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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)
     
Indiana   35-1931722
(State or other jurisdiction of
incorporation or organization)
  (IRS Employer
Identification No.)
 
111 Monument Circle, 29th Floor,
Indianapolis, Indiana
  46204
(Zip Code)
(Address of principal executive offices)    
Registrant’s telephone number, including area code:
317.971.2000
Securities registered pursuant to Section 12(b) of the Act:
     
Title of Each Class   Name of Each Exchange on Which Registered
     
Common Stock   New York Stock Exchange
Preferred Stock Purchase Rights
  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 registrant’s 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 registrant’s 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
ITEM 1. Business
Guidant Corporation provides innovative, therapeutic medical solutions of distinctive value for customers, patients and healthcare systems around the world. Guidant’s 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 Company’s 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:
  •  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
 
  •  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
 
  •  Coronary stent systems for the treatment of coronary artery disease
 
  •  Angioplasty systems, including dilatation catheters, guidewires and related accessories for the treatment of coronary artery disease
 
  •  Cardiac surgery systems to perform cardiac surgical ablation, endoscopic vessel harvesting (EVH) and beating-heart bypass surgery
 
  •  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 Company’s 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 Company’s products to its overall revenues:
BAR CHART
Products
Guidant’s 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 Guidant’s products.
Cardiac Rhythm Management
Natural electrical impulses stimulate the heart’s 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. Guidant’s 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 Company’s 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 heart’s 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 Company’s 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 Institute’s 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 patient’s 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 patient’s 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 Company’s 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 Guidant’s 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 Company’s 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 patient’s leg, or the radial artery through small incisions in a patient’s arm. Guidant also provides devices to enable a complete less-invasive CABG procedure — a bypass performed while a patient’s heart remains beating. This eliminates the need to stop the patient’s heart and place the patient on a heart-lung machine that circulates the patient’s blood during the CABG procedure. Devices such as Guidant’s 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 Guidant’s largest-selling products are as follows:
     
Therapy   Physicians
     
Defibrillator systems
  Electrophysiologists, implanting cardiologists
Pacemaker systems
  Electrophysiologists, implanting cardiologists, cardiovascular surgeons
Coronary stents and angioplasty
  Interventional cardiologists
Cardiac surgery systems
  Cardiac surgeons
Non-coronary stents and angioplasty
  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.
Guidant’s primary competitors for implantable cardiac rhythm management devices are Medtronic, Inc. (Medtronic) and St. Jude Medical, Inc. (St. Jude). Guidant’s 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 Guidant’s 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 Guidant’s success. It is one of the primary bases of competition in Guidant’s 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.
Guidant’s research and development staff focuses on product design and development, quality, clinical research and regulatory compliance. The Company’s research and development facilities are described in Item 2. Item 7 further describes the Company’s 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 Company’s 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. Guidant’s 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 Company’s 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 Guidant’s business. Guidant also relies upon trade secrets, know-how, continuing technological innovations and licensing opportunities to develop, maintain and strengthen the Company’s 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.
Guidant’s 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 Company’s 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
Product 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 Company’s 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 FDA’s 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 Company’s 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 Company’s 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. Guidant’s 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 Company’s 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 Guidant’s website, www.guidant.com) that applies to the Company’s 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 Company’s overall operations abroad. A substantial portion of cash and cash equivalents is held by the Company’s 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
Guidant’s web address is www.guidant.com. Guidant’s 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 Director’s Corporate Governance Guidelines, the charters of the board’s audit, nominating (governance) and compensation committees, and the Company’s 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.

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ITEM 2. Properties
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 Registrant’s Common Equity and Related Shareholder Matters
Guidant’s common shares (the Company’s only outstanding equity shares) are traded on the New York Stock Exchange (NYSE). The Company’s annual CEO certification to the NYSE for the previous year was submitted as of June 3, 2004.

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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 International’s (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, Guidant’s 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. Management’s Discussion and Analysis of Financial Condition and of Results of Operations
2004 OPERATING RESULTS
     
        2004 SALES BY PRODUCT    2004 SALES BY GEOGRAPHY
       PIE CHART
  PIE CHART
SALES SUMMARY
                                                                         
    2004       2003        
                     
    US   Int’l.   Total       US   Int’l.   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 %