Page 1 of 9 pages
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): December 16, 1996
MOLECULAR BIOSYSTEMS, INC.
(Exact name of registrant as specified in its charter)
Delaware 1-10546 36-30878632
(State or other juris- (Commission file (IRS employer
diction of incorporation) number) identification number)
10030 Barnes Canyon Road, San Diego, California 92121
(Address of principal executive offices)
Registrant's telephone number, including area code: (619) 452-0681
<PAGE>
Item 5. Other Events
(a) Amendment to Mallinckrodt Agreement
In December 1996, Molecular Biosystems, Inc. (the "Company") and
Mallinckrodt Medical, Inc. ("Mallinckrodt") amended the Amended and Restated
Distribution Agreement ("ARDA") that they entered into in September 1995 to
expand the geographical scope of Mallinckrodt's exclusive marketing and
distribution rights for the Company's proprietary first-generation contrast
agent for cardiac ultrasound imaging, ALBUNEX(R), its second generation contrast
agent, FS069, and related products. The amendment extended Mallinckrodt's
exclusive territory to cover the territory that the Company had formerly
licensed to Nycomed Imaging AS ("Nycomed"), from which the Company reacquired
exclusive product rights in October 1995. This additional territory includes
Western Europe, the former Soviet Union, Africa, the Middle East and India.
Under the amendment to ARDA, Mallinckrodt agreed to pay up to a total
of $12.85 million, depending upon the achievement of a specified product
development milestone. Mallinckrodt made an initial payment of $7.05 million,
consisting of reimbursement to the Company of $2.7 million that it paid to
Nycomed to reacquire the exclusive product rights in Nycomed's territory,
payment of $3.0 million to the Company under the terms of ARDA upon the
extension of Mallinckrodt's exclusive rights to Nycomed's former territory, and
payment of $1.35 million to Nycomed in satisfaction of the Company's obligation
to pay 45% of any amounts that the Company receives in excess of $2.7 million
upon the licensing of the former Nycomed territory to a third party. Of the
remaining $5.8 million that may be paid, Mallinckrodt will pay $4.0 million to
the Company (upon the achievement of the specified product development
milestone) and $1.8 million to Nycomed (representing 45% of the $4.0 million
payment to the Company.)
Under ARDA, the Company manufactures all licensed products for sale to
Mallinckrodt at a price generally equal to 40% of Mallinckrodt's quarterly
average selling price to end users. The amendment extends this arrangement to
Mallinckrodt's new territory and also requires Mallinckrodt to pay 60% of the
royalty of 2 1/2% on the first $30 million of annual sales and 3 1/2% on any
annual sales in excess of $30 million, that the Company is required to pay to
Nycomed in respect of product sales in its former territory. In addition, the
amendment requires Mallinckrodt to pay 60% of the royalty of 1.25% that the
Company is required to pay under its June 1989 license agreement with Steven B.
Feinstein, M.D., in respect of product sales in Mallinckrodt's new territory.
A copy of the Company's press release with respect to the amendment to
ARDA is attached to this Report as Exhibit 10.1.
<PAGE>
(b) Appointment of Additional Director
In December 1996, the Company appointed Jerry T. Jackson as a director
of the Company, increasing the size of its Board of Directors to seven members.
At the time of Mr. Jackson's retirement in 1995, he was serving as
Executive Vice President of Merck & Co., Inc., where he had worked since 1965
and had held various senior management positions, in sales, marketing and
planning.
A copy of the Company's press release with respect to Mr. Jackson's
appointment is attached to this Report as Exhibit 10.2.
(c) Review by FDA Advisory Panel Scheduled
On January 9, 1997, the Company announced that it had received notice
from the U.S. Food and Drug Administration ("FDA") that the FDA has scheduled a
review by its advisory Radiological Devices Panel on February 24, 1997 of the
Company's pre-marketing approval ("PMA") application for the Company's
second-generation contrast agent for cardiac ultrasound imaging, FS069, for use
in enhancing endocardial border definition and opacification of the left
ventricular chamber. The Company filed its PMA with the FDA on October 18, 1996.
