Risk Sleuth
REGN · 10-K filed 4 Feb 2026 · year to 31 Dec 2025

Regeneron Pharmaceuticals

32 named things its latest annual report says its results depend on, each in the company's own words. 20 of them are also named by other companies we've read.

Read the filing on SEC.gov ↗

Customers

Two distributor customers

earns from · 77% of our total gross product revenuenamed as a risk
For the years ended December 31, 2025 and 2024, our product sales to two distributor customers accounted on a combined basis for 77% and 74% of our total gross product revenue, respectively.Risk factors (Item 1A)

Suppliers

Catalent Indiana, LLC (Novo Nordisk)

depends onnamed as a risk
The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent.Business (Item 1)

Also named by HALO

Partners and platforms

Sanofi

earns from · 41% of our total revenuesnamed as a risk
For the years ended December 31, 2025 and 2024, Sanofi collaboration revenue (most of which is attributable to our share of profits from the commercialization of Dupixent) represented 41% and 32% of our total revenues, respectively.Risk factors (Item 1A)

Also named by ARWR, LGND, MRNA

Bristol-Myers Squibb / Ono Pharmaceutical (Libtayo license)

depends on · royalties of 2.5%
Under the agreement, we paid royalties of 8.0% on worldwide sales of Libtayo through December 31, 2023, and are obligated to pay royalties of 2.5% from January 1, 2024 through December 31, 2026.Business (Item 1)

Intellia Therapeutics, Inc.

depends on · 75% (Intellia)/25% (us)
Nex-z, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia leads development activities and the parties share development expenses 75% (Intellia)/25% (us).Business (Item 1)

Hansoh Pharmaceuticals Group Company Limited

depends on · $80.0 million up-front payment
Under the terms of the agreement, we made an $80.0 million up-front payment in July 2025.Business (Item 1)

Tessera Therapeutics, Inc.

depends on · $150.0 million
Under the terms of the agreement, the Company made aggregate payments of $150.0 million in January 2026, consisting of an up-front payment and the purchase of Tessera preferred stock.Business (Item 1)

Bayer

depends onnamed as a risk
We rely on Bayer with respect to the commercialization of EYLEA HD and EYLEA outside the United States.Risk factors (Item 1A)

Also named by COO, CTVA, EXEL, GEHC

Santen

depends onnamed as a risk
If Bayer and, in Japan, Santen do not perform their obligations in a timely manner, or at all, our ability to commercialize EYLEA HD and EYLEA outside the United States will be significantly adversely affected.Risk factors (Item 1A)

Alnylam Pharmaceuticals, Inc.

depends on
We and Alnylam Pharmaceuticals, Inc. are parties to a collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver.Business (Item 1)

Also named by ARWR

Other companies

EYLEA HD and EYLEA (U.S.)

concentrated in · 31% of our total revenuesnamed as a risk
For the years ended December 31, 2025 and 2024, our aggregate EYLEA HD and EYLEA net product sales in the United States represented 31% and 42% of our total revenues, respectively.Risk factors (Item 1A)

Competitors

Amgen Inc.

competes withnamed as a risk
In addition, biosimilar versions of EYLEA have been approved and/or launched both in and outside the United States, including Amgen's Pavblu™ (aflibercept-ayyh) (launched in the United States in the fourth quarter of 2024).Risk factors (Item 1A)

Also named by ARWR, VKTX

Merck & Co., Inc.

competes withnamed as a risk
There are several competitors that are marketing and/or developing antibodies against PD-1 and/or PDL-1 (some of which were approved in the relevant indications and commercialized before Libtayo), including Merck's Keytruda® (pembrolizumab), Bristol-Myers Squibb's Opdivo® (nivolumab), Roche's Tecentriq® (atezolizumab), AstraZeneca's Imfinzi® (durvalumab), and Sun Pharma's Unloxcyt™ (cosibelimab).Risk factors (Item 1A)

Also named by GILD, UTHR

Genentech/Roche

competes withnamed as a risk
These include Genentech/Roche's Vabysmo® (faricimab-svoa) and Susvimo® (ranibizumab ocular implant); Novartis and Genentech/Roche's Lucentis® (ranibizumab); Novartis' Beovu® (brolucizumab); and a biosimilar version of Lucentis commercialized in the United States by Biogen Inc.Risk factors (Item 1A)

Compounded bevacizumab

competes withnamed as a risk
For example, a loss in market share to compounded bevacizumab due to patient affordability constraints impacted U.S. net product sales of EYLEA for the year ended December 31, 2025, as further described under Part II, Item 7.Risk factors (Item 1A)

Chinese biotechnology companies

competes withnamed as a risk
We face increasing competition from Chinese biotechnology and pharmaceutical companies, including Chinese state-owned or state-backed enterprises, with respect to both our marketed products and product candidates.Risk factors (Item 1A)

Places

Limerick, Ireland

operates in · approximately 120,000 liters of cell culture capacitynamed as a risk
Third-party service or supply failures, failures at our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, or failures at the facilities of any other party participating in the supply chain would adversely affect our ability to supply our products.Risk factors (Item 1A)

