Company: CORT
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001628280-25-008167
Chunk: 11

Company: CORCEPT THERAPEUTICS INC
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 11
---
istone and our proprietary selective cortisol modulators in a wide range of disorders, including central serous retinopathy, post-traumatic stress disorder, anxiety, alcoholism, cocaine addiction, Alzheimer’s disease, ALS, hypercortisolism, metabolic syndrome, atherosclerosis, fatty liver disease, sarcoma, melanoma and solid tumors, including triple-negative breast, prostate, ovarian and non-small cell lung cancers.

Clinical Trial Agreements

We typically conduct our clinical trials with the assistance of clinical research organizations (“CROs”). Syneos Health is helping us conduct our ROSELLA trial. Medpace Research is helping us conduct our MONARCH trial. We may terminate our agreements with Syneos Health on 60 days’ written notice and with Medpace Research without cause at any time.

Research and Development Spending

We incurred $246.9 million, $184.4 million and $131.0 million of research and development expense in the years ended December 31, 2024, 2023 and 2022, respectively, which accounted for 46 percent, 49 percent and 45 percent, respectively, of our total operating expenses in those years.

Manufacturing

We rely on contract manufacturers to produce our Products and product candidates.

We have agreements with manufacturers to supply mifepristone, the active pharmaceutical ingredient (“API”) in our Products, and to produce and bottle tablets of our Products. We have purchased and hold significant quantities of API.

Competition

Our Products compete with established treatments, including surgery, radiation and other medications, including “off-label” uses of drugs such as ketoconazole, an anti-fungal medication, and metyrapone, which is approved for testing hypothalamic-pituitary function. Our Products also compete with Signifor® (pasireotide) Injection and Isturisa® (osilodrostat). Both of these drugs are approved by the FDA for the treatment of adult patients with Cushing’s disease who are not candidates for pituitary surgery or for whom surgery did not work, and both are sold by the Italian pharmaceutical company Recordati S.p.A (“Recordati”). Cushing’s disease is a subset of hypercortisolism. In the EU, osilodrostat is also approved as a treatment for hypercortisolism. Our Products also compete with Recorlev® (levoketoconazole), a chiral form of the commonly-prescribed cortisol synthesis inhibitor ketoconazole, that is sold by X