Good morning, everyone. My name's Jessica Fye. I'm the Large-Cap Biotech Analyst at JP Morgan, and we're delighted to be continuing the conference today with Intra-Cellular. Good news is you don't have to switch rooms for Q&A. I'm gonna be running the Q&A session at the end of Sharon Mates' presentation. If you wanna submit a question to the portal, I got an iPad up here. You can just shoot it over to me, and I will ask it. With that, let me turn it over to Intra-Cellular's CEO, Sharon Mates. Thank you, Jessica. It's a pleasure to be here today. I'm joined here today with our Chief Commercial Officer, Mark Newman, and our SVP and Head of Clinical Development, Willie Earley, and during the Q&A, they'll come up here and be on the podium to answer any questions. Before I start, my presentation today contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ, and I refer you to our website and to our SEC filings for continuous updates. Hey, haven't seen you in a long time. Nice to see you. It's nice to see all these faces that I haven't seen in a couple of years. Intra-Cellular Therapies is today a fully integrated biopharmaceutical company. Our mission has been to deliver innovative treatments to improve the lives of individuals with neuropsychiatric, neurologic, and other disorders to reduce the burden on patients and their caregivers. We have been fulfilling our mission, and in doing this, we've had a successful commercial launch of CAPLYTA. We're strongly positioned for future growth. We have a robust pipeline, and we're in a strong financial position. Let me start by telling you about CAPLYTA. CAPLYTA is approved for the treatment of schizophrenia and Bipolar I and II depression in adults. CAPLYTA has a proven efficacy and a very favorable safety and tolerability profile. This safety profile is similar to placebo in that in Extrapyramidal symptoms and changes, including Akathisia, are similar to placebo. Weight, fasting glucose, total cholesterol, triglycerides, and mean changes in Prolactin as well. There's convenient dosing. It's once daily, with or without food. Importantly, you can start and stay on the same dose with no dose titration required. An effective dose is given starting on day one. This compelling product profile has resonated with physicians and the prescribing community. You can see on this chart the strong commercial execution. Moreover, I don't have a pointer. You can see we launched in March of 2020 with a label for the treatment of schizophrenia. We received bipolar depression approval. Following that, you can see a substantial Rx inflection following bipolar depression approval in December of 2021. In fact, in 2022, our Rx volume tripled. Let me tell you about bipolar disorder. This is a chronic disease with a substantial burden and unmet need. There are approximately 11 million adults affected by bipolar disorder in the U.S. Depressive episodes are longer and recur more often than manic, hypomanic episodes and can be severely debilitating. There are a few drugs approved for Bipolar I depression, CAPLYTA is one of only two drugs approved for Bipolar II depression. This is important because Bipolar II depression is underdiagnosed and has greater symptom burden than Bipolar I. Patients with Bipolar II experience a higher frequency of depressive episodes that last longer, are more likely to have comorbid psychiatric disorders, and have a higher risk of death by suicide. It's important to note that Bipolar I and Bipolar II disorder patient populations are of similar size. This presents an opportunity to be expanding, treating Bipolar II patients in particular, along with Bipolar I patients. CAPLYTA is approved for this broad range of adult patients, and you can see here comparison to the other product labels, for the treatment of depression, with CAPLYTA having the broadest label, both for monotherapy and adjunctive therapy for both Bipolar I and Bipolar II disorder. Our long-term growth strategy is anchored in three strategic pillars. First, to maximize CAPLYTA performance. Second pillar, to expand CAPLYTA label and additional mood disorders. Three, to advance our pipeline. Let me start with the first pillar, to maximize CAPLYTA performance. We're driving continuous growth with robust prescriber and consumer promotion. On the prescriber promotion side, we're educating 43,000+ prescribers, including psychiatrists, NPs, PAs, and primary care. We do this through experienced sales specialists, peer-to-peer medical education programs, and a robust digital promotion. We also have a consumer promotion through broad national advertising through television and social media platforms. Some of you may have seen our recently launched new DTC and digital campaign to enhance awareness for the 11 million adults with bipolar disorder. We have strong market access positions with over 98% of Medicare and Medicaid lives covered. We also have about 85% of commercial lives covered, and we expect this to grow to approximately 90% in the coming months. We have a very effective