Thank you for standing by. Welcome to the Roivant Second Quarter 2025 Earnings Call. Please note that today's conference is being recorded. I will now hand the conference over to your first speaker, Stephanie Lee. You may begin. Good morning, and thanks for joining today's call to review Roivant's financial results for the second quarter ended September 30, 2025. 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 will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I'll turn it over to Matt.

Thank you, Steph, and good morning, everybody, and thank you for listening. I appreciate all of you dialing in. This was not a quiet quarter for us as we released both the Graves' data and obviously, the Phase III data for brepocitinib in DM. It marked a tremendous moment of transformation for the business, but it will be a relatively quiet earnings call as we're looking forward to getting everyone together in December for a more nuanced discussion of where we are as a business, particularly during our Investor Day on December 11. The registration link is live on our website, and I look forward to seeing you all there. Today will be more of a review of what's happened in the recent quarter before we talk much more about the future in December. I want to start out on Slide 5 with a short victory lap, as this has been a pretty wild year for us. Starting with, and probably most notably, the VALOR data for brepocitinib in DM, which hit on all 10 ranked endpoints, showcasing a phenomenal dataset that we believe will transform the lives of DM patients. The NDA filing remains on track, planned for the first half of next year, and if approved, it will be the first novel oral therapeutic in DM. This quarter, we also put out data from the durable remission part of the Graves' disease trial for batoclimab, which sets us up for the future in our 1402 Graves' program and demonstrates significant disease-modifying potential. Earlier this year, we put out compelling data in MG and CIDP, which valid action for the belief that deeper is better from an IgG suppression perspective. We've also initiated registrational trials at Immunovant this year in Graves', myasthenia gravis, CIDP, D2T RA, and Sjögren’s, as well as a POC trial in CLE. This is exciting progress with IMVT-1402, as we hope to establish it as first-in-class in many instances and potentially best-in-class across all indications. We received a favorable marketing ruling this quarter for Genevant in the Pfizer case and continued progress in the LNP litigation with the jury trial in the Moderna case scheduled for March of 2026. Our capital position remains strong, with $4.4 billion of cash and cash equivalents, which will support our pipeline to reach profitability and potential additional capital returns, including the currently authorized $500 million. On Slide 6, we have a late-stage pipeline that is very promising, featuring 11 potentially registrational trials with blockbuster potential. The first of these is dermatomyositis, which is now behind us, paving the way for many more to come. Lining up, as shown in Slide 7, we have a busy 36 months ahead of us with multiple registrational data sets, such as DM and NIU in brepocitinib followed shortly by 1402 across several blockbuster indications, including Graves'. This represents a moment of real change and transformation for our business, and we are excited to talk more about this at our Investor Day in December. The team internal is genuinely enthusiastic, and we are receiving positive feedback from investigators, patients, and doctors engaged in the DM landscape and from our investors as well. Now I will briefly recap the major data sets from the quarter because they are worth re-mentioning due to their importance. Starting with the brepocitinib VALOR data on Page 9. I remind you that VALOR succeeded with highly significant, robust, and consistent data across the primary endpoint and all key secondary endpoints, showing a clear dose response that positions us for 30 milligrams to be the optimal dose. Responses were rapid, deep, broad, and clinically meaningful, with a statistically significant and clinically important delta to placebo on mean TIS, with deep responses emerging quickly across a range of endpoints, involving muscle and skin. It's imperative to recognize that this is a patient population with significant unmet needs, as 75% of these patients are reliant on either steroids or immunosuppressants and are struggling to achieve well-controlled treatment. Many of them require high doses of oral prednisone for suitable treatment while looking for better options, as only a quarter of the market is currently on other therapies, with some enduring demanding IVIg regimens or a series of off-label therapies, many of which have previously failed DM programs. Hence, we are experiencing an enthusiastic response from physicians we've engaged with about our data, and we look forward to continued engagement through the registration process in the coming year. On Slide 10, we emphasize that this is a patient population with considerable unmet needs, a fact emphasized in our discussions with healthcare physicians. 75% are on only steroids or immunosuppressive therapies which are unable to effectively manage their treatment. So we are encouraged by the physician feedback we've received regarding our data evident thus far, and we anticipate having even more insightful discussions as we progress through the registration process next year. Going on to Slide 11, again, this is the primary endpoint, mean TIS. What we observed was statistically significant at the high dose from the earliest time point, demonstrating nice clear separation and a distinct dose response. Additionally, we had firstly focused on tapering steroids as a risk mitigant to ensure clarity in the benefit from the drug against the background of managed therapy. We successfully showed that we could achieve a significantly greater number of patients lowering their steroid doses or completely going off steroids on high-dose brepocitinib compared to placebo. This finding resonates particularly with the physician community, as they are exceedingly focused on reducing or eliminating high-dose steroids for their patients. The results we observed are fantastic and crucial to our discussions with healthcare professionals moving forward. Furthermore, on Slide 12, I want to highlight a crucial key secondary finding. More than one-third of brepo 30 patients achieved both major TIS responses and minimal or no steroid burden at week 52. Over 50% of patients were able to reach a TIS40, which represents a moderate TIS response, using very low doses of oral