Sharon Mates: Sure. Thanks for the question. I’ll take that. So I think that when we started looking at an LAI, we didn’t have all the data that we have now as to why does safety and tolerability profile and which as you know, has turned out to be very good. So we are developing an LAI, we don’t expect it to take over 50% of the population because of the fact that our oral drug has such a great efficacy and safety and tolerability profile. However, we do think that it’s an option for patients and can be an important option for some patients who either are not compliant to once a day dosing or who simply just don’t want to take drugs every day. So we think that it’s nice to have, we don’t think that, again, that it’s going to take over our oral franchise.
We are also in our development profile, though we are seeking not only a one-month delivery, but we’re seeking a longer period of time, a two months delivery. So hence, we are delivering — we are developing a product that can be useful in both one and two months deliveries.
David Amsellem: So Sharon, can you say if it’s a SUBQ or an intramuscular, I don’t know if you’ve ever mentioned that?
Sharon Mates: I have mentioned it. The Phase 1 study that we did was a SUBQ. We’ve been looking at other ways of administering the drugs. So we are looking at both SUBQ and IM. And so it turns out from a patient perspective, it isn’t — it is really depending upon your formulation, sometimes they are like one over the other, but patients don’t seem to mind an IM injection. So we’re looking at both SUBQ and IM.
David Amsellem: Thank you.
Operator: Thank you. One moment for our next question. And our next question comes from line Graig Suvannavejh from Mizuho. Your question please.
Graig Suvannavejh : Thanks. Good morning. Thanks for taking the questions and congrats on the progress. I’ve got two pipeline questions. My first just has to do with the mixed features study that we’re about to get data for. And my question is just given the trial design, where you do have Madris as an endpoint and given that it’s likely to be mainly in MDD patients or many MDD patients in the study. Is there a possibility that you could consider or you could propose to the FDA that this perhaps should be counted more as an MDD trial, so just wanted to get your thoughts around if that’s part of the thinking? And then secondly, I did also want to revisit the new 505 study that you’ve announced. And I’m curious if the desire to add a study in any way is perhaps hedging against perhaps a negative result in 501 or 502? Thanks.
Sharon Mates: I’ll start with the second part, and then I’ll turn it over to Suresh. So the start of a new study is prudent. It is simply the way the CNS trial are run. It’s the way we’ve conducted our other programs. We did this in bipolar, we did it in schizophrenia, you see every sponsor conduct several trials within an indication. So I don’t think there’s anything, any magic here, anything special here. I think we — you always think it’s prudent to have several shots on goal. And so we thought it prudent to have started — and into the timing of the study, you look around at the different countries you look at how many other studies are ongoing. And we thought that this is the right time to do this, hence the start of the study. And Suresh, did you want to take the other part of the study of the question?
Suresh Durgam: Question. Yeah, I think the next — the first question was about the mixed features can then be used as a MDD study. So the mixed feature study is designed especially to two populations, we have the bipolar depression population and we also have the major depressive population that is a unipolar depression. So we have approximately, similar patients between age groups. And also this patient population has been enriched for mixed feature. So we use the diagnostic features of DSM 5 for specifically indoor patients only who meet the criteria for mixed features. So it would be difficult and if not, I don’t think that it will be agreeable by the FDA to use that as a MDD study.
Sharon Mates: Nor would we want to. These are patients with mixed features, that need to be
Suresh Durgam: In the population, yes.
Sharon Mates: Right, and just to tell you, I mean obviously we don’t have any of the results yet, but the way the study was designed, patients were stratified. So we should have roughly equal patient population in the bipolar and the MDD patient populations.
Operator: Thank you. One moment for our next question, and our next question comes from the line of Ash Verma from UBS. Your question please.
Ash Verma: Hey, thanks for taking my question. Congrats on the quarter. I had two, first just can you elaborate on the new DTC campaign that you launched, seems like it is making a decent buzz based on some of the downstream metrics that we track, anything that you can share on how much of the spend is baked in for the DTC in your SG&A guidance for this year? That’s first and then the second one. So all mixed features like the feedback that we’ve heard from physicians indicates that patients are not specifically treated for mixed features, at least not extensively. And this would require some sort of like an indication establishment. Want to understand if you think differently and can you provide any kind of an example of where psychiatry indication went through a similar path when it was undertreated to begin with and became a bigger market eventually? Thanks.
Sharon Mates: We may need for you to I — you blanked out on me a couple of times. I couldn’t hear what you were saying. I don’t know if anybody else could hear at all.
Mark Neumann: I heard the first part of the question, Sharon on DTC. I could start there, if you’d like.
Sharon Mates: Okay, sure.
Mark Neumann: So yeah, hi Ash. We did recently launch the next iteration of what we call our lead in the light DTC campaign. This is a broad national campaign that we’re implementing. We’re implementing it through television ads, digital platforms, social media platforms, all with the intention of seeking to continue to raise awareness of the very significant unmet need, both in bipolar I and in particular bipolar II depression and educate patients on the potential benefits of CAPLYTA. And yes, we’d agree we’re seeing the same positive metrics that you’re seeing, which is the reasoning behind continuing the campaign and evolving it, and building upon it. Our media is successfully targeting and reaching the bipolar depression audience.
We know that from the metrics we’re looking at. When we’re on air, we drive substantially more visitors to our website, looking for information about CAPLYTA and bipolar depression. And also on the back end when we survey physicians, an increasing number of physicians are reporting an increasing number of patient requests for CAPLYTA and we would expect this to increase as our ad continues to air. So yes, we’ve been pleased with the campaign. We’re seeing the positive metrics and that led to the decision to continue it. I don’t know, I can turn it over to Larry. I don’t know if Larry has a comment on the spend. We don’t typically, specifically talk about the components of our selling and administrative spend. But Larry, I don’t know if you have any comments that you’d like to add to that.
Lawrence J. Hineline: No, I have nothing to add to that.
Sharon Mates: Okay. And then Ash, we’re going to have to ask you to repeat, I know you had a bunch of questions in there. I’m sorry. We couldn’t, I guess none of us could understand what was being asked, so if you could ask it again please?
