Corcept Therapeutics Incorporated (CORT - Free Report) delivered second-quarter 2019 earnings of 17 cents per share, which missed the Zacks Consensus Estimate of 18 cents.
However, excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, and related income tax effects, adjusted earnings came in at 25 cents per share compared with 20 cents in the year-ago quarter.
Although revenues in the quarter under review rose 16% from the prior-year period’s level to $72.3 million, the metric missed the Zacks Consensus Estimate of $73 million.
Research and development expenses increased 5.4% to $21.7 million. Selling, general and administrative expenses escalated 23.1% to $24.6 million.
Shares of the company have lost 6.4% year to date against the industry’s growth of 7.5%
Corcept’s proprietary, selective cortisol modulator is relacorilant. Last November, it dosed the first patient in the phase III GRACE study of relacorilant to treat Cushing’s syndrome. The company is continuing dosing in the above-mentioned study at sites across the United States, Canada and Europe. The GRACE study seeks to confirm relacorilant’s positive phase II results and provide the basis for its approval in the United States and Europe as a treatment for Cushing’s syndrome. Patients in relacorilant’s phase II study exhibited meaningful improvements in glucose control and hypertension.
Corcept plans to start a placebo-controlled study of relacorilant in patients whose Cushing’s syndrome is caused by an adrenal adenoma in the fourth quarter of 2019.
The company is on track to release data from the phase Ib study from its candidate CORT118335in the reduction of weight -gain caused by antipsychotic in late 2019. About 60 healthy subjects will receive Eli Lily’s (LLY - Free Report) Zyprexa (olanzapine) and either miricorilant or placebo for two weeks, the primary endpoint being reduction in weight. The company expects to complete the study and start a double-blind, placebo-controlled phase II study in patients later in 2019 and another in 2020.
Corcept is also advancing miricorilant as a treatment for NASH, a serious and widespread liver disorder, and plans to start a double-blind, placebo-controlled phase II study in 2020.
A phase II study on relacorilant plus Celgene's (CELG - Free Report) Abraxane is ongoing for the treatment of ovarian cancer. The study is enrolling patients. The company plans to start a phase III study in metastatic pancreatic cancer in late 2019 and is seeking FDA guidance regarding the fastest path to approval in that indication.
On Jul 18, the European Medicines Agency Committee for Orphan Medicinal Products (COMP) recommended Orphan designation for relacorilant for the treatment of pancreatic cancer. The European Commission is expected to adopt the COMP’s recommendation later this year.
Corcept reiterated its revenue guidance for the year. The company expects the same to be $285-$315 million.