Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing, and commercializing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's portfolio includes FDA-approved treatments for tardive dyskinesia (TD), chorea associated with Huntington's disease, classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency (CAH), and endometriosis and uterine fibroids in collaboration with AbbVie Inc. The company estimates that TD affects approximately 800,000 people in the U.S., that approximately 90% of the 40,000 people in the U.S. affected by Huntington's disease will develop chorea, and that CAH affects at least 20,000 people in the U.S.

INGREZZA competes with AUSTEDO (deutetrabenazine), marketed by Teva Pharmaceuticals Industries, for the treatment of TD in adults and chorea associated with Huntington's disease, and a once-daily dosing of AUSTEDO (AUSTEDO XR) was introduced in February 2023. CRENESSITY competes with high dose corticosteroid monotherapy which is the current standard of care for patients with CAH, and in the U.S. alone there are more than two dozen companies manufacturing steroid-based products. The company's investigational treatments for potential use in schizophrenia and depression may compete with several development-stage programs being pursued by other companies, including the muscarinic agonist COBENFY.

The company generates revenue primarily through net product sales of INGREZZA and CRENESSITY in the U.S., supplemented by collaboration revenues from royalties on AbbVie net sales of elagolix and Tanabe Pharma Corporation net sales of valbenazine. INGREZZA is sold exclusively in the U.S. through a limited specialty network of select specialty pharmacy providers, wholesale distributors, and specialty distributors, while CRENESSITY is sold in the U.S. through a single specialty pharmacy provider reflecting its rare disease focus. The company's commercial reach is powered by a specialized sales force of approximately 600 professionals across the U.S. focused on neurology, psychiatry, long-term care, and rare diseases.

INGREZZA (valbenazine) is a highly selective VMAT2 inhibitor approved in the U.S. for the treatment of TD and for the treatment of chorea associated with Huntington's disease, and it is covered by 22 issued, FDA Orange Book-listed U.S. patents which are set to expire between 2027 and 2040, with patent term extension for U.S. Patent No. 8,039,627 now expiring in 2031. INGREZZA net product sales were $2.51 billion ¹ for 2025, $2.31 billion ² for 2024, and $1.84 billion ³ for 2023 and accounted for a significant portion of total net product sales during each of these years. Pursuant to settlement agreements resolving all patent litigation against companies that filed ANDAs seeking approval to market generic versions of INGREZZA, such companies have the right to sell generic versions of INGREZZA in the U.S. beginning March 1, 2038, or earlier under certain circumstances.

CRENESSITY (crinecerfont) is a first-in-class CRF1 receptor antagonist approved in the U.S. for the treatment of CAH in adults and children, covered by 4 issued, FDA Orange Book-listed U.S. patents which are set to expire between 2035 and 2041, and CRENESSITY has been granted seven years of orphan drug exclusivity by the FDA. CRENESSITY net product sales were $301.2 million ⁴ for 2025 during its first full-year of launch. The company's clinical development pipeline includes osavampator (NBI-1065845), a potential first-in-class AMPA receptor potentiator in development for adults with major depressive disorder (MDD) for which a comprehensive Phase 3 clinical program has been initiated with initial topline data expected in 2027, and direclidine (NBI-1117568), an investigational oral agonist targeting the muscarinic M4 receptor for the treatment of schizophrenia and bipolar mania for which a comprehensive Phase 3 clinical program has been initiated with initial topline data expected in 2027.

In October 2025, the company announced the planned expansion of the INGREZZA and CRENESSITY sales teams to maximize commercial momentum, with the expansion expected to be completed by the end of the first quarter of 2026. In February 2025, the Board of Directors authorized a new share repurchase program under which the company may repurchase up to $500.0 million ⁵ of common stock, and during 2025 the company repurchased 1.5 million ⁶ shares on the open market under this program for a cost of $167.7 million ⁷ and received an additional 0.3 million ⁸ shares upon settlement of the 2024 accelerated share repurchase program in February 2025. In January 2025, the company received CMS notification that INGREZZA qualifies for the small biotech exception under the Medicare Drug Price Negotiation Program, which provides exemption from selection until 2027 for initial price applicability in 2029, and the company expanded formulary access for INGREZZA to include approximately 70% ⁹ of TD and Huntington's disease Medicare beneficiaries.

