Keryx's Q4 Loss Misses Expectation, Auryxia In Focus - February 27, 2015
Keryx Biopharmaceuticals Inc. (KERX) is a New York-based biopharmaceutical company working in the field of renal diseases. The company entered this field with the launch of its first product, Auryxia in Dec 2014. The product was approved in the U.S. in Sep 2014 for the control of serum phosphorus levels in patients suffering from chronic kidney disease (CKD) and dependent on dialysis.
Given that the market for kidney disease is pretty competitive, Auryxia will face competition from other marketed drugs like Shires’ Fosrenol and Sanofi’s Renagel and Renvela, among others.
Meanwhile, Auryxia is under review in the EU for the treatment for hyperphosphatemia in patients suffering from dialysis- and non-dialysis-dependent CKD. In this scenario, investor focus remains on the performance of the new launch and updates on the EU submission, apart from the usual top-and bottom-line numbers.
Keryx has a disappointing track record with the company delivering negative surprises in each of the last four quarters with an average negative surprise of 21.41%. Analysts have lowered their estimates for 2014 as well as 2015.
Currently, Keryx has a Zacks Rank#4 (Sell), but that could definitely change following the company’s earnings report which was just released. We have highlighted some of the key stats from this just-revealed announcement below:
Earnings: Keryx reported wider-than-expected loss in the fourth quarter of 2014. Our consensus called for a loss of 37 cents per share, while the company reported a loss of 44 cents (these figures take out stock option expenses).
Revenue: Revenues also missed our estimates. Keryx posted revenues of $0.6 million, compared to our consensus estimate of $2 million.
Key Stats: With the launch of Auryxia in the U.S. in late 2014, Keryx transformed from a development-stage company to a fully integrated commercial organization. With only one approved product in its portfolio, the company is largely dependent on it for growth. Meanwhile, Auryxia is under review in the EU as a treatment for hyperphosphatemia in patients with CKD with a response from the European Medicine Agency expected by mid-2015. The company is also conducting a phase III pivotal study to evaluate Auryxia as a treatment for iron deficiency anemia in non-dialysis dependent CKD patients belonging to stages 3 – 5.
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