UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 10-K
ANNUAL REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 20012003 Commission File No. 1-11083
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BOSTON SCIENTIFIC CORPORATION
(EXACT NAME OF COMPANY AS SPECIFIED IN ITS CHARTER)(Exact Name Of Company As Specified In Its Charter)
DELAWARE 04-2695240
(STATE OR OTHER JURISDICTION OF(State or other jurisdiction of (I.R.S. EMPLOYER IDENTIFICATION NO.Employer Identification No.)
INCORPORATION OR ORGANIZATION)incorporation or organization)
ONE BOSTON SCIENTIFIC PLACE, NATICK, MASSACHUSETTS 01760-1537
(ADDRESS, INCLUDING ZIP CODE, OF PRINCIPAL EXECUTIVE OFFICES)(Address, Including Zip Code, Of Principal Executive Offices)
(508) 650-8000
(COMPANY'S TELEPHONE NUMBER, INCLUDING AREA CODE)(Company's Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
COMMON STOCK, $.01 PAR VALUE PER SHARE
(TITLE OF CLASS)(Title Of Class)
Securities registered pursuant to Section 12(g) of the Act:
NONE
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Indicate by check mark whether the Company (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the Company was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes XYes: [X] No ______[ ]
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of Company's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to the
Form 10-K. / /[ ]
Indicate by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Act).
Yes: [X] No [ ]
-1-
The aggregate market value of Common Stock held by non-affiliates (persons other
than directors, executive officers, and related family entities) of the Company
was approximately $7.5$19.7 billion based on the closing price of the Common Stock
on March 15, 2002.June 30, 2003.
The number of shares outstanding of the Company's Common Stock as of March
15, 2002February
27, 2004, was 402,794,350.833,117,550.
DOCUMENTS INCORPORATED BY REFERENCE
The Company's 20012003 Consolidated Financial Statements for the year ended December
31, 20012003 which are filed with the Securities and Exchange Commission (the
"Commission") as an exhibit hereto and the Company's 20022004 Proxy Statement to be
filed with the Securities and Exchange Commission on or about April 5, 20029, 2004 are
incorporated by reference into Parts I, II and III hereof.
2-2-
PART I
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ITEM 1. BUSINESS
THE COMPANY
Boston Scientific Corporation (the "Company")(Boston Scientific or the Company) is a worldwide
developer, manufacturer and marketer of less-invasive medical devices. The Company'sdevices whose products are used
in a broad range of interventional medical specialties, including interventional
cardiology, electrophysiology, gastroenterology,peripheral interventions, neurovascular intervention,
pulmonary medicine, interventional radiology,electrophysiology, vascular surgery, endoscopy, oncology, urology and
vascular surgery.gynecology. Since the Company was formed in 1979, it has advanced the practice
of less-invasive medicine by providing a broad portfolio of innovative products,
technologies and services across a wide range of medical specialties. The
Company's products are generally inserted into the human body through natural
openings or small incisions in the skin and can be guided to most areas of the
anatomy to diagnose and treat a wide range of medical problems. These products
provide effectivehelp physicians and other medical professionals improve their patients' quality
of life by providing alternatives to traditional surgery by reducing risk, trauma, cost, procedure time and the need
for aftercare.surgery.
The Company's history began in the late 1960s when the Company's co-founder,
John Abele, acquired an equity interest in Medi-tech, Inc., a development
company. Medi-tech's initial products, a family of steerable catheters, were
introduced in 1969. They were used in some of the first less-invasive procedures
performed, and versions of these catheters are still being sold today. In 1979,
John Abele joined with PetePeter Nicholas to form the Company, which indirectly
acquired Medi-tech, Inc. This acquisition began a period of active, focused
marketing, new product development and organizational growth. Since then, the
Company's net sales have increased substantially, growing from $1.8 million in
1979 to almost $2.7approximately $3.5 billion in 2001.2003.
The Company's growth has been fueled in part by strategic acquisitions and
alliances designed to improve the ability of the Company to take advantage of
growth opportunities in less-invasive medicine. These acquisitions have helped
the Company to achieve a strategic mass, which allows it to offer one of the
broadest product lines in the world for use in less-invasive procedures. The
depth and breadth of the Company's strategic massproduct portfolio has also enabled it to
compete more effectively in, and better absorb the pressures of, the current
health care environment of cost containment, managed care, large buying groups
and hospital consolidations.
3-3-
SIGNIFICANT 2001 EVENTS
During 2001, the Company received 22 product approvals and clearances from the
U.S. Food and Drug Administration ("FDA") and 25 CE Mark approvals in Europe.THE DRUG-ELUTING STENT OPPORTUNITY
The Company's internally developed Express(TM)broad innovative product offerings have enabled it to become a
leader in the interventional cardiology market. Leadership is in part due to its
coronary stent was launchedproduct offerings. Coronary stents are tiny, mesh tubes used in
European and international markets during September 2001. The Express stent is a
laser cut, balloon-expandable stent designed and built to meet the real-world
needs of clinicians. The technology has also been designed so that it may be
leveraged by the Company for use as the platform for additional product
offerings in interventional cardiology, peripheral vascular and neurovascular
interventions.
The Company also made progress during the year on its TAXUS(TM) drug-eluting
coronary stent program. The Company has planned numerous TAXUS trials to test
the safety and efficacy of its new stent technology under a wide range of
clinical conditions in several countries. The Company expects to launch the
TAXUS paclitaxel-eluting stent for
the treatment of coronary artery disease.
4
During 2001,disease and implanted in patients to prop open
arteries and facilitate blood flow from the heart. The Company, also completed several strategic acquisitions and
alliances, each intendedhowever, looked
to further expandenhance the Company's abilityoutcomes associated with the use of coronary stents,
particularly the processes that lead to offer its
customers effective, quality medical devices that satisfy their interventional
needs. Over the last year, the Company completed the following acquisitionsin-stent restenosis (the growth of
neointimal tissue within an artery after angioplasty and added new or complementary technologies to its already diverse portfolio:
>
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* Cardiac Pathways Corporation Chilli(R) Cooled Ablation Catheter and Realtime Position Management(R)
System technologies broaden existing product line and bring highly
advanced diagnostic and treatment tools to electrophysiology
laboratories.
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* Catheter Innovations, Inc. Expands the Company's technology portfolio in the $500 million venous
access market.
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* Embolic Protection, Inc. Marks the Company's entry into the U.S. embolic protection market with
a proprietary technology for interventional cardiovascular procedures.
Also develops carotid endovascular therapies for the prevention of
stroke.
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* Interventional Technologies, Inc. Unique, proprietary Cutting Balloon(R) device combines the features of
conventional angioplasty with advanced microsurgical procedures.
Additional metallurgy technologies have broad applications to numerous
Company products.
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* Quanam Medical Corporation Broadens Company's drug-delivery portfolio with an additional
implant-based, drug-delivery technology and a family of proprietary
biomaterials.
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* RadioTherapeutics Corporation Expands the Company's oncology technology portfolio with proprietary
radiofrequency-based therapeutic devices in the field of interventional
oncology for the ablation (destruction) of various forms of soft-tissue
lesions (tumors).
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5
stenting), through
dedicated internal and external product development and scientific research. The
Company also focused on key clinical trials involving its core technologies
as well as technologies recently acquired. The trials have been designed to
studybelieves that the safetycombination of certain drugs and efficacy of new products or new usescoronary stents
offers the opportunity for existing products.
Significant clinical programs include:
* TAXUS - A series of clinical trials designed to assess the
safety and efficacy of the Company's TAXUS(TM)drug-eluting
stent under a wide range of clinical conditions. Six- and
nine-month follow up results of the TAXUS I trial, a trial
designed to assess the safety of a slow-release dose
formulation paclitaxel-eluting stent, confirmed safety, and
showed zero percent thrombosis and zero percent restenosis.
TAXUS I is the first of several Company-sponsored
paclitaxel-eluting stent clinical trials. The remaining TAXUS
trials are at various stages of completion or have yet to
commence. In March 2002, the Company reported that
preliminary results from its TAXUS II and III trials have
provided further supportmore lasting solution for the safety of its
paclitaxel-eluting stent. The Company also announced that it
received approval from the FDA to initiate the TAXUS IV
trial, a trial designed to support product commercialization
in the U.S.
* Express(TM)and Express2(TM)coronary stent systems - During
2001, the Company initiated clinicalartery disease.
Clinical trials in the United States and Europe to studyabroad have demonstrated that
drug-eluting stents reduce the safetyneed for repeat procedures - or more expensive
surgical procedures - and efficacy of its
Expresssignificantly reduce health care costs, as well as
overall patient risk, trauma, procedure time and Express2the need for post-procedural
care. Since 1997, the Company has been developing a proprietary polymer-based,
paclitaxel-eluting stent technology for reducing coronary restenosis - the
TAXUS(TM) paclitaxel-eluting coronary stent systems. Followingsystem. The proprietary polymer on
the completionstent allows for controlled delivery of these trials,the drug paclitaxel. Paclitaxel is a
multi-functional microtubular inhibitor that affects platelets, smooth muscle
cells and white blood cells, all of which are believed to contribute to
restenosis. The flexibility of the device facilitates placement of the stent in
March 2002, the Company filed
an application withcoronary anatomy and the FDA for pre-market approvalconformability of these
products. The Expressthe stent is the company's newest
internally developedwithin a diseased
coronary stent and is designed to
provide outstanding performance by optimizing flexibility,
deliverability and scaffolding characteristics. The Express2
stent system is an Express stentartery, combined with the Company's advanced Maverick(R)balloon catheterpolymer-based drug-eluting
technology, and featurescontributes to the clinical differentiation of the TAXUS
paclitaxel-eluting coronary stent platform.
The Company has invested in the TAXUS clinical program, a laser-bonded, flexible tip with a long, low profile
designed for easier tracking.
* Filterwire EX(TM) embolic protection device - Two U.S.
clinical trials are in progress,series of studies
designed to evaluatecollect data on its TAXUS paclitaxel-eluting coronary stent. These
studies have demonstrated dramatic results by significantly reducing restenosis
and reintervention.
During 2003, the benefitsCompany entered the drug-eluting stent market in Europe and
certain other international markets. Since launch, the TAXUS paclitaxel-eluting
coronary stent system has achieved market leadership in the countries in which
it is sold. Adding the TAXUS paclitaxel-eluting coronary stent system to the
Company's interventional cardiology product line has helped the Company to
solidify its full-line leadership in the cardiovascular catheter labs. With the
launch of stentingthe TAXUS paclitaxel-eluting coronary stent in conjunction with embolic
protectionthe United States
during the first quarter of 2004, the Company expects significant revenue growth
over the next few years as physicians continue to adopt this new technology.
The Company is continuing to enhance its product offerings in the coronary and
drug-eluting stent markets. Its next-generation coronary stent, the Liberte(TM)
coronary stent, was recently launched in Europe and certain other international
markets and the Company expects to launch the product in the United States in
the second half of 2004, pending regulatory approval. The Liberte(TM) coronary
stent is designed to enhance deliverability and
-4-
conformability, particularly in challenging lesions, and is expected to serve as
the platform for the treatmentCompany's next generation drug-eluting stent.
The Company believes drug-eluting stent technology represents one of carotid artery diseasethe largest
market opportunities in the history of the medical device industry. It is
estimated that the annual worldwide market for coronary stents, including
drug-eluting stents, may grow to more than $5 billion. The Company believes it
is poised to take advantage of the drug-eluting stent opportunity for a variety
of reasons, including its more than six years of scientifically rigorous
research and saphenous vein grafts.development, the clinical results of its TAXUS program, the success
of TAXUS paclitaxel-eluting coronary stent system in Europe and
Inter-Continental markets where the product has been launched, the combined
strength of the components of its technology, its overall market leadership, and
its sizeable international cardiology sales force.
The introduction of drug-eluting stents is increasingly having a significant
impact on the market size for coronary stents and on the distribution of market
share across the industry. The worldwide coronary stent market is dynamic and
highly competitive with significant market share volatility. Although the
Company's drug-eluting stent system is currently one of only two products in the
United States market, uncertainties exist about the rate of development and
potential size of the drug-eluting stent market, and the Company's share of the
market. The most significant variables that contribute to this uncertainty
include the adoption rate of drug-eluting stent technology, the average number
of stents used per procedure and the average selling prices of drug-eluting
stent systems. In February of 2004, Cordis Corporation (Cordis), a subsidiary of
Johnson & Johnson, and Guidant Corporation entered an alliance to co-promote
Cordis' drug-eluting stent system, which may result in further uncertainty.
The Company's success with drug-eluting stents, and its ability to improve
operating margins, could be adversely affected by more gradual physician
adoption rates, changes in reimbursement policies, delayed or limited regulatory
approvals, unexpected variations in clinical results, third-party intellectual
property, the outcome of litigation and the availability of inventory to meet
customer demand. Inconsistent clinical data from ongoing or future trials
conducted by the Company, or additional clinical data presented by the Company's
competitors, may impact the Company's position in and share of the drug-eluting
stent market.
BUSINESS STRATEGY
The Company's mission is to improve the quality of patient care and the
productivity of health care delivery through the development and advocacy of
less-invasive medical devices and procedures. The Company seeks to accomplish
this missionThis is accomplished through the
continuing refinement of existing products and procedures and the investigation
and development of new technologies whichthat can reduce risk, trauma, cost,
procedure time and the need for aftercare. The Company's strategy has been,approach to innovation
combines internally developed products and will continue to be, to grow by identifyingtechnologies with those specific therapeuticobtained
externally through strategic acquisitions and 6
diagnostic areas which satisfy the Company's missionalliances. Building relationships
with development companies and by making the
investments necessary to capitalize on these opportunities. During 2001,inventors allows the Company executedto enrich its
growth strategy by enhancing its internal development
programscurrent franchises as well as adding to its existing technology portfolio through external
acquisition and licensing activity. The Company will continue to seek out and
review opportunities for acquisitions and strategic alliances consistent with
its corporate mission.expand into complementary businesses.
Key elements of the Company's overall business strategy include the following:
Innovation. The Company is committed to harnessing technological innovation and
its approach to technology innovation includes a mixture of tactical and
strategic initiatives that are designed to offer sustainable growth in the near
and long term. Combining internally developed products and technologies with
those obtained through acquisition and alliances allows the Company to focus on
and deliver products currently in its pipeline as follows:
PRODUCT DIVERSITY.well as strengthen the
Company's technology portfolio by accessing third party technologies.
-5-
Clinical Excellence. The Company's commitment to innovation is further
demonstrated by its rapidly expanding clinical capabilities. The Company's
clinical group has become a clinical center of excellence, driving the
development and analysis of innovative therapies that transform the practice of
medicine. The Company's clinical teams are organized by therapeutic specialty to
better support the Company's research and development pipeline and marketing and
sales efforts. During 2003, the clinical organization planned, initiated and
conducted an expanding series of focused clinical trials that support regulatory
and reimbursement requirements and demonstrate the safe and effective clinical
performance of critical products and technologies.
Product Diversity. The Company offers products in numerous product categories,
which are used by physicians throughout the world in a broad range of diagnostic
and therapeutic procedures. The breadth and diversity of the Company's product
lines permit medical specialists and purchasing organizations to satisfy many of
their less-invasive medical device requirements from a single source.
INNOVATION.Operational Excellence. The Company is committed to driving growth through harnessing
technological innovation both in the near and long term. The Company's approach
to enhancing innovation includes a mixture of tactical and strategic initiatives
that are designed to offer sustainable growth. Combining internally developed
products and technologies with those obtained through acquisition and licensing
arrangements allows the Company to focusfocused on and deliver new products currently
in its pipeline as well as strengthen the Company's technology portfolio and
development processes and tools.
CLINICAL EXCELLENCE. The Company's commitment to innovation is further
demonstrated by its rapidly expanding clinical capabilities. The Company's
clinical teams have been organized by therapeutic specialty to better align with
research and development, marketing and sales teams. During 2001, the clinical
teams focused clinical trials that support regulatory requirements and
demonstrate safe and effective clinical performance of products and technologies
with the greatest market potential.
OPERATIONAL EXCELLENCE. The Company believes thatcontinuously improving its
supply chain effectiveness, strengthening its manufacturing processes and
optimizing its plant network willin order to increase operational efficiencies
within the organization and
generate savings.organization. By centralizing its operations at the corporate level
and shifting global manufacturing along product lines, the Company will be better
positionedis able to
leverage its existing resources and concentrate on new product development,
including enhancement of existing products, and their commercial launch. FOCUSED MARKETING.In
addition, the Company consistently strives to understand and exceed the
expectations of its customers. The Company's commitment to quality and the
success of its quality objectives builds customer trust and loyalty.
Focused Marketing. Each of the Company's business groups maintain dedicated
sales forces and marketing teams focusing on physicians who specialize in the
diagnosis and treatment of different medical conditions and offer products to
satisfy their needs.conditions. The Company believes
that this focused disease state management enables it to develop highly
knowledgeable and dedicated sales representatives and to foster close
professional relationships with physicians.
7
ACTIVE PARTICIPATION IN THE MEDICAL COMMUNITY.Active Participation In The Medical Community. The Company believes that it has
excellent working relationships with physicians and others in the medical
industry, which enable it to gain a detailed understanding of new therapeutic
and diagnostic alternatives, and to respond quickly to the changing needs of
physicians and patients. Active participation in the medical community
contributes to physician understanding and adoption of less-invasive techniques
and the expansion of these techniques into new therapeutic and diagnostic areas.
CORPORATE CULTURE.Corporate Culture. Management believes that success and leadership evolve from a
motivating corporate culture which rewards achievement, respects and values
individual employees and customers, and has a long-term focusfocuses on quality, technology,
integrity and service. The Company believes that its success is attributable in
large part to the high caliber of its employees and the Company's commitment to
respecting the values on which its success has been based.
-6-
RESEARCH AND DEVELOPMENT
The Company's investment in research and development is critical to drive its
future growth. The Company has directed its development efforts toward
innovative technologies designed to expand current markets or enter new markets.
