Intra-Cellular Therapies Reports First Quarter 2024 Financial Results

Published

CAPLYTA Q1 2024 net product sales were $144.8 million, compared to $94.7 million for the same period in 2023, representing a 53% increase

CAPLYTA’s strong prescription uptake continues: Q1 2024 CAPLYTA total prescriptions increased 39%, versus the same period in 2023

CAPLYTA 2024 net product sales guidance reiterated at $645 - $675 million

Announced robust positive Phase 3 results from Study 501 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disorder (MDD)

NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the first quarter ended March 31, 2024 and provided a corporate update.

“We continued to deliver strong growth for CAPLYTA in the first quarter,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We also achieved a significant milestone in our adjunctive MDD program with positive Phase 3 Study 501 results, further advancing our vision for CAPLYTA as a drug of choice across mood disorders.”

First Quarter Financial Highlights:

  • Total revenues were $144.9 million for the first quarter of 2024, compared to $95.3 million for the same period in 2023. Net product sales of CAPLYTA were $144.8 million for the first quarter of 2024, compared to $94.7 million for the same period in 2023.
  • Net loss for the first quarter of 2024 was $15.2 million compared to a net loss of $44.1 million for the same period in 2023.
  • Cost of product sales was $9.9 million in the first quarter of 2024 compared to $6.8 million for the same period in 2023.
  • Selling, general and administrative (SG&A) expenses were $113.1 million for the first quarter of 2024, compared to $98.9 million for the same period in 2023.
  • Research and development (R&D) expenses were $42.8 million for the first quarter of 2024, compared to $38.0 million for the same period in 2023.
  • Cash, cash equivalents, investment securities and restricted cash totaled $477.4 million at March 31, 2024. In April 2024, we completed an underwritten public offering of 7,876,713 shares of our common stock resulting in gross proceeds of approximately $575 million and net proceeds to us of approximately $543 million, after deducting underwriting discounts and commissions and offering expenses.

Fiscal 2024 Financial Outlook:

  • Full year 2024 CAPLYTA net product sales guidance of $645 to $675 million reiterated.
  • Full year 2024 SG&A expense guidance of $450 to $480 million and R&D expense guidance of $215 to $240 million reiterated.

CLINICAL HIGHLIGHTS

Lumateperone:

  • Adjunctive MDD program: Studies 501, 502 and 505 are our global Phase 3 clinical trials evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD.In April 2024, we announced robust positive results from Study 501 with lumateperone achieving statistically significant and clinically meaningful results in both the primary and the key secondary endpoints. Lumateperone given as adjunctive therapy to antidepressants met the primary endpoint by demonstrating reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score compared to placebo plus antidepressants at Week 6 (4.9 point reduction vs. placebo; p

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