Roivant Sciences Ltd. (NASDAQ:ROIV) Q2 2023 Earnings Call Transcript

But along the way as we’ve shown historically, we are going to evaluate options and we are going to make sure we understand the competitive landscape and understand the strategic options available to us and we are going to be ruthlessly economic in assessing that position and that’s just who we are, well then.

Yaron Werber: Thank you.

Operator: Thank you. One moment please for our next question. Our next question will come from Corinne Jenkins of Goldman Sachs. Your line is open.

Corinne Jenkins: Yes, good morning. Maybe a couple from us. First, you mentioned the commercial potential you see Graves’ disease. Could you just step us through how you’re thinking about the market opportunity there? And in particular which patients within Graves’ disease do you think are candidates for new therapeutic agents?

Matt Gline: Yes, perfect. Thanks. And I’ll add Frank in and if he’s got anything after I give a first cut here, but look, this is a large indication and it has hundreds of thousands of patients in that and our study is on patients who are uncontrolled by ATDs that’s the existing study. There’s a pretty significant percentage of patients, especially accounts 14%, 15% of patients on ATDs do not wind up fully controlled. So, there’s hundreds of thousands of uncontrolled patients. You know surgery and radiation are effective but surgery and radiation are complicated and not everyone wants to sign up for that. So, uncontrolled patients currently don’t have a great therapeutic option. There has not been real novel drug development in Graves for a long time.

So did this is a — it’s one of these indications where there’s just a very large patient population that has unmet need. And if you talk to these patients they are clear about that. Frankly, some of the patients who our controlled on ATDs feel like they have symptoms, although obviously going to start with the uncontrolled patients. So we think this has the potential to be really, really large market, but people are not appreciating because it’s been a while since development. The only thing I’ll add to that, before handing over to Frank is you know this sort of interesting dynamic here where immunovant gathering this data and in some ways, the better the data is the more closely, we mainly to keep some of it to the vast because we said before anyone Phase 2 studies, everyone Phase 2 study, and that worked in our favor in many other indications, which is something we need to be thoughtful about here.

But in short, we think the commercial potential is really, really large. Frank, anything you’d add there?

Frank Torti: I think you covered most of the important part. I mean, just to restate it. You know there is a substantial opportunity in patients who are anti-thyroid medicine factory. And there is going to you know very large both incident and prevalent partnering population of patients who were just not getting enough benefit. This is a category of medicines that hasn’t seen meaningful innovation in this disease state in decades. And so there’s a ripe opportunity to come in, something that really matters and disrupt that and we’ll look forward to talking about it more detail soon.

Corinne Jenkins: Great. Thanks. And then you mentioned anyone’s Phase 2 means everyone’s Phase 2 for various inhibitors. That’s a good segue to the data over the weekend in rheumatoid arthritis. From J&J. I guess, what were your takeaways from those results? And how are you thinking about the read-across your own program and plan in rheumatic disease?

Matt Gline: Yes perfect. So immunovant will obviously speak more to this consistently over-time, as we as we lay out our study plans and get everything geared up. Yes, yes. I continue to feel that the J&J RA data in the way that I felt when we are first seen the abstract, which is it’s tremendously exciting to see an FcRn show signs of activity in an immune complex disease and it opens a large envelope of what of what could be possible, you know and say like, this data in and of itself need some work to better understand and characterize and J&J is doing some of that work. You know I think encouraging signs, include that you know the response rates look pretty solid specifically in patients who have the autoantibody measured in these sort of efficacy is well correlated with oral antibody suppression.

And as we’ve talked about before, you know I think one of the things that’s interesting about nipocalimab and the studies, it was it seemed to us somewhat under dosed. And so they really only got to, I think was about a 58% suppression of IgG, I think lower than that on the autoantibody. And so I think it’s sort of possible understand that there is room for better efficacy at higher IgG suppression. You know I think it is not very likely, although this is for immunovant ultimately announced that we are going to immediately begin a large Phase 3 program in RA, but I think it’s certainly really informative data for how we see the FcRn class developing and it suggests activity in an even broader set of indications one might have originally imagined.

So I think that’s kind of how we think about it.

Corinne Jenkins: Great. Thank you.

Matt Gline: Thank you.

Operator: Our next question will come from the line of Robyn Karnauskas of Truist Securities. Your line is open.

Robyn Karnauskas: Hi guys, thanks for taking my question and I love the word ruthless economic. I think that’s a great, great terms for company to you. So, I have three. So first, you just mentioned graves may have to keep some of that data close to how much data would you release or would you just say the results were positive and you’re moving forward? The second question is really about the other comment you made about VTAMA may shape up to be an opportunity for diluted financing. And given that you’ve sold assets before how do you think about running the company and thinking about where you can need to serve like a breeding ground where you get drugs and develop and then you sell them? And then you have some that you keep and how do you figure that out?

And then the last question is on VTAMA. You mentioned gross margins of 28%, the relatively flat hoping — over time. How — what’s influencing the gross margin are you still sampling? Is that still influencing that how do we model those, how do you help us model gross margins over the next say 18 months? Thanks.

Matt Gline: Yes, thanks, Robyn. I appreciate all of the great question. The first question, I’ll say having not yet seen the Graves data it’s hard to say exactly what we would disclose. And it probably depends a little bit on the data and exactly what we seeing in the controllers of the outcome, but you know I think the full range is on the table in terms of when and how we share that data other than we expect to get the main thrust of it in the relatively near future. And so we will be able to say something. I’m confident. That would be helpful. On the other two questions. I guess, I will take the bigger strategic one first and I’ll come back to sort of the VTAMA GTN progression. We are here to build a great durable long-lasting important biopharma company that delivers medicines to patients.