steroids. This indicates a truly phenomenal outcome across the endpoints we assessed. Additionally, the dataset we present on Slide 12 has statistically robust data with low p-values across every secondary endpoint we assessed, showcasing the benefits on muscle, skin, and patient-reported outcomes like the HAQ-DI questionnaire concerning disability. Overall, it has been an incredibly positive outcome. For next year, we are moving forward with our NDA submission as quickly as possible. The only genuine gating item is the ongoing drafting, which is currently in progress. We expect to file within the first half of the year. We anticipate data from our ongoing proof-of-concept study in CS to emerge next year, while the NIU study is enrolling well and estimated to read out around the same time we anticipate brepocitinib's potential registration and launch in DM. Shortly after, we plan to submit the sNDA for NIU, with further indications to follow, so that is the situation regarding brepocitinib. I'm certain we will receive questions regarding this at the end. However, I want to make succinct that it was a remarkable quarter and we are eager to carry that momentum forward. Next, I will touch upon the Graves' disease remission data released earlier this quarter. Moving to Slide 16, I want to reiterate that this patient population is vast with significant unmet needs. There has been a definite movement away from ablation procedures as patients increasingly prefer to avoid surgical intervention or radioactive iodine treatment. Therefore, current medical therapies have left an important gap, particularly for the roughly 25% to 30% of Graves' disease patients who relapse, remain uncontrolled, or are intolerant to antithyroid drugs. This significant proportion reflects a dire situation for many patients who struggle with management. Slide 17 highlights just how severe the disease can be. Patients with Graves' disease carry a much higher risk of cardiovascular events and preeclampsia than the general population, with a risk 4 times greater for preeclampsia and 7 times higher for thyroid cancer. These patients experience extreme sickness, often leading to additional complications like thyroid eye disease; approximately 40% develop eye symptoms, and some of these lead to optic neuropathy with detrimental vision issues. Also noteworthy, around 16% are diagnosed with thyroid storm, resulting in a 20% mortality rate—indicating that this demographic of patients has considerable health risks associated with the disease. We are excited about this program and will provide further insights on the 11th. To continue with our discussion on Slide 18, furnish the audience with data that shows this disease affects many people. Each year, around 65,000 patients are newly diagnosed, with roughly 20,000 landing in the refractory category. There are about 880,000 diagnosed patients in the U.S., with 330,000 in the prevalent population struggling with uncontrolled or intolerable treatment. The immense size of this patient demographic signifies a critical medical requirement. Our earlier batoclimab study demonstrated real disease-modifying benefits. Of the 25 patients enrolled at baseline, following 12 weeks on high-dose batoclimab and another 12 weeks on a low-dose regimen, we tracked follow-up at 48 weeks with a fascinating outcome: 17 out of 21 individuals were still responding to treatment even after a drug hiatus for six months. These statistics prove significant disease-modifying potential. On Slide 20, we want to emphasize the data showing that nearly half of the off-drug responders were entirely off antithyroid drugs, while over 75% were on only minimal doses or completely off. This forms the basis for our exceptional results in delivering benefits for patients who previously had uncontrolled Graves' disease. Our findings on Slide 21 demonstrate that our data was consistent across clinical markers, including T3 and T4. Notably, TRAb reductions reflect the expected behavior from FcRn therapy, with rapid declines in both general IgG and TRAb levels, particularly noted during the higher dose periods. Remarkably, these patients managed to maintain reduced TRAb counts long after stopping medication. Looking at Slide 22, our pipeline for 1402 is packed as we anticipate data on various indications, including D2T RA and CLE next year, followed by Graves', MG in 2027, and Sjögren’s and CIDP thereafter. A quick update: the TED study is on track to conclude this year. Our last patient visit is approaching, but we plan to hold off reporting the top line data until we receive the outcomes for the second study in the first half of next year. The competitive landscape in TED, particularly relating to Graves' disease, has led us to adopt a more cautious approach. We aim to gather comprehensive data before making any announcements. Continuing to the LNP litigation. For the Moderna case, we are currently in the pretrial phase concerning the narrowing of claims and defenses, focusing on summary judgment. The judge is reviewing our summary judgment deliberations, and we've established a calendar hoping to proceed to trial come March. The international proceedings are also anticipated in the first half of 2026. The Pfizer case is active in discovery, and a favorable market ruling was issued in September that enables us to approach subsequent needs positively. Before we transition to Q&A, let me provide a brief financial update. Overall, it was a straightforward quarter financially, with a loss from continuing operations net of tax of $166 million. We hold $4.4 billion in cash and cash equivalents, with no debt on the balance sheet. Our share count reflects significant share buybacks over the last 18 months. In general, our financial strength is expected to facilitate our pathway to profitability. We have more information in the financials and a roadmap for our catalysts on Slide 28. We are genuinely enthusiastic about the past 12 months and similarly excited about the prospects of the next 36 months. I am proud of how far we've positioned this business within a very short timeframe and looking forward to building on that success. Just a friendly reminder, we have an Investor Day in NYC for those who can attend in person on December 11, 2025. The registration link is available in the presentation we shared, as well as our website. April 11, would be a great chance to connect and round out the year discussing future plans. With that, I appreciate your time and attention during the call. Although it may seem like a quiet earnings call, the quarter was anything but drab. I will now turn it back over to the operator for Q&A. Thank you for being with us.

