Intra-Cellular Therapies Q1 2024 Financial Results

Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company dedicated to developing treatments for central nervous system disorders, announced its financial results for the first quarter of 2024, ending March 31, 2024.

CAPLYTA, the company's flagship product, demonstrated significant growth in the first quarter. Net product sales of CAPLYTA reached $144.8 million, a 53% increase from $94.7 million in the same period in 2023. Total revenues for the quarter were $144.9 million, up from $95.3 million in the previous year. This growth is driven by a 39% increase in total prescriptions for CAPLYTA compared to the first quarter of 2023. Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, highlighted the company's advancement in its adjunctive major depressive disorder (MDD) program, noting positive Phase 3 results from Study 501.

In terms of financial performance, Intra-Cellular Therapies reported a net loss of $15.2 million for the first quarter of 2024, significantly lower than the $44.1 million net loss in the same quarter of 2023. The cost of product sales increased to $9.9 million from $6.8 million in the previous year. Selling, general, and administrative (SG&A) expenses also rose to $113.1 million from $98.9 million, while research and development (R&D) expenses increased to $42.8 million from $38.0 million during the same period.

The company maintained strong financial health with $477.4 million in cash, cash equivalents, investment securities, and restricted cash as of March 31, 2024. Additionally, Intra-Cellular Therapies completed a public offering in April 2024, generating approximately $575 million in gross proceeds.

For the fiscal year 2024, Intra-Cellular Therapies reiterated its guidance for CAPLYTA net product sales to range between $645 million and $675 million. SG&A expenses are expected to be between $450 million and $480 million, while R&D expenses are anticipated to be between $215 million and $240 million.

Among clinical highlights, the company announced positive results from Study 501, a Phase 3 trial evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disorder. The study met its primary endpoint, showing a significant reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score compared to placebo. Lumateperone also achieved favorable outcomes in key secondary endpoints, including the Clinical Global Impression Scale for Severity of Illness (CGI-S) score and the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) scale.

The lumateperone pediatric program is progressing, with ongoing patient enrollment in studies for bipolar depression and autism spectrum disorder. The company also plans to start clinical trials for a long-acting injectable (LAI) formulation of lumateperone in the second half of 2024.

Other pipeline programs include ITI-1284-ODT-SL, a deuterated form of lumateperone for sublingual administration, which is being evaluated in Phase 2 trials for generalized anxiety disorder (GAD) and psychosis and agitation in Alzheimer's disease. The phosphodiesterase type I inhibitor (PDE1) program, including the lenrispodun (ITI-214) Parkinson's disease program, is ongoing, with topline results expected in 2025. The ITI-333 program is exploring treatments for opioid use disorder and pain, while the ITI-1500 Non-Hallucinogenic Psychedelic Program is focused on developing treatments for mood and anxiety disorders without the hallucinogenic effects of traditional psychedelics.

CAPLYTA (lumateperone) is approved for treating schizophrenia and depressive episodes associated with bipolar disorder in adults. It works through a combination of antagonist activity at serotonin 5-HT2A and dopamine D2 receptors. The safety and efficacy of CAPLYTA in other conditions are still being studied.