Good morning, ladies and gentlemen, and welcome to the Intra-Cellular Therapies second quarter earnings call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If you would like to ask a question, please press star one on your telephone keypad. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, today's conference is being recorded. I would now like to turn the conference over to Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Thank you. Please go ahead. Good morning, and thank you all for joining us on the call today. Our earnings press release provides a corporate update and details of the company's financial results for the second quarter ended June 30, 2022. The press release crossed the wire earlier this morning and is available on our website at intracellulartherapies.com. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer, Mark Neumann, Executive Vice President and Chief Commercial Officer, Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer, and Larry Hineline, Senior Vice President and Chief Financial Officer. As a reminder, during today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety, and intended use of the company's product development candidates, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and results of ongoing and future clinical trials, plans regarding regulatory filings, future research and development, our plans and expectations regarding the commercialization of CAPLYTA, the potential impact of the COVID-19 pandemic on our business, and possible uses of existing cash and investment resources. These forward-looking statements are based on current information, assumptions, and expectations. Those are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You're cautioned not to place undue reliance on these forward-looking statements, and the company disclaims any obligations to update such statements. I will now turn the call over to Sharon. Thanks, Juan. Good morning, everyone. Today, I am pleased to share with you our second quarter results. We will update you on the strong performance of CAPLYTA following our launch in bipolar one and bipolar two depression, as well as the progress in our clinical development programs. We are pleased to report that total revenues for the second quarter 2022 were $55.6 million compared to $20 million for the same period in 2021, representing a 178% increase. CAPLYTA net product revenues for the Q2 2022 were $55.1 million, representing a 190% increase over the same period in 2021 and a 58% increase over the first quarter of 2022. Larry will provide additional details on our financial performance in his remarks. Our commercialization of CAPLYTA continues to go extremely well. Following the FDA's approval of CAPLYTA for bipolar depression in late December 2021, we have seen tremendous enthusiasm from healthcare professionals, which has been reflected in our strong prescription growth. In the second quarter, CAPLYTA new and total prescriptions increased 225% and 191% respectively versus the same period in 2021. Second quarter 2022, CAPLYTA new and total prescriptions increased 55% and 51% respectively versus first quarter 2022. In addition to continued increases in CAPLYTA prescriptions, we have received highly positive feedback from healthcare practitioners regarding the strength of CAPLYTA's clinical profile, including both the efficacy and safety profile and the positive experience their patients are having on the medication. We are proud to be helping a growing number of patients manage their bipolar disorder. CAPLYTA is the first and only treatment indicated for depressive episodes associated with bipolar one or bipolar two disorder in adults as monotherapy or as adjunctive therapy with lithium or valproate. Prior to CAPLYTA, there was only one medicine approved for bipolar two depression and only as monotherapy. We are pleased to have seen such a significant uptake of CAPLYTA to treat both bipolar one and bipolar two disorders that have a similar patient population size. We have also seen an increase in CAPLYTA prescriptions for the treatment of schizophrenia. Mark will further elaborate during his comments. CAPLYTA's profile makes it an important medicine for patients. CAPLYTA interacts with key neurotransmitter systems believed to be involved in major neuropsychiatric conditions, including depressive disorders. Although the mechanism of action of lumateperone is unknown, the modulation of the dopamine system coupled with 5-HT2A antagonism, serotonin reuptake inhibition, and indirect interaction with the glutamate system offers distinct pharmacologic characteristics relevant to treating mood disorders in addition to schizophrenia. There is a significant need for medicines that safely and effectively treat these disorders. In our clinical studies, CAPLYTA has shown consistent efficacy supported by a favorable safety and tolerability profile. In fact, changes in key safety metrics such as weight change, fasting glucose, total cholesterol, triglycerides, and EPS, including akathisia, were all similar to placebo. The pharmacologic properties and clinical results of CAPLYTA have led us to expand our programs beyond schizophrenia and bipolar disorder to include major depressive disorder, or MDD, and mixed features in MDD and bipolar depression. We are currently enrolling patients in our global phase III MDD studies to evaluate lumateperone 42 mg as an adjunctive treatment to antidepressants. To remind you, studies 501 and 502 are global double-blind placebo-controlled studies with approximately 470 patients in each study. The primary endpoint is change from baseline in the MADRS at week