Myriad Genetics (MYGN) risk factors, FY2024 10-K

Risks Related to Government Regulation

1. 01General Risks and Risks Related to Our Common Stock
2. 32If 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 condition
3. 33Our 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 business
4. 34We 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
5. 35Changes in health care policy could increase our costs, decrease our revenue and impact sales of and reimbursement for our tests
6. 36Planned changes in the way the FDA regulates tests performed by laboratories like ours will result in delay and/or additional expense in offering our tests and tests that we may develop in the future
7. 37As of December 31, 2024, none of our products other than MyChoice CDx and BRACAnalysis CDx are marketed by us under the FDA's requirements for medical devices
8. 38FDA regulation of our GeneSight Psychotropic test could be disruptive to our business
9. 39Companion 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. 40Our 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. 41Our business involves environmental risks that may result in liability for us
12. 42Our stock price is highly volatile, and our stock may lose all or a significant part of its value
13. 43If 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. 44Anti-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. 45Future 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
16. 46We do not intend to pay dividends so any returns will be limited to changes in the value of our common stock
17. 47If 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
18. 48Increasing 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 growth 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 basis
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 harmed
4. 05If we do not generate sufficient cash flow from operations and are unable to secure additional funding, we may have to reduce our operations
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 liquidity
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 business
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. 10Failure 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
10. 11If 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 affected
11. 12Artificial intelligence introduces emerging risks and challenges to our business
12. 13Each 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
13. 14Our international business exposes us to business, regulatory, political, operational, financial, and economic risks associated with doing business outside of the United States
14. 15Ethical, legal and social concerns related to the use of genetic information could reduce demand for our tests
15. 16Our core business depends on our ability to quickly and reliably receive biological material from patients and deliver test results to our customers. We typically receive biological material for analysis at our laboratory facilities within days of collection from the patient
16. 17Our financial condition and results of operations could be adversely affected by adverse public health developments
17. 18We face risks associated with currency exchange rate fluctuations, which could adversely affect our operating results
18. 19Impairment in the value of our goodwill or other intangible assets could have a material adverse effect on our operating results and financial condition
19. 20Our 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
20. 21Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
21. 22Changes 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. 23Our 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. 24These 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. 25If 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. 26If 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. 27If we fail to protect our proprietary technology, others could compete against us more directly, which would harm our business
2. 28If 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 tests
3. 29If 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. 30We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets
5. 31If 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