A copy of the Company's press release with respect to the scheduling of
this FDA advisory panel review is attached to this Report as Exhibit 10.3.
<PAGE>
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.
Date: February 14, 1997
Molecular Biosystems, Inc.
By:/s/ Gerard A. Wills
Gerard A. Wills
Vice President, Finance and
Chief Financial Officer
<PAGE>
Exhibit Index
Sequentially
Numbered
Exhibit Description Page
10.1 Press release (December 16, 1996) 6
10.2 Press release (December 18, 1996) 8
10.3 Press release (January 9, 1997) 9
Exhibit 10.1
NEWS RELEASE
FOR IMMEDIATE RELEASE
Molecular Biosystems , Inc.
Gerard A Wills, Chief Financial Officer
Stephen F. Keane, Director Investor Relations (619) 824-2212
Mallinckrodt Group
Barbara Abbett, Vice President Communications (314) 854-5230
Peter Faur, Director, Corporate Communications (314) 854-5234
Cole Lannum, Director, Investor Relations (314) 854-5370
Molecular Biosystems, Mallinckrodt
Expand Partnership for Marketing of FS069
San Diego, California and ST. LOUIS, Missouri, December 16, 1996 -- Molecular
Biosystems, Inc. (NYSE:MB) (MBI) and Mallinckrodt Inc. (NYSE:MKG) today jointly
announced that Mallinckrodt's sales and marketing rights for FS069 have been
expanded to include Europe, Africa, India and Russia. FS069 is MBI's
second-generation ultrasound imaging agent. It is designed to enhance ultrasound
imaging by enabling physicians to visualize blood flow and enhance resolution of
anatomical structures in those patients with suboptimal non-contrast ultrasound
examinations.
The companies anticipate filing for European market clearance for FS069
in early 1997. MBI and Mallinckrodt announced in October that a pre-marketing
approval application for FS069 has been submitted to the U.S. Food and Drug
Administration. Mallinckrodt already holds extensive marketing rights for the
second generation agent, FS069, and for ALBUNEX(R), an MBI product that is the
first ultrasound imaging agent to be cleared for marketing in the United States.
The new agreement also covers future ultrasound contrast agents that Molecular
Biosystems has in development.
In exchange for the expanded marketing rights, Mallinckrodt will pay
fees of up to $12.9 million plus 40 percent of product sales to cover royalties
and manufacturing. Of the amount, $7.1 million is payable within 30 days, with
the remainder contingent upon certain milestones being met. The fees are
considered incremental to agreements already in place between the two companies.
Under these agreements, Mallinckrodt has marketing rights for ALBUNEX(R) and
FS069 in all parts of the world except Japan, South Korea and Taiwan. Molecular
Biosystems has not yet assigned it recently reacquired marketing rights for the
products in these territories.
"All of us at Mallinckrodt are delighted that we can extend our partnership
with Molecular Biosystems in this way," said James C. Carlile, President of
Mallinckrodt's Medical Imaging Division. "Products like FS069 and ALBUNEX(R) are
critical elements of our portfolio and help keep us a leader in the field of
contrast media."
Kenneth J. Widder, M.D., Molecular Biosystems' chairman and chief
executive officer, said, "Mallinckrodt is a major player in the European
contrast media market. This expanded partnership validates the commercial value
of FS069 as well as secures a partner with proven marketing prowess in these
territories. We can now focus on building a global franchise for FS069. The
companies are currently involved in additional clinical studies for FS069,
including myocardial perfusion and radiology imaging trials."
MBI, Inc., based in San Diego, California, is a leader in the
development and manufacture of ultrasound contrast agents for medical imaging.
MBI shares are listed on the New York Stock Exchange under the symbol "MB.
