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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 (Date of earliest event reported): July 13, 1999
THE COOPER COMPANIES, INC.
(Exact name of registrant as specified in its charter)
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<S> <C> <C>
Delaware 1-8597 94-2657368
(State or other jurisdiction (Commission File Number) (IRS Employer Identification No.)
of incorporation)
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6140 Stoneridge Mall Road, Suite 590, Pleasanton, California 94588
(Address of principal executive offices)
(925) 460-3600
(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS.
On July 13, 1999, The Cooper Companies, Inc. issued a press release announcing
that its CooperSurgical unit (CSI) has entered into two separate agreements to
co-market its FemExam pH and Amines Test Card in the United States. This release
is filed as an exhibit hereto and is incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
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Exhibit
No. Description
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99.1 Press Release dated July 13, 1999 of The Cooper Companies, Inc.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
THE COOPER COMPANIES, INC.
By /s/ Stephen C. Whiteford
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Stephen C. Whiteford
Vice President and
Corporate Controller
(Principal Accounting Officer)
Dated: July 14, 1999
STATEMENT OF DIFFERENCES
The trademark symbol shall be expressed as........................'TM'
The registered trademark symbol shall be expressed as.............'r'
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[COOPER COMPANIES LETTERHEAD]
NEWS RELEASE
CONTACT:
Norris Battin
[email protected]
FOR IMMEDIATE RELEASE
COOPER COMPANIES' UNIT SIGNS MARKETING AGREEMENTS FOR FEMEXAM
TESTCARD DIAGNOSTIC PRODUCT
3M PHARMACEUTICALS AND MATRIA HEALTHCARE TO PARTNER WITH COOPERSURGICAL TO
CO-MARKET VAGINITIS TEST REIMBURSEMENT CODE TO BE ISSUED IN DECEMBER
IRVINE, Calif., July 13, 1999 -- The Cooper Companies, Inc. (NYSE/PCX: COO)
today announced that its CooperSurgical unit (CSI) has entered into two separate
agreements to co-market its FemExam pH and Amines Test Card in the United
States. The first is with 3M Pharmaceuticals, a division of 3M (NYSE: MMM), and
the second is with Matria Healthcare Inc. (NASDAQ: MATR). Cooper also said that
the American Medical Association recently assigned a third party reimbursement
code for amines testing. This new code will allow physicians to obtain full
reimbursement for the TestCard beginning in January 2000. CSI markets diagnostic
products and surgical instruments and accessories for the women's healthcare
market.
The FemExam TestCard is a rapid, economic, point of care diagnostic used in the
differential diagnosis of vaginitis. It combines two tests on a small disposable
card that indicate the presence or absence of bacterial vaginosis (BV).
Gynecologists and obstetricians now consider BV to be the most common vaginal
infection. It affects as many as 25% of women in the United States, accounts for
13 million physician office visits annually in the U.S. and represents half of
all vaginal infections.
The FemExam tests are performed by collecting vaginal fluid with a cotton swab
and wiping it across the colorimetric reagent sections of the card. The TestCard
provides results almost immediately. It is a "yes" or "no" device that, in
conjunction with clinical signs and symptoms, can distinguish bacterial from
yeast infections. The test results indicate whether antibacterial or anti-fungal
pharmacological therapy should be prescribed.
3M Pharmaceuticals markets MetroGel-Vaginal'r', (metroniadazole vaginal gel)
0.75% vaginal gel which is indicated for the treatment of BV. Under the 3M
agreement, the two hundred 3M Pharmaceutical sales
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representatives who call on obstetricians, gynecologists and general and family
practitioners, will educate physicians about the benefits of using the Fem Exam
TestCard to help detect BV. These representatives will also distribute samples
and literature, provide information about the TestCard at 250 clinical seminars
focused on BV each year and refer potential customers to CooperSurgical. The 3M
marketing program will begin regionally in July and nationally in October.
Under the Matria Healthcare agreement, Matria's 78 sales representatives will
inform obstetricians and gynecologists who focus on high risk obstetrics about
the benefits of the TestCard in screening and monitoring obstetrical patients.
Matria Healthcare is a leading provider of comprehensive disease management
services to health plans and employers for women's health and the chronic
conditions of diabetes, cardiovascular disease and respiratory disorders.
BV can lead to serious complications during pregnancy. It has been associated
with pre-term rupture of membranes, low birth weight babies and endometritis. BV
has also been linked with pelvic inflammatory disease (PID), one of the leading
causes of infertility. Recent studies indicate that 10 to 30 percent of pregnant
women have BV. As about 50 percent of BV cases are asymptomatic, screening is
becoming more common in pregnant patients.
Health experts estimate 7% of all pregnancies in the U.S. are at risk for a
preterm delivery, representing a cost of as much as $4.7 billion per year to
employers and workers. The lifetime cost of caring for a low birthweight baby
can reach as much as $500,000. CSI estimates that in the U.S., about 4 million
obstetrical patients each year could be TestCard candidates. A 1998 Committee
Opinion standard of care from the American College of Obstetricians and
Gynecologists recommended screening for BV in women at high risk for preterm
labor.
