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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
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, 2004
Commission File Number 1-13388
GUIDANT CORPORATION
(Exact name of registrant as specified in its charter)
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Indiana |
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35-1931722 |
(State or other jurisdiction of
incorporation or organization) |
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(IRS Employer
Identification No.) |
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111 Monument Circle, 29th Floor,
Indianapolis, Indiana |
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46204
(Zip Code) |
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(Address of principal executive offices) |
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Registrants telephone number, including area code:
317.971.2000
Securities registered pursuant to Section 12(b) of the
Act:
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| Title of Each Class |
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Name of Each Exchange on Which Registered |
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Common Stock |
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New York Stock Exchange |
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Preferred Stock Purchase Rights
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New York Stock Exchange |
Securities registered pursuant to Section 12(g) of the
Act:
None.
Indicate by check mark whether the registrant (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, and (2) has been subject to such filing
requirements for the past
90 days. Yes þ No o
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
registrants knowledge, in the definitive proxy or
information statement incorporated by reference in Part III
of this Form 10-K or any amendment to this
Form 10-K. þ
Indicate by check mark whether the registrant is an accelerated
filer (as defined in Exchange Act
Rule 12b-2). Yes þ No o
The aggregate market value of the registrants common
shares (the only outstanding equity shares) as of June 30,
2004 (the last trading day of the second fiscal quarter), less
shares held by officers and directors of the registrant, was
approximately $17.5 billion.
The number of shares of Common Stock outstanding as of
February 10, 2005: 322,599,255
PART I
Overview
Guidant Corporation provides innovative, therapeutic medical
solutions of distinctive value for customers, patients and
healthcare systems around the world. Guidants lifesaving
medical technologies are designed to extend the lives and
improve the quality of life of millions of patients suffering
from life-threatening cardiovascular disease. Approximately
12,000 employees develop, manufacture and market the
Companys medical devices in nearly 100 countries,
with key operations in the US, Europe and Asia. As used herein,
the terms the Company and Guidant mean
Guidant Corporation and its consolidated subsidiaries.
Cardiovascular disease is the leading cause of death for both
men and women in the US today and claims more lives each year
than the next five leading causes of death combined. Within
cardiovascular disease, Guidant develops, manufactures and
markets products that focus on the treatment of cardiac
arrhythmias, heart failure and coronary and peripheral disease
including:
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Implantable defibrillator systems used to detect and treat
abnormally fast heart rhythms (tachycardia) that could
result in sudden cardiac death (SCD), including implantable
cardiac resynchronization therapy defibrillator (CRT-D) systems
used to treat heart failure |
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Implantable pacemaker systems used to manage slow or irregular
heart rhythms (bradycardia), including implantable cardiac
resynchronization therapy pacemaker (CRT-P) systems used to
treat heart failure |
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Coronary stent systems for the treatment of coronary artery
disease |
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Angioplasty systems, including dilatation catheters, guidewires
and related accessories for the treatment of coronary artery
disease |
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Cardiac surgery systems to perform cardiac surgical ablation,
endoscopic vessel harvesting (EVH) and beating-heart bypass
surgery |
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Peripheral systems, including those to treat biliary, peripheral
vascular and carotid artery disease |
On December 15, 2004, the Company entered into an agreement
and plan of merger with Johnson & Johnson (J&J)
pursuant to which J&J will acquire the Company for
approximately $25.4 billion in fully diluted equity value.
Under the terms of the agreement, each Company common share will
be exchanged for $30.40 in cash and $45.60 in J&J stock,
provided that the average J&J common stock price is between
$55.45 and $67.09 during the fifteen-day trading period ending
three days prior to the transaction closing. Accordingly, each
Guidant share will be converted into not more than .8224 and not
less than .6797 of a J&J common share, plus $30.40 in cash.
The boards of directors of the Company and J&J have approved
the transaction, which remains subject to the approval of the
Companys shareholders, clearance under the
Hart-Scott-Rodino Antitrust Improvements Act, the European
Union merger control regulation, and other customary closing
conditions.
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The graph below depicts the contributions of the Companys
products to its overall revenues:
Products
Guidants primary medical devices treat the heart, managing
its rhythms, clearing its arteries, and permitting less-invasive
surgeries. Less-invasive therapies have also been extended
beyond the heart to clear and treat non-coronary vessels and
biliary strictures. The following sections further describe
Guidants products.
Cardiac Rhythm Management
Natural electrical impulses stimulate the hearts chambers
to pump blood. In healthy individuals, the electrical current
causes the heart to beat at an appropriate rate and in
synchrony. Guidant makes a variety of implantable devices that
can monitor the heart and deliver electricity to treat cardiac
abnormalities, including the following:
Tachycardia (abnormally fast or chaotic heart
rhythms) can prevent the heart from pumping blood efficiently
and can lead to SCD, sudden cardiac death. Implantable
cardioverter defibrillator systems (defibrillators, leads,
programmers and accessories) monitor the heart and can deliver
electrical energy, restoring a normal rhythm. Guidants
defibrillators can deliver tiered therapy a staged
progression from lower intensity pacing pulses designed to
correct the abnormal rhythm to more aggressive shocks to restore
a heartbeat. The Companys products, including the
VITALITY® family of defibrillators, provide a broad range
of atrial (upper chambers of the heart) and ventricular (lower
chambers) therapies to serve patients various needs.
