Roivant Sciences Ltd at Jefferies Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Dennis Ding - Jefferies - Analyst : Matt, I mean, there's obviously been a ton of interest around the company, around the pipeline. You guys had some really interesting and promising data, particularly around TL1A, which is only one aspect of the story. So maybe, before we start off, just level-set us. Talk about some of the Phase 2 data you guys had in January, the induction data in ulcerative colitis, and the path forward and some of the next steps for that program.

Question: Dennis Ding - Jefferies - Analyst : Right. So in terms of the 52-week data, that's obviously a really big catalyst for the company and the class, the space overall, that's coming in the next couple of weeks. So maybe just talk about what you hope to see from that data set on remission, clinical remission, but also perhaps some of the secondary endpoints.

Question: Dennis Ding - Jefferies - Analyst : Great. And I think there's a lot to unpack there, actually, from what you just said. 12-week induction -- or the induction data, which I think 12 weeks, or is it --

Question: Dennis Ding - Jefferies - Analyst :

Question: Dennis Ding - Jefferies - Analyst : And what you want to see in maintenance at 52 weeks is 31% holdup at around 31%, 30%. That's kind of what you call a home run, right?

Question: Dennis Ding - Jefferies - Analyst : Okay. And that's Phase 3 dose in induction to Phase 3 dose in maintenance. Because like you said, there's some complexity in terms of dosing combinations.

Question: Dennis Ding - Jefferies - Analyst : If you hold the dose steady through the whole 52-week period, you want to see the remission holdup.

Question: Dennis Ding - Jefferies - Analyst : Okay. And then you guys have already seen some of the interim data last year in 2022 when you were doing your due diligence with Pfizer, and the data looked promising. And you made an interesting comment that, based off of the interim data, that you have confidence that remission would improve. And you (multiple speakers) --

Question: Dennis Ding - Jefferies - Analyst : There's a good chance that remission could improve.

Question: Dennis Ding - Jefferies - Analyst : Right.

Question: Dennis Ding - Jefferies - Analyst : Yeah.

Question: Dennis Ding - Jefferies - Analyst : Got it. And then the fourth -- like, you mentioned that at the interim, most of the patients were at 40 weeks. They had not done their endoscopy yet. But clinical remission is a composite, right, where --?

Question: Dennis Ding - Jefferies - Analyst : Where endoscopy is only one part of it. But based off of the other components, you guys feel relatively comfortable that there's a chance that remission could improve in maintenance.

Question: Dennis Ding - Jefferies - Analyst : And how many patients at the 52 weeks that you guys see at the interim?

Question: Dennis Ding - Jefferies - Analyst : Minority?

Question: Dennis Ding - Jefferies - Analyst : Okay.

Question: Dennis Ding - Jefferies - Analyst : Okay. And if we take a step back and think about etrasimod, which was the other recent Phase 3 data set that used a treat-through design, their remission went from 27% up to 32% from induction to maintenance. So that's a plus 5% delta, right?

Question: Dennis Ding - Jefferies - Analyst : And that's an S1P. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 07, 2023 / 2:00PM, ROIV.OQ - Roivant Sciences Ltd at Jefferies Healthcare Conference

Question: Dennis Ding - Jefferies - Analyst : And you guys are a TL1A which has anti-fibrotic effects, which could impact efficacy the longer you treat patients. So is there a reason why remission would not be up with maintenance?

Question: Dennis Ding - Jefferies - Analyst : Okay, okay.

Question: Dennis Ding - Jefferies - Analyst : Okay, okay. Very cool. And that data's coming up imminently --

Question: Dennis Ding - Jefferies - Analyst : In the next couple of weeks. The guidance is Q2.

Question: Dennis Ding - Jefferies - Analyst : We'll have a couple of weeks left. So does the team have the data in-house, and they're doing analysis on it, or can you give a little bit of color there?

Question: Dennis Ding - Jefferies - Analyst : Got it. Okay. So it's more reliant on Pfizer completing that analysis, giving it to you, and then you guys reporting it.

Question: Dennis Ding - Jefferies - Analyst : High degree of confidence. Okay, that's great. And then maybe if we take a step back just around TL1A. Ever since the deal was done back in December, there have been a lot of questions from investors around why did Pfizer let this asset go. And although there are theories out there and the companies have said different -- various things, investors are still -- I've sensed there's still a little bit of skepticism in the marketplace, especially given Merck acquired Prometheus for $11 billion, essentially.

