Impax Labs Q1 Results Miss Estimates

(RTTNews) - Impax Laboratories, Inc. (IPXL) reported a net loss for the first quarter of $6.3 million or $0.09 per share, compared to a net loss of $6.4 million or $0.09 per share for the year-ago quarter.

Excluding items, adjusted earnings per share for the first quarter was $0.09, compared to $0.24 in the prior year quarter.

first quarter revenues rose 20.5% to $143.1 million from $118.7 million a year ago.

Analysts polled by Thomson Reuters expected the company to earn $0.18 per share on revenue of $146.13 million for the first quarter. Analysts' estimates typically exclude special items.

Separately, Impax Laboratories said that the U.S. Food and Drug Administration performed a three week inspection of the company's Hayward, California manufacturing facility.

The inspection included a general GMP as well as Pre-Approval Inspections for multiple generic products currently pending approval at the FDA.

At the conclusion of the inspection on May 8, the FDA issued a Form 483 with three inspectional observations, none of which were designated as repeat observations, the company said.

"While our goal is to have no observations from any inspection at any of our facilities, the agency found additional items for us to focus on which we will promptly respond to within 15 days of the receipt of the Form 483," said Fred Wilkinson, president and chief executive officer of Impax Laboratories. "The fact that the FDA returned to Hayward to perform a GMP and PAI inspections on multiple products was one of the options we had prepared for."