease and myasthenia gravis in 2027 while maintaining a balance sheet intended to fund operations through its first potential commercial launch.

• Gline highlighted that the RA data supported the thesis that deep IgG suppression is required for efficacy, as the 300 mg dose failed to differentiate from placebo.
• The company noted that LISRAYA's initial revenue included a meaningful amount of undispensed drug held by specialty pharmacies as of Sept. 30, 2026.
• Management plans to engage with the FDA later this year or early next year to align on the registrational path for IMVT-1402 in rheumatoid arthritis.
• Gline stated that for mosliciguat, "every form of pulmonary hypertension is exciting to us now" following the data in PH-ILD, and plans for additional indications are in development.
• The company reported that 98% of patients in the mosliciguat PH-ILD study achieved the high dose, which management used to illustrate the drug's safety and tolerability profile.

INDUSTRY GLOSSARY

• ACR20: A standard measure used in rheumatoid arthritis clinical trials indicating a 20% improvement in specific disease activity criteria.
• CDAI: Clinical Disease Activity Index, a composite score used to assess disease severity and treatment response in rheumatoid arthritis.
• D2T RA: Difficult-to-treat rheumatoid arthritis, a patient population that has failed multiple advanced therapies.
• FcRn: Neonatal fragment crystallizable receptor, a protein that regulates the half-life of IgG antibodies.
• IgG: Immunoglobulin G, the most common type of antibody in the blood; reduction is a key therapeutic goal for FcRn inhibitors.
• PH-ILD: Pulmonary Hypertension associated with Interstitial Lung Disease.
• PVR: Pulmonary Vascular Resistance, a measure of the resistance the heart must overcome to pump blood through the lungs.
• SDAI: Simplified Disease Activity Index, a tool for monitoring disease activity in rheumatoid arthritis patients.

Full Conference Call Transcript

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Roivant Second Quarter 2026 Earnings Call. [Operator Instructions] 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 Griffin: Good morning, and thanks for joining today's call to review Roivant's second quarter ended September 30, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Klein, CEO of Roivant. 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 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 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.

Matthew Gline: Thanks, Steph, and thank you all for joining this morning. I'm glad you're all here. We have -- I'm going to go through the deck, and I'll announce the slide numbers that I hit them. I'll start with the agenda on 3. Just a lot to hit today. So between stuff that we've already talked about on calls and some pretty exciting new updates. So I'm not going 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 LISRAYA as well as some other items.

So I'll start on Page 4, which just hitting -- because this is our last quarterly update in 2026. Just 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 in CS. We got LISRAYA approved. We got the NIU data. So the sort of brepo franchise, the Priovant team executing at 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, but that we're not going to wind up progressing in all likelihood in Sjögren's based on various updates in the field. We're going to run that study out and learn what we can from it.

Then an amazing year for mosli as well, with obviously the phenomenal data earlier this quarter in PH-ILD, as well as the starting of the phase III study there and the ongoing combo study with TYVASO. 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 LISRAYA approved. It's a really exciting moment for us, for the dermatomyositis community, for patients, for prescribers. We're really proud that it's out on the market.

This quarter reflects on slide seven, really five weeks on the market from approval. 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 it really is 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 with what this means in terms of patient and physician demand, in terms of execution from the Priovant team. I think it's really just a signal of how high the 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. 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 2 of the IMVT-1402 RA study has now read out. As a reminder on Slide 9 of the way the study worked, this was a randomized withdrawal trial in which in Period 1, all patients were on 600 mg, that's the high dose of 1402, and we reported that data. As a reminder, we had 70%+ ACR20 responses, 50%+, kind of mid-50s ACR50 responses, and around 35% ACR70 responses at the end of that Period 1.

In Period 2, those patients who had achieved an ACR20 response were then put into a randomized withdrawal portion, where they were either kept on 600 mg or randomized down to 300 mg or placebo. 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 it's 100% of those patients roughly started or were randomized into this, had ACR20 responses. So 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.

The disposition was pretty straightforward in terms of balance across the arms. 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 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 have struggled to get adequately treated, and we know that autoantibody pathology matters, at least in some of these patients, and 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. This enrolled -- the trial on 13 enrolled a difficult-to-treat population. These were fourth line plus patients having failed conventional therapy, and again, 2-plus mechanisms of advanced therapy. You can see a little bit about this. 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. A pretty well-balanced study. I think what we saw on Slide 15 was just phenomenal across a couple of dimensions.

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 mg arm. Notably, and I think this is an important finding, 300 mg was not enough to preserve the response.

300 mg 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 on 600 mg had, I think, a nominal p-value, the stats weren't worked, 80% on ACR50 had an ACR50 response at that week 28 versus 56% on placebo.

