IMVT
ImmunovantBDocument history
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Related articleQuarter not tagged2026-10-21Immunovant to Report Financial Results for the Second Fiscal Quarter Ended September 30, 2026, and Provide Business Update on Monday, November 9, 2026
GlobeNewswire
Immunovant to Report Financial Results for the Second Fiscal Quarter Ended September 30, 2026, and Provide Business Update on Monday, November 9, 2026
DURHAM, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT) today announced that it will report its financial results for the second fiscal quarter ended September 30, 2026 on Monday, November 9, 2026 before the market opens. Roivant Sciences Ltd. (Nasdaq: ROIV), Immunovant's majority stockholder, will host a live conference call and webcast at 8:00 a.m. ET that same day, which will include a business update for Immunovant. To access the Roivant conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "News & Events" in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant's website after the conference call. About Immunovant Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. Contacts: Investors Keyur Parekh [email protected] Media Stephanie Lee [email protected]
Related articleQuarter not tagged2026-09-23Immunovant Announces Topline Results from Proof-of-Concept Study of IMVT-1402 in Cutaneous Lupus Erythematosus
GlobeNewswire
Immunovant Announces Topline Results from Proof-of-Concept Study of IMVT-1402 in Cutaneous Lupus Erythematosus
Immunovant’s proof-of-concept study of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12 Positive trends were observed on multiple endpoints, with deeper IgG reductions resulting in improved clinical outcomes, but the study did not meet Immunovant’s internal bar to continue development of IMVT-1402 in CLE IMVT-1402 demonstrated a favorable safety and tolerability profile, consistent with prior studies All other clinical development timelines remain on track DURHAM, N.C., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT) today announced topline results from Period 1 of its proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE). The study did not achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. Numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE. “On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care. Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward,” said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant. Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402 across multiple autoimmune diseases with significant unmet need, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease. About the Proof-of-Concept Study of IMVT-1402 in CLEThe proof-of-concept clinical study (NCT06980805) of IMVT-1402 (imeroprubart) in CLE is a randomized, double-blind, placebo-controlled, global trial that assessed the safety and efficacy o…Read full documentShow less
Immunovant’s proof-of-concept study of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12 Positive trends were observed on multiple endpoints, with deeper IgG reductions resulting in improved clinical outcomes, but the study did not meet Immunovant’s internal bar to continue development of IMVT-1402 in CLE IMVT-1402 demonstrated a favorable safety and tolerability profile, consistent with prior studies All other clinical development timelines remain on track DURHAM, N.C., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT) today announced topline results from Period 1 of its proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE). The study did not achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. Numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE. “On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care. Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward,” said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant. Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402 across multiple autoimmune diseases with significant unmet need, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease. About the Proof-of-Concept Study of IMVT-1402 in CLEThe proof-of-concept clinical study (NCT06980805) of IMVT-1402 (imeroprubart) in CLE is a randomized, double-blind, placebo-controlled, global trial that assessed the safety and efficacy of IMVT-1402 in adult patients with CLE. The study enrolled 57 patients. In Period 1, patients were randomized to IMVT-1402 vs. placebo for a 12-week treatment period. The primary endpoint was the percent change from Period 1 baseline in CLASI-A score at Week 12. About ImmunovantImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. Forward-Looking StatementsThis press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding Immunovant’s plans and progress towards developing IMVT-1402 across a broad range of indications. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, regulatory strategy, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402; Immunovant is at various stages of clinical development for IMVT-1402; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 20, 2026, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Contacts:InvestorsKeyur [email protected] MediaStephanie [email protected]
Related articleQuarter not tagged2026-09-23Roivant Announces Topline Results from Proof-of-Concept Study of IMVT-1402 in Cutaneous Lupus Erythematosus
GlobeNewswire
Roivant Announces Topline Results from Proof-of-Concept Study of IMVT-1402 in Cutaneous Lupus Erythematosus
Immunovant’s proof-of-concept study of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12 Positive trends were observed on multiple endpoints, with deeper IgG reductions resulting in improved clinical outcomes, but the study did not meet Immunovant’s internal bar to continue development of IMVT-1402 in CLE IMVT-1402 demonstrated a favorable safety and tolerability profile, consistent with prior studies All other clinical development timelines remain on track BASEL, Switzerland and LONDON and NEW YORK, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced topline results from Period 1 of Immunovant’s proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE). The study did not achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. Numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE. “On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care. Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward,” said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant. Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402 across multiple autoimmune diseases with significant unmet need, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease. About the Proof-of-Concept Study of IMVT-1402 in CLEThe proof-of-concept clinical study (NCT06980805) of IMVT-1402 (imeroprubart) in CLE is a randomized, double-blind, placebo-controlled, global trial tha…Read full documentShow less
Immunovant’s proof-of-concept study of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12 Positive trends were observed on multiple endpoints, with deeper IgG reductions resulting in improved clinical outcomes, but the study did not meet Immunovant’s internal bar to continue development of IMVT-1402 in CLE IMVT-1402 demonstrated a favorable safety and tolerability profile, consistent with prior studies All other clinical development timelines remain on track BASEL, Switzerland and LONDON and NEW YORK, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced topline results from Period 1 of Immunovant’s proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE). The study did not achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. Numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE. “On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care. Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward,” said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant. Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402 across multiple autoimmune diseases with significant unmet need, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease. About the Proof-of-Concept Study of IMVT-1402 in CLEThe proof-of-concept clinical study (NCT06980805) of IMVT-1402 (imeroprubart) in CLE is a randomized, double-blind, placebo-controlled, global trial that assessed the safety and efficacy of IMVT-1402 in adult patients with CLE. The study enrolled 57 patients. In Period 1, patients were randomized to IMVT-1402 vs. placebo for a 12-week treatment period. The primary endpoint was the percent change from Period 1 baseline in CLASI-A score at Week 12. About ImmunovantImmunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. About RoivantRoivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com. Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product and product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts:InvestorsKeyur [email protected] MediaStephanie [email protected]
Related articleQuarter not tagged2026-08-13Immunovant (IMVT) Q1 2027 Earnings Call Transcript
Motley Fool
Immunovant (IMVT) Q1 2027 Earnings Call Transcript
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:00 a.m. ET Chief Executive Officer - Matthew Gline Investor Relations - Stephanie Lee Griffin Operator: Good day, and thank you for standing by. Welcome to Roivant's First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today, Stephanie Lee. Thank you. Please go ahead. Stephanie Lee Griffin: Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, 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: Thank you, Steph, and good morning, everybody, and thank you for joining. This is a little bit of a time before the storm moment for us. And so a pretty quiet quarter and maybe not the most interesting of our earnings calls in recent memory. But nonetheless, a lot of great progress in the business. And certainly, we're expecting a Genpact second half, as I'll get to in a moment. So I'll be relatively brief in my remarks, and then we'll go to Q&A. I want to start on Slide 4. This is a slide we took from our own prior deck. This is from the Investor Day that we did in December of last year, and this was a list of our priorities for the year. And we're sitting here a little bit more than halfway through the year. So just wanted to highlight that it's gone well for us, but we feel really good about the setup. And so on Slide 5, looking across the list here, we've got brexpiprazole expected to launch by the end of September. Obviously, we got priority review and our PDUFA date, as you said, is this quarter. We had great data from 1402 and DCRA study that…Read full documentShow less
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:00 a.m. ET Chief Executive Officer - Matthew Gline Investor Relations - Stephanie Lee Griffin Operator: Good day, and thank you for standing by. Welcome to Roivant's First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today, Stephanie Lee. Thank you. Please go ahead. Stephanie Lee Griffin: Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, 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: Thank you, Steph, and good morning, everybody, and thank you for joining. This is a little bit of a time before the storm moment for us. And so a pretty quiet quarter and maybe not the most interesting of our earnings calls in recent memory. But nonetheless, a lot of great progress in the business. And certainly, we're expecting a Genpact second half, as I'll get to in a moment. So I'll be relatively brief in my remarks, and then we'll go to Q&A. I want to start on Slide 4. This is a slide we took from our own prior deck. This is from the Investor Day that we did in December of last year, and this was a list of our priorities for the year. And we're sitting here a little bit more than halfway through the year. So just wanted to highlight that it's gone well for us, but we feel really good about the setup. And so on Slide 5, looking across the list here, we've got brexpiprazole expected to launch by the end of September. Obviously, we got priority review and our PDUFA date, as you said, is this quarter. We had great data from 1402 and DCRA study that we presented on our last quarterly call. Probably the most notable update for today in the top center of this slide is that we've now enrolled patients in the Phase III study in cutaneous sarcoidosis for brexpiprazole, which follows on the positive results that we had in our Phase II data, which I think we announced on our first quarterly call of this year, earlier in the calendar year. We've now received the initial payment from Moderna in the settlement and that -- the sort of second part of that, the 1498 part of that case is progressing, and we filed international proceedings against Pfizer and BioNTech in that case. And finally, earlier this year, we added LPP as a fourth brexpiprazole indication. And as I'll remind people later today, that study is continuing to enroll really well. As I mentioned at the top of the call here on Slide 6, I'll just say this is a quiet quarter, and this is a quiet day. I don't know exactly how the following statement could be true, but I think it is. The next 6 to 12 months are, in many ways, busier than the prior 6 to 12 months for us. And so we just have an enormous amount coming up, starting, as I mentioned, with the upcoming potential brexpiprazole launch in DM, which should happen imminently assuming everything goes as we hope and expect it will with FDA. We've got top line data in brexpiprazole from the NIU study, an indication that could easily be as large as dermatomyositis. That data is coming in the second half of this year. We also have top line data coming shortly in the second half from mostly, the Phase III study in PH-ILD. I know that's being closely watched, and we're looking forward to getting that data and presenting it. We will provide updates -- further updates on the DroTRA program at Immunovant in the second half of this year, including hopefully a download on a conversation we hope to have with FDA about that program as well as the results the second part of the study and a little bit more about our plans going forward. And then finally, probably the smallest of these, we're expecting top line data from the POC study in CLE also in the second half of this year and looking forward to finding out what we've got there when that comes in as well. So just a jampacked second half and even more coming in 2027 with the GRA data and beyond. So just a lot in the I'll just hit a couple of highlights in terms of the pipeline updates in a little more detail here before we get to Q&A. Starting on Slide 8 with a reminder because it's been a few months since we've talked about it. The initiation of the cutaneous sarcoidosis Phase III study is a pretty exciting event. It's a little bit ahead of schedule in terms of what we've been able to do here. And this is a disease that we're just privileged to be able to work in here. It's a high morbidity, very difficult disease with high urgency to treat. You can see on Slide 8, some of the photos we've shared before, but these are patients who are really can have very few treatment options. On Slide 9, as a reminder of the data that we generated in our Phase II study, we have set for ourselves a goal of a sort of 5-point benefit on the CSAMI scale for clinical meaningfulness. And in the study on the top left of this chart, we showed a greater than 20-point benefit compared to roughly nothing on placebo. So just a huge benefit to those patients in the Phase II study and really excited to carry that forward into the pivotal program. As a reminder on Slide 10, we think this is a pretty decent sized indication given high unmet need, probably about 40,000 patients in the U.S. and reasonable overlap with some other organ systems, including topical sarcoidosis or eye sarcoidosis where that overlaps with NIU that is one of the types of NIU that we're studying as well as pulmonary sarcoidosis, which is a big potential indication as well and where we hope to be able to treat some of those patients via either their ocular sarcoidosis or CS. The Phase III study that we've now begun, the design is laid out on Slide 11. I know there were some questions after the Phase II about what exactly this study would look like. It is designed to take all of the learnings from the Phase II study that was successful. It is a 16-week study with the primary endpoint of CSAMI greater than equal to 50% response rate. It's 140-patient study across about 70 sites, 3 to 2 randomized with patients either on 45 milligrams of brexpiprazole or placebo and with a mandatory -- sorry, mandatory steroid taper going from week 2 to week 8 down to 0, which is consistent with -- roughly consistent with what we did in the Phase II and generally consistent with what we think is appropriate for patients in this indication. So that study, as I said, has already begun enrolling patients, and we expect top line data in 2028, which just adds to the list of registrational -- potential registrational indications for brexpiprazole coming up. I'll reiterate on Slide 12, the other ongoing registrational program is the brexpiprazole study in lien RS LPP that we announced earlier this year. That study is enrolling, I'd say, extremely well. There's a lot of enthusiasm from physicians and patients for that, speaks to the high unmet need in the indication, speaks to the quality of the work being done by Ben and the Biovant team and looking forward to sharing more about that as soon as we've got it. So that's also move along nicely. Look, finally, and I'm sure there will be questions about this in Q&A and lots of opportunity to talk about it, hopefully, with a potential approval and beyond. Obviously, one of the major events in the near term here is the launch -- potential launch of brexpiprazole in dermatomyositis. Obviously, I think we're in a phenomenal position here in terms of what we've got in terms of what we hope to be able to do, starting with the quality of our clinical data, which, as you know, from the multiple times we've talked about it from the publications, including a New England Journal and so on, just phenomenal data, static across all 10 endpoints big clinical benefit, a lot of enthusiasm from the doc community. This is a really tough disease, a large addressable population, most of them on sort of polypharmacy, trying a lot of different things. And frankly, most of them still is satisfied with the available treatments. So we feel like we have an opportunity to do something big and different for this patient population. Our team has been out spending a lot of time with the physician, the patient communities on overall education. And I think the enthusiasm for a new therapy is coming out loud and clear, including with all the academic presentations that have been done and so on. Commercial launches, there's not much to say today other than that it's on track. We're ready to launch on time, having received priority review. The sort of commercial and patient support teams are built out, trained, ready to deploy. We feel really great about the hires we've made there, really great about the organization we've built there. We think we're doing this in a way that is both capitalizing on all the learnings from successful launches at other companies in recent years and doing it in a Roivant way. There's nobody in the world that will be more excited to see oversee this than the team we've got at Roivant with Ben and Daniel and others. And I think we're going to