Item 1A. Risk Factors
ITEM 1A. RISK FACTORS
In addition to the other information set forth in this quarterly report, you should carefully consider the factors discussed in “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 5, 2025. Other than as described below, there have been no material changes to these Risk Factors since the filing of our Annual Report on Form 10-K.
We are subject to risks of doing business in other countries, including those related to tariffs, trade restrictions and government actions.
We are subject to risks of doing business internationally, including:
• changes in regulatory requirements or other executive branch actions, such as Executive Orders;
• changes in the global trade environment, including potential deterioration in geopolitical or trade relations between countries;
• disputes with authorities in non-U.S. jurisdictions, including international trade authorities;
• imposition of domestic and international taxes, export controls, tariffs, duties, embargoes, sanctions and other trade restrictions;
• tariffs, duties or other costs attributable to the importation of raw materials, parts, products and services, which could impact sales and/or delivery of products and services outside the U.S. and/or impose increased costs on us, our supply chain or our customers; and
• fluctuations in international currency exchange rates.
While the impact of these factors is difficult to predict, any one or more of these factors could adversely affect our operations.
The United States recently announced changes to U.S. trade policy, including adding new or modifying existing tariffs on imports, in some cases significantly. For example, on April 2, 2025, the United States announced a 10% baseline reciprocal tariff on imports from all countries, plus an additional country-specific tariff on imports from select trading partners. Other countries have announced retaliatory actions or plans for retaliatory actions. On April 9, 2025, the United States implemented a 90-day pause on the country-specific tariffs for all countries except China, while maintaining the 10% baseline tariff. Tariffs and
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any retaliatory actions could significantly increase the cost of our products and result in lower demand for our products. On July 9th, 2025, the United States announced a 50% tariff on Brazil, which went into effect on August 6, 2025. On July 28, 2025, the United States announced a 15% tariff on goods from the EU, which went into effect on August 7, 2025.
Impacts from potential deterioration in geopolitical or trade relationships between the United States and other countries, including as a result of the risks described above, could have a material adverse impact on our financial position, results of operations and/or cash flows.
Changes in Medicaid coverage and reimbursement policies may adversely affect our business, financial condition, and results of operations.
A portion of our products are used in pediatric orthopedic procedures that may be reimbursed under Medicaid. Legislative or regulatory changes at the federal or state level that reduce Medicaid enrollment, restrict coverage for specific procedures or devices, or lower reimbursement rates could negatively impact our business. These changes may result in decreased procedure volumes, increased pricing pressure from healthcare providers and payers, and delays in the adoption of our products, particularly in hospitals and clinics serving high volumes of Medicaid patients.
Additionally, because Medicaid is administered at the state level, there is considerable variability in how coverage and reimbursement policies are implemented. This variability introduces uncertainty in forecasting demand and reimbursement levels for our products. Any such changes or uncertainties could materially and adversely affect our revenues, margins, and overall financial performance.
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