More Flu Aches for Chiron

The company says it won't meet its prior flu-vaccine production goals or earnings forecasts.
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Chiron

(CHIR) - Get Report

said Monday that, once again, it would produce less flu vaccine than it had previously predicted.

The biotech company also said financial results for 2005 will be below its previously stated earnings guidance of $1.20 to $1.45 a share, but it didn't provide details in an announcement that was issued after markets had closed.

Chiron said it expects to provide more information on vaccine production and financial guidance "in the weeks ahead." Wall Street's full-year EPS consensus is $1.22, according to Thomson First Call, but individual analyst estimates range from $1.04 to $1.42.

The Emeryville, Calif., company said it has begun shipping its Fluvirin vaccine and will continue to do so in October, November and December. The Food and Drug Administration

gave clearance last week for Chiron to begin selling a portion -- about 1.5 million doses -- of its Fluvirin vaccine.

The company said it wouldn't produce as much vaccine for the 2005-06 U.S. season as the 18 million to 26 million doses that it had estimated in June. That represented

a reduction from the 25 million to 30 million doses that Chiron had predicted earlier in the year.

And

that

figure was less than the 48 million to 50 million doses that the U.S. had been counting on for the 2004-05 flu season. Chiron sold no vaccine during the last flu season because of manufacturing and sterility problems at its Liverpool, England, plant. The facility's license was suspended by British health authorities before being reinstated in March.

On Monday, Chiron blamed the latest cut in its vaccine estimate on "production delays related to remediation as well as lower production output associated with adaptation to new processes and procedures implemented in remediation." The company had to meet many regulatory requirements by U.S. and British regulators.

Howard Pien, the chief executive, said Chiron was operating on a "truncated season" for making flu vaccine. "This year, Chiron devoted more than half of the normal production season to the implementation of our remediation plan," he said.

Pien said he hopes Chiron can return to "normal" production process next year with a Fluvirin output of some 40 million doses. He said the company has commitments from distributors for most of the projected 2006-07 doses.

The Liverpool plant, he said, will provide a foundation not only for future traditional flu vaccine manufacturing, but also for development of an avian flu vaccine and next-generation flu vaccines. "We have not been blinded by this crisis," Pien said.

In regular trading, Chiron's stock closed at $43.30, down 5 cents. After hours, the stock lost another 50 cents.

Other contributors to this year's U.S. flu vaccine supply include

Sanofi-Aventis

(SNY) - Get Report

, which is expected to supply 60 million doses, and

GlaxoSmithKline

(GSK) - Get Report

, which is set to provide 8 million doses.

MedImmune

(MEDI)

is scheduled to offer 3 million doses of its nasal spray vaccine.