On February 28, 2023 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported its results for the quarter and year ended December 31, 2022 (Press release, Corcept Therapeutics, FEB 28, 2023, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2022 [SID1234627837]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Financial Results

Fourth quarter revenue of $103.1 million, compared to $98.8 million in fourth quarter 2021
2022 revenue of $401.9 million, compared to $366.0 million in 2021
2023 revenue guidance of $430 – $450 million
Fourth quarter diluted net income per common share of $0.14, compared to $0.26 in fourth quarter 2021
2022 diluted net income per common share of $0.87, compared to $0.89 in 2021
Cash and investments of $436.6 million, compared to $335.8 million at December 31, 2021
Corcept’s fourth quarter 2022 revenue was $103.1 million, compared to $98.8 million in the fourth quarter of 2021. Revenue for the full year was $401.9 million, compared to $366.0 million in 2021. The company expects 2023 revenue of $430 – $450 million.

Net income was $16.6 million in the fourth quarter of 2022, compared to $32.1 million in the fourth quarter of 2021. For the full year, it was $101.4 million compared to $112.5 million in 2021.

Cash and investments of $436.6 million at December 31, 2022 compared to $335.8 million at December 31, 2021.

"We remain extremely optimistic about the growth potential of our Cushing’s syndrome business. Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are making substantial investments to improve the screening and treatment of these patients. We are providing 2023 revenue guidance of $430 – $450 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.

Clinical Development

"We significantly advanced our clinical development programs, with three of our proprietary selective cortisol modulators – relacorilant, dazucorilant and miricorilant – now in the clinic," added Dr. Belanoff. "We expect to make further progress in the next twelve months with submission of the NDA for relacorilant in Cushing’s syndrome, enrollment of our confirmatory Phase 3 trial of relacorilant in platinum-resistant ovarian cancer and Phase 2 trial of dazucorilant in ALS, and advancement to Phase 2 of miricorilant as a potential treatment for NASH."

Cushing’s Syndrome

Enrollment to close in the coming weeks in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected in the first quarter of 2024
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
CATALYST – 1,000-patient randomized, double-blind, placebo-controlled Phase 4 trial to examine the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and treat the patients determined to have hypercortisolism with Korlym – to begin this quarter
"We are pleased to announce that we believe that we have enough patients in screening in our GRACE trial to complete enrollment in the coming weeks. We expect GRACE to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the first quarter of 2024," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that affects many patients but has not been subject to rigorous, controlled study."

"Our randomized, double-blind, placebo-controlled, Phase 4 CATALYST study will examine the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and treat the patients determined to have hypercortisolism with Korlym. Planned enrollment is 1,000 patients, which we expect to complete by the end of this year. The most prominent diabetologists in the country helped design and are participating in this study. We expect CATALYST to produce data that will improve the screening and treatment of these patients," added Dr. Guyer.

Oncology

Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
Enrollment continues in open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess
Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer expected to begin by mid-year in collaboration with the University of Chicago
"We and our investigators are extremely excited to advance relacorilant in platinum-resistant ovarian cancer. The 40,000 women in the United States and Europe with this disease do not have good treatment options and relacorilant plus nab-paclitaxel has the potential to become a new standard of care," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS
"The 55,000 patients in the United States and Europe with ALS have an urgent need for better treatment. Dazucorilant showed great promise in animal models of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We are conducting this important study in collaboration with TRICALS, the leading ALS academic consortium in Europe, to investigate dazucorilant’s potential to significantly improve the lives of patients with ALS," said Dr. Guyer.

Non-alcoholic Steatohepatitis (NASH)

Screening closed in Phase 1b dose-finding trial of miricorilant in patients with presumed NASH – data expected by mid-year
"Miricorilant, an oral medication, continues to demonstrate great promise as a treatment for NASH. Our Phase 1b study has identified a range of doses, all substantially lower than our originally tested doses, that significantly reduces liver fat without causing excessive liver irritation," said Dr. Guyer. "We expect to share results from this study by mid-year and plan to start a Phase 2 trial later this year."

Conference Call

We will hold a conference call on February 28, 2023, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To access the conference call, please dial 877-407-8029 from the United States or +1-201-689-8029 internationally. A replay of the call will be available on the Investors / Events tab of www.corcept.com.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.