Intra-Cellular Therapies (ITCI) Goldman Sachs 45th Annual Global Healthcare Conference summary

Key value drivers and recent performance

• CAPLYTA revenues grew 86% to $462M last year, with 2024 guidance of $645–675M.

• Growth is driven by broad use in bipolar I/II and schizophrenia, with over 40,000 unique prescribers and 3,000–4,000 new prescribers added quarterly.

• Bipolar depression is the main growth engine, with strong uptake expected to continue for years.

• Compliance and persistency with CAPLYTA outpace other antipsychotics, attributed to favorable safety and tolerability.

• Gross-to-net guidance remains in the mid-30% range, with no expected increase from new indications.

Pipeline and label expansion

• Robust phase 3 program in major depressive disorder (MDD); first study showed robust efficacy, second readout expected soon.

• Additional studies target pediatric bipolar disorder, autism-related agitation, and mania.

• ITI-1284, a deuterated lumateperone, is in phase 2 for Alzheimer's agitation/psychosis and generalized anxiety disorder (GAD).

• Early-stage non-hallucinogenic psychedelics program aims for rapid-acting depression treatments, with clinical entry planned next year.

Market opportunity and competitive landscape

• Mood disorders (bipolar depression, MDD) represent the largest opportunity, with schizophrenia becoming a smaller share over time.

• MDD and bipolar depression have similar addressable populations for antipsychotic use.

• Competitive set in MDD and bipolar depression is limited, similar to each other and less crowded than schizophrenia.