What the changes say
- China barred Illumina from exporting sequencing instruments, intensifying China-specific regulatory and revenue risk.
- Tariffs and trade restrictions are newly identified as raising costs, disrupting supply, and weakening demand.
- GRAIL, LDT, cybersecurity, global operations, and revenue-timing risks were removed or narrowed from the section.
What changed since the prior 10-K
New
- NewRisks Relating to Our Sales of Products and Services, Marketing and Research and Development
Changes in tariffs, trade restrictions, and customs or export/import regulations have impacted, and we expect will continue to impact, our business by increasing costs and administrative burdens, disrupting cross-border flows, and affecting customer demand
Tariffs and changing trade rules, especially involving China, could raise input costs, delay shipments, limit pricing, and reduce customer demand.
Dropped
- DroppedRisks Related to Acquisitions, Including the Acquisition of GRAIL
As previously disclosed, the Acquisition was subject to various legal challenges, including by the FTC and European Commission. As a result, we have been a party to a number of regulatory and administrative proceedings regarding the Acquisition
- DroppedRisks Relating to Government Regulation
Certain of our in vitro diagnostic products, or IVDs, are currently available through laboratories that are certified under the Clinical Laboratory Improvements Amendments (CLIA) of 1988. These IVD products are commonly called “laboratory developed tests,” or LDTs
- DroppedRisks Relating to Information Technology Security and Continuity
into our products, our information technology infrastructure and our products may in the future be, and have in the past been, impacted by cyber-attacks, employee error, malfeasance, or other disruptions
- DroppedRisk Relating to Public Health Crises
Brazil, as well as manufacturing and research facilities in Singapore and the United Kingdom. Shipments to customers outside the United States comprised 48%, 48%, and 50% of our total revenue in 2024, 2023, and 2022, respectively
- DroppedRisk Relating to Public Health Crises
and projects may be subject to significant uncertainty because of the long-term nature of development and collaboration projects, as well as sample availability for population genomics projects
Reworded
- 91% rewrittenRisk Relating to Public Health Crises
Doing business internationally, especially in emerging markets, creates operational risk for our business
The international-risk discussion now identifies Singapore and UK facilities and reports non-U.S. shipments at 48% of revenue for 2025, 2024, and 2023.
- 68% rewrittenRisk Relating to Public Health Crises
Our operating results may vary significantly from period to period
The revised text removes specific discussion of collaboration agreements and government-funded population-genomics projects affecting revenue timing.
- 54% rewrittenRisks Relating to Our Sales of Products and Services, Marketing and Research and Development
Regulatory authorities in China have added Illumina to the List of Unreliable Entities, which could result in fines or restrictions on our ability to do business in China and could have a material adverse effect on our revenue and results of operations
China’s authorities now prohibit Illumina from exporting sequencing instruments to China, effective after a March 4, 2025 notice.
Was: China’s Ministry of Commerce has added Illumina to its List of Unreliable Entities, which could result in fines or restrictions on our ability to do business in China and could have a material adverse effect on our revenue and results of operations
- 45% rewrittenRisks Relating to Information Technology Security and Continuity
Disruption of critical information technology systems could have an adverse effect on our operations, business, customer relations, and financial condition
The IT-risk wording changes from systems being vulnerable to damage to being vulnerable to damage or exploitation, and says recovery planning does not address every eventuality.
- 42% rewrittenRisks Related to Acquisitions
Our acquisitions expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies
No substantive change is visible in the acquisition-risk excerpt provided.
- 30% rewrittenRisks Relating to Our Sales of Products and Services, Marketing and Research and Development
If we do not successfully manage the development, manufacturing, and launch of new products or services, including product updates and transitions, our financial results could be adversely affected
No substantive change is visible in the new-product development and launch excerpt provided.
Was: If we do not successfully manage the development, manufacturing, and launch of new products or services, including product transitions, our financial results could be adversely affected
- 29% rewrittenRisks Relating to Government Regulation
Changes in, or failure to comply with, competition laws could adversely affect our business, financial condition, or results of operations
No substantive change is visible in the competition-law excerpt provided.
- 29% rewrittenRisks Related to Acquisitions
Following the Spin-Off, we remain the obligor on the contingent value rights (the CVRs) we issued in connection with the GRAIL Acquisition, and the Spin-Off could adversely affect the market value of the CVRs
The revised text omits the statement that GRAIL’s post-Spin-Off business could reduce the CVRs’ market value.