Total net product sales for 2025 increased $503.3 million ¹⁰, or 21.6% ¹¹, to $2.83 billion ¹², reflecting increased net product sales of CRENESSITY and INGREZZA driven by record total prescriptions on strong patient demand, partially offset by a lower net price due to new market access investments. Total revenues were $2.8605 billion ¹³ for 2025, compared to $2.3553 billion ¹⁴ for 2024 and $1.8871 billion ¹⁵ for 2023. Net income was $478.6 million ¹⁶ for 2025, compared to $341.3 million ¹⁷ for 2024 and $249.7 million ¹⁸ for 2023, and diluted earnings per share was $4.67 ¹⁹ for 2025, compared to $3.29 ²⁰ for 2024 and $2.47 ²¹ for 2023.

The company expects to continue making substantial investments in research and development personnel to support expansion into the development of biologics, including peptides, proteins, antibodies, conjugates, and gene therapies. The company's goal is to advance at least four new programs into Phase 1 and two programs into Phase 2 each year going forward. The company aims to launch, on average, approximately one new medicine every two years, driving long-term value for patients and shareholders.

The company has initiated a comprehensive Phase 3 clinical program for osavampator in MDD with initial topline data expected in 2027, including three acute randomized, double-blind, placebo-controlled studies, a randomized-withdrawal maintenance-of-effect study, and a long-term open-label safety extension. The company has also initiated a comprehensive Phase 3 clinical program for direclidine in schizophrenia with initial topline data expected in 2027, including studies evaluating efficacy in patients experiencing an acute relapse of schizophrenia and long-term safety, and initiated a Phase 2 study evaluating direclidine in bipolar mania in the fourth quarter of 2025.

The company has initiated a Phase 2 study of NBI-1065890, a next-generation, selective inhibitor of VMAT2, in adults with TD, and has advanced next-generation VMAT2 inhibitors NBI-1065890 into Phase 2 development and NBI-1140675 into Phase 1 development, engineered to have increased half-life, potency, and enhanced physiochemical properties relative to INGREZZA that may enable long-acting injectable administration. The company has initiated a Phase 1 clinical study for NBIP-01435, an investigational, long-acting CRF-1 receptor antagonist peptide administered as a subcutaneous injection for the potential treatment of CAH, and plans to file an IND with the FDA and advance NBIP-2118, a CRF-2 selective agonist for the treatment of obesity and related metabolic diseases, into Phase 1 development in the first half of 2026.

The company expects to incur a higher cost of revenues in future periods that includes the cost of CRENESSITY active pharmaceutical ingredients produced following FDA approval. The company's effective tax rate was 32.2% ²² for 2025, differing from federal and state statutory rates primarily due to foreign tax effects including the impact of GILTI, credits generated for research activities, excess tax benefits related to stock-based compensation, certain nondeductible expenses, and state income tax effects.

The company relies on third-party manufacturers for the production of INGREZZA, CRENESSITY, and product candidates, and believes continuing adequate supply of raw materials and API is assured through long-term commercial supply and manufacturing agreements with multiple manufacturers and a continued focus on the expansion and diversification of third-party manufacturing relationships. The company implemented a company-wide enterprise resource planning (ERP) system in 2024 to streamline certain existing business, operational, and financial processes.

Research and development expenses were $1.0157 billion ²³ for 2025, compared to $731.1 million ²⁴ for 2024 and $565.0 million ²⁵ for 2023. Capital expenditures were $34.0 million ²⁶ for 2025, $38.2 million ²⁷ for 2024, and $28.3 million ²⁸ for 2023. In February 2025, the Board of Directors authorized a share repurchase program under which the company may repurchase up to $500.0 million ²⁹ of common stock, and as of December 31, 2025, $332.3 million ³⁰ remained available for additional repurchases. The company has not paid any cash dividends on common stock since inception and does not anticipate paying cash dividends in the foreseeable future.

The company faces potential future payments of up to $14.87 billion ³¹ upon the achievement of certain milestones under existing collaboration and license agreements. The company may be subject to tariffs on imported pharmaceutical products, and in April 2025 the U.S. Department of Commerce initiated an investigation on imports of pharmaceuticals and pharmaceutical ingredients which may result in actions to impose tariffs on the pharmaceutical industry, and the U.S. presidential administration indicated it may impose a 100% tariff on any branded or patented pharmaceutical product unless a company is building a pharmaceutical manufacturing plant in the U.S.

