Okay. Welcome, everybody. I'm Doug Tsao, senior analyst at H.C. Wainwright. Welcome to the conference. So kicking off our first session of the morning, we have Roivant, represented by the company CFO, Richard Pulik. I've known Richard from even before his time with this company. Richard made the very long commute from his office, I guess, was it on the 14th floor? So we appreciate him, you know, really going out of his way to appear today. So it's been an eventful, you know, 12 months for Roivant. You know, most recently, we got the data for brepocitinib in NIU that looked very positive, and we're awaiting data in dermatomyositis. And that's, you know, been an indication where there's been some competition.
You know, when you think about brepocitinib, what do you think the dual TYK2/JAK1 mechanism offers that perhaps some of those other therapies don't offer? And, you know, we've got you know, if we get this data, you know, how broad and how big a franchise could brepocitinib ultimately become?
Great. So look, I think the NIU data that we had was incredibly positive. Just to remind folks, we did an investor call on that pretty recently. We saw data that was almost 3x as good as Humira. Again, the steroid tapering there was very aggressive. So if you look at the tapering versus Humira, it was almost 2 x as fast, which sets a very high bar, a very high bar. And, you know, look, dermatomyositis, that's in a phase lll study. That's reading out sometime next year. We can file that. We will start the NIU study at the end of this year, and I think with that, we're firmly in place for a multi-blockbuster franchise. If we look at the data that Pfizer generated before we got the program, we saw 6 positive studies.
These are all phase ll studies. Across, if you look at, our data versus JAKs or TYK2s, we beat almost all JAKs and TYK2s in those studies pretty significantly. So, if we lean on that human data, we think, we believe we're firmly in place to here have a very strong mechanism. And we really decided to develop this in rare diseases, so we're looking at... You know, there's really very little company. You know, if you look at NIU, that's really treated with steroids. Dermatomyositis, you know, steroids and Humira, dermatomyositis is really just steroids, so there's really nothing for these patients.
NIU, a lot of these patients, actually, 30,000 of them become blind per year in the U.S., so there's a large unmet need, and we think this will be a very large franchise for us. So we're very excited about the data and bringing this forward in NIU.
You know, how broad, you know, because as you referenced, you're thinking about this from an orphan drug perspective. Pfizer had run a lot of proof-of-concept studies, phase II studies, in sort of more prevalent indications. You know, now that you have the NIU data, does that foster, or encourage you to look in other indications? I mean, obviously, SLE did not necessarily work out. And does that cause you to sort of think about adding others, and is there a right number for this franchise in terms of potential indications?
Look, I think we are looking at, developing this potentially in other places. I would still say the underlying hypothesis is to develop this in rare disease. SLE, that was something that Pfizer ongoing, so it's essentially free for us to continue that study and have it read out. There, we did see disease activity across the two different doses. The issue here is always just with placebo, right? So the placebo response rates there were very high, and it didn't make much sense to bring it forward. As Matt had said, you know, these studies are very difficult to run, especially in SLE, but I think we are in a good place here with NIU and dermatomyositis and are thinking more broadly as well in other rare diseases. We haven't announced which ones yet.
Do you have a plan for when you would potentially start development in other indications with this asset?
I think the team right now is fully focused just to set up the NIU study, get that pivotal underway, meet with the FDA, and get that up and running, and then certainly we can think more broadly after that.
For NIU and for the Phase III, when do you anticipate getting that, getting alignment with the FDA and, and kicking that off?
That would be sometime later this year, and then you should see that on clinical trials, like, up at the end of the year.
Okay. You know, Richard, you are a commercial-stage company, having launched VTAMA. You know, the uptake in psoriasis has probably been a little more slowly than we initially anticipated. We are awaiting approval in atopic dermatitis, which is a much bigger market. How do you see those two indications, you know, and, and, and what makes, gives you confidence that that VTAMA should have more success in AD than it has in psoriasis so far?
