Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson & Johnson’s robust lineup of therapies with $5 billion+ potential in pe ...

Settlement Agreement - Intra-Cellular Therapies has entered into a settlement agreement with Sandoz Inc resolving patent litigation related to CAPLYTA® (lumateperone) [1] - The litigation arose from Sandoz's submission of an Abbreviated New Drug Application to the FDA seeking approval to market a generic equivalent of CAPLYTA [1] - The settlement permits Sandoz to begin selling generic versions of CAPLYTA on July 1, 2040, or earlier under certain circumstances [1] - Intra-Cellular Therapies will submit the agreement to the U S Federal Trade Commission and the U S Department of Justice as required by law [1] - Similar patent litigation brought by Intra-Cellular Therapies against other parties remains pending in the U S District Court for the District of New Jersey [1] Company Overview - Intra-Cellular Therapies is a biopharmaceutical company focused on developing and commercializing therapeutics for central nervous system (CNS) disorders [1][3] - The company was founded on Nobel prize-winning research that enables understanding of how therapies affect the inner-workings of cells in the body [3] - Intra-Cellular Therapies leverages its intracellular approach to develop innovative treatments for complex psychiatric and neurologic diseases [3]

Settlement Agreement - Intra-Cellular Therapies has entered into a settlement agreement with Sandoz Inc resolving patent litigation related to CAPLYTA® (lumateperone) [1] - The litigation arose from Sandoz's submission of an Abbreviated New Drug Application to the FDA seeking approval to market a generic equivalent of CAPLYTA [1] - The settlement permits Sandoz to begin selling generic versions of CAPLYTA on July 1, 2040, or earlier under certain circumstances [1] - Intra-Cellular Therapies will submit the agreement to the U S Federal Trade Commission and the U S Department of Justice as required by law [1] - Similar patent litigation brought by Intra-Cellular Therapies against other parties remains pending in the U S District Court for the District of New Jersey [1] Company Overview - Intra-Cellular Therapies is a biopharmaceutical company focused on developing therapeutics for central nervous system (CNS) disorders [1] - The company was founded on Nobel prize-winning research that allows understanding of how therapies affect the inner-workings of cells in the body [2] - Intra-Cellular Therapies leverages its intracellular approach to develop innovative treatments for complex psychiatric and neurologic diseases [2]

BEDMINSTER, N.J., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 11:15 a.m. PT in San Francisco, CA. The live and archived webcast can be accessed under " ...

BEDMINSTER, N.J., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at three upcoming investor conferences: Evercore 7th Annual HealthCONx ConferenceTuesday, December 3, 2024 at 10:50 a.m. ET in Miami, FL Citi 2024 Global Healthcare Confere ...

Presentations include results from two pivotal studies (Studies 501 and 502) evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) Results show robust efficacy and favorable safety and tolerability profile for CAPLYTA BEDMINSTER, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) d ...

Financial Data and Key Metrics Changes - CAPLYTA's net sales reached $175.2 million in Q3 2024, representing a 39% increase compared to Q3 2023 [6][42] - The company raised its full-year net sales guidance for 2024 to a range of $665 million to $685 million [6][47] - Selling, general, and administrative expenses for Q3 were $132.1 million, up from $105.2 million in the same period last year [44] - R&D expenses increased to $66.8 million in Q3 from $41.6 million in Q3 2023 [45] - Cash and investments totaled $1 billion as of September 30, 2024, compared to $499.7 million at the end of 2023 [47] Business Line Data and Key Metrics Changes - CAPLYTA's total prescriptions grew by 38% year-over-year and 9% sequentially [28] - The product's growth outpaced the branded antipsychotic market, which grew by 4%, and the overall antipsychotic market, which grew by only 1% [29] - The company added 4,000 new first-time prescribers of CAPLYTA, bringing the total to over 49,000 unique prescribers [30] Market Data and Key Metrics Changes - There are over 21 million patients with major depressive disorder (MDD) in the U.S., with current antidepressant therapies inadequately addressing symptoms in more than half of these patients [13] - The potential market for CAPLYTA in mood disorders is estimated to be at least $5 billion over the next 10 years, primarily driven by bipolar depression and MDD [17] Company Strategy and Development Direction - The company aims to position CAPLYTA as a leading treatment option across mood disorders, including bipolar I, bipolar II, and MDD [50][51] - A second primary care sales force expansion is planned for 2025 in connection with the potential approval of CAPLYTA for MDD [39] - The company is advancing its pipeline, including the lumateperone long-acting injectable program and ITI-1284 for generalized anxiety disorder (GAD) [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth potential and the ability to capitalize on substantial opportunities ahead [28] - The recent efficacy and safety data for CAPLYTA in MDD Phase III studies have strengthened the company's market position [10][11] - Management anticipates continued strong prescription demand and a positive impact from the expanded sales force in the upcoming quarters [46][69] Other Important Information - The company is on track to submit a supplemental NDA for the adjunctive treatment of MDD this quarter [7] - The company is exploring the potential of ITI-1284 as a new mechanism of action in treating GAD, with a market opportunity estimated at $1 billion [20] Q&A Session Summary Question: Sales opportunity for CAPLYTA and market share expectations - Management believes CAPLYTA will become a leading treatment option across mood disorders, with significant contributions from both bipolar depression and MDD [50][51] Question: Reason for unveiling the $5 billion target now - The company aims to provide internal forecasts based on refined market research and confidence in CAPLYTA's potential [53][55] Question: Impact of sales force expansion on growth - The sales force expansion is expected to contribute positively, with most impact anticipated in 2025 [34][69] Question: Expectations for long-acting injectable (LAI) formulations - Management does not expect a significant impact on the oral franchise from LAI formulations, as patients prefer oral medications [73] Question: Regulatory strategy for ITI-1284 - If Phase II studies for GAD are positive, the company plans to discuss with the FDA for potential filing based on these studies [116]

Intra-Cellular Therapies, Inc. (ITCI) reported third-quarter 2024 loss of 25 cents per share, wider than the Zacks Consensus Estimate of a loss of 18 cents. The company had incurred a loss of 25 cents per share in the year-ago quarter. Total revenues, comprising product sales and grant revenues, came in at $175.4 million, up 39% year over year. The top line beat the Zacks Consensus Estimate of $172 million. ITCI's Q3 Results in Detail Caplyta, the only approved drug in Intra-Cellular's portfolio, was approv ...

Intra-Cellular Therapies (ITCI) came out with a quarterly loss of $0.25 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -38.89%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.18 per share when it actually produced a loss of $0.16, delivering a surprise of 11.11%. Over the last four quar ...

CAPLYTA (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]