Myriad Genetics (MYGN) risk factors, FY2025 10-K

Risks Related to Government Regulation

1. 01General Risks and Risks Related to Our Common Stock21% rewritten
2. 34If we fail to comply with the complex federal, state, local and foreign laws and regulations that apply to our business, we could suffer consequences that could materially and adversely affect our operating results and financial condition47% rewritten
3. 35We may also be subject to or affected by current or future federal, state, local and foreign laws and regulations, including laws relating to reproductive health care, which could restrict our business, reduce demand for our products, and adversely affect our operations, revenue, and results of operationsNew
4. 36Our actual or perceived failure to comply with data protection laws and regulations could lead to complaints, government enforcement actions, private litigation, and/or adverse publicity and could negatively affect our business23% rewritten
5. 37We may from time to time be subject to government investigation(s), the unfavorable outcome of which may have a material adverse effect on our financial condition, results of operations and cash flows
6. 38Changes in health care policy could increase our costs and impact sales of and reimbursement for our tests26% rewritten
7. 39Planned or potential changes in the way the FDA regulates tests performed by laboratories like ours could result in delay and/or additional expense in offering our tests and tests that we may develop in the future91% rewritten
8. 40FDA regulation of our GeneSight Psychotropic test could be disruptive to our business
9. 41Companion and complementary diagnostic tests require FDA approval, and we may not be able to secure such approval in a timely manner or at all
10. 42Our companion diagnostic tests are subject to ongoing regulatory compliance obligations and continued regulatory review and the failure to comply with such obligations could result in regulatory enforcement and/or penalties
11. 43Our business involves environmental risks that may result in liability for us
12. 44Our stock price is highly volatile, and our stock may lose all or a significant part of its value23% rewritten
13. 45If we are unable to achieve and maintain effective disclosure controls and procedures and internal control over financial reporting, our results of operations, our stock price and investor confidence in us could be adversely affected
14. 46Anti-takeover provisions of Delaware law, provisions in our charter and bylaws and re-adoption of our stockholders’ rights plan, or poison pill, could make a third-party acquisition of us difficult
15. 47Shareholder activism can have a significant impact on our operations, strategy, and overall performanceNew
16. 48Future sales and issuances of our common stock would result in dilution of the percentage ownership of our stockholders and could cause the price of our common stock to decline
17. 49We do not intend to pay dividends so any returns will be limited to changes in the value of our common stock22% rewritten
18. 50Increasing scrutiny and evolving expectations from regulators, business partners, investors, and other stakeholders with respect to our environmental, social, and governance, or ESG, practices may impose additional costs on us or expose us to new or additional risks

Risks Related to Our Business and Our Strategy

1. 02We may not be able to generate sufficient revenue from our existing tests or develop new tests to be profitable
2. 03Our strategic plan may not achieve the anticipated results, and we may not be able to achieve or maintain revenue growth or operate our business on a profitable basis51% rewritten
3. 04If the government and other third-party payors fail to provide coverage and adequate payment for our existing and future tests, if any, our revenue and prospects for profitability will be harmed27% rewritten
4. 05If we do not generate sufficient cash flow from operations and are unable to secure additional funding, we may have to reduce the scale of our operations50% rewritten
5. 06We are subject to debt covenants that impose operating and financial restrictions on us and if we are not able to comply with them, it could have a material adverse impact on our operations and liquidity62% rewritten
6. 07If our existing capital resources and expected net cash to be generated from sales of our tests is not sufficient for us to maintain our currently planned operations, we may find it necessary to raise additional funding, which may not be available on favorable terms, or at all
7. 08An inability to attract and retain experienced and qualified personnel, including key management personnel, could adversely affect our business45% rewritten
8. 09We have acquired and we may continue to acquire technologies, assets or other businesses that could cause us to incur significant expense and expose us to a number of unanticipated operational and financial risks, which could adversely affect our financial condition, results of operations and business prospects
9. 10We may sell or discontinue certain existing products or services, which may adversely impact our business, results of operations, and financial conditionNew
10. 11Failure to comply with laws and regulations related to submission of claims for our services could result in significant monetary damages and penalties and exclusion from the Medicare and Medicaid programs and corresponding foreign reimbursement programs
11. 12If we experience a significant disruption in our information technology systems, or those of third-parties upon which we rely, including cloud-based services, our business operations and financial condition could be adversely affected39% rewritten
12. 13Artificial intelligence introduces emerging risks and challenges to our business73% rewritten
13. 14Each of our tests is processed in a single one of our laboratory facilities, and any loss or prolonged interruption of our ability to use these laboratories or failure to maintain their operation in compliance with applicable regulations would seriously harm our business
14. 15Our international business exposes us to business, regulatory, political, operational, financial, and economic risks associated with doing business outside of the United States
15. 16International trade disputes, including United States trade tariffs and retaliatory tariffs, could adversely impact our businessNew
16. 17Ethical, legal and social concerns related to the use of genetic information could reduce demand for our tests
17. 18We rely on commercial courier delivery services to transport biological materials to our facilities in a timely and cost-efficient manner and if these delivery services are disrupted, our business will be harmedNew
18. 19Our financial condition and results of operations could be adversely affected by adverse public health developments
19. 20We face risks associated with currency exchange rate fluctuations, which could adversely affect our operating results
20. 21Impairment in the value of our goodwill or other intangible assets could have a material adverse effect on our operating results and financial condition57% rewritten
21. 22Our estimates of actionable market size and forecasts of market growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at expected rates
22. 23Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
23. 24Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition

Risks Related to the Development and Commercialization of Our Tests and Test Candidates

1. 25Our tests in development may not be clinically effective or may never achieve significant commercial market acceptance and our test offerings that we have recently launched or acquired may not be commercially successful
2. 26These factors present obstacles to commercial acceptance of our tests, which we would have to spend substantial time and money to overcome, if we can do so at all. Our inability to successfully do so would harm our business
3. 27If we do not compete effectively with scientific and commercial competitors, we may not be able to successfully commercialize our tests, increase our revenue or achieve and sustain profitability
4. 28If our current research collaborators or scientific advisors terminate their relationships with us or develop relationships with a competitor, our ability to discover genes, proteins, and biomarkers, and to validate and commercialize tests could be adversely affected

Risks Related to Our Intellectual Property

1. 29If we fail to protect our proprietary technology, others could compete against us more directly, which would harm our business
2. 30If we are subject to litigation or other proceedings arising from a claim of infringement of the intellectual property of a third party, we might incur significant costs and delays in test introduction or we could be prevented from using technologies incorporated in our tests22% rewritten
3. 31If we fail to comply with our obligations under license or technology agreements with third parties, we could lose license rights that are critical to our business
4. 32We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets
5. 33If we fail to adequately protect our trademarks, service marks, trade names and trade dress, we may lose goodwill and brand equity associated with our business