Impax Labs falls on weak sales, new FDA warning

Impax Labs falls on weak sales, new FDA warning

May 3rd, 2012 // 12:51 pm @

Shares of Impax Laboratories Inc. dropped Tuesday after the generic drugmaker reported disappointing first-quarter revenue and said regulators found ongoing deficiencies at one of its plants.

Impax said its profit shrank 11 percent in the first quarter, to $12.4 million, or 18 cents per share, from $13.9 million, or 21 cents per share. The company said it got $30 million in profit from marketing AstraZeneca PLC’s migraine drug Zomig. Including that income and excluding one-time items, Impax said it earned 52 cents per share.

Revenue rose 18 percent, to $128.6 million from $108.7 million.

Analysts expected the company to report a profit of 47 cents per share on revenue of $161.8 million, according to FactSet.

In June 2011, Impax said it received a warning letter about manufacturing at its facility in Hayward, Calif. The Food and Drug Administration has conducted a new inspection and issued a report, the company said Tuesday. The report, called a Form 483, is issued when an FDA inspection finds deficiencies at a pharmaceutical manufacturing plant. While the problems that were cited in the previous warning letter have been addressed, the company said the FDA found problems in its quality control laboratory. Impax said it was disappointed with the latest report, but was still making products and working to address the FDA’s findings.

Shares of Impax fell $2.01, or 8.2 percent, to close at $22.62. The stock slipped another 8.4 percent in after-hours trading, to $20.71.

Impax started receiving profit on U.S. sales of Zomig starting Jan. 1. It bought those rights from AstraZeneca for $130 million. The company also reported greater sales of its generic version of Adderall XR, a treatment for attention deficit hyperactivity disorder.

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