Natera (NTRA) risk factors, FY2025 10-K

Risks Related to Our Business and Industry

1. 01If we are unable to successfully grow revenues for our products or services, and if our efforts to further increase the use and adoption of our products or to develop new products and services in the future do not succeed, our business will be harmed
2. 02We have incurred net losses since our inception and we anticipate that we will continue to incur losses for the near future, which could harm our future business prospects
3. 03Uncertainty in the development and commercialization of our enhanced or new tests or services could materially adversely affect our business, financial condition and results of operations
4. 04Our quarterly results may fluctuate from period to period, which could adversely impact the value of our common stock
5. 05Competition in our industry is intense; if we are unable to compete successfully with respect to our current or future products or services, we may be unable to increase or sustain our revenues or achieve profitability
6. 06We rely on internal and third-party data centers and platforms to host our laboratory and cloud-based software, and any interruptions of service or failures may impair our operations and harm our business
7. 07If our products do not perform as expected, our operating results, reputation and business will suffer
8. 08We rely on third-party laboratories to perform portions of our service offerings
9. 09If our CLIA-certified laboratory facilities become inoperable, we will be unable to perform our tests and our business will be harmed31% rewritten
10. 10We rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers
11. 11We rely on commercial courier delivery services to transport samples to our facilities in a timely and cost-efficient manner and if these delivery services are disrupted, our business may be harmed
12. 12Security breaches, loss of data and other disruptions, including with respect to cybersecurity, could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and reputation
13. 13We are incorporating artificial intelligence across various areas of our business, which presents risks that could adversely affect our business and results of operationsNew
14. 14The marketing, sale, and use of our tests could result in substantial damages arising from product liability, professional liability, or other claims that exceed our resources
15. 15If we are unable to successfully scale our operations, our business could suffer
16. 16If our sales, distribution, development or other partnerships are not successful and we are not able to offset the resulting impact through our own efforts or through agreements with new partners, our commercialization activities may be impaired and our financial results could be adversely affected
17. 17Our financial condition and results of operations may be adversely affected by international regulatory and business risks
18. 18If we lose the services of our founder and Executive Chairman, our Chief Executive Officer, or other members of our senior management team, we may not be able to execute our business strategy
19. 19We may engage in acquisitions, dispositions or other strategic transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources
20. 20We are involved in legal proceedings, regulatory investigations and inquiries and other legal matters, which may have an adverse effect on our business, financial condition, results of operations and prospects32% rewritten
21. 21We may need to raise additional capital, and if we cannot do so when needed or on commercially acceptable terms, we will be required to slow or cease our investment in our product development and commercialization plans, which would have an adverse effect on our business
22. 22We have incurred indebtedness that may decrease our business flexibility, access to capital, and/or increase our borrowing costs, which may adversely affect our operations and financial results64% rewritten
23. 23Recent macroeconomic pressures resulting from ongoing geopolitical or other matters may have an adverse impact on our business, financial results and prospects
24. 24Ethical, legal and social concerns related to the use of genetic information could reduce demand for our tests
25. 25Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited30% rewritten
26. 26Our estimates of total addressable market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates

Risks Related to Reimbursement

1. 27If we are unable to expand, maintain or obtain third-party payer coverage and reimbursement for Signatera, Panorama, Horizon, and our other tests, or if we are required to refund any reimbursements already received, our revenues and results of operations would be adversely affected
2. 28Our revenues may be adversely affected if we are unable to successfully obtain reimbursement from the Medicare program and state Medicaid programs
3. 29Our revenues may be adversely impacted if third-party payers withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors

Regulatory and Compliance Risks

1. 30We may be subject to increased compliance risks as a result of our rapid growth, including our dependence on our sales, marketing and billing efforts
2. 31If the FDA were to begin actively regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket 510(k) clearance, de novo classification, or premarket approval and incur costs associated with complying with post-market controls42% rewritten
3. 32We may not be able to obtain approval from the FDA for Signatera PMAs currently under review or for applications that we may submit to FDA in the futureNew
4. 33Failure to obtain necessary regulatory approvals may adversely affect our ability to expand our operations internationally
5. 34Changes in laws and regulations, or in their application, may adversely affect our business, financial condition and results of operations
6. 35If we fail to comply with federal, state and foreign laboratory licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business
7. 36Changes in government spending or healthcare policy could increase our costs and negatively impact coverage and reimbursement for our tests by governmental and commercial third-party payers
8. 37If we or our laboratory distribution partners, consultants or commercial partners act in a manner that violates healthcare fraud and abuse laws or otherwise engage in misconduct, we may be subject to civil or criminal penalties
9. 38Failure to comply with privacy and security laws and regulations could result in fines, penalties and damage to our reputation and have a material adverse effect on our business
10. 39Changes in the way the FDA regulates the reagents, other consumables, and testing equipment we use when developing, validating, and performing our tests could result in delay or additional expense in bringing our tests to market or performing such tests for our customers
11. 40Our use of hazardous materials in the development of our tests exposes us to risks related to accidental contamination or injury and requires us to comply with regulations governing hazardous waste materials
12. 41If the validity of an informed consent from a patient intake for Panorama or our other tests is challenged, we could be precluded from billing for such testing, forced to stop performing such tests, or required to repay amounts previously received, which would adversely affect our business and financial results

Risks Related to Our Intellectual Property

1. 42Litigation or other proceedings resulting from either third-party claims of intellectual property infringement, or asserting infringement by third parties of our technology, is costly, time-consuming, and could limit our ability to commercialize our products or services
2. 43Any inability to effectively protect our proprietary technologies could harm our competitive position
3. 44If we are not able to adequately protect our trade secrets and other proprietary information, the value of our technology and products could be significantly diminished
4. 45If our trademarks and trade names are not adequately protected, we may not be able to establish or maintain name recognition in our markets of interest, and our business may be adversely affected
5. 46We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties

Risks Related to Ownership of Our Common Stock

1. 47The market price of our common stock has been and may be volatile, which could subject us to litigation
2. 48If we are unable to implement and maintain effective internal controls over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could be adversely affected
3. 49We do not intend to pay dividends on our capital stock so any returns will be limited to changes in the value of our common stock
4. 50Sales of a substantial number of shares of our common stock in the public markets could cause the price of our common stock to decline
5. 51If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline
6. 52Provisions in our amended and restated certificate of incorporation, amended and restated bylaws, and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our common stock
7. 53In addition, Section 203 of the Delaware General Corporation Law may discourage, delay or prevent a change in control of our company. Section 203 imposes certain restrictions on mergers, business combinations and other transactions between us and holders of 15% or more of our common stock
8. 54Changes in accounting standards and their interpretations could adversely affect our operating results