Company: CORT
Filing Date: 2025-05-05
Form Type: 10-Q
Source: 0001628280-25-022173
Chunk: 77

Company: CORCEPT THERAPEUTICS INC
Filing Date: 2025-05-05
Form: 10-Q
Item: Part I, Item 8
Chunk 77
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 Risk Factors

We face unprecedented political, legal, governmental, regulatory and economic uncertainty and risks that may adversely affect our business.

Actions taken by the presidential administration in the United States have caused great uncertainty. The administration’s policies and their implementation, including with respect to tariffs and trade, funding for the FDA and other key agencies, and funding for scientific research both within the government and at universities, have been unpredictable and generally adverse to our clinical and commercial efforts. The administration may adopt new policies or take new actions, without notice, that damage our commercial interests or make it more difficult or costly to develop our product candidates. Significant cuts or disruptions to the staffing of government agencies or spending may delay review of our NDA for relacorilant as a treatment for patients with hypercortisolism and may hamper our ability to advance our other clinical programs. Similarly, the research programs of our academic collaborators may be defunded.

The imposition of tariffs on materials we or our vendors use to conduct experiments or to make our Products or product candidates have increased our costs and may increase them further. The United States’ tariff regime and the tariff regime of its trading partners are in constant flux. Although we monitor the situation closely, the tariffs that may affect our business are difficult to predict. There can be no assurance that we can anticipate new trade measures or mitigate their impacts, which could be material. Additionally, the laws and regulations governing our operations, as well as their application, may change without notice. Failure by us or by our vendors to comply with new laws or regulations or to respond in a timely way to abrupt changes in the application of existing laws and regulations could adversely affect our operations, cash flow and financial condition or otherwise harm our business.

We need to increase the size of our organization and may experience difficulties in managing growth.

Our commercial and research and development efforts are constrained by our limited administrative, operational and management resources. To date, we have relied on a small management team. Growth will impose significant added responsibilities on members of management, including the need to recruit and retain additional employees. Our financial performance and ability to compete will depend on our ability to manage growth effectively. To that end, we must:

•continue to add talented, experienced personnel to our endocrine, oncology and emerging markets businesses;

•manage our clinical trials, research and manufacturing activities effectively;

•hire more general management, clinical development, administrative and sales and marketing personnel; and

•continue to develop our administrative systems and controls.

Failure to accomplish any of these tasks could harm our business