Our first question comes from Dave Risinger with Leerink Partners.

Congrats on all the progress, Matt, and looking forward to the event on the 11th. So my question is, could you please comment on what we should be watching next with respect to Pfizer litigation, specifically in international markets and then in the U.S.?

Thanks, Dave. I appreciate the question. Obviously, it's something that a number of people are tracking. It is challenging, as always, to comment on ongoing litigation. I cannot provide any potential timing of international cases at this point. The Pfizer case is entering a busier moment, and a scheduling process is underway. We hope to learn more about the timeline, including potentially a trial date in the near future, which is what I recommend keeping an eye on.

Our next question is coming from the line of Brian Cheng with JPMorgan.

Matt, just two quick ones from us. How do you feel about argenx stepping into Graves' and whether that has any impact on your strategy for 1402? And then we have a quick follow-up.

Thanks, Brian. That's a fantastic question. I understand that you're curious, and I appreciate the perspective. We are very much aware of the evolving competitive landscape in Graves' disease. To make a simple comment, imitation is the finest form of flattery. It's wonderful to see others recognizing the significance of Graves' as a disease and stepping up with treatment options for these patients. As indicated in our Phase II study, we observed great benefits with high doses of batoclimab. Moreover, breakpoints of the patients scoring above and below 70% IgG reduction received three times as many patients achieving an off ATD status compared to those below the threshold. I maintain that we should possess a very competitive profile in the market. Ultimately, the opportunity landscape is substantial, and I genuinely believe rising stakes will help everyone. Argenx is an admirable firm with a strong reputation for execution, and while it may be frustrating to us, it validates the pathway we are pursuing.

