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: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Imagine you're sleeping a little bit better. I know you're a little nervous about placebo effects and things like that going into the data. But now that
everything is sorted out and you've got the result that you wanted, maybe that's a good place to start is talking about that data. And if you want
to maybe just contextualize that data, what it means for patients, how doctors you think will interpret the data and what that means for the practice
ultimately of DM.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Yeah. How do you see brepo getting adopted by clinicians, right? Do you anticipate they'll still easily start with steroids and ISTs, and then at some
point, look to down titrate the steroids and onboard brepo? And that IVIg is kind of this last-line thing because you said it's really cumbersome. It's
hard to give somebody IVIg on the schedules and the IV infusion dynamics.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay. So you see it playing in kind of both segments of the world, the IVIg segment as well as like those who are on high-dose steroids and in need
of an alternative. Is there an analog you can look to, to sort of a steroid-sparing benefit in the I&I world? Like Tepezza is like one example I could
think of a drug that docs hate steroids, right? And they went to Tepezza for TED.
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SEPTEMBER 24, 2025 / 9:45AM, ROIV.OQ - Roivant Sciences Ltd at Bank of America Global Healthcare
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Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Yeah. Okay. Maybe just how do you think about the prescriber base? Because you have derms, you have rheumatologists, you have a dermatologic
(technical difficulty) have historically been much more liberal about using JAKs in RA and comfortable with the risk profile of derms, historically,
biologics (technical difficulty) drug for rooms or both? And I just wonder how that --
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: So fast forward a year, a year plus, you're back to being a commercial company again. This is, I would assume, a pretty capital-efficient sort of call
panel reach, if you will, in terms of promotion and promotional outlay. And how do you see this? Maybe VTAMA had its own challenges, right,
because of gross to nets and payer access dynamics and challenges, right? But I imagine here, how you kind of see the go-to-market outlook?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: A focus on those 200 referral centers primarily.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And as we think about the pipeline and the drug aspect of brepo, what derisking DM does in terms of your thought process in terms of other areas
to go? And just remind us your IP runway on the drug and you feel like does this afford you now an opportunity to interrogate some other indications
and go more broadly with brepo?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Yeah. And your point on the landscape of JAK1/TYK2 combination, I think Galapagos might be the only other company in the field. Is there anyone
you're aware of that competitively that deals?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay. And then with NIU, can you just remind us how you arrived at the 45-milligram dose, what discussions you had with FDA, getting them
comfortable you're going up in dose and not wanting you to maybe interrogate a lower effective dose. Just --
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SEPTEMBER 24, 2025 / 9:45AM, ROIV.OQ - Roivant Sciences Ltd at Bank of America Global Healthcare
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Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: So it sounds like probably a comparable size market opportunity to DM ballpark.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay. Maybe we'll pivot to Graves. And you guys had a recent update on Graves. And I guess as we think about the primary endpoint selection in
Graves, euthyroid and ATD-free, I would imagine that these patients are in a clinical trial setting are unlikely to show any response of getting
placebo?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And so was the decision to go with that endpoint versus sort of a lower dose of ATD or just euthyroid, T3, T4 normalization, like was it -- this is the
most impactful sort of endpoint for providers? Was that -- or is it a regulatory discussion? How did you arrive at that as the primary endpoint
selection?
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SEPTEMBER 24, 2025 / 9:45AM, ROIV.OQ - Roivant Sciences Ltd at Bank of America Global Healthcare
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Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And so some of the early data, if we could go back to Phase 2, I think half the subjects on the 600 mg through 12 week where I think half the subjects
had gotten to this endpoint response.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Yeah. Is that -- because I know that when they dosed down after that because of the design of that study --
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: It went down to like mid-30s or something like that, right? So would you expect that rate to just hold based on what you've learned through the
evaluation period, the open-label extension? And is that kind of 50%-ish kind of what you internally think is a likely 26-week response rate?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And then I guess, talk a little bit about how you think this study will inform how doctors will use this -- if the trial is successful and it gets out in the
field, right? Is it going to be a 26-week treatment course, a year and then, hey, the patients should be in remission? Or do you think some doctors
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SEPTEMBER 24, 2025 / 9:45AM, ROIV.OQ - Roivant Sciences Ltd at Bank of America Global Healthcare
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will use it longer term because they still haven't gotten into remission? I'm just wondering how you see the 26-week data and then the remission
data informing the ultimate long-term use case.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: That -- what you said reminded me of something I've heard from some doctors about methimazole or ATDs, which is that they're keeping patients
on longer than they should be on. Basically, like in the hope, and hope is never a good strategy, but in the hope that like they maybe have a response
after a year or two. So when I think about your patient numbers, right, and how you characterize, I wonder how you estimate that dynamic, right?
