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Dec 31, 2024
Intra-Cellular Q4 2024 Earnings Report
Intra-Cellular Therapies reported a net loss for Q4 2024, with CAPLYTA net product sales increasing by 51% compared to the same period in 2023.
Key Takeaways
Intra-Cellular Therapies reported Q4 2024 financial results, featuring a 51% increase in CAPLYTA net product sales to $199.2 million compared to the same period in 2023. The FDA accepted the sNDA submission for lumateperone for adjunctive treatment of major depressive disorder (MDD).
CAPLYTA net product sales grew to $199.2 million in Q4 2024, a 51% increase year-over-year.
The FDA accepted the lumateperone sNDA submission for adjunctive treatment of MDD.
Patient enrollment commenced in two Phase 3 studies in pediatric patients for the treatment of irritability associated with autism spectrum disorder.
Cash, cash equivalents, investment securities, and restricted cash totaled $1.0 billion on December 31, 2024.
Intra-Cellular
Intra-Cellular
Forward Guidance
Intra-Cellular Therapies anticipates potential approval of CAPLYTA for adjunctive treatment of MDD and is expanding its field sales force.
Positive Outlook
- Potential approval of CAPLYTA for adjunctive treatment of MDD.
- Expansion of field sales force in anticipation of potential approval of CAPLYTA for MDD.
- Ongoing patient enrollment in Phase 3 studies for pediatric patients with autism spectrum disorder.
- Advancing ITI-1549 IND enabling studies.
- Patient enrollment ongoing in Phase 2 clinical studies evaluating ITI-1284 in patients with generalized anxiety disorder (GAD).
Challenges Ahead
- There is no guarantee we will complete the pending transaction with Johnson & Johnson within the timeframe we anticipate or at all.
- Challenges associated with execution of our sales activities, which in each case could limit the potential of our product.
- There is no guarantee that a generic equivalent of CAPLYTA will not be approved and enter the market before the expiration of our patents.
- There is no guarantee that our sNDA for the adjunctive treatment of MDD will be approved, if at all, on the timeline that we expect.
- Our other product candidates may not be successful or may take longer and be more costly than anticipated.