be fully ready. Everything is on schedule. So we'll have much more to say about that with the potential approval and after, but looking forward to it. I'll say one more thing about the commercial franchise overall of brexpiprazole on Slide 14. We get a lot of enthusiastic questions from investors around pace of launch. And we've been pretty consistent that our answer to that question is sort of slow and steady is what we're looking to build there. And I think there's a bunch of reasons for that. Obviously, some of them are DM is a new indication and no one's launched a novel therapy basically ever or at least a targeted therapy basically ever. And so it's just hard to know exactly what work will need to be done to get everyone comfortable and excited on drug, although I think we're fully prepared. But also, to me, it's because brexpiprazole is a lot more than just dermatomyositis. And to me, what we're really doing here is not just trying to make that launch as fast as possible, we're trying to lay the groundwork for the overall opportunity, which goes beyond DM into first NIU and then CS and LPP with the data coming thereafter. And I think as you think about that layering, to me, it's much less about what week 1 or month 1 or quarter 1 look like and much more about making sure that the foundation around access, the foundation around patient support, the foundation around the institutional activities, the foundation around our communication with the scientific and physician community and our communication with patients are all set up to deliver the maximum opportunity for brexpiprazole across all of these indications. And so I think slow and steady isn't just about sort of guidance. Slow and steady is about the approach that we're taking with the program to make sure we have maximum reach across everything that we're doing there, including indications that we're excited about beyond the ones we've already announced. So a lot to come, as I said, on track for that launch. You all hear the same thing we do, which is a ton of enthusiasm from patients and physician community for new options in all of these indications and looking forward to sharing more when we know about it. But our guidance is going to continue to be slow and steady because that's what we think we're building. Final business update here is we got the upfront payment in the settlement with Moderna, that $950 million has come in, $770-ish million of it to Genevant and the rest to Arbutus. So that's done. will be progress in terms of return of capital, et cetera, of that by our business and so on. The '498 sort of appellate ruling is that, that process is ongoing in the Federal Circuit. That would be another $1.3 billion if we got a favorable outcome there. And then we continue to advance our litigation against Pfizer and BioNTech. We filed 3 international lawsuits, notably in Canada and the UPC in July, so just last month and continue to progress that case as fast as we can. Obviously, not all in our control, but equally enthusiastic about the potential there in terms of what we could get. I'll wrap up just with our usual financial update on Slide 17. Look, I think overall, most importantly, we are spending in areas that we're excited to be spending. We're excited about all of our R&D programs, about $200 million of R&D expense for the quarter. of just under $100 million of non-GAAP adjusted G&A or $166 million of GAAP G&A expense and cash just under $4 billion, and that's before the receipt of the $772 million. Notably, pretty significant share repurchase activity, about $200 million in the quarter, a bit more than that when you include March. Obviously, what we did there was we accelerated our share repurchase program upon the announcement of the Moderna settlement so that we could get those shares in and the shares that -- and remember, the shares we bought back kind of the first round of this, the $1.5 billion that we have bought back sort of up through mid last year, we bought back at around $10 a share. I think the average price at which we've been able to buy back stock since we kicked off the second round of this in earnest in March has been in the high 20s. So feeling good overall about retiring those shares and getting that capital back to shareholders. I'm going to continue doing that according to our authorizations for now. And all of it ahead of on Slide 19, a really rich catalyst calendar ahead with a lot coming. So looking forward to all of that. with just an incredibly busy stretch ahead. On Slide 20, again, a little bit incredulous for the people around -- rents who are doing all of this work, incredible people to do this work. But by the end of calendar 2028, we'll have had hopefully 3 or more commercial launches, 9 study readouts, 4-plus NDA or BLA filings and a number of proof-of-concept studies, a ton coming up in the near term. So with that, I'm going to wrap up my prepared remarks for the day, and I will hand it back over to the operator for Q&A in just a moment. Thank you again for listening this morning and looking forward to taking your questions. Operator, over to you. Operator: [Operator Instructions] Our first question comes from the line of Brian Chen of JPMorgan. Lut Ming Cheng: Good morning. Thanks for taking our question. Maybe just thinking through the DM launch map, can you give us a quick sense of what metrics we could be receiving way out of the gate to help us better track the initial launch? Secondly, on PH-ILD, as we think about the baseline characteristics here in PHocus, it seems that more patients are on sotatercept. We're curious if there's any implication in terms of the fibrosis versus erythema ratio in the populations, and then further down the line, whether there's any implication towards the bar for success for both six-minute walk and also PVR. Thank you. Matthew Gline: Yes. Perfect. Thanks. I appreciate both questions. I think I've gotten fond of saying as I've watched other companies with commercial launches is that you all don't serve our guidance, which isn't quite fair. But look, I think other than sort of a slow and steady launch and obviously, the sort of top line metrics will be clearly visible in our financials each quarter. I don't know that we're going to provide a ton of detail in the early days. I think it's important for us mostly to spend our time focused on understanding those dynamics ourselves, getting out, talking to patients, talking to physicians, doing the work we need to do. We'll give a little more color on what that's going to look like on a call with potential approvals, and then we'll start to flesh out the package that we share with each successive quarter. But I don't have a lot to say right now about metrics. I'll say, I think typical with these launches, I'm not sure a ton is going to be visible in the early days, just given how the commercial apparatus is set up practical purposes, but we'll provide more guidance on that as it gets closer end here. On PH-ILD, I guess, first of all, we've obviously been watching, for example, the Treprostinil data in IPF and trying to understand a little bit better what's been going on with these PH-ILD patients in treatment of PH-ILD for fibrosis and for lung disease. It's been a view of ours for a while that one of the things to look out for in treatment of PH-ILD with vasodilators is emphysema. And so the study was designed with care around the amount of emphysema allowed in the study overall, and that was an important part of the guiding philosophy of the study to make sure that we could serve the patient population broadly, but also maximizing the potential benefit of the therapy. So that was considered from the beginning. So those are, I think, things we're keeping an eye on. I know there is a local cohort that believes that Treprostinil has antifibrotic benefit. Look, I think our view is if you treat PH-ILD patients well for their pulmonary hypertension, you may well deliver a benefit overall on their lung disease. And I think our view is probably that vasodilation is driving a lot of the activity there. But we also have some evidence from nonclinical models of antifibrotic activity for. Overall, on 6-minute walk and PVR, I'm sure I'll get version of this question more today. Look, I think it's consistent with what we said before. We're hoping to see a clear signal on PVR. We expect if the drug is all active, we will. We don't expect to see very much with clarity on 6-minute walk. The study is not powered for 6-minute walk. It would be nice to see some separation, but I don't think that's essential for our sort of go/no-go decision from here. And we'll just -- we'll know what we've got once we get a closer look at it, including the full balance of that data. Operator: Next question comes from the line of Dave Risinger from Leerink Partners. David Risinger: So I have three questions, but rather than rattling them all off right now, maybe if it's okay, I'll go one by one. So first, on Mosely, you commented just now on 6-minute walk distance. But if you were to run a large trial, what type of 6-minute walk distance would you be hoping for, i.e., what would be relevant to the clinicians and to the patients? So that's my first question. Matthew Gline: Yes. Thanks, Dave. Look, I think obviously, we'll have a slightly better answer to these questions overall once we have a sense of what we saw in Phase II. The truth is the PH-ILD patients are really sick. There are not a lot of options for these patients. And as we saw in Group 1 in PAH, when you have more treatment options, first of all, patients go on multiple options, multiple lines of therapy. And second of all, most importantly, like the actual -- not from a clinical trial perspective, but from a real-world evidence perspective, like survival and mortality rates go down as new classes of drugs are introduced in PAH over time. And I think it's like less about a number on 6-minute walk and more about having an approvable therapy. Remember, these are patients that are trying to walk to the car. They're trying to walk to the bathroom. They're trying to like live their daily lives. So I don't know that I think it's like correct scientifically to describe a specific numerical bar that matters versus just being able to get a new therapy. And some of that's, frankly, because 6-minute walk in clinical settings is an art that is complicated and noisy and like a little bit difficult to translate into daily lives, whereas if these drugs really effectively vasodilate and improve lung function and improve PVR, I think you wind up seeing a lot of benefit for these patients. So I don't know that we're going to articulate or have a specific numerical bar versus a successful study. Obviously, we will be judged, especially by the investor community based on competitor data, but I don't think we even need to be per se better than any other mechanism in order to have a big benefit to patients. David Risinger: Great. That's very helpful. And then regarding the forthcoming Brepocitinib DM launch, could you discuss the cadence of formulary reviews for rare disease drugs? I ask because for mass market drugs, P&T committees often wait until 6 months after launch before putting drugs on formulary. Matthew Gline: Yes. Thanks. Look, I don't have a ton to say about that right now other than we're having all of the normal engagement with the payer community that you'd expect us to have at this stage. And also, and I think this is a critical point about all of these launches. we are super focused on making sure that patients -- the physicians who want to write this drug and patients who want to get on this drug are going to have access. I think that's going to be really important for our engagement with the community for access generally. I think in terms of like literal formulary, it's probably like not so different. It's not like there's a separate committee for different kinds of diseases, but there's lots of medical acceptance procedures and other things that you can do to get patients covered. And we have a whole team of people built out of Priovance dedicated to making sure whether the formulary -- the formulary work has happened yet, whether the PSC committee has happened yet is not something that our patients and physicians have to spend a lot of time thinking about as they're deciding how to use the drug. David Risinger: Excellent. That's really helpful context. And then finally, beyond the list of programs on Slide 19, could you remind us about pipeline and product opportunities for your portfolio, including specific products that you could announce initiation of new studies for over the next year or so? Matthew Gline: I think every single one of the programs that the world is aware of in our pipeline as well as potentially ones that the world does not yet aware of in our pipeline. In all of those cases, we could announce new trials, new indications in the next year. I think every one of those are eligible and all of our molecules could be put into indications beyond the ones we've talked about. And I think it's fair to say, in each case, we have specific ideas of indications we're excited about. We've done active work and are, in fact, like preparing to initiate programs to that degree, depending on how busy those teams are today versus next month or the month after, but real progress. So I think the answer is -- we are actively working on that, but all of our products are, as you call them, pipeline of products and that we're excited to share more indications as we start those studies. Operator: Our next question comes from the line of Samantha Semenkow from Citi. Samantha Lynn Semenkow: I also have two, one on Mosley, one on Brepocitinib. For mostly, I'm wondering if you could just talk about the translatability of PVR reductions in patients with PAH to those with the PH-ILD population that you enrolled in focus. Are there any aspects of either disease that could influence the magnitude of PVR that you could see in the mostly data? And I have a follow-up. Matthew Gline: Yes. So look, I think -- thanks for the question. I appreciate it. I think the translation from PAH to PH-ILD is the fundamental question being answered by our study. And so the first unfortunate answer to that question is we're just going to have to see what we see. And it is the risk of the program at some level that we find something -- again, the Phase I data, including in PAH patients looks very good on a PVR basis. So one of the main "risks" of this program is that there's something, I would call it, unexpected in the PH-ILD translation. And obviously, I use the word unexpected because I think scientifically, it seems relatively straightforward that inhaled vasodilation is an effective mechanism in PH-ILD, but we'll find out. Obviously, the lungs of PH-ILD patients are different. than the lungs of PAH patients. And so you might expect some difference in sort of the pharmacodynamics of the drug in those patients. But overall, it seems pretty clear that when you take an inhaled vasodilator in PH-ILD patient, you get drug to the healthy lung tissue and it matters. So that's what I think. Samantha Lynn Semenkow: Got it. That's very helpful. And then just on Brepocitinib and DM, in your conversations that you've been having with physicians for education, I'm wondering if you could just talk about the reception to Brepocitinib given the JAK class safety concerns. Obviously, the safety profile of VALOR was quite favorable. But from a class perspective, it would just be helpful to hear how the physicians are thinking about safety, particularly since DM patients already tend to have a higher underlying risk for cancer. Matthew Gline: Yes. We've said a few times that when we first in-licensed brepocitinib, we didn't exactly know what the reception to JAK inhibitors was going to be following the addition of black box warnings and our whole view is to choose indications where the safety profile of JAKs is going to be much less of a focus. I think dermatomyositis is a poster child for this in that while JAK inhibitors are at this point, extremely widely used in diseases with much less morbidity, many more alternative therapies. In dermatomyositis, there's really no other options available. And I don't think physicians, therefore, are going to be particularly focused on this question. Remember, these patients are often -- first of all, and I think you sort of alluded to the profile in the trial. Dermatomyositis patients are inherently at risk of many of these concerns, malignancies, cardiometabolic events and treating them well makes them healthier and reduces those risks. And then on top of that, the therapies that they are currently on for dermatomyositis are things like high-dose steroids, which themselves add meaningfully, in fact, in many cases, much worse than JAK inhibitors to those very same risks. So I think in general, physicians are not going to spend a lot of time worrying about this, especially when reminded of the inherent risk of steroids and immunosuppressants that they're on anyway. And it's clear from our conversations with docs across different prescriber bases, they're just very comfortable using these agents, including prescriber basis, as we said, for patients with significantly less severe disease. As a reminder, we fully expect that our label is going to look like the labels for other JAK inhibitors that's going to have the black box warnings that's going to talk about experience with JAK inhibitors and other indications. And like I said, I think docs expect that and I think are not going to be too concerned about it because these patients are, a, very sick and b on other drugs, in many cases, significantly worse safety concerns. Operator: Our next questions will come from the line of Prakhar Agrawal from Cantor Fitzgerald. Prakhar Agrawal: Congrats on the continued execution. So maybe a couple of questions from my side as well. Firstly, on brepocitinib and DM, could you remind us what percentage of DM patients are on off-label JAKs based on your latest primary or secondary research? And would you expect rapid switches from these patients who are on off-label JAKs to brepocitinib? If not, why is that the case? And secondly, for brepocitinib in NIU trial, what do you see as the biggest risk for Phase III, given the Phase II was really strong? And is this geographic variation, which has been a key risk for this trial, which could drive some of the baseline variability that has been flagged as one of the risk factors by some of the KOL checks that we have done. appreciate. Matthew Gline: Great. Thank you. So I -- in terms of your first question on brepocitinib and DM around who's on off-label JAKs and what does that look like? Look, I think, first of all, there's just like variability in physician practice and some physicians use more JAKs and some physicians use less JAKs. And that has more to do, I think, with the docs in many cases than with any specific subcategory of patients. I think what we've said publicly is a low single-digit percentage or mid-single-digit percentage of randomization patients have experience with these things. Some of the docs who are involved who do use -- and some of that -- some docs don't use off-label drugs full stop. I think some of the docs who use off-label docs have said they expect to switch patients over, and I hope they do. And obviously, we'll be working to help them where that's