The Guidant-funded MADIT II study demonstrated the benefit
of Guidant defibrillators in reducing mortality in heart attack
survivors with compromised heart function and is further
described in Item 7. MADIT II enhances
physicians ability to identify and treat an expanded at
risk patient population.
Heart failure (the hearts inability to pump
effectively) is a debilitating, progressive condition, with
symptoms including shortness of breath and extreme fatigue.
Mortality for diagnosed patients is estimated to be 50% after
five years. The condition is pervasive, with nearly five million
Americans affected. Cardiac resynchronization therapy
(CRT) devices, like certain devices in the Companys
CONTAK RENEWAL® family of devices, can help reduce
mortality and hospitalization.
Recent clinical trials continue to support positive market
trends in this area. For example, the results of the National
Heart, Lung and Blood Institutes Sudden Cardiac Death in
Heart Failure Trial (SCD-HeFT) demonstrated positive benefits of
implantable defibrillators in patients with heart failure.
Similarly, investiga-
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tors in the COMPANION clinical trial reported that for advanced
heart failure patients with desynchronized heart contractions,
the addition of resynchronization therapy to optimal drug
treatment reduced the combination of death and hospitalization
when compared with optimal drug treatment alone. SCD-HeFT and
COMPANION are further described in Item 7.
Sales of CRT devices are included in the sales of defibrillators
and pacemaker systems.
Bradycardia (slow or irregular heart rhythms)
often results in an insufficient heart rate to provide adequate
blood flow, creating symptoms such as fatigue, dizziness and
fainting. Cardiac pacemaker systems (pulse generators, leads,
programmers, and accessories) deliver electrical energy to
stimulate the heart to beat more frequently. Pacemakers range
from conventional single-chamber devices to more sophisticated
adaptive-rate, dual-chamber devices. Company pacemakers,
including the INSIGNIA® family, offer proprietary blended
sensor technology designed to measure patient workload through
respiration and motion, providing rate response based on the
patients activity.
Vascular Intervention
The coronary arteries, which supply blood to the heart, are
susceptible to buildups of plaque, which can inhibit essential
blood flow. Historically, these obstructions were treated with
coronary artery bypass grafting (CABG) an open
surgery using a portion of another vessel to route around the
blockage. As described below, angioplasty and stenting have
provided less-invasive alternatives, while drug eluting stents
have further advanced this therapy.
Angioplasty systems and accessories can open
clogged arteries. In a percutaneous transluminal coronary
angioplasty (PTCA) procedure, a local anesthetic is
administered and a small incision is made in the patients
groin area to access the femoral artery. The physician inserts a
guiding catheter through the femoral artery, up through the
aorta and into the entrance of the coronary blood vessel and
then advances a small guidewire through the inside of the
guiding catheter into the blood vessel and across the site of
the blockage. Then a dilatation catheter such as a
Guidant
VOYAGERtm
Catheter is delivered over the guidewire through the
inside of the guiding catheter into the blood vessel and across
the site of the blockage. The dilatation catheter is then
inflated to compress the plaque against the artery wall,
enlarging the opening of the vessel and increasing blood flow to
the heart. At the end of the PTCA procedure, all of the devices
are withdrawn. These systems can also be used as components of a
stent system.
Coronary stents help overcome a major clinical
challenge to PTCA restenosis, the renarrowing of the
blood vessel at the site of the initial treatment. Coronary
stents are metal tubes or coils that are mounted on coronary
dilatation catheters. Coronary stents, such as the
Companys MULTI-LINK® family, are permanently deployed
at a blockage by inflating the coronary dilatation catheter to
expand the stent in the artery. When the coronary dilatation
catheter is removed from the artery, the stent stays in place,
providing scaffolding to keep the artery open.
Drug eluting stents are coated with compounds
designed to prevent excessive cell re-growth within the
stent in-stent restenosis. Their development
represents a revolutionary advance in cardiovascular treatment,
increasing the value of the therapy substantially. Competitive
drug eluting stents were available in the US and Europe
throughout 2004 and in Japan during the second half of 2004.
These introductions have reduced Guidants sales of
metallic coronary stents, particularly in the US. While the
Company has not launched a drug eluting stent, drug eluting
stents present a compelling opportunity for the Company, subject
to completion of appropriate clinical work and receipt of
necessary regulatory approvals for the Companys products.
Guidant currently co-promotes with Cordis Corporation (Cordis),
a subsidiary of J&J, the Cordis CYPHER®
Sirolimus-eluting Coronary Stent in the US, under an agreement
entered into in February 2004.
Additional Therapies
Cardiac surgery devices are used to perform EVH,
cardiac surgical ablation and less-invasive CABG procedures.
Surgical cardiac ablation systems include the FLEX®
Microwave Systems, which allow physi-
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cians to perform cardiac surgical ablation procedures both in an
open setting concomitant to a valve or bypass procedure, and in
a stand-alone minimally invasive procedure.
