TransMedics Group, Inc.

Current report

A prolonged shutdown of the U.S. federal government could adversely affect our business, financial condition, operating results, cash flows and prospects.

Current report

Congressional disagreement over the federal budget and the maximum amount of debt the federal government is permitted to have outstanding (commonly referred to as the "debt ceiling") has caused the U.S. federal government to shut down, and a prolonged government shutdown impacts us and our customers, vendors and others we do business with. During a U.S. government shutdown certain regulatory agencies, such as the FDA, FAA and the SEC, have had to furlough critical FDA, FAA, SEC, and other government employees and stop critical activities. In addition, the current administration has stated that it could eliminate jobs at federal agencies. Furthermore, although air traffic controllers are deemed to be essential employees who are required to continue to work during a government shutdown, in the current and in past shutdowns air traffic controllers have more frequently called out of work, creating staffing shortages that affect flights and which could impact our aviation services.

Current report

Product development and regulatory activities depend on the continuity and capacity of the FDA and other health authorities. Disruptions at the FDA and other agencies may slow the time necessary for new products to be reviewed and/or approved by necessary government agencies, which could adversely affect our business. The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in the past as a result. In addition, government funding of the FDA and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. If a government shutdown continues for an extended period of time, or if there are future shutdowns, our business, financial condition, operating results, cash flows or prospects could be adversely affected.