Corcept Therapeutics (CORT) risk factors, 2025 10-K

Other

1. 01Summary of Principal Risks

Risks Related to our Commercial Activities

1. 02Failure to generate sufficient revenue from the sale of our Products would harm our financial results and would likely cause our stock price to decline
2. 03inexperienced diagnosing or caring for patients with hypercortisolism and it can be hard to persuade them to identify appropriate patients and treat them with our Products
3. 04The availability of generic versions of Korlym could adversely affect our business, results of operations and financial position
4. 05Public perception of mifepristone or legislation limiting or barring its distribution or use for termination of early pregnancy may limit our ability to sell our Products
5. 06New laws, government regulations, or changes to existing laws and regulations could make it difficult or impossible for us to obtain acceptable prices or adequate insurance coverage and reimbursement for our Products, which would adversely affect our results of operations and financial position
6. 07Beginning in 2025, the IRA also shifts a significant portion of the Medicare beneficiary costs from the government and beneficiaries to manufacturers. We anticipate that this provision will significantly limit the revenue we receive and may materially reduce our revenue and profits
7. 08Other companies offer different medications to treat patients with hypercortisolism. The availability of competing treatments could limit our product revenue
8. 09Physician preference for any of these medications, or for the off-label use of generic medications such as ketoconazole, to treat patients with hypercortisolism could reduce our revenue materially and harm our results of operations, which would cause our stock price to decline
9. 10A resurgence of COVID-19 or the widespread occurrence of another deadly illness could adversely affect our business, operations and financial results. The COVID-19 pandemic made it difficult to grow our commercial business and slowed the pace of some of our clinical trials
10. 11If we are unable to maintain regulatory approval of our Products or if we fail to comply with other requirements, we will be unable to generate revenue and may be subject to penalties
11. 12We may be subject to civil or criminal penalties if our marketing of our Products violates FDA regulations or health care fraud and abuse laws

Risks Related to our Research and Development Activities

1. 13Vendors perform many of the activities necessary to carry out our clinical trials, including drug product distribution, trial management and oversight and data collection and analysis. Failure of these vendors to perform their duties or meet expected timelines may prevent or delay approval of our product candidates
2. 14Our current clinical trials may prove inadequate to support marketing approvals. Even trials that generate positive results may have to be confirmed in much larger, more expensive and lengthier trials before we could seek regulatory approval
3. 15We may be unable to obtain or maintain regulatory approvals for our Products or product candidates, which would prevent us from commercializing our product candidates
4. 16Our Products and product candidates may cause undesirable side effects that halt their clinical development, prevent their regulatory approval, limit their commercial potential or cause us significant liability

Risks Related to our Capital Needs and Financial Results

1. 17We may need additional capital to fund our operations or for strategic reasons. Such capital may not be available on acceptable terms or at all

Risks Related to our Stock

1. 18The price of our common stock fluctuates widely and is likely to continue to do so. Opportunities for investors to sell shares may be limited
2. 19Our stock price may decline if our financial performance does not meet the guidance we have provided to the public, estimates published by research analysts or other investor expectations
3. 20We have in the past and may in the future be subject to short selling strategies that may drive down the market price of our common stock and increase its volatility
4. 21We need to increase the size of our organization and may experience difficulties in managing growth
5. 22If we lose key personnel or are unable to attract more skilled personnel, we may be unable to pursue our product development and commercialization goals
6. 23as the U.S. Department of Health and Human Services Office of Civil Rights issued a proposed rule that would amend certain security compliance requirements for covered entities and business associates
7. 24We rely on information technology to conduct our business. A breakdown or breach of our information technology systems or our failure to protect confidential information concerning our business, patients or employees could interrupt the operation of our business and subject us to liability
8. 25Changes in federal, state and local tax laws may reduce our net earnings
9. 26Research analysts may not continue to provide or initiate coverage of our common stock or may issue negative reports
10. 27Any acquisition of Corcept shares through our stock repurchase program or, in certain cases, pursuant to the exercise of stock options, will reduce our cash reserves
11. 28Anti-takeover provisions in our charter and bylaws and under Delaware law may make an acquisition of us or a change in our management more expensive or difficult, even if an acquisition or a management change would be beneficial to our stockholders
12. 29Our officers, directors and principal stockholders, acting as a group, could significantly influence corporate actions
13. 30We face unprecedented political, legal, governmental, regulatory and economic uncertainty and risks that may adversely affect our business