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Corcept Therapeutics Announces Second Quarter 2018 Financial Results and Stock Repurchase Program; Provides Clinical Update

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Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended June 30, 2018.

Financial Highlights

  • Revenue of $62.3 million, a 75 percent increase from second quarter 2017
  • GAAP net income of $0.14 per share, compared to $0.10 per share in second quarter 2017
  • Non-GAAP net income of $0.20 per share, compared to $0.13 per share in second quarter 2017
  • Cash and investments of $159.9 million, a $19.6 million increase from first quarter 2018
  • 2018 revenue guidance revised to $250 – 270 million, from $275 – 300 million
  • Company announces $100 million stock repurchase program

Relacorilant Data
The final 18 patients enrolled in the trial (the “High-Dose” cohort) receive 250 mg/day of relacorilant for four weeks, with dose being increased, as tolerability permits, to 300 mg/day for four weeks, then 350 mg/day for four weeks, then 400 mg/day for four weeks; data are available for the 250 mg/day and 300 mg/day dose levels.

Based on FDA feedback, Corcept has developed response criteria for relacorilant’s Phase 3 trial. Applying these endpoints to the High-Dose cohort at eight weeks of treatment (conclusion of the 300 mg dose level) produces the following results:

  • Fifty-eight percent of patients with hyperglycemia achieved improved glucose control, as shown by a (i) 0.5 percent or greater reduction in HbA1c or (ii) 50 mg/dl or greater reduction (or normalization) in 2-hour glucose as measured in the oral glucose tolerance test or (iii) 25 percent or greater decrease in antidiabetic medications
  • Fifty-five percent of patients with uncontrolled hypertension achieved a five millimeter or greater drop in either systolic or diastolic blood pressure, as measured by 24-hour ambulatory monitoring
  • No evidence of progesterone receptor affinity; no instances of hypokalemia
  • Testing of higher doses is ongoing; Phase 3 trial planned to start this year

Oncologic and Metabolic Disorders

  • Placebo-controlled, Phase 2 trial of relacorilant plus Abraxane® (nab-paclitaxel) in metastatic ovarian cancer planned to start by year-end
  • Results expected by year-end in study of relacorilant plus Abraxane in patients with metastatic pancreatic cancer
  • Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi® (enzalutamide) in patients with metastatic castration-resistant prostate cancer
  • Planning underway for placebo-controlled, Phase 2 trials of CORT118335 in patients with antipsychotic-induced weight gain and non-alcoholic steatohepatitis (“NASH”); both trials planned to start by year-end

Financial Results
Corcept reported quarterly revenue of $62.3 million, compared to $35.6 million in the second quarter of 2017. Second quarter GAAP net income was $18.2 million, compared to $12.6 million in the same period last year. Excluding non-cash expenses related to stock-based compensation, utilization of deferred tax assets, accreted interest on the company’s retired royalty financing obligation and related income tax effects, non-GAAP net income in the second quarter was $25.4 million, compared to $16.0 million in the second quarter of 2017. (A reconciliation of GAAP to non-GAAP net income is set forth below.) The company reduced its 2018 guidance to $250 – 270 million.

CORT 108297 is the lead compound from our three series of proprietary selective GR-II antagonists and is a fused-ring azadecalin. This series of compounds has demonstrated a greater than 1000-fold difference in binding affinity for the GR-II receptor compared to the PR receptor.

About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol. Korlym® is the company’s first FDA-approved medication. Corcept has a large portfolio of proprietary compounds that modulate the effects of cortisol but not progesterone. Corcept owns extensive United States and foreign intellectual property covering the use of cortisol modulators in the treatment of a wide variety of serious disorders, including Cushing’s syndrome. It also holds composition of matter patents covering its selective cortisol modulators.

CONTACT:
Investor Relations
Corcept Therapeutics
650-327-3270
ir@corcept.com
www.corcept.com

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