) 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
Keryx did not generate any revenues in the fourth quarter of
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
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.
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
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
Keryx Biopharmaceuticals currently carries a Zacks Rank #3
(Hold). Better-ranked stocks in the same sector include
). While Actelion and Biogen Idec carry a Zacks Rank #2 (Buy),
Gilead Sciences holds a Zacks Rank #1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
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KERYX BIOPHARMA (KERX): Free Stock Analysis
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