appropriate, facilitate those switches. I think it's just going to be down to the preference and practice of each individual doc. I think one of the things that our team is finding in talking to physicians is that different patients have different docs have different sort of ideals in mind for who their sort of first patients might be. And I think it just varies based on the patient experience with the physician. And so obviously, we'll be able to have much more of these conversations pending potential approval. But I think medically, we'll see a wide variety of different phenotypes. On what is the biggest risk in Phase III? It feels funny to call placebo risk in these trials and that's not quite exactly what I mean, but I think the variability in placebo response rates in immunology trials is significant. If you're asking me what keeps me up at night, it's that we don't know exactly what placebo response rates will be in that study. And that just makes it hard to know exactly what the trial is going to look like on outcome. Obviously, the Phase II data was quite compelling and the level of drug activity seems good. And so I'm pretty optimistic about the study, but there's certainly -- this is biotech, you can lose sleep over anything. Is geography a risk I think there may be geographic variation just as there is in many other indications, and some of that's literally driven by geography and some of it's driven by physician practice and some of it's just noise. I don't know that it's a risk in the sense that it's like unanticipated or whatever. It's just a feature of running immunology studies. But overall, I think the team is doing a great job with the study, and I hope it's going to come out well. Operator: Our next question comes from the line of Andy Chen of Wolfe Research. Andy Chen: I don't think this has been talked about yet. But for the Brepocitinib launch, can you maybe talk about a few launch analogs that you're assessing right now, either patient curve or market share curve? What are the historical products with the most resemblance to Brepocitinib in DM. Matthew Gline: Well, thanks. It's a good question. The truth is there has never been a launch of a targeted therapy in dermatomyositis before. And so there is no good "analog" in the sense that you can point to lots of other launches of lots of other kinds and some have been faster and some have been slower and some have been slow and steady and some have been like different versions of different things. And I think it's hard to say, and there have been successful products with all kinds of different launch phases. So I think the short answer is I don't have a specific analog for another drug that we're watching as like evidence of our own penetration. I think what we're really focused on here is the dermatomyositis opportunity itself, these docs and these patients and the benefit and the cost of being a pioneer in indication is that you don't get to look at others, you have to try your own course. I don't have an analog to point to. Operator: Our next question comes from Yatin Suneja from Guggenheim. Yatin Suneja: Just a quick one on difficult-to-treat RA. Could you maybe talk about the strategy there? Would you need one more study, 2 more studies? How are you thinking about that? What should be our expectations for the randomized withdrawal phase that we're going to get data on? Matthew Gline: Yes. Thanks. Great question. Look, on study design, so we're going to come back later this year with a full update on that program, and that includes -- we don't yet have the randomized withdrawal period data yet, so I can't speak to what in it or how it will or will not inform strategy from here. And I think at some level, the results of that study may inform whether it is usable or not as one of our pivotal studies, et cetera. I think we designed it to serve potentially as 1 or 2. But obviously, it's got to hit for that to work. And as we said, when we announced the data, the quality of the response rates in the open-label period have set a somewhat higher bar for hitting a p-value of randomized withdrawal section. So I think we've got to sort of see all that taken in aggregate, look at the patient level data, understand what's going on. And we are planning for an FDA conversation this fall that will inform both the exact design of that study as well as help us answer those questions. I don't have a specific guidance to give on exactly what those studies are going to look like now because we don't know, but I'll say the team is working on it hard. The data was obviously exciting. It has got noticed. We've got a lot of enthusiastic reception, including from the doctor community on it, and we're excited to finalize those plans and bring them back to you later this year. Operator: Our next question comes from Yaron Werber from TD Cowen. Yaron Werber: I have a couple of questions. The first one was mostly, once you release the data this year, would you release both the mono and the combo data at the same time? And then secondly, for CS, the trial design is super interesting and makes obviously a lot of sense. The primary endpoint is CSAMI more than a 50% response -- can you maybe translate the Phase II data into the same context? Because I think the Phase II looked at C70 over 10 points and the change from baseline. So I'm just trying to get a sense of apples-to-apples kind of what to expect. Matthew Gline: Great. So on mostly, I think the short answer to your question is we will not release the monotherapy data and the combo data at the same time because the combo study started much later and is enrolling now, whereas the monotherapy study, obviously, will read out pretty soon in the second half. So I think the answer is they won't come out at the same time, and we'll put out the combo data when we've got it. The combo study, remember, it's an open-label study. It was designed -- the truth is, I think a lot of the information that we could want will come out of the monotherapy study anyway, since the combo study like won't provide that much incremental. I think it was designed in part to give us really good safety experience in the combination as well as like a little bit of information about incremental efficacy just so that we can get a sense for like inclusion criteria and management in the Phase III. But I'm not sure it's going to be like a super, super informative outcome. Yes. So that's what I'll say on mostly. I think data are going to come at separate times. On CS, I don't have to give right now the exact delta, but I'll say we saw meaningfully higher rates of greater than 50% CSAMI in the treatment arm than in the placebo. So the delta was wide. And I think in the press release that may have gone out around the initiation of the CS study, it will have said well north of 50% of the patients in the treatment arm of the Phase II had a Card response rate greater than 50%, I think the 0 on placebo. So it should be a good bar to set for us in terms of the endpoint. I don't know that we're going to replicate exactly what we saw in the Phase II, but I think the point is it's well powered for probability success given what we saw in the Phase II. Yaron Werber: Right. And if I can may just sneak in the Phase III NIU, do you have a sense, is the percent Humira experience going to be the same as the Phase II, given that the data look pretty good overall. So it must have been pretty good in that segment, too. Matthew Gline: I don't think we've said -- thank you what the percentage of patients in the Phase III have HUMIRA experience. I don't have that number on the top of my head, so I'll have to check into it. But I think the answer is there's no reason to expect it to be very different than what we've seen. There are a meaningful number of HUMIRA experienced patients in the Phase III, which matters in terms of ability to go into all of those patients. But I think the short answer to your question is I wouldn't expect it to be a major driver, and I wouldn't expect anything markedly different about the patient population from the Phase II. Operator: Our next question comes from Thomas Smith from Leerink Partners. Thomas Smith: On the 1402 difficult-to-treat RA program, I just wanted to clarify how you're approaching the disclosure in the second half of the year. Should we expect to see the Part 2 randomized withdrawal data prior to your meeting with FDA? Are you planning to share the data and the regulatory feedback and next steps simultaneously? And then on Graves, just wanted to get your thoughts on the competitive landscape. Obviously, you're the first advanced therapy there with really stellar Phase II data and you'll have the first pivotal readout next year with 1402. But there are a number of different approaches targeting various segments of the Graves patient population. Just wondering if you could comment on the competitive landscape. And as you see some of the approaches some of these competitors are taking with respect to the patient population, wondering how you're thinking about potential future studies for 1402 and Graves. Matthew Gline: Yes, perfect. Those are both really great questions. On the first one, I think what we said we put the data out still holds. I think my dream, our dream for the second half of this year is that we can come back with everything tied as nicely into a bow as possible, which is to say the period 2 data, the FDA conversation, maybe some further analysis of patient experience, period in the RA study, all shared at the same time. Obviously, until we have the Part 2 data in hand, we can't sort of specifically know whether there's anything in there that requires earlier disclosure. But in general, I think the answer is our hope and expectation would be to give a fulsome update later this year on everything all at once for D2GRA. On Graves, look, I think, first of all, I cannot say enough times that discussion of competition in Graves disease among therapeutic categories is just misplaced in the sense that you've got so many patients with unmet need that have had no -- the last time a novel therapy was developed in Graves disease was like the 1950s or 1960s. There's so many patients who have need of novel therapy that it's not about outrunning there. It's not about beating some specific competitor. It's about changing doc behavior in an indication that badly needs new options. 1402 have been studied in lots of patients. It's a safe and well-tolerated drug. Graves is going to have room for lots of mechanisms and lots of products. Among the other mechanisms, some will have specific either safety liabilities or they'll mimic a thyroidectomy and they'll require treatment with steroid or there's like lots of different approaches and most patients may be appropriate -- those drugs may be appropriate for later-line patients or a different subset of the patient population. And over time, I'm sure that segmenting will occur. But first of all, we're going to be first out in the marketplace there long before anybody else. And so we're going to get to have some influence over the treatment paradigms and also just get an option out to patients and physicians before some of those other choices are available. And second of all, I think it's mostly about building the market, not about any specific alternative and so on. So look, we're tremendously excited to be in our position in grades to be first to be able to offer hopefully a new option here. The only other thing I will say is -- you learn a lot running these studies. You learn a lot engaging with this physician community. And I do think there is nuance to the patient population. I think there is nuance to the prescriber behavior. I think there's a lot of heterogeneity in terms of how these patients are managed around the world and around the U.S. And I think one of the things that we're going to be able to do is to take advantage of those learnings in future studies, in these studies, in commercial prep. And I think that will be a big benefit to us being in the first place here. Operator: Our next question comes from Yasmeen Rahimi of Piper Sandler. Yasmeen Rahimi: This is Shannon on for Yasmeen Rahimi. Congrats on the great quarter. Maybe just one more from us about clarity with the readout in second half '26. Could you give us just maybe what you might be thinking about narrowing guidance if you expect to do that? And then sort of how you're thinking about the bar for success? And then timing post data, would you expect to file an sNDA and sort of what would be the cadence on that? Matthew Gline: Thanks. Look, I think I doubt that we're going to provide more specific timing guidance at this point than we have. We announced, I think, when the study was fully enrolled, and I think we're just going to read the study out when it's done and we have the data clean. The truth is NIU is another one of these diseases where there's a lot of unmet need. Humira leaves a lot of room on the table. And frankly, a lot of patients aren't even getting it. And so I think the truth is that the bar for success is successful studies that would support registration. And I think if we get that, we will have a big opportunity to help patients who need it. So I don't think there's like a numerical bar. Obviously, better data is better. And the more we look at Phase II, the happier I'll be about that. Our Phase II was really, really great data. But overall, I think as long as we have a successful clinical trial, a successful outcome, we're going to get what we need and we have a lot of patients we can reach. And I don't want to put Ben on the spot right now on exactly when that sNDA goes in, but we got the DM1 in nice and quickly. And I know the team is enthusiastic for indications if that study is positive. You got to believe that team is going to be working really quickly to get that sNDA in as fast as possible. Operator: Our next question comes from Douglas Tsao from H.C. Wainwright. The next question comes from Sam Slutsky from LifeSci Capital. Samuel Slutsky: Two quick ones for me. I guess for the proof-of-concept readout in CLE, there's a few parts to that study. So just remind me what we'll be getting in that initial release this year. And then for the initial launch in dermatomyositis, remind me how many clinics you're targeting and the concentration of patients at those clinics? Matthew Gline: Yes, thanks. On CLA, and again, I think we've said before in other settings that B was mentioning, I think CLE is an interesting indication. This is a small study. It's really a back finding proof-of-concept study. We've been watching the competitive landscape in CLE closely. There's a lot of other exciting therapies in development as well. Our early data from a couple of patients that we have dosed was encouraging. We're really sort of overall just looking to understand what our treatment benefit looks like, how we could conceptually stack up in the future treatment landscape. And I think that will all be super informative to what we do from here and whether we go forward. I think the primary, as a reminder, is 12 weeks, 600 versus placebo. And then in period 2, all patients collapse 600 at 52 weeks. The thing that we'll be reporting first is that 12 weeks for 600 versus placebo. So that's what we'll see. And then obviously, a bunch of other data beyond just the specific primary endpoint. On the DM launch, I'm not going to share today exactly what our sort of targeting strategy is. But as a reminder, there's about 200 myositis referral centers that treat approximately half of the U.S. patient population. And so obviously, those clinics are -- those docs, those centers are an important part of the overall picture, but there are other important physicians as well. And I think that and the team have done a really great job overall engaging with the physician community. So I'm excited about what we've done there, excited about the sort of medical publication strategy, obviously internal publication was a great outcome. So feeling good overall about that plan. And we're going to talk to as many docs and get out there as much as we can pending potential approval. So thank you. Great questions. Operator: We will now take the last question from Alex Thompson of Stifel. Alexander Thompson: Maybe two more on '402. Going back to the questions around placebo responses, how are you thinking about managing placebo response in the Graves studies, particularly in the backdrop of ATP down titration and the potential for waxing and waning of disease in that context over longer periods of time? And then secondly, what's your current thinking on sort of where 1402 could fit within MG and CIDP as that landscape continues to evolve? Yes. Matthew Gline: Thank you. Great questions. I appreciate it. Look, on Graves, I think the short answer to this question is, if you set the bar high enough on the endpoints, these are just not patients who are spontaneously remitting. And so if you're looking at patients who are getting to proper thyroid hormone levels and off ATDs, I think the simple truth is placebo should be pretty manageable here without saying much more about exactly how the AT titration works and so on and different of the studies being run by different companies are taking slightly different approaches there. So I'm not going to say too much about exactly what we're up to. But overall, I think this is something that is likely manageable. And then I think as far as MG and CIDP are concerned, and I'll say First of all, it's pretty rare that you have a great drug where you can run a clinical trial and be just like very confident that the trial is going to work. FcRns have been studied many times in MG at this point. '402 really should work in MG. The data that we generated in Battle, although I know there was plenty of debate over the deeper better question, we think showed a real treatment benefit, especially on things like MSD and sort of clinical remission that other FcRns in our view, have not been quite as compelling on. So I think we have an opportunity to deliver really great data, and I think that data will translate to adoption. I'll say 2 other things. One is that the MG market has just shown itself to be extremely large. There's room for lots of different classes. There's room for multiple FcRn. There's a little bit of cycling going on. There's differences in dosing paradigm and so on. So I think like no matter what share we take, even a relatively modest share of a market that size is a big opportunity. I think argenx has done a really great job establishing that market, establishing themselves in that market, becoming the drug of choice that people reach to for a next-generation therapy. I think they may very well remain the class leader there. And I think we will find lots of operating room around them with hopefully incremental meaningful benefit to patients beyond what they can deliver and just with another option with different route of administration and so on. So I think in MG, we will be out there. I think we'll have a big opportunity just given the size of the overall market and then exactly what our share is and where we fit in will depend on the clinical data that we generate in the study. CIDP -- my one comment is I think there is -- I think the -- on other indications. I think in CIDP, class leadership has been less concretely established at this point. It's a more recent launch. And I think there's probably a little bit more room for improvement on treatment paradigm. And so I think what we showed with Bato in the CIDP study was pretty encouraging, and I hope we're able to do something similar with 1402. And I think there will be a lot of enthusiasm if we can for our role there. So I think we have an opportunity to be a major driver in that market. Overall, I think the level of success that argenx has had with things like MG and CIDP make me tremendously excited about Graves and about DutragRA and the other indications where we are first in that the first-mover advantage that argenx is able to develop in their indications are significant, and I expect to build a similar moat for ourselves. Look, I think ultimately, these docs are going to be sensitive to clinical data, focused on clinical data. And I think if our data is phenomenal, we'll be able to lead in every indication where we have that kind of data. Big docs are going to follow the quality of the evidence. Operator: With that, I would like to hand the call back to management for closing. Matthew Gline: Great. Okay. Well, look, thank you, everybody, again. Thank you for the thoughtful questions. I appreciate how much work it is to come up with good questions in a quiet quarter. I promise there'll be lots coming in the coming weeks and months to give you more substrate in the future. But in the meantime, we appreciate it. We appreciate everyone for listening. As always, I'm super appreciative of everybody who works for in advance who are working just super hard on all of these programs to move them forward. I've been very proud of our execution and pleased with the quality progress we made. And I want to thank the physicians and investigators and patients in our studies who trust us with their care. And I couldn't be more excited for the 12 months ahead. This is the last -- one way or another, this is the last boring quarter we're going to have for a while. So looking forward to the more exciting ones ahead and moving sleep over them until we get there. Thank you, everybody. Have a good day. Operator: That does conclude today's conference call. Thank you for your participation. You may now disconnect your lines. Before you buy stock in Immunovant, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Immunovant wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $403,337!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,334,946!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. 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. 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. Immunovant (IMVT) Q1 2027 Earnings Call Transcript was originally published by The Motley Fool
