Chiron Revises Production Range for FLUVIRIN Vaccine and Updates Financial Guidance; Delays in Reaching Full-Scale Production Ex
15 Giugno 2005 - 3:00PM
Business Wire
Chiron Corporation (Nasdaq:CHIR) today announced revisions to its
production estimates for FLUVIRIN(R) influenza virus vaccine for
the 2005-2006 influenza season. Due to delays in start-up
procedures for ramping up to full production and normal
manufacturing issues inherent to the complexity of influenza
vaccine production, Chiron will produce fewer FLUVIRIN vaccine
doses than earlier anticipated. Accordingly, the company has also
updated its 2005 financial guidance. Chiron now estimates that it
will produce between 18 million and 26 million doses of FLUVIRIN
vaccine for the 2005-2006 influenza season. The company now expects
2005 income from continuing operations to be 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. As stated in its first-quarter
2005 earnings announcement on April 27, 2005, Chiron had expected
to produce between 25 million and 30 million doses of FLUVIRIN
vaccine for the 2005-2006 influenza season. The company had
expected 2005 income from continuing operations to be between $1.40
and $1.50 per share on an adjusted (pro forma) basis and between
$1.06 and $1.16 per share on a GAAP basis. The revised dose and EPS
estimates assume that demand is sufficient to allow Chiron to sell
FLUVIRIN vaccine through the end of November. 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. "Since March 2, when the UK regulatory authority
reinstated our manufacturing license, we have worked to
simultaneously continue our remediation of our Liverpool facility
and begin our 2005-2006 FLUVIRIN campaign," said Howard Pien, CEO
of Chiron. "As remediation has progressed, we have monitored
numerous factors that affect FLUVIRIN production. While it remains
possible that we will reach our previously announced range, the
delays and other manufacturing issues have had an adverse impact on
our ramp-up to full production, so we are updating our dose
expectations and guidance range. We are committed to our goal of
supplying influenza vaccine in time for the upcoming season, and we
are working diligently toward that objective. We have made
tremendous progress, and we are positive about our prospects for
reaching our goal." Chiron's revised estimated FLUVIRIN dose range
and financial guidance are based on current production estimates.
The number of doses Chiron will produce will depend upon the
success of its remediation efforts, upon encountering no further
adverse manufacturing or regulatory developments, and upon the
major factors that determine production -- volumes, yields and
timing. Chiron currently expects that the U.S. Food and Drug
Administration (FDA) will conduct a full cGMP (current good
manufacturing practices) inspection in July to determine whether
deficiencies noted in its warning letter issued in December 2004
have been resolved. If Chiron fails to adequately address the
matters discussed in the warning letter, the FDA may take further
action that could reduce Chiron's ability to market FLUVIRIN
vaccine. 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 earnings and sales
growth, supply of FLUVIRIN(R) influenza virus vaccine that Chiron
expects to deliver to the U.S. market in future influenza seasons,
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 FLUVIRIN vaccine
or Chiron's manufacturing generally will not arise in the future or
that Chiron 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
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:
FLUVIRIN is a trademark of Chiron Corporation.
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