Roivant Sciences at Goldman Sachs Conference: Strategic Execution Focus

On Tuesday, 10 June 2025, Roivant Sciences (NASDAQ:ROIV) presented at the Goldman Sachs 46th Annual Global Healthcare Conference. CEO Matt Klein emphasized the company’s strategic transition from development to execution, highlighting upcoming Phase III data readouts and commercial launches. While Roivant is optimistic about its pipeline, challenges remain in market penetration and competition.

Key Takeaways

• Roivant is focusing on launching brepocitinib for dermatomyositis (DM) and non-infectious uveitis (NIU), aiming to meet high unmet needs with orphan pricing strategies.
• The company plans to deploy approximately $2 billion for new opportunities, alongside continuing stock buybacks.
• Brepocitinib’s pricing is expected to be between $200,000 and $600,000 annually, depending on the indication.
• Roivant is optimistic about its involvement with Immunovant, focusing on Graves’ disease and the potential of batoclimab in other autoimmune conditions.
• A hearing related to the ongoing Moderna litigation is scheduled, potentially impacting future timelines.

Financial Results

• Roivant has allocated about $2 billion for new opportunities, targeting upfront payments and clinical development outside its existing pipeline.
• The company has completed approximately $1.5 billion in stock buybacks, indicating confidence in the current market for capital deployment and shareholder returns.
• Brepocitinib is projected to be priced similarly to existing therapies, leveraging orphan pricing to capture significant market share.

Operational Updates

• Phase III data for brepocitinib in DM is expected in Q3, with the VALOR study aiming to detect small improvements in patient scores.
• Two pivotal studies in NIU are progressing well, with results anticipated in the first half of 2027.
• A phase two study in cutaneous sarcoidosis is underway, exploring brepocitinib’s potential in this rare inflammatory condition.
• Immunovant has streamlined its clinical programs, focusing on Graves’ disease and maintaining flexibility for additional indications.

Future Outlook

• Roivant is preparing for the launch of brepocitinib in DM, with plans for subsequent launches across other indications.
• The company aims to manage placebo risks more effectively in future studies, potentially influencing its strategic focus.
• Roivant is committed to advancing the MG market towards achieving deeper and more durable response endpoints with next-generation therapies.

Q&A Highlights

• Discussions included the Total Improvement Score (TISS) and its limitations in real-world patient management.
• Patient selection for trials was emphasized, particularly for those with active skin and muscle disease in DM studies.
• The potential for deeper IgG suppression to enhance clinical outcomes was highlighted, especially in the context of MG and CIDP.

In conclusion, Roivant Sciences remains focused on executing its strategic initiatives, with an eye on upcoming data readouts and market opportunities. For more detailed insights, refer to the full transcript below.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Unidentified speaker, Host, Goldman Sachs: This is a pre cocktail hour.

Matt Klein, CEO, Roivant: Yeah, that’s right.

Unidentified speaker, Host, Goldman Sachs: All right. Thanks, everyone. Welcome to the Goldman Sachs Annual Health Care Conference. Thrilled to be closing the day here with Roy Vance CEO Matt Klein. And maybe I’ll just turn it to you, Matt.

There’s a lot going on. So how do you want to think about an overview here?

Matt Klein, CEO, Roivant: Yeah, look. It’s almost cocktail hour. Thank you for having me. It’s great to be here. It’s been a long day.

Look, I feel really excited about what our next sort of run looks like here. And I think it all starts with in the half, we have data coming in brevacitinib in a Phase III challenge of rhinomyositis. And I think to dive right in, think that sets us up for a more or less unprecedented in our history two to three year period in which we have Phase III data and sort of stacking commercial launches, in DM, then in NIU, then starting in And so when I think about kind of what the next phase looks like as an overview, it really, for us, is now about execution and getting these programs that we’ve been talking about for years over the finish line into market.

Unidentified speaker, Host, Goldman Sachs: Yes. I know I feel like we wait for a long time and now we’re talking about Phase III data in the third quarter for brepasitinib. So maybe just talk about the VALOR study and dermatomyositis. Remind us the rationale for Brepo in this patient population and can you talk to some of the clinical evidence that exists for the mechanism?

Matt Klein, CEO, Roivant: Yeah, beautiful. So look, of all, brepasidenib is a dual inhibitor of JAK1 and TYK2. It’s a great drug. It has generated positive data in half a dozen patients. You see Crohn’s, some of the best data ever seen in those indications in psoriasis, in psoriatic arthritis, in alopecia, HS.

