Great. Good morning, everyone. Welcome. I'm Jessica Fye, Senior Biotech Analyst at JP Morgan, and we're continuing the conference this morning with Intra-Cellular. I'm joined by the company's CEO, Sharon Mates. She's going to give a presentation on the business, and then we're going to go into Q&A. If you'd like to ask a question in the room, you can raise your hand, someone will bring you a mic, or you can always use the portal to send questions to me on the iPad, and I can read them up here. So with that, let me pass it over to Sharon. Thanks, Jessica. It's great to be here today, and I am joined by my colleagues, Mark Neumann, our Chief Commercial Officer, and Suresh Durgam, our Chief Medical Officer. So before I begin, I should tell you that our presentation today does contain forward-looking statements, and actual results may differ, and I refer you to our website and to our SEC filings for continuous updates on the company. So today I'm going to tell you about Intra-Cellular Therapies and about the great progress we've made and what we think is a great year that we've had in 2023. With our proven commercial and development capabilities, we're strongly positioned for future growth, and we have a very robust pipeline. So 2023 was a year of very successful execution. We continued the successful launch of CAPLYTA with exceptional Rx growth of about 85% in 2023 versus 2022. We did this through an increased depth and breadth of prescribing with strong market access position, and as you know, we guided you for fiscal year 2023 to $460 million-$470 million in revenues. We also had very positive clinical developments, and most impressively was Study 403, our mixed feature study, with robust results that further validate the broad potential of lumateperone in mood disorders. We advanced our pipeline with multiple pipeline programs, including lumateperone phase III program as an adjunctive therapy in MDD. So CAPLYTA's successful launch has continued. We launched in last few days of March 2020 for the treatment of schizophrenia, and as you can see, we had a very big increase in the trajectory of our revenues with the approval of bipolar depression launch in December of 2021. This growth is driven by a strong underlying Rx demand, with substantial Rx inflection, as I mentioned, following our bipolar depression approval, and this is due to our compelling product profile and our strong commercial execution. Our compelling product profile has shown proven efficacy, with CAPLYTA now being approved for the treatment of schizophrenia and bipolar I and II depression in adults. We have a very favorable safety profile that has not only been demonstrated in our clinical trials, but we're very pleased to say that it has continued in our years post-launch of the product. The favorable safety profile is similar to placebo and an excellent tolerability profile as well. Very importantly, it's a very convenient dosing schedule with once-a-day dosing, with no dose titration required. We have a very broad label for bipolar depression. It is the first and the only treatment indicated for both bipolar I and bipolar II depression in adults as monotherapy and as adjunctive therapy with lithium or valproate. So at ITCI, we're positioned to continue our value creation, and we're doing this in three ways: We're maximizing CAPLYTA for its current indications, we're expanding CAPLYTA across the mood spectrum, mood disorder spectrum, and we are advancing our pipeline. So we're driving growth for CAPLYTA by educating 43,000 prescribers, including psychiatrists, nurse practitioners, PAs, and primary care physicians. We have a very broad national advertising campaign through TV and social media to enhance awareness for the 11 million adults with bipolar disorder. We've achieved very strong market access position, with over 99% covered Medicare/Medicaid lives, and we're pleased to say that late last year, we reached about 90% covered commercial lives. So second, we're positioned to continue value creation by expanding CAPLYTA across the mood disorder spectrum. Our vision is the establishment of CAPLYTA as a first choice across depressive disorders. To this end, we've demonstrated this robust efficacy, favorable safety and tolerability, and convenient dosing that are preferred attributes in prescribing decisions, and we believe it's the reason to believe in the establishment of CAPLYTA as a first choice across depressive disorders. For patients, the burden of depressive disorders is high and significant unmet medical needs remain. Both disorders, both bipolar and major depressive disorder, have high rates of disability. These patients exhibit severe symptoms that are difficult to treat, and have treatments that even unto themselves cause adverse events. These adverse events cause patients to stop taking their meds, and it is the reason for one of the large reasons for the treatment discontinuation among antipsychotics. These disorders are highly prevalent. With an approval in MDD, the total addressable market expands greatly. On the left-hand side here, you can see pictorially the number of patients in each of these disorders, and you can see that this is a very large number of patients. This is reflected on the right in script numbers, with today's market being about 68 million scripts. Presently, we address about 50% of that, of the market of Rxs, and with an approval in MDD, that will open about 80% of the market to us. So to that end, we have a very comprehensive adjunctive MDD phase III program ongoing: Studies 501, 502, and Studies 505. These are all global, six-week, randomized, double-blind, placebo-controlled, multicenter clinical trials in adult patients with MDD, who are having an inadequate response to their antidepressant monotherapy. The primary endpoint is change in MADRS total score at week 6. The key secondary endpoint is change in CGI at week six. Each study has about 