Again, nice separation without a nominal p-value on ACR70 at week 28. Consistent data across depth of response. I really like slide 17, in that you can just see over time that these patients are just, it looks like they're significantly benefiting.

This is the cohort of patients who were on 600 mg for the full period, and you can see already some meaningful ACR50 and ACR70 responses as early as week 4, and those responses really continue to get better and are well-preserved through the end of the study, even though after week 16, there starts to be a, "placebo effect", where some of these patients were where the patients thought they might have been taken off drug at that point. 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 reflect widely used scales in clinical practice for assessing sustained response. 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 experience subset. The JAK experience subset did just about as well as the overall population. 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.

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 have. We had hoped, on Slide 22, to be able to share together with this update, that we were 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.

We will come back to you once we have finished our FDA discussions, probably later this year or early next year, with an update on our trial plans. 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. 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 have gotten the call for, I wanted to remind everybody of what we have 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 it as an agent. NIU is a highly morbid disease, on Slide 24. It is a poorly served indication. It is 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 70,000 to 190,000 patients with posterior intermediate or panuveitis. That is obviously a specific target population here. 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 a phenomenal, I think it is the largest benefit ever seen for a non-steroidal therapy in NIU, in that 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. Look, this data has been incredibly well-received by the doc community as we have been out talking about it. I think it is going to be an important new treatment option for NIU patients.

We are 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 will not 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. Really exciting. Again, not going to go through the data slide by slide, but we have reproduced it here because we are quite proud of it. Same thing with mosliciguat, jumping to Slide 31. As a reminder, PH-ILD is a really tough disease with few current treatment options.

These patients have one and a half to two years median survival despite best available standard of care therapy. We've said about up to 200,000 patients across the U.S. and Europe. It's likely an under-reported disease. You see the market growing as new therapies like Tyvaso are on the market, and there are no non-treprostinil approved therapies for these patients, so there's a big opportunity to deliver something new. Don't need to belabor the data, but on Slide 32, we were just tremendously proud of what mosliciguat 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 m statistically significant improvement in the key secondary, a 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 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 reproduced the data again because we're just tremendously proud of what mosliciguat's been able to demonstrate in this patient population. Just phenomenal. On Slide 37, as a reminder, that phase III 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 mosliciguat in other indications, where we are now hard at work.

I will wrap up here with just a quick financial update on Slide 39. Relatively consistent with expectations in terms of expenses for the quarter. Net of tax, loss from continuing operations of $153 million, or non-GAAP of $133 million. Cash is back at $4.2 billion as of September 30, reflecting in part the receipts from the Moderna litigation that we got over the summer. 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 LISRAYA launch off to a start that we're pretty excited about. But 2027's a very busy year. In addition to getting the sNDA file 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. I think we've got a lot to come. With that, I will pause to just remind everybody, our Investor Day is on December 9th. Please register. The link is in the presentation from today. I will hand it back to the operator to start Q&A. Thank you again, everybody. I want to just, before I do that, just say thank you again to everybody who makes this happen, the Roivant employees, the Vant employees, Priovant, Immunovant, Pulmovant, great updates from all those teams, and then obviously, again, to the patients and investigators who trust us with their care. It has been a phenomenal year.

Thanks. Operator, please go to Q&A.

Operator: [Operator Instructions] Our first question is going to come from Dave Risinger with Leerink Partners.

David Risinger: Congrats, Matt, to you and the team on a phenomenal quarter. My question is on LISRAYA. 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?

Matthew Gline: Yes, perfect. 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 is really everything in that number is, quote, unquote, paid, although obviously it is paid at the time it is purchased by the pharmacy. I will say, without giving specific numbers, we are still in the early innings of payer coverage, and the early innings of payer coverage have been straightforward, and so we are getting very good conversion rates at this point, with relatively straightforward access from a payer dynamic.

Obviously, the concern or the question is, as the payers get their act together, we will start to see plans in place, and we have seen some of those programs in place or access controls in place, and we have seen some of that. I will say it has ranged from, there are significant national plans whose only restriction is that you have to have tried a systemic immunosuppressant. 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 is sort of how we are thinking about those numbers. I think feeling good. I would 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 do not have a lot of specific things to report in terms 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 is a great option for patients, and a lot of patients and physicians are enthusiastic about it. There are even some newly diagnosed patients coming on to drug.

So I think we are seeing a pretty broad variety of uptake, and it really is varying by practice and is hitting the whole spectrum in terms of who we might get.

Operator: The next question will come from Sam Slutsky with LifeSci Capital.

Samuel Slutsky: Congrats on the great updates. I guess on just the RA study, could you just remind us on the IgG reduction differences between 600 mg and 300 mg you saw there? 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?