six. Additionally, study 503 is an open-label rollover study to assess long-term safety in this patient population. We expect to file a Supplemental New Drug Application with the FDA for approval of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD in 2024. I'll now discuss study 403, our mixed-features study. Patient enrollment is progressing well in this study, a large, well-controlled global clinical trial evaluating lumateperone 42 mg in patients with MDD and in patients with bipolar depression who exhibit mixed features. The primary endpoint of this study is change from baseline versus placebo on the MADRS at week six and changes in CGI-S as key secondary endpoint. A follow-up safety assessment is planned approximately two weeks after the last dose of study medication. We expect to complete clinical conduct in this study in late 2022. Following completion of data analysis, we expect to report top-line results in Q1 2023. Study 403 represents another opportunity to study the safety and efficacy of lumateperone in an area where there are important medical needs. During depressive episodes, roughly one-third of patients with unipolar depression and with bipolar disorder present with mixed features. Mixed features is defined by a patient having co-occurring subthreshold mania or hypomanic symptoms during their depressive episode. This clinical presentation is important to highlight as these patients have greater severity of illness, have higher rates of suicide and suicidal ideation, higher recurrence rates, and comorbidities. These patients are more difficult to treat than patients exhibiting classic depressive episodes and tend to respond poorly to antidepressants. The inclusion of mixed features specifier in the DSM-V underscores the recently recognized importance of this clinical presentation. During the quarter, we had multiple scientific presentations featuring CAPLYTA at prominent medical and scientific conferences. These meetings included the American Psychiatric Association Meeting, International Conference for Bipolar Disorders Annual Meeting, the American Society of Clinical Psychopharmacology, and the Schizophrenia International Research Society. I'll now highlight several of these presentations. At ASCP and ISBD, we presented further evidence of favorable metabolic profile of lumateperone. Rates of metabolic syndrome at baseline and at the end of treatment were similar between patients who received lumateperone or placebo. More patients who received lumateperone improved from having metabolic syndrome at baseline to no longer meeting criteria at the end of treatment compared with placebo. These and other results presented at these meetings highlight the favorable placebo-like metabolic profile of lumateperone and support its use in patients with bipolar depression and schizophrenia. At ISBD, we presented data demonstrating broad antidepressant effects of lumateperone as evidenced by improvements versus placebo across the 10 single items of the MADRS total scale, as well as a higher percentage of lumateperone patients versus placebo shifting from severe disease to moderate, mild disease or no illness. At ISBD and ASCP, we presented analysis highlighting marked improvements in functional disability and quality of life. Lumateperone statistically significantly improved the pre-specified secondary outcome measure, the quality of life enjoyment and satisfaction questionnaire short form total score from baseline to day 43 compared with placebo. In a post-hoc analysis, there were marked improvements with lumateperone in items representing the ability to function in daily life, family relationships, household activities, leisure time activities, mood, and overall life satisfaction. At the SIRS meeting, we presented additional safety analysis from our open label safety switching study evaluating lumateperone 42 mg in patients with stable schizophrenia. Data from this post-hoc analysis further support the favorable safety and tolerability profile of lumateperone 42 mg in patients with schizophrenia who switched from another antipsychotic, regardless of the previous antipsychotic. In addition, patients switching from risperidone, paliperidone, or olanzapine to lumateperone had significant improvements in cardiometabolic parameters and prolactin concentrations. We have also continued to advance other programs in our pipeline. We are working to develop long-acting injectable formulations of lumateperone that are effective, safe, and well-tolerated and last one month or longer to provide more treatment options for patients suffering from mental illness. We have completed the preclinical development of an LAI formulation, and we have conducted a phase I single ascending dose study with this formulation. This study evaluated the pharmacokinetic safety and tolerability of lumateperone long-acting injectable in patients with stable symptoms of schizophrenia. We are now exploring alternate sites of injection with this formulation, as well as progressing with other formulations. This will assist us in evaluating dosing strategies and formulation for our efficacy studies. Next is our 1284 program. ITI-1284 is a deuterated form of lumateperone, a new chemical entity formulated as an orally disintegrating tablet for sublingual administration. We are presently evaluating ITI-1284 ODT-SL in phase I studies, including drug-drug interaction studies. We expect to commence clinical conduct in phase II clinical trials in agitation in patients with probable Alzheimer's disease and dementia-related psychosis and in certain depressive disorders in the elderly in 2023. In our PDE1 