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.
In Aug 2016, Keryx noted a temporary interruption in the supply of Auryxia due to a production-related issue in converting active pharmaceutical ingredient to finished drug product.
Meanwhile, Keryx’s top line comprises license revenues and revenues earned from Auryxia sales.
KERYX BIOPHARMA Price and EPS Surprise
Keryx’s track record has been disappointing so far. Over the four trailing quarters, the company has posted an average negative earnings surprise of 27.71%.
Currently, Keryx has a Zacks Rank #3 (Hold), 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 third-quarter 2016 loss was wider-than-expected. The company posted a loss of 39 cents per share wider than consensus estimate of a loss of 22 cents.
Revenues: Revenues, however, surpassed expectations. Keryx posted revenues of $6.3 million above the consensus estimate of $5.8 million.
Key Stats: Auryxia net U.S. product sales came in at $5.1 million, up 58.3% from the year-ago quarter.
Currently, Keryx is working with its existing manufacturer to resolve the issue and resume production. Meanwhile, the company has established adequate supply of Auryxia. In Oct 2016, Keryx entered into a long-term agreement with a second contract manufacturer for the manufacture of commercial supply of finished drug product. The company has also filed a post-approval supplement application with the FDA for the same. A response from the FDA is expected by Nov 13, 2016.
Check back later for our full write up on KERX earnings report later!
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