Intra-Cellular Therapies Q2 2024 Financial Results and Corporate Update, Raises 2024 CAPLYTA Sales Guidance

Intra-Cellular Therapies, Inc., a biopharmaceutical company specializing in therapeutics for central nervous system (CNS) disorders, has announced its financial results for the second quarter ending June 30, 2024, along with a corporate update. The company reported a remarkable increase in net product sales of CAPLYTA, their leading product, which reached $161.3 million, a significant 46% growth compared to $110.1 million in the same quarter of 2023. This surge in sales also contributed to an overall increase in total revenues to $161.4 million from $110.8 million in the previous year.

Despite the revenue increase, the company reported a net loss of $16.2 million for the second quarter of 2024, a notable improvement from the $42.8 million net loss in 2023. The cost of product sales rose to $11.4 million from $7.2 million in the same period last year. Their selling, general, and administrative expenses (SG&A) also saw an increase to $121.6 million from $101.0 million in 2023. Research and development (R&D) expenses climbed to $56.2 million from $49.8 million in 2023. As of June 30, 2024, Intra-Cellular Therapies held a cash reserve totaling $1.025 billion.

CAPLYTA, the company's flagship product, continued its strong market performance with a 36% increase in total prescriptions during the second quarter of 2024 compared to the same period in 2023. The company plans to expand its sales force by approximately 150 representatives to further capitalize on the product's growing demand among primary care physicians.

The company's financial outlook for 2024 has been revised, projecting net product sales between $650 to $680 million for CAPLYTA, reflecting increased confidence in its market potential. SG&A expenses for the full year are expected to range between $480 to $510 million, primarily due to the expansion of their sales force. Conversely, the R&D expense forecast has been lowered to $210 to $230 million.

In terms of clinical progress, Intra-Cellular Therapies announced positive Phase 3 results from Studies 501 and 502, which evaluated lumateperone as an adjunctive therapy to antidepressants for treating major depressive disorder (MDD). This success has led to plans for a supplemental New Drug Application (sNDA) submission to the FDA in the latter half of 2024. The trials demonstrated that lumateperone significantly reduced the Montgomery-Asberg Depression Rating Scale (MADRS) total score compared to the placebo, indicating strong efficacy.

Additionally, the company has initiated patient enrollment in Phase 2 studies of ITI-1284 for Generalized Anxiety Disorder (GAD) and psychosis related to Alzheimer’s disease. Future plans include expanding patient enrollment for treating agitation associated with Alzheimer’s disease and other indications.

Other notable advancements in their pipeline include the ongoing development of lumateperone for bipolar mania, pediatric programs targeting irritability in autism spectrum disorder, and a long-acting injectable formulation. The company's phosphodiesterase type I inhibitor (PDE1) program for Parkinson's disease and ITI-1020 for cancer immunotherapy continue to progress, with anticipated results in 2025.

Intra-Cellular Therapies also reported ongoing studies for ITI-333, aimed at treating opioid use disorder and pain, and the non-hallucinogenic neuroplastogen ITI-1500, focusing on mood and anxiety disorders without the side effects associated with psychedelics.

Overall, the second quarter of 2024 was marked by substantial financial growth, significant advancements in clinical trials, and strategic plans to expand their market presence, setting the stage for continued success in the biopharmaceutical landscape.