Enhancements to existing products which are typically developed within the
Company's research and development, manufacturing and marketing operations,
contribute to each year's sales growth. The Company believes that streamlining,
prioritizing and coordinating its technology pipeline and new product
development activities are essential to its ability to stimulate growth and
maintain leadership positions in its markets. By centralizing certain new
platform technology development at the corporate level, the Company is able to
pursue technologies that can be leveraged across multiple markets. The Company's
approach to new product design and development is through focused, cross -
functional teams. The Company believes that its formal process for technology
and product development aids in its ability to offer innovative and
manufacturable products in a consistent and timely manner. Involvement of the
R&D, clinical, quality, regulatory, manufacturing and marketing teams early in
the process is the cornerstone of the product development cycle. This
collaboration allows the team to concentrate resources on the most viable new
products and technologies and get them to market in a timely manner.
In addition to internal development, the Company works with hundreds of leading
research institutions, universities and clinicians around the world to develop,
evaluate and clinically test its products. The Company believes its future
success will also depend upon the strength of these development efforts. There
can be no assurance that the Company will realize financial benefit from its
development programs, will continue to be successful in identifying, developing
and marketing new products or that products or technologies developed by others
will not render the Company's products or technologies non-competitive or
obsolete.
In 2003, the Company expended approximately $450 million on research and
development, representing approximately 13 percent of the Company's 2003 net
sales. The investment in research and development dollars reflects spending on
new product development programs as well as regulatory compliance and clinical
research, particularly relating to the Company's TAXUS(TM) paclitaxel-eluting
coronary stent program and other development programs acquired in connection
with the Company's business combinations.
STRATEGIC INITIATIVES
Since 1995, the Company has undertaken a strategic acquisition program to
assemble the lines of business necessary to achieve the critical mass that
allows it to continue to be a leader in the medical industry. In 2003, the
Company invested more than $350 million in approximately 25 strategic
initiatives. These initiatives are each intended to further expand the Company's
product offerings by adding new or complementary technologies to its already
diverse technology portfolio.
-7-
Many of the Company's alliances involve complex arrangements with third parties
and include, in many instances, the option to purchase these companies at
pre-established future dates, generally upon the attainment of performance,
regulatory and/or revenue milestones. These arrangements allow the Company to
evaluate new technologies prior to acquisition.
As the health care environment continues to undergo rapid change, the Company
expects that it will continue to focus on strategic acquisitions and alliances
in order to provide new products and technology platforms to its customers. In
addition, the Company expects to make additional investments in several of its
existing relationships.
PRODUCTS
The Company's products are offered for sale by two dedicated business groups -
Cardiovascular and Endosurgery. The Cardiovascular organization focuses on
products and technologies for use in the Company's interventional cardiology, interventional radiology, peripheral
interventions, vascular surgery, electrophysiology, and neurovascular
procedures. The Endosurgery organization focuses on products and technologies
for use growth in oncology, vascular surgery, endoscopy, urology and gynecology procedures. During 2001,2003,
approximately 69%72 percent of the Company's net sales were derived from the
Company's Cardiovascular business and approximately 31%28 percent from its
Endosurgery business.
The Company's principal Cardiovascular and Endosurgery products are offered in
the following medical areas:
CARDIOVASCULAR
CORONARY REVASCULARIZATION.Coronary Stents.
Drug-Eluting Stents. The Company launched its TAXUS(TM) Express(2TM)
paclitaxel-eluting coronary stent system in Europe and certain other
international markets during 2003 and in the U.S., during the first
quarter of 2004. The Company expects to launch the TAXUS Express
paclitaxel-eluting coronary stent system in Japan in late 2005 or early 2006,
pending regulatory approval.
Bare Metal Stents. The Company markets both balloon-expandable and
self-expanding coronary stent systems. Following its launch in Japan in early
2004, the Express(2)(TM) coronary stent system is now offered on a worldwide
basis. The Express(2) coronary stent system -- an Express(R) stent combined with
advanced Maverick(R) balloon catheter technology -- features a laser-bonded,
flexible tip with a long, low profile designed for easy tracking and is the
platform for the Company's drug-eluting stent. Its Bioslide(R) hydrophilic
coating is designed to reduce friction, while the proprietary Crimp 360(TM)
technology secures the stent to the balloon.
-8-
In January 2004, the Company launched its next-generation coronary stent, the
Liberte(TM) coronary stent, in Europe and certain other international markets
and expects to launch the product in the U.S. in the second half of 2004,
pending regulatory approval. The Liberte coronary stent is designed to enhance
deliverability and conformability, particularly in challenging lesions, and is
expected to serve as the platform for the Company's next generation drug-eluting
stent system.
Coronary Revascularization. The Company markets a broad line of products used to
treat patients with atherosclerosis. Atherosclerosis, a coronary vessel disease
and a principal cause of heart attacks, is characterized by a thickening of the
walls of the arteries and a narrowing of arterial lumens (openings) caused by
the progressive development of deposits of plaque. The majority of the Company's
products in this market are used in percutaneous transluminal coronary
angioplasty ("PTCA")(PTCA) and percutaneous transluminal coronary rotational atherectomy
and include PTCA balloon catheters, the Rotablator(R) and Rotalink(R) rotational
atherectomy systems, guide wires, guide catheters and diagnostic catheters.
During 2001,2003, the Company introducedlaunched the Maverick(R) balloonnext generation Cutting Balloon(2TM)
microsurgical dilatation catheter
for commercial saledevice, the Cutting Balloon Ultra(2TM) microsurgical
dilatation device, in both the United States, JapanU.S. and certain European markets. With the needsThe device features
tiny, longitudinally mounted athertotomes (microsurgical blades) that help
reduce resistance of clinicians in mind, the Maverick balloon catheter wasa lesion to expansion and is designed to provide enhanced crossabililty (the ability
8
be used as a
stand-alone treatment for complex lesions or for pre-dilatation prior to
stenting.
Embolic Protection. One of the catheter or delivery systemmost promising areas in interventional medicine
is embolic protection. The Filterwire(TM) System is designed to track and get through difficult lesions).
The catheter features TrakTip(TM) technology,capture embolic
material that may become dislodged during cardiovascular interventions, which
could otherwise travel into the microvasculature where it could cause a soft tubingheart
attack. In the U.S., the Company offers the FilterWire EX(TM) System, which is a
low-profile, embolic filter mounted on a guide wire that is attacheddesigned to the end of the balloon using the Company's patented laser-bonding technology.
The material of the TrakTip is resilient and exceptionally flexible, enhancing
trackability.
During the year, the Company also added the Cutting Balloon(R) catheter, areduce
complications during balloon angioplasty device that combines features of conventional angioplasty
with advanced microsurgical technology, to its interventional cardiology
product offerings through the Company's acquisition of Interventional
Technologies, Inc. ("IVT").
CORONARY STENTS. The Company markets both balloon-expandable and self-expanding
coronary stent systems. Coronary stents are tiny, metal devices usedstenting procedures in the
treatment of coronary artery disease and implantedsaphenous vein grafts (SVGs). The Company's next generation system,
the FilterWire EZ(TM) System, has been granted CE Mark in patients to prop open
arteries and facilitate blood flow to the heart.
During 2000, the Company expanded its stent development efforts to include an
internally developed stent platform - the Express(TM) stent which was launched
in EuropeanEurope and other
international markets during September 2001. The Express
stent is a laser-cut balloon-expandable stent that features a new design concept
called Tandem(TM) architecture (the integration of two separate structural
elements into a single design for enhanced deliverability, conformability and
consistent vessel support). Generations of the Express stent are designed to be
leveragable into coronary, peripheral and neurovascular applications. The
Company anticipates launching the Express stent in the United States during the
second half of 2002 pending regulatory approval.
Despite the significant improvement stents offer over traditional balloon
angioplasty formultiple indications, including the treatment of
disease in peripheral, coronary artery disease, in-stent restenosis -
the regrowth of diseased tissue into a previously stented artery - continues to
be a serious challenge for clinicians. In-stent restenosis occurs after
approximately 15-20 percent of all stent placements and can reach as high as 50
percent in complex lesions. Many patients with complex coronary artery disease
suffer from in-stent restenosis. The Company believes that the combination of
drugscarotid vessels and coronary stents offers the possibility of a more lasting solution for
coronary artery disease, particularly the occurrence of in-stent restenosis.
Through a strategic alliance with Angiotech Pharmaceuticals, Inc., the Company
holds a co-exclusive license for the use of paclitaxel on intraluminal devices
to inhibit restenosis as well as other applications. Paclitaxel is an active
component of a chemotherapeutic agent and has demonstrated promising results in
pre-clinical studies for reducing the processes leading to restenosis. During
2001, the Company entered into an exclusive agreement with Natural
Pharmaceuticals, Inc. for the supply of paclitaxel for use in a wide range of
drug-delivery devices.
9
The Company is currently conducting several clinical trials - known as TAXUS -
involving the Company's drug-eluting stent technology. This TAXUS(TM)
drug-eluting stent is designed to provide direct delivery of paclitaxel through
a polymer on a stent at the desired location with a predictable and controlled
release to reduce restenosis. Six- and nine-month follow up results of the
Company's TAXUS I trial, a trial designed to assess the safety of a slow-release
dose formulation paclitaxel-eluting stent, confirmed safety, and showed zero
percent thrombosis and zero percent restenosis.SVGs. The Company
expects to launch a
paclitaxel-eluting stent in certain international markets during 2002, in Europe
in late 2002 or early 2003 andthis device in the U.S. later in late 20032004 for treatment of SVGs,
pending regulatory approval. The FilterWire EZ System is also currently under
clinical investigation to evaluate the benefits of embolic protection during
primary percutaneous coronary interventions or stenting to treat acute
myocardial infarction (AMI).
Intraluminal Ultrasound Imaging. The Company also markets stentsa family of intraluminal
catheter-directed ultrasound imaging catheters and stent delivery systems which incorporate the
NIR(R) balloon-expandablefor use in coronary
stent, a product developedarteries and manufactured
by Medinol Ltd., Israel with whichheart chambers as well as certain peripheral systems. During 2003,
the Company has an exclusive worldwide
distribution agreement covering stent products.
FLUID MANAGEMENT.launched the Galaxy(R)(2) System, its next generation intravascular
ultrasound (IVUS) imaging system. This next generation technology is used in the
management of coronary and peripheral vascular disease, providing
cross-sectional and longitudinal ultrasound images. The Galaxy(2) System also
images intracardiac structures during electrophysiology procedures.
-9-
Fluid Management. The Company markets a broad line of fluid delivery sets,
pressure monitoring systems, custom kits and accessories that provide forenable the
injection of contrast and saline or the withdrawal and the disposal of bodily waste.
ELECTROPHYSIOLOGY. The Company's electrophysiology product offerings include
catheters and systems for use in less-invasive procedures to diagnose and treat
tachyarrhythmias (abnormally fast heart rhythms). The Company markets RF
generators, mapping systems, intracardiac ultrasound and steerable ablation
catheters, many of which incorporate proprietary steering, temperature
monitoring and control technology, as well as a line of diagnostic catheters and
associated accessories. The Chilli(R) cooled ablation catheter and Realtime
Position Management(R) system are important additions to the Company's
electrophysiology product portfolio through the Company's 2001 acquisition of
Cardiac Pathways Corporation. These products are designed for ablating
(neutralizing) the tissue in the heart that is responsible for starting or
maintaining the tachyarrhythmia and for navigating EP catheters within the
heart.
PERIPHERAL VASCULAR INTERVENTION AND VENOUS ACCESS.Peripheral Interventions. The Company sells various products designed to treat
patients with peripheral vascular disease (disease which appears in blood vessels other
than in the heart)heart and in biliary structures), including a broad line of medical
devices used in percutaneous transluminal angioplasty and thrombolysis (the catheter-based delivery of clot dissolving agents directly to
the site of a blood clot). Additionally, theperipheral vascular
stenting. The Company's peripheral vascular product line includes vascular access
products, balloon catheters, thrombectomy catheters, and stents (including the Express(R) Biliary Stent
System and Wallstent(R) endoprosthesis). and peripheral vascular catheters,
wires, and accessories. During the year, the Company's
product offerings in its venous access line have increased through the Company's
acquisition of Catheter Innovations, Inc. and now include both valved and
non-valved product offerings.
10
EMBOLIC PROTECTION. One of the most promising areas in interventional
medicine is embolic protection. In February of 2001,2003, the Company acquired
Embolic Protection, Inc.,began distributing innovative
angioplasty catheters that employ a developer and manufacturer of embolic protection
filters, including the FilterWire EX(TM) device. This device is designed to
capture material dislodged into the bloodstream during cardiovascular
interventions, potentially preventing a heart attack or stroke. The
FilterWire EX was introducednitrous oxide based inflation system for
use in coronary, carotid and saphenous vein
graft applications in certain European markets during 2001. The Company also
announced during 2001 that it entered into a series of agreements with
ENDOTEX Interventional Systems, Inc. The Company and ENDOTEX have agreed to
collaborate on clinical trials that will study the use of the ENDOTEX carotid
stent (the NEXSTENT(TM)) in combination with the Company's Filterwire embolic
protection device to treat carotid artery disease. The Company will also
serve as the primary distributor for ENDOTEX in international markets.
CAVAL INTERRUPTION SYSTEMS.peripheral use.
Caval Interruption Systems. The Company markets the Greenfield(R) vena cava
filter system for use in patients who are at risk of developing a pulmonary
embolism due to an existing medical condition or post-surgical complications.
Once the filter is implanted, circulating emboli (blood clots) can be captured
and held by the lattice design of the filter, allowing the clots to dissolve
naturally before they can reach the pulmonary system.
INTRALUMINAL ULTRASOUND IMAGING.Electrophysiology. The Company markets a familyoffers medical devices for the diagnosis and
treatment of intraluminal
catheter-directedcardiac conditions called arrhythmias (abnormal heartbeats).
Included in the Company's product offerings are RF generators, mapping systems,
intracardiac ultrasound imagingand steerable ablation catheters, and systems for diagnostic use in
blood vessels, heart chambers and coronary arteries, as well as certain
nonvascular systems.
NEUROVASCULAR INTERVENTIONS.a line of
diagnostic catheters and associated accessories. The Company's Chilli(R) cooled
ablation catheter and Realtime Position Management(TM) system are products
designed for ablating (neutralizing) the tissue in the heart that is responsible
for starting or maintaining tachyarrhythmias (abnormally fast heartbeats) and
for navigating electrophysiology catheters within the heart. During 2003, the
Company launched the Blazer RPM(TM) advanced navigation and ablation catheter -
the first bi-directional navigation catheter available in the United States. The
Company also received Pre-Market Approval (PMA) from the U.S. Food and Drug
Administration (FDA) for its EPT-1000 XP(TM) Cardiac Ablation System for the
treatment of atrial flutter. The Blazer RPM Navigation and Ablation Catheter is
designed to provide guidance of the ablation catheter while creating
three-dimensional representations of the heart chambers, which assist in
identifying tachycardia, a cardiac condition characterized by rapid heartbeats
originating in the atrium or the ventricle. The EPT-1000 XP Cardiac Ablation
System is the first 10mm cardiac ablation catheter and 100-watt radio-frequency
generator approved in the U.S.
-10-
Neurovascular Intervention. The Company markets a line of micro-guidewires,
micro-catheters, coils, guiding catheters and embolics to neuroradiologists and
neurosurgeons to treat diseases of the neurovascular system. TheIn August 2003, the
Company also marketsreceived FDA clearance to market the GDC(R) (Guglielmi Detachable Coil)
system to treat all brain aneurysms. The previous GDC Coil was only approved to
treat high-risk or inoperable ruptured and prevent the rupture of cerebral aneurysms that are
otherwise either considered to be inoperable or high risk for surgery. During
2001, the Company exercised a pre-existing option to acquire Smart Therapeutics,
Inc., a company that has developed a stent system for treating "wide neck"
aneurysms, which are among the most difficult to treat. The combination of
Smart's stent and the Company's GDC coil mayunruptured brain aneurysms. This
expanded approval will provide a less-invasive alternative to surgery to those
patients who have a brain aneurysm.
Vascular Surgery. The Company designs abdominal, thoracic and peripheral
vascular grafts for the treatment alternativeof aortic aneurysms and dissections,
peripheral vascular occlusive diseases, and dialysis access. In 2003, the
Company introduced the next generation of Hemashield(R) grafts to complement its
existing line of Hemashield(R) grafts and fabrics for patients whose only previous option may have been open surgery.peripheral vascular and
cardiovascular indications.
ENDOSURGERY
ESOPHAGEAL, GASTRIC AND DUODENAL (SMALL INTESTINE) INTERVENTION.Esophageal, Gastric And Duodenal (Small Intestine) Intervention. The Company
markets a broad range of products to diagnose, treat and palliate a variety of
gastrointestinal diseases and conditions, including those affecting the
esophagus, stomach and colon. Common disease states include esophogitis, gastric
esophagealesophagitis,
gastroesophageal reflux disease ("GERD")(GERD), portal hypertension, peptic ulcers and
esophageal cancer. The Company's products in this area include disposable single
and multiple biopsy forceps, balloon dilatation catheters devices and enteral feeding
devices. The
11
Company also markets a family of esophogealesophageal stents designed to
offer improved dilatation force and greater resistance to tumor in-growth. During the first
quarter of 2001, the Company signed an agreement with Enteric Medical
Technologies, Inc. ("EMT") providing for the exclusive distribution of EMT's
Enteryx(TM)The
Company's Enteryx(R) liquid polymer technology which is designed to less invasively
treat symptoms associated with chronic GERD. The agreement grants the Company exclusive
distribution rightsGERD in certain international markets, including most European
countriespatients who require and Japan, and also includes an exclusive optionrespond
to purchase EMT.
COLORECTAL INTERVENTION.pharmaceutical therapy.