470 patients in it, randomized 1:1 to receive lumateperone or placebo, plus their antidepressant therapy. Additionally, we have a study called 503, which is an open-label, rollover study to assess safety for six months, and patients have been rolling over into that study, and, that study has gone very well as well. So I know everybody's interested in our readouts for these studies, and we are on track for top-line data readouts in Q1 for Study 501, and in Q2 for Study 502. We're also continuing to build value creation through the advance of our pipeline. So to start with, I've just told you about lumateperone and adjunctive MDD. We also have studies beginning phase III studies in pediatric indications for lumateperone, and we have earlier stage programs with our long-acting injectables. For the rest of my presentation, I'm gonna just focus for a couple of minutes on our earlier stage pipeline. In our earlier stage pipeline, we're advancing multiple pipeline programs, and I'll start with 1284. 1284 is a deuterated form of lumateperone, and we have several programs there. One is generalized anxiety disorder and psychosis with patients with Alzheimer's disease, and in agitation in patients with Alzheimer's disease. The programs have opened, but patient enrollment, we expect to begin in the first half of 2024. We also have a PDE1 platform. Our PDE1 inhibitors are being developed to treat diseases where PDE1 is overexpressed. If you have PDE1 expression, nothing happens. If it's overexpressed, that leads to pathologies, and we make these inhibitors to block that expression and treat different diseases. We're presently in a phase II development program for Parkinson's disease, and we also have another molecule called 102 for cancer immunotherapy program, with phase I studies ongoing. Importantly, what ties everything together in the PDE1 platform is the anti-inflammatory responses that we've been measuring in other studies. We continue to measure that, and we think that the effects of neuroinflammation, and in fact, inflammation in the periphery, is very important to many of these disorders, and we think that these PDE1 inhibitors can address that. We also have a program called ITI-333. This is a 5-HT2A antagonist and a mu-opioid receptor partial agonist that provides potential utility in the treatment of opioid use disorder and pain. We have a multiple ascending dose study and positive positron emission tomography or PET study that are ongoing. We have our platform called ITI-1500. This is a portfolio of non-hallucinogenic psychedelics with potential to treat mood and other neuropsychiatric disorders, without the liabilities of hallucinations and cardiac valvular pathologies of known psychedelics. We're very excited about this program. We've been working on this program for about, you know, somewhere between three and four or five years, and, we're looking to enter the clinic late this year or early next year, with the lead molecule, 1549. So in summary, Intra-Cellular Therapies, we've had a very successful year in 2023 of successful and execution. We've had exceptional Rx growth, we've had positive clinical study results, and we have multiple development programs progressing. We continue our value creation, driving growth for CAPLYTA, positioning CAPLYTA across multiple mood disorders. We're building for the future, expanding into additional neuropsychiatric conditions with our robust pipeline, and we're in a strong financial position with robust revenue growth and a strong cash position and no debt. So that's a short overview of ITCI, and I think now I'll hand it back to Jessica for our Q&A. And I guess I'll stay standing. Thanks for that presentation. As a reminder, if you want to ask a question in the room, someone will bring you a mic, or you can always use the portal. But I'll start off. I guess, maybe just at a high level, can you talk a little bit about how you're thinking about CAPLYTA's sales trajectory in 2024? Yes. I can see you smiling. That's right. I, one good thing about a mask is sometimes people can't see my facial expressions. However, you can't see Mark—so why don't I turn it over to Mark? Yeah, sure. As you saw in the presentation, 2023 was an exceptional year of growth, growing total prescriptions 85% year-over-year, and we expect that strong growth to continue throughout 2024. We're doing that both by expanding our prescriber base, adding thousands of new first-time prescribers of CAPLYTA each quarter-over-quarter. And at the same time, we're increasing the depth of prescribing across that entire prescriber base. So in my experience, those two indicators are very strong indicators of continued future growth. We have very comprehensive promotional programs directed towards both the professional audience, with physicians and nurse practitioners, as well as our consumer audience. And I guess I would just highlight three key drivers of growth as we go from 2023 into 2024. Earlier in 2023, we had added 50 new sales representatives. It takes a little while for them to get fully optimized in their territory. They're now fully optimized. We were beginning to see some of that impact, felt most strongly in the fourth quarter, and we expect that full impact in 2024. Similarly, on the access side, towards the end of the year last year, at the beginning of the fourth quarter, we negotiated a decrease in restrictions on CAPLYTA with two of the largest Medicare Part D payers in the space, moving them from a prior authorization and two generic steps to unrestricted status. So again, we saw some impact of that in the fourth quarter, but we expect the real impact, full impact of that, to be enjoyed in 2024. Lastly, really since our days in schizophrenia and then continued in bipolar depression, we've been consistently running a comprehensive DTC campaign. We'll continue to do that. We've gotten very favorable results from that, and we'll look