Dennis Ding : And if I can just squeeze one last question here around NIU given basic data that’s coming up soon, maybe, if you can comment on what’s the bar for success here, given it’s a small study and there’s no placebo, I know there’s some numbers in your slides around expecting less than 30% treatment failure rate and you’re estimating 80% to 90% stimulated placebo. But just wondering if you may actually need to see a lower failure rates since placebo if you look at Humira and filgotinib, placebo can be highly variable.
Matt Gline: Actually I’ll hand it over to Mayukh, do you have sort of thoughts on that question?
Mayukh Sukhatme: No, I don’t have too much, too much there. I mean, I think, look, I think you both pointed out that there is some variability there, but I think the — look, I think we’re looking at this in the same way that, that we look at all of our trials. We want to see for ourselves a pretty sort of clear signal of efficacy. I think even accounting for some potential variability in sort of notional placebo rate. And we’ll be excited to move forward if it’s clear.
Matt Gline: The only other thing I’d add is, remember this is a, it’s a 24 patient study. It’s randomized in favor of the 45 milligram. My experience — our experience looking at Phase 2 data is you sort of expect it to be a, like you hit F9 on the computer and you get a green thumbs up or red thumbs down, and usually what you get is, like a greenish triangle or something like that, and you’re like, what does that mean? And so I think you can imagine it’s hard to reduce the extra data that we’re going to get from the study into a single number. We did set that bar of a 70% treatment failure rate, but I also think you can be clear, we’re going to be looking at every patient and trying to make sure we understand what the drug is doing. And these are quite sick patients, again, 30,000 new cases of blindness every year. It’s something where we feel like we have an opportunity to make a big difference with the right clinical picture.
Mayukh Sukhatme: There are two other points to add there, I think, look, we are sort of hoping to see a bit of a dose response here and that like, while there’s not a placebo, there is a relatively low dose of repo that ought to give a little bit of a, let’s just call it, maybe not placebo, but something kind of closer to placebo on efficacy and the 15 milligram dose. That’s thing one. And thing two is I think at least in conceptualizing the Humira, sort of comp that you cited. We’ve got a more aggressive steroid taper in our study than in the Humira study. And so, you’d expect to see a higher placebo failure rate as a result.
Operator: Our next question comes from the line of Louise Chen with Cantor.
Louise Chen : I wanted to ask you first on how you plan to address the concentration in the shareholder base. Will that kind of all be done together with some of the announcements that you plan to make before the next earnings call? And then the second thing I wanted to ask you was on expansion of your pipeline, what therapeutic areas are you most interested in? And if you can’t say what therapeutic areas you’re most interested in, how competitive do you want a get with some of the most topical areas that people are investing in right now?
Matt Gline : On the shareholder based side, I think the first answer is that is not a decision that we can make unilaterally. It depends on our desires, but also the desires of some of our concentrated shareholders who in many cases are happy holders and frankly, believe what we believe, which is that our stock is meaningfully undervalued given the sort of overall position of the company. So I think, that’s a discussion we have to have sort of bilaterally with each of them. We’ll take it in turn you, I think, what we expect to do is to be ruthlessly economic and thoughtful about how we use our cash for that purpose. Whether that means we clean them up at once, whether it means we clean some of them up, I think that depends a little bit on their needs and their appetite and on making the right economic decisions.
Stay tuned is the short answer. On the BD question, and again, I’ll ask Mayukh comments as well, but I think the short answer is we are sort of necessarily agnostic to therapeutic area, because so much of our opportunity comes from strategic shifts and focus at our partners and that leading them to need to rethink their portfolio. So if someone is doubling down on immunology, maybe something else is falling out as a consequence. So we’re pretty flexible in general because we’re in that sort of string of pearls one program from here, one program from there dynamic. What that tends to mean is, we are more excited about areas where a single program can kind of stand on its own. So, think of the immunology programs that we’ve developed, for example, and maybe a little bit less excited about areas where you need a concentration, either because it’s like oncology where you’re developing multiple drugs in combination in order to have a coherent plan or maybe because it’s something like cell and gene therapy, where you have a sort of a need for manufacturing expertise that provides an economy of scale.
So it’s not that we would not go into either of those areas, but they’re probably like modestly less likely for that reason. Mayukh, anything you’d add to that?
Mayukh Sukhatme: I think, as we look, and this is really typical of the history of the company, I think as I kind of look at the list of things that I would say that we’re excited about and prosecuting pursuing, right now it’s about an eclectic a list as, as one could kind of imagine in terms of therapeutic areas. So as Matt said, we’re going to continue to be therapeutic area agnostic. I think, we have tended, as for the reasons that Matt stated, we have tended to be in areas that probably at first glance tend to be a little bit off the run or a little bit of contrarian. And sometimes, I think we’ve shown that sometimes those areas tend to heat up as we have sort of seen with FcRn and then with TL1A in the past. And so that could well happen again, but probably again just a mix.
