Thanks for being here. Pleasure to have management team from Intra-Cellular Therapies here. I still remember when we first spoke, and I think you guys were conducting your phase III at the time, and now it's a successful commercial stage company with more indications to come. But before we get into it, maybe let me just turn it over to you to kick things off. You want me to give a little history on the company? No, no, no. What's on top of your mind? I know there's the MDD phase III coming up. The launch is progressing nicely, but anything on top of your mind, and we'll jump right in. A lot of things on top of my mind all the time. Obviously, I'm a CEO and Chairman of Intra-Cellular Therapies, and I think, CAPLYTA is our first product, which we're very pleased has been doing very well in the marketplace and is helping a lot of patients. Before I start going on and on about the attributes of CAPLYTA, maybe I'll turn it over to you for the Q&A. Okay. Okay, excellent. Excellent. Well, lately, Sharon, I noticed, and I don't know if there's an element of seasonality in antipsychotic trends, but there was, across... I'm not even talking CAPLYTA now, I'm talking a collection of branded antipsychotics in the marketplace. There was a little bit of seasonality to the prescription growth trend, and it kind of started to come back on lesser growth, back to more growth again. Anything important from a dynamics perspective that drives that, and how do you think about that growth trend on volume into next year? So I'll just start, and then I'll ask Mark to comment on it. So, typically, with the antipsychotics, you do see a third quarter seasonality. We still, and in fact, the branded antipsychotics were flat, but we were up 7%, so we did have growth in the quarter that we were very pleased with. And maybe I'll ask Mark if you want to expound upon that a little bit. Yeah, sure. This is a dynamic we see each year. If you could probably look back further, but certainly in the last three years, when you look back at the third quarter, there's been zero growth in the overall market each of those years. So we were actually very pleased with the 7% growth that we registered in the third quarter, which means that we gained market share. And if you were asking about some of the reasons, Umer, if you think about it, the summer months, this is when, you know, physicians go on vacation, their staff go on vacation, patients go on vacation. They don't fill their prescriptions at the same time as they usually do. So there's a lot of reasons why it happens, but overall, there is some summer seasonality each third quarter, so it wasn't a surprise to us. And as you said, as we think about the performance so far in the fourth quarter, we see a re-acceleration in the market and a re-acceleration in the CAPLYTA volume. In fact, last Friday, we hit new all-time highs in new Rx and TRx. This past Monday, we hit a new all-time high in NBRx for true new patients coming to CAPLYTA. So we feel very good about. Got it H ow the brand's grown. So 3Q revenues, annualized, is about a $500 million run rate for CAPLYTA I think, consensus expectations are at about $650 million for next year, which implies about a 30% growth or so. I know we discussed some of the underlying volume growth trends right now. So it does seem like, you guys should be in a position to, get to consensus-like numbers, even without any meaningful change in the growth trajectory, which means this is technically ex MDD. I guess, how are you thinking about, gross to net dynamics? Because that would be the only other variable as we think about the volume and the, expectations into next year? Without providing any early guidance on either gross to net or revenues- But nice try. F or next year. What I would say is we feel very good about the growth of CAPLYTA and the volume that we're seeing. We feel very good about the overall access that we have with CAPLYTA. We have very high levels of covered lives, over 98% Medicare and Medicaid, and about 90% in the commercial channel. We've been following a consistent strategy for market access and don't expect a significant change to that strategy as we head into 2024. So while we're pleased with the overall access that we have, we will always look for individual opportunities with individual payers. If we think we can negotiate what we would consider to be a reasonable rebate, and we think we could drive significant volume based on that, then that's a decision that we'll take. In fact, during the third quarter, two of the largest Part D payers in Medicare had CAPLYTA with a prior authorization and two electronic step. We negotiated that down to unrestricted status for those two. One went into effect September first, the other one went into effect October first. So we're okay if our gross to net drifts up a little bit, and as we said, for the fourth quarter, we expect it to remain in the low thirties, a little bit higher than the third quarter, but in the low thirties. And so we look individually around the margins at those opportunities to drive incremental growth, and we'll continue to do that. But so, just so I understand it right- Yeah. What you're saying is, underlying volume growth rate right now is 7%? In the third quarter. No, in the third quarter. In the third quarter. In the third quarter, right. So that's accelerated in t The