On January 30, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the stress hormone cortisol, reported preliminary fourth quarter revenue of $87.9 million, compared to $66.8 million in the fourth quarter of 2018 (Press release, Corcept Therapeutics, JAN 30, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2019 [SID1234553696]). Preliminary 2019 revenue was $306.5 million, an increase of 22 percent from 2018.

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Cash and investments increased by $48.4 million in the fourth quarter, to $315.3 million.

These results are prior to completion of the company’s annual independent audit and are subject to adjustment.

Corcept projects 2020 revenue of $355 – 375 million.

"Our Cushing’s syndrome business had an excellent year," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "As awareness of the poor health outcomes associated with hypercortisolism increased and physicians screened more patients for Cushing’s syndrome, the number of patients receiving Korlym grew. We expect that growth to continue."

"Korlym’s commercial success has given us the resources to develop our proprietary selective cortisol modulators in a wide range of serious disorders," added Dr. Belanoff. "These compounds represent Corcept’s future. We look forward to an important year."

"Our program in Cushing’s syndrome is the most advanced," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "The pivotal trial of Korlym’s planned successor, relacorilant, is actively enrolling patients at sites in the United States, Europe and Israel. We are also launching a Phase 3 trial in patients whose Cushing’s syndrome is caused by adrenal adenomas.

"Our programs in metabolic and oncologic disorders are poised to advance significantly. In the second quarter, we will have results from the second part of our Phase 1b trial of miricorilant for the prevention of antipsychotic-induced weight gain (APIWG). Miricorilant’s Phase 2 trial for the reversal of recent APIWG continues to accrue patients. We plan to start two additional Phase 2 trials – one for the reversal of long-standing APIWG and another for the treatment of patients with non-alcoholic steatohepatitus (NASH) – by year-end.

"Our Phase 2 trial of relacorilant to treat advanced ovarian cancer continues to enroll patients at sites in the United States and Europe," added Dr. Grauer. "In the second quarter, we anticipate starting a Phase 3 trial of relacorilant in metastatic pancreatic cancer and a Phase 1b trial of relacorilant combined with an immunotherapeutic agent in adrenal cancer. By year-end, we expect to conclude the dose-finding trial of our proprietary cortisol modulator exicorilant in combination with enzalutamide in castration-resistant prostate cancer."

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 in the body and can be lethal if not treated effectively.