Matt Gline : The bar for us is not, is it competitive, the bar for us is can we get something that makes sense for us given the development plan, the economic terms, et cetera. And so, there are occasionally programs in very competitive spaces where idiosyncratic factors makes them competitive from a sort of, like many people care about it perspective that are nonetheless easy for us to get. And then there are sometimes programs in less competitive areas where nonetheless they’re harder to pry loose. And so I think it’s not about sort of how many other people are doing it, it’s about what we can get our hands on.
Operator: Our next question comes from the line of Corinne Jenkins with Goldman Sachs.
Corinne Jenkins : Maybe as a follow on to Louise’s question, how do you think about Roivant’s ability to add value to the assets that you’re considering in those deals? And what do you view as the company’s core competencies in that context? And then I was also wondering, you say that the environment is sort of in really good shape, it’s the best it’s ever been, but what metrics are you seeing that inform that comment and as the biotech market kind of has and hopefully will continue to improve, how do you expect the environment to go from here?
Matt Gline : On the first I think it is unquestionably the case, but the thing we have done most in our history and best in our history is creative, thoughtful, aggressive clinical development. We’ve run 10 positive Phase 3 studies. We’ve run many, many Phase 2 studies. We’ve changed indication plans for programs where we thought that made sense. We’ve done — we think quite good job at late stage development for programs that we were happy with the choice of indication. So I think, first and foremost, I think value we add when we look at a new program, I think the ability to be efficient, thoughtful and creative on development strategy, selection of indication and then just strong at execution, the ability to move fast, I think is also something we are really proud of.
In terms of the environment, I guess first of all — Yeah, we’re watching the sort of change in the biotech market unfold. I’d say like there are certain kinds of opportunities like, people used to ask us all the time about the number of biotech companies trading under cash. Some of those dislocations are probably changing a little bit as people feel like they’ve got better access to capital. Some aren’t. There are still plenty of companies out there that because they don’t fit the exact current moment in time are still not sort of obviously in vogue. And so we’re looking broadly and I think that’s all sort of positive. That’s the main driving factor of our opportunity set right now isn’t biotech capital markets. It’s what’s going on in big pharma.
And I’d say that is not changing. That is the level of EPS pressure, is significant. There are patent expirations coming a across a number of different pharma companies, frankly, most of the industry. And the IRA is forcing our partners to rethink their development plans in various ways. And I think that combination of factors means that R&D portfolio prioritization has to happen at these companies. And if you are a big pharma company and if you’re reprioritizing your portfolio, what we think you want in a partner is the capital to run a good program, the execution to do a good job with it, and a willingness to be creative and thoughtful on structure to provide mutual benefit. And I think there is basically nobody else, at least in sort of biotech that has the track record at those things that we do.
So we think that sets us up as a partner of choice for a set of partners that have real need.
Operator: Our next question comes from the line of Neena Bitritto-Garg with Deutsche Bank.
Neena Bitritto-Garg: So just a question about the non-infectious uveitis study. Can you just remind us what the definition of failure is that you’re using the study? I know in some of the other studies that’s a kind of multifactorial definition. And then on CIDP data for batoclimab, just wondering what you would consider to be kind of a meaningful difference, from a dose ranging perspective between 340 milligram and 680 milligram?
Matt Gline: On NIU, Mayukh or Frank feel free to chime in. I think our definition is kind of in line with the other definitions and I don’t — sorry, I don’t have the exact definition right in front of me so I can sort of make sure it gets out there after the fact. But Mayukh or Frank, do you have the exact definition handy? No worries if not. And then on CIDP, again, I think this is a little bit of a balance of factors kind of a question. But look, I think what we’ve seen so far in CIDP is, like IVIg like response rates if I had to characterize them. And I think what we would hope to see in the higher dose is evidence that we can clear that bar something that looks sort of better to a patient’s and provider and physician’s eyes that than IVIg from an efficacy perspective. I think that’s kind of where our general head is at on what we could be able to deliver there. The definition — the primary definition is discontinuation or an inter-current event at week 24.
Operator: Our next question comes from the line of Yatin Suneja with Guggenheim.
Yatin Suneja : Question maybe on VTAMA, could you talk about what you are seeing from a competitive dynamic, your efforts on the marketing front? You continue to invest similar dollar and what — like how should we think about inflection with atopic dermatitis? What is the timeline around it and how much of the infrastructure bill you would have to build around AD? And also, could you also comment on the net yield? How should we think about calendar 2024 from net yield perspective?