inhibitor programs, we have completed or have ongoing phase I trials, including drug-drug interaction, bioavailability from scale-up batches, and food effects studies. We have initiated our phase 2 clinical program with lenrispodun for Parkinson's disease and expect to commence patient enrollment in the second half of 2022. We continue to investigate the anticancer effects of PDE1 inhibitors. At AACR, we presented preclinical data demonstrating the antitumor effects of PDE1 inhibitors when administered in conjunction with checkpoint inhibitor immunotherapy in an animal model of triple-negative breast cancer. We have now shown that our PDE1 inhibitors can potentiate the action of checkpoint inhibitors in various models of colorectal, kidney, breast, and glioblastoma cancers. Finally, our ITI-333 program for opioid use disorder continues to advance. Following the recent completion of our single ascending dose study, we have commenced a neuroimaging study to investigate brain occupancy for receptors that play a role in substance use disorder and have applicability for pain. The results of this study will support the dose selection for future studies. We ended the second quarter in a strong financial position with $679.2 million in cash equivalents, and investment securities, and we have no debt. In summary, we are pleased with our second quarter results and proud of our accomplishments. We look forward to CAPLYTA's continued market growth in bipolar depression and schizophrenia and to advancements in our pipeline. I will now turn the call over to Mark, who will provide additional details about our successful launch. Mark. Thanks, Sharon. I'm pleased to report that we continue to make significant progress. In the first six months of our bipolar launch, CAPLYTA new and total prescriptions have approximately doubled, and new patient starts, as reflected by new-to-brand prescriptions, are at five times the level they were just prior to our label expansion. Significant launch inflection that we saw in the first quarter continued throughout the second quarter in both new and total prescriptions, reflecting sustained and robust growth following CAPLYTA's approval in bipolar depression. Second quarter CAPLYTA new and total prescriptions increased by 55% and 51%, respectively, versus the first quarter. A broad patient population is using CAPLYTA, including patients diagnosed with both bipolar one and bipolar two. Prescribers are using CAPLYTA as both monotherapy and adjunctive therapy. An increasing number of newly diagnosed patients are initiating therapy on CAPLYTA, as well as those switching from other antipsychotics, including both branded and generic medications. While an increasingly larger portion of prescriptions are coming from bipolar depression, we are also pleased with the continued growth of CAPLYTA for the treatment of schizophrenia. CAPLYTA's robust performance has been driven by successful commercial execution, broad market access, and a strong clinical efficacy, safety, and dosing profile. In market research recently fielded with 300 healthcare professionals, these HCPs rated CAPLYTA as well-differentiated on the attributes of a broad bipolar depression indication that includes both bipolar one and bipolar two, low risk of metabolic dysfunction, low risk of weight gain, low risk of extrapyramidal symptoms, including akathisia, and ease of dosing with no titration required. In this research, a significant majority of physicians intend to prescribe CAPLYTA in the future. CAPLYTA maintained broad coverage in the Medicare Part D and Medicaid channels with greater than 98% of lives covered. During the second quarter, we further expanded coverage in the commercial channel to approximately 85% of lives covered. We expect this coverage to continue to increase in the coming months. We are also looking forward to launching two new dosage strengths for CAPLYTA, 10.5 mg and 21 mg, which were FDA approved during the second quarter of 2022. This will expand the patient population who has access to CAPLYTA, specifically for patients taking strong or moderate CYP3A4 inhibitors in patients with moderate or severe hepatic impairment. We anticipate these new dosage strengths to be available in pharmacies later this month. In closing, CAPLYTA is a very appealing option for prescribers and patients with bipolar depression and schizophrenia, and we are confident in our ability to drive continued robust prescription and revenue growth throughout the second half of the year. I will now turn the call over to Larry. Larry? Thank you, Mark. I will now provide a summary of our financial results for the second quarter ending June thirtieth, 2022. Total revenues in the second quarter grew to $55.6 million compared to $20 million in the second quarter of 2021. In the second quarter, we recorded net product revenue of CAPLYTA of $55.1 million compared to $19 million for the same period in 2021 and $34.8 million in the first quarter of 2022. This represents a year-over-year increase of 190% and a 58% increase over the first quarter of 2022. The second quarter of 2022 gross to net percentage was in the low thirties, consistent with our prior guidance. We expect CAPLYTA's gross to net percentage to remain consistently in the low thirties throughout 2022. Cost of product sales were $4.7 million in the second quarter of 2022 compared to $2 million for the same period in 2021. Selling, general, and administrative expenses were $100.3 million for the second quarter of 2022 compared to $69.9 million for the same period in 2021. This increase is primarily due to an increase in marketing and advertising