EVH through the VASOVIEW® Endoscopic Vessel Harvesting
System allows physicians to harvest the saphenous vein, the most
common bypass conduit used in CABG procedures, in a
less-invasive manner through one or two small incisions in a
patients leg, or the radial artery through small incisions
in a patients arm. Guidant also provides devices to enable
a complete less-invasive CABG procedure a bypass
performed while a patients heart remains beating. This
eliminates the need to stop the patients heart and place
the patient on a heart-lung machine that circulates the
patients blood during the CABG procedure. Devices such as
Guidants
ACROBATtm
Systems help stabilize and manipulate the heart during
beating-heart surgery. Guidant estimates that approximately 30%
of all CABG procedures in the US use the beating-heart approach
and in excess of 60% use minimally invasive vessel harvesting.
Biliary, peripheral and carotid systems are used
to treat artery and biliary stricture disease. Guidant products
include the
ABSOLUTEtm
Self-Expanding Stent,
AGILTRACtm
Peripheral Dilatation Catheter and RX
ACCULINKtm
Carotid Stent System, including the RX
ACCUNETtm
Embolic Protection System.
Sales and Marketing
Guidant relies on a direct sales force and independent
distributors to best serve its global customers. Sales personnel
work closely with the primary decision makers who purchase
products, including physicians, material managers, biomedical
staff, hospital administrators and purchasing managers. As
further described below, third-party payors and group purchasers
have become increasingly important.
The primary physician users of Guidants largest-selling
products are as follows:
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Physicians |
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Defibrillator systems
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Electrophysiologists, implanting cardiologists |
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Pacemaker systems
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Electrophysiologists, implanting cardiologists, cardiovascular
surgeons |
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Coronary stents and angioplasty
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Interventional cardiologists |
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Cardiac surgery systems
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Cardiac surgeons |
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Non-coronary stents and angioplasty
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Vascular surgeons, interventional radiologists, interventional
cardiologists, interventional neuro-radiologists |
In the US, Guidant sells substantially all of its products
through a direct sales force. In 2004, 67% of consolidated net
sales was derived from sales to customers in the US.
In 2004, 33% of consolidated net sales was derived from
operations outside the US through a direct sales force and
independent distributors. Guidant sells products in nearly 100
countries. Major markets include Europe and Japan, with 23% and
7% of worldwide net sales in 2004. (Revenues are attributed to
countries based on the location of the customer.) Guidant is not
dependent on any single customer, and no single customer
accounted for more than 10% of consolidated net sales in 2004.
The sales and marketing approach outside the US varies depending
on country size and stage of development.
Competition and Customers
The medical technology industry is highly competitive and is
characterized by rapid product development and technological
change. In order to remain competitive with other developers of
medical devices and other therapies, Guidant must continue to
develop and acquire cost-effective new products and
technologies. Similarly, significant shifts in market share have
occurred in connection with production, regulatory, safety, and
other concerns, reflecting the importance of product quality.
Guidants primary competitors for implantable cardiac
rhythm management devices are Medtronic, Inc. (Medtronic) and
St. Jude Medical, Inc. (St. Jude). Guidants primary
competitors for vascular disease
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products include Abbott Laboratories, Boston Scientific
Corporation (Boston Scientific), CR Bard, Inc., J&J,
Medtronic, Sorin Biomedica and Terumo Medical Corporation.
Guidant faces a number of additional competitors with respect to
Guidants other products. Guidant also faces competition
from providers of alternative medical therapies, such as
pharmaceutical companies. Guidant competes primarily on the
basis of therapy effectiveness, product features, product
quality, customer support, price, field services and cost
effectiveness.
Research and Development
Innovation is essential to Guidants success. It is one of
the primary bases of competition in Guidants markets. The
Company works to introduce new products, enhance the
effectiveness and ease of use of existing products and expand
the applications for its existing products.
Guidants research and development staff focuses on product
design and development, quality, clinical research and
regulatory compliance. The Companys research and
development facilities are described in Item 2. Item 7
further describes the Companys recent development efforts,
including drug eluting stent research and research concerning
advanced patient management features for cardiac rhythm
management devices.
To pursue primary research efforts, Guidant has developed
alliances with several leading research institutions and
universities. Guidant also works with leading clinicians around
the world in conducting scientific studies on the Companys
products. These studies include clinical trials that provide
data for use in regulatory submissions and post-market approval
studies involving applications of products.
Guidant evaluates developing technologies in areas where the
Company may have technological or marketing expertise for
possible investment or acquisition. Guidant also has invested in
several development-stage companies.
In each of the past three years, Guidant has invested 13-14% of
net sales in research and development (excluding purchased
in-process research and development).
Manufacturing and Raw Materials
Guidant vertically integrates operations where integration
provides significant cost, supply or quality benefits. In some
areas, Guidant is highly vertically integrated. In other cases,
the Company purchases raw materials and components. In all
cases, Guidant attempts to work closely with suppliers to ensure
the cost-effective delivery of high quality materials and
components. Major considerations used in the selection and
retention of suppliers are supplier technology, quality,
reliability, consistent on-time delivery, services to be
provided and cost.
In general, production activities occur in a controlled
environment setting or clean room. Manufacturing
employees are trained in the necessary production operations and
quality system standards applicable to the production process.
Guidants facilities are further described in Item 2.
The Company purchases many of the materials and components used
in manufacturing products, some of which are custom made.
