UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
January 11, 1999 000-27078
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Date of Report (Date of earliest (Commission File Number)
event reported)
HENRY SCHEIN, INC.
(Exact name of registrant as specified in its charter)
Delaware 11-3136595
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(State or other jurisdiction of (I.R.S. Employer Identification Number)
incorporation or organization)
135 Duryea Road, Melville, NY 11747
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(Address of Principal Executive Offices) (Zip Code)
(516) 843-5500
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(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS.
On January 12, 1999, Henry Schein, Inc. issued the press release filed as
an Exhibit to this Current Report on Form 8-K with respect to the receipt by its
unconsolidated affiliate, Novocol Pharmaceutical of Canada, Limited, of a
warning letter from the United States Food and Drug Administration regarding
Novocol's compliance with current good manufacturing practices with respect to
its dental anesthetic products. The press release describes, among other things,
the voluntary action being taken by Novocol in connection with the warning
letter.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(a) Not applicable.
(b) Not applicable.
(c) Exhibits:
99. Press Release, dated January 11, 1999.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, Henry
Schein, Inc. has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
HENRY SCHEIN, INC.
By: /s/ Michael Ettinger
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Name: Michael Ettinger
Title: Vice President and Associate
General Counsel
Date: January 11, 1999
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EXHIBIT INDEX
DOC. NO. DOCUMENT DESCRIPTION
99 Press Release, dated January 11, 1999.
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Exhibit 99
[Henry Schein Letterhead]
FOR: Henry Schein, Inc.
CONTACT: Steven Paladino
Senior Vice President and
Chief Financial Officer
(516) 843-5500
Susan Vassallo
Manager, Investor
and Public Relations
(516) 843-5562
[email protected]
FOR IMMEDIATE RELEASE
Investor Relations:
Robert P. Jones/Jill Ruja
Press: Stacy Berns
Morgen-Walke Associates
(212) 850-5600
HENRY SCHEIN, INC. AFFILIATE RESPONDS TO U.S. FDA
Melville, NY -- January 11, 1999 -- Henry Schein, Inc. (Nasdaq:HSIC)
announced today that Novocol Pharmaceutical of Canada, Ltd., (Novocol), an
affiliated company in which it owns a non-controlling interest, has received a
Warning Letter from the United States Food and Drug Administration (FDA)
regarding Novocol's compliance with current Good Manufacturing Practices
(cGMP's) of its dental anesthetic products. Henry Schein's equity in earnings of
this unconsolidated affiliate is estimated at $1.6 million for 1998. In
addition, these products represented $15 million of Henry Schein's estimated
1998 sales.
In cooperation with the FDA, Novocol is conducting a voluntary recall of
certain product batches and has temporarily suspended shipping these products to
the United States. Additionally, at the request of the FDA, Novocol is reviewing
all protocols and policies regarding the manufacturing of the anesthetic
products and is working closely with the FDA to resolve these issues as quickly
as possible. However, Novocol is unable at this time to estimate how long it
will take to resolve these issues with the FDA.
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Henry Schein, Inc. is the largest distributor of healthcare products and
services to officebased healthcare practitioners, including dental practices and
laboratories, physician practices and veterinary clinics. The Company,
recognized for its excellent customer service and low prices, serves more than
250,000 customers worldwide. Henry Schein's world headquarters are in Melville,
N.Y. For more information, visit the Henry Schein website at
http://www.henryschein.com.
Certain information contained herein includes information that is forward
looking. The matters referred to in forward looking statements may be affected
by the risks and uncertainties involved in the Company's business. These forward
looking statements are qualified in their entirety by the cautionary statements
contained in the Company's Securities and Exchange Commission filings.
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