current run rate. My point is, for gross to net expansion to happen, you want to see more growth than that? Sure. The only reason why we would contract for higher rebates and higher gross net is if we think we can offset that with significantly more volume. Got it. We do that on an individual basis. That's always been our strategy, and that'll continue to be our strategy. Makes sense. Makes sense. Okay, anything on the commercial side, Mike? Yeah, I do. I mean, regarding the IMS capture rate, what's going on there? I mean, what are you seeing on your end? Because it greatly dictates how many weekly TRX ads you need to achieve to beat 2023 sales guidance. From my math, when I run my scenario analyses, I'm getting in 3Q around the mid-80s IMS capture rate. But if you assume a 90% IMS capture rate, it implies that you need a lot more- W eekly TRX adds to hit consensus. So do you have any insights as to what's going on on the IMS front and along those lines? Nothing specific. I think that's always a challenge, right? With the data, the datasets we have are the best that we have, and they're reasonably good directionally at telling you which way the business is going. But they're not perfect, and they don't capture everything, and they have fluctuations up and down. I won't comment on anything specific, other than to say, as we look at our business, we feel very good about the volume growth that we're driving. We see that growth continuing certainly into next year and years beyond that. We give guidance each year on our gross to nets, and we've been very consistently within that guidance, throughout this year, and we would expect to be next year as well when we give that guidance. Overall, as it pertains to the business, we feel very good about where we are. Got it. I know a very important update this year was obviously your mixed features study. Not just because it validated the potential in indications beyond what you already have on label, but also possibly as a predictor for what we should expect heading into your MDD phase III. First one's coming up in the first half. But can we go through that step by step? Sharon, I know you and I talked about it previously as it relates to... There are two broad subsets of mixed features. One of them, you may potentially already have on label. Can you speak to that dynamic, and we can talk about the other side of it as well? Okay. I'll start out, and then I'll ask Suresh if he wants to comment. So yes, we did a study in mixed features, patients with mixed features in both bipolar depression and in patients with MDD. And what these patient populations have in common is they both have a major depressive episode, and it was very robustly positive. We do already have a label for bipolar depression, and yes, we think it's a very broad label, and it encompasses mixed features. On the other hand, we don't have a label yet for MDD. And so we do think that we're very pleased with the very robust results that we saw in patients with mixed features in MDD, in unipolar depression. Because again, it gives you confidence that in these patients with these mood disorders, we're able to help these patient populations. I think that's why it, it's really excited us, and that's the overall, study results. Got it. So as we think about scenarios, 'cause you have three phase III trials in depression, is there a possibility that you use your existing mixed feature study with the first phase III in depression, and that alone could form the basis of a regulatory filing? Now, let me tell you what the program is. The program is two studies in patients, being treated, adjunctive treatment for MDD. Positive data is always very good and is always supportive. So, when you look across products that have received approval, sometimes you've gotten two robust studies, sometimes you've gotten one robust study, one not-so-robust study. And in fact, if you look at compounds like Rexulti, sometimes you have one robust or one good study and one study that's almost positive, and they got approval. And again, it's because you have good supporting data. So you know, we obviously are very hopeful that our first two studies are positive. We, as you know, we have a third study ongoing as well, and then we have the study in mixed features patient population that no matter how you looked at that study, combined populations, separate populations, you know, key secondary endpoints, other exploratory endpoints, they were so robustly positive. It was unbelievable. So that's very, very supportive and leads to the fact that you are treating these patient populations. So we'll see how additive it is and, whether, you know, what it really does to, add to the patient populations that we already have in terms of labels. Got it. So Sharon did not say no. No. All right. Ashley, one question on the actually Study 505, the third study that we initiated. Just looking at the ct.gov records, it enrolls a considerably less number of sites than the other two trials, and it's only US, and only two sites are recruiting. Anything to read into there that perhaps may make one think that you're very confident in Studies 501 and 502 reading up? I could say yes, but that's really not correct. So it is the same as in all of our studies. They're all global studies. You start with the US population while you're getting your approvals in