Illumina
22 named things its latest annual report says its results depend on, each in the company's own words. 15 of them are also named by other companies we've read.
Customers
Large centralized laboratory customers
concentrated innamed as a riskA portion of our revenue is increasingly derived from a small number of large, centralized laboratory customers.Risk factors (Item 1A)
Suppliers
Single-source suppliers
depends onnamed as a riskThe complex nature of our products requires customized, precision-manufactured sub-assemblies, components, and materials that currently are available from a limited number of sources, and, in the case of some sub-assemblies, components, and materials, from only a single source.Risk factors (Item 1A)
Also named by ACHR, AMAT, BAX, BSX, BWXT, CL, DOV, EL and 11 more
Other companies
GRAIL
approximately 14.5% of the sharesnamed as a riskFollowing the Spin-Off, we remain the obligor on the CVRs and, accordingly, continue to be required to record in our financial statements the estimated future liabilities associated with the CVRs.Risk factors (Item 1A)
Places
Greater China
earns from · $243 million in 2025named as a riskOur revenue from the Greater China region, which includes China, Taiwan, and Hong Kong, was $243 million in 2025.Risk factors (Item 1A)
International markets (outside United States)
earns from · $2,100 million, or 48%, of total consolidated revenue in 2025Shipments to customers outside the United States totaled $2,100 million, or 48%, of total consolidated revenue in 2025, compared to $2,084 million, or 48%, and $2,145 million, or 48%, in 2024 and 2023, respectively.Business (Item 1)
Also named by ABNB, ADSK, BSX, CROX, CRWD, DOCU, DXCM, EFX and 18 more
Singapore
operates innamed as a riskWe have sales offices located internationally throughout Europe, the Asia-Pacific region, and Brazil, as well as manufacturing and research facilities in Singapore and the United Kingdom.Risk factors (Item 1A)
Also named by A, AAPL, ALAB, AMAT, ANET, APP, AVGO, DLR and 12 more
Hazards
Commodities and inputs
Euro
exposed to its pricenamed as a riskOur foreign currency exposures are primarily concentrated in the euro, Japanese yen, Australian dollar, Canadian dollar, Singapore dollar, Chinese Yuan Renminbi, and British pound.Market risk (Item 7A)
Also named by ABBV, ABNB, ABT, ADBE, ADI, AME, AMG, AMGN and 186 more
Conflict minerals (Democratic Republic of the Congo)
depends onnamed as a riskCurrent or future social and environmental regulations or critical issues, such as those relating to the sourcing of minerals from conflict-affected areas such as the Democratic Republic of the Congo or the need to eliminate environmentally sensitive materials from our products, could restrict the supply of components and materials used in production or increase our costs.Risk factors (Item 1A)
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskDiagnostic products are regulated as medical devices by the FDA and comparable international agencies and may require either clearance from the FDA following the 510(k) pre-market notification process or pre-market approval from the FDA, in each case prior to marketing.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
Internal Revenue Service (IRS)
subject tonamed as a riskIf, notwithstanding the private letter ruling and opinion of tax counsel, the IRS determines that the Spin-Off and certain related transactions did not qualify for tax-free treatment for U.S. federal income tax purposes, the resulting tax liability to the Company and its shareholders could be substantial.Risk factors (Item 1A)
Also named by AAPL, ABNB, ADI, AJG, AMGN, BBSI, BMNR, BRO and 39 more
U.S. National Institutes of Health (NIH)
depends onnamed as a riskMany of our customers’, and a portion of our own, research and development and other activities have been funded, or may be funded in the future, by government grants, including from the U.S. National Institutes of Health, or NIH.Risk factors (Item 1A)
U.S. Federal Trade Commission (FTC) and Department of Justice (DOJ)
subject tonamed as a riskAntitrust enforcement agencies (including the U.S. Department of Justice (DOJ) and the FTC and their non-U.S. equivalents) may continue to closely scrutinize pricing policies or merger activity, with a particular focus on the healthcare sector, and there can be no assurance that our pricing policies or proposed, completed, or future mergers, acquisitions, and divestitures will not be the subject of an investigation or enforcement action by the DOJ, the FTC, or another antitrust enforcement agency.Risk factors (Item 1A)
Laws and programs
Medicare
earns fromnamed as a riskIn addition, insurers, including managed care organizations as well as government payors such as Medicare and Medicaid, have increased their efforts to control the cost, utilization, and delivery of healthcare services.Risk factors (Item 1A)
Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more
Medicaid
earns fromnamed as a riskPhysicians and patients may not order diagnostic tests that we develop, market, sell, or enable, such as our prenatal tests, unless third-party payors, such as managed care organizations as well as government payors such as Medicare and Medicaid and governmental payors outside of the United States, pay a substantial portion of the test price.Risk factors (Item 1A)
Also named by ABBV, ABT, ARE, ARWR, BAX, BMY, BSX, CHE and 39 more
Clinical Laboratory Improvement Amendments (CLIA)
subject tonamed as a riskIf we were to lose our CLIA certification or CAP accreditation, our business, financial condition, or results of operations could be adversely affected.Cybersecurity (Item 1C)
U.S. tariffs and trade restrictions
subject tonamed as a riskRecent tariff measures and related policy actions have already resulted in higher input costs and longer lead times, and we expect continued volatility in tariff rates, sector-specific duties, and licensing or other trade requirements in the U.S. and key international markets (including China) that may further raise costs, constrain pricing, reduce demand, or cause inventory imbalances.Risk factors (Item 1A)
China List of Unreliable Entities
subject tonamed as a riskOn February 4, 2025, regulatory authorities in China announced that Illumina had been added to the List of Unreliable Entities under the Provisions of the List of Unreliable Entities (the UEL Provisions).Risk factors (Item 1A)
EU In Vitro Diagnostic Regulation (IVDR) 2017/746
subject tonamed as a riskOur products sold as medical devices or IVDs in Europe are now regulated under the In Vitro Diagnostics Regulation (EU) 2017/746, the IVDR, that went into full enforcement in May 2022.Cybersecurity (Item 1C)
Russia sanctions and export restrictions
subject tonamed as a riskSanctions or export restrictions currently prohibit our ability to collect or pay liabilities owed by or to certain Russian entities or to supply products and services, directly or indirectly, into Russia.Risk factors (Item 1A)
Technology
Sequencing-by-synthesis (SBS) patents
depends onnamed as a riskFurthermore, as issued patents expire, including those related to our sequencing-by-synthesis technology, we may lose some competitive advantage as others develop, market, and sell competing products, which could negatively affect our revenue.Risk factors (Item 1A)