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Dec 31, 2020
Intra-Cellular Q4 2020 Earnings Report
Intra-Cellular Therapies reported fourth quarter financial results, marked by the successful launch of CAPLYTA and strong commercial execution amidst COVID-19 challenges.
Key Takeaways
Intra-Cellular Therapies reported Q4 2020 financial results, featuring CAPLYTA net product revenues of $12.4 million and a 77% increase in total prescriptions compared to the previous quarter. The company is pursuing CAPLYTA label expansion and advancing its pipeline with ITI-1284.
CAPLYTA achieved net product revenues of $12.4 million in Q4 2020.
Total CAPLYTA prescriptions increased by 77% compared to the previous quarter.
Submitted CAPLYTA supplemental new drug applications (sNDAs) to the FDA for the treatment of bipolar depression in adults.
Initiated late-stage programs in adjunctive major depressive disorder (MDD) and in patients with bipolar depression and MDD exhibiting mixed features.
Forward Guidance
The company anticipates an FDA target action date in the second half of 2021 for lumateperone as monotherapy and as adjunctive treatment with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder. Results from Study ‘403 are anticipated in the second half of 2022. Initial results from the LLAI study and ITI-333 study are anticipated in the second half of 2021.
Positive Outlook
- FDA target action date anticipated in the second half of 2021 for bipolar depression sNDAs.
- Phase 3 clinical program evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD is anticipated to begin in 2021.
- Initial results from LLAI formulation study anticipated in the second half of 2021.
- Phase 2 clinical study in Parkinson’s disease is planned in 2021.
- Results from ITI-333 study are anticipated in the second half of 2021.
Challenges Ahead
- Results from Study ‘403 are anticipated in the second half of 2022.
- The COVID-19 pandemic may negatively impact commercial plans and sales for CAPLYTA.
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