CORCEPT THERAPEUTICS INC

Corcept Therapeutics is a commercial-stage biopharmaceutical 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. The company operates in the pharmaceutical industry, focusing on disorders where cortisol activity plays a significant role, including hypercortisolism (Cushing's syndrome), solid tumors, amyotrophic lateral sclerosis (ALS), and metabolic dysfunction-associated steatohepatitis (MASH). The filing does not disclose an overall market size or growth rate for these therapeutic areas, but it notes that hypercortisolism can affect every organ system and can be lethal if not treated, and that MASH is a leading cause of liver-related mortality afflicting millions of patients.

Corcept's primary competitive advantage lies in its portfolio of more than 1,000 ¹ proprietary selective cortisol modulators that bind to the glucocorticoid receptor (GR) but have no affinity for the progesterone receptor (PR), avoiding effects such as termination of pregnancy, endometrial thickening, and vaginal bleeding. The company's lead product, Korlym (mifepristone) 300 mg Tablets, and an authorized generic version compete with established treatments including surgery, radiation, and other FDA-approved medications such as Signifor (pasireotide), Isturisa (osilodrostat), and Recorlev (levoketoconazole), as well as off-label drugs like ketoconazole and metyrapone. Since January 2024, Corcept's Products also compete with a generic version of Korlym sold by Teva Pharmaceuticals USA, Inc. ². The company holds U.S. and foreign patents covering its compounds and methods of use, with expiration dates ranging from 2028 to 2042 ³.

Corcept generates revenue primarily through the sale of its Products—Korlym and an authorized generic version of Korlym—for the treatment of hypercortisolism in the United States. Revenue is transactional, derived from product sales to patients through specialty pharmacy vendors and a specialty distributor. The company uses sales representatives to call on physicians and a field-based force of medical science liaisons. Patient access is supported by patient support programs and donations to independent charitable foundations that help patients pay for hypercortisolism care, regardless of whether that care includes Corcept's Products. The company's policy is that no patient with hypercortisolism will be denied access to its Products for financial reasons.

Corcept's primary product is Korlym (mifepristone) 300 mg Tablets, approved by the FDA in 2012 for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and for whom surgery has failed or is not an option. In June 2024, the company made an authorized generic version of Korlym available for the same indication. The active ingredient, mifepristone, reduces the binding of excess cortisol to the GR, but it also binds to the progesterone receptor, causing adverse effects including endometrial thickening and vaginal bleeding. The company's lead selective cortisol modulator candidate is relacorilant, which shares Korlym's affinity for the GR but has no affinity for the PR and does not cause hypokalemia (low potassium), a condition experienced by 44% ⁴ of patients in Korlym's pivotal trial. Relacorilant is being developed for hypercortisolism and, in combination with nab-paclitaxel, for platinum-resistant ovarian cancer. Other product candidates include nenocorilant (for solid tumors in combination with immunotherapy), miricorilant (for MASH), and dazucorilant (for ALS). The company also has a portfolio of more than 1,000 ⁵ proprietary selective cortisol modulators across four structurally distinct series.

In the fourth quarter of 2025, substantially all of Corcept's specialty pharmacy services were transferred from Optime Care, Inc. to Curant Health Georgia, LLC, effective with a notice of termination delivered in October 2025 and effective January 8, 2026 ⁶. In June 2025, the company notified Optime that it would cease to be the exclusive specialty pharmacy. The company entered into a Master Pharmacy Services Agreement with Curant in June 2025, with an initial term of three years ⁷ and automatic renewal for successive one-year terms. In December 2024, Corcept submitted a New Drug Application (NDA) to the FDA seeking approval to market relacorilant as a treatment for endogenous hypercortisolism; on December 30, 2025, the FDA issued a Complete Response Letter (CRL) declining to approve relacorilant, stating that additional evidence of efficacy would be required ⁸. In July 2025, the company submitted an NDA seeking approval to market relacorilant plus nab-paclitaxel for platinum-resistant ovarian cancer, which the FDA accepted in September 2025 with a PDUFA date of July 11, 2026 ⁹. In October 2025, the company submitted a marketing authorization application (MAA) to the EMA for the same indication. In January 2024, the Board of Directors authorized the repurchase of up to $200 million ¹⁰ of common stock under the Stock Repurchase Program. During the year ended December 31, 2025, the company purchased 2.6 million ¹¹ shares under this program at an average price of $66.71 ¹² per share, for an aggregate purchase price of $172.9 million ¹³.