Related articleQuarter not tagged2026-08-07Roivant Sciences Q1 Earnings Call Highlights
MarketBeat
Roivant Sciences Q1 Earnings Call Highlights
Interested in Roivant Sciences Ltd.? Here are five stocks we like better. Roivant expects a busy second half of 2026, highlighted by a potential FDA approval and launch of brepocitinib for dermatomyositis by the end of September, plus clinical readouts in noninfectious uveitis, PH-ILD and cutaneous lupus. Brepocitinib development is expanding, with Phase III trials underway in cutaneous sarcoidosis and lichen planopilaris. Roivant also plans further updates on Immunovant’s IMVT-1402 programs in rheumatoid arthritis and Graves’ disease. Roivant reported nearly $4 billion in cash before receiving about $772 million from its Moderna settlement, repurchased roughly $200 million of stock during the quarter and said it will continue buybacks while funding its pipeline. Trump Index: 6 Companies Linked to Trump’s Cabinet Worth Watching Roivant Sciences (NASDAQ:ROIV) said it expects a busy second half of 2026, with a potential launch of brepocitinib in dermatomyositis, several clinical readouts and additional regulatory discussions across its pipeline. Chief Executive Officer Matt Gline characterized the quarter as relatively quiet but said the company has advanced several priorities outlined at its investor day. Those include the anticipated brepocitinib launch, development work at Immunovant, progress in litigation-related matters and continued capital returns. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth “The next 6-12 months are in many ways busier than the prior 6-12 months for us,” Gline said on the company’s first-quarter earnings call. Roivant said brepocitinib, which is under priority FDA review for dermatomyositis, is expected to launch by the end of September if it receives approval. Gline said the commercial and patient-support teams at Priovant have been built, trained and are ready for a potential launch. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Management reiterated that it intends to pursue a “slow and steady” launch rather than focus on near-term sales metrics. Gline said the company is seeking to establish access, patient-support, institutional and physician-engagement infrastructure that can support brepocitinib across multiple potential indications beyond dermatomyositis. Gline said physicians and patients have expressed enthusiasm for new treatment options in dermatomyositis, a condition in which patients often use…Read full documentShow less
Interested in Roivant Sciences Ltd.? Here are five stocks we like better. Roivant expects a busy second half of 2026, highlighted by a potential FDA approval and launch of brepocitinib for dermatomyositis by the end of September, plus clinical readouts in noninfectious uveitis, PH-ILD and cutaneous lupus. Brepocitinib development is expanding, with Phase III trials underway in cutaneous sarcoidosis and lichen planopilaris. Roivant also plans further updates on Immunovant’s IMVT-1402 programs in rheumatoid arthritis and Graves’ disease. Roivant reported nearly $4 billion in cash before receiving about $772 million from its Moderna settlement, repurchased roughly $200 million of stock during the quarter and said it will continue buybacks while funding its pipeline. Trump Index: 6 Companies Linked to Trump’s Cabinet Worth Watching Roivant Sciences (NASDAQ:ROIV) said it expects a busy second half of 2026, with a potential launch of brepocitinib in dermatomyositis, several clinical readouts and additional regulatory discussions across its pipeline. Chief Executive Officer Matt Gline characterized the quarter as relatively quiet but said the company has advanced several priorities outlined at its investor day. Those include the anticipated brepocitinib launch, development work at Immunovant, progress in litigation-related matters and continued capital returns. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth “The next 6-12 months are in many ways busier than the prior 6-12 months for us,” Gline said on the company’s first-quarter earnings call. Roivant said brepocitinib, which is under priority FDA review for dermatomyositis, is expected to launch by the end of September if it receives approval. Gline said the commercial and patient-support teams at Priovant have been built, trained and are ready for a potential launch. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Management reiterated that it intends to pursue a “slow and steady” launch rather than focus on near-term sales metrics. Gline said the company is seeking to establish access, patient-support, institutional and physician-engagement infrastructure that can support brepocitinib across multiple potential indications beyond dermatomyositis. Gline said physicians and patients have expressed enthusiasm for new treatment options in dermatomyositis, a condition in which patients often use multiple therapies and remain dissatisfied with available treatments. He also said Roivant expects brepocitinib’s label to include the boxed warnings associated with other JAK inhibitors, but management believes physicians will weigh those considerations against the severity of dermatomyositis and risks associated with treatments such as high-dose steroids and immunosuppressants. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling The company also began enrolling patients in a Phase III trial of brepocitinib for cutaneous sarcoidosis. The 140-patient study will compare 45 milligrams of brepocitinib with placebo over 16 weeks and uses a primary endpoint of at least a 50% response on the Cutaneous Sarcoidosis Activity and Morphology Instrument, or CSAMI. Participants will undergo a mandatory steroid taper from week two through week eight. Roivant expects top-line data from that study in 2028. Gline said the company estimates there are approximately 40,000 U.S. patients with cutaneous sarcoidosis and pointed to potential overlap with ocular and pulmonary manifestations of sarcoidosis. Roivant also said its registrational study of brepocitinib in lichen planopilaris is enrolling “extremely well,” according to Gline. The company added lichen planopilaris as a fourth brepocitinib indication earlier this year. Roivant expects several important data events during the second half of 2026. These include top-line data from a Phase III study of brepocitinib in noninfectious uveitis, which Gline said could represent an opportunity comparable in size to dermatomyositis. The company also expects top-line data from the Phase II FOCUS study of mosliciguat in pulmonary hypertension associated with interstitial lung disease, or PH-ILD. Management said it is looking for a clear signal in pulmonary vascular resistance, or PVR, while noting that the trial is not powered to provide a definitive assessment of six-minute walk distance. Gline said Roivant believes inhaled vasodilation could benefit PH-ILD patients, though the Phase II study is intended to assess whether results seen in pulmonary arterial hypertension translate to the PH-ILD population. He said the company designed the study with limits on emphysema to support broad enrollment while seeking to maximize the therapy’s potential benefit. For mosliciguat, Roivant said monotherapy data will be released before data from an open-label combination study, which began later and remains in enrollment. Management said the combination trial is intended to add safety experience and provide information that may help inform Phase III trial design. Roivant also expects a proof-of-concept readout in cutaneous lupus erythematosus, or CLE, during the second half. The first disclosure will include 12-week data comparing a 600-milligram dose with placebo. Gline described the trial as a small fact-finding study intended to help the company assess treatment benefit and determine whether to advance the program. Roivant plans to provide a fuller update later this year on Immunovant’s IMVT-1402 program in difficult-to-treat rheumatoid arthritis. That update could include results from the randomized-withdrawal portion of the study, feedback from an anticipated FDA discussion and potential next steps for registrational development. The company is also advancing IMVT-1402 in Graves’ disease. Gline said Roivant views the condition as a market with substantial unmet need, rather than one defined primarily by competition among emerging mechanisms. He said the company expects to be the first to bring an advanced therapy to the market if its program succeeds. Separately, Roivant received the initial payment from its settlement with Moderna. Gline said the $950 million payment included approximately $770 million for Genevant and the remainder for Arbutus. He said litigation under Section 1498 remains under review at the Federal Circuit and could result in an additional $1.3 billion with a favorable outcome. Roivant also filed international lawsuits against Pfizer and BioNTech, including actions in Canada and the Unified Patent Court, during July. Roivant reported approximately $200 million in research-and-development expense for the quarter. Non-GAAP adjusted general and administrative expense was just under $100 million, while GAAP general and administrative expense was $166 million. The company reported cash of just under $4 billion before receipt of approximately $772 million associated with the Moderna settlement payment. Roivant repurchased about $200 million of stock during the quarter, with additional repurchases in March, after accelerating its buyback activity following the Moderna settlement announcement. Gline said the company will continue repurchasing shares under its existing authorizations while preparing for a catalyst-rich period that could include multiple clinical readouts, regulatory filings and commercial launches through the end of 2028. Roivant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies through a network of subsidiary businesses known as “Vants.” Founded in 2014, Roivant acquires or in-licenses clinical-stage assets that have progressed beyond proof of concept and seeks to advance them efficiently toward regulatory approval. By organizing each program into a dedicated subsidiary, the company aims to streamline decision-making, allocate resources more effectively, and accelerate development timelines. The core activities of Roivant involve identifying promising drug candidates across a range of therapeutic areas, including neurology, rare diseases, immunology, oncology, and women's health. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Roivant Sciences Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Related articleQuarter not tagged2026-08-06Immunovant, Inc. Q1 2027 Earnings Call Summary
Moby
Immunovant, Inc. Q1 2027 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management characterizes the current period as a 'time before the storm,' anticipating the next 6 to 12 months will be significantly busier than the prior year due to multiple late-stage readouts. The company has initiated the Phase III study for brepocitinib in cutaneous sarcoidosis ahead of schedule, leveraging a greater than 20-point benefit observed in Phase II data. Performance attribution for the quarter is centered on operational readiness for the imminent brepocitinib launch in dermatomyositis (DM), which received priority review from the FDA. Strategic positioning in DM focuses on the high unmet need for a targeted therapy, as most patients currently rely on polypharmacy and high-dose steroids with significant morbidity. Management emphasizes a 'slow and steady' commercial philosophy intended to build a long-term foundation for brepocitinib across multiple future indications rather than maximizing immediate week-one metrics. The company successfully strengthened its balance sheet by receiving a $950 million settlement payment from Moderna, while continuing to pursue additional litigation against Pfizer and BioNTech. Capital allocation remains focused on shareholder returns, with approximately $200 million in share repurchases executed during the quarter at prices in the high 20s. Top-line data for brepocitinib in non-infectious uveitis (NIU) and mosliciguat in PH-ILD are both expected in the second half of 2026. The company expects a potential FDA approval and commercial launch for brepocitinib in DM by the end of September 2026. Management is planning for a conversation with the FDA this fall to inform the design and pivotal potential of their studies, following which they expect to finalize and share their plans. Guidance for the DM launch assumes a gradual uptake curve due to the novel nature of the therapy and the need for physician and payer education in a previously underserved market. Long-term strategic targets include achieving three or more commercial launches and nine study readouts by the end of calendar year 2028. The $950 million Moderna settlement resulted in approximately $772 million in net proceeds to Genevant, significantly bolstering the cash position to nearly $4.8 billion. Ongo…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management characterizes the current period as a 'time before the storm,' anticipating the next 6 to 12 months will be significantly busier than the prior year due to multiple late-stage readouts. The company has initiated the Phase III study for brepocitinib in cutaneous sarcoidosis ahead of schedule, leveraging a greater than 20-point benefit observed in Phase II data. Performance attribution for the quarter is centered on operational readiness for the imminent brepocitinib launch in dermatomyositis (DM), which received priority review from the FDA. Strategic positioning in DM focuses on the high unmet need for a targeted therapy, as most patients currently rely on polypharmacy and high-dose steroids with significant morbidity. Management emphasizes a 'slow and steady' commercial philosophy intended to build a long-term foundation for brepocitinib across multiple future indications rather than maximizing immediate week-one metrics. The company successfully strengthened its balance sheet by receiving a $950 million settlement payment from Moderna, while continuing to pursue additional litigation against Pfizer and BioNTech. Capital allocation remains focused on shareholder returns, with approximately $200 million in share repurchases executed during the quarter at prices in the high 20s. Top-line data for brepocitinib in non-infectious uveitis (NIU) and mosliciguat in PH-ILD are both expected in the second half of 2026. The company expects a potential FDA approval and commercial launch for brepocitinib in DM by the end of September 2026. Management is planning for a conversation with the FDA this fall to inform the design and pivotal potential of their studies, following which they expect to finalize and share their plans. Guidance for the DM launch assumes a gradual uptake curve due to the novel nature of the therapy and the need for physician and payer education in a previously underserved market. Long-term strategic targets include achieving three or more commercial launches and nine study readouts by the end of calendar year 2028. The $950 million Moderna settlement resulted in approximately $772 million in net proceeds to Genevant, significantly bolstering the cash position to nearly $4.8 billion. Ongoing litigation regarding the '498 patent represents a potential $1.3 billion upside contingent on a favorable appellate ruling from the Federal Circuit. R&D expenses for the quarter reached $200 million, reflecting the heavy investment in all of the company's R&D programs. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management declined to provide specific early-stage launch metrics, stating they will focus on internal dynamics and physician engagement first. They reiterated that the launch will likely not show significant visibility in the very early days due to the structure of the commercial apparatus. Management expects the brepocitinib label to include standard JAK class black box warnings but believes physicians will be less concerned given the severity of DM. They noted that current standard-of-care treatments like high-dose steroids often carry worse safety profiles than the JAK class. Roivant aims to be the first advanced therapy in the Graves' market, which has seen no novel therapy development since the 1950s or 1960s. Management believes the market is large enough for multiple mechanisms and that being the first mover will allow them to influence treatment paradigms. Management identified placebo response variability as the primary risk factor, a common challenge in immunology trials. They expressed confidence in the drug's activity based on strong Phase II data but acknowledged the inherent uncertainty of placebo rates.
