Business overview
BUSINESS Overview We are a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. Cortisol plays a significant role in the body’s response to stress and is essential for survival. Cortisol influences metabolism and the immune system and contributes to emotional stability. Cortisol levels follow a diurnal rhythm that is essential to health, peaking upon awakening and decreasing during the day. Insufficient cortisol activity may lead to dehydration, hypotension, shock, fatigue and hypoglycemia. Excessive cortisol activity, known as hypercortisolism, may lead to hypertension, diabetes, impaired glucose tolerance, obesity, fatty liver disease, depressed mood, psychosis, wasting of the arms and legs, edema, fatigue, insomnia and other problems.
Cortisol reduces a patient’s immune response to oncogenesis, shields certain cancer cells from the apoptotic effects of chemotherapy and facilitates the growth of others. Pre-clinical and clinical data indicate that modulating cortisol activity may improve outcomes in patients with fatty liver disease and metabolic dysfunction-associated steatohepatitis (“MASH”), which are precursors of liver fibrosis and cirrhosis. Pre-clinical and clinical data also suggest that modulating cortisol activity may lead to treatments for patients with amyotrophic lateral sclerosis (“ALS”). 1 Since 2012, we have marketed Korlym in the United States for the treatment of patients suffering from hypercortisolism (also known as “Cushing’s syndrome”). In June 2024, we made an authorized generic version of Korlym available for the same indication.
Read more
The challenge in treating a patient with hypercortisolism is modulating cortisol’s effects without either inappropriately suppressing them or disrupting cortisol’s normal diurnal rhythm. Simply reducing or destroying the ability of the body to make cortisol can cause serious harm. Cortisol activity can be modulated effectively by a drug that competes with cortisol’s binding to the glucocorticoid receptor (“GR”). Because Korlym’s active ingredient, mifepristone, reduces the binding of excess cortisol to the GR, it can modulate the effects of abnormal levels and release patterns of cortisol without compromising cortisol’s healthy functions and rhythms. However, mifepristone also binds to the progesterone receptor (“PR”), thereby terminating pregnancy and causing other adverse effects, including endometrial thickening and vaginal bleeding, a debilitating condition suffered by a significant portion of women who take Korlym.
We have discovered more than 1,000 proprietary cortisol modulators that bind to the GR but have no affinity for the PR and therefore do not cause effects arising from antagonism of progesterone activity, such as termination of pregnancy, endometrial thickening and vaginal bleeding. The composition of these “selective” cortisol modulators and their methods of use in a wide range of indications are covered by U.S. and foreign patents. Our lead compounds are being evaluated in clinical trials as potential treatments for a variety of serious disorders – hypercortisolism, solid tumors (including ovarian, endometrial, cervical, pancreatic and prostate cancers), ALS and MASH. Hypercortisolism (Cushing ’ s syndrome) Background. Hypercortisolism is the result of a tumor that produces either cortisol or adrenal corticotropic hormone, a hormone that causes the adrenal glands to produce cortisol.
Abnormally high levels of cortisol lead to overstimulation of the GR, which gives rise to a wide range of serious adverse effects. Most people with hypercortisolism have one or more of the following symptoms: hypertension, diabetes, impaired glucose tolerance, obesity, fatty liver disease, wasting of the arms and legs, edema, fatigue and insomnia. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system in the body and can be lethal if not treated. If the tumor can be found, the preferred treatment is surgery, which, if successful, can cure the disease. In approximately half of patients who receive surgery, the procedure is not successful.
Depending on the type of tumor, surgery can also result in a range of complications and recurrence of the disease is common. Our Products. We sell Korlym and a generic version of Korlym in the United States (our “Products”) using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons. From 2017 until 2025, we used an exclusive specialty pharmacy vendor, Optime Care, Inc. (“Optime”) and a specialty distributor to distribute our Products and provide logistical support to physicians and patients.
In June 2025, we notified Optime that it would cease to be our exclusive specialty pharmacy and in October 2025, we delivered a notice of termination of our agreement with them, effective January 8, 2026. […]
Source: 10-K · Period ended December 31, 2025 · View report
Latest developments
Recent company filings, newest first. Excerpts retain the original wording.
