Keryx Reports Second Quarter 2001 Financial Results

CAMBRIDGE, Mass. and JERUSALEM, Aug. 13 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX; AIM: KRX), today released financial results for the second quarter ended June 30, 2001. Keryx's core KinAce(TM) 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 three months ended June 30, 2001 was $3,448,364, or $0.17 per share, compared to a net loss of $3,233,806, or $0.40 per share, for the three months ended June 30, 2000. Net of non-cash compensation of $680,898 and $2,089,325 for the three months ending June 30, 2001 and 2000, respectively, the net loss increased by $1,622,985. At June 30, 2001, Keryx had cash, cash equivalents, interest receivable and investments of $44.6 million, compared with $48.9 million at December 31, 2000.

"During the second quarter of 2001, Keryx focused on the pre-clinical advancement of the Company's KinAce-derived compounds, KRX-123 for the treatment of hormone resistant prostate cancer and KRX-613/683 for the treatment of diabetes," said Morris Laster, M.D., Chief Executive Officer and Chairman of Keryx Biopharmaceuticals, Inc. "Additionally, increased manufacturing costs associated with the build up of clinical study supplies for KRX-101 contributed to increased expenses during the quarter."

Keryx, with a staff of 44 people and a network of prestigious research collaborators and consultants, continues to advance KinAce programs in the therapeutic areas of oncology, immunology and metabolic disorders. The Company is also progressing well with the development of KRX-101, for the treatment of diabetic nephropathy. Keryx believes that this 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(TM) drug discovery platform technology, the Company has established therapeutic programs in oncology, immunology, metabolic disorders, and other disease areas. The Company's most advanced drug candidate, KRX-123, is part of the oncology program, and is in pre-clinical development for advanced prostate cancer. The Company is also preparing to initiate clinical trials for its late stage, in-licensed product, KRX-101 (sulodexide), for the treatment of diabetic nephropathy. 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, including, but not limited to, statements concerning the clinical status, possible approval and market potential of Keryx's drug candidates, and growth and future operating results, 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", "hope", "intend", "plan", "believe", "scheduled" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Various risks may cause Keryx's actual results to differ materially, including: adverse results in its drug discovery and clinical development processes; failure to obtain patent protection for its discoveries; commercial limitations imposed by patents owned or controlled by third parties; difficulties or delays in obtaining regulatory approvals to market products resulting from its development efforts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. Important factors that might cause or contribute to such a discrepancy include, but are not limited to, the risks discussed under the heading "Risk Factors" in our Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.

CONTACTS:
Robert Gallahue
Chief Financial Officer & Treasurer
Keryx Biopharmaceuticals
Tel: +1 617 512 6883
E-mail: bobgallahue@mediaone.net

Ron Bentsur
Head of Investor Relations
Keryx Biopharmaceuticals
Tel: +972 2 541 2700
E-mail: ron@keryxbiopharm.com

Fredda Malkoff
Manager
Feinstein Kean Healthcare
Tel: +1 617 577 8110
E-mail: fmalkoff@fkhealth.com

Charlotte Stone
Senior Executive
Gavin, Anderson & Co.
Tel: +44 20 7 457 2345
Email: cstone@gavinanderson.co.uk


Keryx Biopharmaceuticals, Inc
Selected Consolidated Financial Data

Statement of Operations:

Three Months Ended June 30, Six Months Ended June 30,
(unaudited) (unaudited)
2001 2000 2001 2000

OPERATING EXPENSES:
Research and
development $2,711,314 $1,128,791 $4,742,620 $2,529,670
General and
administrative 1,275,384 2,175,083 2,391,886 3,268,596
LOSS FROM
OPERATIONS (3,986,698) (3,303,874) (7,134,506) (5,798,266)

OTHER INCOME (EXPENSE):
Interest income, net 548,823 97,947 1,418,358 152,619
Taxes on income (10,489) (27,879) (120,579) (55,000)

NET LOSS $(3,448,364) $(3,233,806) $(5,836,727)$ (5,700,647)

NET LOSS PER COMMON SHARE
Basic and diluted $(0.17) $(0.40) $(0.30) $ (0.70)

SHARES USED IN COMPUTING
NET LOSS PER COMMON SHARE
Basic and diluted 19,721,973 8,108,306 19,659,159 8,108,306


Balance Sheet:
June 30, December 31,
2001 2000
(unaudited) (audited)

Cash, cash equivalents,
interest receivable and investments $44,595,419 $48,899,874

Total assets 47,228,003 50,264,356

Accumulated deficit (29,749,519) (23,912,792)

Stockholders' equity 44,125,047 48,866,648

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/CONTACT: Robert Gallahue, Chief Financial Officer & Treasurer of Keryx Biopharmaceuticals, +1-617-512-6883, bobgallahue@mediaone.net; or Ron Bentsur, Head of Investor Relations of Keryx Biopharmaceuticals, +972 2 541 2700, ron@keryxbiopharm.com; or Fredda Malkoff, Manager of Feinstein Kean Healthcare, +1-617-577-8110, fmalkoff@fkhealth.com; or Charlotte Stone, Senior Executive of Gavin, Anderson & Co., +44 20 7 457 2345, cstone@gavinanderson.co.uk/

 

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