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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): October 22, 1999
Focal, Inc.
(exact name of registrant as specified in its charter)
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<S> <C> <C>
Delaware 000-23247 94-3142791
(State or other (Commission File No.) (IRS Employer
jurisdiction of Identification Number)
incorporation)
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4 Maguire Road, Lexington, Massachusetts 02421
(Address of principal executive offices) (zip code)
(781) 280-7800
(Registrant's Telephone Number, including Area Code)
With a copy to:
Steven D. Singer, Esq.
Hale and Dorr LLP
60 State Street
Boston, Massachusetts 02109
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Item 5. Other Events
On October 22, 1999, Focal, Inc. (the "Company") issued a press
release (which is attached hereto as an Exhibit) announcing that it had
signed a North American Distribution and Co-Promotional Agreement with
Genzyme Surgical Products ("Genzyme"), pursuant to which Genzyme will serve
as the Company's exclusive distributor for surgical sealant products for
pulmonary, cardiovascular and gastrointestinal surgery in North America
following approval by the Federal Drug Administration. As part of this
arrangement and pursuant to the terms of a Stock Purchase Agreement dated as
of October 21, 1999, Genzyme also committed to purchase up to $20.0 million
of Focal's Common Stock over an 18 month period, subject to the satisfaction
of certain conditions.
Item 7. Financial Statements and Exhibits
(c) Exhibits.
See Exhibit Index attached hereto
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SIGNATURE
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Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the Company has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
FOCAL, INC.
(Registrant)
Dated: November 5, 1999 By: /s/ W. Bradford Smith
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Name: W. Bradford Smith
Title: Chief Financial Officer
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INDEX TO EXHIBITS
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Exhibit No. Description
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99.1 Press release dated October 22, 1999.
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[Focal letterhead]
FOCAL, INC. AND GENZYME SURGICAL PRODUCTS ENTER INTO NORTH AMERICAN
DISTRIBUTION AND CO-PROMOTIONAL AGREEMENT
GENZYME HAS COMMITTED TO MAKE INVESTMENT OF UP TO $20 MILLION IN FOCAL COMMON
STOCK PURCHASES
LEXINGTON, MASS. - OCTOBER 22, 1999 - FOCAL, INC. (NASDAQ: FOCL) today
announced that it has entered into a distribution and co-promotional
agreement with Genzyme Surgical Products (Nasdaq: GZSP). Genzyme Surgical
Products will serve as Focal's exclusive distributor for surgical sealant
products for pulmonary, cardiovascular, and gastrointestinal surgery in North
America following FDA approval. Focal has retained the right to deploy a team
of product specialists to assist Genzyme Surgical Products in promoting the
products. These products are designed to seal air and fluid leaks following
surgery. Focal will retain the North American distribution and marketing
rights to products for all other surgical sealant clinical indications,
including neurosurgery.
Dave Clapper, President and CEO of Focal, Inc., commented, "The
FocalSeal-Registered Trademark--L product is an excellent complement to
Genzyme's existing product portfolio that is sold to cardiothoracic surgeons.
The Genzyme Surgical Products specialty sales force, combined with Focal's
highly trained product specialists, will give us more market entry
horsepower. Our collaboration with Genzyme Surgical Products should
significantly enhance the commercial prospects of our products in the United
States."
Genzyme Surgical Products maintains a strong sales presence in the
cardiothoracic market. Genzyme's portfolio of current products include its
market-leading Pleur-Evac-Registered Trademark- chest drains and fluid
management systems, which are used in thoracic, cardiovascular, critical
care, and trauma surgeries. In addition, Genzyme Surgical Products markets
instruments and sutures for use in a wide range of cardiothoracic procedures
and has established itself as one of the top competitors in the field of
minimally-invasive cardiac surgery. Genzyme Surgical Products also has a
highly respected and complementary leadership position in the biomaterials
field.
"We are very pleased to be collaborating with Focal to bring its first
product to the market in North America," said Duke Collier, President of
Genzyme Surgical Products. "Genzyme Surgical Products and Focal are among the
leaders in the development of a new generation of sophisticated
biomaterials."
