Keryx Biopharmaceuticals Inc.’s KERX second-quarter 2015 loss of 26 cents per share was in line with the Zacks Consensus Estimate but wider than the year-ago figure of a loss of 24 cents.
Keryx generated revenues of $2.5 million in the quarter and missed the Zacks Consensus Estimate of $3 million. The company did not record any revenues in the year-ago quarter.
The Quarter in Detail
Net sales of Auryxia in the U.S. were about $1.8 million compared to $0.4 in the year ago quarter. In the reported quarter, Auryxia prescriptions were approximately 3,700 (as reported by IMS Health and other specialty pharmacies that do not report data to IMS).
Research and development expenses decreased 22.5% year over year to $8 million driven by lower expenses related to the decrease in regulatory and study expenses related to the drug.
Selling, general and administrative expenses were $20.8 million, up 69.2% from the year-ago quarter primarily due to an increase in commercial activities and associated personnel costs for the commercialization of Auryxia.
Pipeline Update
Fexeric (EU trade name for Auryxia) is under review by the European Medicines Agency (EMA) for the control of serum phosphorus levels, or hyperphosphatemia, in patients suffering from chronic kidney disease (CKD) (both non-dialysis and dialysis-dependent). The Committee for Medicinal Products for Human Use recommended Fexeric in Jul 2015. A decision from the EMA is expected in Sep or Oct 2015.
Meanwhile, the company completed patient enrolment in a phase III study on Auryxia for stages 3-5 non-dialysis dependent CKD and iron-deficiency anemia in patients, who showed no response to prior treatment or were intolerant to oral iron therapy. The study is expected to be complete by Jan 2016 with results expected in the second quarter of 2016. Based on these results, Keryx intends to file a supplemental new drug application with the FDA in the third quarter of 2016.
Our Take
We note that Keryx depends solely on Auryxia for growth. The company is in the early stages of Auryxia’s launch. The company’s efforts towards geographic expansion and label expansion of the drug are encouraging.
Keryx carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX, Alcobra Ltd. ADHD and Anacor Pharmaceuticals, Inc. ANAC. While Valeant carries a Zacks Rank #1 (Strong Buy), Alcobra and Anacor hold a Zack Rank #2 (Buy).
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