Immunovant, Inc. Q2 FY2025 Earnings Call

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. So not at all a quiet quarter for us given that we put out both the Graves' data and the Phase III data for brepocitinib in DM. It’s a tremendous moment of transformation for the business, but a relatively quiet earnings call as we look forward to getting everybody together in December for a more fulsome telling of where we are as a business and more about the future on our Investor Day on December 11. That registration link is live on our website. I look forward to seeing you all there. Today will be more of a review of what's happened in the recent quarter, and then we'll talk much more about the future when we get together in December. So, looking forward to that. I want to start out on Slide 5, just by taking a short victory lap because it's been a pretty wild year for us. Obviously, starting with and probably most notably, the VALOR data for brepocitinib in DM, which hit on all 10 ranked endpoints and just a phenomenal data set that we believe is going to transform the lives of DM patients. The NDA filing remains on track and is planned for the first half of next year. It will be the first novel oral therapeutic in DM, if approved. We also put out data in this quarter from the durable remission portion of the Graves' disease trial for batoclimab, which sets us up for the future in our 1402 Graves' program. This demonstrated disease-modifying potential for 1402. Earlier this year, we released data in MG and CIDP, validating the deeper is better idea for FcRns from an IgG suppression perspective. We also initiated at Immunovant this year potentially registrational trials in Graves', myasthenia gravis, CIDP, D2T RA, and Sjögren’s, as well as a POC trial in CLE. We had a favorable marketing ruling this quarter for Genevant in the Pfizer case and made continued progress in the LNP litigation, with the jury trial in the Moderna case scheduled for March 2026. Our capital position remains strong with $4.4 billion of cash and cash equivalents, which will support our current pipeline and expansion, including the $500 million that we have currently authorized. On Slide 6, we're excited about our late-stage pipeline with 11 potentially registrational trials and indications with blockbuster potential. The first of those being dermatomyositis is now behind us, but many more are to come. On Slide 7, we've been showing our stacked 36 months ahead of us with multiple registrational data sets. We're excited to share more about this transformation when we get together in December. I want to do a brief recap of the two major data sets from the quarter. Starting with the brepocitinib VALOR data on Page 9, again, we've gone through this before, but VALOR succeeded with highly significant, robust, and consistent data across the primary and all key secondary endpoints with a nice clear dose response, setting us up for 30 milligrams to be the optimal dose here. Responses were rapid, deep, broad, and clinically meaningful across the board, with a statistically significant and clinically important delta to placebo on mean TIS, with deep responses occurring quickly across a range of endpoints, including muscle and skin. On Slide 10, this is a patient population with very significant unmet need. 75% of these patients are on either steroids or ISTs and are struggling to be well controlled. Many require high doses of oral prednisone to be sort of treated appropriately and are looking for options, with only a relatively small percentage, about 1/4, of the market on other therapies at all. We're getting a predictably enthusiastic response from physicians we've engaged with on this data already and are looking forward to continuing those discussions during the registration process next year. Looking at Slide 11, again a recap of the primary endpoint of mean TIS. We had originally focused on a steroid taper as a risk mitigant but were also able to show a real dose response on steroid reduction. We were able to get a significantly greater portion of patients to lower steroid doses or off steroids on high-dose brepocitinib than on placebo, which has resonated greatly with the physician community. On Slide 12, more than one-third of brepo 30 patients achieved both major TIS responses and minimal or no steroid burden at week 52, an exciting finding across the board. More than half of patients achieved a TIS40 response while on very low doses of oral steroids. Just a phenomenal outcome on the combination of endpoints. We had robust data, with low p-values across every secondary we tested, benefiting muscle, skin, and patient-reported outcomes. In terms of what's next year, NDA submissions are ongoing, and we expect to get it filed in the first half. Data readout from the proof-of-concept study in CS will be next year, and the NIU study is enrolling well, anticipated to read out in the first half of '27. So that's brepocitinib; we'll discuss it more on the 11th. It was a tremendous quarter, and we are excited to carry that forward. Next up, I'll recap the Graves' disease remission data we released earlier this quarter. On Slide 16, there's a large patient population with significant unmet need. There's been a notable shift away from ablation over time as patients don't want to go through surgical procedures or radioactive iodine treatment. I've highlighted that around 25% to 30% of Graves' disease patients are relapsed, uncontrolled, or intolerant to ATD. This is a severe disease; patients are at a much higher risk of cardiovascular events, including a fourfold higher risk of preeclampsia and a sevenfold higher risk of thyroid cancer than the general population. In total, we've got about 880,000 diagnosed U.S. patients, with 330,000 unable to control their condition. The batoclimab study showed remarkable disease-modifying benefit. Of the 25 patients who came in at baseline, after 12 weeks of high-dose treatment, 20 out of 25 were responders. After dropping to low-dose after another 12 weeks, 18 out of 25 responded, and remarkably, even after being off the drug, 17 out of 21 patients remained responders to therapy after 48 weeks. Nearly half of these off-drug responders were completely off ATDs, and more than 75% were on only the lowest doses of ATDs or off entirely, highlighting disease-modifying benefits. On Slide 21, we also saw a rapid decline in TRAb levels, especially on high dose, showing durability of benefit. In the next period, we've got a stacked line of data approaching in 1402 with trials for D2T RA and CLE next year, as well as Graves’ and MG in 2027. The TED study remains on track to conclude this year, but we might hold off reporting data until we see top-line data from the second study early next year, taking a prudent path given the competitive landscape. Moving on to the LNP litigation, I know some are following this closely. We are in a pretrial process around narrowing claims and defenses in the Moderna case, with a trial scheduled for March. The Pfizer case is ongoing in discovery, with a favorable market ruling issued in September that sets us up nicely moving forward. I'll conclude with a brief financial update: A loss from continuing operations net of tax was $166 million, and we have $4.4 billion in cash, cash equivalents, with no debt on the balance sheet. This strong financial position is expected to carry us through to profitability. We have a catalyst roadmap in place. Again, just a really exciting six or 12 months behind us and even more excitement in the months ahead. Looking forward to our Investor Day on December 11, 2025, where we can share more. Thank you for listening to a relatively quiet earnings call, but certainly, not a quiet quarter! I will pass it back to the operator for Q&A.

