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Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2007 Financial Results

Saturday, February 23, 2008 General News
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NEW YORK, Feb. 22 Keryx Biopharmaceuticals, Inc.(Nasdaq: KERX), a biopharmaceutical company focused on the acquisition,development and commercialization of medically important, novel pharmaceuticalproducts for the treatment of life-threatening diseases, including diabetesand cancer (the "Company"), today announced its results for the fourth quarterand year ended December 31, 2007.
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At December 31, 2007, the Company had cash, cash equivalents, investmentsecurities and interest receivable of $64.7 million, as compared to $125.6million at December 31, 2006.
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The net loss for the fourth quarter ended December 31, 2007 was$29,261,000, or $0.67 per share, compared to a net loss of $18,347,000, or$0.42 per share, for the comparable quarter in 2006, representing an increasein net loss of $10,914,000. The increase in net loss was primarilyattributable to a $2,228,000 increase in research and development expensesrelated to the Company's Sulonex(TM) (sulodexide oral gelcap) pivotal Phase 3and Phase 4 clinical program, a $4,372,000 increase in expenses related toKRX-0401, a $2,600,000 increase in expenses related to Zerenex, a $446,000increase in expenses related to the Company's other clinical compounds and a$1,692,000 increase in non-cash compensation expense related to stock optionand restricted stock grants.

The net loss for the year ended December 31, 2007 was $90,062,000, or$2.07 per share, compared to a net loss of $73,764,000, or $1.76 per share,for the year ended December 31, 2006, representing an increase in net loss of$16,298,000. The increase in net loss was primarily attributable to a$7,839,000 increase in research and development expenses related to theCompany's Sulonex pivotal Phase 3 and Phase 4 clinical program, a $6,702,000increase in expenses related to KRX-0401 (perifosine), a $3,294,000 increasein expenses related to Zerenex (ferric citrate) and a $1,580,000 increase inexpenses related to the Company's other clinical compounds. The increase innet loss was also due to a $1,838,000 decrease in interest and other income.The increase in net loss was partially offset by a $4,252,000 decrease in non-cash compensation expense related to stock option and restricted stock grants.

Commenting on the year and the quarter, Michael S. Weiss, Keryx's Chairmanand Chief Executive Officer, said, "This was an important year for the Companyas we made substantial progress toward the potential commercialization ofSulonex, including: completion of the active treatment portion of the SUN-MICRO Phase 3 trial with the subsequent completion of the trial in February2008; enrollment of over 50% of the patients required for completion of theSUN-MACRO Phase 4 trial; completion of four Independent Data Safety MonitoringCommittee (DSMC) meetings surrounding the Phase 3 and Phase 4 trialsculminating in the fourth quarter DSMC final review of the safety and efficacydata related to the Sulonex Phase 3 trial, at which time the DSMC again foundno cogent reason to recommend that we alter or terminate the study; and thecompletion of our first commercial-scale manufacturing facility with finalvalidation anticipated in 2008." Mr. Weiss, continued, "With the Phase 3trial now complete, we anxiously await the final results from the study, andcontinue to target making an announcement of the top line data before the endof next month. In preparation for the potential commercial launch of Sulonex,we continue to build our internal expertise, including key hires in commercial,medical affairs, quality operations, legal and accounting. Financially, weended the year in line with our expectations and believe that we are well-positioned for an exciting and fruitful 2008."

On Monday, February 25, 2008, at 8:30am EST, the Company will host aninvestor conference call during which they will provide a brief financialoverview of the Company's fourth quarter and year-end 2007 fi
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