UPDATE 3-Mylan profit tops views, raises forecast
* Q2 EPS ex-items of 32 cents vs 30-cent Street view
* Sees FY adjusted EPS of $1.13-$1.20
* Shares rise 1.7 pct (Updates with comment from FDA, updates share price)
By Toni Clarke and Ransdell Pierson
BOSTON, July 30 (Reuters) - Mylan Inc (MYL.O) posted better-than-expected second-quarter earnings on Thursday, helped by robust sales of new products, including a generic version of the anti-seizure drug Depakote.
The company, whose shares rose 1.7 percent in afternoon trading, is at the center of a storm of controversy related to possible quality control violations at its Morgantown, West Virginia, facility.
Mylan, the world's third-biggest generic drugmaker, repeated that an investigation by the U.S. Food and Drug Administration into quality control allegations had been closed with no remaining issues outstanding.
The company reported net earnings of $58.1 million, or 19 cents per share compared with a net loss of $16.3 million, or 5 cents a share, a year earlier,
Earnings excluding one-time items of 32 cents a share came in 2 cents ahead of the average estimate of analysts polled by Reuters Estimates.
Revenue rose 5.3 percent to $1.27 billion, driven by its generic and specialty pharmaceuticals.
Sales were bolstered by Divalproex Sodium, which Abbott Laboratories (ABT.N) sells under the brand Depakote for epilepsy and mania associated with bipolar disorder and for preventing migraines.
"Mylan's top line was stronger than expected," Christopher Schott, an analyst at J.P. Morgan, said in a research note. "Every segment except for North America generics posted sales above our estimates."
The company expects new product launches in the United States, Europe and Asia to give investors confidence it will meet 2010 goals. It expects to launch 45 drugs in the United States in 2010, including about a dozen with "limited competition.
Even so, the quality control controversy is not likely to go away overnight.
On Monday, the FDA said it had begun an investigation into the facility following an article in the Pittsburgh Post- Gazette saying workers overrode quality controls intended to ensure the safety and efficacy of the company's drugs.
A day later, Mylan issued a press release saying FDA inspectors visited the site and determined the accusations were "unfounded."
The FDA snapped back, saying its probe was ongoing and that it had formed no conclusions. It said any statements to the contrary were "untrue."
Nonetheless, Mylan's chief executive, Robert Coury, said during a conference call with investors that, while it "absolutely respects the agency's independent processes," it stands by its earlier statement.
"The agency was on-site, reviewed the information and concluded the inspection by conducting a close-out meeting on Tuesday," he said.
The FDA held its ground on Thursday. Christopher Kelly, an agency spokesman, said in an email that, "FDA officials are still in the process of reviewing the results from the investigation and the agency intends to make public those results when there is a conclusion to announce."
Coury declined to answer any further questions related to the matter, saying the company had always enjoyed a "quality and respectful relationship with the FDA."
Mylan's shares rose 1.7 percent to $13.13 in afternoon trading on Nasdaq after rising as high as $13.55 earlier in the day. (Additional reporting by Lewis Krauskopf; editing by Derek Caney and Andre Grenon)
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