Colorectal Intervention. The Company markets a line of hemostatic catheters,
polypectomy snares, biopsy forceps, enteral stents and dilatation catheters for
the diagnosis and treatment of polyps, inflammatory bowel disease,
diverticulitis and colon cancer.
PANCREATICO-BILIARY INTERVENTION.Pancreatico-Biliary Intervention. The Company sells a variety of products to
diagnose, treat and palliate benign and malignant strictures of the
pancreatico-biliary system (the gall bladder, common bile duct, hepatic duct,
pancreatic duct and the pancreas) and to remove stones found in the common bile
duct. The Company's products include diagnostic catheters used with contrast
media, balloon dilatation catheters and sphincterotomes. The Company also
markets self-expanding metal and temporary biliary stents for palliation and
drainage of the common bile duct.
PULMONARY INTERVENTION.Pulmonary Intervention. The Company markets devices to diagnose, treat and
palliate chronic bronchitis and lung cancer, includingdiseases of the pulmonary system. The major devices include pulmonary
biopsy forceps, stentstransbronchial aspiration needles, cytology brushes and
balloon catheterstracheobronchial stents used to dilate strictures or for tumor management.
Included in this product offering isare the
Company's Wallgraft(R)-11-
Ultraflex(TM) Tracheobronchial Endoprosthesis, a coveredStent System and the Wallstent(R)
device designed to treat tracheobronchial
strictures.
URINARY TRACT INTERVENTION.Tracheobronchial Endoprosthesis.
Urinary Tract Intervention and Bladder Disease. The Company sells a variety of
products designed primarily to treat patients with urinary stone disease,
including ureteral dilatation balloons used to dilate strictures or openings for
scope access; stone baskets used to manipulate or remove the stone;
intracorporeal shock wave lithotripsy devices and holmium laser systems used to
disintegrate stones
ureteroscopically;stones; ureteral stents implanted temporarily in the urinary tract
to provide short-term or long-term drainage; and a wide variety of guidewires
used to gain access to a specific site. During 2001, theThe Company announced its
alliance with ESC Medical Systems, Ltd. (Lumenis, Ltd.), the world's largest
marketer of holmium laser systems used for kidney stone removal. This alliance
will greatly enhance the Company's kidney stone management product offering in
the United Stateshas also developed other
devices to diagnose and Japan.
PROSTATE INTERVENTION.treat bladder cancer and bladder obstruction.
Prostate Intervention. For the treatment of Benign Prostatic Hypertrophy
("BPH")Hyperplasia (BPH),
the Company currently markets electro-surgical resection devices designed to
resect large diseased tissue sites and reduce the bleeding
attributable to the resection procedure (a major cause of patient
12
morbidity in connection with traditional surgical treatments for BPH) and an automatic disposable needle biopsy
system, designed to take rapid core prostate biopsies. URINARY INCONTINENCE AND BLADDER DISEASE.In addition, the Company
distributes and markets the Prolieve(TM) thermodilitation system, a
transurethral microwave thermotherapy system for treatment of symptoms
associated with BPH.
Urinary Incontinence. The Company markets a line of less-invasive devices, and dermal sling
materials and injectables to treat stress urinary incontinence. Thisincontinence, an affliction is
commonly treated with various surgical procedures. The Company's line of
Precision Tack(TM) and Precision Twist(TM)Capio(R) devices and Vesica(R) systemsthe Advantage(TM) device offer less-invasive
alternatives for treating incontinence. In addition, the Company also markets
Durasphere(R) EXP, an injectable bulking agent for uterine sphincter deficiency.
Gynecology. The Company has also developed other devices to diagnose and treat bladder
cancer and bladder obstruction.
ONCOLOGY INTERVENTION.markets products in the area of women's health. The
Company's Hydro ThermAblator(R) (HTA(R)) System offers a less-invasive
technology for the treatment of excessive uterine bleeding by ablating the
lining of the uterus, the tissue responsible for menstrual bleeding.
Oncology Intervention. The Company markets a broad line of products designed to
treat, diagnose and palliate various forms of cancer. Its current suite of
products include a variety of microcatheters, embolic materials, coils and other
products used to restrict blood supply to targeted organs of other areas of the
body as well as biopsy devices. During 2001,In addition, the Company acquired
RadioTherapeutics Corporation, a developer and manufacturer ofmarkets radiofrequency
based therapeutic devices for the ablation (destruction) of various forms of soft tissue
lesions (tumors). SURGICAL AND ENDOVASCULAR GRAFTS. The Company designs vascular graftsalso markets Contour SE(TM) Microspheres, a novel
spherical embolization product used to treat hypervascular tumors and
endovascular stent grafts forarteriovenous malformations. The Contour SE Microsphere product is designed to
shrink and destroy hypervasular tumors and arteriovenous malformations by
blocking the treatmentblood supply feeding them.
Central Venous Access. The Company offers a venous access line, which includes
valved and non-valved product offerings. The innovative PASV(R) technology is
designed to reduce the incidence of thoracic dissection, dialysis
access, abdominal aortic aneurysmsocclusion and peripheral vascular occlusive diseases,
including the Exxcel(TM) vascular graft for peripheral indications and dialysis
access and a line of Hemashield(R) grafts and fabrics for peripheral vascular
and cardiovascular indications.
13blood stream infection.
-12-
MARKETING AND SALES
Within its Cardiovascular and Endosurgery groups,In early 2003, Boston Scientific announced a master branding initiative. This
initiative marks the Company's evolution from a collection of divisional
identities into one, unified organization. The master brand will enable the
Company marketsto strengthen recognition of the Boston Scientific name and build equity
in that name. It will convey the depth and breadth of the Company, helping to
grow the business, recruit and retain superior talent, and ultimately to
increase shareholder value.
The initiative's tag line: Delivering what's next.(TM) conveys the essence of
Boston Scientific: a committed, forward looking company executing on its
products through six principal operating divisions, each focusing upon
physicians who specialize inpromises and bringing the diagnosislatest medical innovations to its customers and treatment of different medical
conditions and disease states.
Scimed: markets devices to interventional cardiologists,
interventional radiologists and vascular surgeons for the
diagnosis and treatment of coronary and peripheral vascular
disease and other cardiovascular disorders.
EP Technologies: offers a line of electrophysiology catheters and systems for
use by interventional electrophysiologists in the diagnosis
and treatment of tachyarrhythmias.
Target: markets a line of micro-guidewires, micro-catheters, coils,
embolics and other medical devices which aid
neuroradiologists and neurosurgeons in the treatment of
neurovascular diseases.
Medi-tech: markets devices to interventional radiologists and vascular
surgeons who treat abdominal aortic aneurysmal disease,
diseases requiring management of cancerous and non-cancerous
tumors and patients requiring venous access.
Microvasive markets therapeutic, diagnostic and palliative devices,
Endoscopy: which aid gastroenterologists and pulmonologists in
performing flexible endoscopic procedures involving the
digestive tract and lungs.
Microvasive offers a line of therapeutic and diagnostic devices which
Urology: aid urologists and urogynecologists in performing
ureteroscopic and other less-invasive endoscopic procedures
as well as devices to treat urinary incontinence.their
patients.
A dedicated sales force of approximately 1,200 individuals in over 40 countries
internationally and over 800 individuals in the United States marketU.S. marketed the Company's
products worldwide.worldwide as of December 31, 2003. Sales in countries where the Company
has direct sales organizations accounted for approximately 99%99 percent of the
Company's net sales during 2001.2003. A network of distributors and dealers who offer
the Company's products in approximately 30more than 35 countries worldwide accounts for the
remaining sales. The Company also has a dedicated U.S. corporate sales organization
in the U.S. focused principally on selling to major buying groups and large
integrated health care networks.
In 2001,2003, the Company sold its products to over 10,000 hospitals, clinics,
out-patient facilities and medical offices. The Company is not dependent on any
single institution and no single 14
institution accounted for more than 10%10 percent
of the Company's net sales in 2001.2003. Large group purchasing organizations,
hospital networks and other buying groups are,have, however, becomingbecome increasingly
important to the Company's business.business and represent a significant portion of the
Company's U.S. net sales. The trend toward managed care, and economically motivated
and more sophisticated buyers in the United StatesU.S. may result in continued pressure on
selling prices of certain products and resulting compression on gross margins. TheseFurther, the U.S.
marketplace is increasingly characterized by consolidation among health care
providers and purchasers of medical devices also tend to limit the number of
suppliers from whom they purchase medical products. There can be no assurance
that these entities will continue to purchase products from the Company.
The Company markets NIR(R) coronary stent systems which represented
approximately 11% of the Company's 2001 worldwide sales compared to
approximately 15% in 2000. Sales of the NIR(R) coronary stent declined
throughout 2001; sales of the NIR(R) coronary stent in the fourth quarter of
2001 decreased by approximately 50% as compared to NIR(R) coronary stent sales
recorded in the first quarter of 2001. The Company anticipates that its global
NIR(R) coronary stent market share will continue to decline during 2002 as
physician acceptance of the current NIR(R) coronary stent platform continues to
erode. The NIR(R) coronary stent system consists of a NIR(R) coronary stent
developed and manufactured by Medinol Ltd., Israel, and a balloon delivery
system developed and manufactured by the Company. The Company is currently in
litigation with Medinol with respect to the stent supply agreement and the
management of Medinol.
The Company also distributes several othercertain products for third parties, including an
introducer sheath, certain guidewires and certain guidewires. None ofacellular tissue for use in connection
with urology and gynecology procedures. Together, these otherdistributed products
represented moreless than 10%10 percent of the Company's 20012003 net sales. Leveraging its
sales and marketing strength, the Company expects to continue to seek new
opportunities for distributing complementary products as well as new
technologies.
The Company expects that it will continue to enter into
distribution arrangements that include options to acquire technology from third
parties at pre-established future dates. These distribution arrangements allowINTERNATIONAL OPERATIONS
Internationally, the Company to evaluate new technologies prior to acquisition.
INTERNATIONAL OPERATIONSoperates through three business segments divided
among the geographic regions of Europe, Japan and Inter-Continental. Maintaining
and
-13-
expanding its international presence is an important component of the Company's
long-term growth plan. Through its international presence, the Company seeks to
increase net sales and market share, leverage relationships with leading
physicians and their clinical research programs, accelerate the time within
which new products can be brought to market and gain access to worldwide
technological developments that may be implemented across its product lines.
In 2001, internationalInternational sales accounted for approximately 40%45 percent of the Company's net
sales.sales in 2003. Net sales, operating income (excluding special charges) and total
assets attributable to significant geographic areas are presented in Note OP to
the Company's 2001 Consolidated Financial
15
Statements,2003 consolidated financial statements, which are filed with the
Securities and Exchange Commission as an exhibit to this document.
In recent years, the Company has expanded its direct sales presence worldwide so
as to be in a position to take advantage of expanding market opportunities. As
of December 31, 2001,2003, the Company had direct marketing and sales operations in
over 40 countries internationally. The Company believes that it will continue to
leverage its infrastructure in markets where commercially appropriate and to use
distributorsthird parties in those smaller markets where it is not economical or strategic
to establish a direct presence.
The Company has four international manufacturing facilities in Ireland.
Presently, approximately 51%30 percent of the Company's products sold internationallyworldwide are
manufactured at these facilities. The Company also maintains an international
research and development facility in Ireland and a training and research and
development center in Miyazaki, Japan.
The Company's international presence exposes it to certain financial and other
risks. Principal among these is the potentially negative impact of foreign
currency fluctuations on the Company's sales and expenses. Although the Company
engages in nonspeculative hedging transactions that may offset the effect of
fluctuations in foreign currency exchange rates on foreign currency denominated
assets, liabilities, earnings and cash flows, financial exposure may nonetheless
result, primarily from the timing of transactions, forecast volatility and the
movement of exchange rates.
International markets are also being affected by economic pressure to contain
reimbursement levels and health care costs. The Company's ability to benefitprofitability from its
international expansionoperations may be limited by risks and uncertainties relatingrelated to
economic conditions in these regions, regulatory and reimbursement approvals,
competitive offerings, infrastructure development, rights to intellectual
property, and the ability of the Company to implement its overall business
strategy. Any significant changes in the competitive, political, legal,
regulatory, reimbursement or economic environment where the Company conducts
international operations may have a material impact on revenues and profits.profits,
especially in Japan, given its high profitability relative to its contribution
to revenues.
-14-
Further, the trend in countries around the world, including Japan, toward more
stringent regulatory requirements for product clearance, changing reimbursement
models and more vigorous enforcement activities has generally caused or may
cause medical device manufacturers to experience more uncertainty, greater risk
and higher expenses. In addition, the Company is required to renew regulatory
approvals in certain international jurisdictions, which may require additional
testing and documentation. A decision not to dedicate sufficient resources or,
the failure to timely renew these approvals may limit the Company's ability to
market its full line of existing products within these jurisdictions.
MANUFACTURING; RAW MATERIALS
The Company designs and manufactures the majority of its products in sixteen
manufacturing sitestwenty-one
technology centers around the world. During 2000, theThe Company approved and
committed tohas completed a global
operations plan consisting of a series of strategic initiatives designed to
increase productivity and enhance innovation. The Company's plan 16
includes manufacturing process and supply chain programs and a plant
optimization initiative. The manufacturing process and supply chain programs
are designed to lower inventory levels and the cost of manufacturing and to
minimize inventory write-downs. The intent of the plant optimization
initiative is to better allocate the Company's resources by creating a more
effective network of manufacturing and research and development facilities.
The Company is currentlyresulted in the
processconsolidation of consolidating manufacturing operations along product lines, andthe shifting of
significant amounts of production to the Company's facilities in Miami and
Ireland and to contract manufacturing. The Company's plan includesmanufacturing, and resulted in the discontinuation of
manufacturing activities at three facilities in the U.S., The Company's
plan also included a manufacturing process control initiative which strengthened
the Company's technological resources to improve quality, reduce cost and
includes the
planned displacement of approximately 1,800 manufacturing, manufacturing
supportaccelerate time to market. A supply chain optimization initiative focusing on
procurement and inventory management employees. The Company expects the plan will be
substantially completed during the first half of 2002.programs has decreased inventory levels,
lowered inventory holding costs and reduced inventory write-offs.
Most components used in the manufacture of the Company's products are readily
fabricated from commonly available raw materials or off-the-shelf items
available from multiple supply sources. The fabricated items are custom made for
the Company to meet its specifications. The Company believes that in most cases,
redundant capacity exists at theits suppliers and that alternative sources of
supply are available or could be developed within a reasonable period of time.
Generally, the Company has been able to obtain adequate supplies of raw
materials and components in a timely manner from established sources. In certain
cases, the Company may not be able to quickly establish additional or
replacement suppliers for specific components or materials, largely due to the
FDA approval system and other regulatory requirements and the complex nature of
the manufacturing processes employed by the Company and many suppliers.
TheA reduction or interruption in supply, an inability to develop and validate
alternative sources if required, or a significant increase in the price of raw
materials or components could adversely affect the Company's operations and
financial condition.
17
condition, particularly materials or components related to the
Company's TAXUS paclitaxel-eluting coronary stent system.
QUALITY ASSURANCE
The Company is committed to providing high quality products to its customers. To
meet this commitment, the Company has implemented state-of-the-art quality
systems and
-15-
concepts throughout the organization. The Company's quality system starts with
the initial product specification and continues through the design of the
product, component specification process and the manufacturing, sales and
servicing of the product. The quality system is designed to build in quality and
to utilize continuous improvement concepts throughout the product life. CertainThese
systems enable the Company to satisfy the quality system regulations of the FDA
with respect to products sold in the U.S. Many of the Company's operations are
certified under ISO 9001, ISO 9002, ISO 13485, ISO 13488, EN46001EN 46001 and EN46002EN 46002
international quality system standards. ISO 9002 requires, among other items, an
implemented quality system that applies to component quality, supplier control
and manufacturing operations. In addition, ISO 9001 and EN46001EN 46001 require an
implemented quality system that applies to product design. These certifications
can be obtained only after a complete audit of a company's quality system by an
independent outside auditor. Maintenance of these certifications requires that
these facilities undergo periodic reexamination. In March 2003, the Company
received corporate certification to ISO 9001 and ISO 13485. The Company also
received Canadian Medical Device Conformity Assessment System certification for
its quality system in December 2003. During 2001,2002, the Company established an
initiative to becomeseek ISO 14001 certification at various plants around the world.
ISO 14001, the environmental management system (EMS) standard in the ISO 14000
certified.series, provides a voluntary framework to identify key environmental aspects
associated with the Company's businesses. The Company engages in continuous
environmental performance improvement around these aspects. At present, nine of
the Company's manufacturing and distribution facilities have attained ISO 14001
certification and two additional facilities expect to become certified during
2004. This initiative will continue until oureach of the Company's manufacturing
facilities becomebecomes certified.
COMPETITION
The Company encounters significant competition across its product lines and in
each market in which its products are sold from various entities, some of which
may have greater financial and marketing resources than the Company. The
Company's primary competitors include C.R. Bard,include: Abbott Laboratories, Inc., Cook, Inc.,
Guidant Corporation Tyco International,(including its subsidiary Advanced Cardiovascular Systems,
Inc.), Johnson & Johnson (including its subsidiary, Cordis Corporation), and
Medtronic, Inc. (including its subsidiary, Medtronic AVE, Inc.), as well as a
wide range of companies which sell a single or limited number of competitive
products.products or participate only in specific market segment. In addition, the
worldwide coronary stent market is dynamic and highly competitive, with
significant market share volatility. Technology and competitive offerings,
particularly further competitive entries in the earlier introduction of drug-eluting stents by the Company's competitors,stent market, may
negatively impact the Company's revenues. The Company also faces competition
from non-medical device companies, such as pharmaceutical companies, which may
offer non-surgical alternative therapies for disease states which are currently
or intended to be treated using the Company's products.
