On August 1, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development 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, 2019 (Press release, Corcept Therapeutics, AUG 1, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-2019-financial [SID1234538008]).

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Financial Highlights

Revenue of $72.3 million, a 16 percent increase from second quarter 2018
GAAP net income of $0.17 per share, compared to $0.14 per share in second quarter 2018
Non-GAAP net income of $0.25 per share, compared to $0.20 per share in second quarter 2018
Cash and investments of $225.7 million, compared to $215.7 million at March 31, 2019
Reaffirmed 2019 revenue guidance of $285 – $315 million
Corcept reported quarterly revenue of $72.3 million, compared to $62.3 million in the second quarter of 2018. Second quarter GAAP net income was $20.2 million, compared to $18.2 million in the same period last year. 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 $31.0 million, compared to $25.4 million in the second quarter of 2018. A reconciliation of GAAP to non-GAAP net income is included below.

The company reaffirmed its 2019 revenue guidance of $285 – $315 million.

Second quarter operating expenses were $47.6 million, compared to $41.7 million in the second quarter of 2018, primarily due to growth in the number of research and development personnel, increased spending to advance new compounds, and increased spending to formulate and manufacture the selective cortisol modulators relacorilant, exicorilant and miricorilant.

Cash and investments were $225.7 million at June 30, 2019, an increase of $10.0 million from March 31, 2019. This increase was after the expenditure of $17.4 million in the second quarter to repurchase 1.6 million shares of common stock pursuant to Corcept’s stock repurchase program.

"Our Cushing’s franchise had a strong quarter," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "As they have every year, patients taking Korlym successfully overcame the insurance reauthorization hurdles many of them face in the first quarter. These obstacles do not interrupt their care, because we provide them with free Korlym. They do, however, temporarily reduce our revenue. Meanwhile, our business grew as the number of patients receiving Korlym and the number of physicians prescribing the medication continued to increase."

Clinical Highlights

"It is gratifying to work on development programs that may benefit so many patients," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "We are advancing our proprietary, selective cortisol modulators in Cushing’s syndrome, solid tumors and metabolic diseases. Our clinical trials in these areas are progressing and we plan to start important new trials later this year and in 2020."

Cushing’s Syndrome

Dosing continues in Phase 3 trial ("GRACE") of relacorilant in patients with Cushing’s syndrome
Placebo-controlled trial of relacorilant to treat patients with less severe Cushing’s syndrome
to begin late this year
GRACE seeks to confirm relacorilant’s positive Phase 2 results and to provide the basis for its approval in the United States and Europe as a treatment for Cushing’s syndrome.1 Patients in relacorilant’s Phase 2 trial exhibited meaningful improvements in glucose control and hypertension – two of Cushing’s syndrome’s most common and pernicious manifestations. The trial also met a wide range of secondary endpoints, including weight loss, liver function, coagulopathy, insulin resistance, cognitive function, mood and quality of life. These results were achieved without instances of Korlym’s significant off-target effects – vaginal bleeding, endometrial thickening and low potassium.2

In the fourth quarter, Corcept plans to start a double-blind, placebo-controlled trial of relacorilant in patients whose Cushing’s syndrome is caused by an adrenal adenoma – an etiology where the effect of medical treatment has not been extensively studied. A controlled study is possible in these patients because their symptoms, while serious, are usually less severe than those experienced by patients with other etiologies of the disorder. The trial will enroll approximately the same number of patients as the GRACE trial at sites in the United States and Europe. Most of these sites are also participating in GRACE.

Metabolic Disease

Phase 1b trial underway in reduction of antipsychotic-induced weight gain; results expected late this year
Phase 2 trial in reversal of recent antipsychotic-induced weight gain planned to start late this year
Corcept’s Phase 1b trial in the reduction of weight-gain caused by antipsychotic medication is on track to produce results late this year. Approximately 60 healthy subjects will receive olanzapine (Eli Lily’s Zyprexa) and either miricorilant or placebo for two weeks, with the primary endpoint being change in weight. "We modeled this trial on the successful placebo-controlled studies3 we conducted with Korlym," said Dr. Grauer. "Unfortunately, Korlym’s off-target effects preclude its development for such a common disorder. Miricorilant is a better potential medication because it does not bind to the progesterone receptor. Activity at the progesterone receptor is what causes Korlym’s off-target effects. We look forward to completing this trial and starting one double-blind, placebo-controlled Phase 2 trial in patients later this year and another in 2020."

Corcept is also advancing miricorilant as a treatment for NASH, a serious and widespread liver disorder, and plans to start a double-blind, placebo-controlled Phase 2 trial in 2020.

Solid Tumors

Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer planned
to start late this year
European Medicines Agency Committee for Orphan Medicinal Products (COMP) recommends orphan drug designation for relacorilant to treat metastatic pancreatic cancer
"At the American Society of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) meeting this June, we presented data from our Phase 1/2 study of relacorilant plus the taxane nab-paclitaxel (Celgene’s Abraxane)," said Dr. Grauer. "Seven of 25 patients with metastatic, pancreatic cancer and five of 11 patients with advanced ovarian cancer achieved "durable disease control," meaning their tumors either shrank or ceased growing for a period of 16 weeks or longer. Tumor response in two patients with pancreatic disease persisted for more than 50 weeks. One patient’s ovarian tumor disappeared completely; another’s responded for 65 weeks.4Any response to treatment in patients with such advanced disease is surprising. That is especially true in these patients, whose tumors had progressed during multiple lines of prior therapy, including treatments with nab-paclitaxel or another taxane.

"We hope to confirm these findings in larger, more definitive studies. Our 180-patient, placebo-controlled Phase 2 trial in ovarian cancer is enrolling patients. We plan to start a Phase 3 trial in metastatic pancreatic cancer later this year and are seeking FDA guidance regarding the fastest path to approval in that indication. Relacorilant’s designation as an orphan drug for pancreatic cancer in the United States and the European Union will be helpful as our program advances."

On July 18, 2019, the COMP recommended orphan designation of relacorilant for the treatment of pancreatic cancer. The COMP’s letter stated that "relacorilant has the potential to restore tumour sensitivity to taxane therapy. This was demonstrated by non-clinical and clinical results, i.e. the achievement of durable partial responses or disease control in some patients, despite previously failed treatment regimens. The COMP considered that the preliminary clinical data submitted by the sponsor supported the claim [of] significant benefit for the purpose of an initial orphan designation."

The European Commission is expected to adopt the COMP’s recommendation later this year. The FDA designated relacorilant an orphan drug for the treatment of pancreatic cancer in September 2018.

Conference Call

We will hold a conference call on August 1, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-888-394-8218 from the United States or 1-323-794-2590 internationally approximately ten minutes before the start of the call (passcode 9712194). A replay will be available through August 15, 2019 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 9712194).

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 people with Cushing’s syndrome 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 in the body and can be lethal if not treated effectively.