Great. And just one quick one. On the Investor Day next month, are you able to discuss what you want investors to take away from it? Are you giving a broader review of your current strategy, or is it more likely you will unveil new data or strategic directions at Roivant?

Well, it wouldn’t be fun for me to reveal all the details now. But to provide a little insight, this is undoubtedly a moment of huge transformation for our business. The caliber of investors joining our journey is different from before. Many aspects of the business have evolved as well. We want to ensure we're telling that story fully, helping investors see the course of our commercial perspective given current patient needs in these indications. We may share some new things, but we will wait for a few weeks to see where we stand. Overall, it will be an engaging opportunity to evaluate our business and disseminate information regarding our future opportunities.

Our next question is coming from the line of Samantha Semenkow with Citi.

Just for Graves', when thinking about the remission data, can you clarify how to assess the impact of starting on the high-dose batoclimab approach in the study? How significant was its contribution to the observed remission rates? Are there any specific insights you can disclose from your analysis that might assist in evaluating the competitive landscape?

Yes. Thank you for that insight. It's a great question. While I must phrase my responses carefully due to the ongoing competitive landscape in that area, I believe that generally, remission is related to TRAbs stabilizing to normal for an extended period. We think deeper IgG reductions will lead to that. Speed and depth of responses witnessed in the VALOR trial, especially in terms of TRAb lowering, will be crucial steps forward for us. Overall, we are optimistic about our level of IgG suppression achieved at the high dosage.

Our next question is from Yaron Werber from TD Cowen.

Great. Maybe a quick question. We've received queries on the ongoing preliminary summary judgment against Moderna regarding U.S. government involvement in the EUA, and whether the government assumed control over vaccine distribution, potentially making them a commercial party. What are your thoughts on this issue?

Thanks, Yaron. Like always, it's complicated to provide an in-depth commentary on an active litigation case, and ultimately, the final decision rests with the judge regarding the 1498 question. However, consider that Moderna’s sales figures for COVID vaccines in the U.S. are just under half of their total global sales, which is reflective of the overall landscape. Their claims indicate half of the damages requested might be influenced by the 1498 claim from their perspective. Consequently, we find ourselves navigating a rough landscape. We remain confident in our approach, but it’s essential to comprehend the magnitude of the situation.

Next question from Prakhar Agrawal with Cantor Fitzgerald.

Congrats on your progress this quarter. Firstly, regarding Sjögren’s disease, there’s been a lot of excitement around its market opportunity, particularly with Novartis' recent drug data, can you clarify how FcRns can differentiate around ESSDAI scores or other relevant measures? Do you believe we could be first-in-class for this indication? Furthermore, about brepo in DM, do you intend to apply for the FDA's National Priority Voucher?

Thank you for your questions. We share the same excitement about the Sjögren’s market opportunity, given its unmet needs. Various therapeutic classes have shown some benefits, with J&J’s data illustrating the 'lower is better' hypothesis. We aim to position ourselves competitively for first-in-class. While I can’t commit to being ahead of our competitors, we're working diligently to ensure that our offering is sufficiently differentiated. I will also say that the recent Novartis data, while positive, leaves room for improvement as has been the trend in Sjögren’s data generally. We're excited about what FcRn data can provide as we explore deeper IgG suppression benefits. As for brepo, it's still early; this orphan population poses a high unmet need, and we’re evaluating all regulatory pathways to get FDA approval and reach patients efficiently. So stay tuned.

Our next question is from Corinne Johnson with Goldman Sachs.

Following up on the competitive intensity in Graves' disease. I'm curious about the evolving clinical landscape beyond just argenx and how do you plan to navigate those competitive decisions in that space? Additionally, any updates on business development?