The Company believes that its products compete primarily on the basis of their
ability to safely and effectively perform diagnostic and therapeutic procedures
in a less-invasive
-16-
manner, ease of product use, product reliability and physician familiarity. In
the current environment of managed care, economically motivated buyers,
consolidation among health care providers, increased competition and declining
reimbursement rates, the Company has also been increasingly required 18
to compete
on the basis of price.price, value and efficiency. The Company believes that its
continued competitive success will depend upon its ability to create or acquire
scientifically advanced technology, apply its technology cost-effectively across
product lines and markets, develop or acquire proprietary products, attract and
retain skilled development personnel, obtain patent or other protection for its
products, obtain required regulatory and reimbursement approvals, and manufacture
and successfully market its products either directly or through outside parties.
RESEARCH AND DEVELOPMENT
Enhancements of existing products or expansions of existing product lines, which
are typically developed within the Company's manufacturingparties
and marketing
operations, contributesupply sufficient inventory to each year's sales growth. The Company believes that
streamlining and coordinating its technology pipeline and new product
development is essential to its ability to stimulate growth and maintain
leadership positions in its markets. By centralizing platform technology
development at the corporate level, the Company is able to pursue technologies
that can be leveraged across multiple markets. The Company's approach to new
product design and development is through focused, cross functional efforts. The
Company believes that its formal process for technology and product development
aids in its ability to offer innovative and manufacturable products in a
consistent and timely manner. Involvement of the R&D, clinical, quality,
regulatory, manufacturing and marketing teams early in the process is the
cornerstone of a product development cycle. This collaboration allows the team
to concentrate resources on the most viable and profitable new products and
technologies and get them to market in a timely manner.
In 2001, the Company expended approximately $275 million on research and
development, representing approximately 10% of the Company's 2001 net sales. The
investment in research and development dollars reflects spending on new product
development programs as well as regulatory compliance and clinical research. The
increase in research and development is primarily due to increased funding for
the development of, and the clinical trials related to, new products, including
the Company's Express(TM) coronary stent platform, its TAXUS(TM) drug-eluting
stent program, its carotid program and programs acquired in connection with the
Company's business combinations consummated in 2001. In 2002, the Company
expects to increase its investment in research and development over 2001 levels
in order to fund the development of new products and to expand clinical trials,
including the Company's Taxus drug-eluting stent program, carotid program and
Express coronary stent platform.
In addition to internal development, the Company works with hundreds of leading
research institutions, universities and clinicians around the world in
developing, evaluating and clinically testing its products.
The Company believes its future success will depend upon the strength of its
development efforts. There can be no assurance that the Company will realize
financial benefit from its
19
development programs, will continue to be successful in identifying, developing
and marketing new products or enhancing its existing products, or that products
or technologies developed by others will not render the Company's products or
technologies non-competitive or obsolete.meet customer demand.
REGULATION
The medical devices manufactured and marketed by the Company are subject to
regulation by numerous regulatory bodies, including the FDA and comparable
international regulatory agencies. These agencies require manufacturers of
medical devices to comply with applicable laws and regulations governing the
development, testing, manufacturing, labeling, marketing and distribution of
medical devices. Devices are generally subject to varying levels of regulatory
control, the most comprehensive of which requires that a clinical evaluation
program be conducted before a device receives approval for commercial
distribution.
In the United States,U.S., permission to distribute a new device generally can be met in one
of two ways. The first process requires that a pre-market notification (the
"510(k) Submission") be made to FDA to demonstrate that the device is as safe
and effective, that is, substantially equivalent to a legally marketed device
that is not subject to pre-market approval ("PMA")(PMA). Applicants must compare this
device to one or more similar devices commercially available in the United StatesU.S. and
make and support their substantial equivalency claims. A legally marketed device
is a device that (i) was legally marketed prior to May 28, 1976, (ii) has been
reclassified from Class III to Class II or I, or (iii) has been found to be
substantially equivalent to a device following a 510(k) Submission. The legally
marketed device(s) to which equivalence is drawn is known as the "predicate"
device(s). Applicants must submit descriptive data and, when necessary,
performance data to establish that the device is substantially equivalent to a
predicate device. If clinicalIn some instances, data from human experience are
required toclinical trials must also
be submitted in support of a 510(k) Submission,Submission. If so, these data must be
gatheredcollected in compliancea manner that conforms with investigational device exemption ("IDE") regulations for
investigations performedspecific requirements in the United States.accordance
with federal regulations. The FDA must issue an order finding substantial
equivalence before commercial distribution can occur. Changes to existing
devices covered by a 510(k) Submission which do not significantly affect safety
or effectiveness can generally be made by the Company without additional 510(k)
Submissions.
The second process requires that an application for PMA be made to the FDA to
demonstrate that the device is safe and effective for its intended use as
manufactured. This approval process applies to certain Class III devices. In
this case, two steps of FDA
-17-
approval are generally required before marketing in the United StatesU.S. can begin. First,
the Company must comply with IDEinvestigational device exemption (IDE) regulations
in connection with any human clinical investigation of the device in the United
States.U.S.
Second, the FDA must review the Company's PMA application which contains, among
other things, clinical information acquired under the IDE. The FDA will approve
the PMA application if it finds that there is a reasonable assurance that the
device is safe and effective for its intended purpose.
20
The FDA can ban certain medical devices, detain or seize adulterated or
misbranded medical devices, order repair, replacement or refund of these
devices, and require notification of health professionals and others with regard
to medical devices that present unreasonable risks of substantial harm to the
public health. The FDA may also enjoin and restrain certain violations of the
Food, Drug and Cosmetic Act and the Safe Medical Devices Act pertaining to
medical devices, or initiate action for criminal prosecution of such violations.
International sales of medical devices manufactured in the United StatesU.S. that are not
approved by the FDA for use in the United States,U.S., or are banned or deviate from lawful
performance standards, are subject to FDA export requirements. The Export Reform
Act of 1996 has simplified the process of exporting devices which have not been
approved for sale in the United States.U.S.
Exported devices are subject to the regulatory requirements of each country to
which the device is exported. In manySome countries do not have medical device
regulations, but in most foreign countries all regulated medical productsdevices are treated as drugs and the majority of the Company's products are
expected to be so regulated in these countries.regulated.
Frequently, regulatory approval may first be obtained in a foreign country prior
to application in the United
StatesU.S. to take advantage of differing regulatory
requirements.
In the European Union, the Company is required to comply with the Medical
Devices Directive and obtain CE mark certification in order to market medical
devices. The CE mark certification, granted following approval from an
independent Notified Body, is an international symbol of adherence to quality
assurance standards and compliance with applicable European Medical Devices
Directives. The Company has
completed CE Mark registrations for substantiallyalso complies with all other foreign regulations such as
MHLW (Ministry of itsHealth Labor and Welfare) approval in Japan. The time required
to obtain these foreign approvals to market the Company's products in
accordance with the implementation of various medical device directivesmay be longer
or shorter than that required in the European Union.U.S., and requirements for such approval
may differ from those required by the FDA.
The process of obtaining clearance to market products is costly and
time-consuming in virtually all of the major markets in which the Company sells
products and can delay the marketing and sale of new products. Countries around
the world have recently adopted more stringent regulatory requirements which are
expected to add to the delays and uncertainties associated with new product
releases, as well as the clinical and regulatory costs of supporting such
releases. No assurance can be given that any of the Company's new medical
devices will be approved on a timely basis, if at all. In addition, regulations
regarding the development, manufacture and sale of medical devices are subject
to future change. The Company cannot predict what impact, if any, such changes
might have on its
-18-
business. Failure to comply with regulatory requirements could have a material
adverse effect on the Company's business, financial condition and results of
operations.
The Company is also subject to environmental laws and regulations both in the
United StatesU.S. and abroad. The operations of the Company, like those of other medical
device companies, involve the use of substances regulated under environmental
laws, primarily in manufacturing and sterilization processes. The Company
believes that compliance with environmental laws will not have a material impact
on its financial position, results of operations, or liquidity. Given the scope
and nature of these laws, there can, however, be no assurance that environmental
laws will not have a material impact on the Company.
21
THIRD-PARTY COVERAGE AND REIMBURSEMENT
The Company's products are purchased by hospitals, doctors and other health care
providers who are reimbursed for the health care services provided to their
patients by third-party payors,payers, such as governmental programs (e.g., Medicare
and Medicaid), private insurance plans and managed care programs. Third party
payorspayers may provide or deny coverage for certain technologies and associated
procedures based on assessment criteria as determined by the third-party payor. Also,payer.
Reimbursement by third-party payorspayers for these services is based on a wide range
of methodologies that may reflect the services' assessed resource costs,
clinical outcomes and economic value. These reimbursement methodologies confer
different, and often conflicting, levels of financial risk and incentives to
health care providers and patients, and these methodologies are subject to
frequent refinements. Third party payers are also increasingly adjusting
reimbursement rates and challenging the prices charged for medical products and
services. There can be no assurance that the Company's products will be
automatically covered by third-party payors,payers, that reimbursement will be
available or, if available, that the third-party payors'payers' coverage policies will
not adversely affect the Company's ability to sell its products profitably.
Initiatives to limit the growth of healthcare costs, including price regulation,
are also underway in many countries in which the Company does business.
Implementation of healthcare reforms in significant markets such as Japan,
Europe, and other countries may limit the price of, or the level at which
reimbursement is provided for, the Company's products and may influence a
physician's selection of products used to treat patients.
-19-
PROPRIETARY RIGHTS AND PATENT LITIGATION
The interventional medicine market in which the Company primarily participates
is in large part technology driven. Physician customers, particularly in
interventional cardiology, move quickly to new products and new technologies. As
a result, intellectual property rights, particularly patents and trade secrets,
play a significant role in product development and differentiation. Intellectual
property litigation to defend or create market advantage, is however, inherently
complex and unpredictable. Furthermore, appellate courts frequently overturn
lower court patent decisions.
In addition, competing parties frequently file multiple suits to leverage patent
portfolios across product lines, technologies and geographies and to balance
risk and exposure between the parties. In some cases, several competitors are
parties in the same proceeding, or in a series of related proceedings, or
litigate multiple features of a single class of devices. These forces frequently
drive settlement of not only individual cases, but of a series of pending and
potentially related and unrelated cases. In addition, although monetary and
injunctive relief is typically sought, remedies and restitution are generally
not determined until the conclusion of the proceedings, and are frequently
modified on appeal. Accordingly, the outcomes of individual cases are difficult
to time, predict or quantify and are often dependent upon the outcomes of other
cases in other geographies.
Several third parties have asserted that the Company's current and former stent
systems infringe patents owned or licensed by them. Adverse outcomes in one or
more of these proceedings could limit the Company's ability to sell certain
stent products in certain jurisdictions, or reduce the Company's operating
margin on the sale of these products. In addition, damage awards related to
historical sales could be material. The Company has similarly asserted that
stent systems or other products sold by these companies infringe patents owned
or licensed by the Company.
The Company relies on a combination of patents, trademarks, trade secrets and
non-disclosure agreements to protect its intellectual property. The Company
generally files patent applications in the United StatesU.S. and foreign countries where
patent protection for its technology is appropriate and available. The
Company holds moreMore than
2,400 United States3,200 U.S. patents (many of which have foreign counterparts) are held by the
Company and has more than 4,500approximately 5,100 patent applications are pending worldwide that
cover various aspects of itsthe Company's technology. In addition, the Company
holds exclusive and non-exclusive licenses to a variety of third party
technologies covered by patents and patent applications. There can be no
assurance that pending patent applications will result in issued patents, that
patents issued to or licensed by the Company will not be challenged or
circumvented by competitors, or that such patents will be found to be valid or
sufficiently broad to protect the Company's technology or to provide the Company
with a competitive advantage.
The Company relies on non-disclosure and non-competition agreements with
employees, consultants and other parties to protect, in part, trade secrets and
other proprietary technology. There can be no assurance that these agreements
will not be breached, that
-20-
the Company will have adequate remedies for any breach, that others will not
independently develop equivalent proprietary information or that third parties
will not otherwise gain access to the Company's trade secrets and proprietary
knowledge.
There has been substantial litigation regarding patent and other intellectual
property rights in the medical device industry, particularly in the areas in
which the Company competes. The Company has defended, and will likely continue
to defend, itself against claims and legal actions alleging infringement of the
patent rights of others. Adverse determinations in any patent litigation could
subject the Company to significant liabilities to third parties, could require the
Company to seek licenses from third parties, and, could, if licenses are not available,
prevent the Company from manufacturing, selling or using certain of its
products, some of which could have a material adverse effect on the Company.
Additionally, the Company may find it necessary to initiate
22
litigation to
enforce its patent rights, to protect its trade secrets or know-how and to
determine the scope and validity of the proprietary rights of others. Patent
litigation can be costly and time-consuming, and there can be no assurance that
the Company's litigation expenses will not be significant in the future or that
the outcome of litigation will be favorable to the Company. Accordingly, the
Company may seek to settle some or all of its pending litigation. Settlement may
include cross-licensing of the patents which are the subject of the litigation
as well as other intellectual property of the Company and may involve monetary
payments to or from third parties.
OTHER LITIGATION AND RISK MANAGEMENT
The testing, marketing and sale of human health care products entails an
inherent risk of product liability claims. The Company is involved in various
lawsuits arising in the normal course of business from product liability claims,claims.
At the beginning of the third quarter of 2002, the Company elected to become
substantially self-insured with respect to general and product liability claims may be asserted inclaims.
As a result of the future relative
to events not known to management ateconomic factors impacting the present time. The Company hasinsurance industry, meaningful
liability insurance coverage whichbecame unavailable while the cost of insurance
became economically prohibitive. The absence of third party insurance increases
the Company's exposure to unanticipated claims or adverse decisions. However,
based on product liability losses experienced, the decision to become
self-insured is not expected to have a material impact on future operations.
Management believes that the Company's risk management believes ispractices, including
limited insurance coverage, are reasonably adequate to protect against
anticipated general and product liability losses. However, unanticipated
catastrophic losses as could otherwise materially affecthave a material adverse impact on the Company's
financial position. However, there can be no assurance that product liability
claims will not exceed such insurance coverage limits or that such insurance
will be available in the future on commercially reasonable terms, if at all.position, results of operations and liquidity.
See the "Legal Proceedings" section below and Note L - Commitments and
Contingencies to the Company's 2001 Consolidated Financial Statements2003 consolidated financial statements (Exhibit
13.1 filed herewith) for a further discussion of patent and other litigation and
proceedings involving the Company.
-21-
EMPLOYEES
As of December 31, 2001,2003, the Company had approximately 14,40015,000 employees,
including approximately 8,500more than 7,800 in operations, 1,7001,600 in administration, 1,2001,800 in
clinical and research and development and 3,0003,600 in selling, marketing,
distribution and related administrative support. Of these employees,
approximately 3,3002,900 were employed in the Company's international operations. The
Company believes that the continued success of its business will depend, in
part, on its ability to attract and retain qualified personnel.
SEASONALITY
Worldwide sales do not reflect any significant degree of seasonality, however
customer purchases have been lighter in the third quarter of prior years than in
other quarters. This reflects, among other factors, lower demand during summer
months, particularly in European countries.
23
AVAILABLE INFORMATION
Copies of the Company's annual report on Form 10-K, quarterly reports on Form
10-Q, current reports on Form 8-K and amendments to those reports filed or
furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of
1934 are available free of charge through the Company's website
(www.bostonscientific.com) as soon as reasonably practicable after the Company
electronically files the material with or furnishes it to the Securities and
Exchange Commission (SEC). The Company's proxy statement and Code of Conduct
(and amendments thereto), which applies to all directors, officers and employees
of the Company, including its Board of Directors, Chief Executive Officer and
Chief Financial Officer, are also available on the Company's website. Printed
copies of these materials are also available free of charge to shareholders that
request them in writing from Investor Relations. Information on the Company's
website or connected thereto is not incorporated by reference into this Form
10-K.
CAUTIONARY STATEMENT FOR PURPOSES OF THE SAFE HARBOR PROVISIONS OF THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
The Cautionary Statement for Purposes of the Safe Harbor Provisions of the
Private Securities Litigation Reform Act of 1995 appearing on pages 1130 through
1231 of the Company's 2001 Consolidated Financial Statements2003 consolidated financial statements (Exhibit 13.1 filed
herewith) is incorporated herein by reference.
-22-
ITEM 2. PROPERTIES
The Company's world headquarters are located in Natick, Massachusetts. It
maintains regionalRegional
headquarters are located in Tokyo, Japan; Paris, France and Singapore. As of
December 31, 2001,2003, the Company's worldwide facilities (including
administration,manufacturing, research, manufacturing, distribution and sales and marketing
space)other
key facilities totaled approximately 5.3more than 5.5 million square feet of which approximately
76%more than 4.5
million square feet was owned by the Company and the balance wasis leased. As of
December 31, 2001,2003, the Company's principal technology centers were located in
Massachusetts, Indiana, Minnesota, New Jersey, Florida, California, Washington,
Utah, New York, and Ireland and Japan, and its principal distribution centers were located
in Massachusetts, The Netherlands Japan and Singapore.Japan. As of December 31, 2001,2003, the
Company maintained twenty-one technology centers, sixteen manufacturing facilities,
twelve in the United States andU.S., four in
Ireland.Ireland and one in Japan. Many of these manufacturing facilities produce and manufacture
products for more than one of the Company's divisions and include research
facilities.
The Company believes
that its facilities are adequate to meet its current needs and continues to
assess its plant network strategy.
(in square feet) TOTAL SPACE OWNED LEASED
-----------------------------------------------------
Domestic 4,703,000 3,893,000 810,000
Foreign 875,000 653,000 222,000
----------------------------------------------------
TOTAL 5,578,000 4,546,000 1,032,000
ITEM 3. LEGAL PROCEEDINGS
Note L - Commitments and Contingencies to the Company's 2001 Consolidated
Financial Statements,2003 consolidated
financial statements, appearing on pages 2860 through 3369 thereto (Exhibit 13.1
filed herewith), is incorporated herein by reference. The following paragraphs
update the disclosure appearing in Note L.