So first, we had two phase lll studies. I mean, the data was pretty incredible. The patient population was in the moderate to severe population. We saw almost completely clear skin in 39% of patients at week 12 compared to Dupi. That's, you know, Dupi – if you look at some of the Dupi data in a similar population, that was at week 16, 46% clear, almost clear skin, but that was using a topical steroid as well. So as a topical alone, this is really incredible data. And, you know, that data was generated really from the age of two. So this is a disease that's majority under 18 years old. We anticipate that the data will be on label from the age of two.
If you look at some of our competitors, they're really focused on the mild to moderate population. I think if you look at the Incyte data so far and the approved label, that's from the age of 12. Arcutis is likely at the age of six. I know that they have other pediatric studies, but we'll immediately be on from the age of two. And if you look at the numbers of scripts here across psoriasis and atopic dermatitis, there's roughly 400,000 on a weekly basis in the U.S., and it's a really incredible opportunity. So even a modest share there could mean a potential blockbuster. So we're excited to get that going. And this is really something where there isn't a lot for these patients, right? I mean, you have a biologic, you have some...
You know, we are the first novel topical launch in this space in 25 years. We're not taking something that was developed as an oral or that was developed and then putting into a cream. This was really developed from the beginning to think through as a topical, and it impacts the T cells. We see, on label on the psoriasis data that once you stop using the drug, it continues to work for four months, and then when you restart it again, has the same level of efficacy that we saw in the trial. You know, we anticipate patients to be really using these drugs. Once they achieve the clearance that they're comfortable with, they'll end up stopping using the topical, and then they restart. Similarly, we saw data like that in AD.
So again, we're gonna be the only drug here with this remittive effect, and I think that really speaks to the differentiation of this mechanism and the opportunity that we have to change the landscape here and really move away from steroids.
You know, and one of the other sort of key franchises for you is the FcRn, and development of through Immunovant, right? With both batoclimab as well as IMVT-1402. You know, when last time I talked to Matt, he sort of was pointed much more towards IMVT-1402's development or your work in thyroid eye disease as well as Graves' disease versus MG, right? Which has been the first sort of indication that you know, argenx launched VYVGART. You know, do you, when you talk about sort of being more focused or excited about those launches, is that simply a function that you will see greater efficacy than what some of the other FcRns might be able to achieve there?
Or is that simply the fact that you're gonna be, you know, if not a first mover, much closer to market formation in those indications?
I think it's really a mixture of both. So if you look at the data we generated in TED, you saw roughly doubling of responses in the 640-milligram dose versus the 320-milligram dose. We then quickly moved into pivotal studies. So right, that's reading out in the first half of 2025. And again, this is with batoclimab. That'll be what we believe would be a fileable study and one we can use for registration. Right before that, you'll see data for a phase ll study with batoclimab in MG. Look, I think there as well... So TED, we're gonna be first, right?
We saw not this JP Morgan, but JP Morgan before that argenx announced that they were going to phase lll, you know, significantly later than us, and they didn't have any of that, the efficacy data or even differential in the two different doses, right? Because we're the only one that really has shown 80% IgG suppression, since we have that 60 mg dose. And, MG, look, we haven't really seen a broad data set here that IgG matters, so I think that'll be an exciting readout. We did see that in Graves when we had that data at the end of December. We are looking forward to seeing as well in CIDP, that data in Q2, Q3, where again, we're testing two different doses and the potential for better efficacy.
So, within the next, let's call it, you know, within 12 months across all of those different diseases, less than 12 months, we will hopefully continue to generate data that IgG matters across the breadth of these different diseases. We have the only two drugs here with, that are ready, sub-Q. These will eventually be launched with an auto-injector, and, we'll see how that, that progresses and whether even in MG, we have the ability to be, best in class. Obviously, we won't be first there. VYVGART's done a pretty amazing job.
If you look at last quarter, that's well underway of $1 billion in peak sales, and I think we're, we're gonna be certainly, first and best in, in TED and Graves', and then, you know, potentially even in, best in CIDP and MG as, as those readouts follow with broader data.