to refresh our DTC campaign during the course of the year this year. So we think all of those things point to another very robust year of growth in 2024. What's the feedback you hear from providers when they reach for CAPLYTA for their bipolar depression patients? Yeah, it's really all the things that Sharon touched on in her presentations. And like with most things, it all starts with efficacy. And as Sharon noted, in bipolar depression, we're the only antipsychotic that is approved for both bipolar I and bipolar II, both as monotherapy and as adjunctive therapy, and we have the supporting efficacy data across all of those patient populations and treatment uses. So that's really where it all starts. CAPLYTA has a very favorable safety and tolerability profile, whether you're talking about on the metabolic side, where changes in cholesterol and glucose and weight are all comparable to placebo, or on the movement disorder side, where EPS and akathisia is also comparable to placebo. So physicians really appreciate that added safety and tolerability. And lastly, the convenient once-daily dosing that requires no titration. The real benefit for physicians that we hear from them is that they can start the patient at the effective dose. They don't have to wait several weeks to titrate them up to get to the effective dose. So all of those things which were demonstrated in the clinical trials are playing out in the real world, and that's always a very encouraging sign as you're launching a product, and that's really the feedback that we get back from physicians. I can just add a little bit of color to what Mark just said, and that is, for those who have followed our journey, some of you may know there was some skepticism about the no-dose titration needed. To that end, probably COVID helped us. Hmm. And that's because during COVID, you know, docs couldn't see the patients, et cetera. They kept thanking us that they weren't getting phone calls late at night: "What do I do here? Do I titrate them up? Do I titrate them down?" Because they weren't having any motor side effects. They weren't having any issues with CAPLYTA. It was effective on the first dosing. And so it really got doctors very comfortable with not having to fiddle, which is what many of them were very accustomed to doing. So we're very pleased with that, and I think that's very important, and I think we might be the only ones who have no fiddling necessary. Do you guys have an estimate for what proportion of CAPLYTA sales are coming from schizophrenia at this point? We do. Like all of the antipsychotics who have a schizophrenia indication and then have at least one or both of the mood disorders, bipolar depression or MDD, the vast majority of sales and prescriptions come from the mood disorders. So, if you look back historically at other antipsychotics, it's below 20%, getting down to about 15%, and if they have MDD and they have bipolar, it gets down probably closer to 10% for schizophrenia. For us, at the stage that we're in right now, it's probably around 20% of our business comes from schizophrenia, but that's declining as bipolar depression grows. Schizophrenia remains a very important disease area for us. There's a lot of unmet needs. Certainly, it's important for patients, and we continue to grow our business there. But the real explosive growth that you saw on the slides that Sharon was presenting is really coming from bipolar depression, and that's causing the schizophrenia portion to decline and the bipolar depression portion to increase. Got it. Plus, in schizophrenia, the nature of the disease is they cycle through these drugs more frequently than in other indications. So they cycle through all the generics, they cycle through all the branded agents. So that is, in part, due to the nature of the disease and the perception by the patients of the disease. So we'll continue... As Mark said, schizophrenia continues to be an important disorder, but as he said, the explosive growth is really in the mood disorders. Got it. What about gross to nets for CAPLYTA in 2024 relative to 2023? Are there any reasons to expect it to change, and how are you thinking about the eventual, like, steady-state gross to net, if that exists? Yeah. Yeah. So, on our last earnings call, which was for the third quarter call, we had reaffirmed that the quarter was in the low thirties for gross to net, and for the fourth quarter, we expected to remain in the low thirties. Although, with the addition of these two contracts moving to unrestricted status, we expected the gross to net to increase slightly, but remain in the low thirties, and we still expect that to happen. For 2024, we will be providing guidance for that on our fourth quarter earnings call. But what I would say is don't expect a major change in our strategy that would lead to some major change in our gross to net for 2024. I guess you mentioned the, you know, negotiating down coverage restrictions for CAPLYTA. Mm-hmm. Are you gonna try to continue improving access with other plans this year? Yeah. On an individual basis, we'll always look at individual payers, where there exists a situation that if we believe we can drive significantly more volume by reducing restrictions, that offsets the rebate that we would have to pay, then that's a decision that we'll take. We're not averse to our gross to net moving up slightly if it's gonna lead to a lot more volume. So, for example, those two large Part D payers that we contracted with at the beginning of the fourth quarter, we took a look at that situation. We felt we could drive significantly more volume, and that would offset the increase in the rebate, and so we took that decision and executed those contracts. I would say there's some of those opportunities, probably not a lot of them, so it's probably around the margins, and that's why I say don't expect a real major change in any of our market access