On August 9, 2018 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, reported its results for the quarter ended June 30, 2018 (Press release, Corcept Therapeutics, AUG 9, 2018, View Source [SID1234528784]).
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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.
Second quarter operating expenses were $41.7 million, compared to $22.8 million in the second quarter of 2017, primarily due to increased spending to advance relacorilant, CORT118335 and CORT125281 and costs from increased sales volume.
Cash and investments were $159.9 million at June 30, 2018, an increase of $19.6 million from first quarter 2018.
The company announced a program to repurchase up to $100 million of its common stock, which it intends to fund using cash and investments. Details of the program are provided below.
"Our Cushing’s syndrome franchise continues its significant growth, driven by physicians’ increasing realization that hypercortisolism is a serious disorder and that cortisol modulation is the best medical therapy for many patients," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "We are confident this shift in medical practice will continue."
Relacorilant’s Phase 2 Trial
"Interim data from our Phase 2 trial’s High-Dose cohort showed that relacorilant provided clinically meaningful benefit without the two off-target effects – progesterone receptor affinity and increased cortisol levels – that cause Korlym’s most common and serious adverse events – termination of pregnancy, endometrial thickening, vaginal bleeding and low potassium (hypokalemia)," said Robert S. Fishman, MD, Corcept’s Chief Medical Officer.
"That relacorilant did not cause hypokalemia in these patients is surprising – and important," he added. "Forty-four percent of the patients in Korlym’s pivotal trial experienced hypokalemia, which can be life-threatening. It is one of the most common adverse events in patients taking Korlym today.
"Interim efficacy data have also been impressive. Based on our planned Phase 3 endpoints, 58 percent of the patients with hyperglycemia achieved improved glucose control. Applying the same endpoints, this figure was 48 percent at the comparable time in Korlym’s pivotal trial ("SEISMIC") and 23 percent at the conclusion of treatment in the Low-Dose cohort. (See Figure 1) For patients with hypertension, 55 percent responded in the High-Dose cohort, compared to 44 percent in SEISMIC and 45 percent of the Low-Dose cohort. (See Figure 2)
"Relacorilant was well-tolerated," he concluded. "We observed one serious adverse event, a pilonidal abscess, which resolved without discontinuing relacorilant. One patient discontinued due to musculoskeletal pain and fatigue – a relatively common adverse event seen as cortisol modulation decreases cortisol activity."
Oncology
"At ASCO (Free ASCO Whitepaper)’s annual meeting this May, we reported positive data from the dose-finding portion of our Phase 1/2 study of relacorilant plus Abraxane to treat patients with solid tumors," added Dr. Fishman. "At the minimum therapeutic dose, four of nine patients with metastatic pancreatic cancer and four of seven patients with metastatic ovarian cancer demonstrated durable disease control. These results are especially notable in patients with such dire disease, all of whom had progressed on one or more prior taxane-based treatments. Recently, another patient with pancreatic cancer has achieved a partial response.
"These results justify significantly expanding our oncology program. By year-end, we plan to open a placebo-controlled, Phase 2 trial of relacorilant plus Abraxane in metastatic ovarian cancer. We also expect to have enough data by year-end in patients with metastatic pancreatic cancer to determine if a definitive trial is warranted."
Conference Call
Corcept will hold a conference call August 9, 2018, at 5:00 pm Eastern Time (2:00 pm Pacific Time). To participate, dial 1-888-394-8218 from the United States or 1-323-794-2588 internationally ten minutes before the start of the call (passcode: 6703650). A replay will be available through August 23, 2018 at 888-203-1112 from the United States and 719-457-0820 internationally (passcode: 6703650).