Certain supplies are purchased from single sources due to
quality considerations, costs or constraints resulting from
regulatory requirements. Agreements with certain suppliers can
be terminated upon short notice. The Company cannot quickly
establish additional or replacement suppliers for certain
components or materials, largely due to the US Food and Drug
Administration (FDA) and other approval systems, and the
complex nature of the manufacturing processes employed by many
suppliers. Production issues, including capacity constraints,
affecting facilities or those of suppliers can affect the
Companys ability to bring new or existing products to
market.
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Patents, Trademarks, Proprietary Rights and Licenses
Patents and other proprietary rights are essential to
Guidants business. Guidant also relies upon trade secrets,
know-how, continuing technological innovations and licensing
opportunities to develop, maintain and strengthen the
Companys competitive position. The Company reviews
third-party patents and patent applications, as publicly
available, in an effort to develop an effective patent strategy,
avoid infringement of third-party patents, identify licensing
opportunities and monitor the patent claims of others.
The Company owns numerous patents and has numerous patent
applications pending in the US and in foreign countries designed
to protect the inventions contained in many products, as well as
surgical methods in which products are used. The Company is a
party to numerous license agreements pursuant to which patent
rights have been obtained or granted in consideration for cash,
cross-licensing rights or royalty payments.
Guidants policy is to seek patent protection in the US and
elsewhere where it is commercially advantageous to do so.
However, the standards for protection of intellectual property
vary widely.
The Company cannot assure that pending patent applications will
result in issued patents, that patents issued or licensed will
not be challenged or circumvented by competitors, that Company
patents will not be found to be invalid or that the intellectual
property rights of others will not prevent the Company from
selling certain products or including key features in the
Companys products.
The Company operates in an industry susceptible to significant
patent litigation. At any given time, Guidant generally is
involved as both a plaintiff and defendant in a number of patent
infringement and other intellectual-property related actions.
Such litigation can result in significant royalty or other
payments or result in injunctions that can prevent the sale of
products. (See Item 8, Note 16 to the consolidated
financial statements.)
Healthcare Cost Containment and Third-Party Reimbursement
The ability of customers to obtain appropriate reimbursement for
products and services from government and third-party payors is
essential to the success of medical technology companies. The
availability of reimbursement affects which products customers
purchase and the prices they are willing to pay. Reimbursement
varies from country to country and can significantly impact the
acceptance of new technology.
After the Company develops a promising new product, the Company
may find limited demand for the product unless reimbursement
approval is obtained from private and governmental third-party
payors. Reimbursement decisions for products such as
defibrillators, including new or expanded indications, can
materially affect results. The Company is actively engaged in
the policy dialogue concerning healthcare cost containment and
reimbursement and works to demonstrate the value of Company
products.
Major third-party payors for hospital services in the US
(Medicare, Medicaid, private healthcare insurance and managed
care plans) and abroad continue to work to contain healthcare
costs. The introduction of cost containment incentives, combined
with closer scrutiny of healthcare expenditures by both private
health insurers and employers, has resulted in increased
discounts and contractual adjustments to hospital charges for
services performed and in the shifting of services between
inpatient and outpatient settings. Initiatives to limit the
growth of healthcare costs, including price regulation, are also
underway in other countries in which Guidant does business.
Implementation of healthcare reforms in significant markets and
other countries may limit the price of, or the level at which
reimbursement is provided for Company products.
Government Regulation
Medical devices are subject to regulation by numerous regulatory
bodies, including the FDA and comparable agencies in other
countries. The Company must comply with laws and regulations
governing the development, testing, manufacturing, labeling,
marketing and distribution of medical devices.
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Devices are subject to varying levels of regulatory control, the
most comprehensive of which requires that a clinical evaluation
be conducted before a device receives approval for commercial
distribution. In the US, the Company generally can obtain
permission to distribute a new device in two ways. The first
applies to any new device that is substantially equivalent to a
device first marketed prior to May 1976. In this case, to obtain
FDA permission to distribute the device, the Company generally
must submit a pre-market notification application (a 510(k)
submission), and receive an FDA order finding substantial
equivalence to a predicate device (pre-May 1976) and permitting
commercial distribution of that device for its intended use. A
510(k) submission must provide information supporting its claim
of substantial equivalence to the predicate device. If clinical
data from human experience is required to support the 510(k)
submission, this data must be gathered in compliance with
investigational device exemption (IDE) regulations for
investigations performed in the US.
The second, more comprehensive, approval process applies to a
new device that is not substantially equivalent to a pre-1976
product. In this case, two steps of FDA approval generally are
required before the Company can market the product in the US.
First, the Company must comply with IDE regulations in
connection with any human clinical investigation of the device.
Second, the FDA must review the Companys pre-market
approval (PMA) application, which contains, among other
things, clinical information acquired under the IDE. The FDA
will approve the PMA application if it finds there is reasonable
assurance the device is safe and effective for its intended use.
Certain changes to existing devices that do not significantly
affect safety or effectiveness can be made with in vitro
testing under reduced regulatory procedures, generally without
human clinical trials and by filing a PMA supplement to a prior
PMA.
Exported devices are subject to the regulatory requirements of
each country to which the device is exported, as well as certain
FDA export requirements. Frequently, regulatory approval may
first be obtained in a foreign country prior to application in
the US. For example, the Company often completes Conformité
Européene (CE) Mark registrations for Company products
under various medical device directives in the European Union.