So it’s a very effective JAK inhibitor. And we think TYK2 also gives us a lot of great activity on the interferon side. And so it’s just a really, really strong drug. DM is known to be an interferon driven disease, among other things. So the basic biology looks really good for JAK1 and TYK2 inhibitor.

The cytokines involved are the cytokines we work on. There is also a fair amount of clinical experience with JAK inhibitors in DM. There are three now investigator initiated studies, including a pretty large one, entofacitinib, that have shown good clinical benefit, not placebo controlled, and hundreds of case reports. Docs are pretty primed to use these. Remember, is treated by mostly in The U.

S. At these myositis referral centers by specialty room and dermatologists. And a lot of them have a lot of experience with JAK inhibitors. Sure. And clearly the doc community just believes that JAK inhibitors work in DM.

So there’s a fair amount of support of clinical evidence. The study itself is a fifty two week, two forty one patient placebo controlled study. It’s got placebo in two different doses of brepcitinib, although it’s powered for the high dose. It’s fifty two weeks long. The endpoint is mean total improvement score, or TISS, which is an endpoint with some puts and takes.

But obviously it’s the endpoint that is sort of widely validated in DM at this point. And fifty two weeks is what the FDA mandates for new studies in the indication.

Unidentified speaker, Host, Goldman Sachs: Okay, perfect. I want to talk about test in a but let’s start with dosing. You mentioned there’s two doses. How did you determine the doses that were appropriate to take for the patient population?

Matt Klein, CEO, Roivant: Yeah, so I think dosing in the study was largely regulatory driven in nature in terms of having a couple of doses. Yeah. And then thirty milligrams has been a highly efficacious dose of Brepo across other indications and studies and clearly has the level of pharmacodynamic exposure that we want. And so we felt good about it as a dose.

Unidentified speaker, Host, Goldman Sachs: Okay. So talk to me about TIS. How does it work? How is it measured? How do you think about kind of controlling that outcome?

Matt Klein, CEO, Roivant: TIS is a largely artificial measure. It really exists only in the context of studies. It stands for total improvement score, which also defies all kinds of linguistic characterization because you can’t say TIS score because the S already stands for score. And you can’t say TISS delta because it is itself a delta.

Unidentified speaker, Host, Goldman Sachs: And

Matt Klein, CEO, Roivant: so change in TISS is also not a meaningful thing to say because it all starts zero anyway. TISS Literally just TISS? Just TISS. TISS starts at zero for every patient at the beginning of the study. Across a whole bunch of different sub scores.

It’s the same for all myositis. It’s not specific to DM. And it measures muscle activity, skin activity, muscle enzyme levels, muscle testing, a whole bunch of different measures of both muscle and skin. Yes, that’s kind of how it works. Because it starts at zero and is really used in clinical trials, it’s not like the way DM is managed in the community.

So it’s not like patients walk around saying like, My test this year is 27. They don’t know their test. It’s not a thing that was ever measured or described. And so our view is that a statistically significant study here is the win we need, that no one is looking for a specific numerical mean test because it’s not a sort of clinically

Unidentified speaker, Host, Goldman Sachs: so a couple follow-up questions on that. Maybe one, how do you think about baseline patient characteristics then given TIS is not going to be something that can establish your baseline?

Matt Klein, CEO, Roivant: The TIS baseline is All of our patients have a baseline TIS of zero. Exactly. So we have the study is designed to enroll patients who have both so DM, to take a tiny step back, DM is a severe inflammatory disease that presents both with a sort of muscle wasting muscle suffering wasting set of symptoms and skin symptoms.

Unidentified speaker, Host, Goldman Sachs: Yeah.

Matt Klein, CEO, Roivant: And the main requirement of our study on entry is patients who have both active skin and muscle disease. Okay. So there’s a minimum baseline CDASI level. There’s sort of a threshold range of baseline muscle testing scores. By the way, minor plug, we have a dermatomyositis investor event next week on the seventeenth.

Unidentified speaker, Host, Goldman Sachs: Next Tuesday at 1PM, right?

Matt Klein, CEO, Roivant: Yeah, next Tuesday at 1PM, where we will talk a lot about these points. But anyway, the main baseline characteristics for us, we want sick patients across both measures. And that’s how I’d say we thought about baseline characteristics.

Unidentified speaker, Host, Goldman Sachs: Okay, so then given this is an improvement score and there’s a bunch of different things that are improvements, are there things that are easier to get improvement in than others? And how do you think about the impact of the different components of the TISS score on trial execution?