patient support program that we call LYTAlink to support the commercial side. Our second pillar is to expand the CAPLYTA label and additional mood disorders. Lumateperone programs extend across multiple major neuropsychiatric conditions. I've just told you about our approved indications for schizophrenia and bipolar depression that both address very large markets, with bipolar addressing about 11 million patients, in schizophrenia about 2.4 million patients. We're now expanding those indications to the adjunctive treatment of major depressive disorder or MDD, which afflicts approximately 21 million patients, and MDD or bipolar depression with mixed features. Here, about a third of patients with MDD and bipolar depression exhibit mixed features. We also have a long-acting injectable program for the treatment of schizophrenia. Let me just tell you a little bit about some of these programs. The adjunctive treatment of MDD. We have two phase III adjunctive treatment studies ongoing, Study 501 and Study 502, are global double 6-week randomized double-blind, placebo-controlled, multicenter clinical trials in adult patients with MDD who are having inadequate response to antidepressant monotherapy. The primary endpoint of these studies is change in MADRS total score at week six, and key secondary endpoint is change in the CGI-S. We also have a study looking at patients with bipolar depression or MDD who exhibit mixed features. Mixed features is a large patient population with about 1/3 of patients with MDD and bipolar depression exhibiting mixed features. These patients are depressed and exhibit manic symptoms below the clinical threshold for mania, hypomania. They respond poorly to antidepressants, have greater symptom severity, and more comorbidities with a higher risk of suicide attempts. In MDD patients, it is significant risk factor for the development of Bipolar I, Bipolar II disorder. Study 403 is examining lumateperone 42 milligrams as a monotherapy in patients with bipolar depression or MDD with mixed features. The primary endpoint here is change in MADRS total score at week 6, and the key secondary endpoint is change in the CGI-S. Our third pillar is the advancement of our pipeline. And today I'm gonna tell you about our three clinical stage pipelines. First is ITI-1284. This is a deuterated form of lumateperone, and it's formulated as an oral disintegrated tablet for sublingual administration. A phase II program in agitation in patients with Alzheimer's disease is set to begin the first half of this year. We have two other programs that we will be initiating this year as well, one in generalized anxiety disorder and one in psychosis in patients with Alzheimer's disease. Both of these are slated to begin this year. Our second platform is our PDE1 inhibitor platform. This portfolio of PDE1 inhibitors are being developed to treat diseases in which PDE1 activity is highly active. Lenrispodun, which used to be called ITI-214, our lead PDE1 inhibitor, is in phase II development for Parkinson's disease. Our newest candidate within this platform, ITI-1020, is slated to be testing for cancer immunotherapies. An IND has been filed, and a phase I program is anticipated to commence first half of 2023. Our third platform in clinical development is ITI-333. This is a 5-HT2A antagonist and mu-opioid receptor partial agonist, which provides potential utility in the treatment of opioid use disorder, pain, and mood disorders. We have neuroimaging studies ongoing. We've completed a single ascending dose study, a multiple ascending dose study will start shortly in Q1 2023. To put all this together, our portfolio is anchored in our approved product, CAPLYTA, for schizophrenia and bipolar depression, lumateperone, which is in development for major depressive disorder as adjunctive therapy for MDD and bipolar depression with mixed features and a long-acting injectable program. Our 1284 ODT SL for agitation in patients with Alzheimer's disease, psychosis in patients with Alzheimer's disease, and for generalized anxiety disorder. Our PDE inhibitors, where we have a study ongoing in 214 in Parkinson's disease, we have 1020 for cancer immunotherapy and ITI 333 for opioid use disorder, pain, and mood disorders. Lastly, we're in very strong financial position. We have the CAPLYTA revenues, our trajectory has been growing very nicely. Through Q3, our revenues were $162 million, the Q3 2022 net revenue growth was 233% versus Q3 2021, and was a 30% growth over Q2 2022. Additionally, we ended our nine months with about $630 million in cash equivalents, and investment securities, we have no debt. We're very confident in our trajectory for CAPLYTA. We're looking forward to this year. With that, I think we can open up for Q&A and ask Mark and Willie to come on up to the podium. M aybe I'll just say standing here. There's also only three mics. Great. As a reminder, feel free to submit questions electronically, and I can read them off the iPad. Maybe just to start, can you elaborate a little bit