Intra-Cellular Therapies Inc.

Good morning, ladies and gentlemen, and welcome to Intracellular Therapy's fourth quarter and year-end financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, press star 1-1 again. As a courtesy to other analysts, please limit your questions to one. Please note that 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. Please go ahead.

Good morning and thank you all for joining us on our fourth quarter and first year 2023 earnings call. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer Mark Newman, Chief Commercial Officer, Dr. Suresh Durgaon, Chief Medical Officer, and Larry Heinlein, Chief Financial Officer. As a reminder, during today's call, we will be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions, and expectations. These 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. This and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. Your caution not to place on due reliance on these forward-looking statements, and the company disclaims any obligations to such statements. Sharon.

Thanks, Juan. Good morning, everyone, and welcome to today's call. We are excited to share our results for the fourth quarter and the full year 2023. This past year was defined by strong and consistent growth throughout our company. We achieved major milestones as we established Keplida as a key treatment option for broad patient populations with bipolar depression and schizophrenia. We also advanced our pipeline programs and look forward to announcing top line results in our major depressive disorder studies Study 501 and Study 502. Our full year 2023 total revenues were $464 million. Keplita net sales in 2023 were $462 million compared to $249 million in 2022, representing an 86% increase. Similarly, Total scripts grew by 85% in 2023 compared to 2022. Demand for CapLida remains strong. Our well-executed commercial efforts continue to drive prescription growth from both new and existing prescribers. We anticipate continuing strong demand for CapLida. Based on this positive momentum, I am pleased to report that we expect full-year 2024 CapLida net product sales to be in the range of $645 to $675 million. Mark will elaborate on our commercial performance and plans for this year in a moment, and then Larry will share additional details regarding our financials. We continue to strategically invest in our pipeline, and we anticipate further advancements in several of our late, mid, and early stage clinical programs in 2024. I'd like to share more specifics regarding our plans for expanding Capilita beyond its current indications. We have two upcoming phase three top line readouts for the use of Lumetepirone as an adjunctive treatment in major depressive disorder, or MDD. Our 501 study is fully enrolled, and most patients have completed treatment. We allowed the small number of patients who were in screening when we reached our previously determined enrollment target to continue and be randomized to the double-blind treatment phase of the study. The rationale for allowing these patients to continue to participate in the double-blind treatment is that we believe that ethically, if a patient has participated in the screening process and qualified for enrollment, they should be allowed the possibility of receiving treatment. As a result, we expect to report top-line results from study 501 in April of this year rather than late March. We remain on track to report top line results from study 502 late in the second quarter of this year. Subject to those results, we continue to anticipate filing a supplemental new drug application with the FDA in the second half of this year. We have a high degree of confidence in our MDD program. As we have previously shared, multiple lines of evidence support this confidence, starting with Lumetectolone's mechanism of action simultaneously modulating serotonin, dopamine, and glutamate systems. Importantly, we have significant clinical evidence in several patient populations, including patients with schizophrenia with comorbid depression, patients with bipolar depression, and patients with MDD exhibiting mixed features. Of note, Caplida is the only antipsychotic approved for both bipolar I and bipolar II depression. both as monotherapy and as adjunctive therapy. We remain very excited by the possibility of helping millions of patients with MDD. The significant uptake of the last two antipsychotics approved for adjunctive treatment in MDD underscores the continued unmet need and large opportunity in this market. Given the efficacy and safety profile to date, we are confident in Keplitis' future potential in this patient population. As we mentioned to you previously, we were expecting to have a meeting with the FDA to discuss the results of study 403, particularly with respect to the MVD patient population with mixed features. I'm pleased to report that we recently had a constructive meeting, and as you know, we wait for minutes prior to making any statements regarding our interactions with the FDA. We expect to receive the minutes from this meeting later this quarter and plan to update you regarding the outcome and next steps at that time. Beyond our MDD program, we continue to invest in our Lumetepirone R&D program. Accordingly, we have initiated our Lumetepirone pediatric program, which includes an open label safety study in schizophrenia and bipolar disorder, a double-blind placebo-controlled study in bipolar depression, and two double-blind placebo-controlled studies in irritability associated with autism spectrum disorder. Approximately 2.8 percent of children in the United States have autism spectrum disorder. Irritability is a common system that pairs their daily activities with prevalence estimates ranging from about 25 to 45 percent of those patients. There are only two antipsychotic approved for the treatment of irritability associated with autism spectrum disorder, and two antipsychotics approved for the treatment of bipolar depression in the pediatric population. We believe rumetepirone, with its efficacy and favorable safety profile, if approved, can address important medical needs for these younger patients and their families, especially given the heightened concern regarding metabolic and motor issues in these patient populations. Additionally, in the first half of 2024, we will continue to advance our long-acting injectable Lumetepirone program, studying four different formulations. In summary, we continue the very successful launch of Keplida and are confident in the continued robust growth throughout 2024. Keplida is an important treatment option for patients with bipolar disorder and schizophrenia. These conditions account for about 50% of the U.S. antipsychotic markets, nearly 68 million scripts each year. With the potential addition of MDD, our total addressable market would expand to cover nearly 80% of the market's prescriptions. In addition, we expect our development programs among younger patient populations and our work with long-acting injectables to further maximize the value of our Lumateparone portfolio. Outside of Lumateparone, our pipeline continues to move forward with several clinical trials underway and others commencing soon. IPI 1284 is an important product candidate in our neuropsychiatry portfolio. In the first half of 2024, we plan to initiate patient enrollment in phase two clinical trial. Starting with our generalized anxiety disorder program, our first study will evaluate 1284 as adjunctive treatment to SSRIs and SNRIs. Also in the first half of 2024, we'll begin clinical conduct to evaluate ITI1284 for the treatment of psychosis and Alzheimer's disease and agitation and Alzheimer's disease. In our phosphodiesterase-1 inhibitor program, our lenlospodin phase two clinical trial in Parkinson's disease is ongoing and we expect to complete enrollment in late 2024 with top line results expected in the first half of 2025. With respect to our ITI 1020 oncology program, our phase one single ascending dose study in healthy volunteers is progressing. Our earlier stage development programs include ITI 333 for opioid use disorder and pain, for which a multiple ascending dose study and a positron emission tomography study are both ongoing. Also in development is our non-hallucinogenic psychedelic program. This past December at the American College of Neuropsychopharmacology, we presented the preclinical data from our lead compound, ITI1549. We are very encouraged by the positive reception our presentation received from the scientific and medical community, and we look forward to advancing ITI 1549 into human testing in late 2024 or early 2025. In 2023, we presented NU-CAP LIDAR data regarding our development programs at several medical and scientific meetings. We also published results in various medical journals demonstrating our progress throughout the course of the year. Looking ahead to 2024, we are starting off operationally and financially strong. As of December 31st, 2023, we had approximately $500 million in cash, cash equivalents and investment security, and we have no debt. I'm incredibly proud of our team and our accomplishments, and I'm excited to embark on our next phase of growth in 2024. I will now turn the call over to Mark to further discuss capillitis performance and our plans for 2024. Mark?