RECENT PATENT-23-
LITIGATION ACTIVITYWITH JOHNSON & JOHNSON
On March 20, 21 andOctober 22, 1997, the Company (through its subsidiaries) filed
additional suits against Johnson & Johnson (through its subsidiaries) in Sweden,
Italy and Spain, respectively, seeking a declaration of noninfringement for the
NIR(R) stent relative to one of the European patents licensed to Ethicon, Inc.Cordis Corporation (Cordis), a subsidiary of Johnson &
Johnson, in Sweden, Italy and Spain andfiled a declaration
of invalidity in Italy and Spain. In Italy, a technical expert was appointed by
the court and a hearing was held January 30, 2002. Both parties have an
opportunity to comment on the expert report with briefs to be filed by April 15,
2002. The next hearing is scheduled for May 8, 2002.
24
On April 14, 2000, the Company (through its subsidiaries) and Medinol filed suit for patent infringement against Johnson & Johnson, Cordis Corporation,the Company and SCIMED
Life Systems, Inc. (SCIMED), a subsidiary of Johnson & Johnson ("Cordis") and a subsidiary of Cordisthe Company, alleging that a patentthe
importation and use of the NIR(R) stent infringes two patents owned by Medinol and exclusively licensed toCordis.
On April 13, 1998, Cordis filed a suit for patent infringement against the
Company is
infringedand SCIMED alleging that the Company's NIR(R) stent infringes two
additional patents owned by Cordis' BX Velocity(TM) stent delivery system.Cordis. The complaint wassuits were filed in the U.S. District
Court for the District of Delaware seeking monetary damages, injunctive relief
and injunctive relief. The Minnesota action was transferred tothat the U.S. District
Court for the District of Delawarepatents be adjudged valid, enforceable and consolidated with the Delaware action
filed by the Company.infringed. A trial on
both actions was held in August 2001 on both actions. On
September 7, 2001, alate 2000. A jury found that Cordis' BX Velocity, Crown, and MINICrown
stents dothe NIR(R) stent does not
infringe thethree Cordis patents, and that the asserted claimsbut does infringe one claim of those
patents are invalid. The jury also found that Cordis' CORINTHIAN stent infringes
a valid Medinolone Cordis patent claim
and awarded damages of approximately $324 million to Cordis. On March 28, 2002,
the Court set aside the damage award, but upheld the remainder of the verdict,
and held that two of the four patents had been obtained through inequitable
conduct in the U.S. Patent and Trademark Office. On May 16, 2002, the Court also
set aside the verdict of infringement, requiring a new trial. The case had been
stayed until October 10, 2003, pending the outcome of a related case. On October
14, 2003, Cordis filed a motion to revise and vacate the Court's decision to
grant the Company a new trial and Medinol $8.3 million in
damages. Post-trial briefing motions were held through December 2001 and on
January 25, 2002,asked the court entered final judgment on the Corinthian stent in
favor ofCourt to enter judgement against the
Company. The Company filed an opposition to Cordis' motion. On February 14,
2004, the Court denied Cordis' motion. A post-trial hearing was held on February 26, 2002.
Judgmentstatus conference has not yet been entered by the Court.scheduled
for March 22, 2004.
On February 14, 2002, the Company and certain of its subsidiaries filed suit for
patent infringement against Medtronic, Inc. ("Medtronic"), Medtronic AVE, Inc.,
a subsidiary of Medtronic, Johnson & Johnson and Cordis alleging certain balloon
catheters, stent delivery systems and guide catheters sold by Medtronic and
Medtronic AVE infringe six U.S. patents owned by the Company and certain
balloon catheters, stent delivery systems, and guide catheters sold by Johnson &
Johnson and Cordis infringe five U.S. patents owned by the Company. The
complaint was filed in the U.S. District Court for the Northern District of
California seeking monetary and injunctive relief. On February 14,October 15, 2002, Scimed Life Systems,Cordis
filed a counter-claim alleging certain balloon catheters and stent delivery
systems sold by the Company infringe three U.S. patents owned by Cordis and
seeking monetary and injunctive relief. On December 6, 2002, the Company filed
an amended complaint alleging two additional patents owned by the Company are
infringed by the Cordis products. A summary judgment hearing is set for April 9,
2004, and trial is expected to begin in January 2005.
On March 26, 2002, the Company and Target Therapeutics, Inc. ("Scimed")(Target), a wholly
owned subsidiary of the Company, filed suit for patent infringement against
Medtronic and Medtronic AVECordis alleging Medtronic AVE's
Guardwire Plus(TM) product infringes onecertain detachable coil delivery systems and/or pushable coil
vascular occlusion systems (coil delivery systems) infringe three U.S. patentpatents,
owned by the Company.or exclusively licensed to Target. The complaint was filed in the U.S.
District Court for the Northern District of California seeking monetary and
injunctive relief. A summary judgment hearing is set for April 19, 2004, and
trial is expected to begin in October 2004.
-24-
On December 15, 2003, the Company and SCIMED filed suit for patent infringement
against Cordis and Johnson & Johnson alleging Cordis' Cypher(R) stent coating
infringes two U.S. patents owned by the Company. The suit was filed in the
District Court of Delaware seeking monetary and injunctive relief. Following the
announcement by Guidant Corporation (Guidant) on February 23, 2004 that it would
begin selling the Cypher drug ___, eluting stent with Johnson & Johnson and
Cordis, the Company moved to amend its complaint against Johnson & Johnson and
Cordis on February 25, 2004 to include Guidant and certain of its subsidiaries
as co-defendants. A trial is scheduled to begin in October 2005.
On December 24, 2003, the Company (through its subsidiary Schneider Europe GmbH)
filed suit against the Belgian subsidiaries of Johnson & Johnson, Cordis and
Janssen Pharmaceutica alleging that Cordis' Bx Velocity(R) stent, Bx Sonic(R)
stent, Cypher stent, Cypher Select stent, Aqua T3(TM) balloon and U-Pass
balloon infringe one of the Company's European patents. The suit was filed in
the District Court of Brussels, Belgium seeking cross-border, injunctive and
monetary relief. A separate suit was filed in the District Court of Brussels,
Belgium against nine additional Johnson & Johnson subsidiaries. On February 14,9,
2004, the Belgium Court linked all Johnson & Johnson entities into a single
action. A hearing is scheduled for June 7, 2004.
LITIGATION WITH GUIDANT CORPORATION
On February 20, 2004, the Company and Guidant Corporation (Guidant) entered into
an agreement to settle all of the outstanding litigation between the two
companies. In addition, the parties agreed to a cross-license of patents in
certain specified technology areas. All pending disputes have been dismissed
with prejudice.
On October 15, 2002, Scimed and Corvita Corporation,Advanced Cardiovascular Systems, Inc. (ACS), a subsidiary
of the
CompanyGuidant, filed suit for patent infringement against Medtronicthe Company and Medtronic AVESCIMED
alleging Medtronic's AneuRx productthe Company's Express stent infringes sevena U.S. patent owned by ACS. The
suit was filed in the U.S. District Court for the Northern District of
California seeking monetary damages and injunctive relief. On December 6, 2002,
the Company answered, denying allegations of the complaint and counterclaimed
seeking a declaration of invalidity, noninfringement and enforceability.
Pursuant to the settlement agreement, the case was dismissed with prejudice.
On December 3, 2002, ACS filed suit for patent infringement against the Company
and SCIMED alleging the Company's Express(R) stent infringes a U.S. patent owned
by ACS. The suit was filed in the U.S. District Court for the Northern District
of California seeking monetary and injunctive relief. On January 30, 2003, the
Company filed an answer denying allegations of the complaint and concurrently
filed a counterclaim seeking declaratory judgment of patent invalidity and
noninfringement and alleging that certain ACS products infringe five U.S.
patents owned by the Company. The Company seeks monetary and injunctive relief.
On March 17, 2003, ACS filed an amended complaint alleging an additional patent
is infringed by the Company's product. Pursuant to the settlement agreement, the
case was dismissed with prejudice.
-25-
On January 28, 2003, ACS filed suit for patent infringement against the Company
and SCIMED alleging the Company's Express stent infringes a U.S. patent owned by
ACS. The suit was filed in the U.S. District Court for the Northern District of
California seeking monetary and injunctive relief. On August 13, 2003, ACS filed
an amended complaint alleging the Company's Express stent infringes a second
U.S. patent owned by ACS. Pursuant to the settlement agreement, the case was
dismissed with prejudice.
On December 30, 2002, the Company and certain of its subsidiaries filed suit for
patent infringement against Guidant, Guidant Sales Corporation and ACS alleging
that certain stent delivery systems (Multi-Link Zeta(R) Stent and Multi-Link
Penta(R) Stent) and balloon catheter products (AGILTRAC(TM) catheter) sold by
Guidant and ACS infringe nine U.S. patents owned by the Company. The complaint
was filed in the U.S. District Court for the Northern District of DelawareCalifornia
seeking monetary and injunctive relief. On February 21, 2003, Guidant filed an
answer denying the allegations of the complaint and filed a counterclaim seeking
declaratory judgment of patent invalidity and noninfringement and alleging that
certain Company products infringe patents owned by ACS. Pursuant to the
settlement agreement, the case was dismissed with prejudice.
LITIGATION RELATING TO COOK, INC.
On September 10, 2001, the Company delivered a Notice of Dispute to Cook, Inc.
("Cook")(Cook) asserting that Cook breached the terms of a certain License Agreement
among Angiotech Pharmaceuticals, Inc. (Angiotech), Cook and the Company (the
"Agreement").
On October 10, 2001, pursuant to the terms of the Agreement, the Company filed a
demand for arbitration with the American Arbitration Association. On October 11,
2001, Guidant and its subsidiary, Advanced Cardiovascular Systems, Inc. (ACS),
and Cook filed suit against the CompanyAgreement) relating to the Agreement. The suit was
filed in the U.S. District Court for the Southern District of Indianaan improper arrangement between Cook and 25
sought declaratory and injunctive relief. The parties subsequently negotiated an
agreement under which the dispute would be litigated on an expedited basis in
the Northern District of Illinois without Guidant or ACS as parties.Guidant. On
December 13, 2001, the Indiana case was dismissed and Cook filed a similar suit in the U.S. District Court for the Northern
District of Illinois seeking declaratory and injunctive relief. The Company
answered the complaint on December 26, 2001, denying the allegations and filed
counterclaims seeking declaratory and injunctive relief. On February 28,June 27, 2002, the
Court dismissedfound in favor of the Company, ruling that Cook breached the Agreement. On
October 1, 2002, the Court granted the Company's request for a permanent
injunction prohibiting certain claimsactivities under the Agreement and setenjoining the
use of the clinical data and technologies developed by Cook or Guidant in
violation of the Agreement. Cook appealed the decision to the U.S. Court of
Appeals for the Seventh Circuit. On June 6, 200219, 2003, the Court of Appeals affirmed
the District Court's decision. The Court of Appeals modified the District
Court's injunction by deleting language that would have prohibited the use of
clinical data to rule on summary judgment motions.obtain regulatory approval, but continued to enjoin the sale of
products. On April 5, 2001, MedinolFebruary 19, 2004, Cook filed a complaintmotion to dissolve the Court's
injunction, or in the alternative to modify the injunction to permit Cook to use
clinical data previously obtained to pursue regulatory approval to market a
paclitaxel-eluting stent. A hearing was held on March 1, 2004, followed by the
Court's request that both parties brief the issue. An in-court ruling is
expected on April 22, 2004.
-26-
OTHER PATENT LITIGATION
On December 16, 2003, The Regents of the University of California (The Regents)
filed suit against Micro Therapeutics, Inc. (Micro Therapeutics) and Dendron
GmbH (Dendron) alleging Micro Therapeutics' Sapphire (TM) detachable coil
delivery systems infringe twelve patents licensed by the Company and certain of
its current and former employees alleging breaches of contract, fraud and other
claims. Medinol supplies NIR(R) stents exclusively to the Company.owned by
The suitRegents. The complaint was filed in the U.S. District Court for the SouthernNorthern
District of New YorkCalifornia seeking monetary and injunctive relief. On April 26, 2001, Medinol amended itsJanuary 8,
2004, Micro Therapeutics and Dendron filed a third party complaint to add claims alleging misappropriation of trade secrets in relation to the
Company's Express(TM) stent development program. Medinol seeks monetary and
injunctive relief, as well as an end to the Company's right to distribute
Medinol stents and access to certain Company intellectual property. On April 30,
2001,include
the Company answered and countersued Medinol and its principals, charging
them with fraud, multiple breaches of contract, unfair and deceptive practices
and defamation. TheTarget as third party defendants. On February 17, 2004, the
Company, seeks monetary and injunctive relief. Duringas third party defendants, filed a motion to dismiss the last quarter of 2001, the Court dismissed several of the individuals and claimsCompany from
the case.
A trial date has not yet been set.LITIGATION WITH MEDINOL LTD.
On February 28, 2002,July 2, 2003, Medinol Ltd. (Medinol) filed a motion against the Company
received from Medinol,seeking a letter purporting to terminate the supply
agreement between the two companies alleging breaches of the supply agreement by
the Company. The Company intends to challenge Medinol's assertion that the
supply agreement has been terminated.
On June 11, 2001, the Company filed suit in the Jerusalem District Court in
Israel against Medinol and its controlling shareholders, alleging among other
things, loss of faith among Medinol's shareholders, breach of duty by Medinol
management and misappropriation of corporate opportunities, including trade
secrets and intellectual property. The suit seeks, among other things, monetary
relief and costs. Preliminary motions were heard on October 29, 2001. On March
14, 2002, the Court accepted jurisdictionpreliminary injunction with respect to certain claims and
ruled that certain claims fall within the jurisdictionsale of the New York Court.Express stent
in Germany. The German Court granted Medinol's motion effective September 23,
2003. The Company appealed the German Court's decision. A hearing was held on
February 26, 2004, and a decision is due April 13, 2004.
NIR is a registered trademark of Medinol Ltd., Jerusalem, Israel. Cypher, Bx
Velocity, Bx Sonic and Aqua T3 are trademarks of Cordis Corporation. Multi-Link
Zeta, Multi-Link Penta and AGILTRAC are trademarks of Advanced Cardiovascular
Systems, Inc. Sapphire is a trademark of Micro Therapeutics, Inc.
RECENT PATENT LITIGATION ACTIVITY
The Company is involved in various lawsuits from time to time. In management's
opinion, the Company is not currently involved in any legal proceedings other
than those specifically identified above or in Note L - Commitments and
Contingencies to the Company's 20012003 Consolidated Financial Statements which,
individually or in the aggregate, could have a material effect on the financial
condition, operations or cash flows of the Company.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
26A Special Meeting of Stockholders of the Company was held on October 6, 2003, at
which stockholders were asked to approve an amendment to the Company's
Certificate of Incorporation increasing the number of authorized common shares
from 600,000,000 to 1,200,000,000. Stockholders of the Company approved the
amendment by a vote of 359,246,082 for, 507,602 against and 1,667,038 abstained.
-27-
DIRECTORS AND EXECUTIVE OFFICERS OF THE COMPANY
The Directors and executive officers of the Company as of December 31, 20012003,
were as follows:
NAME AGE POSITION
- ---- --- --------
DIRECTORS:
John E. Abele 6466 Director, Founder
Chairman
Lawrence C. Best 51Ursula M. Burns 45 Director, Senior Corporate Vice President-Finance & AdministrationPresident and
Chief Financial OfficerPresident, Business Group Operations, Xerox
Corporation
Joseph A. Ciffolillo 6365 Director, Retired Private Investor
Fred A. Colen 49 Senior Vice President and Chief Technology Officer
Paul Donovan 46 Vice President, Corporate Communications
Joel L. Fleishman 6769 Director, Senior Advisor to the Atlantic Philanthropies and Professor of Law and Public Policy, Duke
University
Marye Anne Fox, Ph.D. 5456 Director, Chancellor of North Carolina State
University
Ray J. Groves 6668 Director, PresidentChairman and Chief OperatingExecutive Officer of
Marsh Inc.
Lawrence L. Horsch 67 Director, Chairman of Eagle Management & Financial Corp.
Paul A. LaViolette 44 Senior Vice President and Group President, Cardiovascular
Robert G. MacLean 58 Senior Vice President-Human Resources
Ernest Mario, Ph.D. 6365 Director, Founder of Apothogen, Inc.
Stephen F. Moreci 50 Senior Vice PresidentChairman and Group President, EndosurgeryChief Executive Officer,
Reliant Pharmaceuticals LLC
N.J. Nicholas, Jr. 6264 Director, Private Investor
John E. Pepper 65 Director, Vice President, Finance and
Administration,Yale University
Peter M. Nicholas 6062 Director, Founder, Chairman of the Board
Arthur L. Rosenthal,Uwe E. Reinhardt, Ph.D. 55 Senior Vice President and Chief Scientific Officer66 Director, James Madison Professor, Princeton
University
Senator Warren B. Rudman 7173 Director, Former U.S. Senator, Partner, Paul, Weiss,
Rifkind, Wharton, & Garrison
James R. Tobin 59 Director, President and Chief Executive Officer
EXECUTIVE OFFICERS:
Lawrence C. Best 53 Senior Vice President-Finance & Administration and
Chief Financial Officer
Fredericus A. Colen 51 Senior Vice President and Chief Technology Officer
Paul Donovan 48 Vice President, Corporate Communications
Paul A. LaViolette 46 Senior Vice President and Group President,
Cardiovascular
Robert G. MacLean 60 Senior Vice President, Human Resources
Stephen F. Moreci 52 Senior Vice President and Group President,
Endosurgery
Dennis A. Ocwieja 58 Senior Vice President, Regulatory Affairs and Quality
Paul W. Sandman 5456 Senior Vice President, Secretary and General Counsel
James H. Taylor, Jr. 6264 Senior Vice President, Corporate Operations
James R. Tobin 5759 Director, President and Chief Executive Officer
At the Company's 2002 Annual Meeting of Stockholders, stockholders will be asked
to vote for the election of Ursula M. Burns and Uwe E. Reinhardt, Ph.D. as new
members of the Board of Directors of the Company.