more. I know we saw the nice script chart. Can you talk more about CAPLYTA's launch in bipolar depression in 2022 and how you're thinking about the sales trajectory in 2023? Basically, can you keep up this level of momentum? Can I take that, Sharon? Please do. Thanks, Jess. As you saw, 2022 was an exceptional year for CAPLYTA, as we launched the bipolar depression indication. We sustained a very high level of robust growth throughout the year. You saw the trajectory on the graph through the fourth quarter. We feel like we have a great deal of very positive momentum going into 2023. We have a high degree of confidence that we'll continue to be able to execute commercially and drive continued robust growth in 2023 and in years beyond. What's the feedback you're hearing from providers on why they reach for CAPLYTA for their bipolar depression patients? As you saw from what Sharon presented, we have a very compelling product profile in bipolar depression. The feedback that we get from physicians is overwhelmingly positive. They cite the proven efficacy in both schizophrenia and bipolar depression, the favorable safety and tolerability profile. Some of the specifics that Sharon had shared with you are what physicians tell us that they really value and really resonate. Whether you're talking about changes in weight, changes in metabolic parameters, movement disorders, the CAPLYTA profile is comparable to placebo with each of those, and that's a very differentiated and compelling safety and tolerability profile. In addition to that, we have a convenient single 42 milligram dose that really resonates with physicians as well. I think the other thing that's very important, very rewarding to us is that physicians consistently tell us that their experience with their patients is very consistent with the data that we talk to them about that come out of our clinical trial programs. When you're launching a new product, or a new indication, like in bipolar depression, it's extremely important that their experience, their own experience mirrors the data that came out of the clinical trials, and that's very much the case for CAPLYTA. I would just say overwhelmingly positive feedback on the profile. I would just add to that, I was recently at ACNP, a medical meeting, and another medical meeting before that, where a lot of physicians who are prescribing CAPLYTA were there, and they just had overwhelmingly positive things to say. I'm not allowed to promote, so I'm not allowed to tell you exactly what they were saying but it was, it's been really, really positive and very rewarding for people coming up to us. It is not often that out in the field, once a product has been launched and being used in thousands of patients, that you actually see the same profile that you saw in your clinical trials. We're very, very pleased about that. How do the market dynamics compare? Maybe compare and contrast kind of the market dynamics for CAPLYTA in schizophrenia relative to bipolar depression. There are some similarities and several important differences, I would say. Both indications, both schizophrenia and bipolar disorder, are important indications for us. Both represent patients with serious mental illness and a very significant remaining unmet medical need. Both represent significant opportunities for CAPLYTA. The differences are schizophrenia is the smaller of the two patient populations. There's about 2.4 million US adults with schizophrenia. The majority of those patients are government beneficiaries, so they utilize Medicare and Medicaid for their prescription benefit. With bipolar disorder and bipolar depression specifically, it's a much larger patient population, about 4x-5 x the size of schizophrenia. There's about 11 million US adults suffering from bipolar disorder. There are far many more, commercially insured, patients with bipolar disorder due to the nature of the disorder. What I would also say is in bipolar, the competitive set, is somewhat different than schizophrenia, where there are far fewer approved medications for bipolar disorder and specifically for bipolar depression. In bipolar depression with CAPLYTA, we have the broadest range of indications for bipolar depression, covering both Bipolar I and Bipolar II for both monotherapy and adjunctive therapy. There's a very significant opportunity for us in bipolar depression. How are you guys thinking about CAPLYTA's gross to nets in 2023 relative to 2022? Maybe even kind of within that, are there any reasons to expect fluctuations in gross to net quarter by quarter? I'll start just by saying I'm laughing behind this mask because we knew you'd ask this, and we have not yet given you guidance for 2023. We'll do that on our Q4 call. For right now, we'll stick to 2022 and where we have guided you to in the low 30s, and that has been the case. I think you will see fluctuations in the marketplace. We did not see that with schizophrenia very much because as Mark said, this is primarily a public market, and 70%-85% of the market is