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Intra-Cellular Therapies(ITCI) - 2024 Q3 - Quarterly Results
2024-10-30 11:44
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 ...
Intra-Cellular Therapies Reports Third Quarter 2024 Financial Results, Provides Corporate Update and Raises 2024 Caplyta Sales Guidance
GlobeNewswire News Room· 2024-10-30 11:30
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]
Intra-Cellular Therapies (ITCI) Expected to Beat Earnings Estimates: Should You Buy?
ZACKS· 2024-10-23 15:07
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 ...
Intra-Cellular Therapies to Host Third Quarter 2024 Financial Results Conference Call and Webcast
GlobeNewswire News Room· 2024-10-17 12:00
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 ...
Intra-Cellular Therapies Announces Presentations at the 2024 European College of Neuropsychopharmacology Congress
GlobeNewswire News Room· 2024-09-23 12:00
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 (ITCI) Q2 Loss Narrower Than Expected, Sales Beat
ZACKS· 2024-08-08 14:56
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 ...
Intra-Cellular Therapies (ITCI) Reports Q2 Loss, Tops Revenue Estimates
ZACKS· 2024-08-07 13:46
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 ...
Intra-Cellular Therapies(ITCI) - 2024 Q2 - Quarterly Results
2024-08-07 11:49
[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** |
Intra-Cellular Therapies Announces Appointment of Sanjeev Narula as Chief Financial Officer
Newsfilter· 2024-08-07 11:40
Group 1 - Intra-Cellular Therapies, Inc. announced the appointment of Sanjeev Narula as Executive Vice President and Chief Financial Officer, effective August 12, 2024 [1] - Lawrence Hineline, the current CFO, will retire on the same date but will remain as a consultant to ensure a smooth transition [1] - Dr. Sharon Mates, the CEO, expressed excitement about Mr. Narula's extensive experience in large commercial stage pharmaceutical companies, highlighting his strategic and operational expertise [2] Group 2 - Mr. Narula has significant experience in the pharmaceutical industry, having served as CFO of Viatris since its formation in 2020, and previously held various financial leadership roles at Pfizer [3] - His background includes overseeing finance, procurement, and business technology at Upjohn, and he has held positions at American Express and Xerox India [3] - Mr. Narula holds a bachelor's degree in commerce (honors) from Delhi University and is a Chartered Accountant [3] Group 3 - Mr. Narula expressed his honor in joining Intra-Cellular Therapies and his eagerness to contribute to the company's growth strategy, particularly in building on the commercial success of CAPLYTA and advancing its pipeline [4] - Intra-Cellular Therapies focuses on developing innovative treatments for complex psychiatric and neurologic diseases, based on Nobel prize-winning research [5]
Intra-Cellular Therapies Announces Appointment of Sanjeev Narula as Chief Financial Officer
GlobeNewswire News Room· 2024-08-07 11:40
NEW YORK, Aug. 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) disorders, today announced that Sanjeev Narula will join the Company on August 12, 2024 and will serve as Executive Vice President, Chief Financial Officer. Mr. Narula will report to Dr. Sharon Mates, ITCI's Chairman and Chief Executive Officer. Lawrence Hineline, who currently serves as Chief ...