Keryx Biopharmaceuticals FDA Win Outweighed by Q3 Loss

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Keryx Biopharmaceuticals Inc. (NASDAQ: KERX) shares took a big step back on Tuesday after the company announced its third-quarter results and an update from the U.S. Food and Drug Administration (FDA). Although the FDA approval was great news, this was not enough to offset disappointing earnings.

The FDA approved Keryx’s drug Auryxia for an additional indication. The approval is for the treatment of iron deficiency anemia in adults with chronic kidney disease who are not on dialysis. Auryxia was originally approved in September 2014 for the control of serum phosphorus levels in people with chronic kidney disease who require dialysis. With the new indication, millions of people living with chronic kidney disease have the potential to benefit from treatment with Auryxia.

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Unfortnately, Keryx’s earnings offset its FDA win. The company posted a net loss of $0.20 per share on $15 million in revenue, which compares to consensus estimates of a net loss of $0.17 per share and $18.8 million in revenue.

Greg Madison, president and CEO of Keryx, commented on the results:

Auryxia prescriptions grew 18 percent in the third quarter compared to the second quarter of 2017, reflecting continued adoption of Auryxia; however, this growth was offset by a change in our payer mix. Our confidence in Auryxia remains strong with brand awareness and clinical experience expanding. With the approval of Auryxia for the treatment of iron deficiency anemia in patients with chronic kidney disease, not on dialysis, we are thrilled to have the opportunity to now make Auryxia available to millions of people in the United States living with this condition. With a medicine that can treat two complications of chronic kidney disease, we believe we have a strong foundation from which to build a leading kidney care company.

Shares of Keryx were last seen down 15% at $5.27, with a consensus analyst price target of $8.00 and a 52-week range of $4.47 to $8.38.