For the fiscal year ended December 31, 2025, Corcept reported net product revenue of $761.4 million ¹⁴, compared to $675.0 million ¹⁵ in 2024, driven by a 37.0% ¹⁶ increase in sales volume partially offset by a 17.7% ¹⁷ decrease in average price due to higher sales volume from the authorized generic version. Net income was $99.652 million ¹⁸ in 2025, compared to $141.209 million ¹⁹ in 2024. Diluted net income per common share was $0.82 ²⁰ in 2025 versus $1.23 ²¹ in 2024. Income from operations was $44.797 million ²² in 2025, compared to $136.951 million ²³ in 2024. The company ended the year with cash, cash equivalents, and marketable securities of $532.4 million ²⁴, consisting of cash and cash equivalents of $120.5 million ²⁵ and marketable securities of $411.9 million ²⁶.

A major growth vector is the potential approval and commercialization of relacorilant for platinum-resistant ovarian cancer. The NDA was accepted by the FDA with a PDUFA date of July 11, 2026 ²⁷, and an MAA was submitted to the EMA with a likely regulatory decision date in the fourth quarter of 2026 ²⁸. The pivotal Phase 3 ROSELLA trial met its dual primary endpoints of progression-free survival (PFS) and overall survival (OS), with patients treated with relacorilant plus nab-paclitaxel experiencing a 30% ²⁹ reduction in risk of disease progression (hazard ratio: 0.70; p-value: 0.008) and a 35% ³⁰ reduction in risk of death (hazard ratio: 0.65; p-value: 0.0004), with median OS of 16.0 months ³¹ versus 11.9 months ³² for nab-paclitaxel alone. The company is also advancing relacorilant in additional oncology indications through Phase 2 trials: BELLA (ovarian and endometrial cancers, with Part A completing enrollment of 95 ³³ patients), TRIDENT (pancreatic cancer, planned enrollment of 50 ³⁴ patients), and STELLA (cervical cancer, planned enrollment of 50 ³⁵ patients, to be initiated in the first quarter of 2026). The EC has designated relacorilant as an orphan drug for the treatment of ovarian and pancreatic cancers.

Another growth vector is the expansion of the hypercortisolism franchise through the CATALYST and MOMENTUM studies. CATALYST found that 23.8% ³⁶ of 1,057 ³⁷ patients with difficult-to-control diabetes had hypercortisolism, and the second phase met its primary endpoint with a clinically meaningful and statistically significant decrease in HbA1c of 1.47% ³⁸ in patients who received Korlym compared to a decrease of 0.15% ³⁹ in patients who received placebo (p-value: <0.0001). The MOMENTUM trial, initiated in March 2025 to determine the prevalence of hypercortisolism in patients with resistant hypertension, completed enrollment of over 1,000 ⁴⁰ patients in December 2025. The company is also developing dazucorilant for ALS, where an exploratory analysis showed an 84% ⁴¹ reduction in risk of death for patients receiving 300 mg of dazucorilant (hazard ratio: 0.16; p-value: 0.0009). Following a dose-titration study, the company expects to start a pivotal Phase 3 trial in 2026 ⁴². Additionally, the Phase 2b MONARCH trial of miricorilant in MASH has completed enrollment in both cohorts, with Cohort A enrolling 82 ⁴³ patients and Cohort B enrolling 93 ⁴⁴ patients.The company expects research and development expense to be higher in 2026 than in 2025 as clinical programs advance and new clinical trials are initiated ⁴⁵. Selling, general and administrative expense is also expected to be higher in 2026 due to increased commercial and administrative activities to support increased sales and marketing efforts ⁴⁶. The company's headquarters lease at 101 Redwood Shores Parkway, Redwood City, California, covers 50,632 ⁴⁷ square feet, and in December 2025, the company exercised an expansion option for an additional 40,884 ⁴⁸ square feet, which commenced in the first quarter of 2026. The current lease expires in June 2030 ⁴⁹. As of December 31, 2025, the company had 730 ⁵⁰ employees.

