On November 4, 2014 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 September 30, 2014 (Press release, Corcept Therapeutics, NOV 4, 2014, http://www.corcept.com/news_events/view/pr_1415137296 [SID:1234511994]). The company also provided an update on its clinical programs and revised its 2014 revenue guidance.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Third Quarter Financial Results and 2014 Revenue Guidance
Corcept recognized $7.3 million in net revenue for the third quarter of 2014 compared to $5.9 million in the second quarter, an increase of 24 percent. The company’s net loss in the third quarter on a GAAP basis was $6.0 million, or $0.06 per share, compared to a net loss of $7.6 million, or $0.07 per share, in the second quarter.
The company’s net loss on a GAAP basis included significant non-cash items of $2.1 million in the third quarter and $2.2 million in the second quarter. Excluding these items, the company’s net loss on a non-GAAP basis was $3.9 million, or $0.04 per share, for the third quarter of 2014 and $5.4 million or $0.05 per share, for the second quarter.
As of September 30, 2014, the company held cash and cash equivalents of $26.8 million.
The company revised the range of its 2014 revenue guidance to $25-27 million.
"Our Cushing’s syndrome commercial business continues to grow and now generates cash to fund an increasing portion of our research and development activities," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. "While there is a group of endocrinologists who have seen Korlym’s benefits and have become repeat prescribers, there are many physicians who have not yet written their first prescription. These physicians represent the potential for better treatment for more patients and significant future revenues."
Clinical Pipeline Progress
"We expect to have identified tolerable doses of Korlym and Halaven (eribulin) in our triple-negative breast cancer study by year-end, when the study’s efficacy phase is scheduled to begin. In September, we began dosing patients in our Phase 1 trial of CORT 125134. We will advance additional selective 1 glucocorticoid receptor (GR) antagonists into the clinic next year. GR antagonism is an exciting area of research that will generate interesting data in 2015, both from our own studies and from those being undertaken by our academic collaborators."
Financial Results
For the third quarter of 2014, Corcept recognized net product revenue of $7.3 million. The company reported a net loss of $6.0 million, or $0.06 per share, for the third quarter of 2014 compared to a net loss of $10.9 million, or $0.11 per share, for the same period in 2013.
The net loss on a GAAP basis for the third quarter of 2014 and for the third quarter of 2013 included non-cash stock-based compensation expenses of $1.2 million and $1.3 million, respectively. The company also recognized non-cash interest expense related to its capped royalty financing transaction of $895,000 in the third quarter of 2014 and $1.1 million in the same period in 2013.
After adjusting for these items, the company’s net loss on a non-GAAP basis was $3.9 million, or $0.04 per share, for the third quarter of 2014, compared to $8.5 million, or $0.08 per share, for the third quarter of 2013. A reconciliation of GAAP net loss to non-GAAP net loss is included below.
Operating expenses were $12.4 million for the third quarter of 2014 and also for the corresponding period in 2013.
Selling, general and administrative expenses in the third quarter were $9.1 million compared to $7.2 million for the comparable period in 2013.
Research and development expenses in the third quarter of 2014 were $3.0 million, compared to $5.2 million for the third quarter of 2013.
Corcept’s cash balance as of September 30, 2014 was $26.8 million, compared to $54.9 million at December 31, 2013. Net cash used in the company’s operating activities for the third quarter of 2014 was $5.9 million as compared to $9.0 million for the second quarter of 2014 and $11.1 million for the first quarter of 2014.
About Korlym
Korlym competitively blocks the glucocorticoid receptor type II (GR), one of the two receptors to which cortisol normally binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. In April 2012, Corcept 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 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
Triple-negative breast cancer 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 triple-negative breast cancer. There is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed triple-negative breast cancer patients exists.
About CORT 125134
CORT 125134 is a potent, competitive antagonist at the GR-II receptor, but does not have affinity for the progesterone, estrogen, AR androgen or GR-I (mineralocorticoid) receptors. The company has begun a Phase 1 study of the safety and tolerability of CORT 125134, one of its next-generation selective GR-II antagonists.