NBIX · 10-K filed 11 Feb 2026 · year to 31 Dec 2025

Neurocrine Biosciences

30 named things its latest annual report says its results depend on, each in the company's own words. 19 of them are also named by other companies we've read.

Read the filing on SEC.gov ↗

Customers

Specialty pharmacy providers and distributors (top four customers)

concentrated in · over 90% of our total gross product salesnamed as a risk

In the aggregate, four of these customers across our INGREZZA and CRENESSITY distribution arrangements represent over 90% of our total gross product sales.Risk factors (Item 1A)

Pharmacy benefit managers

named as a risk

In addition, we could also be subject to amendments in our rebate agreements with pharmaceutical benefit managers that require us to pay larger rebate amounts or modify our formulary position, which could have a material adverse effect on our business.Risk factors (Item 1A)

Also named by ABBV, AMGN, HROW, WMT

CRENESSITY single specialty pharmacy provider

concentrated innamed as a risk

In addition, CRENESSITY is distributed by one specialty pharmacy provider.Risk factors (Item 1A)

Suppliers

Third-party contract manufacturers

depends onnamed as a risk

We depend on a limited number of suppliers for the production (including API) of INGREZZA, CRENESSITY, and our product candidates and for the packaging of INGREZZA and CRENESSITY.Risk factors (Item 1A)

Also named by CIEN, KVUE, ON, SYM, WDFC

Partners and platforms

AbbVie Inc.

depends onnamed as a risk

For example, we depend on AbbVie for the manufacture and commercialization of ORILISSA and ORIAHNN and for the continued development of elagolix.Risk factors (Item 1A)

Tanabe Pharma Corporation

depends onnamed as a risk

We collaborate with TPC for the commercialization of DYSVAL in Japan and for the continued development and commercialization of valbenazine for movement disorders in other select Asian markets.Risk factors (Item 1A)

Takeda Pharmaceutical Company Limited

depends on

Osavampator was in-licensed from Takeda Pharmaceutical Company Limited (Takeda) in 2020, and we have exclusive worldwide rights to develop and commercialize osavampator, except in Japan, where Takeda has exclusive development and commercialization rights.Business (Item 1)

Also named by ARWR

Nxera Pharma UK Limited

depends on

Direclidine was in-licensed from Nxera Pharma UK Limited (Nxera) in 2021, and we retain global rights.Business (Item 1)

Xenon Pharmaceuticals Inc.

depends on

NBI‑921355 was in-licensed from Xenon Pharmaceuticals Inc. in 2019, and we retain global rights.Business (Item 1)

Other companies

INGREZZA generic entry (ANDA settlements)

competes withnamed as a risk

Pursuant to the terms of the respective settlement agreements, such companies have the right to sell generic versions of INGREZZA in the U.S. beginning March 1, 2038, or earlier under certain circumstances.Business (Item 1)

Competitors

Teva Pharmaceutical Industries (AUSTEDO)

competes withnamed as a risk

Lower negotiated prices for AUSTEDO and AUSTEDO XR may increase competitive pressures on INGREZZA, including heightened pricing pressure and potential adverse effects on formulary coverage.Risk factors (Item 1A)

Places

Europe

depends onnamed as a risk

The third parties that manufacture our products have manufacturing facilities located in Europe.Risk factors (Item 1A)

Also named by ADSK, AME, AMRC, ATR, BCSF, BKNG, BMI, BMY and 60 more

China

depends onnamed as a risk

Some of our suppliers and research and development collaborators are located in China, exposing us to the possibility of supply disruption in the event of changes to the laws, rules, regulations, and policies of the governments of the U.S. or China.Risk factors (Item 1A)

Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk

A prolonged government shutdown could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.Risk factors (Item 1A)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

Centers for Medicare & Medicaid Services (CMS)

subject tonamed as a risk

In April 2024, we were notified by CMS that it qualified as a “specified small manufacturer” and will receive the discount phase-in discussed above for INGREZZA.Risk factors (Item 1A)

Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more

U.S. Department of Justice (DOJ)

subject tonamed as a risk

In August 2025, we received a civil investigative demand from the U.S. Department of Justice (DOJ) requesting certain documents and information related to our sales and marketing of INGREZZA.Risk factors (Item 1A)