After approval or clearance to market is given, the FDA and
foreign regulatory agencies, upon the occurrence of certain
events, have the power to withdraw the clearance or require
changes to a device, its manufacturing process, or its labeling
or additional proof that regulatory requirements have been met.
The Company is also required to register with the FDA as a
device manufacturer. As a result, the Company is subject to
periodic inspection by the FDA for compliance with the
FDAs Quality System Regulation requirements and other
regulations. In the European Community, the Company is required
to maintain certain International Organization for
Standardization (ISO) certifications in order to sell
product and it undergoes periodic inspections by notified bodies
to obtain and maintain these certifications. These regulations
require the Company to manufacture products and maintain
documents in a prescribed manner with respect to design,
manufacturing, testing and control activities. Further, the
Company is required to comply with various FDA and other agency
requirements for labeling and promotion. The Medical Device
Reporting regulations require that the Company provide
information to the FDA whenever there is evidence to reasonably
suggest that a device may have caused or contributed to a death
or serious injury or, if a malfunction were to occur, could
cause or contribute to a death or serious injury. In addition,
the FDA prohibits the Company from promoting a medical device
for unapproved indications.
The delivery of the Companys devices is also regulated by
the US Department of Health and Human Services (HHS) and
comparable state and foreign agencies responsible for
reimbursement and regulation of health care. US federal health
care laws apply when the Company submits a claim on behalf of a
federal health care program beneficiary, or when a customer
submits a claim reimbursed under Medicare, Medicaid or most
other federally funded health care programs. The principal
federal laws prohibit the filing of false or improper claims for
federal payment and unlawful inducements for the referral of
business. They also prohibit health care service providers from
providing certain services to a patient if that patient was
referred by a physician who has certain types of direct or
indirect financial relationships with the service provider.
These laws are subject to interpretations.
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If the FDA believes that a company is not in compliance with
applicable regulations, it can issue a warning letter, issue a
recall order, institute proceedings to detain or seize products,
impose operating restrictions, enjoin future violations and
assess civil penalties against the company, its officers or its
employees and can recommend criminal prosecution to the
Department of Justice. Other foreign and domestic regulatory
agencies may have similar powers. HHS also can impose severe
criminal and civil penalties including, for example, exclusion
from participation as a supplier of product to beneficiaries
covered by Medicare or Medicaid. In June 2003, in connection
with the resolution of the ANCURE® matter further described
in Item 8, Note 16 to the consolidated financial
statements, Guidant and its EndoVascular Technologies, Inc.
(EVT) subsidiary entered into a Corporate Integrity
Agreement with the Office of Inspector General of HHS. The
agreement has a five-year term.
Guidant cannot assure that all necessary regulatory approvals,
including approvals for new products or product improvements,
will be granted on a timely basis, if at all. Delays in or
failures to receive approval, product recalls or warnings and
other regulatory actions and penalties can materially affect
operating results.
Environmental Regulation
The Company uses substances regulated under environmental laws,
primarily in manufacturing and sterilization processes. While it
is difficult to quantify, the Company believes the ongoing
impact of compliance with environmental protection laws and
regulations will not have a material impact on the
Companys financial position or results of operations.
Product Liability and Insurance
The design, manufacture and marketing of medical devices of the
types the Company produces entail an inherent risk of product
liability claims. Company products are often used in intensive
care settings with seriously ill patients. In addition, many of
the medical devices the Company manufactures and sells are
designed to be implanted in the human body for long periods of
time or indefinitely. A problem with a product can result in
product liability claims or a recall of, or safety alert or
advisory notice relating to, the product. Product liability
insurance remains available to the Company on terms consistent
with those available in prior periods. However, like many of its
industry peers, the Company has elected to increase
substantially the degree to which it self-insures for product
liability exposures. The decision does not affect coverage with
respect to claims made under previous policies. Guidant cannot
assure that insurance will be available or adequate to satisfy
future claims. (See Item 8, Note 16 to the
consolidated financial statements.)
Corporate History
Guidant incorporated in Indiana in September 1994 to be the
parent of several of the medical device and diagnostics
businesses of Eli Lilly and Company (Lilly). In December 1994,
Guidant consummated an initial public offering of a portion of
outstanding common shares. In September 1995, Lilly, by means of
a split-off, disposed of all of its remaining interests in
Guidant. Biographical information for executive officers is
provided in Item 10 and includes positions held with the
Company and Lilly.
Employees
As of December 31, 2004, Guidant had approximately
12,000 full-time employees, including approximately 3,400
employees outside the US. The Company maintains compensation,
benefits, equity participation and work environment policies
intended to assist in attracting and retaining qualified
personnel. Guidants success depends, in significant part,
on the ability to attract and retain such personnel. In
addition, the Company contracts for services where appropriate.
Contract labor provides management with flexibility, including
dealing with fluctuations in demand and new product transfers to
manufacturing.
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None of the Companys employees is represented by a labor
union. The Company has never experienced an organized work
stoppage or strike and considers relations with employees to be
good. In five of the past seven years, Guidant has been named by
Fortune magazine as one of the 100 Best Companies
to Work For.
