Corcept Therapeutics Inc. Reports Operating Results (10-Q)

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Nov 12, 2009
Corcept Therapeutics Inc. (CORT, Financial) filed Quarterly Report for the period ended 2009-09-30.

Corcept Therapeutics Incorporated is a pharmaceutical company focused on developing drugs for treating severe psychiatric and neurological diseases. Corcept's lead product, CORLUX, is in Phase clinical trials for treating the psychotic features of PMD. The drug is administered orally to PMD patients once per day for seven days. CORLUX, a potent GR-II antagonist, appears to reduce the effects of the elevated and abnormal release patterns of cortisol seen in PMD. The company has also initiated a proof-of-concept study to evaluate the ability of CORLUX to mitigate weight gain associated with the use of olanzapine. Corcept Therapeutics Inc. has a market cap of $105.5 million; its shares were traded at around $2.12 with and P/S ratio of 504.8.

Highlight of Business Operations:

Research and development expenses decreased 5% to $3.1 million for the three-month period ended September 30, 2009 from $3.3 million for the comparable period in 2008. Compared to the year earlier period, there was a cost increase of approximately $460,000 related to research and preclinical work with our selective GR-II antagonists, including preparations for the submission of the IND for CORT 108297, expected later this year. There was also a cost increase of approximately $215,000 related to the study of CORLUX for the treatment of Cushings Syndrome. These were offset by a decrease of approximately $455,000 in clinical trial costs related to our psychotic depression program, as we scaled back our ongoing Phase 3 trial and completed reporting activities for the previous Phase 3 trials. There was a decrease of approximately $240,000 in manufacturing expenses as the year-earlier period included the acquisition and manufacture of the initial supply of materials for the CORLUX clinical trials and completion of certain manufacturing process development activities related to CORLUX. There was also a decrease of approximately $85,000 in consulting expenses.

For the nine-month period ended September 30, 2009, research and development expenses increased 13% to $10.7 million from $9.4 million for the comparable period in 2008. The increase in expenses reflects increases of approximately $1.4 million in costs related to research and preclinical work with our selective GR-II antagonists, including CORT 108297, $945,000 related to the clinical trials that commenced enrollment during 2008 in Cushings Syndrome and the mitigation of weight gain caused by Risperdal, $260,000 due to increases in staffing costs and $35,000 of consulting expenses. Offsetting these increases was a decrease in manufacturing expenses related to CORLUX of approximately $1.3 million due to the acquisition and manufacture during 2008 of the initial supply of materials for the CORLUX clinical trials and completion of certain manufacturing process development activities related to CORLUX.

General and administrative expenses decreased 7% to $1.5 million for the three-month period ended September 30, 2009 from $1.7 million for the comparable period in 2008. This change between periods reflects a decrease of approximately $315,000 in legal expenses due primarily to a reduction in patent-related legal costs, which was offset by increases of approximately $105,000 in professional fees and consultancy expenses due primarily to preparations for the initial year of auditor attestation of the effectiveness of our internal controls in accordance with Sarbanes Oxley (SOX) section 404 and an increase of approximately $90,000 in staffing costs due primarily to the recruitment of a new chief financial officer, who commenced work with us in November 2008. Approximately $55,000 of the staffing increase in the third quarter was non-cash stock-based compensation. On October 2, 2009, the SEC announced the deferral of the requirement of auditor attestation for non-accelerated filers, such as Corcept, until fiscal years ending on or after June 15, 2010.

For the nine-month period ended September 30, 2009, general and administrative expenses increased 4% to $4.5 million from $4.3 million for the nine-month period ended September 30, 2008. This increase reflects higher staffing costs of approximately $320,000, due primarily to the recruitment of our new chief financial officer. The increase in staffing costs in the year-to-date period included a net increase in stock-based compensation of $125,000, which reflects the cost of stock options granted to our new chief financial officer, other employees and directors. During this period, there were also increases in professional fees and consultancy costs of approximately $200,000, primarily related to the costs associated with periodic filings with the SEC and the preparations for the initial year of auditor attestation under SOX section 404. These increases were offset by a decrease of approximately $415,000 in legal expenses due primarily to the reduction in patent legal costs.

Interest and other income, net Interest and other income, net of investment management fees, was approximately $5,000 and $95,000, respectively, for the three- and nine-month periods ended September 30, 2009, compared to $290,000 and $745,000, respectively, for the comparable periods in 2008. Interest income for the three- and nine-month periods ended September 30, 2008 included approximately $145,000 and $260,000, respectively, that was earned on the note receivable issued in connection with our private placement of our common stock and warrants in March 2008 (the March 2008 Financing), which we collected in February 2009. The remainder of the decrease was attributable to lower yields on the investment portfolio and a lower level of invested funds.

In March 2008, we entered into a Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Limited (Kingsbridge), a private investment group. Under the terms of the agreement, Kingsbridge committed to provide up to $60 million of capital in exchange for newly-issued shares of our common stock for a period of up to three years after the Securities and Exchange Commission declares effective the registration statement filed by us covering the resale of the shares of common stock issuable in connection with the CEFF and the shares of common stock underlying the warrant issued to Kingsbridge. The maximum number of shares that can be sold by us under this agreement is approximately 9.6 million shares. Under the terms of the agreement, the determination of the exact timing and amount of any CEFF financings will be made solely by us, subject to certain conditions. The agreement currently requires a minimum stock price of $1.50 per share to allow us to issue shares to Kingsbridge under the CEFF. Based on the volume weighted average price on the NASDAQ Capital Market for our common stock for the period from March 25, 2008, the date of the signing of the Kingsbridge CEFF, through November 6, 2009, the maximum amount of net proceeds that could be raised under the CEFF is approximately $17 million. Over the 60 trading day period ended November 6, 2009, the price for our common stock on the NASDAQ Capital Market has ranged from $1.00 to $3.10. The actual amount of funds that can be raised under this agreement will be dependent on the number of shares actually sold under the agreement and the market value of our stock during the pricing periods of each sale.

Read the The complete ReportCORT is in the portfolios of Jean-Marie Eveillard of Arnhold & S. Bleichroeder Advisers, LLC, Jean-Marie Eveillard of Arnhold & S. Bleichroeder Advisers, LLC.