Also named by AAPL, ACN, AMAT, ASO, BEN, BSX, CAH, CDNA and 21 more

FDA Office of Prescription Drug Promotion

subject tonamed as a risk

In September 2025, the FDA Office of Prescription Drug Promotion issued numerous untitled letters and warning letters to drug manufacturers regarding advertising and promotion, including one untitled letter addressed to us which alleges that certain claims made in promotional material for INGREZZA are misleading.Risk factors (Item 1A)

Laws and programs

Medicare

earns from · a majority of our current revenuenamed as a risk

Further, a majority of our current revenue is derived from federal healthcare program payors, including Medicare and Medicaid.Risk factors (Item 1A)

Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more

Medicaid

earns from · a majority of our current revenuenamed as a risk

Further, a majority of our current revenue is derived from federal healthcare program payors, including Medicare and Medicaid.Risk factors (Item 1A)

Also named by ABBV, ABT, ARE, ARWR, BAX, BMY, BSX, CHE and 39 more

U.S. pharmaceutical tariffs (Section 232 investigation)

subject to · 100% tariffnamed as a risk

The U.S. presidential administration also indicated that 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.Risk factors (Item 1A)

Also named by ARE, OSCR, VTRS

Orphan Drug Act

subject to · seven years

CRENESSITY has been granted seven years of orphan drug exclusivity by the FDA.Business (Item 1)

Also named by ARWR, IONS, KRYS, PVLA, UTHR, VKTX

One Big Beautiful Bill Act (OBBBA)

subject tonamed as a risk

In addition, the OBBBA is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding and limiting provider taxes used to fund the program.Risk factors (Item 1A)

Also named by AA, ABR, ADI, ADM, ALB, AMAT, AMGN, AMKR and 121 more

OECD Pillar Two

subject tonamed as a risk

Based on our current understanding of the minimum revenue thresholds contained in the Pillar Two proposal, we currently expect to fall within the scope of its rules.Risk factors (Item 1A)

Also named by APO, BAM, BAX, BF/B, CHRW, COHR, CPNG, CRM and 45 more

Inflation Reduction Act of 2022 (IRA)

subject tonamed as a risk

Enacted healthcare reform, drug pricing measures and other recent legislative initiatives, including the Inflation Reduction Act of 2022 (IRA), could adversely affect our business.Risk factors (Item 1A)

Also named by ABBV, APD, ARE, BKH, DD, DHR, ELV, ENPH and 30 more

340B Drug Pricing Program

subject tonamed as a risk

Continued expansion of the 340B Drug Pricing Program and growth of entities claiming entitlement to 340B pricing, including in ways that may be inconsistent with the statutory scheme, could impact our revenue.Risk factors (Item 1A)

Also named by ABBV, BAX, BIIB, BMY, CAH, COR, CVS, EXEL and 13 more

Medicare Part D

subject tonamed as a risk

INGREZZA is reimbursed under Medicare Part D, and increased discounts could impact INGREZZA revenues, while also having an industry-wide impact on the cost of other Part D program drugs such as AUSTEDO and AUSTEDO XR.Risk factors (Item 1A)

Also named by ABBV, AMGN, BMY, CI, CNC, CVS, ELV, INCY and 5 more

Medicare Drug Price Negotiation Program

subject tonamed as a risk

We were notified in January 2025 that INGREZZA qualifies for the small biotech exception, which provides an exemption from selection until 2027 (for initial price applicability year 2029, pursuant to which negotiated pricing would go into effect, if selected).Risk factors (Item 1A)

Also named by IONS, JNJ, PFE

Most-Favored-Nation drug pricing

subject tonamed as a risk

In December 2025, CMS issued proposed regulations that, if finalized, would create CMMI demonstrations that would institute MFN-level pricing in the Medicare Part D and Part B markets.Risk factors (Item 1A)

Also named by EXEL, MTD, VTRS

Technology

INGREZZA (valbenazine)

earns from · $2.51 billion for 2025named as a risk

INGREZZA net product sales were $2.51 billion for 2025, $2.31 billion for 2024, and $1.84 billion for 2023 and accounted for a significant portion of our total net product sales during each of these years.Business (Item 1)

CRENESSITY (crinecerfont)

earns from · $301.2 million for 2025named as a risk

CRENESSITY net product sales were $301.2 million for 2025 during its first full-year of launch.Business (Item 1)