other countries. I see. I see. They come on board, and it takes a while to get it onto ClinicalTrials.gov, too. I don't know- No, that's exactly correct. Yeah. All our trials are global trials. All right. Suresh, okay, so since they're global trials, I do have a question. The first phase III in depression that's coming up, 75% of sites are ex-U.S. In the second trial, they're more balanced, U.S. versus ex-U.S., and by the time we get to the third trial, which is later, which Mike talked about, it's effectively just U.S. In my mind, I'm always thinking of ex-U.S. sites being more higher placebo response in neuropsych in general. Is that a norm, or is that not really the case? That varies. I think that most of the information comes from... I read a paper published by FDA in schizophrenia studies where they looked at all the studies done so far, which had approvals. Right. They have shown that ex-U.S. versus U.S., ex-U.S. did little better, Ex-U.S. did better on? Better on in the schizophrenia studies. In schizophrenia. So it's the opposite from what you said. Placebo-adjusted efficacy is doing better. Okay. In schizophrenia. However, in depression, placebo effects are always there, no matter it's U.S. or ex-U.S., and that's what we have to try to control that. Do you guys get any level of visibility in what the, on a pooled basis, what the MADRS performance is looking like across these trials or no? Usually, again- Pool blinded. For example, right now we have our studies, what we have looked at for our bipolar depression studies. Most of the studies were in the range of 30. That was the average baseline. We expect- MADRS score. MADRS score. Right. We expect the same to be in this. In MDD, 'cause the inclusion is above 24, but you expect the baseline to be about- Around similar, yeah. Okay, got it. All right. Just to go to your question about percent of patients, we aim to have about 30% of our patient population in the U.S. for all of our studies. So it could be less- But why is there- Because that's what the FDA has asked for in the past. Oh, I see. It's pretty simple. I see. I see. Okay, makes sense. And then, as we think about sort of the effect size, is there a reason to expect effect size looking meaningfully different in MDD versus how it looked in bipolar depression MDD? Sorry, in the mixed features MDD subset. In terms of the... When we design studies, right, this is after the fact, that was what we have seen. Right. When we design studies, we power the studies to around 90% for registration trials. And we also, for example, depending on the indication, we look at the historical data, and we use the data to come to that power, and we take into consideration what the drug placebo difference would be. Usually, in depression studies, the drug placebo difference is usually between 2-4 points. 2 points towards lower end of the scale for adjunctive treatment, for monotherapy, it will be towards the upper end of that scale. Got it. This study also was powered similarly. Got it. Any question on MDD? Yeah. In the past, you said that, like a 2-point effect size would be considered clinically meaningful, on the MADRS score, and that even some competitors with as much as a 1.8-point difference got approved. That's correct. My question is simply like, has the bar risen? I mean, where perhaps this 1.8 points, 1.8 points may no longer cut it. I mean, has the bar risen in that regard? No. Again, the recent drugs approvals, you have seen whatever the drugs recently have been approved, the last two drugs have in the similar range. Got it. Got it. And, in terms of like in how we should think about the standard deviation in the MADRS scores as we try to better handicap these trials, any comments along those lines in terms of standard deviation in adjunctive MDD trials versus regular MDD trials? When you mean standard deviation, if you're talking about variability? Yeah, variability in terms of maybe just parallel- So, depression trials generally are, you know, higher, you know, will have. But when we take that all into account when we design the studies to make sure when we're powering it, standard deviation is one that goes into the powering, and also the drug placebo difference is one thing that goes into the powering, that determines the sample size for that. So when we consider even between monotherapy and adjunctive therapy, all those are considered to come to that conclusion. Right. Got it. So, maybe in the last five minutes or so, I mean, obviously there's a near-term biotech catalyst, if I may, which is the MDD phase III, and we could judge off of the prior trial, but. But that's more near-term, and we'll be past that pretty soon. But Sharon, I think from your perspective, there's bigger strategic questions coming up now. For example, the way I see it, by the time this first MDD phase III reads out, and some of the underlying growth in CAPLYTA is continuing, you guys are probably break even on your P&L. Which means the conversations will very quickly be evolving towards, what types of earnings power could ITCI have in 2025 and onwards. So that's one question. Has that been a consideration internally, and what type of earnings power you guys think you can have as a standalone company? Because there's growth managers in the room, and oftentimes, it's a whole different type of valuation construct when companies