Intra-Cellular Therapies (ITCI) Jefferies 2024 Global Healthcare Conference summary

Company overview and recent performance

• Focuses on intracellular mechanisms for drug development, originating from Paul Greengard's research.

• CAPLYTA approved for schizophrenia in 2019 and for bipolar depression in 2021, with strong revenue growth.

• 2023 revenues reached $462 million, with 2024 guidance of $645–$675 million.

• Prescription growth remains robust, with 3,000–4,000 new prescribers added quarterly.

• Market access is strong, with over 99% coverage in Medicare/Medicaid and 90% in commercial channels.

Product expansion and clinical milestones

• CAPLYTA is being studied for adjunctive treatment in major depressive disorder (MDD), with positive phase III data expected soon.

• Plans to file for MDD indication in the second half of the year, pending FDA discussions.

• Mixed features in MDD are under consideration for label expansion, with strategy to be determined after data review.

• Pediatric programs underway for bipolar depression and irritability in autism.

• Additional studies and indications are being pursued beyond current approvals.

Commercial strategy and growth drivers

• Direct-to-consumer (DTC) campaigns and physician education are key promotional activities.

• Recent DTC campaign launched, with qualitative feedback indicating potential for further growth.

• Prescription growth re-accelerated in Q2, tracking at about 10% quarter-to-date.

• No plans to update full-year guidance until Q2 results are finalized.

• MDD and bipolar depression are seen as equally significant market opportunities, each larger than schizophrenia.