Medicare, Medicaid, unlike for bipolar disorder, where you have a commercial market as well. With the commercial market, you will see fluctuations more in the first quarter than in other quarters. Mark, do you wanna add to that? No, I think that's good. Can you talk about the market opportunity in adjunctive MDD and when we can expect the phase IIIs in that setting to read out? I'll start with what we've said about adjunctive treatment in MDD. What we've guided you to right now is a 2024 filing. I think as we get closer to the time, we'll talk about the readouts. Maybe, Willie, do you wanna talk about the unmet need in MDD and why we're so excited about adjunctive treatment in MDD? Sure. As you may be aware, a major depressive disorder represents about 20 million people are affected with the illness in the United States. Of that, although there are a number of antidepressants approved for treatments, about anywhere between one half to two-thirds of the patients fail to respond to antidepressants alone. When that occurs, the physician usually adds, there are now four agents approved for the treatment as an adjunct, as an add-on for those patients who failed to respond initially. We believe that our profile, if it proves to be similar to the profile that we've already exhibited or demonstrated in schizophrenia, in bipolar depression, will add another treatment possibility for patients who are suffering from major depressive disorder who fail to respond to antidepressants alone. We hope, and we plan, we are on course, to have submission in 2024. I've asked you this before. Would you consider starting a third trial in adjunctive MDD as insurance in the event one of the ongoing phase IIIs doesn't work out? We would consider it. We are considering it. We haven't made any final decisions. We'll let you know as soon as we do. What represents a clinically meaningful benefit in adjunctive MDD? I think it sounds better coming from a psychiatrist, so. As you are aware that, with the historic data that's out there, the antidepressants usually show change of around 2 to 4 on the MADRS or the HAM-D, whichever scale has been utilized. In the adjunct paradigm, they tend to be on a lower side, around 2, or some have even shown a little less than 2. We expect a similar finding, with our program as well. Do you guys think of the data from the upcoming Mixed Features trial as reading through to the adjunctive MDD trials in any way? If so, why? If not, why not? Willie? Would you like me to answer that? Again, the mixed features population is different from the adjunct MDD population. There are several differences. First of all, the adjunct MDD population is at an adjunct paradigm, where patients, as I said earlier, who fail to respond to antidepressants, the lumateperone is added to that regimen. In the mixed features paradigm, this is a monotherapy discussion or monotherapy design. Those patients are also, they have depressive episodes, but they have features, as we know that anywhere between 25% - 35% of patients who have depression exhibit features of the opposite pole, subspecial features of the opposite pole. We call those now mixed episodes. That's the population that we're targeting for the mixed episode study. We're looking at mixed episodes in both MDD as well as bipolar depression. We hope to identify patients. I mean, we have got conducted the study, and we hope to be able to show a difference between the use of lumateperone in this population. We know now that there are no current treatment currently approved for mixed features in depression. While there are several agents approved for mixed features in bipolar mania, mixed depression, there's nothing there. We hope to have ongoing discussions with the FDA once our data is read out. Can you also remind us of the IP protecting CAPLYTA and how long it extends? Sure. Our Orange Book lists patents that range between 2028 and 2039. We're very confident in this patent portfolio. Additionally to what's in the Orange Book, we have a list of patents and a family of patents that really builds your picket fence, and that protects you from having allowing other people to come into the space. These patents cover, collectively, everything from anything with lumateperone and the molecule and formulations and salts and crystals and administration and formulation. It's a very, very broad patent portfolio, so we're confident in our IP. Can you also talk about the, switching to the pipeline, the progress you've made with the long-acting injectable lumateperone program, and have you made any decisions on the formulation and injection site that are gonna enable you to move forward? Great. Let me tell you a little about that program. We started this program to have a 1-month formulation for the treatment of schizophrenia. We have since decided that really you want to be able to have more than a 1-month formulation. You wanna have a 1-month and a 2-month formulation. The formulation we had been testing, we know will, in all likelihood, not be a 2-month