Guidant has adopted a Code of Business Conduct (available on
Guidants website, www.guidant.com) that applies to the
Companys Board of Directors and all employees.
Financial Information Relating to Classes of Products
Financial information relating to classes of products is
provided in Item 8, Note 12 to the consolidated
financial statements.
Financial Information Relating to Foreign and Domestic
Operations
Financial information relating to foreign and domestic
operations is provided in Item 8, Note 12 to the
consolidated financial statements. Additional information
concerning foreign exchange risks is provided in Item 7A,
Quantitative and Qualitative Disclosures about Market
Risk, and Item 8, Note 13 to the consolidated
financial statements.
Local restrictions on the transfer of funds from abroad
(including the availability of dollar exchange) have not to date
been a significant deterrent to the Companys overall
operations abroad. A substantial portion of cash and cash
equivalents is held by the Companys non-US subsidiaries.
Additional information concerning the planned repatriation of
cash from a foreign affiliate is discussed in Item 8,
Note 10 to the consolidated financial statements.
Available Information
Guidants web address is www.guidant.com. Guidants
electronic filings with the SEC (including all Forms 10-K,
10-Q, and 8-K and any amendments to these reports) are available
free of charge on the website as soon as reasonably practicable
after they are electronically filed with or furnished to the SEC.
Guidant has also posted the Board of Directors Corporate
Governance Guidelines, the charters of the boards audit,
nominating (governance) and compensation committees, and
the Companys Code of Business Conduct covering directors
and all employees on the website. These materials also are
available free of charge in print to shareholders who request
them in writing.
10
As of December 31, 2004, the Company owned or leased the
following principal operating facilities:
| |
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
Approximate | |
|
Leased or | |
| Location |
|
Type of Facility |
|
Square Feet | |
|
Owned | |
| |
|
|
|
| |
|
| |
|
Brussels, Belgium
|
|
Regulatory affairs, research and development, quality assurance,
administration and sales and marketing |
|
|
73,000 |
|
|
|
Leased |
|
|
Clonmel, Ireland
|
|
Cardiac Rhythm Management (CRM) and Vascular Intervention
(VI) manufacturing and administration |
|
|
181,000 |
|
|
|
Owned |
|
|
Dorado, PR
|
|
CRM, VI and Cardiac Surgery (CS) manufacturing and
administration |
|
|
182,000 |
|
|
|
Owned |
|
|
Indianapolis, IN
|
|
Administration |
|
|
54,000 |
|
|
|
Leased |
|
|
Redmond, WA
|
|
CRM research and development |
|
|
35,000 |
|
|
|
Leased |
|
|
Santa Clara, CA
|
|
CS manufacturing, VI, CS and Endovascular Solutions
(ES) research and development, administration, and sales
and marketing |
|
|
368,000 |
|
|
|
Owned |
|
|
St. Paul, MN
|
|
CRM manufacturing, research and development, administration,
sales and marketing and warehouse |
|
|
1,398,000 |
|
|
|
Owned |
|
|
Temecula, CA
|
|
VI and ES manufacturing, VI, CRM and ES research and development |
|
|
500,000 |
|
|
|
Owned |
|
|
Temecula, CA
|
|
VI, ES and CS warehouse and distribution |
|
|
186,000 |
|
|
|
Leased |
|
|
Tokyo, Japan
|
|
Regulatory affairs, research and development, quality assurance,
administration, sales and marketing and warehouse |
|
|
63,000 |
|
|
|
Leased |
|
Guidant maintains executive offices at 111 Monument Circle, 29th
Floor, Indianapolis, Indiana. Subject to normal expansion, the
Company believes that Company facilities are adequate to meet
present and reasonably foreseeable needs.
|
|
| ITEM 3. |
Legal Proceedings |
The Company is subject to various legal proceedings, many
involving routine litigation incidental to the business. Other
matters contain allegations that are not routine and involve
compensatory, punitive, or treble damage claims, or claims for
injunctive relief related to alleged infringement of third
parties rights, or seek declarations affecting the
validity of Company patents. (See Item 8, Note 16 to
the consolidated financial statements.)
|
|
| ITEM 4. |
Submissions of Matters to a
Vote of Security Holders |
During the fourth quarter of 2004, no matters were submitted to
a vote of security holders.
PART II
|
|
| ITEM 5. |
Market for the
Registrants Common Equity and Related Shareholder
Matters |
Guidants common shares (the Companys only
outstanding equity shares) are traded on the New York Stock
Exchange (NYSE). The Companys annual CEO certification to
the NYSE for the previous year was submitted as of June 3,
2004.