Mallinckrodt (NYSE:MKG) is an international growth company serving
specialty markets in human healthcare and chemicals. Dedicated to improving
healthcare and chemistry, the company is a major producer of diagnostic imaging
agents, medical devices, analgesic pharmaceuticals, catalysts, and laboratory
and microelectronic chemicals. The St. Louis, Missouri-based company, with
fiscal 1996 net sales of $2.2 billion, sells more than 2,000 products in more
than 100 countries. Mallinckrodt employs about 10,400 people worldwide. The
Mallinckrodt web site address is www.mallinckrodt.com.
Exhibit 10.2
NEWS RELEASE
Molecular Biosystems Appoints
Jerry T. Jackson to Board of Directors
San Diego, California, December 18, 1996 -- Molecular Biosystems, Inc. (NYSE:MB)
(MBI) today announced that Jerry T. Jackson, former Executive Vice President of
Merck & Co., Inc., has been appointed to the Company's Board of Directors. Mr.
Jackson brings 30 years of worldwide marketing, sales and product launch
experience to MBI.
From 1965 to 1995, Mr. Jackson served in several key senior management
positions in sales, marketing and planning at Merck & Co., Inc. The various
positions included, Senior Vice President of Worldwide Human Health Marketing,
President of Merck Sharp & Dohme International and President of Merck's
Worldwide Human Health Division. Until his retirement in 1995 he served as
Executive Vice President of Merck & Company.
Mr. Jackson is the second appointment to MBI's Board of Directors this
year. In June, David W. Barry, M.D., Chairman and Chief Executive Officer of
Triangle Pharmaceuticals and former President of Wellcome Research Laboratories
joined MBI's Board. Their combined expertise in worldwide marketing, strategic
planning, R&D and regulatory affairs will assist the Company in the objective of
becoming the global leader in ultrasound imaging agents.
Commenting on the appointment, MBI's Chairman and Chief Executive
Officer, Kenneth J. Widder, M.D. stated, "We are pleased that Mr. Jackson has
chosen to join our board and we welcome his vast knowledge of the industry. He
will be extremely helpful to us as we move forward with commercialization of our
portfolio of diagnostic products including FS069."
Molecular Biosystems, Inc., based in San Diego, California, is a world
leader in the development of ultrasound contrast agents for medical imaging.
ALBUNEX(R), the first FDA approved ultrasound imaging agent, is currently
marketed in the United States by Mallinckrodt Medical, Inc. (Mallinckrodt Group
Inc. NYSE:MKG). MBI shares are listed on the New York Stock Exchange under the
symbol "MB."
Investor Contacts: Gerard A. Wills, Chief Financial Officer
Stephen F. Keane, Director, Investor Relations
Ph. (619) 824-2212
Exhibit 10.3
NEWS RELEASE
FOR IMMEDIATE RELEASE
Molecular Biosystems , Inc.
Gerard A Wills, Chief Financial Officer
Stephen F. Keane, Director Investor Relations (619) 824-2212
FDA Advisory Panel Meeting Scheduled for FS069
San Diego, California, January 9, 1997 -- Molecular Biosystems, Inc. (NYSE:MB)
(MBI) today announced that the Company received notification from the United
States Food and Drug Administration (FDA) that it has scheduled an advisory
panel review for MBI's second generation ultrasound contrast agent, FS069, on
February 24, 1997.
The Radiology Device Advisory Panel will review the use of FS069 for use with
2-D echocardiography (ultrasound of the heart). This is the first in a series of
cardiovascular and radiology indications for FS069 for which MBI will be seeking
approval from the FDA. The indications will include myocardial perfusion and
enhancement of liver and kidney ultrasound imaging. Following FDA approval,
Mallinckrodt Inc. (NYSE:MKG) will market and sell FS069 in the United States.
Molecular Biosystems, Inc., based in San Diego, California, is a leader in the
development and manufacture of ultrasound contrast agents for medical imaging.
ALBUNEX(R), the first FDA approved ultrasound imaging agent, is currently
marketed in the United States by Mallinckrodt Inc. MBI shares are listed on the
New York Stock Exchange under the symbol "MB".
