Intra-Cellular Therapies, Inc. (NASDAQ: ITCI), a biopharmaceutical company focused on developing and commercializing therapeutics for central nervous system (CNS) disorders, has reported its financial results for the second quarter ended June 30, 2024, and provided a corporate update. The company's flagship product, Caplyta, has shown significant growth and positive momentum in various aspects.
Financial Performance: Total revenues for the second quarter of 2024 were $161.4 million, compared to $110.8 million for the same period in 2023. Net product sales of Caplyta were $161.3 million for the second quarter of 2024, a substantial increase from $110.1 million for the same period in 2023. The company reported a net loss of $16.2 million for the second quarter of 2024, significantly improved from a net loss of $42.8 million for the same period in 2023. Cost of product sales increased to $11.4 million in the second quarter of 2024 from $7.2 million for the same period in 2023. Selling, general and administrative (SG&A) expenses rose to $121.6 million for the second quarter of 2024, up from $101.0 million for the same period in 2023. Research and development (R&D) expenses also increased to $56.2 million for the second quarter of 2024, compared to $49.8 million for the same period in 2023. * The company had cash, cash equivalents, investment securities, and restricted cash totaling $1.025 billion at June 30, 2024.
Commercial Update: Caplyta's total prescriptions increased by 36% in the second quarter of 2024 compared to the same period in 2023 and 10% compared to the first quarter of 2024. In anticipation of the growing opportunity with primary care physicians, the company plans to increase the size of its sales force during the third quarter of 2024 by adding approximately 150 sales representatives. * The Centers for Medicare and Medicaid Services notified that Caplyta qualified for the specified small manufacturer exception pertaining to the Part D redesign of the Inflation Reduction Act.
Financial Outlook: The full-year 2024 net product sales guidance range for Caplyta was raised to $650 to $680 million. Full-year 2024 SG&A expense guidance range was increased to $480 to $510 million, primarily due to sales, marketing, and other expenses associated with the sales force expansion. * Full-year 2024 R&D expense guidance range was lowered to $210 to $230 million.
Clinical Highlights: Lumateperone, the active ingredient in Caplyta, showed positive results as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in pivotal clinical trials. The company initiated phase 3 studies to evaluate lumateperone in the acute treatment of manic or mixed episodes associated with bipolar I disorder and expects to enroll pediatric patients for the treatment of irritability associated with autism spectrum disorder. * Additionally, the company is advancing its pipeline programs, including ITI-1284 for generalized anxiety disorder and psychosis associated with Alzheimer's disease, PDE1 inhibitors for Parkinson's disease, ITI-1020 for cancer immunotherapy, and ITI-333 for opioid use disorder and pain.
This comprehensive update demonstrates the company's strong financial performance, robust commercial growth, and promising clinical advancements. Intra-Cellular Therapies remains focused on leveraging its flagship product, Caplyta, while advancing its pipeline to address unmet needs in CNS disorders. Following these announcements, the company's shares moved 0.5%, and are now trading at a price of $78.17. For the full picture, make sure to review Intra-Cellular Therapies's 8-K report.