expenses and labor-related costs. Research and development expenses for the second quarter of 2022 were $38.5 million compared to $17.3 million for the second quarter of 2021. This increase is due to higher lumateperone clinical trial and non-clinical related costs and an increase in non-lumateperone project costs. The net loss for the second quarter of 2022 was $86.6 million compared to a net loss of $68.7 million for the second quarter of 2021. Cash, cash equivalents, restricted cash, and investment securities totaled $679.2 million at June 30, 2022 compared to $413.7 million at December 31, 2021. In January 2022, we completed a $460 million public offering resulting in net proceeds to the company of approximately $433.7 million from the sale of 10,952,381 shares of our common stock after deducting offering expenses paid by the company. This concludes our prepared remarks. Operator, could you please open the line for questions? Thank you. The floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. If you would like to remove your question from the queue, please press star two. We do ask analysts to please limit themselves to one question to allow everyone the opportunity to ask their questions today. Once again, that is star one if you would like to register a question. The first question is coming from Andrew Tsai of Jefferies. Please go ahead. Hey, thanks and good morning. Ask on the outlook of the prescription trends. You know, maybe your touch points so far, whether you know, your sales reps have exhausted all the targeted physicians, or do you think you've barely scratched the surface and that you still remain in the early innings? Just curious if we can expect the trajectory to maintain or could scripts inflect even further over time? Thanks. Go ahead and take that. Yeah. So Andrew, yeah, thanks for your question. What I would say is we're very confident in our ability to drive continued robust growth throughout 2022, and remain bullish on the long-term potential for CAPLYTA. Our awareness levels continue to rise as we continue to further penetrate our target audience. The physicians in the market research that we've recently fielded recognize the differentiated profile that we have with CAPLYTA, and we continue to execute in a very strong way on our promotional activities. What I would say about the reach to our target audience is that we've been pleased with the significant progress we're making in reaching our target audience, and educating them on the clinical profile and the benefits of CAPLYTA in bipolar. I'd say we've reached the majority of the target prescriber audience, but we continue to make additional strides in furthering that reach, both with our in-person promotional activities with our sales force, with the virtual capability our sales representatives have, and then also supplementing that effort with a comprehensive digital and non-personal programs that we have. We're making very good progress with that. Still room for additional reach, still room for additional frequency, but we've been pleased with the progress at this stage of the launch so far. Great. Thanks for all the color. Thank you. The next question is coming from Jessica Fye of JP Morgan. Please go ahead. Wait, can you hear me? Before Jessica asked something. Okay, you couldn't hear me before. I just wanted to add to what Mark said. Yes, we think that we are still on a good trajectory, Andrew, to give you the short answer, and then you can add into that what everything Mark added into that. Thank you. Jessica, please go ahead. Okay. Great. Maybe kind of following up on that. I don't know if it's for Sharon or for Mark, but last quarter, you talked about the launch phase being sort of a six- to 12-month period characterized by the most robust new to brand growth. Now that we're a little more than 6 months into the bipolar depression launch, do you think the launch phase here is gonna be closer to that 6 months or closer to the 12 months you talked about before? Jessica, in a launch there's always gonna be sort of week-to-week variability. I think in the recent period that we've just gone through, we've seen some summer seasonality, where you have some holidays with more, you know, that kind of interrupt the week. You have Memorial Day weekend, you have Fourth of July, you have Juneteenth. Summertime is when you tend to have vacations for physicians and patients, et cetera. We have seen some impact of the rise in the COVID cases, which has impacted the overall market. We think that the longer-term prescription trends remain very healthy for CAPLYTA. As Sharon said, we continue to believe that we're on a very good trajectory, that'll take us into the second half of the year. Got it. If I could just ask a follow-up. Were there any changes in the amount of inventory days on hand in the channel at the end of Q2 relative to the end of Q1? Mark or Larry? Yeah. Larry, you want to take it? Days on hand have been relatively stable, a bit, you know, rising when sales rise, but, you know, they're pretty much stable. Thank you. Thank you. The next question is coming from Umer Raffat of Evercore ISI. Please go ahead. Hi, guys. This is Mike DiFiore in for Umer. Thanks so much for taking my question. First on the mixed features trial. You know, you saw in the bipolar phase III a solid stat sig effect size was seen on the MADRS about halfway into the six-week trial and continued to improve through the end of the trial. However, the MADRS score of these patients was around 30, whereas the mixed features trial's inclusion criteria specifies a score of at least 24. What I'm going with this is, can you