Financial Performance & Guidance - 2022 INGREZZA net product sales reached $1.428 billion[18] - The company anticipates 2023 INGREZZA net product sales to be in the range of $1.67 billion to $1.77 billion (Tardive Dyskinesia Only)[2, 167] - Non-GAAP net income for 2022 was $343 million, with diluted earnings per share at $3.47, representing an 83% year-over-year growth[15] - Cash and investments as of December 31, 2022, totaled approximately $1.3 billion[2] Research & Development - Non-GAAP R&D expense for 2022 was $406 million, driven by an expanded portfolio[15] - The company expects GAAP R&D expenses for 2023 to be between $550 million and $580 million[18] - The company has 12 programs currently in mid-to-late-stage studies[2] Key Milestones & Activities - Potential sNDA approval of Valbenazine for the treatment of Chorea Associated with Huntington Disease, with a PDUFA date of August 20[8] - Anticipate several mid-to-late-stage data readouts in the second half of 2023, including registrational data for Crinecerfont in Congenital Adrenal Hyperplasia (CAH) in adults and pediatrics[8] - Initiated Phase 2 study of NBI-1117568, a selective M4 agonist, for the treatment of Schizophrenia in Q3[8] Market Opportunity - Approximately 600,000 people in the U S are affected by Tardive Dyskinesia (TD), with 70% remaining undiagnosed[2, 65, 66]
Neurocrine(NBIX) - 2022 Q4 - Earnings Call Presentation