Intra-Cellular Therapies(ITCI) - 2024 Q2 - Quarterly Results

Q2 2024 Financial Highlights 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 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] - 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] 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 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][5] 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] - Commenced patient enrollment in Phase 2 studies for ITI-1284 in Generalized Anxiety Disorder (GAD) and psychosis associated with Alzheimer's disease[5] - Ongoing Phase 2 trial of Lenrispodun (ITI-214) for Parkinson's disease, with topline results expected in 2025[6] About CAPLYTA (lumateperone) 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][11] - 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] - The most common adverse reactions observed in clinical trials were somnolence/sedation, dizziness, nausea, and dry mouth[10] Financial Statements 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 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 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 |