Question: Dennis Ding - Jefferies - Analyst : Right? So when you talk about that, address that -- the skepticism on the Street.

Question: Dennis Ding - Jefferies - Analyst : Yeah. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 07, 2023 / 2:00PM, ROIV.OQ - Roivant Sciences Ltd at Jefferies Healthcare Conference

Question: Dennis Ding - Jefferies - Analyst : Right.

Question: Dennis Ding - Jefferies - Analyst : Got it. And here's also a level of investor questions or debates around how much value can Roivant -- or at least, like, how much value TL1A is factored into the company's valuation right now, considering that Merck acquired Prometheus for $11 billion. And there's some dislocation between valuation and that takeout price.

Question: Dennis Ding - Jefferies - Analyst : So -- of course. And maybe talk about -- internally, what are ways that you see over the next six to 12 months where you could bridge that valuation gap. What would you -- like what would need to happen? I mean, more data, more time I think would help. But just wondering what other ways could you get more value from the TL1A program? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 07, 2023 / 2:00PM, ROIV.OQ - Roivant Sciences Ltd at Jefferies Healthcare Conference

Question: Dennis Ding - Jefferies - Analyst : Right. So can you elaborate on that a little bit more? Because if some -- like AbbVie and maybe Bristol were in talks with Prometheus -- and my view is that there are other people shopping for a TL1A. So in case there is a potential change in control, how much can Pfizer kind of block that transaction, or do you have confidence that something like that could go through without --?

Question: Dennis Ding - Jefferies - Analyst : Okay.

Question: Dennis Ding - Jefferies - Analyst : That's very helpful. And then all of your data so far has been in UC. And obviously, Crohn's is also the other big market in IBD. Prometheus has some pretty strong data in Crohn's. And you guys have not really talked about your Phase 2 plans for Crohn's. So maybe comment on that program.

Question: Dennis Ding - Jefferies - Analyst : Okay. So Phase 3 not too far behind UC.

Question: Dennis Ding - Jefferies - Analyst : Okay. And then in terms of trial design, like how would that look? You mentioned dose ranging. But what are the different doses that you could use? Could you go higher in -- higher doses in Crohn's, and maybe you could squeak out a little bit more efficacy that way? Like how do you (multiple speakers) --

Question: Dennis Ding - Jefferies - Analyst : Okay, maybe along with the maintenance data

Question: Dennis Ding - Jefferies - Analyst : Okay. All right. So look, investors on the Street are obviously very keen around the TL1A story. I think that's totally valid. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 07, 2023 / 2:00PM, ROIV.OQ - Roivant Sciences Ltd at Jefferies Healthcare Conference But another program that I feel like is underappreciated is the lupus program that you guys have, which --you're in Phase 2b with data in Q4 of this year. And that asset was also licensed-in from Pfizer. So maybe talk about how that process came to be and some of the puts and takes going to that data.

Question: Dennis Ding - Jefferies - Analyst : Yeah.

Question: Dennis Ding - Jefferies - Analyst : Right. And let me summarize that real quick. TYK2, JAKs -- they all have kind of mid-teens efficacy on SRI-4. Standard of care is just [case] Benlysta.

Question: Dennis Ding - Jefferies - Analyst : That gets you 10% to 14%.

Question: Dennis Ding - Jefferies - Analyst : But it's an old drug.

Question: Dennis Ding - Jefferies - Analyst : But it's also doing $1 billion in sales, right? That's interesting. And the idea for your TYK2 and JAK1, which is a bigger gun, is to squeeze out a little bit more efficacy on top of what others have shown in the mid-teens. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 07, 2023 / 2:00PM, ROIV.OQ - Roivant Sciences Ltd at Jefferies Healthcare Conference

Question: Dennis Ding - Jefferies - Analyst : Yeah.

Question: Dennis Ding - Jefferies - Analyst : Very cool. And that data is coming out in Q4, right?

Question: Dennis Ding - Jefferies - Analyst : The SLE data. Right. Okay.

Question: Dennis Ding - Jefferies - Analyst : All right. Well, I think that's all the time that we have today. But obviously, there's a ton of things going on at Roivant. A lot of data coming up, especially the maintenance data over the next couple of weeks. And we're all very keen to see that data. So thank you so much, Matt, for joining us here.