The company received a civil investigative demand from the U.S. Department of Justice in August 2025 requesting certain documents and information related to the sales and marketing of INGREZZA, and the company is cooperating with the DOJ's request. The company's designation as a specified small manufacturer under the new Medicare Part D manufacturer discount program and INGREZZA's qualification for the small biotech exception for purposes of the Medicare drug price negotiation program are subject to various requirements and there is no assurance that the company will continue to qualify for these exemptions in the future, and the loss or potential loss of these exemptions, including as a result of a third party acquiring the company, could have an adverse impact on the business.

Management's message emphasizes the company's simple purpose to relieve suffering for people with great needs and highlights key elements of the commercial strategy including maximizing opportunities in INGREZZA and CRENESSITY through consistent and effective commercial execution, continued development of valbenazine as the best-in-class treatment for new patient populations, and leading the evolving understanding of VMAT2 biology. Management highlights the planned expansion of the INGREZZA and CRENESSITY sales teams to maximize commercial momentum, expected to be completed by the end of the first quarter of 2026, and notes that a larger sales force and enhanced infrastructure position the company for potential upcoming product launches from a diversified pipeline including late-stage candidates in major depressive disorder (osavampator) and schizophrenia (direclidine). Management states the goal to advance at least four new programs into Phase 1 and two programs into Phase 2 each year going forward and to launch, on average, approximately one new medicine every two years.

Total revenues were $2.8605 billion ³² for 2025, compared to $2.3553 billion ³³ for 2024 and $1.8871 billion ³⁴ for 2023. Net income was $478.6 million ³⁵ for 2025, compared to $341.3 million ³⁶ for 2024 and $249.7 million ³⁷ for 2023. Diluted earnings per share was $4.67 ³⁸ for 2025, compared to $3.29 ³⁹ for 2024 and $2.47 ⁴⁰ for 2023. Operating income was $619.1 million ⁴¹ for 2025, compared to $570.5 million ⁴² for 2024 and $250.9 million ⁴³ for 2023. Total cash, cash equivalents and marketable securities were $2.5434 billion ⁴⁴ as of December 31, 2025, compared to $1.8156 billion ⁴⁵ as of December 31, 2024. Cash flows from operating activities were $782.7 million ⁴⁶ for 2025, compared to $595.4 million ⁴⁷ for 2024 and $389.9 million ⁴⁸ for 2023. The provision for income taxes was $226.8 million ⁴⁹ for 2025, compared to $144.7 million ⁵⁰ for 2024 and $82.4 million ⁵¹ for 2023, with effective tax rates of 32.2% ⁵², 29.8% ⁵³, and 24.8% ⁵⁴ respectively. INGREZZA net product sales were $2.5137 billion ⁵⁵ for 2025, $2.3135 billion ⁵⁶ for 2024, and $1.8360 billion ⁵⁷ for 2023. CRENESSITY net product sales were $301.2 million ⁵⁸ for 2025 and $1.7 million ⁵⁹ for 2024. Research and development expenses were $1.0157 billion ⁶⁰ for 2025, $731.1 million ⁶¹ for 2024, and $565.0 million ⁶² for 2023. Selling, general, and administrative expenses were $1.1562 billion ⁶³ for 2025, $1.0072 billion ⁶⁴ for 2024, and $887.6 million ⁶⁵ for 2023. Charges associated with convertible senior notes were $138.4 million ⁶⁶ in 2024, and acquired in-process research and development was $17.4 million ⁶⁷ for 2025, $12.5 million ⁶⁸ for 2024, and $143.9 million ⁶⁹ for 2023.

The company may not be able to continue to successfully commercialize INGREZZA or successfully launch and commercialize CRENESSITY, and if physicians and patients do not accept these products or sales and marketing efforts are not effective, the company may not generate sufficient revenue. The company faces intense competition from AUSTEDO (deutetrabenazine) marketed by Teva Pharmaceuticals Industries for TD and chorea associated with Huntington's disease, and from high dose corticosteroid monotherapy for CAH. Government and third-party payors may impose sales and pharmaceutical pricing controls, and the Inflation Reduction Act of 2022 provides for Medicare drug price negotiation; INGREZZA qualifies for the small biotech exception providing exemption from selection until 2027 for initial price applicability in 2029, but there is no assurance the company will continue to qualify for these exemptions. The company depends on a limited number of third-party suppliers for the production of INGREZZA, CRENESSITY, and product candidates, and four customers across distribution arrangements represent over 90% of total gross product sales. The company received a civil investigative demand from the U.S. Department of Justice in August 2025 requesting documents and information related to sales and marketing of INGREZZA, and no assurance can be given as to the timing or outcome of the investigation.