Matthew Gline: Yes. Perfect. It's a great question. This was a tremendously exciting data. We have not shared IgG or antibody data in this study because what we've learned is this field is competitive, and everything we do gets closely followed. 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 I study, we saw pushing high 70s IgG reduction at 600 mg.

You can see in this data that indeed the 600 mg dose outperformed the 300 mg dose on the primary and secondary endpoints, which is consistent with deeper IgG suppression of the kind we saw in the phase I study mattering here. So we're feeling pretty good about that. I think we have learned a lot of interesting things. Both to your question from 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 analysis 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 2. This was consistent across multiple endpoints. I think that just about covers it.

Operator: The next question will come from Yaron Werber with TD Cowen.

Yaron Werber: Great. Congrats on really a terrific, amazing quarter all around. Maybe just a quick couple. Is there inventory for LISRAYA this quarter? Can you quantify it? Secondly, I know you're obviously continuing your discussion with FDA on imeroprubart 1402. Any sense that whether just one phase III will be sufficient for approval? With the endpoint, one would presume is going to be longer than 16 weeks.

Matthew Gline: Yes. 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 the variability going forward. I think those inventory builds were 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 III 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 dataset, and B, the level of unmet 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. 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 endpoints. So, looking forward to a further discussion once we know that.

Operator: The next question will come from Thomas Smith with Leerink Partners.

Thomas Smith: 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? Is that something that could perhaps be discussed within the context of the upcoming regulatory engagement? Then, also just wondering on the current Period 2 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.

Matthew Gline: Those are both great questions. The first one, I confess, has a what have you done for me lately flavor, and that we 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 have tried. 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 are 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. I think in terms of what we are going to learn for evolution of responses from this continued data, I think we have already learned an enormous amount from this study. I think we will continue to learn a little bit as we continue to see what is going on in this study.

More importantly, I think we just want to get the phase III program up and running, because I think this is going to be a big benefit to patients, and we got to get going. I will note that we were aware of one other program in late-stage studies in this patient population from Artiva, and obviously that program was not able to proceed for safety reasons. We think the unmet need looks even more urgent today than it did not very long ago, and it is a reminder of just what FcRn is able to deliver in terms of the risk-benefit trade-off, and we hope that is going to continue in this disease. Thank you, Tom.

Operator: The next question will come from Dennis Ding with Jefferies.

Yuchen Ding: Congrats on a fantastic quarter. I have a question on LISRAYA. It is tough to square the math for me between the hundreds of patients on paid drug that you reported and the $31 million that is booked. I know you guys will not disclose a specific inventory revenue number, but is it fair to say that the majority of the revenue booked came from inventory? Then, remind me how many patients from your phase III were in the U.S., and who converted to commercial drug in the quarter, but also the pace of conversion.

Matthew Gline: Yes. Look, I think the truth is we are not going to break out the specifics of how these numbers add up right now, in part because remember, LISRAYA was approved in late August, and so you are talking about five weeks in total. 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.

I think it is 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 has all been dispensed now, and demand continues to be very good. There were tens of patients from the phase III in the U.S., so I think that is the mechanical answer to that question. Of those, there was no U.S. EAP. There was no sort of defined path to get on commercial drug. There is 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 is an order of magnitude more patients on drug than the entire number of U.S. patients from the OLE. So it is just not a meaningful driver of any of this.

Operator: The next question is going to come from Brian Cheng with JPMorgan.

Brian Cheng: Matt, do you have any color in terms of the number of touchpoints you have had with the DM specialists, and how many of them have been converted and actively prescribing with LISRAYA? One more on RA. Just giving the slight difference in the baseline CDAI score between 600 mg and placebo, how should we think about the potential of it influencing the efficacy output?

Matthew Gline: Yes. Look, on the first, we have many hundreds of prescribers at this point, which is awesome. It is just a phenomenal number in terms of the number of people who have written. Again, I think it is a reflection of the level of enthusiasm. The Priovant team is excellent at many things. One of the things they are excellent at is pounding pavement. I do not have a number, but we have had lots of touchpoints with the DM specialists, and I think that has been great.

I think it has been an important moment for the field, and I think we have been out there from a med affairs perspective, we have been out there from a commercial perspective. I think you see it even this weekend at the conference. There is just a lot of enthusiasm for brepo, and we are excited to be continuing to talk about the drug in every setting that we are able. Anyway, that is it on the brepo question. On 1402, I think the short answer to that is not much to read into on CDAI. Remember that because it is a randomized withdrawal trial, it is not exactly obvious which direction is better.

A higher starting point could be better or easier, but it is a little bit unclear. As a reminder, all of these scores are actually positively biased by the fact that these patients were on drug for 16 weeks and were limited to the responders. I think it is a little bit difficult to read in exactly to the meaning of that number. But overall, I do not think anything that we have seen, anything notable from that sort of relatively small delta across the arms. The numbers are strong and consistent across the board, and I think it is just about overall clinical benefit.