Matria will also help CSI obtain third party insurance coverage for the TestCard
through 18 managed care specialists who work with over 1000 health insurance
industry customers. Matria's economic outcomes research experts will conduct
clinical studies to support the TestCard reimbursement program. The marketing
program with Matria will begin immediately.
CSI also announced that third party reimbursement for both tests on the TestCard
will soon be possible as the American Medical Association has assigned a Common
Procedural Terminology (CPT) code covering amines testing. A CPT code for pH
testing already exists. Reimbursement under the amines code will begin in
January 2000 after the Health Care Financing Administration establishes a fee.
Commenting on the new marketing initiatives, A. Thomas Bender, chief executive
officer of the Cooper Companies said, "These new partnerships coupled with a
more clearly defined reimbursement profile will give FemExam product line added
strength in the marketplace. The 3M arrangement significantly broadens our
ability to target the physicians who write over 85% of the prescriptions for
antibacterials used to treat BV. The Matria agreement allows us to participate
in the market where BV can have the most serious consequences,
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high-risk pregnancy, and to reach directly those third party insurers who have
the most to benefit financially from diagnosing it quickly."
Bender added that the new reimbursement code would go a long way toward
overcoming the medical economic barriers that have slowed FemExam's acceptance.
"It puts additional financial incentives in place to use the card, allows
practitioners to bill electronically to obtain reimbursement and supports the
clinical value of using both tests to diagnose vaginitis," he said.
With its partners, CSI plans to spend about a million dollars and substantial
sales time over the next two years to establish the FemExam card as the
preferred point of care test for vaginitis wherever it presents. In addition,
CSI expects to complete clinical studies of the economic benefit of the TestCard
in private practice and in a large prepaid health plan during 2000.
The FemExam TestCard is the first in a series of diagnostic products for the
women's healthcare market developed under CSI's licensing agreement with Litmus
Concepts, Inc. Litmus is an emerging in vitro diagnostics company that develops
and manufactures unique, proprietary products for the on-site diagnosis and
management of infectious diseases to improve female healthcare. CSI has the
exclusive North American medical marketing rights for these technologies in the
women's healthcare market and expects to launch additional tests currently under
development by Litmus through partnerships with companies who can target
appropriate customer segments.
More information about vaginitis can be found at the 3M National Vaginitis
Association website, www.vaginalinfections.org. For full prescribing information
for Metrogel-Vaginal see www.3M.com/mgv. The Litmus Concepts' website,
www.litmusconcepts.com, offers clinical background on the FemExam TestCard and
links to many other sites that discuss women's healthcare. Information on Matria
Healthcare's Women's Health Division and on prematurity and maternity expenses
can be found at www.matria.com or through NetNursesm, Matria's web-based
healthcare information line at www.netnurse.com.
FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995 including statements about
Cooper's capital resources, anticipated revenue growth, operating results and
market conditions. Since the outcome of forward-looking forecasts is uncertain,
risky and, indeed, may not occur, investors should not rely on them to predict
the future.
To identify forward-looking statements, look for words like "believes,"
"expects," "may," "will," "should," "seeks," "approximately," "intends,"
"plans," "estimates" or "anticipates" or their negatives, and similar words or
phrases. Discussions of strategy, plans or intentions often contain
forward-looking statements. These necessarily depend on assumptions, data or
methods that may be incorrect or imprecise.
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The following events, among others, could cause actual results and future
actions to differ materially from those described by or contemplated in the
forward-looking statements: major changes in business conditions and the
economy, loss of key senior management, major disruptions in the operations of
Cooper's manufacturing facilities, new competitors or technologies, significant
disruptions caused by third parties failing to address the year 2000 issue or by
unforeseen delays in completing our year 2000 compliance program.
Also, acquisition integration costs, foreign currency exchange exposure
including the potential impact of the Euro, investments in research and
development and other start-up projects, dilution to earnings per share from
acquisitions or issuing stock, regulatory issues, significant environmental
clean-up costs above those already accrued, litigation costs, costs of business
divestitures, and forward-looking statements in Cooper's Securities and Exchange
Commission filings, including the "Business" section in our Annual Report on
Form 10-K for the year ended October 31, 1998.
Cooper cautions investors not to rely unduly on forward-looking statements. They
reflect our analysis only on their stated date or the date of this press
release.
The Cooper Companies, Inc. and its subsidiaries develop, manufacture and market
specialty healthcare products. CooperSurgical, Inc., headquartered in Shelton,
Conn., markets diagnostic products, surgical instruments and accessories for the
gynecological market. CooperVision, Inc., headquartered in Irvine, Calif., with
manufacturing facilities in Huntington Beach, Calif., Rochester, N.Y., Toronto,
Canada and Hamble, England, markets a broad range of contact lenses for the
vision care market. Corporate offices are located in Irvine and Pleasanton,
Calif. A toll free interactive telephone system at 1-800-334-1986 provides stock
quotes, recent press releases and financial data. Cooper's Internet address is
www.coopercos.com.
FemExam'r' TestCard System'TM' is a trademark of The Cooper Companies, Inc.
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