On February 15, 2024 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, reported its results for the quarter and year ended December 31, 2023 (Press release, Corcept Therapeutics, FEB 15, 2024, View Source [SID1234640140]).

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Financial Results

•Fourth quarter revenue of $135.4 million, a 31 percent increase over the same period in 2022
•Full year 2023 revenue of $482.4 million, a 20 percent increase over 2022
•Reiterated 2024 revenue guidance of $600 – $630 million
•Fourth quarter net income of $31.4 million, compared to $16.6 million in fourth quarter 2022
•2023 net income of $106.1 million, compared to $101.4 million in 2022
•Cash and investments of $425.4 million as of December 31, 2023
"The medical field is increasingly recognizing that Cushing’s syndrome is much more prevalent than was previously assumed. Our strong 2023 commercial results reflect that physicians are more regularly screening for hypercortisolism. The results demonstrate our ability to support these physicians as they manage this complex disease. We are confident these trends will continue and are reiterating our 2024 revenue guidance of $600 – $630 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.
Corcept’s fourth quarter 2023 revenue was $135.4 million, compared to $103.1 million in the fourth quarter of 2022. Revenue for the full year was $482.4 million, compared to $401.9 million in 2022.
Diluted net income per common share was $0.28 in the fourth quarter of 2023, compared to $0.14 in the fourth quarter of 2022. For the full year, it was $0.94 compared to $0.87 in 2022.
Cash and investments were $425.4 million at December 31, 2023 compared to $436.6 million at December 31, 2022. In 2023, Corcept paid $154.5 million to purchase its common stock in connection with the April 2023 tender offer, the exercise of employee stock options and vesting of restricted stock grants.
Clinical Development
"Our clinical development programs are advancing rapidly and will reach important milestones this year. We are on-track to submit our NDA for relacorilant in Cushing’s syndrome and will report data from our trials in Cushing’s syndrome (GRACE, GRADIENT and CATALYST), ovarian cancer (ROSELLA) and ALS (DAZALS)," added Dr. Belanoff.
Cushing’s Syndrome
•GRACE – Phase 3 trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – results from open label and randomized withdrawal phases expected in the second quarter
•Relacorilant New Drug Application (NDA) – NDA submission for Cushing’s syndrome expected in the second quarter
•GRADIENT – Phase 3 trial of relacorilant in patients with Cushing’s syndrome caused by adrenal adenomas – enrollment continues; results expected in the second half of this year
•CATALYST – Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes; patients with hypercortisolism may enter a randomized, double-blind, placebo-controlled study of Korlym – enrollment continues; preliminary prevalence phase results: 24%

prevalence rate in the first 700 patients enrolled; final results from prevalence and treatment phases expected by year-end
"We are on-track to submit our relacorilant NDA in the second quarter. Relacorilant has demonstrated tremendous promise as a treatment for patients with Cushing’s syndrome and we are eager to make it more broadly available," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
"Our CATALYST trial is the largest study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. We expect CATALYST’s findings to greatly stimulate physicians’ efforts to screen for hypercortisolism in patients with difficult-to-control diabetes and to treat them when hypercortisolism is found. Almost all of these patients currently go undiagnosed. We believe that CATALYST will be a landmark study and look forward to presenting the final results from the prevalence phase at the American Diabetes Association’s 84th Scientific Sessions in June," added Dr. Guyer.
Oncology
•ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer – enrollment continues; results expected by year-end
•Open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess – enrollment completed; results expected by mid-year
•Randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer in collaboration with the University of Chicago – enrollment continues
"If our ROSELLA trial replicates the results of our Phase 2 trial in patients with platinum-resistant ovarian cancer (results published in The Journal of Clinical Oncology, June 2023), it will constitute a major medical advance and could establish the combination of relacorilant and nab-paclitaxel as a new standard of care for women with this devastating disease. We expect data from ROSELLA by the end of this year," said Dr. Guyer.
Amyotrophic Lateral Sclerosis (ALS)
•DAZALS – Randomized, double-blind, placebo-controlled, Phase 2 trial of dazucorilant in patients with ALS – enrollment continues; results expected by year-end
"ALS is a lethal illness with an urgent need for better treatment. Dazucorilant showed great promise in animal models of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. Our DAZALS study is investigating dazucorilant’s potential to significantly improve the lives of patients with ALS. We expect data by the end of this year," said Dr. Guyer.
Non-alcoholic Steatohepatitis (NASH)
•MONARCH – Randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed NASH – enrollment continues
"Miricorilant has the potential to greatly benefit the millions of patients with NASH. Our Phase 1b study demonstrated that miricorilant effectively reduces liver fat, improves liver health and key metabolic and lipid measures and is well-tolerated. We look forward to building on these promising results in our MONARCH study," said Dr. Guyer.

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