On March 1, 2016 Corcept Therapeutics Incorporated (NASDAQ: CORT), 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, reported its financial results for the fourth quarter and full year ended December 31, 2015 (Press release, Corcept Therapeutics, MAR 1, 2016, http://www.corcept.com/news_events/view/pr_1456870143 [SID:1234509336]).

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Corcept reported revenue of $15.0 million for the fourth quarter of 2015 and $50.3 million for the full year. GAAP net income for the fourth quarter of 2015 was $1.0 million or $0.01 per share, compared to a net loss of $3.9 million or $0.04 per share in the fourth quarter of 2014. For the full year, the company reported a GAAP net loss of $6.4 million or $0.06 per share for 2015, compared to a net loss of $31.4 million or $0.31 per share in 2014.

The company’s cash and cash equivalents were $40.4 million at year-end, an increase of $4.0 million from September 30, 2015.

The company reiterated its 2016 revenue guidance of $76-81 million.

"2015 was a pivotal year for Corcept," said Dr. Joseph K. Belanoff, Corcept’s Chief Executive Officer. "We made a GAAP profit in the fourth quarter, while conducting our Phase 1/2 trial of mifepristone to treat TNBC and advancing our lead selective cortisol modulator toward Phase 2 trials in Cushing’s syndrome and solid-tumor cancers. In 2016, we plan to expand our pipeline further by advancing additional selective modulators towards human use – funded by our cash on hand and revenue from the sale of Korlym."

Financial Discussion

Corcept’s GAAP net income in the fourth quarter of 2015 was $1.0 million, compared to a net loss of $3.9 million in the fourth quarter of 2014. The company’s net loss for the full year was $6.4 million, compared to a net loss $31.4 million in 2014. Excluding non-cash expenses related to stock-based compensation and accreted interest on the company’s capped royalty obligation (the "Royalty Financing"), Corcept generated $3.1 million of non-GAAP net income in the fourth quarter, compared to a non-GAAP net loss of $1.7 million in the fourth quarter of 2014. Non-GAAP net income for 2015 was $2.5 million, compared to a non-GAAP net loss of $22.5 million for 2014. A reconciliation of GAAP to non-GAAP net operating results is set forth below.

Operating expenses for the fourth quarter of 2015 were $13.3 million, compared to $12.1 million for the fourth quarter of 2014. The increase was primarily due to spending on the company’s expanded sales force and operational costs associated with increased sales volumes. For the full year, operating expenses declined to $53.7 million, from $54.2 million in 2014, as savings from discontinuation of the company’s Phase 3 trial of mifepristone to treat psychotic depression more than offset increased spending on its Phase 1/2 trial of TNBC, clinical development of CORT125134, pre-clinical development of other selective cortisol modulators and costs related to the company’s larger sales force and increased sales volumes.

Corcept’s cash and cash equivalents totaled $40.4 million as of December 31, 2015, compared to $24.2 million as of December 31, 2014. These cash balances reflect Corcept’s scheduled payments due under the Royalty Financing. Pursuant to the terms of the agreement, Corcept paid $2.8 million in the fourth quarter of 2015, with payments totaling $9.2 million for the full year. In 2014, Corcept paid $1.6 million in the fourth quarter and $4.9 million for the year. Corcept expects to make its final payment under the Royalty Financing in 2017.

About Cushing’s Syndrome

Endogenous Cushing’s syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s syndrome is an orphan indication that most commonly affects adults aged 20-50. An estimated 10-15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients annually in the United States. An estimated 20,000 patients in the United States have Cushing’s syndrome. Symptoms vary, but most people have 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.

About Triple-Negative Breast Cancer (TNBC)

TNBC is a form of the disease in which the three receptors that fuel most breast cancer growth – estrogen, progesterone and the HER-2/neu gene – are not present. Because the tumor cells lack the necessary receptors, treatments that target estrogen, progesterone and HER-2 receptors are ineffective. In 2013, approximately 40,000 women were diagnosed with TNBC. It is estimated that more than 75 percent of these women’s tumor cells expressed the GR receptor to which cortisol binds. There is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed TNBC patients exists.

About Korlym

Korlym modulates the effect of cortisol at GR, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness and the FDA has designated it as an Orphan Drug for that indication.

About CORT125134

CORT125134 is the lead compound in Corcept’s portfolio of selective cortisol modulators. It is a non-steroidal competitive antagonist of GR that does not bind to the body’s other hormone receptors, including the progesterone receptor. It is the affinity of Korlym for the progesterone receptor that results in termination of pregnancy and can cause endometrial thickening and irregular vaginal bleeding in some women. CORT125134 will not have these effects. The compound is proprietary to Corcept and is protected by composition of matter and method of use patents extending to 2033.