Keryx Biopharmaceuticals Inc. (KERX - Free Report) is a Boston-based biopharmaceutical company working in the field of renal diseases.
The company’s only marketed product, Auryxia (ferric citrate) was approved in the U.S. in Sep 2014 for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. In Sep 2015, Keryx gained EU approval for Fexeric (EU trade name for Auryxia) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in adult patients with CKD, including dialysis and non-dialysis dependent CKD. Keryx’s top line comprises license revenues and revenues earned from Auryxia sales.
In August 2016, Keryx announced an interruption in the supply of Auryxia, as its contract manufacturer had issues related to the conversion of the API into the finished product, leading to a disruption in the supply of Auryxia. However, in Nov 2016, Keryx announced that the FDA has approved a second drug product manufacturer, Patheon Manufacturing Services, for supplying Auryxia as a finished product. Following the approval, the company has rebuilt supply and made Auryxia available to wholesalers. In Mar 2017, 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. Keryx’s earnings track record has been disappointing so far. Over the four trailing quarters, the company has posted an average negative earnings surprise of 39.32%.
Currently, Keryx has a Zacks Rank #2 (Buy), 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’s second-quarter 2017 loss was wider-than-expected. The company posted a loss of 22 cents per share wider than consensus estimate of a loss of 17 cents.
Revenues: Revenues, however, surpassed expectations. Keryx posted revenues of $15.1 million above the consensus estimate of $14 million.
Key Stats: Auryxia net U.S. product sales came in at $14.1 million, up 71% from the year-ago quarter.
2017 Guidance: Keryx increased its guidance for 2017 and expects net U.S. Auryxia product sales to be in the range of $62 to $66 million up from the previous guidance of $56 to $60 million, as provided on May 4, 2017.
Share Price Impact: In-active in pre-market trading.
Check back later for our full write up on KERX earnings report later!
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