Intra-Cellular Therapies(ITCI) - 2024 Q4 - Annual Results

Financial Performance - CAPLYTA net product sales for Q4 2024 reached $199.2 million, a 51% increase from Q4 2023[1] - Full year 2024 CAPLYTA net product sales totaled $680.5 million, reflecting a year-over-year growth of 47%[3] - Total revenues for Q4 2024 reached $199.2 million, a 50.4% increase from $132.1 million in Q4 2023[20] - Product sales, net for the twelve months ended December 31, 2024, were $680.5 million, up 47.3% from $462.2 million in 2023[20] - The net loss for Q4 2024 was $16.9 million, an improvement from a net loss of $28.3 million in Q4 2023[20] - The company reported interest income of $12.0 million in Q4 2024, compared to $6.2 million in Q4 2023, reflecting a 93.5% increase[20] Expenses - Selling, general and administrative (SG&A) expenses increased to $504.5 million for 2024, up from $409.9 million in 2023[3] - Research and development (R&D) expenses rose to $236.1 million in 2024, compared to $180.1 million in 2023, driven by higher project costs[3] - Operating expenses for Q4 2024 totaled $228.4 million, compared to $166.2 million in Q4 2023, reflecting a 37.5% increase[20] - Research and development expenses for the twelve months ended December 31, 2024, were $236.1 million, a 31.1% increase from $180.1 million in 2023[20] Cash and Assets - Cash, cash equivalents, and investment securities amounted to $1.0 billion as of December 31, 2024, compared to $499.7 million at the end of 2023[3] - Cash and cash equivalents increased to $306.9 million as of December 31, 2024, up from $147.8 million in 2023[23] - Total assets grew to $1.37 billion in 2024, compared to $728.3 million in 2023, marking an increase of 87.8%[23] - Total stockholders' equity rose to $1.15 billion in 2024, up from $591.4 million in 2023, indicating a 94.5% increase[23] Clinical Development - The FDA accepted the supplemental New Drug Application (sNDA) for lumateperone for the adjunctive treatment of major depressive disorder (MDD)[1] - In Q1 2025, the company began expanding its field sales force in anticipation of CAPLYTA's potential approval for MDD[6] - The company initiated 10 late-stage clinical trials in 2024, including six Phase 3 trials for lumateperone[6] - Patient enrollment is ongoing in multiple Phase 2 and Phase 3 studies for various indications, including bipolar disorder and generalized anxiety disorder[4][5] - The company is advancing its pipeline with ongoing studies for ITI-1284 and other neuropsychological programs[6] Shareholder Information - The weighted average number of common shares outstanding increased to 106.1 million in Q4 2024 from 96.3 million in Q4 2023[20]