Cooper Companies (COO) Risk Factor Changes

Our effective tax rate could fluctuate based on the geographic composition of income, which could significantly change based on our business results and acquisitions.

We are subject to the examination of our tax returns and other matters by tax authorities.

As a result of our international operations, currency exchange rate fluctuations may affect our results of operations and financial position.

•the federal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presente…

In foreign countries where we market our products, recent healthcare reform has taken place as well.

We are also subject to laws and regulations in countries other than United States covering data privacy and the protection of health-related and other personal information.

The ability of the FDA, foreign agencies and notified bodies to review and clear, approve or certify new products can be affected by a variety of factors, including government budget and funding levels, statutory, reg…

We are subject to the CLIA, a federal law regulating clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of d…

We offer certain genetic testing services to help identify the likelihood of pregnancy as well as identify possible disorders or diseases of a child prior to birth, and we have historically marketed these tests as LDT…

In the United States, in vitro diagnostic devices (IVDs) are a type of medical device that can be used in the diagnosis or detection of diseases or other conditions.

In the EU, regulatory authorities have the power to carry out announced and, if necessary, unannounced inspections of companies, as well as suppliers and/or sub-contractors and, where necessary, the facilities of prof…

Our medical devices and pharmaceutical products require clearance or approval by the FDA before they can be commercially distributed in the United States and may require similar approvals by foreign regulatory agencie…

On January 31, 2024, the FDA issued a final rule to amend the QSR regulations to align more closely with the International Organization for Standardization standards.

After a drug or device is placed on the market, numerous regulatory requirements apply, including the FDA's cGMP and QSR regulations, which require manufacturers to follow, among other things, design, testing, product…

In addition, the EU landscape concerning medical devices (including IVDs) has recently evolved and may be subject to further developments in 2026.

actions, which may prevent or delay approval or clearance of our future products under development or impact our ability to modify our currently cleared products on a timely basis.

In addition, new disclosure standards and rules related to ESG matters have been adopted and may continue to be introduced in various states and other jurisdiction.

Product innovations are important in the contact lens market in which CooperVision competes and in the areas of the health care industry in which CooperSurgical competes.

CooperSurgical competes with a number of manufacturers and service providers in its women’s family health care market areas.

Each of our businesses operates within a highly competitive environment.

Our businesses utilize various chemicals, packaging materials, components, parts and raw materials which are generally available from more than one source.

We rely on independent suppliers and third-party logistics providers in our supply chain for raw materials, packaging materials and components, mechanical equipment and some finished goods; we could experience invento…

We previously identified a material weakness in our internal control over financial reporting related to an ineffective information technology (IT) general control for the U.S.

Cybersecurity threats continue to increase in frequency and sophistication; a successful cybersecurity attack could interrupt or disrupt our information technology systems, or those of our third-party service provider…

Rica, the United Kingdom and the United States, with other smaller locations also existing in multiple locations around the world.

Economic and trade sanctions, including tariff and import/export regulations by the U.S.

We are subject to the examination of our tax returns and other matters by tax authorities.

As a result of our international operations, currency exchange rate fluctuations may affect our results of operations and financial position.

•the federal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presente…

In foreign countries where we market our products, recent healthcare reform has taken place as well.

We are also subject to laws and regulations in countries other than United States covering data privacy and the protection of health-related and other personal information.

States government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities.

Embryology Association (HFEA) regulating IVF.

requirements on CooperVision and CooperSurgical that could increase the costs of compliance or otherwise create competition that may negatively affect our business.

Following the end of the “Brexit” transitional period, from January 1, 2021, the MHRA became the UK’s independent regulatory agency for medical devices.

uniform, transparent, predictable and sustainable regulatory framework across the EU for medical devices (including IVDs) and ensure a high level of safety and health while supporting innovation.

products will successfully compete in the marketplace and, as a result, justify the expense involved in their development and regulatory approval or certification.

and to achieve manufacturing efficiencies and sufficient manufacturing capacity and capabilities for such products.

loss of confidential or protected data which could disrupt our business, force us to incur excessive costs or cause reputational harm.

Ongoing federal efforts to streamline government operations, including agency-wide efficiency programs, may further impact the resources and staffing levels available to the FDA.

authorities’ observations and to implement corrective and preventive actions, as appropriate.

and approvals will be granted on a timely basis, if at all, and significant delays in the introduction of any new products or product enhancements may occur, which could adversely affect our competitive position and r…

and consumers which could reduce the sales of our products.

Following the end of the “Brexit” transitional period, from January 1, 2021, the MHRA became the UK’s independent regulatory agency for medical devices.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulation of drugs and medical devices.

International ESG disclosure standards have also been produced (and further standards will be produced) under the auspices of the International Sustainability Standards Board (ISSB), which some countries (such as the…

successful than us at innovating in these and other areas.

We also rely on third-party logistics providers for storage and distribution of our components and products.

Biofinity, Avaira and clariti, are supplied by few or sole suppliers, and the failure of a key or sole supplier to timely supply sufficient items and materials necessary for the manufacture of our silicone hydrogel co…

CooperVision manufactures molded contact lenses, which represent the majority of our contact lens revenues, primarily at our facilities in Costa Rica, Hungary, Puerto Rico, the United Kingdom and the United States, wi…

Changes in import and export policies, including new, increased or retaliatory tariffs, sanctions and countersanctions and customs restrictions by the U.S.