27-28-
COMMITTEES OF THE BOARD OF DIRECTORS
The Board of Directors of the Company has standing Audit, Executive Compensation
and Human Resources, Governance and Strategic Investment and Governance Committees. Joseph A.
Ciffolillo, Joel L.
Fleishman, Lawrence L. HorschMarye Anne Fox, Ernest Mario, John E. Pepper and Ernest MarioUwe E. Reinhardt
currently serve on the Audit Committee. Joel L. Fleishman, Marye Anne Fox,Warren B. Rudman, Ursula M. Burns,
Joseph A. Ciffolillo and Ray J. Groves
Lawrence L. Horsch and Senator Warren B. Rudman currently serve on the Executive
Compensation and Human Resources Committee. Ursula M. Burns, Joseph A.
Ciffolillo, Marye Anne Fox, Ernest Mario, N.J. Nicholas, Jr., John E. Pepper and
James R. Tobin currently serve on the Strategic Investment Committee. Joel L.
Fleishman, Ray J. Groves, Peter M. Nicholas, Uwe E. Reinhardt, and Senator Warren B.
Rudman currently serve on the Corporate Governance Committee. A description of the
committees of the Board of Directors of the Company is set forth in the
Company's definitive Proxy Statement to be filed with the Commission on or about
April 5, 20029, 2004, and is incorporated herein by reference. As of February 24, 2004,
the name of the Governance Committee has changed to the Nominating and
Governance Committee and Mr. Peter M. Nicholas no longer serves as a member of
that committee.
BIOGRAPHICAL SUMMARIES
John E. Abele, a co-founder of the Company, has been a Director of the Company
since 1979 and Founder Chairman since 1995 and Co-Chairman from 1979 to 1995. Mr. Abele held the position of
Treasurer from 1979 to 1992, Co-Chairman from 1979 to 1995 and Vice Chairman and
Founder, Office of the Chairman from February 1995 to March 1996. He was
President of Medi-tech, Inc. from 1970 to 1983, and prior to that served in
sales, technical and general management positions for Advanced Instruments, Inc.
Mr. Abele is the Vice Chairman of the Board and Treasurer of the FIRST (For Inspiration and
Recognition of Science and Technology) Foundation and is also a member of
numerous not-for-profit boards. Mr. Abele received a B.A. degree from Amherst
College.
Lawrence C. Best joined the Company in August 1992has served as Senior Vice President--Finance & AdministrationPresident and Chief Financial Officer. Previously,Officer
for the Company since 1992. Prior to his work with the Company, Mr. Best had beenwas a
partner atin the accounting firm of Ernst & Young, certified public accountants, since
1981. From 1979 to 1981, Mr. Bestwhere he specialized in serving
multinational companies in the high technology and life sciences fields. He
served a two year term as a Professional
Accounting Fellow in the Office of Chief Accountanttwo-year fellowship at the Securities and Exchange Commission from 1979
to 1981 and a one-year term as a White House-appointed Presidential Exchange
Executive in Washington, D.C. He serves on the Board of Directors of
Biogen-Idec, Inc. and Haemonetics Corp. Mr. Best received a B.B.A. degree from
Kent State University.
-29-
Ursula M. Burns became a Director of the Company in 2002. Ms. Burns is President
of the Business Group Operations and Corporate Senior Vice President of Xerox
Corporation. Ms. Burns joined Xerox in 1980, subsequently advancing through
several engineering and management positions. Ms. Burns served as Vice President
and General Manager, Departmental Business Unit from 1997 to 1999, Senior Vice
President, Worldwide Manufacturing and Supply Chain Services from 1999 to 2000,
Senior Vice President, Corporate Strategic Services from 2000 to October 2001
and President of Document Systems and Solutions Group until her most recent
appointment in January 2003. She serves on the Boards of Directors of the
American Express Company, the National Association of Manufacturers, the
University of Rochester and the Rochester Business Alliance. Ms. Burns served on
the Board of Directors of Banta Corporation from 2001 to 2003. Ms. Burns earned
a Bachelor of Science degree from Polytechnic Institute of New York and a Master
of Science degree in mechanical engineering from Columbia University.
Joseph A. Ciffolillo joined the Company in 1983 as President of Medi-tech, Inc.
During his tenure at the Company, he also served as President of Microvasive,
Inc. and as Executive Vice President and Chief Operating Officer from 1989 until
his retirement in 1996. In 1992, Mr. Ciffolillo became a director of the
Company. Previously, Mr. Ciffolillo spent twenty years with Johnson & Johnson
where he held a number of management positions including Executive Vice President, Codman and President, Johnson &
Johnson Orthopedic Company, a company of which he was also a co-founder.Company. Mr. Ciffolillo is a member of the Spray Venture Fund
Investment Committee and a member of the Board of Directors of MedSource
Technologies, Inc. He also serves on a number of for-profit and not-for-profit
boards. Mr. Ciffolillo is Chairman of the Advisory Board of the Health Science
Technology Division of Harvard University and the Massachusetts 28
Institute of
Technology. He is also Chairman of the President's Council of the Massachusetts
General Hospital and a Director of South Coast Health Systems. Mr. Ciffolillo
received his B.A. from Bucknell University, where he also serves as a Member of
the Board of Trustees.
FredFredericus A. Colen was appointed to the Executive Committee of the Company in
July 2001 as Senior Vice President and Chief Technology Officer in July 2001.Officer. Mr. Colen
joined the Company in 1999 as Vice President of Research and Development of
Scimed and, in February 2001, he was appointedpromoted to Senior Vice President,
Cardiovascular Technology of Scimed. Prior toBefore joining the Company, he worked for
several medical device companies, including Guidant, where he launched the Delta
T DDD Pacemaker platform, and St. Jude Medical, where he served as Managing
Director for the European subsidiary of the Cardiac Rhythm Management Division
and as Executive Vice President, responsible for worldwide R & D for implantable
pacemaker systems. Mr. Colen was Executiveeducated in The Netherlands and Germany and
holds the U.S. equivalent of a Master's Degree in Electrical Engineering with
focus on medical technology from the Technical University in Aachen, Germany. He
was the Vice President of Quality/Speedthe International Association of Prosthesis
Manufacturers (IAPM) in Brussels from 1995 to Market at St. Jude Medical - CRMD Division from 1996 where
he was responsible for St. Jude's global bradycardia research and development
and product planning operations. Mr. Colen received an M.S. in Electrical
Engineering, Medical Technology from Technical University, RWTH Aachen, Germany.1997.
-30-
Paul Donovan joined the Company in March 2000 as Vice President, Corporate
Communications. Most recently, Mr. Donovan was the Executive Director of
External Affairs at Georgetown University Medical Center, where he directed
media, government and community relations as well as employee communications
since 1998. From 1997 to 1998, Mr. Donovan was Chief of Staff at the United
States Department of Commerce. From 1993 to 1997, Mr. Donovan served as Chief of
Staff to Senator Edward M. Kennedy and from 1989 to 1993 as Press Secretary to
Senator Kennedy. Mr. Donovan received a B.A. degree from Dartmouth College.
Joel L. Fleishman joined the Company as a Director in October 1992. Mr.
Fleishman served as President of The Atlantic Philanthropies (U.S.A.) from
September 1993 until January 2001, when he became Senior Advisor of that
organization. He is also Professor of Law and Public Policy and has served in
various administrative positions, including First Senior Vice President at Duke
University, since 1971. Mr. Fleishman is a founding member of the governing
board of the Duke Center for Health Policy Research and Education and was the
founding director of Duke University's Terry Sanford Institute of Public Policy.
He is the director of the Samuel and Ronnie Heyman Center for Ethics, Public
Policy and the Professions. Mr. Fleishman also serves as Chairman of the Board
of Trustees of The John and Mary Markle Foundation, Vice-ChairmanChairman of the Board of
Trustees of the Urban Institute, Chairman of The Visiting Committee of the
Kennedy School of Government, Harvard University, and as a director of Polo
Ralph Lauren Corporation. Mr. Fleishman received A.B., M.A. and J.D. degrees
from the University of North Carolina at Chapel Hill, and an LL.M. degree from
Yale University.
Marye Anne Fox became a directorDirector of the Company in October 2001. Dr. Fox is
Chancellor of North Carolina State University and Distinguished University
Professor of Chemistry. From 1976 to 1998, she was a member of the faculty at
the University of Texas, where she taught chemistry and held the Waggoner
Regents Chair in Chemistry from 1991 to 1998. She served as the University's
Vice President for Research from 1994 to 1998. Dr. Fox is the Co-Chair of the
National Academy of Sciences' Government-University-Industry Research Roundtable
and serves on President Bush's Council of Advisors on Science and Technology.
She has served as the Vice Chair of the National Science Board. She also serves
on the boards of a number of other scientific, 29
technological and civic
organizations, and is a member of the BoardBoards of Directors of Red Hat Corp.,
Pharmaceutical Product Development, Inc., Burroughs-Wellcome Trust and the
Camille and Henry Dreyfus Foundation. Dr. Fox also serves on the Board of
Directors of W.R. Grace Co., a specialty chemical company that filed a petition
for reorganization under Chapter 11 of the Federal Bankruptcy Code in April
2001. She has been honored by a wide range of educational and professional
organizations, and she has authored more than 350 publications, including five
books. Dr. Fox holds a B.S. in Chemistry from Notre Dame College, an M.S. in
Organic Chemistry from Cleveland State University, and a Ph.D. in Organic
Chemistry from Dartmouth College.
-31-
Ray J. Groves joined the Company as a Director in May 1999. Mr. Groves is PresidentChairman and Chief OperatingExecutive Officer of Marsh Inc., a
subsidiary of Marsh & McLennan Companies, Inc. He served as Chairman of Legg
Mason Merchant Banking, Inc. from 1995 to 2001. Mr. Groves served as Chairman
and Chief Executive Officer of Ernst & Young for 17 years until his retirement
in 1994. Mr. Groves currently serves as a member of the Boards of Directors of
American Water Works
Company, Inc., Electronic Data Systems Corporation, The Gillette Company and Marsh & McLennan
Companies, Inc. Mr. Groves serves on the Boards of Trustees of the New York
State Public Policy Institute and is a member of the Council on Foreign Relations. He
is a former member of the Board of Governors of the American Stock Exchange and
the National Association of Securities Dealers. Mr. Groves is former Chairman of
the Board of Directors of the American Institute of Certified Public
Accountants. He is a member and former Chair of the Board of Directors of The
Ohio State University Foundation and a member of the Dean's Advisory Council of
the Fisher College of Business. He is a former member of the Board of Overseers
of The Wharton School, University of Pennsylvania and served as the Chairman of
its Center for the Study of the Service Sector. Mr. Groves is a managing
director a member of the executive committee and Secretary-Treasurer
of the Metropolitan Opera Association. Mr. Groves received a B.S.
degree from The Ohio State University.
Lawrence L. Horsch joined the Company as a Director in February 1995.
Previously, he had been Chairman of the Board of SCIMED Life Systems, Inc. from
1977 to 1994, director from 1977 to 1995 and Acting Chief Financial Officer from
1994 to 1995. Since 1990, Mr. Horsch has served as Chairman of Eagle Management
& Financial Corp., a management consulting firm. He was Chairman and Chief
Executive Officer of Munsingwear, Inc., from 1987 to 1990. Mr. Horsch also
serves on several private company boards. Mr. Horsch received a B.A. degree from
the University of St. Thomas and an M.B.A. degree from Northwestern University.
Paul A. LaViolette joined the Company as President, Boston Scientific
International, and Vice President--InternationalPresident-International in January 1994. In February
1995, Mr. LaViolette was elected to the position of Senior Vice President and
Group President--NonvascularPresident-Nonvascular Businesses. In October 1998, Mr. LaViolette was
appointed President, Boston Scientific International, and in February 2000
assumed responsibility for the Company's Scimed, EPT and Target businesses as
Group President, Cardiovascular. In March 2001, he also assumed the position of
President, SCIMED.
30
Prior to joining the Company, he was employed by C.R. Bard,
Inc. in various capacities, including President, U.S.C.I. Division, from July
1993 to November 1993, President, U.S.C.I. Angioplasty Division, from January
1993 to July 1993, Vice President and General Manager, U.S.C.I. Angioplasty
Division, from August 1991 to January 1993, and Vice President U.S.C.I.
Division, from January 1990 to August 1991. Mr. LaViolette received his B.A.
degree from Fairfield University and an M.B.A. degree from Boston College.
Robert G. MacLean joined the Company as Senior Vice President--HumanPresident-Human Resources
in April 1996. Prior to joining the Company, he was Vice President--WorldwidePresident-Worldwide
Human Resources for National Semiconductor Corporation in Santa Clara,
California from October 1992 to March 1996. Mr. MacLean has held various human
resources management positions in the U.S. and Europe during his career. Prior
to his business endeavors, he was Economics Professor at the University of the
Pacific. Mr. MacLean received his B.A. and M.A. degrees and completed his
doctoral studies in economics from Stanford University.
-32-
Ernest Mario became a directorDirector of the Company in October 2001. Dr. Mario is
currently the FounderChairman and Chief Executive Officer of Reliant Pharmaceuticals
LLC. Prior to joining Reliant Pharmaceuticals in April 2003, he was the Chairman
of IntraBiotics Pharmaceuticals, Inc. from April 2002 to April 2003. Dr. Mario
also served as Chairman and Chief Executive Officer of Apothogen, Inc., a
pharmaceutical development company and hasfrom January 2002 to April 2002 when Apothogen was
acquired by IntraBiotics. Dr. Mario served as a senior executivethe Chief Executive of a number of major international companies.Glaxo
Holdings plc from 1989 until March 1993 and as Deputy Chairman and Chief
Executive from January 1992 until March 1993. From 1993 to 1997, Dr. Mario
served as Co-Chairman and Chief Executive Officer of ALZA Corporation, a
research-based pharmaceutical company with leading drug-delivery technologies,
and Chairman and Chief Executive Officer from 1997 to 2001. Dr. Mario presently
serves on the Boards of Directors of Catalytica Energy Systems, Inc., Maxygen, Inc., Millenium Pharmaceuticals,
Inc., Orchid Biosciences, Inc., Pharmaceutical Product
Development, Inc. and SonoSite,IntraBiotics, Inc. He is also a Trustee of Duke University
and Chairman of the Board of the Duke University Health System. He is thea past
Chairman of the American Foundation for Pharmaceutical Education and serves as
an advisor to the colleges of pharmacy schools at the University of Maryland, the University
of Rhode Island and The Ernest Mario School of Pharmacy at Rutgers University.
Dr. Mario holds a B.S. in Pharmacy from Rutgers, and an M.S. and a Ph.D. in
Physical Sciences from the University of Rhode Island.
Stephen F. Moreci was appointed to the Executive Committee of the Company as
Senior Vice President and Group President, Endosurgery in December 2000. Mr.
Moreci joined the Company in 1989 and most recently served as the Company's
President of its Medi-tech division since 1999. From 1989 until 1999, Mr. Moreci
held a variety of management positions within the Company, including Vice
President and General Manager of Cardiac Assist from 1989 to 1991, Vice
President and General Manager of Microvasive Endoscopy from 1991 until 1995,
Group Vice President of Nonvascular from 1995 until 1996 and President of
Microvasive Endoscopy from 1996 until 1999. Mr. Moreci received a B.S. degree
from Pennsylvania State University.
31
N.J. Nicholas, Jr. joined the Company as a Director in October 1994. Mr.
Nicholas is a private investor. Previously, he served as President of Time, Inc.
from September 1986 to May 1990 and Co-Chief Executive Officer of Time Warner,
Inc. from May 1990 until February 1992. N.J. Nicholas, Jr. is a director of
Xerox CorporationCorporation. He has served as a director of Turner Broadcasting and Priceline.com.member
of the President's Advisory Committee for Trade Policy and Negotiations and the
President's Commission on Environmental Quality. Mr. Nicholas is the Chairman of
the Board and a Trustee of Environmental Defense and a member of the Council of
Foreign Relations. Mr. Nicholas received an A.B. degree from Princeton
University and an M.B.A. degree from Harvard Business School. He is also the
brother of PetePeter M. Nicholas, Chairman of the Board of the Company.
-33-
Peter M. Nicholas, a co-founder of the Company, has been the Chairman of the Board of the Company
since 1995. He has been a Directordirector since 1979 and served as the Chief Executive
Officer from 1979 to March 1999 and Co-Chairman of the Board from 1979 to 1995.
Prior to joining the Company, he was corporate director of marketing and general
manager of the Medical Products Division at Millipore Corporation, a medical
device company, and served in various sales, marketing and general management
positions at Eli Lilly and Company. He is currently Vice Chairman of the Board of
Trustees of Duke University and a member of the Board's Executive Committee. Mr.
Nicholas is also a member of
the American Academy of Achievement and has recently received the Phoenix
Lifetime Achievement Award. He is also a recent recipient of the Ellis Island
Medal of Honor, and is a Fellow of the American Academy of Arts and Sciences.Sciences and a
member of the Trust of that organization. He has also served on several for
profit and not-for-profit boards. Mr. Nicholas is also a member of the
Massachusetts Business Roundtable, Massachusetts Business High Technology
Council, CEOs for Fundamental Change in Education and currently serves
on the boards of the Boys &and Girls Club of
Boston, Massachusetts High
Technology Council, and CEO's for Charter Schools. Mr. Nicholas also serves
on several for profit and not-for-profit boards.Boston. After college, Mr. Nicholas served as an officer in the U.S. Navy,
resigning his commission as lieutenant in 1968.1966. Mr. Nicholas received a B.A.
degree from Duke University, and an M.B.A. degree from The Wharton School of the
University of Pennsylvania. He is also the brother of N.J. Nicholas, Jr., a
Directordirector of the Company.
