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Jun 30, 2021
Intra-Cellular Q2 2021 Earnings Report
Intra-Cellular Therapies reported strong second-quarter results with increased revenue and prescription growth and made progress on clinical programs.
Key Takeaways
Intra-Cellular Therapies reported total revenues of $20.0 million for the second quarter of 2021, compared to $1.9 million for the second quarter of 2020. CAPLYTA net product revenues were $19.0 million for the second quarter, a 22% increase from the prior quarter.
Total revenues were $20.0 million for the second quarter of 2021, compared to $1.9 million for the second quarter of 2020.
CAPLYTA net product revenues were $19.0 million for the second quarter of 2021, compared to $1.9 million for the same period in 2020.
Net loss for the second quarter of 2021 was $68.7 million compared to a net loss of $63.7 million for the second quarter of 2020.
Cash, cash equivalents, restricted cash and investment securities totaled $556.2 million at June 30, 2021, compared to $658.8 million at December 31, 2020.
Intra-Cellular
Intra-Cellular
Forward Guidance
The company is focused on the commercialization of CAPLYTA and the development of treatments for psychiatric and neurological disorders. They anticipate results from clinical trials and initiation of new programs in the second half of 2021 and 2022.
Positive Outlook
- CAPLYTA supplemental new drug applications (sNDAs) for the treatment of bipolar depression are under review by the FDA, with a PDUFA target action date of December 17, 2021.
- Patient enrollment in Study ‘501, a Phase 3 clinical trial evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD), has commenced.
- Clinical conduct continues in Study ‘403 evaluating lumateperone 42 mg in patients with MDD and in patients with bipolar depression who exhibit mixed features.
- A Phase 2 study evaluating lenrispodun (ITI-214) in Parkinson’s disease is expected to commence in the second half of 2021.
- Results from ITI-333 program in opioid use disorder are anticipated in the second half of 2021.
Challenges Ahead
- There are no guarantees that CAPLYTA will be commercially successful.
- The COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA.
- We may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities.
- Our other product candidates may not be successful or may take longer and be more costly than anticipated.
- Our reliance on collaborative partners and other third parties for development of our product candidates.