Keryx (KERX) Q1 Loss Wider Than Expected, Revenues Beat

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) reported first-quarter 2017 loss of 21 cents per share, narrower than the year-ago loss of 39 cents. However, the loss was wider than the Zacks Consensus Estimate of a loss of 18 cents per share.

Revenues came in at $11.82 million in the quarter, exceeding the Zacks Consensus Estimate of $10.14 million. Further, revenues improved almost 109% from the prior-year figure of $5.8 million.

Keryx’s share price rose 6.5% following its first-quarter earnings release. In fact, so far this year, the company’s price has increased 5.3%, while the Zacks classified Medical - Biomedical and Genetics industry has witnessed a gain of 4.7% in the same time frame.

Quarter in Details

Net sales of Auryxia in the U.S. were $10.5 million, up 87.5%, following strong prescription growth. A total of 15,800 prescriptions were written in this quarter, up 72% year over year. Also, Auryxia was added to Medicare Part D drug list of two of the largest Medicare Part D insurance providers, which will give the drug unrestricted access to approximately 95% of phosphate binder patients.

Keryx is working on expanding Auryxia's label to include the treatment of iron-deficiency anemia (IDA) in adults with stage III–V NDD CKD. In Mar 2017, the FDA accepted the company’s supplemental New Drug Application (sNDA) for Auryxia for review and gave a Prescription Drug User Fee Act (PDUFA) target action date of Nov 6, 2017.

License revenues came in at $1.3 million, up 8.33% year over year. Keryx earns license revenues from royalties on net sales of Riona (Japan trade name for Auryxia) from its Japanese partners,

Research and development expenses declined 10.5% year over year to $6.8 million, primarily due to a decrease in development work at the company’s contract manufacturers following the approval of a second drug product contract manufacturer. Further, it was affected by a decline in clinical costs following the completion of phase III clinical trial of Auryxia in early 2016.

Selling, general and administrative expenses were $23.1 million, up 11% due to expansion of sales force to support commercialization of Auryxia and costs related to potential launch of Auryxia in IDA.

2017 Outlook

Auryxia sales are expected in the range of $56 to $60 million for the full year. The outlook does not include any sales of Auryxia if it gets approved for the IDA indication

Our Take

Auryxia faces stiff competition in the U.S. from existing players. Apart from over-the-counter drugs like some calcium carbonate and metal-based products including aluminum and magnesium, Sanofi’s (NYSE:SNY) specialty medicines arm, Genzyme’s Renagel and Renvela, Shire plc’s (NASDAQ:SHPG) Fosrenol, and Fresenius Medical Care’s (NYSE:FMS) PhosLo and Velphoro are already available in the market. Since Auryxia is in early stages of commercialization, the company may face a tough time gaining share.

The company intends to focus on the growth of Auryxia in the U.S. dialysis market. The company’s label expansion efforts on Auryxia in the iron-deficiency anemia (IDA) indication are encouraging, given that the IDA market holds great potential.

Zacks Rank

Keryx currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

More Stock News: 8 Companies Verge on Apple-Like Run

Did you miss Apple (NASDAQ:AAPL)'s 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.

A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>