Was: Following the Spin-Off, we remain the obligor on the contingent value rights (the CVRs) we issued in connection with the GRAIL Acquisition
- 25% rewrittenRisks Relating to Our Sales of Products and Services, Marketing and Research and Development
The markets we serve are dynamic — we face intense and increasing competition, which could render our products obsolete, result in significant price reductions, or substantially limit the volume of products that we sell, and increasing customer concentration makes us more dependent on key customers
Was: We face intense competition, which could render our products obsolete, result in significant price reductions, or substantially limit the volume of products that we sell
- 23% rewrittenRisks Relating to Our Sales of Products and Services, Marketing and Research and Development
Our success depends upon the continued emergence and growth of markets for analysis of genetic variation, and continued substantial increases in the use of sequencing as the cost of sequencing declines
All 26 risk factors
Headings as the filing states them, in filing order.
Risks Relating to Our Sales of Products and Services, Marketing and Research and Development
- 01Our success depends upon the continued emergence and growth of markets for analysis of genetic variation, and continued substantial increases in the use of sequencing as the cost of sequencing declines23% rewritten
- 02The markets we serve are dynamic — we face intense and increasing competition, which could render our products obsolete, result in significant price reductions, or substantially limit the volume of products that we sell, and increasing customer concentration makes us more dependent on key customers25% rewritten
- 03Regulatory authorities in China have added Illumina to the List of Unreliable Entities, which could result in fines or restrictions on our ability to do business in China and could have a material adverse effect on our revenue and results of operations54% rewritten
- 04Changes in tariffs, trade restrictions, and customs or export/import regulations have impacted, and we expect will continue to impact, our business by increasing costs and administrative burdens, disrupting cross-border flows, and affecting customer demandnew
- 05If we do not successfully manage the development, manufacturing, and launch of new products or services, including product updates and transitions, our financial results could be adversely affected30% rewritten
- 06Our continued growth is dependent on continuously developing and commercializing new products
- 07As we develop, market, or sell diagnostic tests, we may encounter delays in receipt, or limits in the amount, of reimbursement approvals and public health funding, which will impact our ability to grow revenues in the healthcare market
- 08Uncertainties with respect to the development, deployment, and use of artificial intelligence in our business and products may result in harm to our business and reputation
Risks Relating to Supply Chain, Manufacturing, and Quality
- 09If we are unable to increase our manufacturing or service capacity and develop and maintain operation of our manufacturing or service capability, we may not be able to launch or support our products or services in a timely manner, or at all
- 10An interruption in our ability to manufacture our products or an inability to obtain key components or raw materials due to a catastrophic disaster, infectious disease, or infrastructure failure could adversely affect our business
Risks Relating to Our Strategic Collaborations
- 11If we fail to maintain and successfully manage our strategic collaborations, our future results may be adversely impacted
Risk Relating to the Protection of Our Intellectual Property
- 12Any inability to effectively protect our proprietary technologies could harm our competitive position
Risks Related to Acquisitions
- 13Our acquisitions expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies42% rewritten
- 14The Spin-Off could result in substantial tax liability
- 15Following the Spin-Off, we remain the obligor on the contingent value rights (the CVRs) we issued in connection with the GRAIL Acquisition, and the Spin-Off could adversely affect the market value of the CVRs29% rewritten
Risks Relating to Litigation
- 16Litigation, other proceedings, or third-party claims of intellectual property infringement could require us to spend significant time and money and could prevent us from selling our products or services
- 17If product or service liability lawsuits are successfully brought against us, we may face reduced demand for our products and incur significant liabilities
Risks Relating to Government Regulation
- 18Changes in, or failure to comply with, competition laws could adversely affect our business, financial condition, or results of operations29% rewritten
Risks Relating to Information Technology Security and Continuity
- 19Disruption of critical information technology systems could have an adverse effect on our operations, business, customer relations, and financial condition45% rewritten
Risk Relating to Public Health Crises
- 20We are unable to predict the extent to which public health crises may adversely impact our business operations and financial performance
- 21Doing business internationally, especially in emerging markets, creates operational risk for our business91% rewritten
- 22Armed conflict in Ukraine, Russia, the Middle East or elsewhere could also negatively impact us
- 23We are exposed to risks associated with transactions denominated in foreign currency
- 24We are subject to risks related to taxation in multiple jurisdictions
- 25Our operating results may vary significantly from period to period68% rewritten
- 26Adverse economic or market conditions may harm our business
Other Illumina 10-Ks
- 2025 10-K risk factors
30 risks. China’s List of Unreliable Entities designation threatens Illumina’s Chinese revenue and operations.
Filed Feb 12, 2025
About this page
Item 1A of the 10-K on EDGAR was split into its risk factors and, where the company's previous 10-K is on file, each heading was matched to last year's and the text compared word for word. The headings are the filing's own. The one-line readings and the overview were written by a language model from the text of the new, dropped, and rewritten risks; they refer to risks by position and cannot misquote a heading.