formulation. We've been doing a series of different studies, these are preclinical studies now, looking at different formulations, different vehicles, different methods of delivery. We have now finished those studies, and we will expect to be able to tell you what we've come up with by our year-end call, and move along in the program. What about for ITI-1284? You touched on this in the presentation, but what are the next steps for that product? Right. We're very excited about the ITI-1284 program. Our next steps will be the initiation of a study in agitation in patients with Alzheimer's disease that will start the first half of this year. We'll also be starting studies. We haven't spoken about this before in generalized anxiety disorder. Maybe I can ask Willie to tell you a little bit about it after I just say the third indication that we'll be testing is in psychosis in patients with Alzheimer's disease later this year as well. Willie, you wanna just tell what the market opportunity is in generalized anxiety disorder and why we're excited about these studies? Sure. As you may be aware that, anxiety disorders represents some of the most common psychiatric illnesses that we face. Generalized anxiety disorder represents about a little less than 3% of the population. It's estimated around 2.7 or so. Although there are approved medications, the first line of treatment are antidepressants. There are four of them approved. About 50% of the patients fail to respond to antidepressants alone. When that occurs, doctors are often left with using benzodiazepines, which, while they're effective, they have the potential for dependency and abuse. It's not the preferred option. We believe that CAPLYTA, ITI-1284, the deuterated form of lumateperone's profile that specifically the 5-HT2A mechanism may have potential in helping with those patients with anxiety who fail to respond to antidepressants alone or possibly even as a monotherapy. We're looking at the population in generalized anxiety disorder. This represents about little less than 3%, which is about 7 million people in the U.S. Then if you look at the lifelong exposure to GAD, it's more around 6%, which is about double that population, about 14 million. You're looking at your PDE1 inhibitors, not just for Parkinson's, but also in antitumor settings. Is there a reason you're diversifying into oncology, and should we think about this as maybe a potential licensing opportunity in the future? I'll work backwards, the answer is yes. If our first studies are successful, we would look at licensing opportunities for oncology. Let me just start with why did we go here? We went here because this is where the science took us. PDE1 is an enzyme that in a normal state, it's not active. It's called an on-demand system because it's only active if there's a problem in the tissue. We have been studying PDE1 for many years now. Our first molecule in the series, ITI-214, w e've seen utility in animal models, in cognition, in preventing movement disturbances. Then we started, we've also seen where it is immune modulating, so which is what led us into the cancer arena. It is a really diverse platform with much utility. I think that what we've seen in the brain is the effect on macrophages and what we see on glial cells, sorry, and in the periphery on macrophages. That is what led us to the oncology area, both within the brain and outside the brain in the periphery. For ITI-333, can you describe for us the mechanism of action and talk a little bit more about just where you are with that program and the next steps? Sure. ITI-333 is a program that we believe has utility in both opioid use disorder as well as in pain. Our first indication here is an opioid use disorder. It has been funded by the NIH. And we have again been doing a series of phase I studies, and we will shortly start this quarter a multiple ascending dose study. The mechanism of action here is a 5-HT2A antagonist and a new opioid partial agonist. We think this lends to transition from addiction to health and that the use of ITI-333 can be beneficial to these patients. Switching to our financial questions. What's the right way to think about SG&A investment in 2023? Even you're laughing. I think we're not gonna give you guidance for 2023. T hat we will do that on our Q4 Call. We have told you just to give you some frame of reference, that our spend for 2022 would be up to $500 million. On a GAAP basis, our operating expenses have been $379 million. I think that was through nine months of 2022. I think that you'll hear more in our Q4 call. And similarly, w hat's the right way to think about R&D in 2023? Just particularly assuming we're approaching the conclusion of these big adjunctive MDD studies, is it possible R&D like declines after that? I would not count on that. We do have a lot of programs either ongoing that are advancing, and new programs starting. I would certainly not decrease R&D for 2023. Well, we are just about out of time, we will leave it there. Thank you. Great. Thanks very much.