NEW YORK, Aug. 8 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. , a biopharmaceutical company focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer, today announced its financial results for the second quarter ended June 30, 2006.
At June 30, 2006, the Company had cash, cash equivalents, investment securities and interest receivable of $155.1 million.
The net loss for the second quarter ended June 30, 2006 was $17,828,000, or $0.41 per share, compared to a net loss of $5,952,000, or $0.19 per share, for the comparable quarter in 2005, representing an increase in net loss of $11,876,000. The increase in net loss was primarily attributable to a $5,556,000 increase in research and development expenses related to the Company’s Sulonex(TM) pivotal Phase III and Phase IV clinical program. The increase in net loss was also due to a $5,340,000 increase in non-cash compensation expense primarily related to the adoption of the Statement of Financial Accounting Standards (SFAS) No. 123R “Share-Based Payment”.
Commenting on the quarter, Michael S. Weiss, Keryx’s Chairman and Chief Executive Officer, said, “The second quarter was a busy one in which we experienced great progress within the Company’s clinical programs. We announced positive results in both the Zerenex(TM) and KRX-0401 Phase II clinical programs and we continued active enrollment into the Sulonex(TM) Phase III and Phase IV programs. We look forward to continuing our aggressive clinical development programs as a way of creating long-term shareholder value.”
On Wednesday, August 9, 2006, at 8:30am EDT, the Company will host an investor conference call during which they will provide a brief financial overview on its second quarter financial results.
In order to participate in the conference call, please call 1-800-862-9098 (U.S.), 1-785-424-1051 (outside the U.S.), call-in ID: KERYX. The conference call also will be available for audio 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 novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx’s lead compound under development is Sulonex(TM), 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.
Contact: Ronald C. Renaud, Jr. Thomas Redington Chief Financial Officer 203 222-7399 212 531-5965 212 926-1733 rrenaud@keryx.comtredington@redingtoninc.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 Six Months Ended June 30, June 30, (unaudited) (unaudited) 2006 2005 2006 2005 REVENUE: Diagnostic revenue $23 $-- $23 $-- Service revenue 224 126 336 283 TOTAL REVENUE 247 126 359 283 OPERATING EXPENSES: Cost of diagnostics sold 19 -- 19 -- Cost of services 98 161 269 342 Research and development: Non-cash compensation 2,104 137 4,828 313 Other research and development 12,352 5,180 24,685 9,222 Total research and development 14,456 5,317 29,513 9,535 Selling, general and administrative: Non-cash compensation 3,541 168 6,358 353 Other selling, general and administrative 1,860 699 4,505 1,344 Total selling, general and administrative 5,401 867 10,863 1,697 TOTAL OPERATING EXPENSES 19,974 6,345 40,664 11,574 OPERATING LOSS (19,727) (6,219) (40,305) (11,291) OTHER INCOME: Interest and other income, net 1,899 267 2,881 507 NET LOSS $(17,828) $(5,952) $(37,424) $(10,784) NET LOSS PER COMMON SHARE Basic and diluted $(0.41) $(0.19) $(0.92) $(0.34) SHARES USED IN COMPUTING NET LOSS PER COMMON SHARE Basic and diluted 43,117,656 31,528,862 40,608,571 31,503,469 Balance Sheet Information: (unaudited) June 30, 2006 December 31, 2005* Cash, cash equivalents, interest receivable and investment securities $155,111 $100,733 Total assets 166,792 105,097 Accumulated deficit (151,872) (114,448) Stockholders’ equity 155,807 94,678 * Condensed from audited financial statements.
Keryx Biopharmaceuticals, Inc.
CONTACT: Ronald C. Renaud, Jr., Chief Financial Officer of KeryxBiopharmaceuticals, Inc., +1-212-531-5965, rrenaud@keryx.com; or ThomasRedington, +1-203-222-7399, +1-212-926-1733, tredington@redingtoninc.com