Related articleQuarter not tagged2026-08-06Immunovant Provides Corporate Updates and Reports Financial Results for the Quarter Ended June 30, 2026
GlobeNewswire
Immunovant Provides Corporate Updates and Reports Financial Results for the Quarter Ended June 30, 2026
All IMVT-1402 clinical development timelines remain on track, including ongoing studies in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA), Sjögren’s disease (SjD) and cutaneous lupus erythematosus (CLE) Current cash balance provides runway to the potential launch of IMVT-1402 in GD Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026 DURHAM, N.C., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its first fiscal quarter ended June 30, 2026. Recent Highlights and Upcoming Milestones: Immunovant’s development plans for IMVT-1402 remain on track across all six announced indications. The Company expects to provide further updates on its potentially registrational IMVT-1402 D2T RA program and report topline data from the proof-of-concept trial of IMVT-1402 in CLE in the second half of calendar year 2026. In calendar year 2027, topline data are anticipated for the potentially registrational trials evaluating IMVT-1402 in GD and MG. Topline data are expected to follow in calendar year 2028 for the potentially registrational trials of IMVT-1402 in CIDP and SjD. Financial Highlights for Fiscal First Quarter Ended June 30, 2026: Cash Position: As of June 30, 2026, Immunovant’s cash and cash equivalents totaled $797.8 million, providing runway to the potential commercial launch of IMVT-1402 in GD, based on our current operating plan. Research and Development Expenses: Research and development (R&D) expenses were $142.6 million for the three months ended June 30, 2026, compared to $101.2 million for the three months ended June 30, 2025. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs, partially offset by lower overall costs as we wind-down our batoclimab clinical trials. Non-GAAP R&D expenses were $135.4 million for the three months ended June 30, 2026, compared to $93.3 million for the three months ended June 30, 2025. General and Administrative Expenses: General and administrative (G&A) expenses were $17.7 million for the three months ended June 30, 2026, compared t…Read full documentShow less
All IMVT-1402 clinical development timelines remain on track, including ongoing studies in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA), Sjögren’s disease (SjD) and cutaneous lupus erythematosus (CLE) Current cash balance provides runway to the potential launch of IMVT-1402 in GD Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026 DURHAM, N.C., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its first fiscal quarter ended June 30, 2026. Recent Highlights and Upcoming Milestones: Immunovant’s development plans for IMVT-1402 remain on track across all six announced indications. The Company expects to provide further updates on its potentially registrational IMVT-1402 D2T RA program and report topline data from the proof-of-concept trial of IMVT-1402 in CLE in the second half of calendar year 2026. In calendar year 2027, topline data are anticipated for the potentially registrational trials evaluating IMVT-1402 in GD and MG. Topline data are expected to follow in calendar year 2028 for the potentially registrational trials of IMVT-1402 in CIDP and SjD. Financial Highlights for Fiscal First Quarter Ended June 30, 2026: Cash Position: As of June 30, 2026, Immunovant’s cash and cash equivalents totaled $797.8 million, providing runway to the potential commercial launch of IMVT-1402 in GD, based on our current operating plan. Research and Development Expenses: Research and development (R&D) expenses were $142.6 million for the three months ended June 30, 2026, compared to $101.2 million for the three months ended June 30, 2025. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs, partially offset by lower overall costs as we wind-down our batoclimab clinical trials. Non-GAAP R&D expenses were $135.4 million for the three months ended June 30, 2026, compared to $93.3 million for the three months ended June 30, 2025. General and Administrative Expenses: General and administrative (G&A) expenses were $17.7 million for the three months ended June 30, 2026, compared to $26.0 million for the three months ended June 30, 2025. The decrease was primarily due to lower personnel-related expenses, professional fees, market research costs and information technology costs. Non-GAAP G&A expenses were $11.2 million for the three months ended June 30, 2026, compared to $15.4 million for the three months ended June 30, 2025. Net Loss: Net loss was $153.2 million ($0.75 per common share) for the three months ended June 30, 2026, compared to $120.6 million ($0.71 per common share) for the three months ended June 30, 2025. Net loss for the three months ended June 30, 2026 and June 30, 2025 included $13.8 million and $18.5 million, respectively, related to non-cash stock-based compensation expense. Non-GAAP net loss was $139.4 million for the three months ended June 30, 2026, compared to $102.1 million for the three months ended June 30, 2025. Common Stock: As of June 30, 2026, there were 206,264,878 shares of common stock issued and outstanding. Non-GAAP Financial Measures: In addition to reporting the financial results in accordance with accounting principles generally accepted in the United States of America (GAAP), Immunovant reports certain financial results that differ from what is reported under GAAP. Immunovant believes these non-GAAP financial measures are useful to investors and others because they allow for additional information with respect to financial measures used by management in its financial and operational decision-making and they may be used by institutional investors and the analyst community to help them analyze the health of Immunovant’s business. However, there are a number of limitations related to the use of non-GAAP financial measures, and these non-GAAP measures should be considered in addition to, not as a substitute for or in isolation from, Immunovant’s financial results prepared in accordance with GAAP. Other companies, including companies in Immunovant’s industry, may calculate these non-GAAP financial measures differently or not at all, which reduces their usefulness as comparative measures. About Immunovant, Inc. Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 6, 2026. To access the conference call by phone, please register online using this Registrational link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant’s website after the conference call. Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant’s progress towards developing IMVT-1402 across a broad range of indications; Immunovant’s expectations regarding the availability of results of clinical trials of IMVT-1402 and whether those results may be adequate to support registration; and the Company’s beliefs regarding the potential sufficiency of its cash runway. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, regulatory strategy, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402; Immunovant is at various stages of clinical development for IMVT-1402; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 20, 2026, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. (1) Represents non-cash stock-based compensation expense Contacts:InvestorsKeyur [email protected] MediaStephanie [email protected]
Related articleQuarter not tagged2026-08-06Immunovant Q1 Earnings Call Highlights
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Immunovant Q1 Earnings Call Highlights
Interested in Immunovant, Inc.? Here are five stocks we like better. FDA decision and potential launch: Roivant expects an FDA decision by the end of September on brepocitinib for dermatomyositis after priority review. The company says its commercial and patient-support infrastructure is ready, though it plans a gradual launch. Multiple pipeline catalysts: Second-half 2026 readouts include Phase III data for brepocitinib in noninfectious uveitis, Phase II data for mosliciguat in PH-ILD, and proof-of-concept data in cutaneous lupus. Immunovant also plans an update on IMVT-1402 in difficult-to-treat rheumatoid arthritis, while its Graves’ disease pivotal readout is expected in 2027. Strong liquidity and shareholder returns: Roivant received approximately $770 million from the Moderna settlement for Genevant and plans to continue share repurchases after buying back about $200 million of stock during the quarter. Cash was just under $4 billion before the settlement proceeds. Roivant said its first quarter was relatively quiet operationally but positioned the company for a more active second half of 2026, with a potential launch of brepocitinib in dermatomyositis, multiple clinical readouts and further updates from Immunovant (NASDAQ:IMVT). Chief Executive Officer Matt Gline said Roivant expects a decision from the U.S. Food and Drug Administration on brepocitinib for dermatomyositis by the end of September after receiving priority review. The company said its commercial, field-support and patient-support teams are trained and prepared for a potential launch. → 3 Drone Stocks That Should Soar After the Summer Slump “We’re ready to launch on time,” Gline said, while emphasizing that Roivant expects to build the product franchise through a “slow and steady” approach rather than focusing on early launch metrics. Beyond dermatomyositis, Roivant has begun enrolling patients in a Phase III trial of brepocitinib for cutaneous sarcoidosis. The 140-patient study will compare 45 milligrams of brepocitinib with placebo over 16 weeks, with a mandatory steroid taper from week two through week eight. The primary endpoint is a CSAMI response of at least 50%. Roivant expects top-line data in 2028. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Gline said the Phase III design incorporates findings from the company’s Phase II study, in which he said brepocitini…Read full documentShow less
Interested in Immunovant, Inc.? Here are five stocks we like better. FDA decision and potential launch: Roivant expects an FDA decision by the end of September on brepocitinib for dermatomyositis after priority review. The company says its commercial and patient-support infrastructure is ready, though it plans a gradual launch. Multiple pipeline catalysts: Second-half 2026 readouts include Phase III data for brepocitinib in noninfectious uveitis, Phase II data for mosliciguat in PH-ILD, and proof-of-concept data in cutaneous lupus. Immunovant also plans an update on IMVT-1402 in difficult-to-treat rheumatoid arthritis, while its Graves’ disease pivotal readout is expected in 2027. Strong liquidity and shareholder returns: Roivant received approximately $770 million from the Moderna settlement for Genevant and plans to continue share repurchases after buying back about $200 million of stock during the quarter. Cash was just under $4 billion before the settlement proceeds. Roivant said its first quarter was relatively quiet operationally but positioned the company for a more active second half of 2026, with a potential launch of brepocitinib in dermatomyositis, multiple clinical readouts and further updates from Immunovant (NASDAQ:IMVT). Chief Executive Officer Matt Gline said Roivant expects a decision from the U.S. Food and Drug Administration on brepocitinib for dermatomyositis by the end of September after receiving priority review. The company said its commercial, field-support and patient-support teams are trained and prepared for a potential launch. → 3 Drone Stocks That Should Soar After the Summer Slump “We’re ready to launch on time,” Gline said, while emphasizing that Roivant expects to build the product franchise through a “slow and steady” approach rather than focusing on early launch metrics. Beyond dermatomyositis, Roivant has begun enrolling patients in a Phase III trial of brepocitinib for cutaneous sarcoidosis. The 140-patient study will compare 45 milligrams of brepocitinib with placebo over 16 weeks, with a mandatory steroid taper from week two through week eight. The primary endpoint is a CSAMI response of at least 50%. Roivant expects top-line data in 2028. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Gline said the Phase III design incorporates findings from the company’s Phase II study, in which he said brepocitinib showed a greater than 20-point benefit on the CSAMI scale relative to little change on placebo. Roivant estimates there are approximately 40,000 cutaneous sarcoidosis patients in the United States. The company also said its registrational trial of brepocitinib in lichen planus, or LPP, is enrolling “extremely well,” according to Gline. Roivant added LPP as a fourth development indication for brepocitinib earlier this year. → Jersey Mike's Serves Fresh Gains After IPO Stumble Top-line data from brepocitinib’s Phase III noninfectious uveitis, or NIU, study are expected during the second half of 2026. Gline said variability in placebo response rates is a key uncertainty in immunology trials, but described the company’s Phase II NIU data as compelling. He said Roivant would seek to submit a supplemental new drug application quickly if the study produces a successful result. In discussing the planned dermatomyositis launch, Gline said the company sees no direct launch analog because no targeted therapy has previously been launched for the disease. He noted that roughly 200 myositis referral centers treat about half of the U.S. dermatomyositis population. Gline also addressed potential safety concerns surrounding the JAK inhibitor class. He said Roivant expects brepocitinib’s label to include boxed warnings consistent with other JAK inhibitors, but added that physicians treating dermatomyositis patients are accustomed to managing substantial risks associated with current treatment options, including high-dose steroids and immunosuppressants. Roivant expects top-line Phase II data in the second half from mosliciguat in pulmonary hypertension associated with interstitial lung disease, or PH-ILD. The company said it is primarily looking for a clear signal in pulmonary vascular resistance, or PVR. The study was not powered for six-minute walk distance, although Gline said separation on that measure would be welcome. The mosliciguat monotherapy results will be reported before data from a separate combination study, which began later and remains in enrollment. Gline said the combination study is open-label and is intended to provide additional safety experience and information that could help guide Phase III planning. Roivant also expects an initial proof-of-concept readout for brepocitinib in cutaneous lupus erythematosus, or CLE, during the second half. The initial results will cover 12-week data comparing the 600-milligram dose with placebo. Gline described the trial as a small, fact-finding study intended to help the company evaluate the treatment benefit and potential position in an increasingly competitive development landscape. At Immunovant, Roivant plans to provide a broader update later this year on IMVT-1402 in difficult-to-treat rheumatoid arthritis. The update is expected to include results from the randomized-withdrawal portion of the study, feedback from an anticipated FDA discussion, and the company’s plans for future trials. Gline said the open-label response data have generated positive attention, though the randomized-withdrawal results could affect whether the study can serve as a pivotal trial. Roivant also highlighted its Graves’ disease program for IMVT-1402, with a pivotal readout expected in 2027. Gline said the company sees substantial unmet need in Graves’ disease and views the opportunity as one of building a new treatment market rather than competing for a limited number of patients. Roivant said it received the initial payment from its settlement with Moderna. The $950 million payment included approximately $770 million for Genevant and the remainder for Arbutus. The company said its separate appellate process related to a Section 1498 matter remains ongoing and could result in an additional $1.3 billion if the outcome is favorable. Roivant also said it filed international proceedings against Pfizer and BioNTech, including actions in Canada and the Unified Patent Court, during July. For the quarter, Roivant reported approximately $200 million in research and development expense, nearly $100 million in non-GAAP adjusted general and administrative expense, and $166 million in GAAP general and administrative expense. Cash stood at just under $4 billion before the receipt of $772 million associated with the Moderna settlement proceeds. The company repurchased about $200 million of shares during the quarter, with additional repurchases occurring in March. Gline said Roivant accelerated its repurchase activity following the Moderna settlement announcement and plans to continue repurchasing shares under its existing authorizations. Immunovant Inc is a clinical-stage biopharmaceutical company focused on the development of novel monoclonal antibody therapies that target the neonatal Fc receptor (FcRn) to treat severe autoimmune diseases. By inhibiting FcRn, Immunovant's approach is designed to reduce levels of pathogenic immunoglobulin G (IgG) antibodies, which play a central role in the pathology of disorders such as myasthenia gravis and immune thrombocytopenia. The company's lead asset, efgartigimod, is an engineered Fc fragment that selectively binds to FcRn, accelerating the degradation of circulating IgG. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Immunovant Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
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TranscriptFY2027 Q12026-08-06FY2027 Q1 earnings call transcript
Earnings source - 102 paragraphs
FY2027 Q1 earnings call transcript
Good day, and thank you for standing by. Welcome to Roivant First Quarter 2026 Earnings Conference 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 need to press star one and one on your telephone. Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today, Stephanie Lee. Thank you. Please go ahead.
Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, 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. With that, I'll turn it over to Matt.
Thank you, Steph, and good morning, everybody, and thank you for joining. This is a little bit of a calm before the storm moment for us, and so a pretty quiet quarter and maybe not the most interesting of our earnings calls in recent memory. Nonetheless, a lot of great progress in the business. Certainly, we're expecting a jam-packed second half, as I'll get to in a moment. I'll be relatively brief in my remarks, and then we'll go to Q&A. I'd like to start on slide four. This is a slide we took from our own prior deck. This is from the investor day that we did in December of last year, and this was a list of our priorities for the year. We're sitting here a little bit more than halfway through the year.
Just wanted to highlight that it's gone well for us, that we feel really good about the setup. On slide five, looking across the list here, we've got brepocitinib expected to launch by the end of September. Obviously, we got priority review and our PDUFA date, as you said, is this quarter. We had great data from IMVT-1402 in D2T RA study that we presented on our last quarterly call. Probably the most notable update for today, the top center of this slide, is that we've now enrolled patients in the phase III study in cutaneous sarcoidosis for brepocitinib, which follows on the positive results that we had in our phase II data, which I think we announced on our first quarterly call of this year or earlier in the calendar year.
We've now received the initial payment from Moderna in the settlement, the 1498 part of that case is progressing, and we filed international proceedings against Pfizer and BioNTech in that case. Finally, earlier this year, we added LPP as a fourth brepocitinib indication, and as I'll remind people later today, that study is continuing to enroll as well. As I mentioned at the top of the call here on slide six, I'll just say this is a quiet quarter and this is a quiet day. I don't know exactly how the following statement could be true, but I think it is. The next 6-12 months are in many ways busier than the prior 6-12 months for us, we just have an enormous amount coming up.
Starting, as I mentioned, with the upcoming potential brepocitinib launch in DM, which should happen imminently, assuming everything goes as we hope and expect it will with FDA. We've got top-line data in brepocitinib from the NIU study, an indication that could easily be as large as aromatase inhibitors. That data is coming in the second half of this year. We also have top-line data coming shortly in the second half from mosliciguat, the phase II study in PH-ILD. I know that's being closely watched and we're looking forward to getting that data and presenting it.
We will provide further updates on the D2T RA program at Immunovant in the second half of this year, including hopefully a download on a conversation we hope to have with FDA about that program as well as the results from the second part of the study and a little bit more about our plans going forward. Finally, probably the smallest of these, we're expecting top-line data from the PoC study in CLE also in the second half of this year, and looking forward to finding out what we've got there when that comes in as well. Just a jam-packed second half and even more coming in 2027 with the Graves' data and beyond. Just a lot in the here. I'll just hit a couple of highlights in terms of pipeline updates in a little more detail here before, again, turning to our Q&A.
Starting on slide eight with a reminder because it's been a few months since we talked about it. The initiation of this cutaneous sarcoidosis phase III study is a pretty exciting event. It's a little bit ahead of schedule in terms of what we're able to do here. This is a disease that we're just privileged to be able to work in here. It's a high morbidity, very difficult disease with a high urgency to treat. You can see on slide eight some of the photos we've shared before, but these are patients who are really sick and have very few treatment options. On slide nine, as a reminder of the data that we generated in our phase II study, we had set for ourselves a goal of a sort of five-point benefit on the CSAMI scale for clinical meaningfulness.
In the study in the top left of this chart, we showed a greater than 20-point benefit compared to roughly nothing on placebo. Just a huge benefit to those patients in the phase II study and really excited to carry that forward into the pivotal program. A reminder on slide 10, we think this is a pretty decent-sized indication, again, with high unmet need, probably about 40,000 patients in the U.S., and reasonable overlap with some other organ systems, including optical sarcoidosis or eye sarcoidosis, where that overlaps with NIU. That is one of the types of NIU that we're studying, as well as pulmonary sarcoidosis, which is a big potential indication as well, and where we hope to be able to treat some of those patients via either tracheal sarcoidosis or OCS.
The phase III study that we've now begun, the design is laid out on slide 11. I know there were some questions after the phase II about what exactly this study would look like. It is designed to take all of the learnings from the phase II study that was successful. It is a 16-week study with the primary endpoint of CSAMI greater than or equal to 50% response rate. It's a 140-patient study across about 70 sites, 3:2 randomized with patients either on 45 milligrams of brepocitinib or placebo and with a mandatory steroid taper going from week two to week eight, down to zero. Which is roughly consistent with what we did in the phase II, and generally consistent with what we think is appropriate for patients in this indication. That study, as I said, has already begun enrolling patients, and we expect top-line data in 2028.
Which just adds to the list of potential registrational indications for brepocitinib coming up. I'll reiterate on slide 12, the other ongoing registrational program, is the brepocitinib study in lichen planus or LPP that we announced earlier this year. That study is enrolling, I'll say, extremely well. There's a lot of enthusiasm from physicians and patients for that. Speaks to the high unmet need in the indication. Speaks to the quality of the work being done by Ben and the Priovant team. I'm looking forward to sharing more about that as soon as we've got it. That's also moving along nicely. Finally, I'm sure there will be questions about this in Q&A and lots of opportunity to talk about it hopefully with regulatory approval and beyond. One of the major events in the near term here is the potential launch of brepocitinib in dermatomyositis.
I think we're in a phenomenal position here in terms of what we've got and in terms of what we hope to be able to do. Starting with the quality of our clinical data, which as you know from the multiple times we've talked about it from the publications, including "The New England Journal of Medicine" and so on, just a phenomenal data set taken across all 10 endpoints, big clinical benefit, a lot of enthusiasm from the doc community. This is a really tough disease, a large addressable population, most of them on sort of polypharmacy, trying a lot of different things, and frankly, most of them still dissatisfied with the available treatments. We feel like we have an opportunity to do something big and different for this patient population.
Our team has been out spending a lot of time with the physician, the patient communities on overall education, and I think the enthusiasm for a new therapy is coming out loud and clear, including with all the academic presentations that have been done and so on. Commercial launches, there's not much to say today other than that it's on track. We're ready to launch on time, having received priority review. The sort of commercial and base support teams are built out, trained, ready to deploy. We feel really great about the hires we've made there, really great about the organizations we've built there. We think we're doing this in a way that is both capitalizing on all the learnings from successful launches at other companies in recent years and doing it in a Roivant private way.
There's nobody in the world that'd be more excited to oversee this than the team we've got at Priovant with Ben and Daniel and others, and I think we're going to be fully ready. Everything's on schedule. We'll have much more to say about that with the potential approval, and after, but looking forward to it. I'll say one more thing about the commercial franchise overall of brepocitinib on slide 14. We get a lot of enthusiastic questions from investors around pace of launch, and we've been pretty consistent that our answer to that question is sort of slow and steady, is what we're looking to build there. I think there's a bunch of reasons for that. Some of them are DM is a new indication and no one's launched a novel therapy basically ever, or at least a targeted therapy, basically ever.
It's just hard to know exactly what work will need to be done to get everyone comfortable and excited and on drug. Although I think we're fully prepared. Also to me, it's because brepocitinib is a lot more than just dermatomyositis. To me, what we're really doing here is not just trying to make that launch as fast as possible. We're trying to lay the groundwork for the overall opportunity, which goes beyond DM into first NIU and then CS and LPP with the data coming thereafter.
I think as you think about that layering, to me, it's much less about what week one or month one or quarter one look like, and much more about making sure that the foundation around access, the foundation around patient support, the foundation around the institutional activities, the foundation around our communication with the scientific and physician community and our communication with patients are all set up to deliver the maximum opportunity for brepocitinib across all of these indications. I think slow and steady isn't just about sort of guidance. Slow and steady is about the approach that we're taking with the program to make sure we have maximum reach across everything that we're doing there, including indications that we're excited about beyond the ones we've already announced. A lot to come. As I said, on track for that launch.
You all hear the same thing we do, which is a ton of enthusiasm from the patients and physician community for new options in all of these indications. I'm looking forward to sharing more when we know about it. Our guidance is going to continue to be slow and steady because that's what we think we're building. Final business update here is we got the upfront payment in the settlement with Moderna. That $950 million has come in, 770-ish of it to Genevant and the rest to Arbutus. That's done. There'll be progress in terms of return of capital, et cetera, of that via Arbutus and so on. The '498 sort of appellate ruling is that process is ongoing at the Federal Circuit. That'd be another $1.3 billion if we got a favorable outcome there. We continue to advance our litigation against Pfizer and BioNTech.
We filed three international lawsuits, notably in Canada and the UPC, in July, just last month, continue to progress that case as fast as we can. Not all of it in our control, but equally enthusiastic about the potential there in terms of what we could get. I'll wrap up just with our usual financial update on slide 17. Overall, most importantly, we are spending in areas that we're excited to be spending. We're excited about all of our R&D programs, about $200 million of R&D expense for the quarter of just under $100 million of non-GAAP adjusted G&A or $166 of GAAP G&A expense. Cash just under $4 billion, and that's before the receipt of the $772 million. Notably, pretty significant share repurchase activity, about $200 million in the quarter, a bit more than that when you include March.
What we did there was we accelerated our share repurchase program upon the announcement of the Moderna settlement so that we could get those shares in. Remember, the shares that we bought by kind of the first round of this, the billion and a half that we had bought back sort of up through mid last year, we bought back at around $10 a share. I think the average price at which we've been able to buy back stock since we kicked off the second round of this in earnest in March has been in the high 20s. Feeling good overall about retiring those shares and getting that capital back to shareholders. Going to continue doing that according to our authorizations for now. All of it ahead of, on slide 19, a really rich catalyst calendar ahead with a lot coming.
Looking forward to all of that with just an incredibly busy stretch ahead. On slide 20, again, incredible for the people around Regeneron who have to do this work. By the end of calendar 2028, we'll have had hopefully three or more commercial launches, nine full multiple studies readouts, four plus NDA or BLA filings, a number of proof of concept studies. Just a ton coming up in the near term. With that, I'm going to wrap up my prepared remarks for the day. I will hand it back over to the operator for Q&A in just a moment. Thank you again for listening this morning and looking forward to taking your questions.
Thank you.
Operator, over to you.
Certainly. We will now begin the question-and-answer session. As a reminder, to ask a question, please press star one and one on your telephone. If you'd like to cancel your request, you can also press star one and one again. Our first question comes from the line of Brian Cheng of JPMorgan. Your line is open. Please go ahead.
Hey, guys. Good morning. Thanks for taking our question. Maybe just thinking through the DM launch map, can you give us a quick sense of what metrics we could be receiving way out of the gate to help us better track the initial launch? Secondly, on PH-ILD, as we think about the baseline characteristics here in PHocus, it seems that more patients are on [batoclimab]. We're curious if there's any implication in terms of the fibrosis versus erythema ratio in the populations, and then further down the line, whether there's any implication towards the bar for success for both six-minute walk and also PVR. Thank you.
Yeah, perfect. Thanks. I appreciate both questions. Look, on DM, a thing I've gotten fond of saying as I've watched other companies with commercial launches is that you all don't deserve our guidance, which isn't quite fair. Look, I think other than sort of a slow and steady launch, and obviously the sort of top-line metrics will be plainly visible in our financials each quarter. I don't know that we're going to provide a ton of detail in the early days. I think it's important for us mostly to spend our time focused on understanding those dynamics ourselves, getting out, talking to patients, talking to physicians, doing the work we need to do. We'll give a little more color on what that's going to look like on a call with potential approval, and then we'll start to flesh out the package that we share with each successive quarter.
I don't have a lot to say right now about metrics. I'll say, I think typical with these launches, I'm not sure a ton is going to be visible in the early days, just given how the commercial apparatus is set up for practical purposes. We'll provide more guidance on that as it gets closer and is here. On PH-ILD, I guess, first of all, we've obviously been watching, for example, the treprostinil data in IPF and trying to understand a little bit better what's been going on with these PH-ILD patients in treatment of PH-ILD for fibrosis and for lung disease.
It's been a view of ours for a while that one of the things to look out for in treatment of PH-ILD with vasodilators is emphysema, the study was designed with care around the amount of emphysema allowed in the study overall, and that was an important part of the guiding philosophy of the study to make sure that we could serve the patient population broadly, but also while maximizing the potential benefit of the therapy. That was considered from the beginning. Those are, I think, things we're keeping an eye on. I know there is a local cohort that believes the treprostinil has anti-fibrotic benefit. Look, I think our view is if you treat PH-ILD patients well for their pulmonary hypertension, you may well deliver a benefit overall on their lung disease.
I think our view is probably that vasodilation is driving a lot of the activity there. We also have some evidence from some non-clinical models of anti-fibrotic activity for Overall, on six-minute walk and PVR, I'm sure I'll get versions of this question more today. Look, I think it's consistent with what we said before. We're hoping to see a clear signal on PVR. We expect if the drug is at all active, we will. We don't expect to see very much disparity on six-minute walk. The study is not powered for six-minute walk. It would be nice to see some separation, but I don't think that's essential for our sort of go, no go decision from here. We'll know what we've got once we get a closer look at it, including the full balance of that data. Thanks, Brian.
Thank you, Matt.
Thank you for the questions. Next question comes from the line of David Risinger from Leerink Partners. Your line is open. Please go ahead.
Thanks very much, and thanks for all the updates, Matt. I have three questions, but rather than rattling them all off right now, maybe if it's okay, I'll go one by one. First, on mosliciguat, you commented just now on six-minute walk distance. If you were to run a large trial, what type of six-minute walk distance would you be hoping for? I.e., what would be relevant to the clinicians and to the patients? That's my first question.
Yeah. Thanks, Dave. Look, I think obviously we'll have a slightly better answer to these questions overall once we have a sense of what we saw in phase II. The truth is that PH-ILD patients are really sick. There are not a lot of options for these patients. As we saw in group 1 in PAH, when you have more treatment options, first of all, patients go on multiple options, multiple lines of therapy. Second of all, most importantly, the actual, not from a clinical trial perspective, from a real-world evidence perspective, survival and mortality rates go down as new classes of drugs are introduced in PAH over time. I think it's less about a number on six-minute walk and more about having an approvable therapy. Remember, these are patients that are trying to walk to the car. They're trying to walk to the bathroom.
