ITCI - Intra-Cellular's Caplyta Is Likely A Blockbuster For Bipolar Depression Barring Generic Entry

2023-03-05 21:14:52 ET

Summary

• Intra-Cellular Therapies develops small-molecule drugs targeting the central nervous system for neuropsychiatric and neurological disorders. Caplyta is their lead drug, approved by the FDA for schizophrenia and bipolar depression.
• Caplyta's exceptional tolerability sets it apart from other antipsychotics, with a low incidence of weight gain, metabolic abnormalities, and movement disorders like tardive dyskinesia, making it an appealing treatment option.
• In the fourth quarter of 2022, Intra-Cellular Therapies reported net product sales of $87.4 million for Caplyta, representing a year-over-year increase of 243%.
• Intra-Cellular expects Caplyta to generate $430-$455 million in revenue this year, driven by strong growth and demand. With a projected 30% growth, Caplyta is on track to become a blockbuster drug in the near future.
• Intra-Cellular will face a significant challenge when Caplyta's NCE patent expires in December 2024, relying on Orange Book patents for exclusivity. With no significant value drivers beyond Caplyta for bipolar depression, Intra-Cellular is currently reasonably valued at $4 billion, making it a "Hold" recommendation until further developments arise.

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