Relacorilant

2025 revenue of $761.4 million Full year 2026 revenue guidance of $900 – $1,000 million 2025 net income of $99.7 million Cash and investments of $532.4 million at December 31, 2025 REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), 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, today reported its results for the quarter and year ended December 31, 2025. Financial Results “In 2025, our Cushing’s syndrome business experienced a surge in demand due to growing recognition among physicians of hypercortisolism’s true prevalence and the necessity of appropriate treatment. We had a record number of new prescriptions written for our medications and a record number of new prescribers in 2025, which translated to a 37 percent increase in the number of tablets sold compared to the prior year. We should have achieved higher growth but were not able to fully meet demand because of capacity constraints at our previous specialty pharmacy vendor. There were also operational disruptions in the fourth quarter as we transitioned our business to our new specialty pharmacy. This transition is now fully complete and February is on track to be a record month for the number of new patients that have started treatment with our medications. We expect that our Cushing’s syndrome business will expand for many years,” said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. Corcept’s fourth quarter 2025 revenue was $202.1 million, compared to $181.9 million in the fourth quarter of 2024. Revenue for the full year was $761.4 million, compared to $675.0 million in 2024. Net income was $24.3 million in the fourth quarter, or $0.20 diluted net income per common share, compared to net income of $30.7 million, or $0.26 diluted net income per common share, in the fourth quarter of 2024. For the full year, net income was $99.7 million, or $0.82 diluted net income per common share, compared to net income of $141.2 million, or $1.23 diluted net income per common share, in 2024. Cash and investments were $532.4 million at December 31, 2025, compared to $603.2 million at December 31, 2024. In 2025, Corcept paid $245.9 million to purchase its common stock, pursuant to the company’s stock repurchase program, net exercise of employee stock options and net vesting of restricted stock grants. Clinical Development “We are engaged with the FDA to determine the best path forward for our New Drug Application (NDA) for relacorilant in Cushing’s syndrome and are confident that the ultimate outcome will be approval,” said Dr. Belanoff. “Our NDA for relacorilant in platinum-resistant ovarian cancer, which is now bolstered by the final overall survival results from our ROSELLA study, has a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026. In addition, our ongoing clinical studies will soon produce important data. Results from MOMENTUM, our trial evaluating the prevalence of hypercortisolism in patients with resistant hypertension, will be featured in an oral presentation at the American College of Cardiology (ACC) meeting in March. Results from our BELLA trial in patients with advanced ovarian cancer will be available by the end of this year, as will results from MONARCH, our Phase 2b trial in patients with metabolic dysfunction-associated steatohepatitis (MASH). By the end of next year, we expect results from our studies in platinum-sensitive ovarian, endometrial, cervical and pancreatic cancers.” “We are also planning to start a Phase 3 trial of dazucorilant in patients with ALS, which will seek to replicate the benefit patients exhibited in our DAZALS trial, by the middle of this year,” added Dr. Belanoff. Hypercortisolism (Cushing’s Syndrome) New Drug Application – Engaged with FDA to determine best path forward to approval following Complete Response Letter for relacorilant in patients with Cushing’s syndrome GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with Cushing’s syndrome – Results published in The Lancet Diabetes & Endocrinology (Pivonello et al, February 2026) MOMENTUM – Enrollment completed in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension; results will be presented at ACC meeting in March “Relacorilant has the potential to become the new standard of care for patients with Cushing’s syndrome. In its Phase 2 and Phase 3 studies, patients treated with relacorilant showed clinically meaningful and statistically significant improvements in hypertension and a wide range of Cushing’s syndrome’s other signs and symptoms. Importantly, these benefits were observed without off-target effects and toxicities such as drug-induced hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency and QT prolongation. These adverse events can have serious health consequences and are associated with currently available treatments. We are working with the FDA to bring relacorilant to patients as soon as possible,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. Oncology Relacorilant in Combination with Chemotherapy New Drug Application – FDA reviewing NDA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, with a July 11, 2026 PDUFA date Marketing Authorization Application (MAA) – European Medicines Agency reviewing MAA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer – Approval expected by the end of this year ROSELLA – Both dual primary endpoints (progression-free and overall survival) met, without the need for biomarker selection and without increased safety burden – Complete results will be presented at the Society of Gynecology Oncology (SGO) meeting in April BELLA Part A – Enrollment completed in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer – Results expected by the end of this year BELLA Part B – Enrollment underway in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-sensitive ovarian cancer whose disease progressed while on a PARP inhibitor BELLA Part C – Enrollment underway in Phase 2 trial of relacorilant plus nab-paclitaxel in 90 patients with endometrial cancer (who have received one or two prior lines of therapy) STELLA – Phase 2 trial of relacorilant plus nab-paclitaxel in 50 patients with cervical cancer (received one or two prior lines of therapy) to begin in coming weeks, conducted in collaboration with ARCAGY-GINECO, an academic clinical research group specializing in gynecologic cancers TRIDENT – Enrollment underway in Phase 2 trial of relacorilant plus nab-paclitaxel and gemcitabine as first-line therapy in 50 patients with pancreatic cancer Relacorilant in Combination with Androgen Deprivation Therapy Prostate cancer – Enrollment continues in randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in 90 patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago Nenocorilant in Combination with Immunotherapy SYNERGY – Enrollment underway in Phase 1b dose-finding trial of nenocorilant plus nivolumab in 30 patients with a variety of