They're trying to live their daily lives. I don't know that I think it's correct scientifically to describe a specific numerical bar that matters versus just being able to get a new therapy. Some of that's frankly because six-minute walk in clinical settings is an artifact that is complicated and noisy and a little bit difficult to translate into daily lives. Whereas if these drugs really effectively vasodilate and improve lung function and improve PVR, I think you wind up seeing a lot of benefit for these patients. I don't know that we're going to articulate or have a specific numerical bar versus a successful study. Obviously, we will be judged, especially by the investor community, based on competitor data. I don't think we even need to be per se better than any other mechanism in order to have a big benefit to patients. Thanks, Dave.
Great. That's very helpful. Regarding the forthcoming brepocitinib DM launch, could you discuss the cadence of formulary reviews for rare disease drugs? I ask because for mass-market drugs, P&T committees often wait until six months after launch before putting drugs on formulary.
Yes. Thanks. Look, I don't have a ton to say about that right now other than we're having all of the normal engagement with the payer community that you'd expect us to have at this stage. I think this is a critical point about all of these launches, we are super focused on making sure that the physicians who want to write this drug and patients who want to get on this drug are going to have access. I think that's going to be really important for our engagement with the community for access generally. I think in terms of literal formulary, it's probably not so different. It's not like there's a separate committee for different kinds of diseases. There's lots of medical exception procedures and other things that you can do to get patients covered.
We have a whole team of people built out of Priovant that's dedicated to making sure whether the formulary work has happened yet, whether the P&T committee has happened yet, is not something that our patients and physicians have to spend a lot of time thinking about as they're deciding how to use the drug.
Excellent. That's really helpful context. Finally, beyond the list of programs on slide nineteen, could you remind us about pipeline or product opportunities for your portfolio, including specific products that you could announce initiation of new studies for over the next year or so?
I think every single one of the programs that the world is aware of in our pipeline, as well as potentially ones that the world is not yet aware of in our pipeline, in all of those cases, we could announce new trials, new indications in the next year. I think every one of those are eligible and all of our molecules could be put into indications beyond the ones we've talked about. I think it's fair to say in each case, we have specific ideas of indications we're excited about. We've done active work and are, in fact, preparing to initiate programs to varying degrees, depending on how busy those teams are today versus next month or the month after, but real progress.
I think the answer is we are actively working on that all of our products are, as you called them, pipe limited products, that we're excited to share more indications as we start those studies.
Excellent. Thanks so much.
Thanks. Thank you.
Thank you for the questions. The next question comes from the line of Samantha Semenkow from Citi. Please go ahead.
Hi. Good morning. Thanks very much for taking the questions. I also have two, one on mosliciguat, one on brepocitinib. For mosliciguat, I'm wondering if you could just talk about the translatability of PVR reductions in patients with PAH to those with the PH-ILD population that you enrolled in PHocus. Are there any aspects of either disease that could influence the magnitude of PVR that you could see in the mosliciguat data? I have a follow-up.
Look, thanks for the question. I appreciate it. I think the translation from PAH to PH-ILD is the fundamental question being answered by our study. The first unfortunate answer to that question is we're just going to have to see what we see. Yeah. It is the risk of the program at some level that we find some risk. Again, the phase I data, including in PAH patients, looks very good on the PVR basis. One of the main "risks" of this program is that there's something, I would call it unexpected, in the PH-ILD translation. Obviously I use the word unexpected because I think scientifically it seems relatively straightforward that inhaled vasodilation is an effective mechanism in PH-ILD, but we'll find out. Obviously, the lungs of PH-ILD patients are different than the lungs of PAH patients.
You might expect some difference in sort of the pharmacodynamics of the drug in those patients. Overall, it seems pretty clear that when you take an inhaled vasodilator in PH-ILD patient, you get drug to the healthy lung tissue and it matters. That's what I'd say.
Got it. Thank you. That's very helpful. Just on brepocitinib and DM, in your conversations that you've been having with physicians for education, I'm wondering if you could just talk about the reception to brepocitinib given the JAK class safety concerns. Obviously, the safety profile on VALOR was quite favorable, from a class perspective, it would just be helpful to hear how the physicians are thinking about safety, particularly since DM patients already tend to have a higher underlying risk for cancer. Thanks very much.
Yeah. We've said a few times that when we first in-licensed brepocitinib, we didn't exactly know what the reception to JAK inhibitors was going to be following the addition of black box warnings and a whole slew of two indications where the safety profile of JAKs was going to be much less of a focus. I think dermatomyositis is a poster child for this, in that while JAK inhibitors are at this point extremely widely used in diseases with much less morbidity, many more alternative therapies. In dermatomyositis there's really no other options available, I don't think physicians therefore are going to be particularly focused on this question.
Remember, these patients are, first of all, I think you sort of alluded to the profile in the trial, dermatomyositis patients are inherently at risk of many of these concerns, malignancies, cardiometabolic events, treating them well makes them healthier and reduces those risks. On top of that, the therapies that they are currently on for dermatomyositis are things like high-dose steroids, which in themselves add meaningfully, in fact, in many cases, much worse than JAK inhibitors to those very same risks. Yeah, I think in general, physicians are not going to spend a lot of time worrying about this, especially when reminded of the inherent risk of steroids and immunosuppressants that they're on anyway.
It's clear from our conversations with docs across different prescriber bases that it was very comfortable using these agents, including prescriber bases, as we said, for patients with significantly less severe disease. As a reminder, we fully expect that our label is going to look like the labels for other JAK inhibitors. It's going to have the black box warnings, it's going to talk about experience with JAK inhibitors from other indications. Like I said, I think docs expect that and I think are not going to be too concerned about it because these patients are, A, very sick, and B, on other drugs, in many cases, significantly worse safety concerns.
Thanks, Matt. Very helpful.
Questions. Our next questions will come from the line of Prakhar Agrawal from Cantor Fitzgerald. Your line is now open.
Hi. Thank you so much for taking my questions, congrats on the continued execution. Maybe a couple of questions from my side as well. Firstly, on brepocitinib and DM, could you remind us what percentage of DM patients are on off-label JAKs based on your latest primary or secondary research? Would you expect rapid switches from these patients who are on off-label JAKs to brepocitinib? If not, why is that the case? Secondly, for brepocitinib in NIU trial, what do you see as the biggest risk for phase III given the phase II was really strong? Is this geographic variation, which has been a key risk for this drug, which could drive some of the baseline variability that has been flagged as one of the risk factors by some of the table checks that we have done? Thank you. Really appreciate it.
Great. Thank you. So, in terms of your first question on brepocitinib and DM around who's on off-label JAKs and what does that look like. Look, first of all, there's just variability in physician practice, and some physicians use more JAKs and some physicians use less JAKs. That has more to do, I think, with the docs in many cases than with any specific subcategory of patient. I think what we've said publicly is a low single-digit percentage or mid-single-digit percentage of dermatomyositis patients have experience with these things. Some of the docs who are involved do use. Some docs don't use off-label drugs full stop. Some of the docs who use off-label JAKs have said they expect to switch patients over, and I hope they do, and obviously we'll be working to help them where that's appropriate, facilitate those switches.
It's just going to be down to the preference and practice of each individual doc. One of the things that our team is finding in talking to physicians is that different docs have different sort of ideals in mind for who their sort of first patients might be. It just varies based on the patient experience, the physician. Obviously we'll be able to have much more of these conversations pending a potential approval. Medically we'll see a wide variety of different phenotypes. On NIU, what is the biggest risk in phase III? It feels funny to call placebo a risk in these trials, and that's not quite exactly what I mean, but the variability in placebo response rates in immunology trials is significant.
If you're asking me what keeps me up at night, it's that we don't know exactly what placebo response rates will be in that study, and that just makes it hard to know exactly what the trial's going to look like on outcomes. Obviously, the phase II data was quite compelling, and the level of drug activity seems good. I'm pretty optimistic about the study. But this is biotech, you can lose sleep over anything. Is geography a risk? There may be geographic variation, just as there is in many other indications, and some of that's literally driven by geography and some of it's driven by physician practice, and some of it's just noise. I don't know that it's a risk in the sense that it's unanticipated or whatever. It's just a feature of running immunology studies.
Overall, the team is doing a great job with the study, and I hope it's going to come out well. Thank you.
Thank you.
For the questions. Our next question comes from the line of Andy Chen of Wolfe Research, your line is now open.
Hey, thank you for taking the question. I don't think this has been talked about yet, but for the brepocitinib launch, can you maybe talk about a few launch analogs that you're assessing right now, either patient curve or market share curve? What are the historical products with the most resemblance to brepocitinib in DM? Thank you.
Well, thanks. It's a good question. The truth is, there has never been a launch of a targeted therapy in dermatomyositis before, so there is no good, quote-unquote, analog in the sense that you can point to lots of other launches of lots of other kinds, and some have been faster and some have been slower, and some have been slow and steady, and some have been It's quite different versions of different things. I think it's hard to say, there have been successful products with all kinds of different launch phases. I think the short answer is, I don't have a specific analog for another drug that we're watching as evidence of our own penetration. I think what we're really focused on here is the dermatomyositis opportunity itself, these docs, these patients.
The benefit and the cost of being a pioneer in the indication is that you don't get to look at others. You have to chart your own course. I don't have an analog to point to. Thanks, Andy.
Thank you for the questions. One moment for our next question. Our next question comes from Yatin Suneja from Guggenheim. Please go ahead.
Hey, guys. Thank you for taking my questions. Just a quick one on difficult to treat RA. Could you maybe talk about the strategy there? Would you need one more study, two more studies? How are you thinking about that? What should be our expectations for the randomized withdrawal phase that we're going to get data on? Thank you.
Yeah, thanks. Great question. Look, on study designs, we're going to come back later this year with a full update on that program, that includes we don't yet have the randomized withdrawal period data yet, I can't speak to what's in it or how it will or will not inform strategy from here. I think at some level, the results of that study may inform whether it is usable or not as one of our pivotal studies, et cetera. I think we designed it to serve potentially as one of two, obviously it's got to hit for that to work. As we said when we announced the data, the quality of the response rates in the open label period have set a somewhat higher bar for hitting a P value we want to randomize the withdrawal section.
I think we've got to sort of see all that, take an aggregate look at the patient level data, understand what's going on, and we are planning for an FDA conversation this fall that will inform both the exact design of that study as well as help us answer those questions. I don't have a specific guidance to give on exactly what those studies are going to look like now because we don't know, but I'll say the team's working on it hard. The data was obviously exciting. It has gotten noticed. We've got a lot of enthusiastic reception, including from the doc community on it. We're excited to finalize those plans and bring them back to you later this year. Thank you.
Thank you for the questions. Our next question comes from Yaron Werber from TD Cowen. Yaron, you may ask.
Great. Thanks so much. I have a couple of questions. The first one with mosliciguat, once you release the data this year, would you release both the mono and the combo data at the same time? Secondly, for CS, the trial design is super interesting and makes obviously a lot of sense. The primary endpoint is CSMI more than a 50% response. Can you maybe translate the phase II data into the same context? Because I think the phase II looked at CSMI over 10 points and the change from baseline. I'm just trying to get a sense of the apples to apples, kind of what to expect. Thank you.
Great. On mosliciguat, I think the short answer to your question is we will not release the monotherapy data and the combo data at the same time because the combo study started much later and is enrolling now, whereas the monotherapy study obviously will read out pretty soon in the second half. I think the answer is they won't come out at the same time, and we'll put out the combo data when we've got it. The combo study, remember, it's an open label study. The truth is, I think a lot of the information that we could want will come out of the monotherapy study anyway, such that the combo study won't provide that much incremental.
I think it was designed in part to give us really good Safety experience in the combination as well as a little bit of information about incremental efficacy, just so that we can get a sense for inclusion criteria and management in the phase III. I'm not sure it's going to be a super informative outcome. That's what I'll say on mosliciguat. I think data are going to come at separate times. On CS, I don't have to give right now the exact delta. I'll say we saw meaningfully higher rates of greater than 50% CSAMI in the treatment arm than in zero. The delta was wide.
I think in the press release that may have gone out around the initiation of the CS study, it almost said well north of 50% of the patients in the treatment arm of the phase II had a CSAMI response rate of greater than 50% compared to I think the zero on CS. It should be a good bar to set for us in terms of the endpoint. I don't know that we're going to replicate exactly what we saw in the phase II. I think the point is it's well powered for population success given what we saw on the phase II.
Right. If I can just sneak in the phase III NIU, do you have a sense, is the percent HUMIRA experience going to be the same as the phase II, given that the data looked pretty good overall? It must have been pretty good in that segment too. Thank you.
I don't think we've said, thank you, what the percentage of patients in the phase III have HUMIRA experience. I don't have that number on the top of my head. I'll have to check into it. I think the answer is there's no reason to expect it to be very different than what we've seen. There are a meaningful number of HUMIRA-experienced patients in the phase III, which matters in terms of ability to go into all of those patients. I think the short answer to your question is I wouldn't expect it to be a major driver and I wouldn't expect anything markedly different about the patient population from the phase II. Thanks, Yaron.
Our next question comes from Thomas Smith from Leerink Partners. Your line is now open.
Hey, good morning. Thanks so much for the updates and for taking our questions. On the IMVT-1402 difficult to treat RA program, I just wanted to clarify how you're approaching the disclosure in the second half of the year. Should we expect to see the Part 2 randomized withdrawal data prior to your meeting with FDA, or are you planning to share the data and the regulatory feedback and next steps simultaneously? On Graves', just wanted to get your thoughts on the competitive landscape. Obviously, you're the first advanced therapy there with really solid phase II data, and you'll have the first pivotal readout next year with IMVT-1402. There are a number of different approaches targeting various segments of the Graves' patient population. Just wondering if you could comment on the competitive landscape.
As you see some of the approaches some of these competitors are taking with respect to the patient population, wondering how you're thinking about potential future studies for IMVT-1402 in Graves'. Thanks so much.
Yeah, perfect. Those are both really great questions. On the first one, I think what we said when we put the date out still holds. I think my dream, our dream for the second half of this year is that we can come back with everything tied as nicely into a bow as possible, which is to say the Period 2 data, the FDA conversation, maybe some further analysis of patient experience through both periods in the RA study, all shared at the same time. Obviously, until we have the Part 2 data in hand, we can't sort of specifically know whether there's anything in there that requires earlier disclosure. In general, I think the answer is our hope and expectation would be to give a fulsome update later this year on everything all at once for D2T RA.
