Roivant Sciences Ltd. Q2 FY2025 Earnings Call

Good day, and thank you for joining us. Welcome to Roivant's Second Quarter 2025 Earnings Call. Please note that today's conference is being recorded. I will now turn the call 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 everyone dialing in. This was not a quiet quarter for us, as we put out both the Graves' data and, obviously, the Phase III data for brepocitinib in dermatomyositis. It is a tremendous moment of transformation for the business, but a relatively quiet earnings call as we're looking forward to getting everybody together in December for a more comprehensive discussion of where we are as a business and more about the future at our Investor Day on December 11. That 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 has happened in the recent quarter, and then we'll talk much more about the future when we get together in December. I want to start out on Slide 5 with a short victory lap because it has been a remarkable year for us. The VALOR data for brepocitinib in dermatomyositis hit on all 10 ranked endpoints and is a phenomenal data set that we believe will transform the lives of dermatomyositis patients. The NDA filing remains on track, planned for the first half of next year, and it will be the first novel oral therapeutic in dermatomyositis if approved. We also released data in this quarter from the durable remission segment of the Graves' disease trial for batoclimab, which sets us up for the future in our 1402 Graves' program. That data demonstrated the disease-modifying potential of 1402. Earlier this year, we also shared data on myasthenia gravis and chronic inflammatory demyelinating polyneuropathy that validates the deeper is better hypothesis for FcRn from an IgG expression perspective. We initiated registrational trials in Graves', myasthenia gravis, CIDP, difficult-to-treat rheumatoid arthritis, and Sjögren's, as well as a proof-of-concept trial in cutaneous lupus erythematosus this year at Immunovant. We are excited about the progress there with IMVT-1402, which we hope will become first-in-class in many cases and best-in-class across all indications. We received a favorable Markman ruling this quarter for Genevant in the Pfizer case and have continued progress in the lipid nanoparticle litigation, with the jury trial and the Moderna case scheduled for March of 2026. Our capital position remains very strong with $4.4 billion in cash and cash equivalents, which will support our current pipeline's path to profitability, pipeline expansion, and potential additional capital return, including the $500 million that we have currently authorized. On Slide 6, we have been showing this slide for a while, but it feels more real with each passing quarter, highlighting a late-stage pipeline that we are genuinely excited about, with 11 potentially registrational trials and indications with blockbuster potential. The first of those, dermatomyositis, is now behind us, but many more are to come, setting us up for a slide we've shown since June on Slide 7, which depicts a packed 36 months ahead of us between multiple registrational data sets, starting with dermatomyositis and NIU to brepocitinib, followed closely by a myriad of opportunities in 1402 for a series of launches. We're genuinely excited about this transformative moment for the business, and we are looking forward to discussing this further when we get together in December. The buzz we hear from investigators, patients, and doctors in the dermatomyositis landscape is encouraging, and we appreciate the excitement from investors as well. I'm now going to briefly recap the two major data sets from the quarter. I won’t spend much time on either because we've discussed them in setting before, but they are worth mentioning again due to their excitement. Starting with the brepocitinib VALOR data on Page 9, VALOR succeeded with highly significant and robust data across the primary and key secondary endpoints, showing a clear dose-response that positions 30 mg as the optimal dose. Responses were rapid, deep, broad, and clinically meaningful across the board, demonstrating a statistically significant and clinically important difference compared to placebo on mean TIS, with deep responses occurring quickly across various endpoints, including muscle and skin. As a reminder, these patients represent a population with significant unmet medical need; 75% of these patients are currently treated only with either steroids or immunosuppressive therapies and struggle to achieve adequate control. A relatively small segment—only one-fourth—are on other therapies, and among those that do, many are on challenging IVIg regimens, spending multiple days each month in infusion centers and relying on a series of off-label therapies, many of which have previously failed dermatomyositis programs. This has resulted in excited feedback from the physicians we've engaged with regarding these data, and we are looking forward to sustaining this enthusiasm as we navigate through the registration process in the coming year. Looking at Slide 11, this is the primary endpoint—mean TIS—which provides a clear picture of positive clinical data, statistically significant at the highest dose starting at the earliest time point with clear separation and a distinct dose-response. One of the standout findings I want to highlight is our original focus on steroid tapering as a risk mitigator to ensure we observed a clear drug benefit against the background of active management therapy rather than placebo. Additionally, we were able to demonstrate a real dose-response in terms of reducing steroid use, where a significantly greater proportion of patients were able to reduce dosages or be weaned off steroids entirely on high-dose brepocitinib than those on placebo. This finding has resonated deeply within the medical community, as the treatment of dermatomyositis with higher doses of steroids is something physicians keenly want to avoid, and we're pleased that we could evidence this through our study, incorporating it as part of one of the key secondary endpoints. On Slide 12, more than a third of brepocitinib 30 patients achieved both major TIS responses and minimal or no steroid use at week 52, which is an immensely encouraging outcome. Furthermore, over