Myriad Genetics (MYGN)

Risks

• We may not be able to generate sufficient revenue from our existing tests or develop new tests to be profitable.
• We may not be able to maintain revenue growth or operate our business on a profitable basis, and our transformation plan may not achieve the anticipated results.
• If we do not continue to generate sufficient revenue from sales of our molecular diagnostic tests and are unable to secure additional funding, we may have to reduce our operations.
• An inability to attract and retain experienced and qualified personnel, including key management personnel, could adversely affect our business.
• We 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.
• If our current operating plan changes and we find that our existing capital resources will not meet our needs, we may find it necessary to raise additional funding, which may not be available.
• We may 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.
• We are currently subject to, and in the future may be subject to, securities class action lawsuits and stockholder derivative actions, as well as product or professional liability claims. These, and potential similar or related litigation, could result in substantial damages and may divert management’s time and attention from our business.
• Security breaches, loss of data and other disruptions, including from cyberattacks, could compromise sensitive information related to our business, prevent us from accessing critical information or expose us to liability, which could adversely affect our business and our reputation.
• If we experience a significant disruption in our information technology systems, including security breaches, or if we fail to implement new systems and software successfully, our business operations and financial condition could be adversely affected.
• Our business involves environmental risks that may result in liability for us.
• Changes in health care policy could increase our costs, decrease our revenues and impact sales of and reimbursement for our tests.
• Ethical, legal and social concerns related to the use of genetic information could reduce demand for our tests.
• We 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 harmed.
• We face risks associated with currency exchange rate fluctuations, which could adversely affect our operating results.
• Our molecular diagnostic and companion diagnostic tests in development may never achieve significant commercial market acceptance.
• If 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.
• Our international business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
• Foreign governments may impose reimbursement standards, which may adversely affect our future profitability.
• Domestic and international data protection laws and regulations may restrict our activities and increase our costs.
• Each of our molecular diagnostic 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.
• We depend on a limited number of third parties for some of our supplies of equipment and reagents. If these supplies become unavailable or are disrupted, including as a result of COVID-19 and responses to it, then we may not be able to successfully perform our research or operate our business on a timely basis or at all.
• If 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 molecular diagnostic and companion diagnostic tests could be adversely affected.
• If we are not able to protect our proprietary technology, others could compete against us more directly, which would harm our business.
• If we were sued for patent infringement by third parties, we might incur significant costs and delays in test introduction.
• We may be unable to adequately prevent disclosure of trade secrets, proprietary databases, and other proprietary information.
• If 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.
• We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets.
• If we fail to comply with the complex federal, state, local and foreign laws and regulations that apply to our business, we could suffer severe consequences that could materially and adversely affect our operating results and financial condition.
• If the government and 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.
• FDA regulation of our industry generally or our tests specifically could be disruptive to our business.
• Failure 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.
• Our business could be harmed by the loss, suspension, or other restriction on a license, certification, or accreditation, or by the imposition of a fine or penalties, under CLIA, its implementing regulations, or other state, federal and foreign laws and regulations affecting licensure or certification, or by future changes in these laws or regulations.
• Changes in the way that the FDA regulates tests performed by laboratories like ours could result in delay or additional expense in offering our tests and tests that we may develop in the future.
• Companion and complementary diagnostic tests require FDA approval and we may not be able to secure such approval in a timely manner or at all.
• Our stock price is highly volatile, and our stock may lose all or a significant part of its value.
• We have identified two material weaknesses in our internal control over financial reporting related to our income tax provision process and our general information technology controls and such weaknesses led to a conclusion that our internal control over financial reporting and disclosure controls and procedures were not effective as of December 31, 2021. Our inability to remediate these material weaknesses, our discovery of any additional weaknesses, or our inability to achieve and maintain effective disclosure controls and procedures and internal control over financial reporting could adversely affect our results of operations, our stock price and investor confidence in us.
• Anti-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.
• We do not intend to pay dividends on our common stock so any returns will be limited to changes in the value of our common stock.
• If 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.
• Our restated bylaws provide that a state court located within the State of Delaware is the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.