Corcept Therapeutics Provides Clinical Update and Announces First Quarter 2021 Financial Results

• In a 178-patient, controlled, Phase 2 trial, women with platinum-resistant ovarian cancer who received relacorilant plus nab-paclitaxel experienced improved progression free survival (PFS) compared to women who received nab-paclitaxel alone, with comparable safety and tolerability; planning underway for Phase 3 pivotal trial
  
• In Phase 2 trial, patients with presumed nonalcoholic steatohepatitis (NASH) administered miricorilant experienced large, rapid reductions in liver fat
• Revenue of $79.4 million, compared to $93.2 million in first quarter 2020
• GAAP diluted net income of $0.18 per share, compared to $0.25 per share in first quarter 2020
• Non-GAAP diluted net income of $0.20 per share, compared to $0.34 per share in first quarter 2020
• Cash and investments of $454.8 million, compared to $476.9 million at December 31, 2020
• Modified 2021 revenue guidance of $355 to $385 million
  

MENLO PARK, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- 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, today reported its results for the quarter ended March 31, 2021.

First quarter 2021 revenue was $79.4 million, compared to $93.2 million in the first quarter of 2020. The decrease in revenue in the first quarter was primarily due to the effects of the COVID-19 pandemic on our business.

First quarter operating expenses were $59.8 million, compared to $55.5 million in the first quarter of 2020, due to increased spending on clinical trials in Cushing’s syndrome and metabolic diseases and the formulation and manufacture of the company’s proprietary selective cortisol modulators.

First quarter 2021 GAAP net income was $23.5 million, compared to $30.1 million in the first quarter of 2020. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the first quarter was $25.8 million, compared to $41.2 million in the first quarter of 2020. A reconciliation of GAAP to non-GAAP net income is included below.

Cash and investments were $454.8 million at March 31, 2021, compared to $476.9 million at December 31, 2020. The company repurchased 2.1 million shares of its common stock in the first quarter – 1.3 million shares for $33.5 million pursuant to the company’s stock repurchase program and 0.8 million shares for $16.4 million in connection with the net exercise of stock options – at a total cost of $50.0 million.   Under the stock repurchase program’s currently authorized terms, $156.8 million remains available for the purchase of shares.

Corcept modified its 2021 revenue guidance to $355 – $385 million. Corcept anticipates positive cash flow for the foreseeable future.

“The lingering effects of the spike in COVID-19 in the fourth quarter of last year extended further into the first quarter than we anticipated, coloring our commercial results,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “Many physicians are still not able to see their patients often enough to optimally diagnose and treat a complex disease such as Cushing’s syndrome. Further, many patients introduced to Korlym during the pandemic have so far not reached their ideal dose, as many physicians are seeing their patients less frequently, particularly in person, and testing them less frequently, slowing optimal titration.

“We expect these effects to diminish as COVID restrictions and fears diminish. The best treatment for Cushing’s syndrome involves substantial and frequent engagement between patients and physicians,” said Dr. Belanoff. “Our modified 2021 revenue guidance assumes that pandemic-related obstacles will ease substantially in the third quarter – about two quarters later than we had originally thought.   Leading physicians increasingly believe that the number of patients with hypercortisolism is substantially greater than once assumed. Korlym is an excellent treatment for hypercortisolism.   Relacorilant, if approved, will be even better.   We expect significant revenue growth and profits in the years ahead.”

Clinical Development Highlights

“Despite having to contend with pandemic-related headwinds,” said Dr. Belanoff, “our clinical development efforts, particularly in the United States, gained momentum in the first quarter. Today we announced positive data related to two of our proprietary, selective cortisol modulators as possible treatments for platinum-resistant ovarian cancer and NASH. These are important advances for the potential treatment of these diseases, which have a high unmet need. In addition, we are encouraged that these results provide further clinical validation of our cortisol modulation platform as a treatment for a broad range of diseases. In contrast to the past when sometimes a year would pass between releases of clinical results, we now expect important information to emerge every quarter.”

Solid Tumors

• In a 178-patient, controlled, Phase 2 trial, women with platinum-resistant ovarian cancer who received relacorilant plus nab-paclitaxel experienced improved progression free survival (PFS) compared to women who received nab-paclitaxel alone, with comparable safety and tolerability *
• Planning underway for a Phase 3 pivotal trial in ovarian cancer
• Preliminary results in the first 40 patients enrolled in open-label Phase 3 RELIANT trial of relacorilant
  plus nab-paclitaxel in patients with metastatic pancreatic cancer expected this quarter
• Selection of the optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer (“CRPC”) expected by third quarter 2021
• Enrollment continues in a 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
  

“We are extremely pleased with the results of our trial of relacorilant as a possible treatment for platinum-resistant ovarian cancer,” said Andreas Grauer, MD, Corcept’s Chief Medical Officer. “Delaying disease progression in these women, without causing additional side effects, is heartening. We are planning a Phase 3 pivotal trial which we hope will replicate these positive data.”

Participants in the trial were randomized 1:1:1 to receive either (i) nab-paclitaxel plus a daily dose of relacorilant (100 mg), (ii) nab-paclitaxel plus relacorilant (150mg) given “intermittently” (i.e., the day before, the day after, and the day of each weekly nab-paclitaxel infusion) or (iii) nab-paclitaxel alone.

Women who received the higher dose of relacorilant intermittently exhibited a statistically significant improvement in median progression free survival com