Guidant Announces Preliminary, Unaudited 2005 Fourth Quarter Sales; Guidant Receives Anticipated FDA Follow-up Letter; No New Ob
January 10 2006 - 7:37AM
Business Wire
Guidant Corporation (NYSE:GDT) today announced that management
believes preliminary, unaudited fourth quarter sales will be
approximately $828 million, reflecting a decline of approximately
15 percent versus the fourth quarter of 2004. Preliminary,
unaudited U.S. and worldwide implantable defibrillator sales for
the quarter are expected to be approximately $272 million and $372
million, representing declines of 23 percent and 19 percent
compared to the fourth quarter of 2004. Fourth quarter sales are
expected to be above the Company's previously announced guidance of
$790 million to $820 million due primarily to higher U.S.
implantable defibrillator sales. The company also announced that it
has received a follow-up letter from the U.S. Food and Drug
Administration (FDA) related to the previously reported warning
letter received from the FDA in late December 2005. The warning
letter and follow-up letter both relate to the FDA's inspection of
Guidant's Cardiac Rhythm Management facility in St. Paul,
Minnesota. The follow-up letter makes no new observations on the
company's Quality System. Guidant management believes that the
questions contained in both the warning letter and follow-up letter
can be fully addressed and will be providing a written response to
the FDA within 15 working days from January 5, 2006, as requested
by FDA. Management anticipates that all company actions will be
completed on or before their target dates and that the company will
be ready for the FDA's follow-up inspection in mid 2006. Further,
all of the company's products remain available for sale in all
geographies in which they were previously approved. Guidant does
not expect that any questions raised in either the warning letter
or the follow-up letter will have a material impact on the
business. A copy of the FDA's letters, the Form 483 and Guidant's
response to the Form 483 is available at
http://www.guidant.com/physician/Form483/. Guidant Corporation
pioneers lifesaving technology, giving an opportunity for better
life today to millions of cardiac and vascular patients worldwide.
The Company develops, manufactures and markets a broad array of
products and services that enable less invasive care for some of
life's most threatening medical conditions. For more information,
visit www.guidant.com. NOTE TO MEDIA: For more information about
Guidant, including products, services and patient profiles, please
visit the company's newsroom at www.guidant.com/newsroom. This
release includes forward-looking statements concerning anticipated
financial results. The statements are based on assumptions about
many important factors, including trends affecting ICD and coronary
stent sales; other clinical, regulatory, competitive, and market
developments; reporting of final, audited results; progress with
respect to the company's acquisition; and other factors identified
on Exhibit 99.1 to the company's most recent 10-Q. Actual results
may differ materially. The company does not undertake to update its
forward-looking statements.
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