Operator Instructions: Our first question comes from the line of Dave Risinger with Leerink Partners.

Congrats on all the progress, Matt, and looking forward to the event on the 11th. 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. It’s tough to comment on ongoing litigation. I have nothing to say about any potential timing of international cases. I think there should be a scheduling process for the Pfizer case underway, and we should learn more about the timeline, including a potential trial date in the near future. That's probably what I would be most watching for in terms of what's public at this point.

Our next question comes 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. It's a great question. We're aware of the competitive landscape in Graves' disease. I think to make a gentle comment, imitation is the finest form of flattery. It’s great to see others recognizing the importance of Graves' as a disease and working on treatment options for these patients. We saw a significant benefit to the high dose of batoclimab in our Phase II study, along with better results in patients with greater than 70% IgG reduction compared to those below. We think we have a competitive profile there. But ultimately, it's a large patient population, and a rising tide will lift all boats. Argenx is a formidable company with significant execution, and it's validating of our strategy that they are following in our footsteps.

Great. And just one quick one. So on the Investor Day next month, just curious if you can talk about what you want investors to get out of the Investor Day? Is this more of a broader recap of your current strategy? Or do you think there will be some unveiling of completely new data or a new strategic direction at Roivant?

Yes. I think most importantly, this is a moment of huge transformation for our business. We want to share that story fully and help people see our commercial perspective and patient needs in these indications, and the reasons we are excited about the potential blockbuster opportunities. There might be some new things we can share by then in terms of updates, but it will be an exciting opportunity to take stock of the business and discuss the future opportunities.

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

Just for Graves', when thinking about the remission data, is there any way to tease out the impact of starting on the high-dose batoclimab in that study? How much did that contribute to the remission rates you saw? Is there anything you could share from the data when analyzed to think about the competitive landscape?

Yes. It's a great question. We're going to be careful about some of what we say here because of the evolving competitive landscape. We generally view remission as being connected to TRAb levels normalizing over time and believe deeper IgG reductions will lead to better outcomes. Our data supports that view from the VALOR trial. So we feel confident about our level of IgG suppression at high doses.

Our next question comes from the line of Yaron Werber with TD Cowen.