half of the patients achieved a TIS40, a moderate TIS response, while using very low doses of oral steroids. The data available is statistically robust with low p-values across every secondary endpoint we analyzed, reflecting benefits related to muscle strength, skin involvement, and patient-reported outcomes like the HAQ-DI questionnaire, evidencing a strong result overall. Regarding what’s next year, the NDA submission is currently progressing well, with the only significant gating item being the drafting process, which is ongoing. We anticipate that the submission will occur in the first half of the year. The data readout from the proof-of-concept study in CS, which we have ongoing, is also expected next year, alongside the NIU study, which is enrolling nicely and is guided to read out around the first half of 2027, coinciding with the potential registration of brepocitinib and launch in dermatomyositis. We plan to submit the sNDA for NIU shortly thereafter with further indications to follow. Regarding brepocitinib's progress, I expect we will have robust discussions about this program and what it could mean commercially on the 11th. It's been a phenomenal quarter that we are eager to build on from here. I will now briefly recap the Graves' disease remission data released earlier this quarter. On Slide 16, we remind you that this patient population is substantial with significant unmet medical needs. An essential point to consider here is the shifting away from surgical procedures over time, as patients are increasingly hesitant to undergo surgery or radioactive iodine therapy, leaving 25-30% of Graves' patients either relapsed, uncontrolled, or intolerant to antithyroid drugs. Thus, there is a notably high proportion of patients who remain inadequately controlled. On Slide 17, it's important to understand that Graves' disease has serious implications; these patients face a significantly elevated risk for cardiovascular events, a fourfold higher risk of preeclampsia and a sevenfold higher risk of thyroid cancer compared to the general population. Moreover, many develop complications like thyroid eye disease; approximately 40% suffer from eye symptoms, with some undergoing optic neuropathy and others experiencing considerable vision issues. Additionally, around 16% of hospitalized Graves' disease patients are diagnosed with thyroid storm, a condition with a 20% mortality rate—indicating that this population is unwell and at high risk for developing severe comorbidities. As we look towards our findings, on Page 18, it's crucial to note the prevalence of this disease, with about 65,000 newly diagnosed patients annually and 20,000 landing in the refractory category. In total, approximately 880,000 U.S. patients diagnosed with Graves' disease exist, of which 330,000 are struggling to manage their disease adequately or are intolerant to treatment options. Thus, we are dealing with a vast patient population facing significant medical needs. Earlier this year, in our batoclimab study, we demonstrated a remarkable disease-modifying benefit for these patients. Of the 25 patients who entered the trial, after 12 weeks of high-dose batoclimab followed by an additional 12 weeks of low-dose therapy, a considerable number responded positively, and impressively, 17 of the 21 patients followed up at week 48 were still responders post-treatment. Therefore, the evidence strongly supports that we can deliver meaningful benefits for patients previously uncontrolled on standard therapies and significantly reduce or eliminate their need for antithyroid drugs. These results were further underscored on Slide 21, particularly demonstrating reductions in TRAb levels alongside the general IgG decreases we observed during the high-dose treatment. The majority of patients maintained their TRAb levels significantly reduced even at week 48 after concluding the treatment, signifying a durable benefit. Lastly, on Slide 22, looking ahead, the next period is stacked for us in 1402, with data rolling in across various indications, including D2T RA and CLE after next year and extending to Graves' disease and MG in 2027, followed by Sjögren's and CIDP later. One final note is regarding the Evolving competitive landscape in the TED study; we will likely hold off on reporting the top-line data from that first trial until the second one concludes in the first half of next year. We made this decision to allow for a comprehensive data collection considering the landscape's complexities in both TED and Graves' disease. Moving on to a brief update regarding the LNP litigation, which I know some people are following closely. In the Moderna case, we are in the pretrial process, focusing on the narrowing of claims and defenses, along with summary judgment currently being reviewed by the judge. The trial is set for March, and we anticipate international proceedings beginning in the first half of 2026. The Pfizer case is ongoing in the discovery phase, and we received a favorable Markman ruling earlier this month, setting us up positively for future progress. Now, concluding with a brief financial update, I can say this quarter has been straightforward from a financial standpoint, with a loss from continuing operations net of tax of 166 million. We maintain cash and cash equivalents totaling $4.4 billion, with no debt reported on our balance sheet. Importantly, our share count reflects the substantial buybacks executed over the past 18 months, yielding a solid overall position that we believe will lead us to profitability. More in-depth financials and our catalyst roadmap can be found on Slide 28. In summary, we experienced an exhilarating six months behind us and look forward to a promising 12 to 36 months ahead. We are confident in the transformation our profile has undergone in recent months, and we are excited to carry this momentum forward. As a reminder, we have an Investor Day in New York City on December 11, 2025. The registration link is live, and I hope to see many of you there to wrap up the year and discuss future opportunities. Thank you again for listening. Once more, while this may have been a relatively quiet earnings call, it has certainly not been a quiet quarter. I will now pass the call back over to the operator for Q&A. Thank you, everybody.

