UPDATE:Mylan Stands By FDA Probe Statements; Reports Strong 2Q
31 7월 2009 - 2:07AM
Dow Jones News
Mylan Inc. (MYL) reported strong second-quarter results and
raised its 2009 earnings outlook Thursday.
It also continued to assert the U.S. Food and Drug
Administration's recent allegations of misconduct at Mylan's West
Virginia plant are unfounded, despite the agency's ongoing
investigation.
The potential quality-control issues came to light in a recent
Pittsburgh Post-Gazette report. The confusing statements from the
company and regulators have created volatility in the generic drug
maker's stock price.
In a terse statement at the beginning of the Pittsburgh
company's second-quarter conference call Thursday, Chief Executive
Robert Coury implied that unspecified parties were exacerbating the
situation.
"There are some outside the company who attempt to speak on
behalf of Mylan to the point that statements being made were
purposely being mischaracterized in an attempt to further incite
the overreaction that we witnessed earlier in the week and even to
go so far as to attempt to pit us against the regulatory agency,"
Coury said.
The company declined to answer questions on the issue, and
analysts on the call didn't raise the issue with the company.
"The FDA is in the process of reviewing the investigation
findings, and we have not concluded the investigation," an agency
spokeswoman said Thursday. She declined to provide a timeline for
inquiry's conclusion.
Mylan's stock fell 13% to $12.10 on Monday but then rose as high
as 10.5% on Tuesday after the company said the FDA "determined that
all accusations were unfounded". The FDA later disclosed that the
investigation is ongoing and "statements to the contrary are
untrue."
Mylan shares recently rose 18 cents, or 1.4%, to $13.10.
About 24% of Mylan's float is sold short, meaning those
shareholders expect the stock price to decline, which can add to
price volatility.
On Sunday, the Pittsburgh Post-Gazette reported that Mylan had
launched an internal probe into workers routinely overriding
computer-generated warnings about the drugs being produced at the
plant.
Coury blasted the reporting in that article as "highly
irresponsible" and "sensational" and containing allegations that
were "false, misleading and unfounded."
He also stressed the company's reputation of manufacturing
quality, a factor that many on Wall Street have stressed in recent
days. Analyst Corey Davis with Natixis Bleichroeder stressed that
Mylan has had only one product recall since 2005, compared to 19
from Teva Pharmaceutical Industries Ltd. (TEVA).
Several analysts hypothesized that the mix-up came from a
communication breakdown between the local inspector, who may have
made comments to company officials, and the official FDA assessment
of the investigation as a whole.
Coury added weight to that scenario, saying that the FDA's
inspection Monday ended with a "closeout meeting" and the agency
didn't issue a Form 483, which covers any findings in an
inspection.
The FDA spokeswoman wouldn't confirm that information and said
that any comments about the ongoing investigation would be
premature.
Davis, of Natixis, also noted that Mylan has a "history of
botched communications" that have led to a "management discount" in
the stock price.
"The timing of this latest debacle is disappointing to us since
Mylan was finally starting to overcome the discount after several
straight quarters of highly respectable earnings reports," the
analyst wrote.
For the three months ended June 30, Mylan earned $58.1 million,
or 19 cents a share, compared to a year-ago loss of $16.3 million,
or 5 cents a share, which included merger costs.
Excluding items, the company earned 32 cents a share, beating
the average analyst estimate of 29 cents a share, according to
Thomson Reuters.
Revenue rose 5.3% to $1.26 billion, surpassing expectations of
$1.22 billion.
Mylan forecast a "much stronger second half" and raised its 2009
adjusted earnings guidance range to $1.13 to $1.20 a share. It
raised that view in April to 90 cents to $1.10 a share, while
analysts currently project $1.08 a share.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com