Intra-Cellular Therapies(ITCI) - 2023 Q4 - Annual Results

Financial Performance - Full year 2023 total revenues reached $464.4 million, a significant increase from $250.3 million in 2022[1] - CAPLYTA net product sales for 2023 were $462.2 million, reflecting an 86% year-over-year growth, with fourth quarter sales of $131.5 million, up 50% from Q4 2022[4] - Total revenues for the year 2023 were $464.370 million, up 85.5% from $250.314 million in 2022[28] - Product sales for Q4 2023 reached $131.506 million, a 50.5% increase from $87.433 million in Q4 2022[28] - The net loss for Q4 2023 was $28.579 million, an improvement from a net loss of $44.026 million in Q4 2022[28] Expenses - SG&A expenses for 2023 were $409.9 million, up from $358.8 million in 2022, primarily due to increased commercialization and marketing costs[4] - R&D expenses for 2023 totaled $180.1 million, compared to $134.7 million in 2022, driven by higher costs associated with lumateperone and other projects[7] - Operating expenses for Q4 2023 totaled $166.196 million, compared to $135.281 million in Q4 2022, reflecting a 22.8% increase[28] - Research and development expenses for the year 2023 were $180.142 million, up 33.8% from $134.715 million in 2022[28] Cash Position - Cash and cash equivalents stood at $499.7 million as of December 31, 2023, down from $593.7 million a year earlier[7] - Cash and cash equivalents as of December 31, 2023, were $147.767 million, slightly down from $148.615 million at the end of 2022[30] - The company reported a total stockholders' equity of $591.424 million as of December 31, 2023, down from $656.070 million in 2022[30] Clinical Development and Pipeline - The company is advancing multiple clinical programs, including Phase 3 trials for lumateperone in major depressive disorder, with topline results expected in 2024[10] - The company is focused on expanding its pipeline, including new formulations and indications for lumateperone, with several studies expected to report results in 2024[11] - The company has plans for further commercialization of CAPLYTA, with ongoing clinical trials and regulatory submissions to the FDA[25] Market Access and Growth - CAPLYTA's market access now covers approximately 90% of commercially insured lives and over 99% of Medicare Part D and Medicaid lives[8] - CAPLYTA's acceptance among patients and physicians remains a key focus for future growth and market expansion[25] - The company projects CAPLYTA net product sales for 2024 to be between $645 million and $675 million[6] Risks - The company faces risks related to supply chain challenges and potential safety issues with CAPLYTA post-commercial launch[25]