give us a sense of where the baseline MADRS scores in the mixed feature trial may fall relative to the bipolar depression trial? Also, is there any reason why the placebo group may behave differently in this patient population? Whether there could be any U.S. versus ex-U.S. dynamics that may affect the results. Just separately, really quick, on inventory, how many weeks do you typically keep in the channel? Thank you. Let's break that into a couple of questions, and I'll ask Suresh to address our mixed features. Yeah. Mixed features study, it is ongoing right now. We are on track for enrollment by end of the year. In terms of the question about mixed, the baseline, it is 24, that you're correct in terms of what we have for this trial, but it will usually be in the range same what we have seen. The baselines would be what we have seen in our monotherapy and adjunctive trials. That is around 30-32. I expect that will be in the same range for this trial too. In terms of your question about placebo response, we have to, again, that's as you know, that these trials have. Depression trials in general have a 50% successful rate, and with bipolar it is even little bit higher. However, we have shown that in bipolar depression we were able to demonstrate efficacy in both monotherapy and adjunctive therapy. Also in the post-hoc analysis for the 404 study where we have seen patients with mixed features, where we use a proxy of YMRS as mixed features, there in that analysis, post-hoc analysis, we saw a clear separation in this mixed feature population in that trial. We'll wait and see for the results. I would just add to that you have cutoff points for these, for the MADRS scores. Again, as Suresh mentioned, there is a range of MADRS scores that these patients can come in at, just like in our bipolar, both monotherapy and adjunctive therapy studies. Great. Very helpful. Thank you. Also just real quick on the inventory question, how many weeks do you typically keep in the channel? Yeah. I'll start, and then I'll ask if Larry wants to chime in. Yeah. Remember, this is not a category where you keep large stocks of inventory. The distributors are amazingly efficient at being able to move product around the country on very, very short order. There aren't large inventory stocks for this category, at least in our hands. I don't know, Larry, if you wanted to add anything to that. Yeah. There was a question asked earlier about days on hand, and days on hand has been stable and is relatively low, and it's more of a just-in-time sort of effect that we're seeing. So there's not a lot of inventory in the channel. I mean, we have a lot of inventory on our balance sheet, but it does, you know, doesn't stockpile in the channel. Very efficient, as Sharon said. Got it. Thanks very much. Thank you. The next question is coming from Brian Abrahams of RBC Capital Markets. Please go ahead. Hi. Good morning. Thanks for taking my question, and congrats on the continued strong launch. Maybe a question for Mark. I'm curious how you're thinking about the impact that the DTC campaign is having on the bipolar launch and also the inflection we're seeing. Do you have a sense as to how much it may be contributing relative to the growth that you might expect from the label expansion alone? I guess I'm also curious, you know, how long you expect the DTC campaign to run for and what the potential long-term impact on SG&A and margins would be. Thanks. Yeah. Sure, Brian. Thanks for the question. As I think you know, our bipolar TV ad began running in early second quarter with a mix of media and broadcast, cable, syndicated, streaming TV, et cetera. We do have some interim metrics. We don't have all of the metrics at this point. What I would say is we are pleased with how our media is successfully targeting and reaching the bipolar depression audience. Our TV ad has driven substantially more visitors to our website, where they're seeking information about CAPLYTA. We are seeing an increasing number of physicians reporting patient requests for CAPLYTA, and we would expect to see this continue to increase as our ad continues to air. Overall, I'd say we've been very pleased with the impact of the DTC, and our expectation is that we would continue to run DTC throughout 2022. Thanks. Thank you. The next question is coming from Charles Duncan of Cantor Fitzgerald. Please go ahead. Yeah. Hi. Good morning, Sharon and team. Congratulations on a good quarter. Thanks for taking our questions. It's a multi-part single question for Mark or you, Sharon. That is, relative to some of the prepared remarks on positive experience that the patients are experiencing, I guess I'm wondering if you could provide any qualitative information on persistence and if that is providing a halo effect to drive the additional schizophrenia prescribing. Relative to the new dosage forms, I'm wondering if you could provide even qualitative information on what percentage of patients are not being prescribed CAPLYTA, and how could that result in an uptick, further uptick in adoption? Thanks. Thank you, Charles, for the questions. I'll ask Mark to take them. Yes, just to comment on your first comment on, yes, our continued strong launch. We are very pleased with the continued strong launch. Into that, we'll now also launch these lower doses, and I will ask Mark to further comment from here. Yeah. Sure. Charles, let me start there. We are pleased to be able to offer appropriate dose strengths now for an expanded patient population who will now have access to CAPLYTA. That's specifically, as you saw in the press release, for patients with either moderate to