Intra-Cellular Therapies (ITCI) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Company overview and recent performance

• Founded in 2002, leveraging Nobel-winning research on intracellular signaling pathways in the brain.

• Developed CNS Profile platform to compare drug actions in the brain.

• CAPLYTA approved for schizophrenia in 2019 and for bipolar depression in 2021, with strong launch performance despite the pandemic.

• 2022 CAPLYTA revenues exceeded $462 million; 2023 guidance raised to $650–$680 million, with a 50% year-over-year increase in H1.

• Majority of revenue now comes from bipolar depression, reflecting a larger patient population than schizophrenia.

Clinical development and pipeline updates

• Ongoing phase III program for CAPLYTA as adjunctive treatment in major depressive disorder (MDD), targeting a larger market than bipolar.

• Two successful phase III studies (501, 502) in adjunctive MDD showed robust efficacy and safety, with sNDA filing planned for later this year.

• Pipeline includes ITI-1284 (deuterated lumateperone) in phase II/III for generalized anxiety disorder and Alzheimer's-related psychosis/agitation.

• PDE1 platform in phase II for Parkinson's disease and certain cancers; early-stage neuroplastogen program (ITI-1549 series) for mood disorders.

• Long-acting injectable lumateperone in clinical development, with both one- and two-month formulations being tested.

Commercial strategy and market expansion

• Sales force expanded from 370 to over 500, targeting both psychiatrists and high-volume primary care prescribers.

• Direct-to-consumer (DTC) campaigns and digital efforts have delivered strong ROI and increased brand awareness.

• Quarterly addition of 3,000–4,000 new prescribers, with over 43,000 unique prescribers since launch.

• Primary care now accounts for 25% of bipolar depression antipsychotic prescriptions, prompting deeper engagement.

• Future sales force expansion planned for MDD launch, leveraging existing relationships with high-volume prescribers.