Matt Klein, CEO, Roivant: I mean, almost certainly the answer to that question is yes. There are, just like in general, some of these things are easier to hit than others. I’ll say like we’ve talked a lot about MG ADL and MG improvement at MG. TIS is in this narrow and specific way a quote unquote better endpoint than MG ADL. In that MG ADL has this scale problem where the example I always give is one of the MG ADL subscores is respiratory.

And you get zero points if you have no shortness of breath, one point if you have shortness of breath in motion, two points if you have shortness of breath at rest, and three points if you’re mechanically ventilated. So this is not an even score. Right. And placebo will affect these points very differently. And that’s one of the problems with MJDL is, like, you get these weird distortions.

The nice thing about TIS is it’s a compose it’s a it’s there’s so many subcomponents

Unidentified speaker, Host, Goldman Sachs: Mhmm.

Matt Klein, CEO, Roivant: That each individual thing is quite small. And so it’s not like it’s not like MJDL where there’s, like, enormous weighting on, like, relatively small numbers of things. Okay. You know, I I think there is speculation in at least the investor community that JAK inhibitors should work particularly well on the skin symptoms, which represent maybe 20% or 30% of the total components of TIS. I think that’s fair.

JAKs work really well and TYK2’s work really well on skin disease. But also, we have lots of evidence from the investigator sponsored studies and other things of patients improving on muscle function as well. So we feel pretty good about sort of the breadth of it.

Unidentified speaker, Host, Goldman Sachs: Okay. In terms of powering assumptions, what’s embedded in those? How are you?

Matt Klein, CEO, Roivant: We’re going to put all of that out next week in more detail. So maybe mostly I’ll ask to wait until then. But the short answer is we can detect quite small deltas in tests with statistical significance. Okay.

Unidentified speaker, Host, Goldman Sachs: There is a forced taper in the steroid taper study. How do you anticipate that affects outcomes?

Matt Klein, CEO, Roivant: Yeah, look, I think if you were going to spend time being nervous about this study, and it’s a totally reasonable thing to do, the thing you would be nervous about probably is just variability in placebo. And the SteraTaper is designed as it is in every immunology setting to manage that risk. The way that our taper works is it starts at week twelve, and we force patients to be below five milligrams by week thirty six. We’ll talk more about this next week, too. But I think the point of that taper is to make sure that as we get into the fifty two week endpoint, the patients on placebo are properly worsening so that we can measure and focus on the drug effect for the patients that are getting benefit.

Unidentified speaker, Host, Goldman Sachs: You maybe just answered this. But what is the thing that you worry about as you think about execution?

Matt Klein, CEO, Roivant: Yeah, think the biggest thing to worry about in this study is placebo. Okay.

Unidentified speaker, Host, Goldman Sachs: What should we think about as next steps pending success on the VALOR trial?

Matt Klein, CEO, Roivant: Yeah. If the trial is successful, I think we will be gearing up for a launch in DM. I think it’s a great market for a biotech company to launch a product. As I think I said before, concentrated prescriber base focused on these myositis referral centers, patient population with very high unmet need. The only sort of quote unquote novel next generation therapy approved is an IVIG Octogam from Pfizer.

Other than that, it’s really steroids and ISTs. And so there’s a huge opportunity for something that’s sort of next generation efficacious therapy to enter into the field. And I think we are really excited about that being the of a number of stacking launches for us. And we think it could be a really big opportunity.

Unidentified speaker, Host, Goldman Sachs: Okay, great. So maybe talk a little bit more about the market opportunity, how many patients, and how should we think about which are like appropriate candidates for new therapies?

Matt Klein, CEO, Roivant: Yeah, perfect. So we have said we think there’s about 40,000 patients. There’s a pretty wide range. So I think Argenx, for example, that has a myositis program has said 70,000. Any which way you shop at sort of tens and tens of thousands of patients.

Probably not like so, so different in size from an MG or something like that. And it’s a sick patient population without a lot of options. I think like most patients ought to be viewed as like eligible.

Unidentified speaker, Host, Goldman Sachs: Sure.

Matt Klein, CEO, Roivant: Obviously this will be in sort of steroid and IST refractory population. But other than that, think anyone’s fair game.

Unidentified speaker, Host, Goldman Sachs: Okay. How should we think about pricing?

Matt Klein, CEO, Roivant: Orphan pricing. Look, I think the two comparators, as it were, is IVIG, which is priced sort of maybe around $200,000 right now. And then we’ve got FcRn. Got Argenxis looking in the space and that would be, you know, FcRn pricing is call it $506,100,000 dollars a year. So that probably sets the bookends and I think we’ll be somewhere in that range.

