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Keryx Reports Fourth Quarter and Year End 2000 Financial Results BOSTON and JERUSALEM, March 29, 2001 - Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX; AIM: KRX) today released financial results for the fourth quarter and year ended December 31, 2000. Keryx's core KinAce™ drug discovery technology provides a direct pathway from kinase sequence data to potential drug candidates. The Company is also developing KRX-101 (sulodexide), an in-licensed product that is in late-stage clinical development for the treatment of diabetic nephropathy. The net loss for the quarter ended December 31, 2000 was $3,023,427, or $0.23 per share, compared to a net loss of $6,908,326, or $0.85 per share, for the quarter ended December 31, 1999. The decrease was primarily attributable to non-cash compensation expense related to stock options grants of $749,000 and $6,014,000 for the quarters ended December 31, 2000 and 1999, respectively. Net of non-cash compensation, net loss increased by $1,380,101 due primarily to increased consulting fees and expenditures on expansion of our existing research and development activities and general and administrative activities. Net loss for the year ended December 31, 2000 was $11,488,897, or $0.89 per share, compared to a net loss of $9,002,762, or $1.11 per share, for the year ended December 31, 1999. The Company completed an initial public offering (IPO) of 4.6 million shares of its common stock on July 28, 2000, and in August the underwriters exercised their over-allotment option for an additional 600,000 shares. Total net proceeds from the Company's IPO were approximately $46.3 million. At December 31, 2000, including the proceeds of the recent IPO, the Company had cash, cash equivalents, interest receivable and investments of $48.9 million, compared with $4.1 million at December 31, 1999. "Our IPO in August enabled us to accelerate the development of our KinAce platform, and to continue to advance the clinical development of KRX-101," said Morris Laster, M.D., Chief Executive Officer and Chairman of Keryx Biopharmaceuticals, Inc. "Our work with KRX-101 led to U.S. Food and Drug Administration (FDA) approval to proceed to Phase III clinical trial design for the compound. Additionally, the United States Patent and Trademark Office granted Keryx a patent for the use of KRX-101 in the treatment of diabetic retinopathy, an eye-related complication of diabetes." Dr. Laster concluded, "We expect to see a number of important events in 2001, including the initiation of Phase III trials for KRX-101, the start of human studies with our first KinAce compound, KRX-123 for the treatment of hormone resistant prostate cancer, and the expansion of our discovery efforts. We also hope to secure our first pharmaceutical partnership." Keryx, whose staff has grown to include 36 people and a network of prestigious research collaborators and consultants, plans to continue to advance KinAce programs in the therapeutic areas of oncology, immunology, metabolic disorders, and tissue remodeling (generation), as well as in the area of functional genomics. The Company also plans to continue developing KRX-101, for the treatment of diabetic nephropathy. Keryx believes that the product has long-term potential for other diseases and intends to expand the future clinical development of the compound as appropriate. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals is building a pipeline of drug candidates that target protein kinases by applying its proprietary bioinformatics technology to genomics data. Kinases, which play a key role in the way cells communicate, are implicated in a wide range of diseases. Using its KinAce™ drug discovery platform technology, the Company has established therapeutic programs in oncology, immunology, metabolic, and other disease areas. The Company's most advanced drug candidate, KRX-123, is part of the oncology program, and is scheduled to enter clinical trials for advanced prostate cancer in 2001. The Company is also developing a late stage, in-licensed product, KRX-101 (sulodexide), for the treatment of diabetic nephropathy. Conditional upon the Food and Drug Administration's (FDA's) response to the clinical protocol to be filed, the Company expects to commence Phase III trials in 2001. Keryx is traded on NASDAQ (KERX) and the London AIM (KRX). Web site address: www.keryxbiopharm.com Statements contained or referenced in this news release that are not historical facts may be forward-looking statements, as the term is defined in the Private Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "anticipate", "estimate", "expect", "project", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Our actual results and the timing of certain events may differ significantly from the results discussed in forward-looking statements. Factors that might cause or contribute to such a discrepancy include, but are not limited to, the risks outlined in our Registration Statement on Form S-1 filed with the Securities and Exchange Commission. The forward-looking statements contained in this filing or in our Registration Statement on Form S-1 include, among other things, statements relating to our drug development and regulatory strategy, growth strategy, use of proceeds, projected capital expenditures, research and development expenditures, other costs and expenses, revenue, profitability, and liquidity and capital resources.
Keryx Biopharmaceuticals, Inc. Ron
Bentsur
Keryx Biopharmaceuticals, Inc
Selected Financial Data
Statement of Operations:
Three Months Ended December 31, Six Months Ended December 31,
2000 1999 2000 1999
OPERATING EXPENSES:
Research and
development $2,263,106 $5,269,844 $6,685,609 $6,922,797
General and
administrative 1,266,927 1,187,355 5,900,380 1,812,508
LOSS FROM OPERATIONS(3,530,033) (6,817,199) (12,585,989) (8,735,305)
OTHER INCOME(EXPENSE):
Financing income
(expenses) 633,606 (81,157) 1,317,092 (257,487)
Taxes on income (127,000) (9,970) (220,000) (9,970)
NET LOSS $(3,023,427) $(6,908,326) $(11,488,897) $(9,002,762)
NET LOSS PER COMMON
Basic and diluted $(0.16) $(0.85) $(0.89) $(1.11)
SHARES USED IN COMPUTING
NET LOSS PER COMMON SHARE
Basic and diluted 19,489,568 8,108,306 12,929,643 8,108,306
Balance Sheet:
December 31, 2000 December 31, 1999
Cash and cash equivalents $48,899,874 $4,126,735.00
Total assets 50,264,356 4,948,216
Accumulated deficit (23,912,792) (12,423,895)
Stockholders' equity 48,866,648 4,436,063
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