Neurocrine Biosciences — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenues for the third quarter ended September 30, 2026, were $1.123 billion, a 41% increase year-over-year compared to $795 million in the prior-year period.
• INGREZZA net product sales were $801 million, representing 17% year-over-year growth.
• CRENESSITY net product sales were $211 million, representing 115% year-over-year growth compared to $98 million.
• VYKAT XR net product sales were $107 million, with no comparable sales in the prior year.
• GAAP net income was $207 million ($1.96 per diluted share) compared to $210 million ($2.04 per diluted share) in the third quarter of 2025.
• Non-GAAP net income was $347 million ($3.29 per diluted share) compared to $222 million ($2.17 per diluted share) in the third quarter of 2025.
• GAAP operating expenses included $11.7 million in acquired in-process research and development (IPR&D) and $10 million in development milestone expenses.
• GAAP R&D expense was $352 million and Non-GAAP R&D expense was $317 million.
• GAAP SG&A expense was $366 million and Non-GAAP SG&A expense was $327 million.
• At September 30, 2026, total cash, cash equivalents, and marketable securities were $790 million, down from $2.543 billion at December 31, 2025.
• The company recorded a $52.3 million loss from changes in fair values of equity investments in the third quarter of 2026, compared to a $30.6 million gain in the same period of 2025.

Guidance and Future Outlook:

• Full-year 2026 INGREZZA net product sales guidance was raised to $2.9 billion to $2.925 billion from a prior range of $2.825 billion to $2.875 billion.
• Full-year 2026 GAAP R&D guidance remains unchanged at $1.275 billion to $1.325 billion.
• Full-year 2026 Non-GAAP R&D guidance remains unchanged at $1.140 billion to $1.190 billion.
• Full-year 2026 IPR&D guidance was updated to $34 million from $23 million.
• Full-year 2026 GAAP SG&A guidance was lowered to $1.540 billion to $1.560 billion from $1.575 billion to $1.600 billion.
• Full-year 2026 Non-GAAP SG&A guidance was lowered to $1.290 billion to $1.310 billion from $1.325 billion to $1.350 billion.
• Full-year 2026 GAAP Amortization of Acquired Intangible Assets guidance remains unchanged at $85 million to $90 million.
• Management anticipates meaningful growth opportunities in 2027 across INGREZZA, CRENESSITY, and VYKAT XR.
• Key clinical milestones expected include Phase 3 readouts for osavampator in major depressive disorder and direclidine in schizophrenia.

Business Segments and Product Lines:

• INGREZZA results reflected double-digit volume growth with record TRx and NRx supported by strong demand and high persistency rates.
• CRENESSITY sales were driven by steady new patient demand and high persistency, with approximately 80% reimbursement for dispensed prescriptions.
• VYKAT XR sales were driven by steady and consistent patient demand and persistency.
• The company announced the initiation of a Phase 1 first-in-human clinical study for NBIP-1968, a GLP-1/GIP/glucagon receptor triple agonist for obesity.
• The company announced the initiation of a Phase 1 first-in-human clinical study for NBIP-2118, a CRF2 peptide agonist for obesity.
• The company announced the initiation of a Phase 2 clinical study for NBI-567, an investigational muscarinic agonist for cognitive impairment in Alzheimer's disease.
• KINECT-PRO™ Phase 4 study results demonstrated substantial and sustained improvements in patient-reported quality of life and functionality with INGREZZA.
• The acquisition of Soleno Therapeutics, Inc. closed in May 2026, adding VYKAT XR to the portfolio and resulting in approximately $2.2 billion of intellectual property recorded on the balance sheet.

Market and Competitive Landscape:

• The company operates in the biopharmaceutical sector focusing on neurological, psychiatric, endocrine, and immunological disorders.
• The company has a diverse portfolio of first-in-class medicines including treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis, and uterine fibroids.
• The company is developing novel co-formulated combination therapies for obesity based on data from NBIP-1968 and NBIP-2118.

Risks and Challenges:

• Risks include the possibility that anticipated benefits from the Soleno acquisition may not be realized or integrated successfully.
• Risks related to the development of product candidates include potential failure to demonstrate safety and efficacy, regulatory delays, or adverse decisions by the FDA.
• Risks associated with commercialization include market uptake of VYKAT XR, competition from other therapies, and potential generic entrants.
• Risks include dependence on third parties for development, manufacturing, and commercialization activities.
• Risks include government and third-party regulatory efforts that may impose pricing controls or limit coverage and reimbursement.

Management Commentary and Tone:

• CEO Kyle W. Gano, Ph.D., stated that the third quarter marked a milestone with net product sales exceeding $1 billion for the first time.
• Management described the growth as reinforcing the strength of their strategy and expanding capacity to invest in innovation and the pipeline.
• The tone regarding the future is confident, citing "meaningful opportunities for continued growth" across the portfolio in 2027.
• Eiry W. Roberts, M.D., rejoined the executive management team as Chief Medical Officer.

Other Key Points:

• The acquisition of Soleno Therapeutics, Inc. closed in May 2026.
• The company recorded approximately $2.2 billion of intellectual property related to VYKAT XR on the balance sheet, to be amortized over an expected life of 16 years.
• Non-GAAP adjustments included $52 million loss from changes in fair values of equity investments and acquisition-related transaction and integration costs.
• The company will host an R&D Day in New York on December 15, 2026.
• A pre-tax gain of $28.6 million was recognized on the sale of Neurocrine Group Limited in January 2026.
• Stock-based compensation expense related to the acceleration of vesting of equity awards for Soleno employees was included in Non-GAAP guidance adjustments.