Unidentified speaker, Host, Goldman Sachs: Okay. You’re also evaluating this in NIU, non infectious uveitis. Remind us the phase II data you reported last year.

Matt Klein, CEO, Roivant: Yeah, great. So NIU is a inflammatory eye disease. There are about four hundred thousand NIU patients, but most of those have front of the eye disease and are treated with topical steroids. About seventy thousand patients have inflammation in the back of the eye and are basically treated either with steroids and ISTs or Humira is approved, but does not work very, very well. We ran a non placebo controlled dose ranging study in brepicitinib studying fifteen and forty five milligrams in NIU, which read out last year.

So for context, the sort of FDA phase three endpoint for NIU is time to clinical failure, or time to treatment failure, sorry, which is what it sounds like. It’s like how long you were on therapy for before you worsened such that the treatment’s not working. And the way these NIU studies work is they start out with a very high burst dose of steroids that then rapidly tapers. And during that tapers when a lot of these patients fail because they’re no longer on systemic steroids. So in Humira’s case, they had a time to treatment failure of about, I think, a little bit under six months.

And a placebo time to treatment failure of, call it, three months or two to three months, I Our phase two study, at the end of the twelve month study, more than half the patients had not failed yet.

Unidentified speaker, Host, Goldman Sachs: Okay.

Matt Klein, CEO, Roivant: So it was greater than twelve months, was the median time of treatment The other thing that we measured was just the percentage of patients who had a treatment failure. And so again, in Humira, which is the only other sort of real placebo controlled recent study that succeeded, their placebo was like, I want to say, as we measured it. There’s a couple of different ways of measuring these things. But we measured it maybe eighty percent of these patients approximately. This is little while since I looked at the data, I’m giving you not the exact numbers right.

But about eighty percent of these patients failed versus about sixty in the drug arm. Our study had at the high dose something like twenty something percent, low 20s percent treatment failure rates. So really exciting data as compared with what the field’s been able to I

Unidentified speaker, Host, Goldman Sachs: think the dosing is higher in this patient population than in DM. So talk about that.

Matt Klein, CEO, Roivant: Yes. So I think, of all, obviously some time passed between the initiation of the DM study and the initiation of the NIU study. And so we saw just like more data from other programs. And that reaffirmed more data from really Pfizer’s other studies. And that reaffirmed our view that forty five is likely a pretty safe dose for this patient population.

Also, NIU is an inflammatory disease where you want to hit it hard fast. These endpoints are about time to failure. There’s this rapid steroid taper. So you want to deliver the anti inflammatory benefit quite quickly, especially because, so NIU is actually like, I think the leading cause of blindness in America. Like these patients who have an acute disease and need rapid treatment.

And so our view was it was a patient population that would be happy to take on whatever liabilities came from 45 to 30 in order to get sort of And that’s how we made that decision.

Unidentified speaker, Host, Goldman Sachs: Okay. Can you talk to us about the phase three trial design?

Matt Klein, CEO, Roivant: So there are two ongoing pivotal programs in NIU now, two ongoing pivotal studies in NIU. We said they’re gonna read out in the first half of ’twenty seven. They’re enrolling really nicely. That phase two data is obviously a huge boon to enrollment. And they’re as simple as it gets.

They are fifty two ish week studies that measure time to treatment as their primary, and we’ll measure other things like treatment failure rate and other sort of measures of eye progression across the different subcomponents of treatment failure. And yeah, it’s measuring a pretty sick patient population. We’re not specifically studying the humero refractory setting, but we have humero refractory patients in the trial. And our view is it should be representative of NIU patients needing treatment.

Unidentified speaker, Host, Goldman Sachs: Okay, what is, you talked about a steroid burst in taper, guess. Like what is the role of that in this patient population?

Matt Klein, CEO, Roivant: This is actually an important point that I sort of neglected to mention earlier. So of all, you have to use the steroid tapers for a few different reasons in this study. One of them is again, these are acutely sick patients who are coming in for treatment. Steroids work really quickly, and you really don’t want these patients going blind or failing immediately. So you start them on this high burst dose of steroids, quite a high dose of oral prednisone, like a miserably high dose of oral prednisone.

And then you take them off pretty quickly over about six to eight weeks. And we actually had in our phase two, we didn’t have a placebo arm, but our steroid taper was actually quite a bit more aggressive than the Humira phase three steroid taper. And because the data was good, we’re sort of pulling that aggressive steroid taper into our own phase three study, which among other things should be helpful for separation from placebo. Because with an aggressive taper, would expect more placebo patients to worsen Okay.

