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Wider Q4 Loss at Keryx

Zacks Equity Research

Keryx Biopharmaceuticals (KERX) reported a loss of 21 cents in the fourth quarter of 2013, wider than the Zacks Consensus Estimate of a loss of 19 cents per share. The loss reported in the year-ago quarter was 9 cents per share.

Keryx did not generate any revenues in the fourth quarter of 2013.

Quarter in Detail

Research and Development expenses jumped 113.3% from the year-ago quarter to $10.5 million. We note that Keryx is a clinical stage biopharmaceutical company with a focus on renal diseases.

Keryx is currently developing Zerenex (ferric citrate coordination complex) for the treatment of hyperphosphatemia and management of elevated serum phosphorus levels and iron deficiency anemia in patients with stage III to V non-dialysis dependent chronic kidney disease (:CKD). The increase in R&D expense was related to Zerenex development activities.

General & Administrative expense came in at $7.3 million, up from $1.8 million in the year-ago quarter.

Annual Results

Loss per share in 2013 came in at 58 cents, wider than the Zacks Consensus Estimate of 54 cents per share. The loss reported in 2012 was 32 cents per share. License revenues came in at $7.0 million.

Pipeline Update

Keryx completed a phase III trial on Zerenex for the treatment of hyperphosphatemia. The phase III trial was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (:FDA). Zerenex is currently under review in the U.S. with an assigned Prescription Drug User Fee Act (:PDUFA) goal date of Jun 7, 2014.

We remind investors that Keryx recently submitted a Marketing Authorization Application filing to the European Medicines Agency seeking the approval of Zerenex for the treatment for hyperphosphatemia in patients with CKD, including dialysis- and non-dialysis dependent CKD.

In Jan 2014, Keryx’s Japanese partner, Japan Tobacco Inc. (:JT), received manufacturing and marketing approval for Zerenex as an oral treatment for the improvement of hyperphosphatemia in patients. Zerenex will be marketed in Japan by JT's subsidiary, Torii Pharmaceutical Co., Ltd., under the brand name Riona.

Since Keryx does not have any approved product in its portfolio, we expect investor focus to remain on Zerenex updates.

Keryx Biopharmaceuticals currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Gilead Sciences (GILD), Actelion (ALIOF), and Biogen Idec (BIIB). While Actelion and Biogen Idec carry a Zacks Rank #2 (Buy), Gilead Sciences holds a Zacks Rank #1 (Strong Buy).

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