Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2007 Financi... (was primarily attributable to a$7839000 ...)

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

Date:2/22/2008

was primarily attributable to a $7,839,000 increase in research and development expenses related to the Company's Sulonex pivotal Phase 3 and Phase 4 clinical program, a $6,702,000 increase in expenses related to KRX-0401 (perifosine), a $3,294,000 increase in expenses related to Zerenex (ferric citrate) and a $1,580,000 increase in expenses related to the Company's other clinical compounds. The increase in net 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 Chairman and Chief Executive Officer, said, "This was an important year for the Company as we made substantial progress toward the potential commercialization of Sulonex, including: completion of the active treatment portion of the SUN- MICRO Phase 3 trial with the subsequent completion of the trial in February 2008; enrollment of over 50% of the patients required for completion of the SUN-MACRO Phase 4 trial; completion of four Independent Data Safety Monitoring Committee (DSMC) meetings surrounding the Phase 3 and Phase 4 trials culminating in the fourth quarter DSMC final review of the safety and efficacy data related to the Sulonex Phase 3 trial, at which time the DSMC again found no cogent reason to recommend that we alter or terminate the study; and the completion of our first commercial-scale manufacturing facility with final validation anticipated in 2008." Mr. Weiss, continued, "With the Phase 3 trial now complete, we anxiously await the final results from the study, and continue to target making an announcement of the top line data before the end of 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 ac
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SOURCE Keryx Biopharmaceuticals, Inc.
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Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2007 Financi...(was primarily attributable to a$7839000 ...)