Unidentified speaker, Host, Goldman Sachs: What do you think the market’s missing with respect to the NIU opportunity? Like

Matt Klein, CEO, Roivant: Everything. I mean, are we getting any credit for NIU at all?

Unidentified speaker, Host, Goldman Sachs: No. That’s why I’m asking.

Matt Klein, CEO, Roivant: So look. I mean, I I I don’t know. I’m on maternity leave. Fair. Welcome back.

Thank you. Congratulations. I look. I think the people that have spent time on NIU have gotten increasingly excited about it. And I think people look at our phase two data and think it’s a pretty clean shot on goal from a probability of success perspective.

I think mostly what it takes at this point is spending time talking to docs about our data. Sure. Humira, there’s about forty thousand patients on biologics generally, most of which are on Humira. Humira, as we said before, fails in fifty percent to sixty percent of patients depending on how you count it. And so the Humira refractory population is probably twenty thousand patients.

Sure. And at the kind of price points that we’re talking about, if we got twenty five percent of that population, would be a large blockbuster drug. And so I think the answer is people are just not engaging with it, in part because the data’s still twenty twenty seven.

Unidentified speaker, Host, Goldman Sachs: Yeah. We said

Matt Klein, CEO, Roivant: that That’s little ways away, it’s on the back end of DM and other things. But I think Once people spend time in the market opportunity, I’m not getting a lot of pushback from people who have done that work. I think the biggest knock against it is just it’s not a very big indication for Humira. But part of that is it doesn’t work And part of that is the 30,000 patients on Humira at a Humira price point is very different than 10,000 patients on something at an orphan price point.

Unidentified speaker, Host, Goldman Sachs: I see. Okay. You’ve also disclosed phase two study in cutaneous sarcoidosis. Maybe you can share the mechanistic clinical data, like rationale for this program.

Matt Klein, CEO, Roivant: Yes, so cutaneous sarcoid is another one of these orphan inflammatory diseases. So we know sarcoid pretty well because we had a failed phase two program in sarcoid late last year. Cutaneous sarcoid is a bad disease. If you look it up online, you’ll get a sense for it. It’s like a very bad skin disease.

Very painful, very uncomfortable. Really no good options for these patients. Mechanistically, it’s an inflammatory disease driven by some of the very same cytokines as some of these others. It’s clearly got interferon involvement. It’s clearly got involvement from a number of these other sort of classic JAK and tick cytokines.

And like DM, there’s a little bit of clinical evidence pointing in favor of the indication. In this case, there was an open label study of tofacitinib in which I forget how many patients it was. It was like very small, six or eight or 10 or something. But one hundred percent of the patients in the study had clinically meaningful improvement. Again, that’s an open label study.

JAKs clearly have some benefit. And obviously, we don’t need to show one hundred percent response rate to have a promising drug in here. So we’re running a dose ranging phase two designed to like show that we can deliver benefits to ketone sarcoid patients. And if we’re successful, I think it’ll set us up for a nice pivotal program.

Unidentified speaker, Host, Goldman Sachs: Okay, so what does that look like in terms of a nice clinical profile to set us up for registration?

Matt Klein, CEO, Roivant: Yeah, look, I think it depends a lot on what placebo does. But in general, I think you’re looking for like a meaningful separation, decent response rate across a number of endpoints.

Unidentified speaker, Host, Goldman Sachs: Okay. What are the most relevant endpoints in this?

Matt Klein, CEO, Roivant: Yeah. These are similar to other derm indications. There’s like overall sort of investigator assessments of disease involvement. Okay.

Unidentified speaker, Host, Goldman Sachs: Do you think about further indication expansion? We just talked about three.

Matt Klein, CEO, Roivant: There’s some

Unidentified speaker, Host, Goldman Sachs: places JECS could work.

Matt Klein, CEO, Roivant: The more time we spend thinking about brepo, the more excited we get about it. So there’s other indications that we are actively working up right now, some of which we could be prepared to initiate late stage trials shortly. And it just depends on how the final work comes through for us. But I think there’s a number of other indications that we think could really matter here. And frankly, it feels like the kind of drug that could stack, that if you get a couple of indications approved that you could sort of start building on it a little bit like HUBRIA or RINVOQ or something like that, where sort of as you get these indications, they kinda add and build on each other.

And some of them have overlapping prescribers as well.

Unidentified speaker, Host, Goldman Sachs: Okay. I guess where does like REPO indication expansion sit on your priority list? And this will hopefully be a good segue to the rest of our conversation. But like how do you think about allocating resources behind this program versus some of the other things you could be doing?