September 23, 2026Management8-K
Changes to directors, officers or compensation
Original filing excerpt · Item 5.02, 7.01
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On September 22, 2026, Sean Maduck, the President of Corcept Endocrinology, notified the Board of Directors of Corcept Therapeutics Incorporated (the “Company”) of his decision to resign effective as of October 1, 2026. The Company thanks Mr. Maduck for his significant contributions to the Company and his dedication to helping patients. Mr. Maduck did not resign because of any disagreement with the Company on any matter relating to the Company’s operations, financial statements, policies or practices.
Read more
In connection with Mr. Maduck’s resignation, the Company and Mr. Maduck entered into a Consulting Services Agreement (the “Agreement”), dated as of September 22, 2026 and effective as of October 1, 2026, pursuant to which Mr. Maduck will provide consulting services to the Company’s Chief Executive Officer and executive management team. The Agreement has an initial term expiring on September 30, 2027, unless earlier terminated. Pursuant to the Agreement, Mr.
Maduck will be paid a cash fee of $57,000 per month. The Agreement further provides that during Mr. Maduck’s consulting term with the Company, Mr. Maduck’s previously awarded and currently outstanding stock options shall continue to vest according to the original vesting schedule of each such stock option. Either party may terminate the Agreement upon thirty (30) days’ prior written notice. […]
Regulation FD Disclosure. On September 23, 2026, the Company issued a press release announcing the retirement of Mr. Maduck and that Justin Gunn will succeed Mr. Maduck. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The information in this
and the information contained in the press release attached as Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this
and the information contained in the press release attached as Exhibit 99.1 is not incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in the filing unless specifically stated so therein.
July 29, 2026Disclosure8-K
Regulation FD disclosure
Original filing excerpt · Item 7.01
Regulation FD Disclosure. On July 29, 2026, Corcept Therapeutics Incorporated (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2026 and a corporate update. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The information in this
Read more
and the information contained in the press release attached as Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this
and the information contained in the press release attached as Exhibit 99.1 is not incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in the filing unless specifically stated so therein.
June 17, 2026Company update8-K
Other events
Original filing excerpt · Item 8.01
Other Events. On June 17, 2026, Corcept Therapeutics Incorporated (the “Company”) issued a press release announcing that the Company has resubmitted its New Drug Application to the U.S. Food and Drug Administration for relacorilant as a treatment for patients with Cushing’s syndrome. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
View report
Show 3 more filings
June 3, 2026Company update8-K
Other events
Original filing excerpt · Item 8.01
Other Events. On May 19, 2026, Corcept Therapeutics Incorporated (the “Company”) learned that the United States Department of Justice (the “DOJ”) had filed a Notice of Election to Decline Intervention (the “Notice”) in a civil qui tam action filed against the company, captioned U.S. et al. ex rel. Stephen Elliott v. Corcept Therapeutics, Inc. , No. 17-CV-1303 (SRC) (D.N.J.). That action was initiated in February 2017, in the District Court of New Jersey, by a former employee of the Company (the “Relator”).
Read more
In connection with that action, the DOJ previously issued a records subpoena to the Company in November 2021, seeking information relating to the sale and promotion of Korlym ® , the Company’s relationships with and payments to health care professionals who prescribe or recommend Korlym, and prior authorizations and reimbursement for Korlym, to which the Company responded in full. The DOJ’s Notice indicates that the DOJ, the California Department of Insurance, and the named Plaintiff States have all declined to intervene in the Relator’s lawsuit. On June 2, 2026, the Relator served the Company with an amended complaint. The Company intends to vigorously defend against all of the Relator’s claims.
Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements that involve risks and uncertainties, such as statements related to the Company’s intent to vigorously defend against all of the Relator’s claims. […]
May 28, 2026Management8-K
Changes to directors, officers or compensation
Original filing excerpt · Item 5.02, 5.07
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On May 21, 2026, Corcept Therapeutics Incorporated (the “Company”) held its 2026 Annual Meeting of Stockholders (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders approved the Amendment to the Corcept Therapeutics Incorporated 2024 Incentive Award Plan (the “Amended 2024 Plan”) to increase the number of shares available thereunder by 8,000,000 shares and clarify certain other language in the plan. The Amended 2024 Plan was previously approved by the Board of Directors of the Company, subject to stockholder approval. The Amended 2024 Plan became effective on May 21, 2026 upon stockholder approval at the Annual Meeting and replaces the Corcept Therapeutics Incorporated 2024 Incentive Award Plan.
