SHARE

News Alert: Citius Pharmaceuticals Receives FDA Approval For LYMPHIR™ (Denileukin Diftitox-Cxdl) Immunotherapy For The Treatment Of Adults With Relapsed Or Refractory Cutaneous T-Cell Lymphoma. Click to Read More.

Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX) has disclosed on Monday that it is currently experiencing a production interruption for Auryxia (ferric citrate) due to an issue relating to the conversion of active pharmaceutical ingredient (API) to finished product. In line with this, the company expects the availability of Auryxia to normalize by the fourth quarter.

Auryxia Production Interruption

The ongoing issue has led to the exhaustion of the company’s finished product reserves. Consequently, Keryx Biopharmaceuticals cannot guarantee uninterrupted access to Auryxia given the insufficient supply. However, the company assured that the safety profile of the available Auryxia tablets today is not affected.

Moreover, Keryx Biopharmaceuticals is closely working with its manufacturer to speed up the resolution of the problem and restore the sufficiency of Auryxia supply immediately. Scott Holmes, Keryx Biopharmaceuticals Chief Financial Officer (CFO), expressed in behalf of the company his confidence that the company has a strong balance sheet to efficiently get through the current production interruption for Auryxia.

Q2 Financial Highlights

For the second quarter, the pharmaceutical giant had a total revenue of $9.30 million, which is nearly four times as much as the revenue of $2.50 million reported during the same quarter last year. Auryxia net sales in the US accounted for $8.30 million of the reported figures during the said period.

Research and Development (R&D) expenses came in at $7 million, down by $1 million from the same period last year. Meanwhile, Selling, General, and Administrative (SG&A) expenses came in at $20.20 million, slightly down year-over-year from $20.80 million.

Keryx Biopharmaceuticals ended the quarter with cash and cash equivalents of roughly $156 million. Meanwhile, the quarterly net loss was seen at $44.70 million, which is significantly greater than the net loss of $26.90 million reported last year.

Ongoing Investigation

Glancy Prongay & Murray LLP and Goldberg Law PC have revealed on Monday that they are conducting an investigation about possible federal violations committed by Keryx Biopharmaceuticals and a number of its officers. Investors, particularly those who had incurred losses with the company, are highly encouraged to get in touch with the law firms for more information.