Intra-Cellular Therapies (ITCI) Q2 2024 earnings summary

Executive summary

• Caplyta net product sales reached $161.3 million in Q2 2024, up 46% year-over-year, driven by increased prescription volume for schizophrenia and bipolar depression indications, with total prescriptions rising 36%.

• Announced positive Phase 3 results for lumateperone as adjunctive therapy in major depressive disorder (MDD), supporting a supplemental NDA submission expected in the second half of 2024.

• Expanded development pipeline with progress in pediatric, bipolar mania, long-acting injectable programs, and new indications such as Parkinson's disease, substance use disorders, and Alzheimer's-related psychosis.

• Completed a $575 million public offering in April 2024, resulting in net proceeds of $543.1 million to support operations and R&D.

• Net loss for Q2 2024 narrowed to $16.2 million from $42.8 million in Q2 2023.

Financial highlights

• Q2 2024 total revenues were $161.4 million, up from $110.8 million in Q2 2023; six-month revenues reached $306.3 million, a 49% increase year-over-year.

• SG&A expenses were $121.6 million, and R&D expenses were $56.2 million for Q2 2024, both increasing from the prior year.

• Cash, cash equivalents, and investment securities totaled $1.025 billion as of June 30, 2024, with no debt.

• Q2 2024 net loss per share was $0.16, compared to $0.45 in Q2 2023.

• Operating loss for Q2 2024 was $27.7 million, improved from $47.2 million in Q2 2023.

Outlook and guidance

• Raised full-year 2024 Caplyta net product sales guidance to $650 million–$680 million, reflecting confidence in continued strong demand.

• Increased full-year SG&A expense guidance to $480 million–$510 million due to sales force expansion; reduced R&D expense guidance to $210 million–$230 million.

• Expansion of sales force by 150 representatives in Q3 2024 to target primary care physicians.

• Expect most impact from sales force expansion in 2025, with further expansion planned for potential MDD label approval.

• sNDA for lumateperone as adjunctive therapy for MDD expected to be submitted in the second half of 2024.