strategy or anything that would lead to a significantly higher gross to net for 2024. Maybe turning to IP, can you just remind us of CAPLYTA's intellectual property position? Sure. So we have Orange Book protection right now through 2039. We have other patents that would be added to the Orange Book with a successful label expansion for MDD. As you know, we also got a patent extension on our 839 patent, which is a very strong patent covering any formulation, any for any product that contains lumateperone structure in it. So we think that's very strong in nature, and that one is through mid-2033, with pediatric extension, would be into 2034. But again, the Orange Book listings go into 2039. So maybe turning to kind of clinical development, I think we've seen multiple data points supporting CAPLYTA's impact on depressive symptoms. How confident are you in the readouts for the adjunctive MDD studies? You know, that's a double-edged question for somebody who's very superstitious because we are very confident. However... That's why it's a double-blind, placebo-controlled study. I'm gonna ask Suresh, as our Chief Medical Officer and the Head of Clinical Development, to opine first, and then maybe I'll fill in something. So how confident are you, Suresh? In terms of the adjunctive MDD studies, we have demonstrated, first from the mechanism of action, the multiple mechanism of action, both the 5-HT2A antagonism, the SERT inhibition, indirect effects of D1 on AMPA and NMDA, plays a role in the mood disorder space. And then from a demonstration in clinical trials, in our first studies, where we have shown in schizophrenic patients who had comorbid depression, both patients who are on antidepressants and who are not on antidepressants, that's a small cohort of patients who had both schizophrenia and depression, they improved on their depressive symptoms. Next line of evidence would be the bipolar depression studies, the Bipolar I and Bipolar II, where we demonstrated in the major depressive episode within bipolar depression, patients have shown efficacy in both adjunctive treatment with lithium or valproate and also monotherapy. Recently, this year, we talked... Sorry, last year, we talked about presented the results for mixed features, both in bipolar depression with mixed features, as well as the MDD with mixed features. So multiple levels of evidence demonstrates our confidence in adjunctive MDD studies. Right. And what all of these studies have in common is a major depressive episode, and that's why we believe that we can be the go-to choice as a drug for the treatment of any of these mood disorders. If one or both of the near-term adjunctive MDD trials isn't positive, I'm kinda asking you to speculate here a little bit, but what, what do you think the most likely reason would be? Placebo response. Historically, that's been the case, placebo response. I think we're very confident that the drug actually treats major depressive disorders. And the only thing that you can't control to the nth degree is your placebo response, and of course, we do whatever we can. But I think that anyone who tells you they've got that all solved, best of luck to them. We try. What about if one of those two near-term adjunctive trials hits, and one is, say, like a near miss? Is there any scenario where you could potentially file for a label expansion prior to the third study reading out, maybe, like, supported by the mixed features results? Yes. I think, of course, what we would do is talk to the FDA about it. But I do think that what the FDA does is they take into account the totality of your development programs. And so, of course, if you miss on one of your studies, it depends why you missed, and it depends how much you missed by. But there certainly is precedent. If you look at brexpiprazole as the most recent example in this space, they had one study that worked, was robust, and one study that missed. And the FDA did look at the totality of the evidence, for that program, for the- for that product, and they did give them an approval. So I think it really depends. I think the fact that we have these very robust results in the mixed feature studies, can only help us. It can't hurt us. How should we think about the timeline for data from that third trial that you're running? Yeah. So the third trial will be about a year after the second trial reads out. I have a feeling you're not gonna wanna speak to this one, but, you know, you talked about kind of annualizing over the, sales force expansion and how that would contribute to top-line growth. What about, what's the right way to think about SG&A and R&D spend in 2024? You know, our answer is that we'll give you the guidance when we do our year-end call. I, I think, we haven't given you 2024 guidance yet. I don't know, Mark, if you wanna add anything to that. No, I think that's right. We'll, we'll lay everything out on our fourth-quarter earnings call. Okay. And maybe lastly, you know, you think you flashed up the, kind of the pipeline beyond CAPLYTA. Can you talk about what milestones investors should look forward to for the rest of your pipeline over the course of the year? Sure. So starting with 1284, I would tell you that, our starting to enroll patients, would be a milestone there. In the PDE1 program, the completion of enrollment, towards the end of the year, with the readouts in early 2025, would be a milestone there. With 1500 series, which are the, non-hallucinogenic psychedelics, I think you can expect to see, more scientific presentations there, as well as, entering a clinical study in late 2024 or early 2025 there. And I think we'll also have some other programs that we'll be, rolling out for you this year that are early stage, but will be just, in their IND-enabling studies to enter clinical trials in 2025. Great. Great. If there's no other questions, we'll leave it there. Thank you. Thank you. Thanks, Jess. Thank you.