11
|
|
| ITEM 6. |
Selected Consolidated Financial
Data |
In millions, except per share and other data
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Year Ended December 31 |
|
2004(1) | |
|
2003(2) | |
|
2002(3) | |
|
2001(4) | |
|
2000(5) | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales
|
|
$ |
3,765.6 |
|
|
$ |
3,644.8 |
|
|
$ |
3,120.9 |
|
|
$ |
2,636.8 |
|
|
$ |
2,464.3 |
|
|
Cost of products sold
|
|
|
921.6 |
|
|
|
877.4 |
|
|
|
742.0 |
|
|
|
612.9 |
|
|
|
570.3 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Gross profit
|
|
|
2,844.0 |
|
|
|
2,767.4 |
|
|
|
2,378.9 |
|
|
|
2,023.9 |
|
|
|
1,894.0 |
|
|
Research and development
|
|
|
516.0 |
|
|
|
515.0 |
|
|
|
410.5 |
|
|
|
355.2 |
|
|
|
318.7 |
|
|
Purchased in-process research and development
|
|
|
99.8 |
|
|
|
83.7 |
|
|
|
54.9 |
|
|
|
15.0 |
|
|
|
|
|
|
Sales, marketing and administrative
|
|
|
1,191.0 |
|
|
|
1,189.0 |
|
|
|
938.4 |
|
|
|
778.6 |
|
|
|
698.7 |
|
|
Income from continuing operations
|
|
|
573.0 |
|
|
|
419.3 |
|
|
|
669.3 |
|
|
|
538.5 |
|
|
|
397.2 |
|
|
Earnings per share basic:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Income from continuing operations
|
|
$ |
1.84 |
|
|
$ |
1.37 |
|
|
$ |
2.22 |
|
|
$ |
1.79 |
|
|
$ |
1.32 |
|
|
Earnings per share diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Income from continuing operations
|
|
$ |
1.78 |
|
|
$ |
1.34 |
|
|
$ |
2.19 |
|
|
$ |
1.76 |
|
|
$ |
1.28 |
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Basic
|
|
|
312.04 |
|
|
|
305.10 |
|
|
|
301.74 |
|
|
|
300.86 |
|
|
|
301.10 |
|
| |
Diluted
|
|
|
321.24 |
|
|
|
312.52 |
|
|
|
305.99 |
|
|
|
306.22 |
|
|
|
310.11 |
|
|
Cash dividends declared per
share(6)
|
|
$ |
0.40 |
|
|
$ |
0.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| December 31 |
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
2000 | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Financial Position:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital
|
|
$ |
2,679.2 |
|
|
$ |
2,017.5 |
|
|
$ |
1,437.4 |
|
|
$ |
759.2 |
|
|
$ |
453.1 |
|
|
Current ratio
|
|
|
3.6:1.0 |
|
|
|
2.9:1.0 |
|
|
|
2.7:1.0 |
|
|
|
2.0:1.0 |
|
|
|
1.6:1.0 |
|
|
Capital expenditures, net
|
|
|
212.8 |
|
|
|
249.3 |
|
|
|
141.1 |
|
|
|
149.1 |
|
|
|
159.9 |
|
|
Total assets
|
|
|
5,372.2 |
|
|
|
4,640.1 |
|
|
|
3,716.1 |
|
|
|
2,916.8 |
|
|
|
2,521.4 |
|
|
Borrowings
|
|
|
659.2 |
|
|
|
948.3 |
|
|
|
368.5 |
|
|
|
760.0 |
|
|
|
808.9 |
|
|
Borrowings as a percentage of total capitalization
|
|
|
15.0% |
|
|
|
25.9% |
|
|
|
13.7% |
|
|
|
33.0% |
|
|
|
40.6% |
|
|
Shareholders equity
|
|
|
3,742.1 |
|
|
|
2,713.3 |
|
|
|
2,321.8 |
|
|
|
1,545.8 |
|
|
|
1,183.5 |
|
|
Book value per share
|
|
$ |
11.65 |
|
|
$ |
8.68 |
|
|
$ |
7.59 |
|
|
$ |
5.05 |
|
|
$ |
3.82 |
|
|
Other Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective income tax rate
|
|
|
34.7% |
|
|
|
11.8% |
|
|
|
27.3% |
|
|
|
28.4% |
|
|
|
37.3% |
|
|
Full-time employee equivalents
|
|
|
14,491 |
|
|
|
13,578 |
|
|
|
12,540 |
|
|
|
12,076 |
|
|
|
10,452 |
|
|
Common shareholders of record
|
|
|
5,080 |
|
|
|
5,356 |
|
|
|
5,790 |
|
|
|
5,866 |
|
|
|
5,797 |
|
All financial information reflects the GALILEO and AAA product
lines and Brazil operations as discontinued operations.
