Immunovant, Inc. Q2 FY2025 earnings call

• VALOR data for brepocitinib in DM hit all 10 ranked endpoints, NDA filing on track for first half of next year. - Graves' disease remission data for batoclimab showed disease-modifying potential. - Capital position strong with $4.4 billion cash and cash equivalents. - Favorable marketing ruling for Genevant in Pfizer case, LNP litigation with Moderna trial scheduled for March 2026. - Initiated registrational trials in multiple indications at Immunovant. - Pipeline has 11 potentially registrational trials with blockbuster potential.

No detailed segment-wise financial performance with absolute terms and revenue contribution % provided in the transcript.

• NDA submission for brepocitinib planned for first half of next year. - NIU study expected to read out in first half of 2027. - TED study data to be reported with other studies, and data from various registrational trials in 1402 to come.

• LNP litigation risks with ongoing pretrial processes and uncertainties. - Competitive landscape risks in various indications like Graves' disease, TED, etc.

Q: Could you please comment on what we should be watching next with respect to Pfizer litigation, so specifically in international markets and then in the U.S.?

A: Thanks, Dave. I appreciate the question. And obviously, it's something that a number of people are watching. It's tough, as always, to comment on ongoing litigation. I have nothing to say about any potential timing of any kind of international cases. Look, it's a busier moment coming up. I think there should be a sort of scheduling process for the Pfizer case underway, and we should learn more about the exact time line, including hopefully a trial date in the near future. And I think that's probably what I would be most watching out for in terms of what's public at this point is just getting that schedule together and progressing from here.

Q: How do you feel about argenx stepping into Graves' and whether that has any impact on your strategy of 1402?

A: Thanks, Brian. It's a great question. And look, I think you heard my comment on the timing of the intended sort of production of the batoclimab TED data. Obviously, we're acutely aware of the competitive landscape in Graves' disease. And look, I think to make a gentle comment, whatever imitation is the finest form of flattery. I think it's great to see others recognizing the importance of Graves' as a disease. It's great to see more people working on treatment options for these patients. Obviously, in our Phase II study, we studied both high and low-dose batoclimab, and we saw a great benefit to the higher dose batoclimab in the study. And then also, we reported in the past data breaking out the patients between that 70% cutoff below and -- above and below 70% IgG reduction. And we had 3x as many patients getting off ATDs at the above 70% group than in the below 70% group. So we think we should have quite a competitive profile there. But most importantly, to be honest, it's a big patient population, there's a lot of sick people. And I think a rising tide there will lift all boats. And like I said, argenx is a formidable company with a wide following and has done a great job of execution. And I know there's at least some people out there who find it, although it might be frustrating to us validating of our strategy that they're following in our footsteps. And so we'll always take it. Thanks, Brian.

Q: 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? And how much that actually contributed to the remission rates you saw?

A: Yes. Look, thanks. That's a -- it's a great question. And I do think we're going to -- like I said, be a little bit careful about some of what we say here because of the evolving competitive landscape, and we're going to learn more about this from the hypothyroid TED patients and so on in that study as well. But look, I think in general, remission is about TRAbs getting normal for longer. And our view is that deeper IgG reductions are going to drive towards exactly that outcome. And so both in terms of the speed of responses that we saw in the VALOR trial and the depth of responses that we saw in the VALOR trial in terms of TRAb lowering, I think that's going to be a significant driver for us. So I think we feel good, put it this way, about our level of IgG suppression in that program at high dose. Thanks. It's a great question.