Operator: The next question is going to come from Alex Thompson with Stifel.

Patrick Culliton: Congrats on the quarter. This is Patrick on for Alex. Switching gears a little bit, I guess, could you guys just talk about, for mosli, what additional phase II starts we should maybe expect next year, or how you're thinking about prioritizing these other PH indications?

Matthew Gline: Yes. It's one that I'm personally really excited about, given what mosli was able to show in that PH-ILD study. 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 III study starts. I think what we've said in various settings before is that we were excited about IPF, that we were worried about competitive dynamics in PAH. I think our world sort of turned upside down in a great way once we saw the data. 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 IIIs, some of them might be phase IIs, 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.

Operator: Our next question will come from Yasmeen Rahimi with Piper Sandler.

Yasmeen Rahimi: Congrats on 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. 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.

Matthew Gline: I appreciate it. I will say enrollment has been strong in Graves'. I think we benefited from pioneering that field and being first. I do not 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.

Operator: The next question is going to come from Derek Archila with Wells Fargo.

Unknown Analyst: Congrats on all the updates. Just one from us on difficult-to-treat RA. Could you comment on what you saw from the degree of ACPA positivity or autoantibody levels relative to IgG? Then, given what you saw in the II-B, would you expect the same ACPA positivity criteria to get carried forward into the phase III? Thanks.

Matthew Gline: On the autoantibody side, I will say I think we have learned interesting, exciting things that are highly competitively valuable, so we are going to say almost nothing about autoantibody reduction for that reason. What I will say is, I think based on what we have learned, I think we have got a good amount of confidence going into phase III. I do not think we intend to make a significant change to our enrollment criteria, but again, we have not finished that conversation with FDA, so we are 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 I mean, honestly, and kudos to the various teams here who have worked on it. I think we have really found a patient population that is well-suited to this therapy, and we are excited to carrying forward in that patient population given what we have seen today.

Operator: The next question will come from Samantha Semenkow with Citi.

Samantha Semenkow: 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 dataset where you've seen this pattern. I'm wondering just how are you thinking about the Sjögren's opportunity again in this context, even given the recent competitor data? Thanks very much.

Matthew Gline: And obviously the J&J Sjögren's study looked like there was a dose response as well. We said today we're probably not expecting to progress Sjögren's. The truth is, argenx's futility analysis had a really low bar, and they failed in 500 patients, which is just a tough sign. Among other reasons, one of the reasons we're 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 II or to add a phase III on right about now, and I think it just doesn't make sense to do that given what we know.

So, look, we're hoping to learn as much as we can from our phase II 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 discussions with the FDA, what we've seen from Amgen, et cetera, we're just thinking it's relatively unlikely at this point. We'll learn what we can from the phase II, and if there's something interesting, we'll come back.

Operator: The next question is going to come from Douglas Tsao at HC Wainwright.

Douglas Tsao: 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 sort of a difference in part two. I'm just curious, given the fact that we did see some nice separation ultimately, what was sort of the key takeaway from you? Was it the rapidity that placebo patients sort of declined, or was it that the treatment effect sort of really continued to maintain itself? What does that tell you about the opportunity for you from a commercial standpoint?

Matthew Gline: It's a great question, and part of what is interesting is, again, you're thinking all of 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 had a response at the end, I think 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 sort of durability of off-drug effect as well as the durability of 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. I think it is just pretty interesting data overall, and we think that translates to an exciting commercial opportunity. Again, I am looking forward to --one of the things we are going to do on our Investor Day is spend some time digging in on this and why we are so excited about it. I will plant that as a flag for please come and listen. I think that will be a good session.

I think the data really did us a solid here.

Operator: The next question is coming from Ash Verma with UBS.

Ashwani Verma: 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 TNFs, or are you thinking of monotherapy? Just in terms of trial design, is it likely to be parallel or randomized withdrawal?

Matthew Gline: Look, I think the first thing is, the right study design here is the one that gets the drug approved, so that's ultimately got to be a conversation together with FDA. We think this population has a big effect. 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.

I think other than that, in terms of patient population, it will be quite similar to what we've done here in the phase II-B 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 end and specifics around endpoints and things like that. I think we're hoping for a reasonable dialogue with FDA on those points. 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.

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

Matthew Gline: 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. It's tremendously rewarding when something like the LISRAYA 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. It's a really great moment, and it feels amazing.

Huge kudos to the Roivant team, to the Priovant team, to the Pulmovant team, the Immunovant team. These things are a ton of work, and even in the AI age, there is no substitute for hard work and pavement pounding, and it has been a lot of that. Then, 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 dermatomyositis. It is a great moment for Roivant, and I am looking forward to lots of good stuff coming.

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.

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.

The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.