NEW YORK, April 25 /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 first quarter ended March 31, 2007.
At March 31, 2007, the Company had cash, cash equivalents, investment securities and interest receivable of $108.0 million, as compared to $125.6 million at December 31, 2006.
The net loss for the first quarter ended March 31, 2007 was $21,813,000, or $0.50 per share, compared to a net loss of $19,596,000, or $0.51 per share, for the comparable quarter in 2006, representing an increase in net loss of $2,217,000. The increase in net loss was primarily attributable to a $2,823,000 increase in research and development expenses related to the Company’s Sulonex(TM) (sulodexide) pivotal Phase III and Phase IV clinical program and due to a $1,919,000 increase in expenses related to our other clinical compounds, offset by a decrease of $2,540,000 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 first quarter, we experienced important progress with respect to Sulonex as enrollment into both the Phase III and Phase IV clinical programs continued as planned, and in February, we announced the closing of enrollment into the Phase III portion of this pivotal clinical program. On the financial side, our balance sheet remains strong as we continue to execute on our business strategy and begin preparation for the commercialization of Sulonex(TM).”
On Thursday, April 26, 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 first quarter financial results.
In order to participate in the conference call, please call 1-800-987-6057 (U.S.), 1-785-832-1523 (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, a novel, first-in-class, oral modulator of Akt, a pathway associated with tumor survival and growth, and other important 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.
KERYX CONTACT: Ron Renaud Chief Financial Officer Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail: rrenaud@keryx.com Keryx Biopharmaceuticals, Inc. Selected Consolidated Financial Data (Thousands of US Dollars, Except Share and Per Share Data) Statements of Operations Information: Three Months Ended March 31, (unaudited) 2007 2006 REVENUE: Diagnostic revenue $30 $-- Service revenue 12 112 TOTAL REVENUE 42 112 OPERATING EXPENSES: Cost of diagnostics sold 22 -- Cost of services 32 171 Research and development: Non-cash compensation 995 2,724 Other research and development 17,446 12,333 Total research and development 18,441 15,057 Selling, general and administrative: Non-cash compensation 2,006 2,817 Other selling, general and administrative 2,795 2,645 Total selling, general and administrative 4,801 5,462 TOTAL OPERATING EXPENSES 23,296 20,690 OPERATING LOSS (23,254) (20,578) OTHER INCOME: Interest and other income, net 1,441 982 NET LOSS $(21,813) $(19,596) NET LOSS PER COMMON SHARE Basic and diluted $(0.50) $(0.51) SHARES USED IN COMPUTING NET LOSS PER COMMON SHARE Basic and diluted 43,506,236 38,071,609 Balance Sheet Information: March 31, December 31, 2007 2006* (unaudited) Cash, cash equivalents, interest receivable and investment securities $108,019 $125,610 Total assets 123,365 140,313 Accumulated deficit (210,025) (188,212) Stockholders’ equity 105,122 123,821 * Condensed from audited financial statements.
Keryx Biopharmaceuticals, Inc.
CONTACT: Ron Renaud, Chief Financial Officer of Keryx Biopharmaceuticals,Inc., +1-212-531-5965, rrenaud@keryx.com
Web site: http://www.keryx.com/