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As part of the agreement, Genzyme Surgical Products has committed to purchase
up to $20 million of Focal, Inc. common stock over the next eighteen months,
upon the satisfaction of certain conditions. The initial $5 million
investment will be made in early November and will be priced at a 25% premium
to the average closing price over the ten days following this announcement,
with a ceiling of $8 per share. At Focal's option, up to three additional $5
million investments will be made by Genzyme Surgical Products. The first of
these optional investments will be made at a 25% premium to the then current
share price, or at the market price if the price including the premium is
over $8 per share. The remaining two $5 million investments, which are
subject to receipt of regulatory approval for the FocalSeal-L sealant product
in the United States and certain other conditions being met, will also be
made at Focal's option and at the then current market share price.
"The strategic investment of up to $20 million from Genzyme Surgical Products
over the next eighteen months will help advance our pipeline of surgical
sealant products through clinical trials and into the U.S. marketplace. In
addition, Genzyme's sales infrastructure should allow us to efficiently
introduce our products into the U.S. market," commented Brad Smith, Chief
Financial Officer of Focal, Inc.
Focal, Inc. develops, manufactures and commercializes synthetic, absorbable,
liquid surgical sealants based on the Company's proprietary polymer
technology. The Company's FocalSeal-L and FocalSeal-S surgical sealant
products are currently being developed for use inside the body to seal leaks
resulting from pulmonary surgery, neurosurgery, cardiovascular and
gastrointestinal surgery. Ethicon, a Johnson & Johnson subsidiary, has the
marketing rights to the Company's surgical sealant products outside North
America.
Genzyme Surgical Products develops and markets a portfolio of instruments,
devices, biomaterials, and biotherapeutics primarily for the cardiovascular
and general surgery markets. It is pioneering the field of "biosurgery,"
which is being created by the increasing convergence of mechanical and
biological approaches to surgery and other interventional procedures. A
division of the biotechnology company Genzyme Corporation, Genzyme Surgical
Products has its own common stock intended to reflect its value and track its
economic performance.
There will be a conference call hosted by management on Friday, October 22,
1999 at 10:00 a.m. EST. The dial-in number: 800-288-8976. It is recommended
that participants register at least 10 minutes prior to the broadcast.
EXCEPT FOR HISTORICAL INFORMATION, STATEMENTS MADE IN THIS PRESS RELEASE ARE
"FORWARD-LOOKING STATEMENTS" AND ARE SUBJECT TO CERTAIN RISKS AND
UNCERTAINTIES THAT COULD CAUSE THE COMPANY'S FUTURE PERFORMANCE AND RESULTS
OF OPERATIONS TO DIFFER MATERIALLY FROM SUCH STATEMENTS. FACTORS THAT COULD
ADVERSELY AFFECT THE COMPANY'S FUTURE PERFORMANCE AND RESULTS OF OPERATIONS
INCLUDE, BUT ARE NOT LIMITED TO, UNCERTAINTIES RELATING TO THE SUCCESSFUL
COMMERCIALIZATION OF THE COMPANY'S PRODUCTS IN NORTH AMERICA PURSUANT TO ITS
AGREEMENT WITH GENZYME SURGICAL PRODUCTS, UNCERTAINTIES RELATING TO THE
COMPANY'S ABILITY TO SATISFACTORILY SATISFY THE CONDITIONS TO GENZYME'S
OBLIGATION TO MAKE FUTURE EQUITY INVESTMENTS, UNCERTAINTIES RELATED TO
DEVELOPMENT AND COMMERCIALIZATION OF NEW PRODUCTS, RISKS ASSOCIATED WITH
CLINICAL TRIALS INCLUDING THE RISK OF INABILITY TO DEMONSTRATE SAFETY AND
EFFICACY OF PRODUCTS IN HUMAN BEINGS, RISKS ASSOCIATED WITH OBTAINING
REGULATORY APPROVALS FOR PRODUCTS INCLUDING UNCERTAINTIES RELATING TO THE
APPROVAL BY THE FDA OF THE FOCALSEAL-L PRODUCT FOR LUNG SURGERY, UNCERTAINTY
OF MARKET ACCEPTANCE, RISKS ASSOCIATED WITH THE COMPANY'S STRATEGIC
ALLIANCES, AND COMPETITION AND TECHNOLOGICAL CHANGE. THESE AND OTHER RISK
FACTORS ARE DESCRIBED IN THE COMPANY'S ANNUAL REPORT ON FORM 10-K AND OTHER
DOCUMENTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
FOCALSEAL-Registered Trademark- SURGICAL SEALANT IS A REGISTERED TRADEMARK OF
FOCAL, INC.
