NEW YORK, Oct. 24 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. , a biopharmaceutical company focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer, today announced its results for the third quarter ended September 30, 2007.
At September 30, 2007, the Company had cash, cash equivalents, investment securities, interest receivable and license receivable of $82.7 million, as compared to $125.6 million at December 31, 2006. The nonrefundable license receivable of $12.0 million was received in October 2007 and related to a recent licensing agreement entered into with Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
The net loss for the third quarter ended September 30, 2007 was $19,528,000, or $0.45 per share, compared to a net loss of $17,993,000, or $0.42 per share, for the comparable quarter in 2006, representing an increase in net loss of $1,535,000. The increase in net loss was primarily attributable to a $627,000 increase in research and development expenses related to the Company’s Sulonex(TM) (sulodexide) pivotal Phase III and Phase IV clinical program, a $346,000 increase in expenses related to the Company’s other clinical compounds, and a $845,000 decrease in interest and other income, offset by a $344,000 decrease in non-cash compensation expense related to stock option and restricted stock grants.
The net loss for the nine months ended September 30, 2007 was $60,801,000, or $1.40 per share, compared to a net loss of $55,417,000, or $1.34 per share, for the comparable period in 2006, representing an increase in net loss of $5,384,000. The increase in net loss was primarily attributable to a $5,610,000 increase in research and development expenses related to the Company’s Sulonex pivotal Phase III and Phase IV clinical program, a $3,834,000 increase in expenses related to the Company’s other clinical compounds, a $1,085,000 decrease in interest and other income, and a $730,000 increase in other selling, general and administrative expenses, offset by a $5,944,000 decrease in non-cash compensation expense related to stock option and restricted stock grants.
Commenting on the quarter, Michael S. Weiss, Keryx’s Chairman and Chief Executive Officer, said, “During the third quarter we were excited to announce a Zerenex licensing arrangement with Japan Tobacco and Torii Pharmaceutical Co., pursuant to which Japan Tobacco and Torii will seek to develop and commercialize Zerenex in Japan. In addition to bolstering our balance sheet, we believe this deal represents an early window into the value of our product portfolio. We continue to stay focused on completing the Sulonex clinical development program, with data from our Phase III study expected in the 1st quarter of 2008.”
On Thursday, October 25, 2007, at 8:30am EDT, the Company will host an investor conference call during which they will provide a brief financial overview of the Company’s third quarter financial results.
In order to participate in the conference call, please call 1-800-909-7113 (U.S.), 1-785-830-1914 (outside the U.S.), call-in ID: KERYX. The audio recording of the conference call will be available for replay at http://www.keryx.com, for a period of 15 days after the call.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx’s lead compound under development is Sulonex(TM) (sulodexide), previously referred to as KRX-101, a first-in-class, oral heparinoid compound for the treatment of diabetic nephropathy, a life-threatening kidney disease caused by diabetes. Sulonex is in a pivotal Phase III and Phase IV clinical program under a Special Protocol Assessment with the Food & Drug Administration. Additionally, Keryx is developing Zerenex(TM), an oral, inorganic, iron-based compound that has the capacity to bind phosphate and form non-absorbable complexes. Zerenex is currently in Phase II clinical development for the treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients with end- stage renal disease. Keryx is also developing clinical-stage oncology compounds, including KRX-0401 (perifosine), a novel, first-in-class, oral anti-cancer agent that inhibits activation of Akt, a protein in the body associated with tumor survival and growth, and modulates a number of other key signal transduction pathways. KRX-0401 is currently in Phase II clinical development for multiple tumor types. Keryx also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release and made by our management on the conference call, particularly those anticipating future financial performance, clinical and business prospects for our lead drug candidates Sulonex, Zerenex and KRX-0401, growth and operating strategies and similar matters, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully complete cost-effective clinical trials for the drug candidates in our pipelines, including Sulonex, Zerenex and KRX-0401; we may not be able to meet anticipated development timelines for Sulonex, Zerenex or KRX-0401 due to recruitment, clinical trial results, manufacturing capabilities or other factors; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
lfischer@keryx.com
CONTACT: Lauren Fischer, Director - Investor Relations, Keryx
Biopharmaceuticals, Inc., +1-212-531-5965, lfischer@keryx.com
Web site: http://www.keryx.com/