Read more
A description of the material terms of the Amended 2024 Plan was included in “Proposals to be Acted upon at the 2026 Annual Meeting - Proposal No. 4 - Approval of the Amendment to the Corcept Therapeutics Incorporated 2024 Incentive Award Plan” in the Company’s Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on April 17, 2026, and which description and text are incorporated by reference into this
of this Current Report on Form 8-K. The foregoing summary is qualified in its entirety by reference to the full text of the Amended 2024 Plan, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Submission of Matters to a Vote of Security Holders On May 21, 2026, the Company held the Annual Meeting to consider and vote on the following proposals: 1) to elect eight directors to hold office until its 2027 annual meeting of stockholders and until their successors are duly elected and qualified , 2) to ratify the appointment of Ernst & Young LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2026, 3) to approve, on an advisory basis, the compensation of the Company’s named executive officers, and 4) to approve the Amended 2024 Plan. A total of 107,356,686 shares of the Company’s common stock held by stockholders of record at the close of business on April 9, 2026 were entitled to vote at the Annual Meeting.
The total number of shares voted at the Annual Meeting was 93,270,175. The voting on the four matters is set forth below: Proposal 1 - Election of Directors. The following directors were elected to serve until the Company’s 2027 annual meeting of stockholders. Director For Withheld Broker Non-Votes Gregg Alton 67,977,943 9,316,514 15,975,718 G. Leonard Baker, Jr. 64,912,506 12,381,951 15,975,718 Joseph K.
Belanoff, M.D. 76,965,512 328,945 15,975,718 David L. Mahoney 51,078,278 26,216,179 15,975,718 Joshua M. Murray 76,753,606 540,851 15,975,718 Kimberly Park 70,288,833 7,005,624 15,975,718 Daniel N. Swisher, Jr. 67,594,098 9,700,359 15,975,718 James N.
[…]
April 30, 2026Disclosure8-K
Regulation FD disclosure
Original filing excerpt · Item 7.01
Regulation FD Disclosure. On April 30, 2026, Corcept Therapeutics Incorporated (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026 and a corporate update. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The information in this
Read more
and the information contained in the press release attached as Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this
and the information contained in the press release attached as Exhibit 99.1 is not incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in the filing unless specifically stated so therein.
Latest results
Original excerpts. Reporting periods, units and comparisons are retained in the text.
Revenue
We anticipate this provision will limit the revenue we receive from Medicare patients and may materially reduce our profits in 2026 and beyond. The IRA permits CMS to negotiate prices for certain high-expenditure Medicare Part B or Part D drugs. The IRA imposes a one percent excise tax on certain share repurchases and a 15 percent corporate alternative minimum tax on adjusted financial statement income. The corporate alternative minimum tax became effective for us on January 1, 2024. We do not expect either of these provisions to significantly affect our condensed consolidated financial statements. Please see the risk factor under Item 1A of this Quarterly Report on Form 10-Q, “ 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 […]
Read more
Results of Operations Product Revenue, Net – Product Revenue, Net, or Net product revenue, is gross product revenue from sales to our customers less deductions for estimated government rebates and chargebacks, patient assistance programs, discounts provided to our specialty pharmacies and distributors for prompt payment and reserves for expected returns. Net product revenue was $256.1 million and $421.1 million for the three and six months ended June 30, 2026, respectively, compared to $194.4 million and $351.6 million for the comparable periods in 2025. The increases were driven by higher net product revenue from our Hypercortisolism Products and net product revenue from Lifyorli. Lifyorli’s commercial launch was on April 1, 2026.