Because if 1402 is approved, I imagine this is a paradigm change, right, for these doctors. And so perhaps some of that practice stops, right, where
doctors are like, you know what, I'm not going to keep somebody on an ATD beyond a certain time point. How does that paradigm shift?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay. And so you have these two buckets. You have an incident kind of bucket, right? And so those patients may get determined to be candidates
in a more expeditious manner than you have the prevalent pool of patients and perhaps they're lingering on methimazole for --
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Who's taking care of these patients right now? Like how do you kind of understand kind of where these patients are at in the treatment system?
And is this all generally a primary care setting?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Yeah. Okay. So you'll have some data for the previous generation of FcRn, 1401, and TED.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: I think toward the end of this year?
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SEPTEMBER 24, 2025 / 9:45AM, ROIV.OQ - Roivant Sciences Ltd at Bank of America Global Healthcare
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Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: So let's just say you see fabulous data, right? I think you've shown some data through five week, I think, was what I recall.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And it looks directionally similar to IGF1R approaches.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Well, small sample, right?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: But as someone who would cover Horizon, I remember looking at that and handicapping that as a competitive threat. But if that data are encouraging
and support the FcRn hypothesis in TED, how do you think about maybe would you adjust your Graves' study to include a stratified subsegment
of TED? Would you want to elucidate the benefit for 1402 to get some label language around treating specific thyroid eye disease manifestation?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay. And maybe just a few other topics within the FcRn realm, RA. What underpins the confidence here? I think J&J was supposed to have some
Phase 2 data for nipo here in the ACPA plus population. I don't think we've seen it yet.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: You've seen it?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Yeah. So, this is probably in the higher risk of your portfolio of indications.
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SEPTEMBER 24, 2025 / 9:45AM, ROIV.OQ - Roivant Sciences Ltd at Bank of America Global Healthcare
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Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Then what would you just need to see then in this open-label trial?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Yeah. And then with MG and CIDP, there's great validation commercially now, right, the lead. And so I know that there was some data that you
guys had with your first generation. And it's obviously difficult for the comparisons to be made across trial because there's some different metrics
that are out there around super responders. And so ultimately, as we kind of fast forward, where do you see that fitting within the broader portfolio?
I imagine Graves' is the anchor.
Something like RA is -- I don't want to call it a moonshot, but it's the higher risk, big opportunity. And then MG and CIDP feel like low risk and maybe
don't have the upside opportunity unless maybe you ultimately end up differentiating on the form factor and/or the IgG suppression gives you
some directional unique data points to market?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay. Maybe I'll come back to some early pipeline, but I wanted to hit on LNP litigation because it seems like we're in a very actionable phase here
in 4Q with the Section 1498 government-contractor defense and whether that's applicable. I guess, the consequence of it could sort of fragment
the litigation pathway a little bit if it was deemed applicable. But I guess, will we get clarity on 1498 applicability? I know that we have to size that
applicability in trial, right, as I understand.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And just so I know, is there -- is it tied to a specific hearing for summary judgment or we just don't know more specifically when within this time
between now and the March trial, like when that would --
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay, all right. And any clarity on that OUS legal proceedings? I know that that's kind of kicked off. And just like generally, how should investors
think about that? I imagine OUS litigation tends to be a little more fragmented.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Well, it seems like you can't have a conversation until 1498 is decided.
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And then you have the Pfizer matter where there's been claim construction. Is 1498 still a similar relevant consideration or not?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And with respect to the claim construction rulings in the Pfizer matter, do you feel like there are any material difference in outcomes on the
interpretations of key claims?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay. Maybe coming back to pipeline. Your sGC. I cover United Therapeutics. So PH-ILD is a very interesting high-growth market.
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SEPTEMBER 24, 2025 / 9:45AM, ROIV.OQ - Roivant Sciences Ltd at Bank of America Global Healthcare
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Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: And so just kind of curious, as you advance the program, I think you have some Phase 2 data next year, second half. Is the focus really concordance
of both the hemodynamic aspect of the benefit on PVR as well as six-minute walk? I know six-minute walk can sometimes be considered a little
noisy in these trials, PVR a little bit more of an objective measure. So how do you think about those data and informing steps?
Question: Jason Gerberry - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Okay. Well, we are at time. So, Matt, I appreciate you taking some time to talk on the latest developments.
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