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Mar 31, 2021
Intra-Cellular Q1 2021 Earnings Report
Intra-Cellular Therapies reported financial results for Q1 2021 and provided a corporate update.
Key Takeaways
Intra-Cellular Therapies reported total revenues of $15.9 million for the first quarter of 2021, with CAPLYTA net product revenues reaching $15.6 million. The FDA accepted the sNDAs for lumateperone for bipolar depression treatment, setting a PDUFA target action date of December 17, 2021.
Total revenues for the first quarter were $15.9 million, compared to $1.1 million for the same period in 2020.
CAPLYTA net product revenues were $15.6 million, compared to $0.9 million for the same period in 2020.
The FDA accepted sNDAs for lumateperone for bipolar depression treatment with a PDUFA target action date of December 17, 2021.
First quarter CAPLYTA total prescriptions increased 23% versus the previous quarter.
Intra-Cellular
Intra-Cellular
Forward Guidance
Intra-Cellular Therapies is focused on the commercialization of CAPLYTA and advancing its clinical programs. They anticipate results from lumateperone long-acting injectable and ITI-333 clinical trials in the second half of 2021 and plan to advance lenrispodun (ITI-214) into a Phase 2 clinical study in Parkinson’s disease.
Positive Outlook
- Potential approval of sNDAs for lumateperone for bipolar depression.
- Advancing lumateperone clinical studies in major depressive disorder.
- Expected results from lumateperone long-acting injectable clinical trial.
- Advancing ITI-214 into a Phase 2 clinical study in Parkinson’s disease.
- Ongoing ITI-333 clinical trial with expected results in the second half of 2021.
Challenges Ahead
- Uncertainty regarding FDA approval of sNDAs.
- Potential delays or challenges in commercializing CAPLYTA.
- Negative impact of COVID-19 pandemic on commercial plans and sales.
- Risks associated with current and planned clinical trials.
- Potential safety or tolerability issues with CAPLYTA.