Company: VCYT
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001384101-25-000014
Chunk: 89

Company: VERACYTE, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 89
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 cost of compliance with these laws and regulations may become significant, and our failure to comply may result in substantial fines or other business or reputational consequences, any of which could negatively affect our operating results.

Aspects of our international business expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.

Our business strategy currently includes international presence and expansion in select countries and may include developing and maintaining physician outreach and education capabilities outside of the United States, establishing agreements with laboratories, and expanding our relationships with international payers. For example, in 2021, we acquired HalioDx, an immuno-oncology diagnostics company that is based in Marseille, France, and operates globally. In addition, in 2024, we acquired C2i, an oncology diagnostics company based in Tel Aviv, Israel, with global operations. Doing business internationally involves a number of risks, including:

•multiple, conflicting and changing laws and regulations such as tax laws, privacy laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

•potential disruptions to the development and launch of additional products or services as a result of having technology and research and development operations in Israel, including disruptions related to maintaining key research and development employees in Israel and the potential impact of the escalating hostilities in the Middle East on operations and business continuity as well as Company personnel who are performing, or on reserve to perform, military services as a result of such conflict;

•failure by us to obtain regulatory approvals, authorizations, or certifications where required for the use of our solutions in various countries;

•complexities associated with managing multiple payer reimbursement regimes, rebate requirements, government payers or patient self-pay systems, including payers mandating additional evidence requirements for reimbursement consideration;

•disagreements, challenges, work stoppage, labor shortages, strikes or other labor unrest, and litigation, including with the French employee work council or French union;

•logistics and regulations associated with shipping tissue samples, including infrastructure conditions and transportation delays;

•challenges associated with establishing laboratory partners, including proper sample collection techniques, management of supplies, sample logistics, billing and promotional activities;

•difficulties in staffing and managing foreign operations;

•limits on our ability to penetrate international markets if we are not able to process tests locally;

•financial risks, such as longer payment cycles, difficulty in collecting from payers, the effect of local and regional financial crises, and exposure to foreign currency exchange rate fluctuations;