On July 29, 2021 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 hormone cortisol, reported its results for the quarter ended June 30, 2021 (Press release, Corcept Therapeutics, JUL 29, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-results [SID1234585367]).
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Financial Results
Revenue of $91.6 million, compared to $88.6 million in second quarter 2020
GAAP diluted net income of $0.21 per share, compared to $0.23 per share in second quarter 2020
Non-GAAP diluted net income of $0.30 per share, compared to $0.32 per share in second quarter 2020
Cash and investments of $471.6 million, compared to $454.8 million at March 31, 2021
Reiterated 2021 revenue guidance of $355 – $385 million
Second quarter 2021 revenue was $91.6 million, compared to $88.6 million in the second quarter of 2020. First quarter 2021 revenue was $79.4 million. Second quarter 2021 GAAP net income was $26.5 million, compared to $28.3 million in the second 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 second quarter was $38.2 million, compared to $39.7 million in the second quarter of 2020. A reconciliation of GAAP to non-GAAP net income is included below.
Second quarter operating expenses were $59.6 million, compared to $53.3 million in the second quarter of 2020, due to increased employee compensation expenses, commercial spending, spending on clinical trials in Cushing’s syndrome and pre-clinical activities.
Cash and investments were $471.6 million at June 30, 2021, compared to $454.8 million at March 31, 2021. The balance at June 30, 2021 reflects the acquisition of $30.8 million of common stock in the second quarter – 1.4 million shares pursuant to the company’s stock repurchase program and 0.1 million shares in connection with the net exercise of stock options. Under the repurchase program’s current terms, $127.6 million remains available for the purchase of shares.
The company reiterated its 2021 revenue guidance of $355 – $385 million.
"Diminishing COVID-19 public health restrictions and the availability of safe and effective vaccines have allowed our commercial business to resume growing," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Our second quarter results reflect the fact that physicians are seeing their patients more frequently, which allows them to diagnose and optimally treat those who have Cushing’s syndrome. Provided COVID-19 restrictions continue to abate – as we believe they will – we expect growth to continue. Korlym is an excellent treatment for hypercortisolism and there are many eligible patients who have yet to receive it. Our planned successor to Korlym, relacorilant, which is currently in its pivotal trial, promises to be an even better medication."
Clinical Development
"We are enthusiastic about the potential of cortisol modulation to help treat many diseases, not just Cushing’s syndrome," added Dr. Belanoff. "Our programs in solid tumors, non-alcoholic steatohepatitis (NASH) and antipsychotic-induced weight gain (AIWG) continue to make progress. We are especially excited about our advancing platinum-resistant ovarian cancer program. Based on the statistically significant and clinically meaningful results of our 178-patient, controlled Phase 2 trial, we plan to initiate a pivotal trial in the first quarter of next year."
Solid Tumors
Phase 3 pivotal trial in patients with platinum-resistant ovarian cancer to start in the first quarter of 2022
Selection of the optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer (CRPC) expected later this year
Enrollment continues in 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
"We look forward to starting a Phase 3 pivotal trial in women with platinum-resistant ovarian cancer," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Our Phase 2 results illustrated that women who received relacorilant with nab-paclitaxel experienced improved progression free survival (PFS) without experiencing additional side effects, a welcome finding for women with few good treatment options. We will present detailed results of our Phase 2 trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting in September in a proffered paper oral presentation, with overall survival data expected later in the year. And we continue to evaluate relacorilant as a possible treatment for patients with other glucocorticoid receptor-expressing tumors."
Metabolic Diseases
Phase 1b dose-finding trial in patients with presumed NASH to start in the fourth quarter of 2021
Enrollment continues in GRATITUDE, a 100-patient double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent AIWG
Enrollment continues in GRATITUDE II, a 150-patient, double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse long-standing AIWG
"We plan to begin a Phase 1b, dose-finding trial of miricorilant in patients with presumed NASH in the fourth quarter of this year," said Dr. Grauer. "Patients who received miricorilant in our previous trial experienced exceptionally large and rapid reductions in liver fat accompanied by substantial, but transient, elevations of the liver enzymes ALT and AST. Our hypothesis is that the rapidity and magnitude of miricorilant’s fat reducing effect irritated the liver. The objective of our planned study is to identify a dosing regimen that can produce significant reductions in fat without causing liver irritation."
"Meanwhile, our Phase 2 trials evaluating miricorilant as a treatment for patients with AIWG – GRATITUDE and GRATITUDE II – continue to advance," added Dr. Grauer. "We expect to complete enrollment in GRATITUDE II by year-end and in GRATITUDE by mid-2022."
Cushing’s Syndrome
Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome; NDA submission expected in the second quarter of 2023
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
"We advanced relacorilant to Phase 3 based on its extremely promising Phase 2 efficacy and safety data, which we recently published in Frontiers in Endocrinology (Pivonello 2021)," said Dr. Grauer. "We expect our GRACE trial, which is accruing patients and generating data, to serve as the basis for relacorilant’s NDA in Cushing’s syndrome. We expect to submit this relacorilant NDA in the second quarter of 2023. The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that affects many patients, but has not been subject to rigorous, controlled study."
Conference Call
We will hold a conference call on July 29, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, Click this link (listen-only mode) or dial 1-833-693-0540 from the United States or 1-661-407-1581 internationally approximately 15 minutes before the start of the call. The passcode will be 1482035. A replay will be available on the Investors / Past Events tab of our website.
Hypercortisolism
Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the 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 diagnosed each year. Symptoms vary, but most patients 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. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents covering the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.