Our first question is coming 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 concerning the Pfizer litigation? Specifically regarding international markets and then in the U.S.

Thanks, Dave. I appreciate the question. Obviously, it's an area of significant interest for many people. It's always a challenge to comment on ongoing litigation. I cannot provide specifics about potential timing for international cases. I do sense that we are entering a busier moment now. There should be a scheduling process underway for the Pfizer case, so we hope to learn more about the exact timeline, including a trial date, in the near future. That is likely the information to keep an eye on publicly at this point, getting that schedule organized and moving forward from here.

Our next question comes from Brian Cheng with JPMorgan.

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

Thanks, Brian. That's a great question. As you heard me mention regarding our timeline for the batoclimab TED data, we are very much aware of the competitive landscape in Graves' disease. To put it mildly, I’d say imitation is the sincerest form of flattery. I think it's fantastic to see others recognizing the importance of treating Graves’ disease. Ensuring new treatment options are developed is crucial for these patients. We previously ran a Phase II study looking at both high and low doses of batoclimab and observed significant benefits from the higher dose. Also, we reported data splitting patients based on whether they achieved greater than or less than a 70% IgG reduction. We had three times as many patients getting off antithyroid drugs in the above 70% group compared to the below 70% group. We believe we have a competitive profile in this space. More importantly, there are numerous patients in need. A rising tide will benefit everyone in this case. Argenx has done a tremendous job executing their strategy, and while it can be frustrating, it also validates our choice to focus on this disease.

Great. And just one quick follow-up. On the Investor Day next month, can you discuss what you want investors to take away from it? Is this more of a recap of your current strategy, or are you expecting to unveil new data or a new strategic direction for Roivant?

Yes. I don’t want to reveal everything now, but it will be an exciting Investor Day highlighting the transformative nature of our business. The type of investors who are now engaged with us has changed, and numerous aspects of our operations have also been altered. We want to make sure we fully communicate this story, touching on the commercial perspective, patient needs in these indications, and why we are excited about certain blockbuster opportunities. There may also be new things we can share by then in terms of updates, but we’ll see where we stand in a few weeks. Overall, it will be an engaging opportunity for us to assess the business and discuss future prospects.

Our next question comes from Samantha Semenkow with Citi.

For Graves' disease, regarding the remission data, can you offer any insights on how much starting on high-dose batoclimab in that study contributed to the observed remission rates? I'm curious if there's anything you could share from the data analysis that may inform our views of the competitive landscape.

Thanks for the question. Regarding remission, we must be cautious given the evolving competitive landscape. That said, we believe remission ties closely to TRAb normalization over time. Our hypothesis holds that achieving deeper IgG reductions will likely influence that outcome. The speed and depth of the responses seen in the bato trial regarding TRAb lowering support this perspective. We are confident in our level of IgG suppression in the high-dose arm.

Our next question comes from Yaron Werber with TD Cohen.

Great. I have a quick question regarding the ongoing preliminary summary judgment against Moderna concerning U.S. government involvement in the Emergency Use Authorization. Do you think that the government ever took 'control' of vaccine distribution and does that provide Moderna the potential to make an argument?

Thanks, Yaron. As usual, it's tricky to comment on ongoing litigation. It will be ultimately up to the judge’s decision on the 1498 question. However, I will point out two things that are important to consider. First, Moderna's sales of COVID vaccines in the U.S. make up slightly less than half of their total global sales, which are themselves less than half of the overall aggregate sales including Pfizer. Furthermore, Moderna has asserted in their briefings that it claimed damages in the U.S. case totaling around $5 billion, asserting that roughly half of this amount could be tied back to the 1498 issue. So the 1498 summary judgment question essentially boils down to a portion of a fairly small fraction of a fraction. We believe our stance is clearly defined in our motions, and Moderna's position is similarly elaborated upon in their documentation. While we believe we have a robust case, the ultimate determination lies with the judge. I wanted to clarify the scope of the question at hand.

