What the changes say
- FDA and other agency disruptions, Medicaid cuts, and tariff changes now threaten approvals, costs, reimbursement, and patient-assistance spending.
- Competition intensified as osilodrostat expanded to all adult hypercortisolism and Teva’s generic Korlym patent appeal failed.
- Clinical disclosures now emphasize changing interim results and trials’ statistical significance, while natural disasters replace a vendor-manufacturing risk.
What changed since the prior 10-K
New
- NewRisks Related to our Research and Development Activities
Interim results from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
Interim clinical and preclinical results may materially change after additional patient data, audits, verification, or more complete analysis.
- NewGeneral Risk Factors
Actions by the federal government of the United States have created unprecedented legal, governmental, regulatory and economic uncertainty and risks that may adversely affect our business
Federal research funding cuts, agency staffing reductions, Medicaid changes, and volatile tariffs could delay approvals, raise costs, and hinder clinical development.
- NewGeneral Risk Factors
The significant cuts to funding for Medicaid contained in the OBBBA enacted in July 2025 will increase the cost of our financial assistance and charitable donation programs. There may be further reductions in federal healthcare spending that harm our business
Medicaid cuts may increase financial-assistance costs, while tariffs, changing regulations, and FDA disruptions could damage operations, cash flow, and product development.
Dropped
- DroppedRisks Related to our Commercial Activities
Beginning 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
- DroppedGeneral Risk Factors
We face unprecedented political, legal, governmental, regulatory and economic uncertainty and risks that may adversely affect our business
Reworded
- 92% rewrittenRisks Related to our Commercial Activities
Physician preference for any of these approved 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, causing our stock price to decline
The risk changed from vendor manufacturing, packaging, and dispensing failures to natural disasters or disease outbreaks disrupting operations and facilities.
Was: Physician 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
- 86% rewrittenRisks Related to our Commercial Activities
Other companies offer medications that treat patients with hypercortisolism by mechanisms different than Korlym’s. The availability of such competing treatments could limit our product revenue
The competition discussion now notes osilodrostat’s April 2025 expansion to all adult hypercortisolism, rather than only Cushing’s disease.
Was: Other companies offer different medications to treat patients with hypercortisolism. The availability of competing treatments could limit our product revenue
- 72% rewrittenRisks Related to our Research and Development Activities
Vendors 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
The risk now emphasizes limited control over third-party trial timing, quality, and resources, while removing specific staffing and financial-distress examples.
- 72% rewrittenRisks Related to our Commercial Activities
New 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
The reimbursement and pricing discussion is substantively unchanged.
- 67% rewrittenRisks Related to our Research and Development Activities
We may be unable to obtain or maintain regulatory approvals for our Products or product candidates, which would prevent us from commercializing our product candidates
The risk adds EMA approval requirements and specifically identifies FDA disruptions and funding shortages as threats to timely development and approvals.
- 51% rewrittenRisks Related to our Research and Development Activities
Our 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
The trial-failure examples now add statistical significance and compliance by Corcept or vendors with broader regulatory requirements.
- 38% rewrittenRisks Related to our Commercial Activities
The availability of generic versions of Korlym could adversely affect our business, results of operations and financial position
The risk now says the Federal Circuit affirmed no infringement by Teva on February 19, 2026, and adds settlements with Sun and Hikma.
- 31% rewrittenRisks Related to our Commercial Activities
Failure to generate sufficient revenue from the sale of our Products would harm our financial results and would likely cause our stock price to decline
The discussion is substantively unchanged, with only minor grammatical wording changes.
- 30% rewrittenGeneral Risk Factors
If we lose key personnel or are unable to attract more skilled personnel, we may be unable to pursue our product development and commercialization goals
- 25% rewrittenRisks Related to our Commercial Activities
Public perception of mifepristone or legislation limiting or barring its distribution or use for termination of early pregnancy may limit our ability to sell our current Products
Was: Public 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
All 28 risk factors
Headings as the filing states them, in filing order.
Risks Related to our Commercial Activities
- 01Failure to generate sufficient revenue from the sale of our Products would harm our financial results and would likely cause our stock price to decline31% rewritten
- 02The availability of generic versions of Korlym could adversely affect our business, results of operations and financial position38% rewritten
- 03Public perception of mifepristone or legislation limiting or barring its distribution or use for termination of early pregnancy may limit our ability to sell our current Products25% rewritten
- 04New 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 position72% rewritten
- 05Other companies offer medications that treat patients with hypercortisolism by mechanisms different than Korlym’s. The availability of such competing treatments could limit our product revenue86% rewritten
- 06Physician preference for any of these approved 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, causing our stock price to decline92% rewritten
- 07Any widespread occurrence of deadly illness could adversely affect our business, operations and financial results. For example, the COVID-19 pandemic made it difficult to grow our commercial business and slowed the pace of some of our clinical trials
- 08If 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
- 09We 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
- 10Vendors 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 candidates72% rewritten
- 11Our 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 approval51% rewritten
- 12Interim results from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final dataNew
- 13We may be unable to obtain or maintain regulatory approvals for our Products or product candidates, which would prevent us from commercializing our product candidates67% rewritten
- 14Our 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
- 15We 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
- 16The price of our common stock fluctuates widely and is likely to continue to do so. Opportunities for investors to sell shares may be limited
- 17Our 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
- 18We 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
General Risk Factors
- 19Actions by the federal government of the United States have created unprecedented legal, governmental, regulatory and economic uncertainty and risks that may adversely affect our businessNew
- 20The significant cuts to funding for Medicaid contained in the OBBBA enacted in July 2025 will increase the cost of our financial assistance and charitable donation programs. There may be further reductions in federal healthcare spending that harm our businessNew
- 21We need to increase the size of our organization and may experience difficulties in managing growth
- 22If we lose key personnel or are unable to attract more skilled personnel, we may be unable to pursue our product development and commercialization goals30% rewritten
- 23We 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
- 24Changes in federal, state and local tax laws may reduce our net earnings
- 25Research analysts may not continue to provide or initiate coverage of our common stock or may issue negative reports
- 26Any 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
- 27Anti-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
- 28Our officers, directors and principal stockholders, acting as a group, could significantly influence corporate actions
Other Corcept Therapeutics 10-Ks
- FY2024 10-K risk factors30 risks
Teva launched a generic Korlym in January 2024 after a court found it would not infringe Corcept’s asserted patents.
Filed Feb 26, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.