Stryker provides an update regarding Sage warning letter and revised financial guidance
August 23 2017 - 8:00AM
Kalamazoo, Michigan - August 23, 2017 - Stryker
Corporation (NYSE: SYK) announced today that the company has
informed the U.S. Food and Drug Administration (FDA) of a voluntary
product recall involving specific lots of Oral Care products sold
through the company's Sage Products business unit (Sage). The
recalled products contain Oral Care solutions manufactured for Sage
by a third-party supplier and were distributed between July 2015
and August 2017. The recall is being initiated due to a potential
for cross-contamination of Oral Care solutions manufactured by the
third party on equipment shared with non-pharmaceutical products,
as stated in a Warning Letter from FDA dated July 17, 2017. To
date, Stryker has not been made aware of any serious adverse events
associated with the Oral Care products recall. However, there have
been some reports of minor irritation and allergic reaction.
Stryker has discontinued business with the third-party supplier and
all Oral Care solutions are being manufactured in-house by Sage.
Stryker expects to resume shipping Oral Care products in September
and anticipates a return to full supply capacity by year end.
Additionally, the FDA Warning Letter sets forth
concerns regarding microbiological testing methods used for all
products containing solutions sold by Sage. These include Oral Care
solutions in the recalled products and solutions contained in
cloth-based products manufactured by Sage. FDA indicated that
products must now be tested using a verified compendial
microbiological method, a growth-based method that requires more
time to complete than the one previously used at Sage. Both methods
can detect the presence of microorganisms, while the compendial
method provides additional information about the type and number of
microorganisms. As a result, in August, Stryker placed cloth-based
products, which represents approximately 50% of Sage's revenue, on
a temporary ship hold until they are tested using this method.
Stryker anticipates it will resume shipping products manufactured
by Sage and tested under the compendial method in September, and
anticipates a return to full supply capacity by year end.
Based on the estimated impact to sales and
operating income, Stryker now expects full year organic sales
growth and adjusted net earnings per diluted share to be at the
lower end of its previously stated range of 6.5% to 7.0% and
$6.45-$6.55, respectively. For the third quarter, Stryker
anticipates that adjusted net earnings per diluted share will be at
the lower end of its previously stated range of $1.50-$1.55. Our
third quarter range does not assume any dilution related to the
pending acquisition of Novadaq; based on a September 30, 2017 close
date for Novadaq, the dilution is expected at approximately
$0.03-$0.05 in 2017.
Forward-looking
statements
This press release contains information that
includes or is based on forward-looking statements within the
meaning of the federal securities law that are subject to various
risks and uncertainties that could cause our actual results to
differ materially from those expressed or implied in such
statements. Such factors include, but are not limited to:
unanticipated issues in addressing in a timely manner the Sage
product-related issues discussed above; weakening of economic
conditions that could adversely affect the level of demand for our
products; pricing pressures generally, including cost-containment
measures that could adversely affect the price of or demand for our
products; changes in foreign exchange markets; legislative and
regulatory actions; unanticipated issues arising in connection with
clinical studies and otherwise that affect U.S. Food and Drug
Administration approval of new products; potential supply
disruptions; changes in reimbursement levels from third-party
payors; a significant increase in product liability claims; the
ultimate total cost with respect to the Rejuvenate and ABG II
matter; the impact of investigative and legal proceedings and
compliance risks; resolution of tax audits; the impact of the
federal legislation to reform the United States healthcare system;
changes in financial markets; changes in the competitive
environment; our ability to integrate acquisitions; and our ability
to realize anticipated cost savings. Additional information
concerning these and other factors is contained in our filings with
the U.S. Securities and Exchange Commission, including our Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q.
Stryker is one of the world's leading medical
technology companies and, together with our customers, we are
driven to make healthcare better. The Company offers a diverse
array of innovative products and services in Orthopaedics,
Medical and Surgical, and Neurotechnology and Spine that help
improve patient and hospital outcomes. Stryker is active in
over 100 countries around the world. Please contact us for
more information at www.stryker.com.
Contacts
For investor inquiries please
contact:
Katherine A. Owen, Stryker Corporation, 269-385-2600 or
katherine.owen@stryker.com
For media inquiries please
contact:
Yin Becker, Stryker Corporation, 269-385-2600 or
yin.becker@stryker.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Stryker Corporation via Globenewswire
Stryker (NYSE:SYK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Stryker (NYSE:SYK)
Historical Stock Chart
From Apr 2023 to Apr 2024