[KERYX BIOPHARMACEUTICALS GRAPHIC] NEWS
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FOR IMMEDIATE RELEASE
KERYX CONTACT:
Ron Bentsur
Vice President - Finance & Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: ron@keryx.com
KERYX BIOPHARMACEUTICALS, INC. ANNOUNCES FIRST QUARTER 2004
FINANCIAL RESULTS
-REPORTS NON-CASH CHARGE RELATED TO ACCESS ONCOLOGY, INC. ACQUISITION-
-KERYX TO HOLD INVESTOR CONFERENCE CALL ON MONDAY, MAY 10, 2004 AT 10:00AM EDT-
NEW YORK, NEW YORK, MAY 7, 2004 - Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX;
AIM: KRX), 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 released
financial results for the first quarter ended March 31, 2004.
As part of a previously announced acquisition of ACCESS Oncology, Inc., the
Company incurred a non-cash, acquired in-process research and development charge
in the quarter ended March 31, 2004 of $18.8 million, all of which was included
in research and development expenses. This charge arose as a result of purchase
accounting treatment for the acquisition, as mandated by accounting principles
generally accepted in the United States of America.
At March 31, 2004, the Company had cash, cash equivalents, interest receivable
and investment securities of $56.1 million, compared to cash, cash equivalents,
interest receivable and investment securities of $31.4 million at December 31,
2003, representing an increase of $24.7 million. This increase is primarily
attributable to the $31.8 million in net proceeds raised by the Company in a
private placement of common stock to institutional investors completed in
February 2004 and approximately $2.2 million of exercise proceeds from the
exercise of options and warrants during the first quarter ended March 31, 2004.
This increase was partially offset by approximately $7.4 million of assumed
liabilities, comprised of $6.3 million of debt and $1.1 million of accounts
payable and accrued liabilities, paid by the Company following the acquisition
of ACCESS Oncology, Inc.
The net loss for the quarter ended March 31, 2004 was $(21,823,000), or $(0.78)
per share, compared to a net loss of $(3,788,000), or $(0.19) per share, for the
quarter ended March 31, 2003. The increase in net loss in the first quarter of
2004, as compared to the first quarter of 2003, was primarily attributable to
the $18,800,000, or $(0.68) per share, non-cash acquired in-process research and
development charge taken in the first quarter of 2004 arising from the
acquisition of ACCESS Oncology, Inc.
Commenting on the quarter, Michael S. Weiss, Keryx's Chairman and Chief
Executive Officer, said, "This quarter was very successful for Keryx. Through
the acquisition of ACCESS Oncology, we built out our product pipeline with
KRX-0401 (Perifosine), our lead oncology compound in Phase II clinical
development. In addition, we raised $32 million from some of the most
prestigious institutional investors in the industry, and we view this as a major
vote of confidence in our compounds and our business plan. In the coming
quarters we intend to continue to build Keryx into a leading biotechnology
company through the clinical development of our lead product candidates KRX-101
and KRX-0401 and the pursuit of additional product acquisitions."
KERYX WILL HOST AN INVESTOR CONFERENCE CALL ON MONDAY, MAY 10, AT 10:00AM EDT
to discuss 2004 first quarter results and provide an update on the Company's
projects. In order to participate in the conference call, please call
1-800-895-0198 (if calling from the U.S.) or 1-785-424-1053 (if calling from
outside the U.S.). Conference ID: KERYX.
The press release can be accessed by visiting the Company's website at
www.keryx.com. The webcast of the conference call will be available for replay
at www.keryx.com for a period of 15 days after the call.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
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Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX; London AIM: KRX) is 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. Keryx is developing
KRX-101 (sulodexide), a novel first-in-class oral heparinoid compound, for the
treatment of diabetic nephropathy, for which Keryx recently commenced its
U.S.-based Phase II/III clinical program. Additionally, Keryx is developing
three clinical-stage oncology compounds including KRX-0401, a novel, oral,
first-in-class AKT inhibitor in Phase II. Keryx also has an active in-licensing
and acquisition program designed to identify and acquire clinical-stage drug
candidates. Keryx Biopharmaceuticals 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, BUSINESS PROSPECTS, 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 KRX-101 AND KRX-0401; THE SUCCESSFUL COMPLETION OF THE NATIONAL CANCER
INSTITUTE-SPONSORED CLINICAL TRIALS FOR KRX-0401; THE SUCCESS OF THE SULODEXIDE
OPEN ACCESS RESEARCH PROGRAM AND ITS ABILITY TO DEVELOP USES FOR KRX-101 THAT
CAN IMPACT A NUMBER OF DISEASE STATES BEYOND DIABETIC NEPHROPATHY; AND OTHER
RISK FACTORS IDENTIFIED FROM TIME TO TIME IN OUR SEC REPORTS. 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
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.
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KERYX BIOPHARMACEUTICALS, INC.
SELECTED CONSOLIDATED FINANCIAL DATA
(THOUSANDS OF US DOLLARS, EXCEPT SHARE AND PER SHARE DATA)
STATEMENT OF OPERATIONS:
THREE MONTHS ENDED MARCH 31,
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(UNAUDITED)
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2004 2003
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SERVICE REVENUE $ 95 $ --
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OPERATING EXPENSES:
Cost of services 80 --
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Research and development
Non-cash compensation 202 (266)
Non-cash acquired in-process
research and development 18,800 --
Other research and development 1,652 3,371
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Total research and development 20,654 3,105
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General and administrative
Non-cash compensation 185 $ 2
Other general and administrative 1,093 664
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Total general and administrative 1,278 666
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TOTAL OPERATING EXPENSES 22,012 3,771
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OPERATING LOSS (21,917) (3,771)
OTHER INCOME (EXPENSE):
Interest income, net 95 85
Income taxes (1) (102)
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NET LOSS $(21,823) $(3,788)
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NET LOSS PER COMMON SHARE
Basic and diluted $ (0.78) $ (0.19)
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SHARES USED IN COMPUTING NET LOSS PER COMMON
SHARE
Basic and diluted 27,828,090 20,011,036
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BALANCE SHEET:
MARCH 31, 2004 DECEMBER 31, 2003
(UNAUDITED) (AUDITED)
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Cash, cash equivalents, interest
receivable and investment securities $ 56,086 $ 31,414
Total assets 57,202 32,223
Accumulated deficit (76,433) (54,610)
Stockholders' equity 48,820 31,226