Illumina (ILMN) risk factors, 2025 10-K

Risks Relating to Our Sales of Products and Services, Marketing and Research and Development

1. 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 declines
2. 02We face intense competition, which could render our products obsolete, result in significant price reductions, or substantially limit the volume of products that we sell
3. 03China’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
4. 04If 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
5. 05Our continued growth is dependent on continuously developing and commercializing new products
6. 06As 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
7. 07Uncertainties 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

1. 08If 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
2. 09An 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

1. 10If 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

1. 11Any inability to effectively protect our proprietary technologies could harm our competitive position

Risks Related to Acquisitions, Including the Acquisition of GRAIL

1. 12Our 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
2. 13As 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
3. 14The Spin-Off could result in substantial tax liability
4. 15Following the Spin-Off, we remain the obligor on the contingent value rights (the CVRs) we issued in connection with the GRAIL Acquisition

Risks Relating to Litigation

1. 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
2. 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

1. 18Changes in, or failure to comply with, competition laws could adversely affect our business, financial condition, or results of operations
2. 19Certain 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

Risks Relating to Information Technology Security and Continuity

1. 20into 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
2. 21Disruption of critical information technology systems could have an adverse effect on our operations, business, customer relations, and financial condition

Risk Relating to Public Health Crises

1. 22We are unable to predict the extent to which public health crises may adversely impact our business operations and financial performance
2. 23Doing business internationally, especially in emerging markets, creates operational risk for our business
3. 24Brazil, 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
4. 25The armed conflict between Russia and Ukraine, the international sanctions imposed on Russia, and the restrictions imposed on exports to Russia will likely continue to negatively affect our business. Armed conflict in the Middle East or elsewhere could also negatively impact us
5. 26We are exposed to risks associated with transactions denominated in foreign currency
6. 27We are subject to risks related to taxation in multiple jurisdictions
7. 28Our operating results may vary significantly from period to period
8. 29and 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
9. 30Adverse economic or market conditions may harm our business