On Graves', look, I think first of all, I cannot say enough times that discussion of competition in Graves' disease among therapeutic categories is just misplaced in the sense that you've got so many patients with unmet need that have had no option. The last time a novel therapy was developed in Graves' disease was like the 1950s or 1960s. There's so many patients who have need of novel therapy that it's not about outrunning a bear. It's not about beating some specific competitor. It's about changing doc behavior in an indication that badly needs new options. IMVT-1402 will have been studied in lots of patients. It's a safe and well-tolerated drug. Graves' is going to have room for lots of mechanisms and lots of products.
Among the other mechanisms, some will have specific either safety liabilities where they'll mimic a thyroidectomy and they'll require treatment with SYNTHROID, or there's lots of different approaches and most patients may be appropriate for those drugs may be appropriate for later line patients or a different subset of the patient population. Over time, I'm sure that segmenting will occur. First of all, we're going to be first out in the marketplace there long before anybody else. We're going to get to have some influence over the treatment paradigms and also just get an option out to patients and physicians before some of those other choices are available. Second of all, I think it's mostly about building the market, not about any specific alternative and so on.
Look, we're tremendously excited to be in our position in Graves' to be first to be able to offer hopefully a new option here. The only other thing I will say is you learn a lot running these studies. You learn a lot engaging with this physician community. I do think there is nuance to the patient population, and I think there is nuance to the prescriber behavior. I think there's a lot of heterogeneity in terms of how these patients are managed around the world and around the U.S. I think one of the things that we're going to be able to do is to take advantage of those learnings in future studies, in these studies, in commercial prep. I think that will be a big benefit to us in being in the first place here.
Thank you.
Our next question comes from Yasmeen Rahimi of Piper Sandler. Your line is now open.
Hi, this is Shannon on for Yasmeen Rahimi. Congrats on the great quarter. Maybe just one more from us about clarity with the readout in second half of 2026. Could you give us just maybe what you might be thinking about narrowing guidance, if you expect to do that, and then how you're thinking about the bar for success? Timing post-data, would you expect to file an sNDA, and what would be the cadence on that? Thanks.
Thanks. Look, I doubt that we're going to provide more specific timing guidance at this point than we have. We announced, I think, when the study was fully enrolled, I think we're just going to read the study out when it's done and we have the data cleaned. The truth is, NIU is another one of these diseases where there's a lot of unmet need. HUMIRA leaves a lot of room on the table. Frankly, a lot of patients aren't even getting it. I think the truth is that the bar for success is successful studies that would support registration. I think if we get that, we will have a big opportunity to help lots of patients who need it. I don't think there's a numerical bar.
Obviously, better data is better. The more we look like phase II, the happier I'll be about that. Phase II was really great data. Overall, I think as long as we have a successful clinical trial, a successful outcome, we're going to get what we need, and we have a lot of patients we can reach. I don't want to put Ben on the spot right now on exactly when that sNDA goes in, but we got the DM one in nice and quickly. I know the team is enthusiastic for NIU's indications if that study's positive. You got to believe that team's going to be working really quickly to get that sNDA in as fast as possible. Thank you.
Our next question comes from Douglas Tsao from H.C. Wainwright. Please go ahead. Douglas, your line is open. You can unmute locally. In that case, we'll move on to our next questions. One moment, please. The next question comes from Sam Slutsky from LifeSci Capital. Please go ahead.
Hey, thanks for taking the questions. Two quick ones from me. I guess, for the proof of concept readout in CLE, there's a few parts to that study, just remind me what we'll be getting in that initial release this year. For the initial launch in dermatomyositis, remind me how many clinics you're targeting and the concentration of patients at those clinics. Thanks.
Yeah, thanks. On CLE, again, I think we've said this before in other settings, but it bears mentioning. I think CLE is an interesting indication. This is a small study. It's really a fact-finding proof of concept study. We've been watching the competitive landscape in CLE closely. There's a lot of other exciting therapies in development as well. The early data from the couple of patients that we have dosed was encouraging. We're really sort of overall just looking to understand what our treatment benefit looks like, how we could conceptually stack up in the future treatment landscape, I think that will all be super informative to what we do from here and whether we go forward. I think the primary, as a reminder, is 12 weeks, 600 versus placebo, then in period two, all patients go out to 600 at 52 weeks.
The thing that we'll be reporting first is that 12 weeks for 600 versus placebo. That's what we'll see. Then, obviously, a bunch of other data beyond just the specific primary endpoint. On the DM launch, I'm not going to share today exactly what our sort of targeting strategy is, but as a reminder, there's about 200 myositis referral centers that treat approximately half of the U.S. patient population. Obviously those clinics, those docs, those centers are an important part of the overall picture. There are other important physicians as well. I think Ben and the team have done a really great job overall engaging with the physician community. I'm excited about what we've done there, excited about the sort of medical publication strategy. Obviously, The New England Journal publication was a great outcome.
Feeling good overall about that plan, we're going to talk to as many docs and get out there as much as we can at [audio distortion] Global. Thank you. Great questions.
Further questions? We will now take the last questions from Alex Thompson of Stifel. Please go ahead.
Hey, great. Thanks for taking our question. Maybe two more on IMVT-1402. Going back to the questions around placebo responses. How are you thinking about managing placebo response in the Graves' studies, particularly in the backdrop of ATD down titration, and the potential for waxing and waning of disease in that context over longer periods of time? Secondly, what's your current thinking on sort of where IMVT-1402 could fit within MG and CIDP as that landscape continues to evolve? Thanks.
Yeah. Thank you. Great questions. Appreciate it. Look, on Graves', I think the short answer to this question is, if you set the bar high enough on the endpoints, these are just not patients who are spontaneously remitting. If you're looking at patients who are getting to proper thyroid hormone levels and off ATDs, I think the simple truth is placebo should be pretty manageable here. Without saying much more about exactly how the ATD titration works and so on, different other studies being run by different companies are taking slightly different approaches there, I'm not going to say too much about exactly what we're up to. Overall, I think this is something that is likely manageable.
I think as far as MG and CIDP are concerned, it's pretty rare that you have a great drug where you can run a clinical trial and be just very confident that the trial is going to work. FcRns have been studied many times in MG at this point. IMVT-1402 really should work in MG. The data that we generated in batoclimab, although I know there was plenty of debate over the deeper is better question, we think showed a real treatment benefit, especially on things like MFR and sort of clinical remission that other FcRns, in our view, have not been quite as compelling on. I think we have an opportunity to deliver really great data, and I think that data will translate to adoption. I'll say two other things.
One is that the MG market has just shown itself to be extremely large. There's room for lots of different classes. There's room for multiple FcRns. There's a little bit of cycling going on. There's differences in dosing paradigm and so on. I think no matter what share we take, even a relatively modest share of a market that size is a big opportunity. I think argenx SE has done a really great job establishing that market, establishing themselves in that market, becoming the drug of choice that people reach to for a next-generation therapy. I think they may very well remain the class leader there. I think we will find lots of operating room around them with hopefully incremental meaningful benefit to patients beyond what they can deliver and just with another option, with different route of administration and so on.
I think in MG, we'll be out there. I think we'll have a big opportunity just given the size of the overall market and then exactly what our share is and where we fit in will depend on the clinical data that we generate in the study. CIDP, my one comment is, I think in CIDP, class leadership has been less concretely established at this point. It's a more recent launch. I think there's probably a little bit more room for improvement on treatment paradigm. I think what we showed with batoclimab in the CIDP study was pretty encouraging, and I hope we're able to do something similar with IMVT-1402, and I think there will be a lot of enthusiasm if we can for our role there.
I think we have an opportunity to be a major driver in that market. Overall, I think the level of success that argenx SE se has had with things like MG and CIDP makes me tremendously excited about Graves' and about D2T RA and the other indications where we are first, in that the first-mover advantage that argenx SE se has been able to develop in their indications are significant, and I expect to build a similar moat for ourselves. Look, I think ultimately these docs are going to be sensitive to clinical data, focused on clinical data. I think if our data is phenomenal, we'll be able to lead in every indication where we have that kind of data. I think docs are going to follow the quality of the evidence.
Great. Thanks, Matt.
Appreciate the question.
Thank you for the questions. With that, I would like to hand the call back to management for closing.
Thank you, everybody, again. Thank you for the thoughtful questions. I appreciate how much work it is to come up with good questions in a quiet quarter. I promise there'll be lots coming in the coming weeks and months to give you more substrate in the future. In the meantime, we appreciate it. We appreciate everyone for listening. As always, I'm super appreciative of everybody who works for Roivant and our advancements, who are working just super hard on all of these programs to move them forward. I've been very proud of our execution and pleased with the progress we've made. I want to thank the physicians and investigators and patients in our studies who trust us with their care. I couldn't be more excited for the 12 months ahead.
One way or another, this is the last boring quarter we're going to have for a while. Looking forward to the more exciting ones ahead and moving swiftly over them until we get there. Thank you, everybody. Have a good day.
That does conclude today's conference call. Thank you for your participation. You may now disconnect your line.
Related articleQuarter not tagged2026-07-23Immunovant to Report Financial Results for the First Quarter Ended June 30, 2026, and Provide Business Update on Thursday, August 6, 2026
GlobeNewswire
Immunovant to Report Financial Results for the First Quarter Ended June 30, 2026, and Provide Business Update on Thursday, August 6, 2026
DURHAM, N.C., July 23, 2026 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT) today announced that it will report its financial results for the first quarter ended June 30, 2026 on Thursday, August 6, 2026 before the market opens. Roivant Sciences Ltd. (ROIV), Immunovant’s majority stockholder, will host a live conference call and webcast at 8:00 a.m. ET that same day, which will include a business update for Immunovant. To access the Roivant (Nasdaq: ROIV) conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “News & Events” in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant’s website after the conference call. About Immunovant Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. Contacts: Investors Keyur Parekh [email protected] Media Stephanie Lee [email protected]
Related articleQuarter not tagged2026-06-19Immunovant (IMVT) Up 3.6% Since Last Earnings Report: Can It Continue?
Zacks
Immunovant (IMVT) Up 3.6% Since Last Earnings Report: Can It Continue?
A month has gone by since the last earnings report for Immunovant, Inc. (IMVT). Shares have added about 3.6% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Immunovant due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers. Immunovant's Q4 Loss Wider Than Expected, Pipeline in Focus Immunovant incurred a fourth-quarter 2026 net loss of 73 cents per share, wider than the Zacks Consensus Estimate of a loss of 60 cents. The company had reported a loss of 64 cents per share in the year-ago quarter.Excluding stock-based compensation expense, IMVT reported a net loss of 67 cents per share.Currently, Immunovant does not have any approved products in its portfolio and has yet to generate revenues. IMVT’s Q4 Results in Detail Research and development expenses totaled $142.3 million, up 51.9% from the year-ago quarter’s figure. The increase was primarily due to clinical activities for IMVT-1402, as well as $39 million in costs associated with the discontinuation of batoclimab, partially offset by lower expenses related to batoclimab studies.General and administrative expenses were $17.3 million, down 14.4% year over year, primarily due to lower personnel-related expenses, market research and information technology costs, legal and other professional fees.As of March 31, 2026, Immunovant’s cash and cash equivalents totaled approximately $902.1 million compared with $994.5 million as of Dec. 31, 2025. The cash balance is expected to extend IMVT’s cash runway through the commercial launch of IMVT-1402 for GD. IMVT’s Full-Year 2026 Results For full-year 2026, Immunovant recorded a net loss of $2.77 per share compared with a net loss of $2.73 per share reported in 2025. In the past month, investors have witnessed a downward trend in estimates review. At this time, Immunovant has a subpar Growth Score of D, though it is lagging a bit on the Momentum Score front with an F. Charting a somewhat similar path, the stock was allocated a score of D on the value side, putting it in the bottom 40% for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be inter…Read full documentShow less
A month has gone by since the last earnings report for Immunovant, Inc. (IMVT). Shares have added about 3.6% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Immunovant due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers. Immunovant's Q4 Loss Wider Than Expected, Pipeline in Focus Immunovant incurred a fourth-quarter 2026 net loss of 73 cents per share, wider than the Zacks Consensus Estimate of a loss of 60 cents. The company had reported a loss of 64 cents per share in the year-ago quarter.Excluding stock-based compensation expense, IMVT reported a net loss of 67 cents per share.Currently, Immunovant does not have any approved products in its portfolio and has yet to generate revenues. IMVT’s Q4 Results in Detail Research and development expenses totaled $142.3 million, up 51.9% from the year-ago quarter’s figure. The increase was primarily due to clinical activities for IMVT-1402, as well as $39 million in costs associated with the discontinuation of batoclimab, partially offset by lower expenses related to batoclimab studies.General and administrative expenses were $17.3 million, down 14.4% year over year, primarily due to lower personnel-related expenses, market research and information technology costs, legal and other professional fees.As of March 31, 2026, Immunovant’s cash and cash equivalents totaled approximately $902.1 million compared with $994.5 million as of Dec. 31, 2025. The cash balance is expected to extend IMVT’s cash runway through the commercial launch of IMVT-1402 for GD. IMVT’s Full-Year 2026 Results For full-year 2026, Immunovant recorded a net loss of $2.77 per share compared with a net loss of $2.73 per share reported in 2025. In the past month, investors have witnessed a downward trend in estimates review. At this time, Immunovant has a subpar Growth Score of D, though it is lagging a bit on the Momentum Score front with an F. Charting a somewhat similar path, the stock was allocated a score of D on the value side, putting it in the bottom 40% for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, Immunovant has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Immunovant belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, TG Therapeutics (TGTX), has gained 35.6% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026. TG Therapeutics reported revenues of $204.92 million in the last reported quarter, representing a year-over-year change of +69.6%. EPS of $0.17 for the same period compares with $0.03 a year ago. For the current quarter, TG Therapeutics is expected to post earnings of $0.42 per share, indicating a change of +147.1% from the year-ago quarter. The Zacks Consensus Estimate has changed +10.6% over the last 30 days. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for TG Therapeutics. Also, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Immunovant, Inc. (IMVT) : Free Stock Analysis Report TG Therapeutics, Inc. (TGTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