Cash flow & liquidity
For a complete discussion of such statements and the potential risks and uncertainties that may affect their accuracy, see the “Risk Factors,” “Overview” and “Liquidity and Capital Resources” sections of this Form 10-Q. Overview We are a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. We have been selling and distributing Korlym in the United States for the treatment of patients suffering from hypercortisolism (also known as “Cushing’s syndrome”) since 2012. In June 2024, we made an authorized generic version of Korlym available. […]
Read more
Income tax - Income tax expense was $2.9 million for the three months ended June 30, 2026, while income tax benefit was $10.0 million for the six months ended June 30, 2026, compared with income tax benefits of $3.5 million and $14.4 million for the comparable periods in 2025, respectively. The increase in income tax expense during the three months ended June 30, 2026 and decrease in income tax benefit during the six months ended June 30, 2026 were primarily due to a decrease in stock compensation deductions in 2026 as compared to the comparable periods in 2025. Liquidity and Capital Resources Since 2015, we have relied on revenues from the sale of our Products to fund our operations.
Management commentary
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to help the reader understand our results of operations and financial condition and is provided as a supplement to, and should be read in conjunction with our condensed consolidated financial statements and the accompanying notes to financial statements, risk factors and other disclosures included in this Form 10-Q. Our condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”). We make statements in this section that are “forward-looking” within the meaning of the federal securities laws.
Read more
For a complete discussion of such statements and the potential risks and uncertainties that may affect their accuracy, see the “Risk Factors,” “Overview” and “Liquidity and Capital Resources” sections of this Form 10-Q. Overview We are a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. We have been selling and distributing Korlym in the United States for the treatment of patients suffering from hypercortisolism (also known as “Cushing’s syndrome”) since 2012. In June 2024, we made an authorized generic version of Korlym available. In March 2026, the FDA approved Lifyorli™ (relacorilant) in combination with the chemotherapy medication nab-paclitaxel as a treatment for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
In April 2026, we began selling and distributing Lifyorli in the United States. Our portfolio of proprietary selective cortisol modulators consists of five structurally distinct series totaling more than 1,000 compounds. Hypercortisolism (Cushing’s syndrome) Our Hypercortisolism Products. We sell Korlym and our authorized generic version of Korlym in the United States (our “Hypercortisolism Products”) using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons. We use an exclusive specialty pharmacy vendor, Curant Health Georgia, LLC (“Curant”) to distribute our Hypercortisolism Products directly to patients and provide patients and physicians with logistical and pharmacy support.
From 2017 to 2025, our specialty pharmacy was Optime Care, Inc. We use a specialty distributor to distribute our Hypercortisolism Products to hospital pharmacies and other purchasers. Our policy is that no patient with hypercortisolism will be denied access to our medications for financial reasons. To help us achieve that goal, we have patient support programs and donate money to independent charitable foundations that help patients pay for all aspects of their hypercortisolism care, whether or not that care includes taking our Hypercortisolism Products. Because most people who suffer from hypercortisolism are undiagnosed or inadequately treated, we have developed and continue to refine and expand programs to educate physicians and patients about screening for hypercortisolism and the role our Hypercortisolism Products can play in treating patients with the disorder.
We also conduct clinical research: In 2023, we initiated our CATALYST study to determine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes, defined as hemoglobin A1c (“HbA1c” – a measure of glucose control that rises in people with diabetes) of 7.5 percent or higher, despite receiving optimum treatment. Of the 1,057 patients enrolled in the first phase of CATALYST, 23.8 percent were found to have hypercortisolism. These patients were offered the chance to enter CATALYST’s second phase, in which 136 eligible patients were randomized 2:1 to receive either Korlym or placebo for 24 weeks. The primary endpoint of CATALYST’s second phase was a reduction in HbA1c in patients who received Korlym compared to patients who received placebo.
CATALYST met this primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant decrease in HbA1c of 1.47 percent, compared to a decrease of 0.15 percent in patients who received placebo (p-value: <0.0001). This phase of the trial also met its secondary endpoints. Patients who received Korlym exhibited significantly greater reductions in body weight (5.1 kg; p-value: 0.001) and waist circumference (5.1 cm; p-value: 0.002) than patients who received placebo. The safety profile of Korlym in CATALYST was manageable and consistent with the medication’s label: No new side effects or adverse events were identified. CATALYST’s results were published in Diabetes Care (Buse et al., April 2025 (first phase) and DeFronzo et al., June 2025 (second phase)), the peer-reviewed journal of the American Diabetes Association.
