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Keryx Biopharmaceuticals, Inc. Announces Third Quarter 2013 Financial Results

Stocks in this article: KERX

NEW YORK, Nov. 4, 2013 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease (the "Company"), today announced its results for the third quarter ended September 30, 2013.

At September 30, 2013, the Company had cash, cash equivalents and interest receivable of $67.9 million, as compared to $14.7 million at December 31, 2012. In July 2013, the Company paid a $2.0 million New Drug Application ("NDA") user fee related to the submission of its NDA filing to the Food and Drug Administration ("FDA"). In October 2013, the Company received a full refund of the $2.0 million NDA user fee following its receipt of a waiver granted under the small business waiver provision of the Federal Food, Drug, and Cosmetic Act. On January 30, 2013, the Company completed an underwritten public offering of common stock, which provided proceeds to the Company of approximately $74.8 million, net of underwriting discounts and offering expenses of approximately $5.6 million. Also in January 2013, the Company received a $7.0 million milestone payment from its Japanese partner for Zerenex (ferric citrate coordination complex), Japan Tobacco Inc. ("JT") and Torii Pharmaceutical Co., Ltd. ("Torii"), related to JT's January 2013 filing of a NDA with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease ("CKD").

The net loss for the quarter ended September 30, 2013 was $15.7 million, or $0.19 per share, compared to a net loss of $5.5 million, or $0.08 per share, for the comparable quarter in 2012, representing an increase in net loss of $10.2 million.  For the third quarter ended September 30, 2013, other research and development expenses increased by $6.6 million, as compared to the third quarter of 2012, primarily related to the Company's Zerenex program, including costs associated with the filing of the NDA, preparation of the Marketing Authorization Application ("MAA") submission, and manufacturing of pre-launch inventory and capacity expansion. The three months ended September 30, 2013, includes a one-time $1.0 million milestone payment to the licensor of Zerenex, related to the Company's submission of the NDA in August 2013. Other general and administrative expenses during the third quarter of 2013 increased by $3.4 million, as compared to the third quarter of 2012, primarily related to pre-commercial activities related to Zerenex. The three months ended September 30, 2013, included $0.7 million of non-cash compensation expense related to equity incentive grants.

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