severe hepatic impairment who are taking moderate to strong CYP3A4 inhibitors. You know, precise numbers are difficult to obtain for these patient populations, but we estimate it to be about 5% of the population taking antipsychotics. We will be launching this shortly. We expect actually these new dosage strengths to be available and in pharmacies by next week. We're looking forward to that launch and making CAPLYTA available to additional patients who may not have had access to it before. On your first question, yeah, from a persistence perspective, we continue to track and see the same kind of improved persistence on CAPLYTA, particularly in patients with schizophrenia that we've been monitoring since the beginning of the launch. You know, we talk about this quite a bit each time we get together, and we did have the hypothesis that given the safety and tolerability profile of CAPLYTA, that we would see that translate into a good compliance and persistence profile. All the data that we've seen through our most recent data suggests that that's the case. We're pleased with what we're seeing there as well. Very good. Thanks for the added color. Thank you. The next question is coming from Marc Goodman of SVB. Please go ahead. Yes, good morning. I think the questions about inventory are related to the fact that if you just simplistically took the IQVIA prescriptions from first quarter and second quarter, and then you listen to your guidance about gross to nets, which are low 30s% for both quarters, that you struggle a little bit to get to the sales moving from, you know, $35-$55 without some inventory change in the channel, which I guess we all assume that the channel keeps 2-3 weeks. Sometimes you can move from the low end to the high end, and I think that's where the questioning was or maybe IQVIA is not picking up all the scripts, or maybe you can give us a flavor for that. Is gross to net, you know, lower in the second quarter versus first quarter? Anything you can do to help us with that will be helpful. Then I just had one other question, which is on mixed features. Mark, can you give us a sense of if you get that indication, you know, how many new patients do you think that brings as a potential new market for you? Thanks. I'll start. This is Larry. Our days Yeah. Let me ask Larry to take the first part of the question, and then, I'll take the second part on how many new patients mixed features would bring. Like I said earlier, the days on hand at distributors and elsewhere is been stable. There's not been a big increase in that. I think when you're in a launch mode and sales are rising, it's hard to take the IQVIA data and match with the gross to net and then match to our revenue. It's you can try to do it, but you're gonna be off just by the mathematics involved. I would say there's, you know, there's nothing to worry about, 'cause we see the data as far as the days on hand and the inventory in the channel. I don't know if I can add any more color to that, but when sales are rising, it's hard to do that math. Is the gross to net in the second quarter a little higher than the first quarter? No. The gross to net was fairly consistent and will be consistent the rest of the way. It's in that range, and we didn't see a large change in our gross to net in this quarter. Which is interesting, Larry, because usually gross to nets on the first quarter are so high relative to the rest of the year, just for every product out there. We talked about that on our last call, as the commercial channel is increasing, you know, the impact of gross to net, even though you have the seasonality of the first quarter, you have an increase in commercial channel usage, and that'll keep the gross to net at a higher range, higher end of the range. I think the mechanics behind it, we're pretty comfortable with and it's pretty clear to us. Maybe when we talk one-on-one, I can give you a little more insight on the mechanics of it, but it's pretty straightforward. Thank you. The next question is coming from Corinne Jenkins of Goldman Sachs. Please go ahead. Hi, good morning. I think in the past, you guided to reaching 85%-95% of covered lives under the commercial payer infrastructure. I'm curious, now that you're at 85%, how much incremental coverage gain should we expect to see? And then can you provide any additional detail on what we can expect to prior authorization policies as you expand that commercial coverage? Mark, do you want to take? Yeah. Yeah. Corinne. Yeah, sure. Corinne, we actually where we've been, what we've communicated previously is that we've had over 80% coverage in the commercial channel, and that was up from approximately 50%-55% in the part of last year. As we approached the bipolar depression approval and as we began that launch, we were very pleased to be able to get that coverage from the mid-50s up to over 80%. What we're communicating this quarter is during the second quarter, we improved even further on that coverage, and now we're approximately 85% covered in the commercial channel, and we do expect that number to continue to climb in the coming months. As far as the utilization criteria, they've been pretty consistent. You have certain plans and channels that make CAPLYTA available unrestricted, which means there's no prior authorizations, there's no step edits through a generic. There are other plans who use electronic step edits, which is not a significant barrier at all to accessing CAPLYTA. We've talked in the past about sort of the patient churning through antipsychotics that happens both in schizophrenia and bipolar, where they're dissatisfied, typically due