[…]
Key risks
Annual risk disclosures
RISK FACTORS Investing in our common stock involves significant risks. Before investing, carefully consider the risks described below and the other information in this Annual Report on Form 10-K, including our consolidated financial statements and related notes. The risks and uncertainties described below are the ones we believe may materially affect us. There may be others of which we are unaware that could materially harm our business or financial condition and cause the price of our stock to decline, in which case you could lose all or part of your investment. Summary of Principal Risks The following bullet points summarize the principal risks we face, each of which could adversely affect our business, operations and financial results.
Below, we have arranged these risks by the part of our business they most directly affect. Risks 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 availability of generic versions of Korlym could adversely affect our business, results of operations and financial position. • 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. • 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.
Read more
20 Risks 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. • Our efforts to discover, develop and commercialize our product candidates may not succeed. Clinical drug development is lengthy, expensive and often unsuccessful. Results of early studies and trials are often not predictive of later trial results. Failure can occur at any time.
Even if we deem that our product candidates’ clinical trial results demonstrate safety and efficacy, regulatory authorities may not agree. Failure to obtain or maintain regulatory approvals for our product candidates would prevent us from commercializing them. Risks Related to our Intellectual Property • We may not be able to secure, maintain or effectively assert patent protection for the composition, manufacture, or methods of use of our proprietary, selective cortisol modulators and for the use of our Products to treat hypercortisolism. Litigation is slow and expensive and its outcome is uncertain and subject to challenge on appeal. Risks Related to our Stock • The price of our common stock fluctuates widely and is likely to continue to do so.
Opportunities for investors to sell shares may be limited. • Our 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. General 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. • We 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.
Risk Factors – Discussion The following section discusses the principal risks listed above, as well as other risks we believe to be material. Risks 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. Our ability to generate revenue and to fund our commercial operations and development programs is dependent on the sale of our Products to treat patients with hypercortisolism. Physicians will prescribe our Products if they determine that they are preferable to other treatments, even if those treatments are not approved for hypercortisolism. Most physicians are inexperienced 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.
[…]
Quarterly risk disclosures
The quarterly report's own risk disclosure is shown below. No changes have been inferred by comparing reports.
RISK FACTORS Investing in our common stock involves significant risks. Before investing, carefully consider the risks described below and the other information in this quarterly report, including our condensed consolidated financial statements and related notes. The risks and uncertainties described below are the ones we believe may materially affect us. There may be others of which we are unaware that could materially harm our business or financial condition and cause the price of our stock to decline, in which case you could lose all or part of your investment. Summary of Principal Risks The following bullet points summarize the principal risks we face, each of which could adversely affect our business, operations and financial results.
Below, we have arranged these risks by the part of our business they most directly affect. Risks Related to our Commercial Activities • Failure to generate sufficient revenue from the sale of Korlym, our authorized generic of Korlym, and Lifyorli (collectively, our “Products”) would harm our financial results and would likely cause our stock price to decline. • The availability and adoption of generic versions of Korlym, other than our authorized generic of Korlym, could adversely affect our business, results of operations and financial position. • 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.
Read more
• 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. 28 Risks 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. • Our efforts to discover, develop and commercialize our product candidates may not succeed.
Clinical drug development is lengthy, expensive and often unsuccessful. Results of early studies and trials are often not predictive of later trial results. Failure can occur at any time. Even if we deem that our product candidates’ clinical trial results demonstrate safety and efficacy, regulatory authorities may not agree. Failure to obtain or maintain regulatory approvals for our product candidates would prevent us from commercializing them. Risks Related to our Intellectual Property • We may not be able to secure, maintain or effectively assert patent protection for the composition, manufacture, or methods of use of our Products and our proprietary, selective cortisol modulators.
Litigation is slow moving, expensive and its outcome is uncertain and subject to challenge on appeal. Risks Related to our Stock • The price of our common stock fluctuates widely and is likely to continue to do so. Opportunities for investors to sell shares may be limited. • Our 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. General 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. • We 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. Risk Factors – Discussion The following section discusses the principal risks listed above, as well as other risks we believe to be material. Risks Related to our Commercial Activities Failure to generate sufficient revenue from the sale of Korlym, our authorized generic of Korlym, and Lifyorli (collectively, our “Products”) would harm our financial results and would likely cause our stock price to decline. Our ability to generate revenue and to fund our commercial operations and development programs is dependent on the sale of our Products.