Great. Maybe a quick question. We've been getting a few questions about the ongoing preliminary summary judgment against Moderna regarding U.S. government involvement in the EUA. Can you comment on that, if possible?

Yes. It's difficult to comment on ongoing litigation. The judge’s decision on the 1498 question is critical. Moderna's sales of COVID vaccines in the U.S. represent a small fraction of their total global sales. Moderna has claimed that a portion of the damages we requested relates to that, but that's an aspect for the judge to consider. We believe our case is strong based on the motions we've filed.

And our next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald.

Congrats on the progress in the quarter. Firstly, on Sjögren's disease, there has been excitement around that market opportunity. How do you think FcRns can differentiate on ESSDAI scores and do you think you could be first-in-class in this indication? Secondly, on brepo in DM, do you plan to apply for the FDA's National Priority Voucher for brepo?

Those are both great questions. On Sjögren's, we believe there’s a significant unmet need and a large patient population. There is a possibility for first-in-class positioning, and we aim for our FcRn therapy to approach that. Regarding the CNPV program for brepo, we haven't determined our course yet, as we're evaluating different ways to expedite FDA approval for patients.

Our next question comes from the line of Corinne Johnson with Goldman Sachs.

Following up on competitive intensity in Graves' disease, how do you think about the evolving competitive clinical landscape, and how does it impact your decisions moving forward? Also, can you provide an update on business development?

The competitive landscape is exciting. We see many players trying different mechanisms, which is great for the Graves' space. We've learned from the myasthenia gravis landscape that FcRn therapies can have a strong position. We’re confident in our timing, mechanism, and overall understanding. The high unmet need is significant, and we believe FcRns are well-suited for treating Graves' disease. As for business development, we are well-capitalized and continuously look for ways to expand our pipeline, focusing on programs that can significantly impact our goals.

Our next question comes from the line of Dennis Ding with Jefferies.

We have two questions. First on Pulmovant, what’s your confidence in the translation from PH to PH-ILD? Secondly, on LNP litigation, have you estimated the percentage of U.S. doses administered to federal government employees?

On Pulmovant, I think the data could translate well, but there’s inherent risk without data in PH-ILD. We are cautiously optimistic but will feel better after Phase IIb data next year. For LNP litigation, we don’t have estimates of the doses for federal employees directly in our motions, but it’s a relatively small percentage.

And our next question comes from the line of Yasmeen Rahimi with Piper Sandler.

Congrats on a great quarter. I have a question regarding the TED data. Could you help us understand your expectations for the studies reading out soon and what you hope to see given the competitive landscape?

We look forward to sharing our TED data. The competitive bar in TED is high with IGF-1Rs showing efficacy, but we see opportunities from a safety perspective. We’re also eager to learn how hyperthyroid Graves' patients may be impacted by this study. Final decisions on launch in batoclimab will depend on the TED data and coordination with our partner.

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

As the two diseases are interrelated, how do you think about pursuing TED with 1402 versus batoclimab? Will you consider the market dynamics of having two different molecules?

It’s a great question. We’ll know more once we have TED data in hand. The Graves' population is bigger, and we focused there first for 1402. The interplay between Graves' and TED allows us to market potential benefits of the treatment prior to TED onset. We have thought exhaustively about potential indications for brepo. We have exciting possibilities but want to chart a market-defining course for our current choices.

Our next question comes from the line of Thomas Smith with Leerink Partners.

Can you provide any analogs for the DM launch and what to expect for the cadence longer term?

DM has high unmet need but also lacks recently launched novel therapies. It's difficult to find perfect analogs. The market opportunity is large, and we will do all we can to ensure success. The long-term trajectory is significant.

Our next question comes from the line of Sam Slutsky with LifeSci Capital.

Regarding Graves', how does the uncontrolled opportunity compare to what FcRns have shown in the MG market?

Both markets have tremendous potential, but the Graves' patient population is large, with significant opportunities for improvement in their lives. We'll discuss this further on December 11.

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, everyone, for listening this morning. Once again, it was a fantastic quarter for us in terms of results delivered. I'm looking forward to our event on the 11th to talk about the future and address questions that came up on today’s call. I hope to see many of you there. Have a great end to your year! Thanks very much, and have a good day.

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