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]

Exhibit 99.1 INTRA-CELLULAR THERAPIES REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS, PROVIDES CORPORATE UPDATE AND RAISES 2024 CAPLYTA SALES GUIDANCE CAPLYTA Q3 2024 net product sales were $175.2 million, compared to $125.8 million for the same period in 2023, representing a 39% increase CAPLYTA's strong prescription uptake continues: Q3 2024 CAPLYTA total prescriptions increased 38%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance range raised to $665 to $685 million Following a succe ...

Core Insights - CAPLYTA's net product sales for Q3 2024 reached $175.2 million, a 39% increase from $125.8 million in Q3 2023 [1][3] - Total revenues for Q3 2024 were $175.4 million, compared to $126.2 million in the same period last year [3] - The company raised its full-year 2024 net product sales guidance to a range of $665 to $685 million [1][5] - A supplemental NDA submission for lumateperone as an adjunctive treatment for major depressive disorder is expected in Q4 2024 [1][5] Financial Performance - Net loss for Q3 2024 was $26.3 million, compared to a net loss of $24.3 million in Q3 2023 [3] - Selling, general and administrative (SG&A) expenses increased to $132.1 million in Q3 2024 from $105.2 million in Q3 2023 [3] - Research and development (R&D) expenses rose to $66.8 million in Q3 2024, up from $41.6 million in the same period last year [3] - Cash, cash equivalents, and investment securities totaled $1.0 billion as of September 30, 2024 [3] Commercial Developments - CAPLYTA total prescriptions increased by 38% in Q3 2024 compared to Q3 2023 [4] - The company expanded its sales force by approximately 150 representatives to enhance outreach to primary care physicians [4] - A second expansion of the primary care sales force is planned for 2025 in anticipation of potential approval for the adjunctive treatment of major depressive disorder [4] Clinical Pipeline - Patient enrollment is ongoing in Phase 2 studies for ITI-1284 targeting generalized anxiety disorder and psychosis associated with Alzheimer's disease [1][7][8] - The lumateperone pediatric program is advancing, with ongoing studies for bipolar depression and irritability associated with autism spectrum disorder expected to start in Q4 2024 [7] - The company is also conducting a Phase 2 trial for lenrispodun in Parkinson's disease, with completion anticipated by the end of 2025 [9] Upcoming Events - Results from Phase 3 studies of lumateperone for major depressive disorder were presented at recent conferences, demonstrating significant efficacy [6] - The company plans to continue sharing results from its clinical studies at various medical conferences throughout 2024 and 2025 [6]

Wall Street expects a year-over-year increase in earnings on higher revenues when Intra-Cellular Therapies (ITCI) reports results for the quarter ended September 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released ...

NEW YORK, Oct. 17, 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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Wednesday, October 30, 2024, to provide a corporate update and discuss details of the Company's financial results for the quarter ended September 30, 2024. To attend the live confe ...

Oral and poster presentations of results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) Poster presentations of post-hoc analyses from Study 403 including the prespecified patient population with MDD or bipolar depression with mixed features who also had anxious distress NEW YORK, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the developmen ...

Intra-Cellular Therapies, Inc. (ITCI) reported second-quarter 2024 loss of 16 cents per share, narrower than the Zacks Consensus Estimate of a loss of 18 cents, primarily due to higher product sales. The company had incurred a loss of 45 cents per share in the year-ago quarter. Total revenues, comprising product sales and grant revenues, came in at $161.4 million, up 46% year over year. The top line beat the Zacks Consensus Estimate of $158 million. Quarter in Detail Caplyta, the only approved drug in Intra ...

Company Overview - Intra-Cellular Therapies, Inc. is a biopharmaceutical company focused on developing and commercializing therapeutics for central nervous system (CNS) disorders [1][3] - The company is founded on Nobel prize-winning research that enhances the understanding of how therapies affect cellular functions [3] Upcoming Event - Sharon Mates, Ph.D., the CEO and Chairman of Intra-Cellular Therapies, is scheduled to present at the Canaccord Genuity 44th Annual Growth Conference on August 13, 2024, at 12:00 p.m. ET in Boston, MA [1] - The live and archived webcast of the presentation will be available under "Events & Presentations" in the Investor Relations section of the company's website [2]

Intra-Cellular Therapies (ITCI) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.45 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 11.11%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.31 per share when it actually produced a loss of $0.16, delivering a surprise of 48.39%. Over the last four quart ...

