The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: David Risinger - Leerink Partners LLC - Analyst
: 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? So specifically in international markets and then in the US.
Question: Brian Cheng - JPMorgan Chase & Co - Analyst
: Just two quick ones from us. How do you feel about argenx stepping into Graves' and whether that has any impact on your strategy
of 1402? And then we have a quick follow-up.
Question: Brian Cheng - JPMorgan Chase & Co - Analyst
: Great. And just one quick one. So on the Investor Day next month, just curious if you can talk about what do 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 that there will be some unveiling
of completely new data or a new strategic direction at Roivant?
Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst
: 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? I'm just wondering if there's
anything that you could share that you were able to tease out from the data when you analyzed it so as we think about the competitive
landscape?
Question: Yaron Werber - Cowen and Company LLC - Analyst
: Great. Maybe a quick question. We've been getting a few questions about the ongoing preliminary -- the summary judgment against
Moderna with respect to the US government involvement in the EUP -- I'm sorry, EUA and whether the government ever took control
of the vaccines for distribution and whether that made them a commercial party and whether that impacts their involvement and
as a result, would potentially provide Moderna some venue to make an argument. Any thoughts about that, if you can comment at
all would be great.
Question: Prakhar Agrawal - Cantor Fitzgerald LP - Analyst
: Congrats on the progress in the quarter. Maybe firstly, on Sjogren's disease. Recently, there has been a lot of excitement around
Sj÷gren's market opportunity, especially with the recent data from Novartis' BAFF drug, ianalumab. Maybe you can contextualize
how FcRns can differentiate on ESSDAI scores or other specific endpoints? And do you think you could be first-in-class in this
indication? And secondly, just quickly on Brepo and DM, do you plan to apply for FDA's National Priority Voucher for Brepo?
Question: Corrine Johnson - Goldman Sachs. - Analyst
: Maybe following up on an earlier question about competitive intensity in Graves' disease. I think it goes beyond argenx in terms of
number of companies that have announced plans there. So how are you thinking about the kind of competitive clinical landscape
that's evolving? And what do you expect to inform sequencing decisions in that space over time? And then maybe separately, just
on business development. Curious if you could give an update on what you're seeing on that front.
Question: Dennis Ding - Jefferies LLC - Analyst
: We have two, if we may. Number one is on Pulmovant. So you guys will have Phase II PH-ILD data in the second half of next year. I
guess, how confident are you about the translatability from PAH to PH-ILD? And how should we think about that update? And what's
the positive delta on PVR? And secondly, on the LNP litigation, I'm curious if you've done any work on what percentage of the US
doses were given to actual federal government employees as we think about a middle scenario for summary judgment?
Question: Dennis Ding - Jefferies LLC - Analyst
: Got it. And if I can sneak one more in about the LNP litigation. Maybe remind us what's the status in terms of the OUS trials. We're
not that familiar with the OUS process. So I guess, can you remind us how many cases you filed, which one is the furthest along?
And can you get an initial decision in 2026?
Question: Dominic Risso-Gill - Piper Sandler - Analyst
: Congrats on a great quarter. This is Dominic, on for Yasmeen Rahimi. We just had a question going into the TED data. Could you help
us understand what you're thinking about with the expectations for the studies that are reading out here soon? And what do you
hope to see to consider development considering the competitive landscape?
Question: Hao Shen - Wells Fargo Securities LLC - Analyst
: This is a Hao, calling in for Derek Archila from Wells Fargo. I guess we have a question on brepo. We were at AACR. So very positive
feedback from all the KOLs. So question is about really the competitive landscape. I guess we've seen VYVGART having data next
year and the CAR-T is also starting their pivotal trials. How do you see the kind of the treatment paradigm evolve over the years?
And brepo, do you have also plan to explore in other subtypes of myositis like IMNM and AS?
Question: Thomas Smith - Leerink Partners LLC - Analyst
: Congrats on the progress. Just with respect to the TED program and the competitive landscape, could you comment on some of
the data we recently saw from the IL-6 class, whether you think Sat is approvable with that data set and sort of your expectations
for batoclimab relative to those results? And then secondly, is there any update you could provide from the overseas study that
you're running with 1402? And any sort of timing guidance for when we might see data from additional indications from that study?
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NOVEMBER 10, 2025 / 1:00PM, ROIV.OQ - Q2 2025 Roivant Sciences Ltd Earnings Call
Question: Brandon Frith - Wolfe Research LLC - Analyst
: This is Brandon on for Andy. Have you provided any analogs for the DM launch? And we're curious to know what to expect for the
cadence out of the gate in longer term.
Question: Gaurav Maini - LifeSci Capital LLC - Analyst
: This is Gaurav, on for Sam from LifeSci. So just a question on Graves' here. Based on all the market research done to date, as you
compare the uncontrolled Graves' disease opportunity versus what FcRns have shown in the MG market, I guess, how do you size
these up? How are you thinking about the opportunity? Is it bigger, smaller, similar as we think about MG for FcRns?
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consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
NOVEMBER 10, 2025 / 1:00PM, ROIV.OQ - Q2 2025 Roivant Sciences Ltd Earnings Call
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