On November 1, 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 September 30, 2018 (Press release, Corcept Therapeutics, NOV 1, 2018, View Source [SID1234530622]).
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Financial Highlights
Revenue of $64.4 million, a 51 percent increase from third quarter 2017
GAAP net income of $0.14 per share, compared to $0.11 per share in third quarter 2017
Non-GAAP net income of $0.22 per share, compared to $0.14 per share in third quarter 2017
Cash and investments of $196.7 million, a $36.8 million increase from second quarter 2018
Reaffirmed 2018 revenue guidance of $250-270 million
Corcept reported revenue of $64.4 million for the third quarter, compared to $42.8 million in the same period last year. GAAP net income was $17.7 million, compared to $13.8 million in the third quarter of 2017. Excluding non-cash expenses related to stock-based compensation, use of deferred tax assets, interest on the company’s retired royalty financing obligation and related income tax effects, non-GAAP net income in the third quarter was $27.9 million, compared to $17.4 million in the third quarter of 2017. A reconciliation of GAAP to non-GAAP net income is set forth below.
Operating expenses for the third quarter were $41.5 million, compared to $29.1 million in the third quarter of 2017, primarily due to increased spending to advance relacorilant, CORT118335 and CORT125281 and costs arising from increased sales volume.
Cash and investments were $196.7 million at September 30, 2018, compared to $159.9 million at June 30, 2018. The company spent $8.9 million in the third quarter repurchasing 674,000 shares of its common stock. Under the terms of Corcept’s stock repurchase program as currently authorized, $91.1 million remains available for the repurchase of shares.
Relacorilant to Treat Patients with Cushing’s Syndrome
Enrollment open in relacorilant’s 130-patient Phase 3 trial
Relacorilant designated orphan drug for treatment of Cushing’s syndrome
The Phase 3 trial of Corcept’s proprietary, selective cortisol modulator, relacorilant, is expected to enroll 130 patients at sites in the United States and Europe. In the trial’s initial, open-label phase, patients will receive relacorilant for 22 weeks. Any patients who exhibit clinically meaningful improvements in hypertension or glucose tolerance will then enter a twelve-week, double-blind, placebo-controlled "withdrawal phase," during which half will continue to receive relacorilant and the rest, placebo. The rate and degree of relapse in patients receiving placebo will be measured against the rate and degree of relapse in those continuing relacorilant.
For more information about the trial, go to clinicaltrials.gov.
Because the FDA has designated relacorilant as an orphan drug for the treatment of Cushing’s syndrome, Corcept will receive tax credits for clinical trial costs, marketing application filing fee waivers if the drug is approved, as well as assistance from the FDA in the drug development process. Patents covering relacorilant’s composition of matter and use to treat Cushing’s syndrome expire in 2033.
"We’re excited to have started relacorilant’s Phase 3 trial," said Joseph K. Belanoff, MD. "Our Cushing’s syndrome franchise continues to add new prescribers of our first-generation cortisol modulator, Korlym, in every region of the country, and we expect it will continue to do so. Relacorilant promises to make the benefits of cortisol modulation even more widely available. Patients in relacorilant’s Phase 2 trial experienced significant clinical benefit, but not Korlym’s serious off-target effects – endometrial thickening, vaginal bleeding and hypokalemia. If these safety and efficacy results are confirmed in Phase 3, relacorilant will constitute a major clinical and commercial advance."
Oncologic & Metabolic Disorders
Selective cortisol modulator CORT118335 safe and well-tolerated in Phase 1; Phase 2 trials in antipsychotic-induced weight gain and non-alcoholic steatohepatitis (NASH) planned to start in first quarter 2019
Further results expected by year-end in Phase 1/2 trial of relacorilant plus Abraxane (nab-paclitaxel) to treat metastatic pancreatic cancer; FDA grants relacorilant orphan drug status for that indication
Controlled Phase 2 trial of relacorilant plus Abraxane to treat metastatic ovarian cancer planned to start by year-end
Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi (enzalutamide) in patients with metastatic castration-resistant prostate cancer
"Our clinical programs continue to make significant progress," said Robert S. Fishman, MD, Corcept’s Chief Medical Officer. "CORT118335 was well-tolerated in its Phase 1 trial. This compound is very potent in animal models of antipsychotic-induced weight gain and NASH – serious, widespread disorders for which patients have no good treatment options. We plan to open placebo-controlled, Phase 2 trials in both indications early next year.
"We are also excited to advance relacorilant as a treatment for solid tumors," said Dr. Fishman. "Our Phase 1/2 trial of relacorilant plus Abraxane has produced encouraging data. At ASCO (Free ASCO Whitepaper) earlier this year we reported that four of nine patients with metastatic pancreatic cancer who received the minimum therapeutic dose exhibited durable disease control, as did four of seven patients with metastatic ovarian cancer – notable results in patients with such dire disease, all of whom had progressed on prior taxane-based therapies. By year-end, we plan to open a controlled Phase 2 trial in patients with metastatic ovarian cancer and to have collected sufficient data in patients with metastatic pancreatic cancer to determine if a pivotal trial is warranted."
Conference Call
We will hold a conference call on November 1, 2018, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 877-260-1479 from the United States or 334-323-0522 internationally approximately ten minutes before the start of the call (passcode: 7489528). A replay will be available through November 15, 2018 at 888-203-1112 from the United States and 719-457-0820 internationally (passcode: 7489528).
Hypercortisolism
Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the stress 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 being diagnosed each year. Symptoms vary, but most people 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. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively. Our first approved product, Korlym, inhibits the effects of excess cortisol by modulating activity at the glucocorticoid receptor, one of the two receptors to which cortisol binds. Korlym was the first FDA-approved treatment for patients with Cushing’s syndrome.