Nanosphere (NSPH) Receives FDA Warning Letter, CFO Steps Down

Nanosphere (NASDAQ: NSPH) reported revenue for the quarter came in at $4.6 million versus the consensus estimate of $4.32 million.

Nanosphere also announced today that it has received a warning letter from the FDA resulting from inspections of the Company's facility in Northbrook, Illinois by the FDA's Chicago District Office that occurred in March 2014. The warning letter relates to deficiencies in the Company's quality system regulation. Nanosphere takes this matter seriously and is in the process of evaluating the corrective actions required to address the matters raised in the warning letter. Nanosphere also is in the process of preparing a response to the warning letter and intends to respond fully to the issues raised by the FDA within 15 business days as requested by the FDA, and to work diligently and expeditiously to resolve the issues raised by the FDA. The warning letter does not restrict the manufacture, production or shipment of any of Nanosphere's products, nor require the withdrawal of any product from the marketplace. However, failure to promptly address the issues raised in the warning letter to the FDA's satisfaction or to comply with U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA. These actions could include, among other things, product seizures, injunctions and civil money penalties.

Nanosphere also announced that on January 26, 2015, Roger Moody notified Nanosphere that he would be stepping down as Nanosphere's Chief Financial Officer effective on February 11, 2015. In connection with Mr. Moody's resignation, Nanosphere has appointed Ann Wallin, Nanosphere's Vice President of Finance and Accounting, as interim Chief Financial Officer and as Chief Accounting Officer effective after Mr. Moody's departure on February 11, 2015. Also effective January 26, 2015, Sheli Z. Rosenberg, Nanosphere's Chair of the Board of Directors, advised the Company that she has resigned from the Board of Directors. The Board intends to form an Executive Committee of the Board to discharge the function of Chairman of the Board on an interim basis and conduct search for a successor Chair.

For earnings history and earnings-related data on Nanosphere (NSPH) click here.

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