On August 6, 2015 Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, oncologic and psychiatric disorders, reported its financial results for the quarter ended June 30, 2015 and provided a corporate update (Press release, Corcept Therapeutics, AUG 5, 2015, http://www.corcept.com/news_events/view/pr_1438807699 [SID:1234507046]).

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Corcept recorded net revenue of $12.0 million in the second quarter of 2015, compared to $5.9 million for the same period in 2014, an increase of 104 percent. The company has revised its 2015 revenue guidance from $47 – $53 million to $49 – $53 million.

At June 30, 2015, the company held cash and cash equivalents of $37.0 million, compared to $38.0 million at the end of the prior quarter. Based on its current plans, the company expects to reach cash-flow breakeven without needing to raise additional funds.

"More patients are receiving Korlym’s benefits and we’re confident that Korlym’s sales growth will continue. We fully expect that our newly-hired clinical specialists will make an increasing contribution to our revenue over the course of the year," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. "We are proud of our second quarter results. As we have said before, our efficient cost structure and revenue growth are allowing us to fund our planned development programs."

Triple-Negative Breast Cancer Program

Corcept continues to dose patients in the efficacy portion of its Phase 1/2 open label trial of Korlym in combination with eribulin (Halaven) to treat GR-positive TNBC. Efficacy results are expected by the end of 2015. If the trial’s outcome is positive, the company plans to begin a Phase 3 study in early 2016.

Advancement of Selective GR Modulator CORT125134

Unblinded data from its Phase 1 study confirms that CORT125134, the lead compound in Corcept’s portfolio of next-generation selective GR modulators, is well-tolerated and shares Korlym’s ability to potently reverse the effect of excess cortisol activity, an important quality in treating metabolic disorders such as Cushing’s syndrome. CORT125134 is inactive at the progesterone receptor. In addition, studies in transgenic mice have shown CORT125134 to be even more potent than Korlym in treating certain solid tumor cancers. Corcept plans to advance the compound to Phase 2 as a potential treatment for Cushing’s syndrome and an oncology indication in early 2016.

"Our development program has grown in both depth and breadth," said Dr. Belanoff. "We are studying our approved product, Korlym, as a treatment for a severe form of breast cancer and are preparing to advance one of our next-generation selective GR modulators to Phase 2 as a potential treatment for both metabolic and oncologic diseases. Cortisol modulation is a critical medical platform and we are the leader in advancing it."

Financial Discussion

Corcept recorded a net loss of $1.9 million in the second quarter of 2015, compared to $7.6 million in the second quarter of 2014, including non-cash expenses of $2.3 million and $2.2 million in the second quarter of 2015 and 2014, respectively. Excluding these non-cash expenses, Corcept generated net income on a non-GAAP basis of $369,000 in the second quarter of 2015, compared to a non-GAAP net loss of $5.4 million in the second quarter of 2014.

Corcept’s cash balance at June 30, 2015 was $37.0 million, compared to $24.2 million at December 31, 2014.

Operating expenses for the second quarter were $13.1 million, compared to $12.4 million for the second quarter of 2014.

Selling, general and administrative expenses in the second quarter of 2015 were $9.3 million, compared to $8.0 million for the same period in 2014, due to higher staffing costs.

Research and development expenses in the second quarter of 2015 were $3.3 million, compared to $4.3 million for the second quarter of 2014. The decrease was primarily due to discontinuation of the company’s Phase 3 study in psychotic depression, offset by increased spending on its Phase 1/2 study of Korlym for the treatment of GR-positive TNBC and development of next-generation GR modulators.

Net loss for the second quarter of 2015 and 2014 included accreted interest expense for Corcept’s capped royalty financing obligation of $737,000 and $935,000, respectively.