Hologic (HOLX)

Risks

• The COVID-19 pandemic and associated economic disruptions have had and may continue to have a material adverse effect on manufacturing, distribution and supply chain.
• Continuing worldwide political and social uncertainty, as well as tariffs and social tensions, may adversely affect our business and prospects, both domestically and internationally.
• Our international operations and foreign acquisitions expose us to additional operational challenges that we might not otherwise face.
• Our reliance on one third-party manufacturer for certain of our product lines and a limited number of suppliers for some key raw materials, components and subassemblies for our products exposes us to increased risks associated with production delays, delivery schedules, manufacturing capability, quality control, quality assurance and costs.
• Interruptions, delays, shutdowns or damage at our manufacturing or laboratory facilities could harm our business.
• Our Diagnostics segment depends on a small number of customers for a significant portion of its product sales, and the loss of any of these customers or any cancellation or delay of a large purchase by any of these customers could significantly reduce revenues in our Diagnostics segment.
• We utilize distributors for a portion of our sales, the loss of which could harm our revenues in the territory serviced by these distributors.
• Our success depends on our ability to attract, motivate and retain key personnel and plan for future executive transitions.
• Increased cybersecurity requirements, vulnerabilities, threats and more sophisticated and targeted computer crime could pose a risk to our systems, networks, products, solutions, services and data.
• Failure to comply with laws relating to the confidentiality of sensitive personal information or standards related to the transmission of electronic health data, may require us to make significant changes to our products, or incur penalties or other liabilities.
• Healthcare cost containment legislation and the failure of third-party payors to provide appropriate levels of coverage and reimbursement for the use of products and treatments facilitated by our products could harm our business and prospects.
• Guidelines, recommendations and studies published by various organizations may reduce the use of our products.
• Changes in tax laws or exposures to additional tax liabilities could negatively impact the Company's operating results.
• We operate in a highly regulated industry, and changes in healthcare laws and regulations or our inability to obtain in a timely manner or at all U.S. or foreign regulatory clearances or approvals for our current and newly developed products and services or product or service enhancements, could adversely affect our business and prospects.
• Some of our activities may subject us to risks under federal and state laws prohibiting “kickbacks” and false or fraudulent claims.
• We are subject to the risk of product liability claims relating to our products for which we may not have adequate insurance.
• We are subject to environmental, health and safety laws and regulations, including related to our use and recycling of hazardous materials and the composition of our products.
• Our business is dependent on technologies we license, and if we fail to maintain these licenses or license new technologies and rights to particular nucleic acid sequences for targeted diseases in the future, we may be limited in our ability to develop new products.
• Our business could be harmed if we are unable to protect our proprietary technology.
• Our business could be harmed if we infringe upon the intellectual property rights of others.
• We may not be able to generate sufficient cash flow to service all of our indebtedness and other obligations.
• A significant portion of our indebtedness is subject to floating interest rates, which may expose us to higher interest payments.
• The proposed discontinuation or replacement of LIBOR would require us to amend certain agreements and may otherwise adversely affect our business.
• Provisions in our charter, bylaws, and indebtedness may have the effect of discouraging advantageous offers for our business or common stock and limit the price that investors might be willing to pay in the future for shares of our common stock.
• Our stock price is volatile.