[Q2 2024 Financial Highlights](index=1&type=section&id=Second%20Quarter%20Financial%20Highlights) Intra-Cellular Therapies reported total revenues of **$161.4 million** in Q2 2024, driven by a **46% rise in CAPLYTA sales**, significantly narrowing its net loss to **$16.2 million** Q2 2024 Financial Performance vs. Q2 2023 (in millions) | Financial Metric | Q2 2024 | Q2 2023 | Change | | :--- | :--- | :--- | :--- | | CAPLYTA Net Product Sales | $161.3 | $110.1 | +46% | | Total Revenues | $161.4 | $110.8 | +45.7% | | Net Loss | ($16.2) | ($42.8) | +62.1% (Improvement) | | SG&A Expenses | $121.6 | $101.0 | +20.4% | | R&D Expenses | $56.2 | $49.8 | +12.8% | | Cash & Investments | $1,025.0 | N/A | N/A | [Commercial Update and 2024 Outlook](index=2&type=section&id=Commercial%20Update%20and%202024%20Outlook) CAPLYTA's commercial momentum led to a **36% increase in prescriptions**, prompting a sales force expansion and revised **2024 net sales guidance of $650-$680 million** - CAPLYTA total prescriptions increased **36%** in Q2 2024 compared to Q2 2023, and **10%** compared to Q1 2024[3](index=3&type=chunk) - The company plans to add approximately **150 sales representatives** in Q3 2024 to expand reach into primary care offices, with a second expansion planned for 2025 pending potential MDD approval[3](index=3&type=chunk) Updated Fiscal 2024 Financial Guidance (in millions) | Guidance Metric | Updated 2024 Range | | :--- | :--- | | CAPLYTA Net Product Sales | $650 - $680 | | SG&A Expenses | $480 - $510 | | R&D Expenses | $210 - $230 | [Clinical Development Highlights](index=2&type=section&id=CLINICAL%20HIGHLIGHTS) Positive Phase 3 results for lumateperone in MDD support an sNDA submission in H2 2024, alongside pipeline advancements in GAD, Alzheimer's, bipolar mania, and Parkinson's disease - Announced positive results from Phase 3 Studies 501 and 502 for lumateperone in MDD and plans to submit a supplemental NDA in the second half of 2024[1](index=1&type=chunk)[5](index=5&type=chunk) Lumateperone MDD Phase 3 Primary Endpoint Results (MADRS Total Score) | Study | Treatment Group | LS Mean Reduction vs. Baseline | LS Mean Difference vs. Placebo | p-value | Cohen's d | | :--- | :--- | :--- | :--- | :--- | :--- | | **Study 501** | Lumateperone 42 mg + ADT | 14.7 | -4.9 | <0.0001 | 0.61 | | | Placebo + ADT | 9.8 | | | | | **Study 502** | Lumateperone 42 mg + ADT | 14.7 | -4.5 | <0.0001 | 0.56 | | | Placebo + ADT | 10.2 | | | | - Pipeline advancements include: - Initiated two Phase 3 studies for lumateperone in bipolar mania[5](index=5&type=chunk) - Commenced patient enrollment in Phase 2 studies for ITI-1284 in Generalized Anxiety Disorder (GAD) and psychosis associated with Alzheimer's disease[5](index=5&type=chunk) - Ongoing Phase 2 trial of Lenrispodun (ITI-214) for Parkinson's disease, with topline results expected in 2025[6](index=6&type=chunk) [About CAPLYTA (lumateperone)](index=4&type=section&id=About%20CAPLYTA%20%28lumateperone%29) CAPLYTA is an oral, once-daily atypical antipsychotic approved for schizophrenia and bipolar depression, with boxed warnings for elderly dementia-related psychosis and suicidal thoughts in young adults - CAPLYTA is indicated for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder in adults, both as monotherapy and as adjunctive therapy[7](index=7&type=chunk)[11](index=11&type=chunk) - The drug has boxed warnings regarding increased risk of death in elderly patients with dementia-related psychosis and increased risk of suicidal thoughts and behaviors in pediatric and young adult patients[8](index=8&type=chunk) - The most common adverse reactions observed in clinical trials were somnolence/sedation, dizziness, nausea, and dry mouth[10](index=10&type=chunk) [Financial Statements](index=8&type=section&id=Financial%20Statements) This section presents the unaudited condensed consolidated statements of operations and balance sheets for Q2 2024 and year-to-date periods [Condensed Consolidated Statements of Operations](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Net product sales increased to **$161.3 million** in Q2 2024, significantly reducing the net loss to **$16.2 million** or **($0.16) per share** Condensed Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | :--- | :--- | | | **2024** | **2023** | **2024** | **2023** | | **Total revenues, net** | **$161,388** | **$110,792** | **$306,254** | **$206,098** | | Product sales, net | $161,276 | $110,128 | $306,119 | $204,859 | | **Total operating expenses** | **$189,111** | **$157,971** | **$354,929** | **$301,669** | | Cost of product sales | $11,354 | $7,163 | $21,254 | $13,914 | | SG&A | $121,574 | $101,014 | $234,659 | $199,937 | | R&D | $56,183 | $49,794 | $99,016 | $87,818 | | **Loss from operations** | **($27,723)** | **($47,179)** | **($48,675)** | **($95,571)** | | **Net loss** | **($16,220)** | **($42,784)** | **($31,467)** | **($86,837)** | | **Net loss per share** | **($0.16)** | **($0.45)** | **($0.31)** | **($0.91)** | [Condensed Consolidated Balance Sheets](index=10&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Total assets reached **$1.32 billion** as of June 30, 2024, driven by increased cash and investments, with total stockholders' equity at **$1.14 billion** Condensed Consolidated Balance Sheets (Unaudited, in thousands) | | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $693,306 | $147,767 | | Investment securities, available-for-sale | $329,601 | $350,174 | | Total current assets | $1,264,251 | $667,799 | | **Total assets** | **$1,320,504** | **$728,295** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $161,775 | $123,545 | | **Total liabilities** | **$175,892** | **$136,871** | | **Total stockholders' equity** | **$1,144,612** | **$591,424** | | **Total liabilities and stockholders' equity** | **$1,320,504** | **$728,295** |