Chiron Reduces Supply Expectations for BEGRIVAC(TM) Influenza Virus Vaccine to Non-U.S. Markets
15 Luglio 2005 - 2:00PM
Business Wire
Chiron Corporation (Nasdaq:CHIR) -- Company is working to cover
BEGRIVAC vaccine shortfall with other non-U.S. influenza virus
vaccines -- No change to financial guidance Chiron Corporation
(Nasdaq:CHIR) today announced that it has reduced its supply
expectations for its BEGRIVAC(TM) influenza virus vaccine for the
2005-2006 influenza season by approximately 8 million doses and may
delay shipments until early October. Chiron had expected to supply
approximately 12 million doses of BEGRIVAC vaccine to customers
outside of the United States. Chiron now expects to supply
approximately 4 million doses of BEGRIVAC vaccine in these markets.
BEGRIVAC vaccine is manufactured at Chiron's facility in Marburg,
Germany. In conducting its regular internal quality assurance
tests, Chiron identified a small number of lots of the BEGRIVAC
vaccine that did not meet product sterility specifications. Chiron
has taken presumptive corrective action, and is working closely
with the German regulatory agency, the Paul Ehrlich Institute
(PEI), to complete additional testing in order to determine the
full extent of the issue. Chiron will not release any BEGRIVAC
vaccine until those tests are complete. It is possible that the
timing or results of such additional tests, or any additional
manufacturing or regulatory developments, may result in Chiron
being unable to supply any BEGRIVAC vaccine doses to non-U.S.
markets this season. Chiron manufactures influenza vaccine in two
facilities for Europe and other non-U.S. markets. Chiron's facility
in Marburg produces BEGRIVAC vaccine predominantly for the German
and UK markets, and Chiron's facility in Siena/Rosia, Italy,
produces AGRIPPAL(R) S1 influenza virus vaccine and FLUAD(R)
influenza virus vaccine. Chiron is working to mitigate the impact
of the reduced supply of BEGRIVAC vaccine by reallocating non-U.S.
vaccine doses among affected markets, and by allocating the
shipment of the company's non-U.S. influenza virus vaccines from
extra production in Siena. Chiron does not expect to record any
sales of BEGRIVAC vaccine in the third quarter of 2005. However,
Chiron still expects to be within the range of its updated 2005
financial guidance of income from continuing operations of between
$1.20 and $1.45 per share on an adjusted (pro forma) basis and
between $0.86 and $1.11 per share on a GAAP basis. Chiron
management uses adjusted financial statements to gain an
understanding of the company's operating performance on a
comparative basis. Adjusted guidance excludes amortization expense
on acquired intangible assets related to the acquisitions of
PathoGenesis, Chiron Behring, Pulmopharm and PowderJect
Pharmaceuticals, totaling approximately $0.34 per share. About
Chiron Chiron delivers innovative and valuable products to protect
human health by advancing pioneering science across the landscape
of biotechnology. The company works to deliver on the limitless
promise of science and make a positive difference in people's
lives. For more information, please visit www.chiron.com. This news
release contains forward-looking statements, including statements
regarding supply of BEGRIVAC(TM) influenza virus vaccine and other
influenza virus vaccines that Chiron expects to deliver to non-U.S.
markets, and assumptions regarding supply of FLUVIRIN(R) influenza
virus vaccine that Chiron expects to deliver to the U.S. market, in
future influenza seasons, sales and earnings expectations and
improvements to manufacturing facilities, that involve risks and
uncertainties and are subject to change. A discussion of the
company's operations and financial condition, including factors
that may affect its business and future prospects that could cause
actual results and developments to differ materially from those
expressed or implied by forward-looking statements, is contained in
documents the company has filed with the SEC, including the Form
10-K for the year ended December 31, 2004, and the Form 10-Q for
the quarter ended March 31, 2005, and will be contained in all
subsequent periodic filings made with the SEC. These documents
identify important factors that could cause the company's actual
performance to differ from current expectations, including, among
others, additional adverse developments resulting from the
suspension of Chiron's UK license to manufacture FLUVIRIN vaccine
from October 5, 2004, through March 2, 2005, the announcement of
such suspension and the litigation and investigations relating to
those matters, the outcome of clinical trials, regulatory review
and approvals, manufacturing capabilities, intellectual property
protections and defenses, litigation, stock-price and interest-rate
volatility, marketing effectiveness, and the severity of the
2005-2006 influenza season. In particular, there can be no
assurance that additional issues with respect to the BEGRIVAC or
FLUVIRIN vaccines or Chiron's manufacturing generally will not
arise in the future or that Chiron will be able to sell BEGRIVAC
for the 2005-2006 influenza season, will be able to cover vaccine
shortfalls, or will successfully address matters raised in a
warning letter from the FDA with respect to its FLUVIRIN vaccine
manufacturing facility or resume sale of FLUVIRIN vaccine for the
2005-2006 influenza season. In addition, the company may face
additional competition in the influenza market in the future and
challenges in distribution arrangements as a result of the recent
BEGRIVAC and FLUVIRIN vaccine developments. In addition, the
company may engage in business opportunities, the successful
completion of which is subject to certain risks, including approval
by Novartis AG, shareholder and regulatory approvals, and the
integration of operations. Chiron does not undertake an obligation
to update the forward-looking information the company is giving
today. NOTE: AGRIPPAL, BEGRIVAC, FLUAD and FLUVIRIN are trademarks
of Chiron Corporation.
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