Thank you, Corinne. Yes, we’re observing the competitive landscape closely, since several companies are actively pursuing developments in Graves' disease, which is encouraging. It’s thrilling to be engaged in this particular space, as it signifies another opportunity for improved patient outcomes. During the historical observation of myasthenia gravis's landscape, we noticed substantial competitive dynamics, with FcRn firmly establishing itself so far as a leading mechanism. The first FcRn to launch likely has an exceptional head start. We believe this parallels what we have achieved in Graves' disease, which presents a much larger market than MG. Additionally, the biology of FcRn is quite elegant. It is well-suited for addressing the underlying causes of Graves' disease pathology without causing adverse effects, contrasting with treatment mechanisms that induce undesirable reactions. Simply put, FcRn therapy is viewed favorably because of safety and tolerability, both of which will stand out in the current patient landscape. We remain optimistic our message will resonate with healthcare providers in this market. Regarding business development, we maintain a robust financial position, enabling us to scrutinize and target opportunities for pipeline expansion. We are optimistic about our current pipeline offerings. There’s a lot of enthusiasm surrounding our pathways, and we continue to explore potential for moving forward in development and in new indications. We have countless ideas to consider.

Our next question is coming from Dennis Ding with Jefferies.

We have two questions, if possible. Firstly, concerning Pulmovant, you plan to have Phase II PH-ILD data in the second half of next year. How confident are you about the transferability from PH to PH-ILD? What can we expect from the update, especially regarding the positive changes on PVR? Secondly, regarding the LNP litigation, have you assessed the percentage of U.S. doses that were administered to federal government employees as you evaluate the summary judgment scenarios?

Thanks, Dennis. Both fantastic questions. With Pulmovant, we are thrilled about mosli's upcoming phase II data. You're correct to identify that risks around translating data from PH to PH-ILD intersect us. Given the positive translatability of PVRs generally, we’ve foundational confidence in the data we will see, and we’re optimistic about the changes we’ll note. However, the complete perspective will solidify post publication of the Phase IIb data. Concerning your second question, our best estimates on the proportion of U.S. doses administered to federal employees are not inflected in our motions yet, but suffice it to say, it’s a relatively minimal percentage.

And just to sneak one more question about the LNP litigation — could you update us on the status of the OUS trials? How many cases did you file, which is furthest along? And do you expect to reach an initial decision in 2026?

Absolutely. In the Moderna case, we’ve filed multiple OUS actions, including those in the UPC in Europe, Canada, Japan, and a few other jurisdictions. These cases continue to progress. There are critical hearings expected in 2026 which could yield several outcomes. Many European jurisdictions offer a more rapid process, meaning we might see outcomes emerge within that timeline.

Our next question comes from Yasmeen Rahimi with Piper Sandler.

Congrats on a stellar quarter. This is Dominic on for Yasmeen Rahimi. We just had a question about the TED data. Could you help us understand your expectations for the studies reading out soon? Specifically, how do you hope to see data to consider moving forward in that competitive landscape?

Yes, that's a great question. We eagerly anticipate revealing that data soon. The competitive threshold within TED does set a rather high bar due to IGF-1Rs’ demonstrated efficacy. That being said, IGF-1Rs show significant safety concerns. Therefore, we expect data that allows us to meaningfully distinguish our program within a robust competitive landscape. Beyond that, we also aim to learn concerning potential interactions of Graves' disease and TED, so our analysis is likely to yield crucial insights. Ultimately, we will determine our direction for batoclimab based on data at hand and after consulting with our partners.

Our next question is from Douglas Tsao with H.C. Wainwright.

Maybe as another follow-up regarding Graves' and TED. Considering the interconnectedness of these diseases, can you share your thoughts on how to manage the dual markets with argenx. How will you pursue TED with 1402 versus batoclimab, especially given the challenges of introducing two different molecules?

That's a great question, Douglas. We are venturing into this space with numerous insights, though we are still in the process of understanding the TED data's complete implications. The competition allows us to gain valuable data, yielding opportunities for addressing both conditions. Each will likely necessitate different methods of engagement depending on the physician background involved. Thus, we are preparing to communicate the advantages of our offering in Graves' and the preventative benefits potentially offered in TED throughout this process. Until we have the TED results in our possession, we will keep evaluating our approach to both.