solid tumors “Results from our pivotal Phase 3 ROSELLA study demonstrate a 35 percent reduction in the risk of death in patients with platinum-resistant ovarian cancer (PROC). These results – without the need for biomarker selection, without increased safety burden and with oral administration – highlight relacorilant’s potential to become the new standard of care in PROC. Our applications are under review with regulatory authorities in both the United States and Europe, and we are working with urgency to bring this medication to patients with this highly challenging form of ovarian cancer,” said Dr. Guyer. “Our ROSELLA results, as well as other pre-clinical and clinical oncology data, highlight the potential of glucocorticoid receptor antagonism to benefit patients across a wide variety of solid tumor types beyond PROC. We are currently studying relacorilant in other solid tumors, including platinum-sensitive ovarian, endometrial, cervical, pancreatic and prostate cancers, and we will continue to broaden our research to help as many patients as possible,” added Dr. Guyer. Metabolic Dysfunction-Associated Steatohepatitis (MASH) MONARCH – Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in 175 patients with biopsy-confirmed or presumed MASH – Results expected by the end of this year “In our Phase 1b study, miricorilant was well-tolerated and very rapidly reduced liver fat while improving fibrosis, liver enzymes and other markers of liver health, as well as key metabolic and lipid measures. We look forward to building on these promising findings in our Phase 2b MONARCH study, with results expected by the end of this year,” said Dr. Guyer. Amyotrophic Lateral Sclerosis (ALS) DAZALS – Exploratory analyses showed that patients who received dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009) Phase 3 trial – Planned to begin by the middle of this year “Elevated cortisol activity is linked to ALS. In our Phase 2 DAZALS study, patients who received dazucorilant experienced a profound reduction in early mortality – a period when many patients with ALS retain significant function and quality of life,” said Dr. Guyer. “We are currently conducting a dose titration study, with the goal of improving gastrointestinal tolerability, to inform the direction of our Phase 3 program.” Conference Call We will hold a conference call on February 24, 2026, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here . Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here . A replay of the call will be available on the Investors / Events tab of Corcept.com . About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym ® , the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous Cushing’s syndrome. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com . Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements. In this press release, forward-looking statements include those concerning: our 2026 revenue guidance; our ability to achieve a record number of new patients that have started treatment with our medications in a month; the expected expansion of our Cushing’s syndrome business for many years; regulatory review of relacorilant, including engagement with the FDA regarding our NDA for relacorilant in Cushing’s syndrome and our confidence that the ultimate outcome will be approval, FDA review of our NDA for relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, and our expectation to receive approval of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer from the European Medicines Agency based on its review of our MAA; our ability to bring relacorilant to patients and the timing thereof; statements related to ongoing and planned clinical trials, including statements regarding the potential to produce important data, timing of such trials, expected patient enrollment, and the timing and publication or presentation of results; our ability to broaden our research to help as many patients as possible; relacorilant’s potential, including as a treatment for patients with Cushing’s syndrome, ovarian cancer and other cancers and as the new standard of care for patients with Cushing’s syndrome or platinum-resistant ovarian cancer; the potential of glucocorticoid receptor antagonism to benefit patients with a wide variety of solid tumors; nenocorilant as a treatment for patients with cancer; miricorilant as a treatment for patients with MASH; the expectation that we will have results from our Phase 2b MONARCH study of miricorilant in patients with biopsy-confirmed or presumed MASH by the end of 2026 and our ability to build on the findings from this study; dazucorilant as a treatment for patients with ALS; our intent to replicate our DAZALS findings in a Phase 3 trial and to use a dose titration study to improve gastrointestinal tolerability of dazucorilant in patients with ALS and inform the design of the Phase 3 trial and the timing of this trial. A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release. CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) December 31, 2025 (1) December 31, 2024 (1) Assets Cash and investments $ 532,422 $ 603,165 Trade receivables, net of allowances 59,786 53,976 Inventory 23,962 15,995 Operating lease right-of-use asset 4,583 5,324 Deferred tax assets, net 168,197 130,914 Other assets 47,701 31,179 Total assets $ 836,651 $ 840,553 Liabilities and Stockholders’ Equity Accounts payable $ 40,444 $ 15,376 Operating lease liabilities 6,107 6,936 Other liabilities 142,295 138,652 Stockholders’ equity 647,805 679,589 Total liabilities and stockholders’ equity $ 836,651 $ 840,553 (1) Derived from audited financial statements at that date CORCEPT THERAPEUTICS INCORPORATED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (In thousands, except per share data) Three Months Ended Year Ended December 31, December 31, 2025 2024 2025 2024 Revenues Product revenue, net $ 202,125 $ 181,890 $ 761,407 $ 675,040 Operating expenses Cost of sales 2,545 2,956 12,977 10,882 Research and development 64,856 70,300 254,908 246,887 Selling, general and administrative 130,237 83,372 448,725 280,320 Total operating expenses 197,638 156,628 716,610 538,089 Income from operations 4,487 25,262 44,797 136,951 Interest and other income 5,423 6,698 21,666 24,542 Income before income taxes 9,910 31,960 66,463 161,493 Income tax benefit (expense) 14,378 (1,214 ) 33,189 (20,284 ) Net income $ 24,288 $ 30,746 $ 99,652 $ 141,209 Net income attributable to common stockholders $ 23,905 $ 30,395 $ 98,171 $ 139,733 Basic net income per common share $ 0.23 $ 0.29 $ 0.95 $ 1.35 Diluted net income per common share $ 0.20 $ 0.26 $ 0.82 $ 1.23 Weighted-average shares outstanding used in computing net income per common share Basic 103,695 103,643 103,862 103,232 Diluted 119,855 118,459 119,987 113,480 Contacts Investor inquiries: ir@corcept.com Media inquiries: communications@corcept.com