Capital allocation priorities include funding operations and planned research and development activities from product revenue and cash reserves. The company spent $172.9 million ⁵¹ on share repurchases under the Stock Repurchase Program during 2025, with $200 million ⁵² authorized. The company also spent $56.8 million ⁵³ acquiring shares in connection with the net exercise of employee and director stock options and $16.1 million ⁵⁴ to satisfy tax withholding requirements from vesting of restricted stock grants. The company has never declared or paid cash dividends and does not anticipate paying cash dividends in the foreseeable future ⁵⁵. Research and development expense was $254.9 million ⁵⁶ in 2025, $246.9 million ⁵⁷ in 2024, and $184.4 million ⁵⁸ in 2023.

A key headwind is the availability of generic versions of Korlym. Teva launched a generic version in January 2024 ⁵⁹, and on February 19, 2026, the Court of Appeals for the Federal Circuit affirmed the District Court's ruling that Teva's generic product would not infringe Corcept's patents ⁶⁰. The company also has litigation settlements with Sun Pharmaceutical Industries Limited and Hikma Pharmaceuticals USA Inc. that allow them to begin selling mifepristone, with customary restrictions, provided the FDA has approved their products and Teva's generic product remains commercially available ⁶¹. Another headwind is the regulatory setback for relacorilant in hypercortisolism; the FDA issued a Complete Response Letter on December 30, 2025, declining to approve the NDA and stating that additional evidence of efficacy would be required ⁶². The company is working with the FDA to determine the optimal path to approval. Additionally, the Inflation Reduction Act of 2022 includes provisions that may limit revenue from Medicare patients, and the company anticipates this will materially reduce profits in 2026 and beyond ⁶³.

Structural headwinds include the potential impact of the Dobbs v. Jackson Women's Health Organization decision, which has stimulated many states to enact laws restricting the legality of abortion and mifepristone, the active ingredient in Corcept's Products ⁶⁴. In September 2025, the HHS announced it will re-examine the safety of mifepristone for use in the termination of early pregnancy, and there can be no assurance this re-examination will not result in restrictions on the distribution of mifepristone for any use, including the treatment of hypercortisolism ⁶⁵. The company also faces risks from the imposition of tariffs on international trade, which have increased costs and made planning difficult ⁶⁶. Furthermore, the One Big Beautiful Bill Act of 2025, signed into law on July 4, 2025, reduced funding to federal healthcare programs and imposed additional requirements, which may result in decreased access to healthcare, particularly in Medicaid programs ⁶⁷.

The most material risks to Corcept's business include the availability of generic versions of Korlym, which could materially harm results of operations; Teva launched a generic in January 2024 ⁶⁸, and the company's patent infringement lawsuit was ultimately unsuccessful, with the Federal Circuit affirming no infringement on February 19, 2026 ⁶⁹. The regulatory setback for relacorilant in hypercortisolism—the FDA issued a Complete Response Letter on December 30, 2025, requiring additional evidence of efficacy ⁷⁰—creates significant uncertainty for a key pipeline asset. The company's reliance on a single specialty pharmacy vendor, Curant, which dispenses Products and collects payments from insurers representing more than 99% ⁷¹ of revenue, introduces concentration risk; any operational difficulties at Curant could adversely affect business. The Inflation Reduction Act of 2022 and the One Big Beautiful Bill Act of 2025 impose new manufacturer financial liability and reduce Medicaid funding, which the company anticipates will materially reduce profits in 2026 and beyond ⁷². Finally, public perception of mifepristone as an abortifacient and potential legislation restricting its distribution could limit the company's ability to sell its Products, as the HHS announced in September 2025 it will re-examine the safety of mifepristone for use in termination of early pregnancy ⁷³.

Management's tone in the filing is forward-looking and focused on advancing the pipeline despite regulatory setbacks. Key themes include the commitment to working with the FDA to determine relacorilant's optimal path to approval following the Complete Response Letter for hypercortisolism ⁷⁴, the advancement of relacorilant for platinum-resistant ovarian cancer with a PDUFA date of July 11, 2026 ⁷⁵, and the expansion of the hypercortisolism franchise through the CATALYST and MOMENTUM studies. Management emphasizes the company's policy that no patient with hypercortisolism will be denied access to its Products for financial reasons ⁷⁶. Strategic priorities for the period ahead include: (1) obtaining regulatory approval for relacorilant in platinum-resistant ovarian cancer in the U.S. and EU, (2) determining the path forward for relacorilant in hypercortisolism, and (3) advancing the clinical pipeline in oncology, metabolic diseases, and ALS, including starting a pivotal Phase 3 trial for dazucorilant in ALS in 2026 ⁷⁷.