Great. Lastly, regarding brepo — impressive results in DM! Given the competitive situation with VYVGART and the CAR-Ts starting pivotal trials, how do you anticipate the treatment paradigm evolving in the coming years? Are you considering exploring other subtypes of myositis, like IMM?

You raise an excellent point regarding the competitive landscape, which can often seem daunting. Nonetheless, we believe we possess a formidable lead, particularly since brepocitinib has shown strong results across many indications in which it’s been tested. While we understand that CAR-Ts function differently and don't specifically correlate to our therapeutic paradigm, we still view the competition positively. We feel our access to the entire DM patient population provides a unique advantage, permitting us to establish a significant foothold in that market. Regarding the exploration of other myositis subtypes, it’s worth noting we have contemplated numerous exciting indications. Consequently, there remains a wealth of opportunities available for brepo, and we're keen on leveraging our advancements.

Our next question comes from Thomas Smith with Leerink Partners.

With respect to the TED program and the competitive landscape, can you comment on the recent data stemming from the IL-6 class? How do you evaluate their chances of approval with that dataset, and what are your expectations for batoclimab relative to those results? Can you provide any overseas study updates from 1402 and anticipated timelines for further indication data?

Thanks for the fantastic questions, Thomas. It’s worth noting that it’s not within my purview to comment on other companies' data and feasibility. The recent IL-6 studies feature a notably high placebo response that we’ve monitored closely. However, I cannot speculate on the direction that program takes from here. We see robust competition in TED and acknowledge the efficacy levels of IGF-1Rs, coupled with their safety and tolerability dilemmas. Conversely, we remain focused on how we could strategically position ourselves within TED. In terms of the overseas studies regarding 1402, we have several large registrational programs that are progressing effectively on a global scale. We're also interested in the potential for small, speedy proof-of-concept trials overseas that may help fuel subsequent studies. We will disclose any significant information once we acquire additional data, guiding our design and approach.

Our next question comes from Brandon Frith with Wolfe Research.

This is Brandon on behalf of Andy. Have you shared any performance analogs regarding the DM launch, and what can we anticipate in terms of post-launch cadence?

The DM indication certainly has a notable unmet need. However, there have been few recent novel therapies. Therefore, the landscape yields few useful direct analogs to assess. On that note, our strategy is to approach launch cautiously while ardently maintaining that we are eager to get the product introduced and physicians informed. We carry significant confidence in the market size, and the captured opportunity grows substantially. How quickly we reach peak penetration remains contingent on several factors rolling out after launch, but we intend to facilitate widespread adoption.

Our next question is from Sam Slutsky with LifeSci Capital.

Congrats on an impressive quarter. This is Gaurav in for Sam from LifeSci. About Graves' disease — based on recent market research, how do you compare the uncontrolled Graves' disease opportunity with the FcRn market seen in MG? Is it larger, smaller, or comparable?

The MG market has been excellent, undeniably so. However, there is a significant opportunity with uncontrolled Graves' disease, and we’re exceptionally excited about it. Our view shows a clear path to help hundreds of thousands of patients. A multitude of growth strategies can usher us into the market, demonstrating how impactful we could be. We anticipate discussing the commercial prospects in Graves' disease further on December 11 and hoping to address investor inquiries about our strategies. The perspective gained during this ongoing engagement with physicians has been invaluable and will prepare us to launch effectively.

There are no further questions at this time. I will now turn the call back over to Mr. Matthew Gline for any closing remarks.

Thank you. I sincerely appreciate everyone for joining us today. Once again, this quarter allowed us to shine in terms of results. I'm especially excited to engage during the Investor Day on the 11th, where we can delve into the future in deeper detail and also address many of the questions raised during today’s call. I hope to see many of you then. Best wishes for a productive remainder of the year, and thank you!

This concludes today's conference call. Thank you for your participation, and you may now disconnect. Goodbye.