And when you think about TED and Graves' disease. They're two indications that are sort of closely related, in that, right, TED is sort of a late stage form, you know-
Mm-hmm
... manifestation of Graves' disease. I'm just curious, with your development of batoclimab, where, you know, I think your view is that the LDL effect is not necessarily as important in TED because it's a treatment that you sort of would not necessarily be chronic for over the long term. But you've highlighted wanting to develop IMVT-1402 for Graves' disease. Does that imply that eventually you would want to potentially move IMVT-1402 into TED as well? Or do you think that you would potentially have both, both assets for those two?
So, to be honest, as we generated data last year at some point that looked at batoclimab and statins. So we saw that with a statin, this is certainly very well managed. I think a lot of these patients, you've got to remember, these are very rare diseases, so LDL should be a liability here that's manageable. But as the data reads out, I think we will think through what is the plan and do we flip some of these into 1402 , but we haven't made a decision on that yet. And, you know, it's certainly very appealing to have a near-term launch for both of these as those phase lll studies read out. So we'll have to weigh the risks and benefits there and see what the batoclimab data looks like.
You know, when you sold Telavant, which brought in, you know, over $5 billion in cash to the company, you spoke about it potentially allowing you to pursue bigger opportunities. Should we think about that in terms of M&A and looking at bigger targets, or is that, in the context of, you know, sort of your burn rate and it affording you more to spend on R&D?
So if you look at, you know, look, we celebrated our ten-year anniversary last year, so in the life of our company, a pretty incredible achievement, and I think where we are today, we, as of the last quarter, just to remind folks, had $6.7 billion in cash. So probably one of the best capitalized biopharma companies, even looking at some of the pharma peers. And that gives us incredible power here to continue to do great deals. I would say most of the deals we've done had upfront in sort of the $17 million range, if you look at the history of all of our deals. There is a pretty awesome opportunity here across the pharma space. I mean, you've seen across most of the big pharma earnings that they are now looking to outlicense or reprioritize portfolios.
We've had multiple discussions with all these different companies and look at this very closely. There's one company that has the ability to fund this, right, given their cash balance, to actually run successfully, lots of different trials in many different therapeutic areas. So we've, you know, have now had six different FDA approvals across, the many different therapeutic areas. That's, like, in the life of our, 10-year history. I mean, that's probably pretty unprecedented if you look at the rest of the space. And, I would say we have established ourselves as the go-to partner. So I would—the majority of the focus still remains on big pharma to do those types of deals. We're pretty flexible as well in terms of how these are structured.
So as you have seen with some of the deals we did with Pfizer, they we had, U.S. and Japan, and they had, rest of the world. They owned 25% of the entity that we sold, so they received a significant amount of proceeds from over the $7 billion in cash that was total for Telavant from Roche. So there's a lot of flexibility here. I think we're, we're pretty thoughtful. At the same time, we want to do good deals. You know, M&A, you know, I had done M&A as a banker for 10 years, can be, can drive large premiums. And I think we're being very thoughtful, around the use of our cash. We think most of the deals we'll do will still be low up fronts.
It does give us, though, an opportunity to run, you know, large phase III pivotals. So if there's something that requires a significant outlay for a pivotal study, we have a lot more flexibility here to do that. But generally, the way we do deals is we'll do something where there's a very small upfront. We'll then do another study. So we had just announced something in a phase II. We haven't talked about exactly what it is. We think through, you know, how much do we invest to get to that next inflection point, and then we talk broadly as a team about doing something in the pivotal phase, right? Go to the agency and think through that.
Some of those may not work out, but we can do this again and again, given our cash balance, and I think it will create a lot of opportunities for us going forward.
And Richard, last year, there was a period where you had a sort of flurry of activity from a business development standpoint. You brought in, you know, Telavant, the TL1A for Telavant, as well as brepocitinib. Been a little quieter of late, although you did, you know, handle the sale of Telavant to Roche. I'm just curious about how should investors think about the cadence of business development for you? You've obviously got a lot going on, but, you know, will this be a period of continued activity from bringing in new assets-
Yeah
... at that same rate?