Dr. Arthur L. RosenthalDennis A. Ocwieja was appointed to the Executive Committee of the Company as
Senior Vice President - Regulatory Affairs and Quality in February 2003. Mr.
Ocwieja joined the Company in January 1994February 2000 as Senior Vice President of Corporate
Quality. In February 2002, his role was expanded to Vice President, Corporate
Quality and Regulatory Affairs. From 1995 until 2000, Mr. Ocwieja was an
independent consultant to several Fortune 100 companies in the medical product
industry. He also served as Vice President, Quality and Regulatory Affairs for
the Clintec Nutrition Company from 1993 until 1995 and Vice President, Quality
and Regulatory Affairs for Arjo-Century from 1992 through 1993. From 1968 until
1992 Mr. Ocwieja held a variety of positions at Baxter Healthcare in Product
Development, Product Service, Corporate Documentation and Quality/Regulatory.
Mr. Ocwieja received a Bachelor of Science in Biology from Roosevelt University.
John E. Pepper was elected to the Board of Directors in 2003. He previously
served as a director of the Company from November 1999 to May 2001. Effective
January 1, 2004, Mr. Pepper became Vice President for Finance and Administration
of Yale University. Previously, he served as Chairman of the Executive Committee
of the Board of Directors of The Procter & Gamble Company. Since 1963, he served
in various positions at Procter & Gamble, including Chairman of the Board from
2000 to 2002, Chief DevelopmentExecutive Officer and became Chief Scientific Officer in
February 2000. PriorChairman from 1995 to joining1999, President
from 1986 - 1995 and director since 1984. Mr. Pepper is a member of the Company, he was Vice President--Research &
Development at Johnson & Johnson Medical,Board of
Directors of Xerox Corporation and Motorola Inc., serves on the Board of
Directors and is Honorary Co-Chair of the National Underground Railroad Freedom
Center, and is a member of the Executive Committee of the Cincinnati Youth
Collaborative. Mr. Pepper graduated from April 1990 to January 1994.
Between 1973Yale University in 1960 and 1990,holds
honorary doctoral degrees from The Ohio State University, Xavier University,
Mount St. Joseph College and St. Petersburg University (Russia).
-34-
Uwe E. Reinhardt became a Director in 2002. Dr. Rosenthal held several executive technical management
positionsReinhardt is the James Madison
Professor of Political Economy and Professor of Economics and Public Affairs at
PfizerPrinceton University, where he has taught since 1968. Dr. Reinhardt is a senior
associate of the University of Cambridge, England and serves as a Trustee of
Duke University and the Duke University Health System, H&Q Healthcare Investors
and H&Q Life Sciences Investors. He is also a member of the Board of Directors
of Amerigroup Corporation and Triad Hospital, Inc., 3M Dr. Reinhardt is also a
member of the National Advisory Council (NAC) for Health Care Policy, Research
and C.R. Bard, Inc., primarily inEvaluation for the fieldsAgency for Healthcare Research and Quality and U.S.
Department of device clinical researchHealth and biomedical engineering.Human Services. Dr. RosenthalReinhardt received his
B.A. in bacteriologya Bachelor of
Commerce degree from the University of Connecticut,Saskatchewan, Canada and hisa Ph.D. in
biochemistryeconomics from the University of Massachusetts.Yale University.
Senator Warren B. Rudman joined the Company as a Director in October 1999.
Senator Rudman became a partner in the international law firm Paul, Weiss,
Rifkind, Wharton, and Garrison LLP in 1992 after servingand became Of Counsel to the firm as
of January 1, 2003. Prior to joining the firm, he served two terms as a U.S.
Senator from New Hampshire from 1980 to 1992. Senator Rudman serves on the BoardsBoard
of TrusteesDirectors of Valley Forge Military Academy, the Brookings Institution, and the Council on Foreign Relations. He also serves on the boards
of Allied Waste Industries, Inc., The Chubb Corporation, Collins & Aikman
Corporation, Raytheon Corporation and several funds managed by the Dreyfus
Corporation. He is also the
32
founding co-chairman of the Concord Coalition. Senator
Rudman received a B.S. from Syracuse University and a LL.B. from Boston College
Law School and served in the U.S. Army during the Korean War.
Paul W. Sandman joined the Company as Senior Vice President, Secretary and
General Counsel in May 1993. From March 1992 through April 1993, he was Senior
Vice President, General Counsel and Secretary of Wang Laboratories, Inc., where
he was responsible for legal affairs. From 1984 to 1992, Mr. Sandman was Vice
President and Corporate Counsel of Wang Laboratories, Inc., where he was
responsible for corporate and international legal affairs. Mr. Sandman received
his A.B. from Boston College, and his J.D. from Harvard Law School.
James H. Taylor, Jr. joined the Company as Senior Vice President of Corporate
Operations in August 1999. Mr. Taylor most recently served as Vice President of
Global Technology at Nestle Clinical Nutrition from 1995 to 1997. Prior to
joining Nestle, he completed a thirty-year career at Baxter International, where
he held a broad range of positions in operations management, including from 1992
to 1995, the position of Corporate Vice President of Manufacturing Operations
and Strategy. Mr. Taylor received his B.A. degree from the University of North
Carolina.
-35-
James R. Tobin joinedis the Company as Director, President, and Chief Executive Officer in March 1999.and Director of the
Company. Prior to joining the Company in March 1999, Mr. Tobin served as
President and Chief Executive Officer of Biogen, Inc. from 1997 to 1998 and
Chief Operating Officer of Biogen from 1994 to 1997. From 1972 to 1994, Mr.
Tobin served in a variety of executive positions with Baxter International,
including President and Chief Operating Officer from 1992 to 1994. Previously,
he served at Baxter as Managing Director in Japan, Managing Director in Spain,
President of Baxter's I.V. Systems Group and Executive Vice President. Mr. Tobin
currently serves on the Boards of Directors of Beth Israel Deaconess Medical
Center, the Carl J. Shapiro Institute for Education and Research,Osiris, Inc., Curis, Inc. and
Applera Corporation (formerly PE Corporation).Corporation. Mr. Tobin holds an A.B. from Harvard College and an M.B.A.
from Harvard Business School. Mr. Tobin also served as a lieutenant in the U.S.
Navy from 1968 to 1972.
33-36-
PART II
- ------------------------------------------------------------------------------
ITEM 5. MARKET FOR THE COMPANY'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
The Company's common stock is traded on the New York Stock Exchange under the
symbol "BSX".
The information set forth under the caption "Market for the Company's Common
Stock and Related Matters" included in the Company's 2001 Consolidated Financial
Statements2003 consolidated financial
statements (Exhibit 13.1 filed herewith) is incorporated herein by reference.
On December 11, 2001, the Company issued an aggregate of 925,862 shares of its
common stock pursuant to the acquisition by the Company of RadioTherapeutics
Corporation. All of the Company's common shares issued in this transaction were
issued in a non-public offering pursuant to an exemption from the registration
requirements of the Securities Act of 1933, as amended (the "Act"), under
Section 4(2) of the Act. This sale was made without general solicitation or
advertising. The Company has a currently effective Registration Statement on
Form S-3 (Reg. No. 333-76346) covering the resale of these securities. All net
proceeds from the sale of the securities will go to the selling stockholders who
offer and sell these shares. The Company has not received and will not receive
any proceeds from the sale of these shares.
The closing price of the Company's Common Stock on March 15, 2002February 27, 2004 was $24.06.$40.85.
ITEM 6. SELECTED FINANCIAL DATA
The information set forth under the caption "Five-Year Selected Financial Data"
included in the Company's 20012003 Consolidated Financial Statements (Exhibit 13.1
filed herewith) is incorporated herein by reference.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The statements and information set forth under the caption "Management's
Discussion and Analysis of Financial Condition and Results of Operations"
included in the Company's 20012003 Consolidated Financial Statements (Exhibit 13.1
filed herewith) are incorporated herein by reference.
34
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The information set forth under the subcaption "Market Risk Disclosures"
contained under the caption "Management's Discussion and Analysis of Financial
Condition and Results of Operations" included on page 1027 through page 28 of the
Company's 20012003 Consolidated Financial Statements (Exhibit 13.1 filed herewith)
is incorporated herein by reference.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The consolidated financial statements of the Company and its subsidiaries
included in the Company's 20012003 Consolidated Financial Statements (Exhibit 13.1
filed herewith) are incorporated herein by reference. The statements and
information set forth under the caption "Quarterly Results of Operations"
included in the Company's 20012003 Consolidated Financial Statements (Exhibit 13.1
filed herewith) are incorporated herein by reference.
-37-
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
35ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of disclosure controls and procedures
The Company's management, with the participation of the Company's President and
Chief Executive Officer and Senior Vice President - Finance & Administration and
Chief Financial Officer, evaluated the design and operation of the Company's
disclosure controls and procedures as of December 31, 2003. Based on this
evaluation, the Company's Chief Executive Officer and Chief Financial Officer
concluded that as of December 31, 2003, the Company's disclosure controls and
procedures are effective in ensuring that material information relating to the
Company required to be included in the Company's periodic SEC filings was made
known to them on a timely basis. It should be noted that any system of controls
is designed to provide reasonable, but not absolute, assurances that the system
will achieve its stated goals under all potential circumstances.
Changes in internal controls over financial reporting
There were no significant changes in the Company's internal controls over
financial reporting, or to the Company's knowledge, in other factors that could
significantly affect the Company's internal controls over financial reporting
subsequent to December 31, 2003.
-38-
PART III
- ------------------------------------------------------------------------------
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE COMPANY
The required information concerning directors and executive officers set forth
in the Company's definitive Proxy Statement to be filed with the Commission on
or about April 5, 20029, 2004 is incorporated herein by reference. See also "Directors
and Executive Officers of the Company" following Item 4 herein.
ITEM 11. EXECUTIVE COMPENSATION
The required information concerning executive compensation set forth in the
Company's definitive Proxy Statement to be filed with the Commission on or about
April 5, 20029, 2004 is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
The required statements concerning security ownership of certain beneficial
owners and management and related stockholder matters set forth in the Company's
definitive Proxy Statement to be filed with the Commission on or about April 5, 20029,
2004 are incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The required statements concerning certain relationships and related
transactions set forth in the Company's definitive Proxy Statement to be filed
with the Commission on or about April 5, 20029, 2004 are incorporated herein by
reference.
36ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The required statements concerning principal accountant fees and services set
forth in the Company's definitive Proxy Statement to be filed with the
Commission on or about April 9, 2004 are incorporated herein by reference.
-39-
PART IV
- ------------------------------------------------------------------------------
ITEM 14.15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
(a)(1) Financial Statements.
The response to this portion of Item 1415 is set forth under Item 8.
(a)(2) Financial Schedules.
The response to this portion of Item 1415 is filed herewith as a separate
attachment (Schedule II) to this report.
(a)(3) Exhibits (* documents filed herewith).
-40-
EXHIBIT
NO. TITLE
- ------ -----
3.1 Second Restated Certificate of Incorporation of the Company (Exhibit 3.1, Annual Report on Form 10-K for the year
ended December 31, 1993, File No. 1-11083).
3.2 Certificate of Amendment of the Second Restated Certificate of Incorporation of the Company (Exhibit 3.2, Annual
Report on Form 10-K for the year ended December 31, 1994, File No. 1-11083).
3.3 Certificate of Second Amendment of the Second Restated Certificate of Incorporation of the Company (Exhibit 3.3,
Annual Report on Form 10-K for the year ended December 31, 1998, File No. 1-11083).
*3.4 Certificate of Third Amendment of the Second Restated Certificate of Incorporation of the Company.
3.5 Restated By-laws of the Company (Exhibit 3.2, Registration No. 33-46980).
4.1 Specimen Certificate for shares of the Company's Common Stock (Exhibit 4.1, Registration No. 33-46980).
4.2 Description of Capital Stock contained in Exhibits 3.1, 3.2, 3.3, 3.4 and 3.5.
4.3 Form of Debt Securities Indenture (Exhibit 4.4, Registration Statement on Form S-3 of the Company, BSC Capital Trust,
BSC Capital Trust II and BSC Capital Trust III, Registration No. 333-64887).
4.4 Form of First Supplemental Indenture dated as of December 6, 2001 (Exhibit 4.4, Annual Report on Form 10-K for the year
ended December 31, 2002, File No. 1-110830).
4.5 6.625% Promissory Notes due March 15, 2005 issued by the Company in the aggregate principal amount of $500 million,
each dated as of March 10, 1998 (Exhibit Nos. 4.1, 4.2 and 4.3 to the Company's Current Report on Form 8-K dated March
30, 1998, File No. 1-11083).
10.1 Form of Credit Agreement among the Company, The Several Lenders and Banc of America Securities LLC dated as of August
15, 2001 (Exhibit 10.2, Quarterly Report on Form 10-Q for the quarter ended September 30, 2001, File No. 1-11083).
10.2 Form of Credit Agreement among the Company and The Several Lenders dated as of May 30, 2003 (Exhibit 10.1, Quarterly
Report on Form 10-Q for the quarter ended June 30, 2003, File No. 1-11083).
3.2 Certificate of Amendment of the Second Restated Certificate of
Incorporation of the Registrant (Exhibit 3.2, Annual Report on
Form 10-K for the year ended December 31, 1994, File No.
1-11083).
3.3 Certificate of Second Amendment of the Second Restated
Certificate of Incorporation of the Registrant (Exhibit 3.3,
Annual Report on Form 10-K for the year ended December 31,
1998, File No. 1-11083).
3.4 Restated By-laws of the Company (Exhibit 3.2, Registration No.
33-46980).
4.1 Specimen Certificate for shares of the Company's Common Stock
(Exhibit 4.1, Registration No. 33-46980).
4.2 Description of Capital Stock contained in Exhibits 3.1, 3.2,
3.3 and 3.4.
37
-41-
4.3 Form of Debt Securities Indenture (Exhibit 4.4, Registration
Statement on Form S-3 of the Company, BSC Capital Trust, BSC
Capital Trust II and BSC Capital Trust III, File No.
333-64887).
*4.4 Form of First Supplemental Indenture dated as of December 6,
2001
10.1 Boston Scientific Corporation 1992 Long-Term Incentive Plan, as
amended (Exhibit 10.1, Annual Report on Form 10-K for the year
ended December 31, 1996,
EXHIBIT
NO. TITLE
- ------ -----
10.3 Form of Credit and Security Agreement dated as of August 16, 2002 among Boston Scientific Funding Corporation, the
Company, Blue Ridge Asset Funding Corporation, Victory Receivables Corporation The Bank of Tokyo-Mitsubishi Ltd., New
York Branch and Wachovia Bank, N.A. (Exhibit 10.1, Quarterly Report on Form 10-Q for the quarter ended September 30,
2002, File No. 1-11083).
10.4 Form of Receivables Sale Agreement dated as of August 16, 2002 between the Company and each of its Direct or Indirect
Wholly-Owned Subsidiaries that Hereafter Becomes a Seller Hereunder, as the Sellers, and Boston Scientific Funding
Corporation, as the Buyer (Exhibit 10.2, Quarterly Report on Form 10-Q for the quarter ended September 30, 2002, File
No. 1-11083).
10.5 License Agreement among Angiotech Pharmaceuticals, Inc., Cook Incorporated and the Company dated July 9, 1997, and
related Agreement dated December 13, 1999 (Exhibit 10.6, Annual Report on Form 10-K for the year ended December 31,
2002, File No. 1-11083).
10.6 Agreement Containing Consent Decree, dated as of February 23, 1995, between the Company and the Federal Trade
Commission (Exhibit 10.16, Annual Report on Form 10-K for the year ended December 31, 1994, File No. 1-11083).
10.7 Letter Agreement, dated June 22, 1992, between the Company and Lawrence C. Best (Exhibit 10.11, Annual Report on Form
10-K for the year ended December 31, 1993, File No. 1-11083).
*10.2 Form of Amendment to the Boston Scientific Corporation 1992
Long-Term Incentive Plan
10.3 Boston Scientific Corporation 1992 Non-Employee Directors'
Stock Option Plan, as amended (Exhibit 10.2, Annual Report on
Form 10-K for the year ended December 31, 1996, Exhibit 10.3,
Annual Report on Form 10-K for the year ended December 31,
2000, File No. 1-11083).
10.4 Boston Scientific Corporation 1995 Long-Term Incentive Plan, as
amended (Exhibit 10.1, Annual Report on Form 10-K for the year
ended December 31, 1996, File No. 1-11083).
*10.5 Form of Amendment to the Boston Scientific Corporation 1995
Long-Term Incentive Plan
10.6 SCIMED Life Systems, Inc. 1987 Non-Qualified Stock Option Plan,
amended and restated (Exhibit 4.3, Registration No. 33-89772
which was incorporated by reference to Exhibit A to SCIMED's
Proxy Statement dated May 23, 1991 for its 1991 Annual Meeting
of Shareholders, Commission File No. 0-9301).
10.7 SCIMED Life Systems, Inc. 1991 Directors Stock Option Plan, as
amended (Exhibit 4.2, Registration No. 33-89772 which was
incorporated by reference to Exhibit A to SCIMED's Proxy
Statement dated June 8, 1994 for its 1994 Annual Meeting of
Shareholders, Commission File No. 0-9301).
10.8 Letter Agreement dated March 17, 1999, between the Company and James R. Tobin (Exhibit 10.34, Annual Report on Form
10-K for the year ended December 31, 1998, File No. 1-11083).
10.9 Form of Indemnification Agreement between the Company and certain Directors and Officers (Exhibit 10.16, Registration
No. 33-46980).
10.10 Form of Retention Agreement between the Company and certain Executive Officers (Exhibit 10.23, Annual Report on Form
10-K for the year ended December 31, 1996, File No. 1-11083).
10.11 Boston Scientific Corporation 401(k) Retirement Savings Plan, as Amended and Restated, Effective January 1, 2001, and
amended as of January 1, 2003, (Exhibit 10, 12, Annual Report on Form 10-K for the year ended December 31,2002, File
No. 1-11083.)