Income from continuing operations and earnings per share
(EPS) include:
(1) 2004
|
|
|
| |
|
In process research and development (IPRD) of $99.8
primarily includes: |
|
|
|
| |
|
$50.0 million IPRD for clinical results related to
Biosensors Internationals (Biosensors) everolimus eluting
stent trial, FUTURE II |
| |
| |
|
$15.0 million IPRD payment made to Novartis Pharma AG and
Novartis AG for completion of enrollment in the SPIRIT FIRST
clinical trial |
| |
| |
|
$6.0 million IPRD payment to purchase the remaining
interest of Bioabsorbable Vascular Solutions (BVS) |
| |
| |
|
$22.8 million IPRD related to the acquisition of AFx, inc.,
a manufacturer of microwave surgical cardiac ablation medical
devices |
12
|
|
|
| |
|
$20.0 million favorable litigation settlement with
Medtronic relating to atrial fibrillation technology |
| |
| |
|
$20.0 million contribution to the Guidant Foundation |
| |
| |
|
$66.0 million corporate-wide restructuring charge |
| |
| |
|
$54.3 million tax impact of items described above,
including a $104.2 million tax on the planned repatriation
of $1.5 billion under the American Jobs Creation Act of 2004 |
(2) 2003
|
|
|
| |
|
IPRD of $83.7 million primarily includes: |
|
|
|
| |
|
$35.2 million IPRD recorded in conjunction with the
acquisition of certain bioabsorbable polymer technologies from
MediVas LLC |
| |
| |
|
$30.6 million IPRD related to the Biosensors acquisition
and the achievement of a performance milestone related to the
six-month clinical data of the everolimus eluting stent trial,
FUTURE I |
| |
| |
|
$16.0 million IPRD recorded in conjunction with the
acquisition of a majority interest in BVS |
| |
| |
|
$422.8 million net litigation charge primarily related to
the arbitration decision involving Cordis |
| |
| |
|
$168.3 million tax impact of items described above |
(3) 2002
|
|
|
| |
|
IPRD of $54.9 million includes: |
|
|
|
| |
|
$35.6 million IPRD for an exclusive license from Novartis
Pharma AG and Novartis AG for the right to utilize the drug
everolimus in drug eluting stents |
| |
| |
|
$19.3 million IPRD recorded in conjunction with the
acquisition of Cardiac Intelligence Corporation |
| |
| |
|
$137.1 million net litigation benefit resulting primarily
from a $158.2 million award plus interest and costs against
Medtronic |
| |
| |
|
$40.0 million contribution to the Guidant Foundation |
| |
| |
|
$60.6 million termination payment and related expenses
associated with the termination of the Cook Group Inc. merger
agreement |
| |
| |
|
$14.0 million for the restructuring of biliary and
peripheral product line operations |
| |
| |
|
$4.9 million tax impact of items described above |
(4) 2001
|
|
|
| |
|
$15.0 million IPRD related to the acquisition of embolic
protection device technology from Metamorphic Surgical Devices,
LLC |
| |
| |
|
$7.5 million of expenses associated with the
first-generation VENTAK PRIZM® Implantable Defibrillator
field action |
| |
| |
|
$8.3 million tax impact of items described above |
(5) 2000
|
|
|
| |
|
$127.0 million related to the write-off of an option to
acquire exclusive rights to certain experimental therapies for
the treatment of heart failure under development by Impulse
Dynamics |
| |
| |
|
$9.8 million tax impact |
|
|
| (6) |
On February 14, 2005, Guidants Board of Directors
declared a first quarter 2005 dividend of $0.10 per common
share outstanding to be paid March 15, 2005, to
shareholders of record on March 1, 2005. |
See Notes to Consolidated Financial Statements for further
description of these items.
13
|
|
| ITEM 7. |
Managements Discussion
and Analysis of Financial Condition and of Results of
Operations |
2004 OPERATING RESULTS
| |
|
|
|
2004 SALES BY
PRODUCT |
|
2004 SALES BY GEOGRAPHY |
|
|
|
 |
SALES SUMMARY
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
2004 | |
|
|
|
2003 | |
|
|
|
|
| |
|
| |
|
|
|
| |
|
|
|
|
| |
|
US | |
|
Intl. | |
|
Total | |
|
|
|
US | |
|
Intl. | |
|
Total | |
|
|
|
Growth | |
| |
|
| |
|
| |
|
| |
|
|
|
| |
|
| |
|
| |
|
|
|
| |
| (In millions) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Implantable defibrillator systems
|
|
$ |
1,395.1 |
|
|
$ |
368.4 |
|
|
$ |
1,763.5 |
|
|
|
47 |
% |
|
$ |
1,210.7 |
|
|
$ |
278.0 |
|
|
$ |
1,488.7 |
|
|
|
41 |
% |
|
|
18 |
% |
|
Pacemaker systems
|
|
|
426.0 |
|
|
|
293.5 |
|
|
|
719.5 |
|
|
|
19 |
% |
|
|
431.7 |
|
|
|
251.8 |
|
|
|
683.5 |
|
|
|
19 |
% |
|
|
5 |
% |
|
Coronary stent systems
|
|
|
259.6 |
|
|
|
278.5 |
|
|
|
538.1 |
|
|
|
14 |
% |
|
|
463.2 |
|
|
|
380.5 |
|
|
|
843.7 |
|
|
|
23 |
% |
|
|
(36) |
% |
|
Angioplasty systems
|
|
|
210.0 |
|
|
|
242.5 |
|
|
|
452.5 |
|
|
|
12 |
% |
|
|
203.3 |
|
|
|
220.3 |
|
|
|
423.6 |
|
|
|
12 |
% |
|
|
7 |
% |
|
Cardiac surgery, biliary, peripheral and carotid systems
|
|
|
234.4 |
|
|
|
57.6 |
|
|
|
292.0 |
|
|
|
8 |
% |
|
|
165.3 |
|
|
|
40.0 |
|
|
|
205.3 |
|
|
|
5 |
% |
|
|
42 |
% |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
$ |
2,525.1 |
|
|
$ |
1,240.5 |
|
|
$ |
3,765.6 |
|
|
|
100 |
% |
|
$ |
2,474.2 |
|
|
$ |
1,170.6 |
|
|
$ |
3,644.8 |
|
|
|
100 |
% |
|
|
3 |
% |
| |
|
|