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Mar 31, 2020
Intra-Cellular Q1 2020 Earnings Report
Reported financial results for the first quarter of 2020 and provided a corporate update.
Key Takeaways
Intra-Cellular Therapies reported net product sales of CAPLYTA of approximately $882,500 for the first quarter of 2020. The company's net loss was $47.4 million, or $0.73 per share.
Successful launch of CAPLYTA with comprehensive promotional activities commencing the week of March 30, 2020.
Completed patient enrollment in Phase 3 clinical trial evaluating lumateperone as an adjunctive treatment in bipolar depression (Study 402).
Clinical conduct completed in Phase 1/2 study evaluating ITI-214 in patients with heart failure.
Recorded net product sales of CAPLYTA for the first quarter of 2020 of approximately $882,500.
Intra-Cellular
Intra-Cellular
Forward Guidance
The company is focused on the commercialization of CAPLYTA, advancing its clinical programs, and ensuring patient safety in accordance with FDA guidelines.
Positive Outlook
- Comprehensive promotional activities for CAPLYTA commenced.
- Substantial progress in market access coverage determinations with payers.
- Manufacturing and supply chain activities are supporting commercial demand for CAPLYTA.
- Patient enrollment completed in Phase 3 study evaluating lumateperone as adjunctive therapy in bipolar depression.
- Clinical conduct completed in Phase 1/2 clinical trial of ITI-214 in patients with chronic systolic heart failure.
Challenges Ahead
- Potential impact of the COVID-19 pandemic on the commercialization of CAPLYTA.
- Risks associated with current and planned clinical trials.
- Possible unexpected safety or tolerability issues with CAPLYTA following commercial launch.
- Other product candidates may not be successful or may take longer and be more costly than anticipated.
- Reliance on collaborative partners and other third parties for development of product candidates.