*10.12 Form of Second Amendment to Boston Scientific Corporation 401(k) Retirement Savings Plan, as amended.
-42-
EXHIBIT
NO. TITLE
- ------ -----
10.13 Boston Scientific Corporation Global Employee Stock Ownership Plan, as Amended and Restated (Exhibit 10.18, Annual
Report on Form 10-K for the year ended December 31, 1997, Exhibit 10.21, Annual Report on Form 10-K for the year ended
December 31, 2000, Exhibit 10.22, Annual Report on Form 10-K for the year ended December 31, 2000, File No. 1-11083).
*10.14 Form of Third Amendment to Boston Scientific Corporation Global Employee Stock Ownership Plan.
10.15 Boston Scientific Corporation Deferred Compensation Plan, Effective January 1, 1996 (Exhibit 10.17, Annual Report on
Form 10-K for the year ended December 31, 1996, File No. 11083).
10.16 Boston Scientific Corporation 1992 Non-Employee Directors' Stock Option Plan, as amended (Exhibit 10.2, Annual Report
on Form 10-K for the year ended December 31, 1996, Exhibit 10.3, Annual Report on Form 10-K for the year ended December
31, 2000, File No. 1-11083).
*10.17 Boston Scientific Corporation 2003 Long-Term Incentive Plan.
10.18 Boston Scientific Corporation 2000 Long Term Incentive Plan (Exhibit 10.20, Annual Report on Form 10-K for the year
ended December 31, 1999, Exhibit 10.18, Annual Report on Form 10-K for the year ended December 31, 2001, File No.
1-11083).
10.19 Boston Scientific Corporation 1995 Long-Term Incentive Plan, as amended (Exhibit 10.1, Annual Report on Form 10-K for
the year ended December 31, 1996, Exhibit 10.5, Annual Report on Form 10-K for the year ended December 31, 2001, File
No. 1-11083).
10.20 Boston Scientific Corporation 1992 Long-Term Incentive Plan, as amended (Exhibit 10.1, Annual Report on Form 10-K for
the year ended December 31, 1996, Exhibit 10.2, Annual Report on Form 10-K for the year ended December 31, 2001, File
No. 1-11083).
10.21 SCIMED Life Systems, Inc. 1991 Directors Stock Option Plan, as amended (Exhibit 4.2, Registration No. 33-89772 which
was incorporated by reference to Exhibit A to SCIMED's Proxy Statement dated June 8, 1994 for its 1994 Annual Meeting
of Shareholders, Commission File No. 0-9301).
10.22 SCIMED Life Systems, Inc. 1992 Stock Option Plan (Exhibit 4.1, Registration No. 33-89772 which was incorporated by
reference to Exhibit A to SCIMED's Proxy Statement dated May 26, 1992 for its 1992 Annual Meeting of Shareholders,
Commission File No. 0-9301).
10.9 Heart Technology, Inc. Restated 1989 Stock Option Plan (Exhibit
4.5, Registration No. 33-99766 which was incorporated by
reference to Exhibit 10.4 to the Registration Statement on Form
S-1 of Heart Technology, Registration No. 33-45203).
10.10 EP Technologies, Inc. 1991 Stock Option/Stock Issuance Plan
(Exhibit 4.6, Registration No. 33-80265 which was incorporated
by reference to EPT's Registration Statement on Form S-8, File
No. 33-82140).
38
-43-
10.11 EP Technologies, Inc. 1993 Stock Option/Stock Issuance Plan,
(Exhibit 4.5, Registration No. 33-80265 which was incorporated
by reference to EPT's Registration Statement on Form S-8, File
No. 33-93196).
10.12 Target Therapeutics, Inc. 1988 Stock Option Plan (Exhibit 10.2,
Quarterly Report of Target Therapeutics, Inc. on Form 10-Q for
the quarter ended September 30, 1996, File No. 0-19801).
10.13 Target Therapeutics, Inc. 1988 Stock Option Plan, (Exhibit 10.3
Quarterly Report of Target Therapeutics, Inc. on Form 10-Q for
the quarter ended September 30, 1996, File No. 0-19801).
10.14 Boston Scientific Corporation 401(k) Retirement Savings Plan,
as Amended and Restated, Effective January 1, 1997 (Exhibit
10.17, Annual Report on Form 10-K for the year ended December
31, 1997, Exhibit 10.1, Quarterly Report on Form 10-Q for the
quarter ended March 31, 1999, Exhibit 10.1, Quarterly Report on
Form 10-Q for the quarter ended September 30, 1999, Exhibit
10.19, Annual Report on Form 10-K for the year ended December
31, 2000, and Exhibit 10.1, Quarterly Report on Form 10-Q for
the quarter ended June 30, 2001, File No. 1-11083).
10.15 Boston Scientific Corporation Global Employee Stock Ownership
Plan, as Amended and Restated (Exhibit 10.18, Annual Report on
Form 10-K for the year ended December 31, 1997, Exhibit 10.21,
Annual Report on Form 10-K for the year ended December 31,
2000, Exhibit 10.22, Annual Report on Form 10-K for the year
ended December 31, 2000, File No. 1-11083).
10.16 Boston Scientific Corporation Deferred Compensation Plan,
Effective January 1, 1996 (Exhibit 10.17, Annual Report on Form
10-K for the year ended December 31, 1996, File No. 11083).
10.17 Boston Scientific Corporation 2000 Long Term Incentive Plan
(Exhibit 10.20, Annual Report on Form 10-K for the year ended
December 31, 1999, File No. 1-11083).
*10.18 Form of Amendment to the Boston Scientific Corporation 2000
Long-Term Incentive Plan
10.19 Embolic Protection Incorporated 1999 Stock Plan (Exhibit 10.1,
Registration Statement on Form S-8 of the Company, File No.
333-61060).
10.20 Quanam Medical Corporation 1996 Equity Incentive Plan (Exhibit
10.2, Registration Statement on Form S-8 of the Company, File
No. 333-61060).
10.21 Quanam Medical Corporation 1996 Stock Plan (Exhibit 10.3,
Registration Statement on Form S-8 of the Company, File No.
333-61060).
39
EXHIBIT
NO. TITLE
- ------ -----
10.23 Heart Technology, Inc. Restated 1989 Stock Option Plan (Exhibit 4.5, Registration No. 33-99766 which was incorporated
by reference to Exhibit 10.4 to the Registration Statement on Form S-1 of Heart Technology, Registration No. 33-45203).
10.24 EP Technologies, Inc. 1991 Stock Option/Stock Issuance Plan (Exhibit 4.6, Registration No. 33-80265 which was
incorporated by reference to EPT's Registration Statement on Form S-8, File No. 33-82140).
10.25 EP Technologies, Inc. 1993 Stock Option/Stock Issuance Plan (Exhibit 4.5, Registration No. 33-80265 which was
incorporated by reference to EPT's Registration Statement on Form S-8, Registration No. 33-93196).
10.26 Target Therapeutics, Inc. 1988 Stock Option Plan (Exhibit 10.2, Quarterly Report of Target Therapeutics, Inc. on Form
10-Q for the quarter ended September 30, 1996, File No. 0-19801).
10.27 Target Therapeutics, Inc. 1988 Stock Option Plan (Exhibit 10.3 Quarterly Report of Target Therapeutics, Inc. on Form
10-Q for the quarter ended September 30, 1996, File No. 0-19801).
10.28 Embolic Protection Incorporated 1999 Stock Plan (Exhibit 10.1, Registration Statement on Form S-8 of the Company,
Registration No. 333-61060).
10.29 Quanam Medical Corporation 1996 Equity Incentive Plan (Exhibit 10.2, Registration Statement on Form S-8 of the Company,
Registration No. 333-61060).
10.30 Quanam Medical Corporation 1996 Stock Plan (Exhibit 10.3, Registration Statement on Form S-8 of the Company,
Registration No. 333-61060).
10.31 RadioTherapeutics Corporation 1994 Stock Incentive Plan (Exhibit 10.1, Registration Statement on Form S-8 of the
Company, Registration No. 333-76380).
11 Statement regarding computation of per share earnings (included in Note O to the Company's 2003 Consolidated Financial
Statements for the year ended December 31, 2003, filed as Exhibit 13.1 hereto).
*12.1 Statement regarding computation of ratios of earnings to fixed charges.
*13.1 The Company's 2003 Consolidated Financial Statements for the year ended December 31, 2003.
13.2 Report of Independent Auditors, Ernst & Young LLP (included in the Company's 2003 Consolidated Financial Statements
for the year ended December 31, 2003, filed as Exhibit 13.1 hereto).
*21.1 List of the Company's subsidiaries as of March 1, 2004.
-44-
10.22 RadioTherapeutics Corporation 1994 Stock Incentive Plan
(Exhibit 10.1, Registration Statement on Form S-8 of the
Company, File No. 333-76380).
10.23 Form of Second Amended and Restated Credit Agreement, dated
September 4, 1998 among the Company, The Several Lenders and
certain other parties (Exhibit 10.1, Current Report on Form 8-K
dated September 25, 1998, File No. 1-11083).
10.24 Form of Second Amendment to the Second Amended and Restated
Credit Agreement among Boston Scientific Corporation, The
Several Lenders and The Chase Manhattan Bank dated as of June
20, 2001. (Exhibit 10.1, Quarterly Report on Form 10-Q for the
quarter ended June 30, 2000, File No. 1-11083).
10.25 Form of Amendment to the Second Amended and Restated Credit
Agreement among Boston Scientific Corporation, The Several
Lenders and The Chase Manhattan Bank dated as of August 21,
2001 (Exhibit 10.1, Quarterly Report on Form 10-Q for the
quarter ended September 30, 2001, File No. 1-11083).
10.26 Form of Credit Agreement among the Company, The Several Lenders
and Banc of America Securities LLC dated as of August 15, 2001
(Exhibit 10.2, Quarterly Report on Form 10-Q for the quarter
ended September 30, 2001, File No. 1-11083).
10.27 Form of Indemnification Agreement between the Company and
certain Directors and Officers (Exhibit 10.16, Registration No.
33-46980).
10.28 Letter Agreement, dated June 22, 1992, between the Company and
Lawrence C. Best (Exhibit 10.11, Annual Report on Form 10-K for
the year ended December 31, 1993, File No. 1-11083).
10.29 Form of Retention Agreement between the Company and certain
Executive Officers (Exhibit 10.23, Annual Report on Form 10-K
for the year ended December 31, 1996, File No. 1-11083).
10.30 Letter Agreement dated March 17, 1999, between the Company and
James R. Tobin (Exhibit 10.34, Annual Report on Form 10-K for
the year ended December 31, 1998, File No. 1-11083).
10.31 Agreement Containing Consent Decree, dated as of February 23,
1995, between the Company and the Federal Trade Commission
(Exhibit 10.16, Annual Report on Form 10-K for the year ended
December 31, 1994, File No. 1-11083).
40
10.32 6.625% Promissory Notes due March 15, 2005 issued by the
Company in the aggregate principal amount of $500 million, each
dated as of March 10, 1998 (Exhibit Nos. 4.1, 4.2 and 4.3 to
the Company's Current Report on Form 8-K dated March 30, 1998,
File No. 1-11083).
11 Statement regarding computation of per share earnings (included
in Note J to the Company's 2001 Consolidated Financial
Statements for the year ended December 31, 2001, filed as
Exhibit 13.1 hereto).
*12.1 Statement regarding computation of ratios of earnings to fixed
charges.
*13.1 The Company's 2001 Consolidated Financial Statements for the
year ended December 31, 2001.
13.2 Report of Independent Auditors, Ernst & Young LLP (included in
the Company's 2001 Consolidated Financial Statements for the
year ended December 31, 2001, filed as Exhibit 13.1 hereto).
*21. List of the Company's subsidiaries as of March 15, 2002. Each
subsidiary does business under the corporate name indicated.
EXHIBIT
NO. TITLE
- ------ -----
*23.1 Consent of Independent Auditors, Ernst & Young LLP.
*31.1 Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*31.2 Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*32.1 Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
*32.2 Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
(b) Reports on Form 8-K.
None.
41-45-
SIGNATURE
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Company has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Dated: March 27, 200215, 2004 BOSTON SCIENTIFIC
CORPORATION
BY:By: /s/ LAWRENCELawrence C. BEST
--------------------------------------------Best
--------------------------
Lawrence C. Best
Chief Financial Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report
has been signed below by the following persons on behalf of the Company and in
the capacities and on the dates indicated.
Dated: March 27, 2002 /s/ JOHN E. ABELE
--------------------------------------------
John E. Abele
Director, Founder
Dated: March 27, 2002 /s/ LAWRENCE C. BEST
---------------------------------------------
Lawrence C. Best
Senior Vice President--Finance and
Administration and Chief Financial
Officer (Principal Financial and
Accounting Officer)
Dated: March 27, 2002 /s/ JOSEPH A. CIFFOLILLO
--------------------------------------------
Joseph A. Ciffolillo
Director
Dated: March 27, 2002 /s/ JOEL L. FLEISHMAN
---------------------------------------------
Joel L. Fleishman
Director
42
Dated: March 27, 2002 /s/ RAY J. GROVES
--------------------------------------------
Dated: March 15, 2004 /s/ John E. Abele
--------------------------------
John E. Abele
Director, Founder
Dated: March 15, 2004 /s/ Lawrence C. Best
--------------------------------
Lawrence C. Best
Senior Vice President--Finance and
Administration and Chief Financial
Officer (Principal Financial and
Accounting Officer)
Dated: March 15, 2004 /s/ Ursula M. Burns
--------------------------------
Ursula M. Burns
Director
Dated: March 15, 2004 /s/ Joseph A. Ciffolillo
--------------------------------
Joseph A. Ciffolillo
Director
Dated: March 15, 2004 /s/ Joel L. Fleishman
--------------------------------
Joel L. Fleishman
Director
Dated: March 15, 2004 /s/ Marye Anne Fox
--------------------------------
Marye Anne Fox
Director
Dated: March 15, 2004 /s/ Ray J. Groves
--------------------------------
Ray J. Groves
Director
Dated: March 27, 2002 /s/ LAWRENCE L. HORSCH
--------------------------------------------
Lawrence L. Horsch
Director
Dated: March 27, 2002 /s/ ERNEST MARIO
--------------------------------------------
Ernest Mario
Director
Dated: March 27, 2002 /s/ N.J. NICHOLAS, JR.
---------------------------------------------
N.J. Nicholas, Jr.
Director
Dated: March 27, 2002 /s/ PETER M. NICHOLAS
---------------------------------------------
Peter M. Nicholas
Director, Chairman of the Board
Dated: March 27, 2002 /s/ WARREN B. RUDMAN
--------------------------------------------
Warren B. Rudman
Director
Dated: March 27, 2002 /s/ JAMES R. TOBIN
---------------------------------------------
-46-
Dated: March 15, 2004 /s/ Ernest Mario, Ph.D.
--------------------------------
Ernest Mario, Ph.D.
Director
Dated: March 15, 2004 /s/ N.J. Nicholas, Jr.
--------------------------------
N.J. Nicholas, Jr.
Director
Dated: March 15, 2004 /s/ Peter M. Nicholas
--------------------------------
Peter M. Nicholas
Director, Chairman of the Board
Dated: March 15, 2004 /s/ John E. Pepper
--------------------------------
John E. Pepper
Director
Dated: March 15, 2004 /s/ Uwe E. Reinhardt, Ph.D.
--------------------------------
Uwe E. Reinhardt, Ph.D.
Director
Dated: March 15, 2004 /s/ Warren B. Rudman
--------------------------------
Warren B. Rudman
Director
Dated: March 15, 2004 /s/ James R. Tobin
--------------------------------
James R. Tobin
Director, President and
Chief Executive Officer
(Principal Executive Officer)
43
FINANCIAL STATEMENT SCHEDULE
The following additional consolidated financial statement schedule should be
considered in conjunction with the Company's 2001 Consolidated Financial
Statements (Exhibit 13.1 filed herewith):
Schedule II - Valuation and Qualifying Accounts
All other schedules have been omitted since the required information is not
present or not sufficiently material to require submission of the schedule, or
because the information required is included in the consolidated financial
statements or the notes thereto.
44
-47-
SCHEDULE II
VALUATION AND QUALIFYING ACCOUNTS
Charges to
Balance at Charges to (Deductions from) Balance at
Beginning Costs and Other End of
Description of Period Expenses Deductions Accounts PeriodCHARGES TO
BALANCE AT CHARGES TO (DEDUCTIONS FROM) BALANCE AT
BEGINNING COSTS AND OTHER END OF
DESCRIPTION OF PERIOD EXPENSES DEDUCTIONS ACCOUNTS PERIOD
- ----------- ---------------------------------------------------------------------------------
(In---------------------------------------------------------------------
(in millions)
YEAR ENDED DECEMBER 31, 2003
Reserves and allowances deducted from
asset accounts:
Allowances for uncollectible
amounts and sales returns and allowances $58 6 5 (a) 2 (b) $61
YEAR ENDED DECEMBER 31, 2002
Reserves and allowances deducted from
asset accounts:
Allowances for uncollectible
amounts and sales returns and allowances $62 3 6 (a) (1)(b) $58
YEAR ENDED DECEMBER 31, 2001
Reserves and allowances deducted from
asset accounts:
Allowances for uncollectible
amounts and sales returns and allowances....allowances $67 9 (7)7 (a) (7)(b) $62
YEAR ENDED DECEMBER 31, 2000
Reserves and allowances deducted from
asset accounts:
Allowances for uncollectible
amounts and sales returns and allowances.... $63 8 (9)(a) 5 (b) $67
YEAR ENDED DECEMBER 31, 1999
Reserves and allowances deducted from
asset accounts:
Allowances for uncollectible
amounts and sales returns and allowances.... $49 11 (10)(a) 13 (b) $63
(a) Uncollectible accounts written off.
(b) Charges for sales returns and allowances, net of actual sales returns
Certain prior years' amounts have been reclassified to conform to the
current year's presentation.