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: Derek Archila - Wells Fargo Securities LLC - Analyst
: Yeah. Well, maybe first off, just kind of give a high level background of Roivant and what you guys are kind of working on. You have many projects
and many things going on. So maybe start at a high level and then we can kind of move on. You had some news yesterday for Immunovant, so we
can go through that. But the overall kind of background would be helpful.
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Awesome. Well, Richard, maybe talk about yesterday. So we have some news from Immunovant batoclimab in Graves. This is an update around
kind of the remittive effects. So maybe you can just walk us through the data and what gets you excited about kind of the FcRn class and Graves'
disease.
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SEPTEMBER 04, 2025 / 7:00PM, ROIV.OQ - Roivant Sciences Ltd at Wells Fargo Healthcare Conference
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. I guess -- and we were just talking about this. I mean, does this change anything, I guess, in terms of like how you guys had designed the
studies prior, but also like maybe commercially how you think -- I guess the future would be 1402 would be dosed in Graves' disease given that
you're seeing this kind of remittive potential.
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you.
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got it. I mean, based on the data that you guys presented yesterday, I mean, how do you think that might impact or possibly impact enrollment
now that that data is now public?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. All right, well, I'm going to shift gears to Brepo just because you know you have an upcoming catalyst there. So maybe you can kind of
just give us the lay of the land in terms of that asset and what's to come here in the second half of '25.
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got it. So maybe you're sticking with dermatomyositis and that upcoming rehab. What gets you confident that Brepo -- like again biologically,
what's the rationale for DM and I guess, the clinical evidence that really supports your confidence in the in the trial success?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. I guess there's -- in DM studies and a lot of these autoimmune diseases where steroids are prominent, like I guess -- you talk about taper.
Can you just walk us through like the tapering strategy in that trial?
I guess, again, the confidence level we've seen trials fail just because of steroid use. But ultimately, like how do you think you guys control that
within the trial?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Like how does that steroid taper compare to other DM trials? Is it similar or other ones going to zero?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. And then in terms of efficacy, what you want to see or what you need to see to kind of be clinically meaningful? What's kind of your
expectation? And I guess from your KOL checks and things like that, like what do the actual physicians in the community want to see for DM
patients?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Interesting okay. So I guess in terms of like next steps after, I guess, in terms of filing and potentially getting to commercial readiness, how do you
work through all that, post data?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: I guess when you think about the current treatment algorithm, obviously you talked about IVIG being approved. It is incoming FcRns that are also
being developed in [dermatomyositis].
I guess where do you think JAK/TYK2 really fits? Is this going to be an early-line therapy? Is there any worry about safety, or do you think it's going
to be, again, later line because of that? I guess where do you think it will fit ultimately? And I guess what's the trial designed to basically show what
population is the best candidates for the drug?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. I guess how do you think about pricing across like this indication and then some of the expansion opportunities that you were talking
about? Where does that need to sit to kind of fully maximize the value of Brepo longer term through all the indications?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got it, okay. And then I know you talked about NIU as an indication. So that's an area also kind of a dearth of development and also some [gravestones]
and for other drugs that we have been trying to --
So I guess in terms of the evidence that you guys have there and your confidence for that trial and opportunity, maybe you can just walk us through
that.
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: How big is that opportunity?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. Okay. I mean, is there any other indications that you're looking potentially with JAK/TYK2 because obviously that's a pretty, good mechanism
for broad autoimmune disease? So it'll be on the three that you mentioned. What else are you evaluating for Brepo?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. Maybe shifting to kind of the Immunovant and then the 1402 pipeline. So obviously we talked about Graves' and you guys are starting a
lot of trials. So maybe how do you think about 1402's profile among some of the other FcRns that are out there? Every day, we're hearing of a new
-- like program or degrader or something.
So it's getting pretty crowded. But I guess like where do you think there can be differentiation? And is this, like, kind of a zero-sum game or is this
like a major class where multiple winners kind of emerge?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. As you think about the indications you guys are already pursuing, I mean, which one do you think is probably the easiest one for you to
win? Like, I guess, is it more like an MG going head to head with kind of incumbents? Or is it a Graves' where you may be able to just kind of position
by yourself but it's kind of an unproven market? Like, which one again do you think is going to be kind of the biggest value driver over the next
couple years?
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SEPTEMBER 04, 2025 / 7:00PM, ROIV.OQ - Roivant Sciences Ltd at Wells Fargo Healthcare Conference
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. And then just -- we saw some updates from J&J on their RA program with their (inaudible) in combination. I mean, the data didn't look
great. It didn't look like it really had an additive effect.
I mean, does that dampen your enthusiasm at all for what your kind of development plan and difficult-to-treat RA? And I guess maybe help us
understand and reconcile like why that -- is there a little bit of a disconnect and ultimately, again, is it just a different strategy here?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. And then maybe just kind of the larger question for 1402, like, you guys continue to bring new Phase 3s forward. I guess, in the subsequent
indications, it was just going to be more Graves' disease type of indications where you're blazing new trails and should we kind of expect that as
we go on, as the FcRn class continues to get larger and larger?
There are still dozens of indications, but I guess, like what strategy should we think that you guys are taking with 1402, I guess, for the next set of
indications?
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SEPTEMBER 04, 2025 / 7:00PM, ROIV.OQ - Roivant Sciences Ltd at Wells Fargo Healthcare Conference
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got it. Okay. And then maybe shifting gears to another topic. I'm less familiar with this one, but the (inaudible) litigation and just maybe you can
share kind of timelines.
It sounds like we're coming to a head sometime next year, clearly an important milestone and catalyst for the stock and for the company. So if you
just walk us through and provide some updates on where you're at there.
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got you. So I guess how would this -- how does this change what's going on at Roivant, like ultimately depending on the outcomes of the trial?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Got it. And then just lastly, what are you seeing in the BD kind of environment right now in terms of like -- you talked about some of the stats around
like, kind of the average upfronts and things like that. How is that evolved since the early days of Roivant? Is that environment different because
there's just a lot more people playing this type of -- pulling in assets, whether it be here in the US or in China, bringing them in developing them?
So is it just gotten more expensive to do this model, or do you still feel like you guys have better chops at finding like kind of diamonds in the
rough, let's say, in terms of assets, worldwide within pipelines that maybe you're just not being utilized or really developed?
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SEPTEMBER 04, 2025 / 7:00PM, ROIV.OQ - Roivant Sciences Ltd at Wells Fargo Healthcare Conference
So like, yeah, just help us understand like where are we in the cycle in terms of just like kind of BD and is it really active or is it really not as active
as it was before?
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: Cool. Well, Richard, I think we'll leave it there. Thank you so much.
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