inflect from being unprofitable to being profitable, and then there's PE multiples that kick in. And because those conversations are also very relevant to valuations in broader neuropsych space, because there's just general M&A interest as well in the broader neuropsych land. So I think the question was, do we think about that? And- EPS, exactly. Of course- How are you thinking about that? Of course, we think about that. I thought you were gonna follow that up with: are we going to give guidance as to that? No. And which we're not doing yet. But of course, we think about that. We look forward to that day. I think we're very cautious about our spending, and we think we've done a very good job at that. So, we definitely think about that constantly. We look forward to that. Remember, I started the company when we had some concepts and some thoughts, and then we had a structure on a piece of paper. Then we got an approved product in schizophrenia, and then we launched in bipolar. Now, we're looking forward to being able to launch in MDD as well, and the progression of the company, I think, has been truly remarkable, and we look forward to continuing that. And we look forward to being a company, you know, with our- I guess, I'll tell you what I'm really trying to get at. If you do a billion dollars in sales, if the cost base kind of stays broadly where it is right now, SG&A and R&D is about $600 million, it's a little less than that. You could be in a position to put up $3 in EPS, meaning even with a $1 billion revenue run rate, you could start to justify the type of stock price where the stock currently trades at. How are you thinking about leveraging the model from an OpEx perspective? Do you think the costs are built out, or does the company expand the plans around SG&A and R&D? Because those will be highly relevant to everything else as we think about some of the other questions around the company. Yeah. As we progress, we have a pretty extensive pipeline, and we will keep developing our pipeline. So, and we will keep investing in CAPLYTA as well. But again, we are looking forward to being a profitable company as well. We haven't given guidance into the future, so I don't think that now is the time to do that, other than to say we certainly keep all of these questions in mind, but we think we can do both. Okay. We think we can develop our internal pipeline. We also look at bringing things in, that have been developed externally, but we're very cautious- Right I n how we do that, and very cognizant of the fact that people are looking at us for our future. Makes sense. Because the first $1 billion in revenues, maybe that's worth about $2 in earnings or so, EPS power for the company, because of the cost base. And let's say you add a couple hundred million in extra costs, once you're at certain revenue thresholds, but what that implies then is in going from the $1 billion-$2 billion revenue, run rate, the incremental EPS out of that second billion could be up to $7 to the company. Have those types of, questions and resource allocations toward SG&A and R&D, those topics, have they come up in medium and more five-year planning of sorts? Yes. I mean, they come up, if not on a daily basis, certainly on a weekly basis. Okay. We do contemplate all of that now as we move forward. Got it. My last one, more around the patent estate. I know, 2033 patent is something you've mentioned quite a bit. There's increasingly a perception around that being sort of the composition patent. As I go through the claims on that patent, clearly there's chemical structures taught in that patent, in the claims. But I also notice, and maybe this is my lack of understanding, I also notice every claim starts off with "method of." That word, method of, goes in every single claim, which makes me ask the question: Is that a composition patent or a method patent? The patent covers both the methods as well as the composition of lumateperone in any dose, in any formulation. So it encompasses the both formulations, composition, as well as the uses. Got it. Excellent. Final point, Sharon, and I know, we're hoping for a positive outcome on the first depression study coming up and the second one, but in a scenario where there's, depression studies do what they do, which is one hits, and one doesn't have a high placebo response, the optionality around using a pooled datasets across mixed features with the emerging data for your MDD, all those are realistic possibilities, is it not? I can't speak for the FDA. I can only tell you what studies we have ongoing, and what studies will read out, when they will read out, and our enthusiasm for the entire program. Got it. And finally, just to confirm, Suresh, you mentioned MADRS 30. That is generally what we should expect across the trials? I would think so, yeah. Well, that's what we've seen- Similar to what we have- That's what we've seen in the past. Yeah. We have to see what these studies have. Got it. But it's- Do you have visibility internally on what the baseline is? We don't look at it regularly, but we do look, monitor the whole trial. But again, with the same inclusion criteria, similar inclusion criteria, I would expect similar, similar baselines. Excellent. Outstanding. I know we're at time. We have a small cap coming up next, Eli Lilly, so... Okay. Thank you. Thank you. Thank Thank you.