to a tolerability issue. They've gone through one, two, three generics already, so they already qualify for meeting that step criteria of having to use a generic first or sometimes two generics. There's other plans that require a prior authorization, but even the prior authorization in this category is not onerous. Basically, the payer just wants to ensure that the patient is appropriate, meaning it's either a patient with schizophrenia or with bipolar depression. We have our LYTAlink program that helps physician offices navigate that process. Typically, when they do that, the payer very frequently approves that medication for that. Overall, I would say we continue to enjoy a very strong market access position. We're happy with where we are, and we expect to see even further continued increases in the commercial channel. Thank you. The next question is coming from Graig Suvannavejh of Mizuho. Please go ahead. Good morning. Thanks for taking my questions. Congrats on the quarter. I was wondering, if you could, if you have this data, can you quantify the magnitude of the current market penetration of CAPLYTA in both schizophrenia and bipolar depression, or at least put some qualifying comments around that? And then second, in terms of the current brand awareness of CAPLYTA within the prescribing community, you know, how would you characterize that right now? And maybe that's, you know, kind of asking like what additional level of market education do you need to do? If there are physicians who have yet to use it or are resistant to using it, I'm wondering if you can provide some color as to what the potential kind of pushback might be. Thanks. Yeah. Greg, thanks for the questions. Yeah. At this stage, without providing real quantification of these numbers, what I would say for your second question is the awareness levels in bipolar depression among our prescriber audience are right about where we would expect them to be at this stage of the launch. We're pleased with both the awareness levels of CAPLYTA, both unaided, they bring it up on their own and even much higher when given a list of products to take a look at, and they can recognize that CAPLYTA is approved for bipolar depression. Perhaps even what's more encouraging to us in the recent market research that we had with over 300 physicians, how they rate CAPLYTA versus the various attributes of the product compared to the other antipsychotics. Our belief and understanding is that physicians have a very good understanding of the clinical profile, and the areas of differentiation, especially in being indicated for both bipolar one and bipolar two, and then all the safety and tolerability measures, the low risk of metabolic dysfunction, low risk of weight gain, low risk of extrapyramidal symptoms, and also the ease of dosing, with no titration. Any color on kind of where you feel you are in terms of penetrating schizophrenia and bipolar depression in terms of market share, anything like that? Depression, you know, this is a category where you have, you know, several big branded products that have been on the market for many years, Latuda for over 10 years, Vraylar for over five years, and certainly, the generics have been around for a long time as well. We think there's plenty of room, for upward penetration, of CAPLYTA, and we continue to make very good progress, in penetrating, each of those areas. We look carefully each month at the source of our new patients. As I mentioned in my prepared remarks, we are seeing, increasingly, more and more patients being newly diagnosed patients being placed on CAPLYTA, for those patients whose insurance allow for first line usage. Also encouragingly, when we look at the switch dynamics, we are seeing switches from a wide variety of antipsychotics, including both generic products and increasingly coming from other branded products as well. We see that as a very healthy sign that physicians understand the clinical profile, they value the clinical profile, and they're taking the steps to make those switches to CAPLYTA. Thank you. Thank you. The next question is coming from Jason Gerberry of Bank of America. Please go ahead. Hey, guys. Thank you for taking my questions or question. Just wanted to better try to connect the script data for the big BPD drugs like Latuda, Vraylar, CAPLYTA to these patient numbers, right? These patient numbers are massive, 6 million-11 million patients we've heard. We know the BPD is sort of an underdiagnosed condition. Do you have a sense sort of what is the diagnosed patient number? Do you have, like, maybe a more realistic, you know, TAM for the market based on how many of these patients you think are getting diagnosed? 'Cause when I look at, like, the Latuda and Vraylar scripts and assume some, you know, reasonable average, you know, duration of therapy, it would suggest only, like, maybe 400,000-500,000 patients might be getting treated for BPD with the brands, right? I don't know what the generic number would be. How do you kind of... 