Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter And Year-End 2013 Financial Results

NEW YORK, March 12, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of renal disease (the "Company"), today announced its financial results for the fourth quarter and year ended December 31, 2013.

At December 31, 2013, the Company had cash and cash equivalents of $55.7 million, as compared to $14.7 million at December 31, 2012. In January 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. Subsequent to December 31, 2013, the Company completed another underwritten public offering of common stock, which provided proceeds to the Company of approximately $107.6 million, net of underwriting discounts and offering expenses of approximately $7.5 million, and also received a $10.0 million milestone payment from Japan Tobacco Inc. ("JT") and Torii Pharmaceutical Co., Ltd. ("Torii") related to the manufacturing and marketing approval of ferric citrate in Japan in January 2014 from the Japanese Ministry of Health, Labour and Welfare.

The net loss for the fourth quarter ended December 31, 2013 was $17.7 million, or $0.21 per share, compared to a net loss of $6.6 million, or $0.09 per share, for the comparable quarter in 2012, representing an increase in net loss of $11.1 million. For the fourth quarter ended December 31, 2013, other research and development expenses increased by $4.1 million, as compared to the fourth quarter of 2012, primarily related to the Company's Zerenex program, including costs associated with the preparation of our Marketing Authorization Application ("MAA") submission for Zerenex TM, and manufacturing of pre-launch inventory and capacity expansion. Other general and administrative expenses during the fourth quarter of 2013 increased by $3.5 million, as compared to the fourth quarter of 2012, primarily related to pre-commercial activities related to Zerenex. The three months ended December 31, 2013, included $4.0 million of non-cash compensation expense related to equity incentive grants.

The net loss for the year ended December 31, 2013, was $46.7 million, or $0.58 per share, compared to a net loss of $22.7 million, or $0.32 per share, for the year ended December 31, 2012, representing an increase in net loss of $24.0 million. In January 2013, the Company recorded license revenue of $7.0 million for a milestone payment received from its Japanese partner for Zerenex, JT and Torii, related to JT's January 2013 filing of a New Drug Application ("NDA") in Japan. For the year ended December 31, 2013, other research and development expenses increased by $13.0 million, as compared to the year ended December 31, 2012, primarily related to costs associated with the filing of our U.S. NDA, preparation of our MAA, and manufacturing of pre-launch inventory. Other general and administrative expenses for the year ended December 31, 2013, increased by $10.2 million, as compared to the year ended December 31, 2012, primarily related to pre-commercial activities related to Zerenex.  The net loss for the year ended December 31, 2012 included a non-cash extraordinary gain of $2.6 million related to a write-off of a contingent equity rights liability following the termination of the license agreement for KRX-0401, and a $1.5 million arbitration award, which was included in interest and other income, net, resulting from a FINRA arbitration against a broker-dealer registered with the Securities and Exchange Commission. The year ended December 31, 2013, included $6.0 million of non-cash compensation expense related to equity incentive grants.

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