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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
----------------------------------------------
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report December 1, 2005
(Date of earliest event reported)
DENTSPLY INTERNATIONAL INC
(Exact name of Company as specified in charter)
Delaware 0-16211 39-1434669
(State of Incorporation) (Commission (IRS Employer
File Number) Identification No.)
221 West Philadelphia Street, York, Pennsylvania 17405
(Address of principal executive offices) (Zip Code)
(717) 845-7511
(Company's telephone number including area code)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of
the following provisions:
_____ Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
_____ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
_____ Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
_____ Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item 7.01. - Regulation FD Disclosure.
The following information is furnished pursuant to Item 7.01.
On December 1, 2005 the Company announced that, as a result of its
continuing evaluation of the actions necessary to address the items raised in
the FDA's pre-approval inspection of its sterile filling plant outside Chicago
(which occurred in the third quarter of 2005), the Company has suspended
production of products at the plant for the U.K., Australia, and New Zealand
markets. Although previously the Company anticipated that it would continue to
manufacture products at the plant for these markets, for which regulatory
approval had already been obtained, upon further evaluation, the Company has
decided to suspend manufacturing at the plant while improvements identified in
its corrective action plan are made. It is anticipated that this suspension of
production will continue at least through the first quarter of 2006. The Company
is investigating whether other supply sources may be available to supply the
U.K., Australia, and New Zealand markets during this suspension.
Gary K. Kunkle, Jr., Chairman and Chief Executive Officer, stated, "While
we are disappointed that a suspension of production is necessary, we believe
that it is the appropriate action to take at this time. We are continuing to
evaluate the corrective actions required at the plant, and it is possible that
further impairment charges to the remaining assets associated with the business,
which total approximately $122 million, may be necessary. This suspension of
production is not expected to impact our 2005 full year guidance of $2.61 -
$2.65 per diluted share (excluding the 3rd quarter impairment charge). We also
remain comfortable with double digit earnings growth in 2006. These expectations
do not factor in any further possible impairment charges, the tax costs from
repatriation of foreign earnings, or the expensing of stock options beginning in
2006." The announcement that was released related to this matter is attached
hereto as Exhibit 99.1 and is hereby incorporated by reference.
Item 9.01. - Financial Statements and Exhibits
(a) Financial Statements - Not applicable.
(b) Exhibits:
99.1 The announcement related to the update of the phamaceutical businss
released on December 1, 2005 as referenced in Item 7.01.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Company has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
DENTSPLY INTERNATIONAL INC
(Company)
/s/ William R. Jellison
William R. Jellison
Senior Vice President and
Chief Financial Officer
Date: December 1, 2005
Dentsply International
World Headquarters
Susquehanna Commerce Center
221 West Philadelphia Street
York, PA 17405-0872
(717) 849-4273
Fax (717) 849-4760
NEWS
For Further
Information
Contact:
William R. Jellison FOR IMMEDIATE RELEASE
Senior Vice President and
Chief Financial Officer
(717) 849-4243
DENTSPLY International Inc.
Provides Update on Pharmaceutical Business
York, PA - December 1, 2005 - DENTSPLY International Inc. (NASDAQ:XRAY) today
announced that, as a result of its continuing evaluation of the actions
necessary to address the items raised in the FDA's pre-approval inspection of
its sterile filling plant outside Chicago (which occurred in the third quarter
of 2005), the Company has suspended production of products at the plant for the
U.K., Australia, and New Zealand markets. Although previously the Company
anticipated that it would continue to manufacture products at the plant for
these markets, for which regulatory approval had already been obtained, upon
further evaluation, the Company has decided to suspend manufacturing at the
plant while improvements identified in its corrective action plan are made. It
is anticipated that this suspension of production will continue at least through
the first quarter of 2006. The Company is investigating whether other supply
sources may be available to supply the U.K., Australia, and New Zealand markets
during this suspension.
Gary K. Kunkle, Jr., Chairman and Chief Executive Officer, stated, "While we are
disappointed that a suspension of production is necessary, we believe that it is
the appropriate action to take at this time. We are continuing to evaluate the
corrective actions required at the plant, and it is possible that further
impairment charges to the remaining assets associated with the business, which
total approximately $122 million, may be necessary. This suspension of
production is not expected to impact our 2005 full year guidance of $2.61 -
$2.65 per diluted share (excluding the 3rd quarter impairment charge). We also
remain comfortable with double digit earnings growth in 2006. These expectations
do not factor in any further possible impairment charges, the tax costs from
repatriation of foreign earnings, or the expensing of stock options beginning in
2006."
This press release contains forward-looking information (within the meaning of
the Private Securities Litigation Reform Act of 1995) regarding future events or
the future financial performance of the Company that involve substantial risks
and uncertainties. Actual events or results may differ materially from those in
the projections or other forward-looking information set forth herein as a
result of certain risk factors. These risk factors include without limitation;
the results of continued evaluation of the dental anesthetic business and
corrective actions at the Company's pharmaceutical plant, uncertainty associated
with the inspection and approval of the plant by the FDA and other regulatory
authorities, the timing of any such inspection and approval, as well as the
timing of production of products at the plant, the ability to obtain alternate
supply sources for anesthetic products and the costs of such products, and the
continued strength of dental markets.
DENTSPLY designs, develops, manufactures and markets a broad range of products
for the dental market. The Company believes that it is the world's leading
manufacturer and distributor of dental prosthetics, precious metal dental
alloys, dental ceramics, endodontic instruments and materials, prophylaxis
paste, dental sealants, ultrasonic scalers, and crown and bridge materials; the
leading United States manufacturer and distributor of dental handpieces, dental
x-ray film holders, film mounts and bone substitute/grafting materials; and a
leading worldwide manufacturer or distributor of dental injectable anesthetics,
impression materials, orthodontic appliances, dental cutting instruments and
dental implants. The Company distributes its dental products in over 120
countries under some of the most well established brand names in the industry.
DENTSPLY is committed to the development of innovative, high quality,
cost-effective new products for the dental market