Intra-Cellular Therapies (ITCI) 7th Annual Evercore ISI HealthCONx Conference summary

Commercial performance and financial outlook

• Caplyta approved for schizophrenia in 2019 and bipolar depression in 2021, with 2023 revenue guidance of $665–$685 million.

• Recent sNDA submitted for adjunctive treatment in major depressive disorder (MDD), with launch expected in the second half of next year.

• Profitability is a near-term goal, but current focus remains on investing in sales force expansion and pipeline development; more guidance expected in February.

• Revenue run rate is $700 million, with consensus for next year at $935 million; break-even expected around this level, but OpEx will rise due to investments.

• Inflation Reduction Act (IRA) impacts and Medicare Part D redesign have been factored into projections.

Product growth drivers and market dynamics

• Bipolar depression is the main growth driver, with schizophrenia now contributing about 15% of Caplyta scripts.

• MDD approval is expected to create a significant inflection in growth, potentially surpassing $1 billion in annual sales.

• Commercial sales are the largest segment, followed by Medicare; commercial share will increase with MDD launch.

• Net selling price is expected to rise moderately due to price increases and gross-to-net improvements.

• Some off-label MDD use is occurring, but major growth is anticipated post-approval and full promotional efforts.

Long-term vision and pipeline development

• Five-year market opportunity estimated at $5 billion, driven by leadership in bipolar depression and MDD.

• Assumptions include best-in-class profile in MDD and continued market share gains; schizophrenia is a smaller contributor.

• Patent protection extends through 2040, with recent additions to the Orange Book; deuterated lumateperone will have further patents upon approval.

• Phase II/III trials for deuterated lumateperone in GAD, psychosis in Alzheimer's, and agitation in Alzheimer's expected to read out in 2027.

• Long-acting injectable formulations are in Phase I, with selection of lead candidates expected in 2025.