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Dec 31, 2019
Intra-Cellular Q4 2019 Earnings Report
Announced fourth quarter and full-year 2019 financial results and provided a corporate update.
Key Takeaways
Intra-Cellular Therapies reported a net loss of $40.6 million for the fourth quarter of 2019. The company is preparing for the commercial launch of CAPLYTA after its recent FDA approval.
FDA approved CAPLYTA for the treatment of schizophrenia in adults.
Company is preparing for the commercial launch of CAPLYTA later this month.
A national sales force consisting of approximately 240 sales representatives is expected to be deployed.
Topline data from lumateperone Phase 3 trial in bipolar depression and topline data from ITI-214 Phase 1/2 trial in heart failure are expected in 2020.
Intra-Cellular
Intra-Cellular
Forward Guidance
The company expects to launch CAPLYTA soon and anticipates data from Phase 3 trials in bipolar depression and a Phase 1/2 trial in heart failure in 2020.
Positive Outlook
- Commercial launch of CAPLYTA is on track.
- National sales force of approximately 240 representatives is expected.
- Topline results from the global adjunctive bipolar depression Phase 3 trial are expected in mid-2020.
- Phase 1 clinical trial for long-acting injectable formulation is planned in 2020.
- Phase 2 clinical trial in major depressive disorder is anticipated in 2020.
Challenges Ahead
- There are no guarantees that CAPLYTA will be commercially successful.
- The company may encounter issues, delays or other challenges in launching or commercializing CAPLYTA.
- CAPLYTA may not receive adequate reimbursement from third-party payors.
- CAPLYTA may not receive acceptance from patients and physicians for its approved indication.
- Other product candidates may not be successful or may take longer and be more costly than anticipated.