Intra-Cellular Therapies(US:ITCI)2024-10-30 11:53CAPLYTA (lumateperone) Clinical Trial Results - CAPLYTA (lumateperone) achieved a statistically significant reduction in MADRS total score by 14.7 points compared to placebo's 9.8 points in Study 501 (p<0.0001; ES=0.61)[57] - CAPLYTA (lumateperone) demonstrated a statistically significant reduction in MADRS total score by 14.7 points compared to placebo's 10.2 points in Study 502 (p<0.0001; ES=0.56)[57] - CAPLYTA (lumateperone) showed a 5.7-point reduction in MADRS total score compared to placebo in Study 403 for MDD and bipolar depression with mixed features (p<0.0001; ES=0.64)[62] CAPLYTA (lumateperone) Adverse Events - CAPLYTA (lumateperone) reported adverse events including dizziness (16.6% vs. 5.0%), dry mouth (12.6% vs. 3.3%), and somnolence (12.4% vs. 2.3%) in pooled safety data from Studies 501 and 502[57] CAPLYTA (lumateperone) Regulatory and Development Plans - The company plans to submit a supplemental new drug application (sNDA) for lumateperone as an adjunctive therapy for MDD in Q4 2024[60] - Study 505, a global Phase 3 trial for lumateperone 42 mg as an adjunctive therapy for MDD, is ongoing with amended entry criteria to include patients with inadequate response to multiple antidepressants[61] - Study 304, evaluating lumateperone for relapse prevention in schizophrenia, is expected to report topline results in Q4 2024[63] Other Pipeline Developments - ITI-1284-ODT-SL, a deuterated form of lumateperone, is in Phase 2 trials for generalized anxiety disorder, psychosis, and agitation in Alzheimer's disease, with patient enrollment ongoing[66] - Lenrispodun (ITI-214), a PDE1 inhibitor, is in Phase 2 trials for Parkinson's disease, with expected completion by the end of 2025[67] - ITI-333, a compound targeting opioid use disorder and pain, completed a multiple ascending dose study and is undergoing neuroimaging studies for dose selection[68] - The ITI-1500 program, focused on non-hallucinogenic psychedelics, is progressing with lead compound ITI-1549 expected to enter human testing in 2025[70] Financial Performance and Sales - Net product sales of CAPLYTA increased by 39% to $175.2 million for the three-month period and by 46% to $481.3 million for the nine-month period ended September 30, 2024, compared to the same periods in 2023[82] - Cost of product sales increased by 68% to $15.3 million for the three-month period and by 59% to $36.6 million for the nine-month period ended September 30, 2024, driven by higher sales volume[83] - Selling, general, and administrative expenses increased by 26% to $132.1 million for the three-month period and by 20% to $366.8 million for the nine-month period ended September 30, 2024, primarily due to sales force expansion and promotional activities[84][86] - Research and development expenses increased by 61% to $66.8 million for the three-month period and by 28% to $165.8 million for the nine-month period ended September 30, 2024, driven by increased clinical trial activities[91][92] Sales Force Expansion and Future Expectations - The company expanded its sales force by approximately 150 representatives in Q3 2024, focusing on CAPLYTA sales to primary care physicians, with further expansion planned for 2025[79] - The company expects selling, general, and administrative costs to increase due to sales force expansion, promotional activities, and infrastructure growth[79] - Research and development expenses are expected to increase moderately as the company expands clinical trial programs and pre-clinical development activities[79] Cash Flow and Liquidity - The company's cash and cash equivalents, investment securities, and restricted cash totaled approximately $1.0 billion as of September 30, 2024, providing liquidity for future operations[93] - Net cash used in operating activities decreased to $60.1 million for the nine months ended September 30, 2024, compared to $122.1 million in the same period in 2023, primarily due to increased net product sales[96] - Net cash used in investing activities increased to $185.3 million for the nine months ended September 30, 2024, compared to $58.1 million provided by investing activities in 2023, driven by increased purchases of investment securities[97] - Net cash provided by financing activities surged to $561.9 million for the nine months ended September 30, 2024, compared to $14.8 million in 2023, mainly due to a public offering of common stock in April 2024, resulting in net proceeds of $543.1 million[98] - The company had cash, cash equivalents, investment securities, and restricted cash of approximately $1.0 billion as of September 30, 2024, primarily held in highly-rated financial institutions and short-term U.S. Treasury bonds[108] - The company recorded an unrealized gain of $1.6 million in Q3 2024 due to a decline in interest rates[108] Cost Management and Financial Risks - The company's cost of product sales is favorably impacted by the sale of drug product previously charged to R&D expenses, a trend expected to continue until post-FDA approval manufacturing costs are fully reflected[78] - Inflation has not yet had a material impact on the company, but future increases could affect clinical trial, labor, and operating costs, potentially impacting financial performance[109] - The company is exposed to foreign currency risk due to international operations, though historical impacts have been minimal[112] - The company may pursue additional financing in the future, including equity or debt securities, which could dilute existing stockholders or impose restrictive covenants[94] - The company maintains cash and investments in highly-rated financial institutions, minimizing concentration and risk[95] - The company's long-term contractual commitments include licensing and royalty agreements with BMS, operating leases, and purchase obligations supporting commercial and R&D operations[99]