Matt Klein, CEO, Roivant: I mean, we judge that indication by indication and opportunity by opportunity. But like so far, the things we are looking at for indication expansion opportunities for repo look very good as things to do. That is like the incremental cost of running these studies as compared with the potential benefit is big. Some of that’s contingent on continuing to find what I would call white space indications, where we can be and have like a meaningful swim lane. But we have a good number of those that we’re excited about.

Unidentified speaker, Host, Goldman Sachs: Is any of this contingent on whether it works in DM?

Matt Klein, CEO, Roivant: Mostly no. I mean, depends a little bit on how it fails in DM, if it fails in DM. But mostly know in the narrow sense that prep has been an active agent in so many indications. It’s not like the DM failure is gonna convince us it’s not active. Frankly, we have a quite large portfolio, a quite large collection of safety data at this point.

So we know what we’ve got.

Unidentified speaker, Host, Goldman Sachs: Yeah.

Matt Klein, CEO, Roivant: Look, I think the Pfizer designed SLE study obviously didn’t work. If we continue to get beaten up by placebo in these studies, I think we’ll be thinking about indications where we can manage that risk a little more aggressively. So it might affect a little bit, just like our own antecedent estimate of how likely we are to be able to win these But that would probably translate to other mechanisms, not only PREPO. I think PREPO’s going to be about as good as it gets in a bunch of these areas.

Unidentified speaker, Host, Goldman Sachs: Okay. Maybe we can spend a little time on Immunovant. You obviously took up greater role in the strategic direction and execution there. I guess what compelled you to take that step on Immunovant?

Matt Klein, CEO, Roivant: It was a natural moment of transition for the business. Botoclimab had kind of rolled off its studies. We were really launching into the 1402 program at scale. And I think it’s a moment where Pete had done a beautiful job with the regulatory dance of last year. We had gotten all of these studies started.

We’d gotten the regulators lined up on paths to pivotal and everything else. But we’re sort of moving to a phase of acute aggressive clinical execution and enrollment. He was ready to retire. And our view was like, this is a good moment for us to put somebody in charge of the company who we know is going to run these trials exactly as we like to run trials, having learned from our experience Represenit, for example, about how we want to do that. And Eric is somebody who’s been on the leadership team at Roivant for a very long time and has seen those things firsthand.

I think he’s going to do an awesome job there.

Unidentified speaker, Host, Goldman Sachs: Okay. One of the changes was just kind of like streamlining the clinical programs you’re executing. Talk to us about why that was the right decision.

Matt Klein, CEO, Roivant: Yeah. So I’d say a couple of things about that, but one of them is, and I take some responsibility for this, our older messaging on FCRN fourteen oh two was we’re gonna do 10 indications by, whatever, a little bit earlier than this time next year. And it turns out if you tell the world you’re going to run 10 indications but don’t tell them what the indications are, what they do is they model a lot of burn and no benefit. And so it was basically useless messaging. Like we were getting no credit for the indications.

We were just getting penalized for the spend. So the thing is just that doesn’t make sense. If we ever want to initiate new indications, we’ll present the cost of those studies as well as the opportunity associated with them at the same time. of all, it didn’t make a ton of sense to us in hindsight to have an antecedent commitment to that breadth versus a laser focus on just executing. And we feel like Graves, for example, is such a big market, such a big opportunity, that if we can win there, it will set us up for the long future in a really sort of powerful way.

And obviously, if we have to choose between rapid enrollment of Graves and slowing that down so that we can study something in a proof of concept, it just obviously made sense to make sure we were able to prioritize Graves. And so by doing away with the sort of overall commitment, we can still add new indications of the great indications, but we can focus on execution and make sure we’re prioritizing winning where we are.

Unidentified speaker, Host, Goldman Sachs: Okay. You did obviously make some personnel changes with the positioning of Eric there. Any other personnel changes that need to happen for Immunovant from here?

Matt Klein, CEO, Roivant: Look, think with any fast growing company, obviously, and with a change in leadership at the top, I’m sure there will be more people making decisions in various directions. But mostly, think the answer is like we’re really happy with the team Pete built. We’re really happy with the overall setup there. And I think we expect that team to be able to execute really well.

Unidentified speaker, Host, Goldman Sachs: Okay. You had MG data, CIDP data earlier this year. Just like what are the key take homes you want people to take from this?