Also named by ADI

Rensselaer, New York

operates in · approximately 100,000 liters of cell culture capacitynamed as a risk
We currently have approximately 100,000 liters of cell culture capacity at our Rensselaer facility and approximately 120,000 liters of cell culture capacity at our Limerick facility.Business (Item 1)

Ireland

operates in · 2,149 employed in Ireland
As of December 31, 2025, we had 15,410 full-time employees, consisting of 11,961 employed in the United States, 2,149 employed in Ireland, and 1,300 employed in other countries (primarily in the United Kingdom, Japan, and Germany).Business (Item 1)

Also named by AAPL, ACN, ADI, AGX, BEN, CDNS, CELH, COR and 13 more

China

depends onnamed as a risk
Our ability or the ability of our collaborators or such other third parties to continue to engage these China-based suppliers or service providers for certain preclinical research programs and clinical development programs could be restricted due to geopolitical developments between the United States and China, including as a result of the escalation of tariffs or other trade restrictions or the recently enacted BIOSECURE Act.Risk factors (Item 1A)

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

Russia

named as a risk
Consequently, we are not able to prevent third parties from practicing our inventions in Russia or from selling or importing products made using our inventions in and into Russia.Risk factors (Item 1A)

Also named by ALSN, ATR, AVY, AXP, BKR, BSX, C, CDNA and 50 more

Commodities and inputs

Natural gas

depends onnamed as a risk
We and our collaborators and contract manufacturers would be unable to manufacture these materials if the relevant facility were to cease production due to regulatory requirements or actions, business interruptions, labor shortages or disputes, supply chain interruptions or constraints (including with respect to natural gas and other raw materials), contaminations, fire, climate change, natural disasters, acts of war or terrorism, or other problems.Risk factors (Item 1A)

Also named by AA, ADM, AEE, AEP, AES, AESI, AGX, ALB and 132 more

Japanese yen

exposed to its pricenamed as a risk
Our primary foreign currency exposure relates to movements in the Japanese yen, euro, British pound sterling, Canadian dollar, Chinese yuan, and Australian dollar.Risk factors (Item 1A)

Also named by ABBV, ABT, ACN, ADBE, ALK, AMAT, AMKR, BMY and 24 more

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk
We have recently received several CRLs from the FDA for regulatory submissions concerning our products or product candidates due to the FDA's findings from inspections at third-party manufacturers responsible for filling drug product.Risk factors (Item 1A)

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

U.S. Department of Justice

subject tonamed as a risk
As described further in Note 16 to our Consolidated Financial Statements included in this report, we are party to civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts concerning certain business activities.Risk factors (Item 1A)

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

Laws and programs

U.S. Section 232 pharmaceutical tariffs

subject to · 15% tariff on imports from the EUnamed as a risk
This investigation may lead to the imposition of tariffs on pharmaceutical imports, consistent with the current U.S. administration's stated policy objective of reshoring pharmaceutical manufacturing to the United States.Risk factors (Item 1A)

Also named by COR, GILD, LLY, MRK, PFE

Inflation Reduction Act (Medicare Drug Price Negotiation Program)

subject tonamed as a risk
The Medicare Drug Price Negotiation Program requires the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D.Risk factors (Item 1A)

Also named by AEE, AMGN, ARWR, BIIB, BKNG, BMY, CAH, CI and 26 more

Medicaid Drug Rebate Program

subject tonamed as a risk
In September 2024, CMS modified the regulations governing the Medicaid Drug Rebate program, which could further increase our costs and the complexity of compliance, impact rebate liabilities, and be time-consuming to implement.Risk factors (Item 1A)

Also named by BIIB, BMY, EXEL, HROW, PFE, VRTX

Medicare Part B

subject tonamed as a risk
The full extent to which the policy changes described above will ultimately impact reimbursement levels of our marketed products, including those covered under Medicare Part B (such as EYLEA HD and EYLEA), or our product candidates that may be covered under Medicare Part B or Medicare Part D in the future, is currently unclear.Risk factors (Item 1A)

Also named by ABBV, COR, HROW, UTHR

Most-favored-nation drug pricing executive order

subject tonamed as a risk
In July 2025, as a follow-up to this executive order, President Trump sent a letter to several pharmaceutical companies (including Regeneron) requesting that within the next 60 days they, among other matters, provide their existing drugs at MFN rates to Medicaid patients, guarantee MFN pricing for newly launched drugs, and provide for direct-to-consumer and direct-to-business distribution models for high-volume, high-rebate prescription drugs.Risk factors (Item 1A)

Also named by ARWR, HALO, INCY, MRNA

BIOSECURE Act

subject tonamed as a risk
Our ability or the ability of our collaborators or such other third parties to continue to engage these China-based suppliers or service providers for certain preclinical research programs and clinical development programs could be restricted due to geopolitical developments between the United States and China, including as a result of the escalation of tariffs or other trade restrictions or the recently enacted BIOSECURE Act.Risk factors (Item 1A)

Also named by AMGN, GILD, IONS, LLY

Biologics Price Competition (PPACA biosimilar pathway)

subject tonamed as a risk
As an EYLEA biosimilar has been launched in the United States following the expiration of the U.S. regulatory exclusivity period for EYLEA (i.e., the period during which no biosimilar product could be approved by the FDA) in May 2024, EYLEA no longer has U.S. market exclusivity.Risk factors (Item 1A)