Our next question comes from Prakhar Agrawal with Cantor Fitzgerald.

Congrats on the progress this quarter. Firstly, regarding Sjögren's disease, there has been growing excitement around the market opportunity there, particularly following Novartis' BAFF drug. How can FcRns differentiate on ESSDAI scores or other specific metrics? Do you believe you could potentially be first-in-class in this indication? Secondly, on Brepo and dermatomyositis, do you plan to apply for the FDA's National Priority Voucher for Brepo?

Thanks for those questions. We're genuinely excited about the market opportunity in Sjögren's disease. It represents a large patient pool with significant unmet needs. Various therapeutic classes have shown some benefit, and we believe our FcRn data gives us a real chance at being best-in-class. While we won't commit to beating competitors, our goal is to launch as close to first-in-class as possible. We do feel there's substantial anticipation among KOLs regarding new therapies, and the unmet need is significant in this market. Regarding brepocitinib, we are currently considering multiple paths and how best to navigate the FDA to get patients the treatment they require as quickly as possible, watching the various options closely.

The next question comes from Corinne Johnson with Goldman Sachs.

In light of the competition in Graves' disease, there are several companies revealing their plans in this area recently. How are you evaluating the evolving competitive clinical landscape? What informs your decisions on how to sequence marketing efforts as we progress forward? Also, any updates on business development would be valuable.

Thanks, Corinne. We're well aware of the competitive landscape as several companies have recently stepped in, which is indeed exciting. Observing the myasthenia gravis landscape, there has been significant competition and success with new mechanisms. FcRn has so far proven to be a strong leader in that market. We think we have built a similar foundation in Graves' disease, which represents a market significantly larger than the MG segment. We feel great about our position regarding both timing and mechanism. FcRn is excellently suited for addressing the disease’s underlying biology. Some other mechanisms focus on high doses that can overlap with the negative effects we see with antithyroid drugs—something FcRn avoids. Safety and tolerability are essential in the Graves' population, and FcRn's profile is advantageous. Increasing voices in this space should only help drive awareness and lead to more efficient treatment options. Regarding business development, we remain exceptionally well capitalized and are enthusiastic about expanding our pipeline. We're keen on identifying programs that can meaningfully expand our current offerings and aim for indications that can significantly impact our existing pipeline.

The next question comes from Dennis Ding with Jefferies.

We have two questions if I may. Firstly, on Pulmovant, you will have Phase II PH-ILD data in the second half of next year. How confident are you about the translation from PAH to PH-ILD? What should we expect from that update, and what do you see as the positive delta on PVR? Secondly, regarding the LNP litigation, what percentage of the U.S. doses were administered to federal employees? How does this factor into your considerations for summary judgment?

Thanks, Dennis. Both are great questions. Regarding Pulmovant, we remain enthusiastic about mosli. You pinpointed the inherent risk involved in reaching the PH-ILD patient group without previous specific data. Overall, PVRs have typically translated well. While there are exceptions—primarily related to VQ mismatch issues with vasodilators in lung disease patients—we think our mosli format addresses this challenge adequately. Thus, I'm cautiously optimistic, although I will feel more confident once we have the Phase IIb data in hand. We expect to see significant PVR reductions and notable clinical benefits in that patient population. Enthusiasm remains high for the program as the market continues to expand, especially concerning prostacyclins in PH-ILD, which leaves substantial room for other mechanisms. As for your second question, I don't think our best estimates regarding the percentage of doses received by federal employees are available in our motions. However, you can deduce that it's relatively small.

Got it. If I could sneak one more regarding the LNP litigation. Could you remind us of the status concerning the OUS trials? We're not fully familiar with the OUS process. How many cases have you filed, which is the furthest along, and can we expect an initial decision in 2026?

Yes, that’s a fantastic question. We have filed several OUS actions in various jurisdictions, including the UPC in Europe, Canada, Japan, and a few other places. These litigations are ongoing, with significant hearings anticipated throughout 2026. Some European jurisdictions tend to move quickly, so outcomes may indeed emerge within that year, and I look forward to providing further updates as we navigate this situation.

Our next question comes from Dominic Risso-Gill with LifeSci Capital.

Congrats on a great quarter. This is Dominic, on for Yasmeen Rahimi. As we look toward the TED data, can you clarify your expectations for the studies reading out soon? What are you hoping to see to consider developing in the competitive landscape?