Physicians will prescribe our Products if they determine that they are preferable to other treatments. Many factors could limit our product revenue, including: • many physicians are inexperienced in diagnosing or caring for patients with hypercortisolism and it can be hard to persuade them to identify appropriate patients and treat them with our Hypercortisolism Products; […]
Annual report details
Read annual management analysis & tone analysis
Annual MD&A Tone Analysis
-42.9
2 · 28.6%Positive terms
5 · 71.4%Negative terms
738Analyzed annual MD&A words
Only the extracted annual management discussion is evaluated using dictionary version 1.1. Score = (positive − negative) ÷ matched terms × 100. Quarterly reports and current filings are excluded. This lexical measure does not assess financial health and may not fully capture context or negation.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to help the reader understand our results of operations and financial condition and is provided as a supplement to, and should be read in conjunction with our audited consolidated financial statements and the accompanying notes to financial statements, risk factors and other disclosures included in this Form 10-K. Our consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”). We make statements in this section that are “forward-looking” within the meaning of the federal securities laws. For a complete discussion of such statements and the potential risks and uncertainties that may affect their accuracy, see the “Risk Factors,” “Overview” and “Liquidity and Capital Resources” sections of this Form 10-K.
Discussions of 2023 items and year-to-year comparisons between 2024 and 2023 are not included, and can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024. Overview We are a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym in the United States for the treatment of patients suffering from hypercortisolism (also known as “Cushing’s syndrome”). In June 2024, we made an authorized generic version of Korlym available.
Our portfolio of proprietary selective cortisol modulators consists of four structurally distinct series totaling more than 1,000 compounds. Hypercortisolism (Cushing’s syndrome) Our Products. We sell our Products using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons. From 2017 until 2025, we used an exclusive specialty pharmacy vendor, Optime and a specialty distributor to distribute our Products and provide logistical support to physicians and patients. In June 2025, we notified Optime that it would cease to be our exclusive specialty pharmacy and in October 2025, we delivered a notice of termination of our agreement with them, effective January 8, 2026.
In the fourth quarter of 2025, substantially all of our specialty pharmacy services were transferred from Optime to Curant. After the first quarter of 2026, Optime will no longer provide specialty pharmacy services related to our Products. Our policy is that no patient with hypercortisolism will be denied access to our Products for financial reasons. To help us achieve that goal, we have patient support programs and donate money to independent charitable foundations that help patients pay for all aspects of their hypercortisolism care, whether or not that care includes taking our Products. Because most people who suffer from hypercortisolism are undiagnosed or inadequately treated, we have developed and continue to refine and expand programs to educate physicians and patients about screening for hypercortisolism and the role our Products can play in treating patients with the disorder.
In 2023 and 2024, we conducted the CATALYST study to determine the prevalence of hypercortisolism in patients with difficult-to-control diabetes (defined as HbA1c of 7.5 percent or higher) despite receiving optimum treatment. Of the 1,057 patients enrolled in the first phase of CATALYST, 23.8 percent were found to have hypercortisolism. These patients were offered the chance to enter CATALYST’s second phase, in which 136 eligible patients were randomized 2:1 to receive either Korlym or placebo for 24 weeks. The primary endpoint of CATALYST’s second phase was a reduction in HbA1c in patients who received Korlym compared to patients who received placebo. CATALYST met this primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant decrease in HbA1c of 1.47 percent, compared to a decrease of 0.15 percent in patients who received placebo (p-value: < 0.0001).
This phase of the trial also met its secondary endpoints. Patients who received Korlym exhibited significantly greater reductions in body weight (5.1 kg; p-value: 0.001) and waist circumference (5.1 cm; p-value: 0.002) than patients who received placebo. The safety profile of Korlym in CATALYST was manageable and consistent with the medication’s label: No new side effects or adverse events were identified. CATALYST’s results were published in Diabetes Care (Buse et al., April 2025 (first phase) and DeFronzo et al., June 2025 (second phase)), the peer-reviewed journal of the American Diabetes Association. […]