Matt Klein, CEO, Roivant: We believe, and it’s clear that maybe not everybody else believes, but we believe that those data sets, especially the MG data set, mostly answered the question deeper IgG suppression can yield better clinical benefit. And we were happy with the way that we showed that against the backdrop of changes in the overall environment and higher placebo rates than historical on MG ADL overall change from baseline. So I think in that sense, those studies did what we wanted them to. They did the best that we frankly thought they could do. And we were happy with the way that looked.

Look, think it reminded us or highlighted it for us the extent to which the bar to, sorry, excuse me, commercially unseat Vivgart is high. Vivgart’s a well loved drug. It’s very popular in MG. The docs like it. The patients like it.

And it works pretty well. And so I think the goal for us in MG has to be one, to generate the most compelling possible data set, leverage the form factor and other things. Two, to help patients and docs understand that switching dynamics and the benefits of trying out multiple among these agents. And three, to move the market toward the places where we will unambiguously win, which are places like driving clinical remission, driving durable clinical remissions, the kinds of things where deeper IgD expression will absolutely win even on a placebo adjusted basis, and to focus the entire patient and doc community on those possibilities. And I think that’s all important.

Those are all lessons from the MG So we were really happy with what the drug delivered in MG. In CIDP we reported a more limited subset of data. But looking at the deeper versus less deep IgG suppression cuts, it looks to us like we have a potentially truly best in class drug with quite differentiated efficacy if the fourteen oh two program delivers in a similar way. And there, I think we have an opportunity to win a market that Argenx is doing a really lovely job with, but where I think efgart’s data looks IVIG like in quality.

And so I think if we can deliver something that is a step function better, which I think our suggests we may be able to do, I think that’ll set us up in a different way.

Unidentified speaker, Host, Goldman Sachs: Myasthenia gravis is relatively crowded. But as you think about where the puck is moving for this indication, you talked a little bit about this. But maybe you could help us understand how you think this market is gonna break down in the next, like, five to ten years.

Matt Klein, CEO, Roivant: Yeah. Perfect. And of all, I’ll say, like, I’m excited about MG. I think it’s a good market. It’s definitely not, like, the indication I’m most excited about Yeah.

Because it’s crowded. Most excited about Graves, some of these other markets. MG is a little lower on that list because these dynamics are, like, hard to unseat. In terms of where I think the puck is moving, of all, and I said this a minute ago, but I think focusing patients and docs on I think in some ways this is the same as has happened in every other immunology area. Moving from IgA to PASI 25 to PASI 50 to PASI 75 to PASI 90 to PASI 100.

Moving from ACR 20 to ACR 50 to ACR 70. Moving from clinical response in UC to clinical remission in UC. Moving to these deeper response endpoints and to these durability of response endpoints is something that as drugs improve in literally every category, we have seen progress. I think the same thing’s gonna happen in MG. I think it is incumbent on us to drive the market in that direction, to try and partner with the other companies entering the space that have the same incentive.

If you’re developing a T cell engager or an MG, you’re also looking to prove to the world that you can drive deeper, more durable response than an FcRn even. And you have to, because the T cell engagers are gonna have different safety liabilities. So I think the whole field is gonna move in that direction. We can be at the forefront. We can be the next generation FcRn that has generated that data, that uses deeper IgG expression to deliver that benefit.

Think that’s a big and important piece of it. And then I think there’s others. You see argenx looking at ocular MG. You see people talking about earlier lines of therapy. I think all of those things are also ways in which the FcRn market can grow.

We will be very focused on how nipocalimab does in its early launch. Because I think one of the things out of our hands and out of our control, the two biggest drivers of the size of the market opportunity for us in MG are gonna be how large the overall market turns out to be. Right? If MG is a overall category is a $5,000,000,000 market, that’s gonna be very different than if it’s a 10 or 11 or $12,000,000,000 market. I just don’t think we know yet.

And then the other piece of that is how high a switch market it is. If it turns out that with nipple on the market, docs who have, whatever, patients who are on a couple of cycles of Vimgart, they’re happy but not happy enough. Docs are like, why don’t you try six months of continuous therapy on nipple? If that is the way this works and patients kind of switch back and and split in and out of different entries in the class, the market opportunity for us is much bigger than if brand loyalty winds up keeping docs more or less exclusively using VivGuard for their patients or something like that.

Unidentified speaker, Host, Goldman Sachs: There’s tons of other things to talk about, but I’d love to let you on Graves’ disease. A lot of people are following you now into this market. So maybe you could talk about why you’re so excited about that one.

Matt Klein, CEO, Roivant: Fast following is the finest form of flattery, right? Look, I think Graves is like the other FcRn or brepicitinib indications in that it is a very high an area of very high unmet need. There has been lot of novel therapeutic development lately because there can’t be, because the biology has only recently caught up with the indication. And it has the other property that we are which is something we couldn’t have said about MG, for example. But then the other thing about Graves’ that’s truly astonishing, actually, is the size of the market.

