We have recently added manufacturing facilities in the Dominican Republic, Ireland, Costa Rica, and Mexico. We may continue to expand our operations by offering our services and entering new lines of business in other markets outside of the U.S. This expansion increases our exposure to the inherent risks of doing business in international markets. Depending on the market, these risks include those relating to:
- Changes in the local economic environment including, among other things, labor cost increases and other general inflationary pressures;- Political instability, armed conflicts, or terrorism;- Public health crises, such as pandemics or epidemics;- Social changes;- Intellectual property legal protections and remedies;- Trade regulations;- Procedures and actions affecting approval, production, pricing, reimbursement and marketing of products and services;- Foreign currency;- Additional U.S. and foreign taxes;- Export controls;- Antitrust and competition laws and regulations;- Lack of reliable legal systems which may affect our ability to enforce contractual rights;- Changes in local laws or regulations, or interpretation or enforcement thereof;- Potentially longer ramp-up times for starting up new operations, and for payment and collection cycles;- Financial, operational and information technology systems integration;- Failure to comply with U.S. laws, such as the foreign corrupt practices act, or local laws that prohibit us, our partners, or our partners' or our agents or intermediaries from making improper payments to foreign officials or any third party for the purpose of obtaining or retaining business; and - Data and privacy restrictions.
- Foreign currency fluctuations
Issues relating to the failure to comply with applicable non-U.S. laws, requirements or restrictions may also impact our domestic business and increase scrutiny of our domestic practices.
Additionally, some factors that will be critical to the success of our international business and operations will be different than those affecting our domestic business and operations. For example, conducting international operations requires us to devote significant management resources to implement our controls and systems in new markets, to comply with local laws and regulations, including fulfilling financial reporting and records retention requirements, and overcoming the numerous new challenges inherent in managing international operations, such as challenges based on differing languages and cultures, as well as differing regulatory and compliance environments, and challenges related to the timely hiring, integration and retention of a sufficient number of skilled personnel to carry out operations in an environment with which we are not familiar.
Any additional expansion of our international operations through acquisitions or through organic growth could increase these risks. Additionally, while we may invest material amounts of capital and incur significant costs in connection with the growth and development of our international operations, including the costs of starting up or acquiring new operations, we may not be able to operate them profitably on the anticipated timeline, or at all.
These risks could have a material adverse effect on our business, results of operations, financial condition, and cash flows, and could materially harm our reputation.