'Cause this is an important, I guess, data point to just trying to understand how much bigger sort of the branded BPD category can get. Thanks. Yeah. Jason, the category is a massive category. You know, our estimates of the epidemiology suggest that there are, you know, upwards of 11 million patients who suffer from bipolar disorder, which is 4x-5x the size of schizophrenia. You know, both schizophrenia and bipolar disorder are serious mental illness with significant symptomatology. I would say the majority of patients are diagnosed. Once diagnosed, then they go sort of on their treatment journey of really zeroing in, and perhaps Suresh would wanna comment on this from a psychiatrist perspective, but they go on their treatment journey where a psychiatrist or other treating physician is trying to determine exactly what their condition is. One of the dynamics in bipolar disorder is distinguishing between a patient who is depressed, who maybe might present as a patient with major depressive disorder, but particularly in bipolar two, because these are sub-threshold mania symptoms, they might go unnoticed, and that patient might not get diagnosed with bipolar two for several years. That physician may try treating them with an antidepressant, and antidepressants typically do not work well in bipolar depression. It takes a little time for them to get an accurate diagnosis and get them appropriately treated with an antipsychotic like CAPLYTA. I don't know, Suresh or Sharon, whether you'd like to add any color to that that might help address Jason's question there. Can you hear me? Yes. Great. Sorry, everybody, I'm having some technical issues with hearing. Yeah, I agree with everything that Mark said and also what you said. Jason, it is a large market and that has still not reached its potential. I do think, as Mark said, the bipolar two patient population is certainly an untapped market to this point. Suresh, did you want to add anything, or are you good? Yeah. No, no, nothing to add. That is true. It is still an untapped market. Great. Thank you. Thank you. The next question is coming from Ash Verma of UBS. Please go ahead. Hi. Good morning. Thanks for taking my question. I have two. Now that we are beyond the half year mark with the first half of CAPLYTA sales at around $90 million, finish up on a strong quarter in Q2, how do you feel about the consensus expectation for second half, which is around $130 million? That's number one. Then just secondly, on the OpEx. It seems like SG&A and R&D, we saw a jump in the second quarter. You mentioned that DTC program is going to continue throughout the year. Is this like a good run rate to assume for the remainder of the year? Thanks. Larry, do you wanna take that? Yeah, I'll take the second part. Yeah, the expenses were higher for R&D and SG&A in the second quarter as were expected, and I think it indicates what the run rate would be for the rest of the year. I'd also like to remind you that we had given guidance earlier, $500 million in cash spend, which doesn't include non-cash expenses for the year, and we spent $260 million of that in the first half, and we are guiding to $240 million for the second half. I would say that within the context of the expenses for the first and second quarter as well as what we project for the rest of the year, you should see that guidance remain intact. I think that tells the story. Yeah. Do you have any further questions related to that? Just on CAPLYTA sales. Oh. Yeah. Mark? We don't give guidance as you know, but with that, we're very pleased with our launch to date and our continued progress and our continued trajectory. Mark, did you wanna add anything to that? Nope. I completely agree with you. Thank you. Unfortunately, we have only time for one more question today. The last question will be coming from Sumant Kulkarni of Canaccord. Please go ahead. Morning. Apologies for any background noise and if this has been asked already, but I'll ask two questions, mainly because you may not answer my first. The first question is, could you give us a split between bipolar depression and schizophrenia for the current sales that you have or any components of growth? Second, now that lumateperone is humming along nicely in the U.S., what are your latest thoughts internally, on taking that product ex-U.S.? Mark, do you wanna take the first part, and I'll take the second part? Yeah, sure. Sumant, with the explosive growth that we've seen in the first half of the year, our business is increasingly being sourced from bipolar depression over schizophrenia. Now, that being said, we are pleased with the continued growth that we've seen in the schizophrenia business, in addition to the more explosive growth that we've seen with all the new patients coming in, consistent with the new indication in bipolar depression. The mix of those two is increasingly weighing more and more towards bipolar depression. I think if you look at the existing branded products, like Latuda and like Vraylar, and you look at the mix of their business, it is significantly more coming from bipolar depression, bipolar disorder, than from schizophrenia. We are tracking along that same track and would expect to have a similar profile as they do once we get to a more mature stage of the business. Sharon, I might kick the second part of that question back to you. Yeah. Thank you. As we've said before, we continue to evaluate opportunities ex-U.S., and we'll let you know as that progresses. We don't have any updates for you right now, and we will update you as soon as we have further information. Thank you. Thank you. At this time, I'd like to turn the floor back over to Dr. Mates for closing comments. Thank you, operator, and thank you, everyone. We're very pleased with our progress made to date, both on our launch, as well as our development programs and the extension of lumateperone into MDD and into mixed features. We look forward to updating you on those programs as we move forward. Thank you very much everyone for joining, and I look forward to speaking with you again. Operator, at this time, you can disconnect, and thank you. Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines or log off the webcast at this time, and enjoy the rest of your day.