If you talk about these other indications with tens or maybe 100,000 patients eligible for therapy, in Graves’ there are probably three hundred and thirty thousand patients who are refractory to all therapeutic options, and whose only answer is either to live sick or to get a thyroidectomy or radiation, and then live on Synthroid and still be sick. And our view is with that size patient population, we don’t need twenty five percent share. We don’t need ten percent share. Like, three percent or four percent of that patient population is a blockbuster indication at FcRn pricing. And it’s just such a large patient population with so much unmet need that it feels great to be there, to be able to paint that market the way that our competitors have painted some of the other markets, to build those relationships with KOLs, and to really get to patients who are suffering with the disease and help them understand what better could look like.

It’s interesting. My weird tip to investors who are trying to understand Graves’ has been on Reddit, the Graves’ disease subreddit. It’s actually a very useful place to go. Because you just see these patients on there talking about how miserable they are on methimazole, talking about their inability to get control, talking about their apprehensions about having thyroidectomies, talking about their difficulties in recovering from thyroidectomies, but how they’re happier anyway because it was such tough. You read these patient stories, you’re like, yeah, wow, this is an underserved patient population.

Unidentified speaker, Host, Goldman Sachs: Yeah. Okay, speaking of things that we’ve been waiting for a long time, kind of going back to the beginning, Moderna litigation’s coming. Can you just give us a timeline and the key decisions we’re waiting for?

Matt Klein, CEO, Roivant: Yes, so the day after tomorrow there’s a hearing about timelines. And so right now, the timelines are a little bit uncertain until that hearing. Sure. Right now, there is no set trial date. Hopefully, maybe we’ll get one at that hearing, but it’s up to the judge.

We will definitely have a large conversation about timelines for summary judgment. Look, I think we feel well, good about how that case is progressing. We feel good about the information we’ve presented to the court so far. Summary judgment will be an important part of this process, where we and Moderna get to argue for things that we think the judge can decide. That should take place over the summer and maybe early fall, and then the trial should follow thereafter.

Unidentified speaker, Host, Goldman Sachs: Okay. Capital allocation from here, remind us kind of like the pillars that you guys are looking at.

Matt Klein, CEO, Roivant: Yeah, buckets that we’ve been focused on are one, sort of making sure that our existing pipeline is funded to profitability, and we’re well situated for that. We sort of set aside $2,000,000,000 ish for deployment into new opportunities, upfront payments, but also just like clinical development for things not yet in our pipeline. Excited to keep prosecuting that over time as those opportunities present themselves. It’s been exciting to see what we might get our hands on and a little bit slower than we would have liked in terms of pulling the trigger on things. And then we’ve bought back close to a billion and a half dollars in stock already continue to look at the market as an attractive place to to put capital, return cash to shareholders, reduce the share count.

Unidentified speaker, Host, Goldman Sachs: Okay. We have about a minute left. I’ve asked you about a number of things, there’s so much going on. Haven’t gotten everything. Anything you want to make sure is highlighted or that you don’t think people quite understood?

Matt Klein, CEO, Roivant: Look, I think the only other the only compound we didn’t talk about is mostly cigarette, which normally I would say that’s fine. The date’s coming in the second half of next year. Today’s a fun day to talk about pulmonary hypertension. Sure. Actually one of our competitors put out some really great data.

Look, we think that market is huge. We think PH ILD looks like PAH did a few years ago. We still have, we think, the highest PVR reduction, even after today, ever observed in a group one PAH study. And the more developed that market is and the better the treprostinil do, especially in PHLD, the more PHLD patients will diagnose and get into care, and the more of an opportunity I think we’ve got. So that data’s coming in second half of next year.

This is not like an immediate near term catalyst. It’s not the thing that I think people miss most of our story, but it is something that I think in this moment, as the pulmonary hypertension patient clearly comes back into relief in people’s minds, I’d like don’t sleep on Mosley. We think it’s going be a really great drug.

Unidentified speaker, Host, Goldman Sachs: Beautiful. Great having you. Thanks, everyone, for joining us here in online. Thanks so much, Matt.

Matt Klein, CEO, Roivant: Great. Thank you.

Unidentified speaker, Host, Goldman Sachs: We couldn’t have timed that any, but

Matt Klein, CEO, Roivant: Sorry?

Unidentified speaker, Host, Goldman Sachs: So we couldn’t have timed that one either.

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