Yeah. Well, we did also the phase ll program that I mentioned, that remains undisclosed. So, you know, I think for the most part, you should probably continue to see kind of that one-two deal flow that we've seen on an annual basis. I would also say, look, we are very selective. There's a lot out there that's available. We want to be very thoughtful about how we deploy our capital. We were also pretty active in terms of reading readouts. Like, you know, we saw obviously the SLE data. We decided not to pursue there. We also saw the data in MDS with Hemavant. We decided not to pursue that.
I mean, that was again a very Roivant-type deal, where very small upfront, small study to then really develop the proof of concept that this could be differentiated in MDS. Unfortunately, didn't read out as we anticipated, but we quickly moved on and shut that down and are focused on other opportunities. So I think we've been very active, and we're—I can tell you right now, the team is very active, looking at lots of different deals. Some of this with Big Pharma is a little bit unpredictable. Obviously, I was at a Big Pharma company for 10 years, so they can be a little bit slow-moving, but there's certainly lots of things in the hopper, and we're very active.
Richard, you've mentioned sort of working with Big Pharma. I mean, is that the primary source of where you are looking to potentially acquire assets, or are you spending time with the universe of sort of smaller biotech companies that, you know, may have, you know, sort of reached a point where they need some additional capital and a partner?
Yeah. Look, we, you know, I think, we spend time with, I would say, those companies as well. A lot of, I think, you know, some of that hypothesis of those companies running out of money and really being desperate, given with the biotech markets, I mean, the, the market's really bounced back, so a lot of them have been able to raise capital. But, you know, the opportunity remains with Big Pharma. We also, as you know, got the Immunovant asset from Korea, so we're also spending time, looking at other geographies and, thinking through opportunities, from similar to things you got from HanAll and companies that are thinking about launching in the US and really need a good, strong partner. So goes beyond just Big Pharma. Certainly, we are engaging across the universe here.
Okay. You know, you recently announced a big, large share repurchase. You know, and you bought back the
Sumitomo.
Sumitomo ownership or their stake in your company. You know, how do you think about the completion of that share repurchase, right? I mean, you got a great price with Sumitomo. Are you anxious to complete that, or, you know, are you gonna be waiting to get as good a price as you did there? Because presumably, you hope that your... You don't, you know, the stock doesn't go back to that level. And so how price sensitive are you in terms of completing the buyback and filling out the authorization?
I would say we're very opportunistic. So just to remind folks, we bought back $648 million of stock at $9.10. That was an incredible price, I would say. At the time, that was a significant discount of where the stock was trading. That reduced our ownership count by roughly 9%. We authorized $1.5 billion buybacks. We have still quite a lot left to go for. I'm also very, very happy to just earn 5.4% interest in short-term T-bills on that money, and and I think that's not a bad place to be and to continue to be very selective and wait for the right opportunities.
Okay, and, I think we're almost out of time, but, you know, Richard, I did want to give you a chance to, like, what are some of the key events that you would highlight for investors to pay attention to on Roivant for the rest of 2024 and even early 2025?
So one we didn't touch on was the LNP litigation. Look, the Markman hearing, I think, set us up very nicely here. That continues to progress. We're obviously in discovery, and we'll see how that moves forward, but I think that put us in a, in a very good place if you look at the breadth of the interpretation there across the various patents. And then the Pfizer litigation also ongoing, the LNP, that's progressing as well, a little bit behind the Moderna litigation. But that creates an incredible opportunity, again, for a large potential capital inflow, assuming we end up winning there. And you know, we certainly have talked about some of the additional anti-FcRn data that's coming through with CIDP in Q2, Q3, with myasthenia gravis at the end of the year.
That's a phase II study with TED in the first half of 2025. And then we didn't talk about sarcoidosis, right? So that is a phase II study that's reading out at the end of the year. There's not a lot for these patients. They're essentially being treated with steroids. It is an incredibly devastating disease. We had a patient talking to us about that disease during our ten-year anniversary and the significant unmet need. Hope to progress that forward, and when we look at that data again, we're gonna think hard and long about whether we move that into a pivotal study, and that creates another potential blockbuster for us, if that data is positive.
Okay, great. So with that, I think we are now over time. So Richard, thank you so much.
Thank you so much.