Thanks, Dominic. That's a vital question. We're anticipating that data shortly for sharing next year. The competitive bar in TED is genuinely high, given that IGF-1Rs are showing considerable efficacy; however, they indeed leave space for safety concerns. We aim to deliver data that aligns with the challenges posed by the competitive landscape. Additionally, we believe we'll gain insight into hyperthyroid Graves' patients through this study and the interplay between Graves' and TED. We intend to finalize our launch decision regarding batoclimab once we have the TED data and in consultation with our partner.

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

Matt, as a follow-up on Graves' and TED, given the interrelation of these conditions, and with argenx potentially coming to market with VYVGART being both for Graves' disease and TED, how do you view pursuing TED with 1402 as opposed to pursuing batoclimab with two separate molecules?

Thanks, Doug. That's an insightful question. Let’s address this globally. We will have more data from the TED trials that will inform the answer to that question, and we will also have unique insights into the broader treatment landscape. The involved specialists treating these conditions treat them at different stages; it is crucial to communicate with endos treating Graves' about the potential benefits in preventing TED. In terms of market dynamics, remember that the Graves' population is significantly larger than that of TED, driving our strategic focus that way with 1402. We could observe other interesting data as it emerges, which may help us strategize effectively. Thanks for your question.

If I could also follow up on brepocitinib; I was at AACR, where KOLs offered very positive feedback. How do you anticipate the treatment landscape evolving in the coming years, especially with VYVGART data coming next year and CAR-T starting pivotal trials? Are there plans to explore subtypes of myositis, such as IMNM and AS?

Great questions. On the competitive landscape, echoing previous statements, I believe we have an excellent opportunity to lead—in particular with oral therapy, which aligns with the preferences of most DM patients, who are currently on oral treatment. While the CAR-T strategies target different patient populations, open questions remain. FcRn could offer unique advantages. I firmly believe we gain a significant head start in DM, with broad access due to our treatment approach. I’m optimistic about the overall data we have in DM specifically. As for exploring additional subtypes of myositis like IMNM and AS, we've explored numerous indications for brepocitinib and do see exciting opportunities ahead.

Next question comes from Tess Smith with Leerink Partners.

Regarding the TED program and the competitive landscape, could you comment on the recent IL-6 data and whether you consider it approvable? How do you expect batoclimab to compare against that data? Additionally, any updates from the overseas study you're conducting with 1402? Do you have a timeline for when we might see data from additional indications?

Thank you for those questions. Naturally, it's not our position to comment on the approvability of other mechanisms. There was a notable placebo response in the IL-6 study, which we've observed closely. Overall, my perspective is that competition in TED is high, with IGF-1R being effective while also carrying safety concerns. Our focus is on investigating where we can add value in TED and, as I’ve said, looking to Graves' to potentially impact the disease early in its course. We have several sizeable registrational programs ongoing in 1402, and we’re combining those efforts to inform our bigger studies. When we have information to share from these trials, we’ll do so, but primarily, those results will guide our decisions on indication selection and study design.

And our next question comes from Brandon Frith with Wolfe Research.

Have you provided any analogs for the DM launch? We're curious to learn what the launch cadence might look like initially and in the longer term.

That's a good question. DM is an area with high unmet need but has seen little in the way of novel therapies recently launched. Therefore, we don't have many analogs for direct comparison. Consequently, we aim to approach launch speed cautiously, as we endeavor to get the therapy widely available while generating excitement among doctors. Our confidence lies in the sizable market opportunity and considerable unmet patient needs. However, the timeline for achieving peak penetration is still uncertain, and we will strive to ensure it’s as successful as possible while aligning our long-term trajectory accurately.

Our next question comes from Gaurav Maini with LifeSci Capital.

I have a question on Graves'. Based on market research to date, when comparing uncontrolled Graves' disease to the FcRns' performance in the MG market. How do you size these up? Are you thinking the opportunity is bigger, smaller, or about the same as MG for FcRns?

It's challenging to compare directly; the MG market has proven to be very lucrative. However, there are numerous uncontrolled Graves’ patients seeking effective treatments, making it an exciting opportunity for us. We believe we could substantially impact this condition. We can also expand on the commercial potential during our December 11 presentation. We’re looking forward to showcasing how we can make a real difference for hundreds of thousands of patients, establishing various pathways to gain market presence. Our first-hand engagement with physicians while enrolling patients in our studies has significantly informed our understanding of the Graves' opportunity, giving us a competitive edge congruently.

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 all for joining us today. Once again, this has been a phenomenal quarter for our company, and I am very much looking forward to having our Investor Day discussions about the future while diving deeper into many of the questions raised on this call. I hope to see many of you there, and I wish you all a pleasant end to the year. Thank you very much, and have a great day.

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