-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, C3UZ3SlmtZKsYkhmCw/OszDGe3brPMg/B7U62fgbxSDgjCcJpN6l3oDITTruP+ZL nXi8Fux0gkhr9AXiGnpJfA== 0000897101-04-000533.txt : 20040315 0000897101-04-000533.hdr.sgml : 20040315 20040315171504 ACCESSION NUMBER: 0000897101-04-000533 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20031231 FILED AS OF DATE: 20040315 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ST JUDE MEDICAL INC CENTRAL INDEX KEY: 0000203077 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 411276891 STATE OF INCORPORATION: MN FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12441 FILM NUMBER: 04670436 BUSINESS ADDRESS: STREET 1: ONE LILLEHEI PLAZA CITY: ST PAUL STATE: MN ZIP: 55117 BUSINESS PHONE: 6514832000 MAIL ADDRESS: STREET 1: ONE LILLEHEI PLAZA CITY: ST PAUL STATE: MN ZIP: 55117 10-K 1 stjude041330_10k.htm St. Jude Medical, Inc. Form 10-K 12/31/2003

UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549

FORM 10-K

__X__   ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2003 OR

____   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM
__________ TO __________.

Commission File No. 0-8672
______________________________

ST. JUDE MEDICAL, INC.
(Exact name of Registrant as specified in its charter)

Minnesota     41-1276891    
(State or other jurisdiction of
incorporation or organization)
   (I.R.S. Employer Identification No.)  

One Lillehei Plaza
St. Paul, Minnesota 55117

(Address of principal executive offices)

(651) 483-2000
(Registrant's telephone number, including area code)
______________________________

SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:

 (Title of class)     (Name of exchange on which registered)    
 
Common Stock ($.10 par value)    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 __X__ No _____

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the Registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [    ]

Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Act). Yes __X__ No _____

The aggregate market value of the voting stock held by non-affiliates of the Registrant was approximately $10.6 billion at June 27, 2003 (the last trading day of the Registrant's most recently completed second fiscal quarter), when the closing sale price of such stock, as reported on the New York Stock Exchange, was $58.57 per share.

The Registrant had 175,022,856 shares of its $0.10 par value Common Stock outstanding as of March 1, 2004.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2003, are incorporated by reference into Parts I and II. Portions of the Company's definitive proxy statement dated March 30, 2004, are incorporated by reference into Part III.





TABLE OF CONTENTS

ITEM DESCRIPTION PAGE
 
PART I
 
1. Business
2. Properties 11 
3. Legal Proceedings 12 
4. Submission of Matters to a Vote of Security Holders 16 
4A. Executive Officers of the Registrant 16 
 
PART II
 
5.
Market for Registrant’s Common Equity and Related
                   Stockholder Matters 18 
6. Selected Financial Data 18 
7.

Management’s Discussion and Analysis of Financial Condition and
    Results of Operations
18 
7A. Quantitative and Qualitative Disclosures About Market Risk 19 
8. Financial Statements and Supplementary Data 19 
9.

Changes in and Disagreements with Accountants on Accounting
    and Financial Disclosure
19 
9A. Controls and Procedures 19 
 
PART III
 
10. Directors and Executive Officers of the Registrant 20 
11. Executive Compensation 20 
12.

Security Ownership of Certain Beneficial Owners and Management
    and Related Stockholder Matters
20 
13. Certain Relationships and Related Transactions 20 
14. Principal Accountant Fees and Services 20 
 
PART IV
 
15. Exhibits, Financial Statement Schedules and Reports on Form 8-K 21 
 
          Signatures 26 




PART I

Item 1. BUSINESS

General

        St.Jude Medical, Inc., together with its subsidiaries (collectively St. Jude, St. Jude Medical or the Company) develops, manufactures and distributes cardiovascular medical devices for the global cardiac rhythm management (CRM), cardiac surgery (CS) and cardiology and vascular access (C/VA) therapy areas. The Company’s principal products in each of these therapy areas are follows:

CRM

  o   bradycardia pacemaker systems (pacemakers),
  o   tachycardia implantable cardioverter defibrillator systems (ICDs), and
  o   electrophysiology (EP) catheters

CS

  o   mechanical and tissue heart valves, and
  o   valve repair products

C/VA

  o   vascular closure devices,
  o   angiography catheters,
  o   guidewires, and
  o   hemostasis introducers

        The Company markets and sells its products through both a direct sales force and independent distributors. The principal geographic markets for the Company’s products are the United States, Europe and Japan. St. Jude also sells its products in Canada, Latin America, Australia, New Zealand and the Asia-Pacific region.

        On April 1, 2003, the Company completed its acquisition of Getz Bros. Co., Ltd. (Getz Japan), a distributor of medical technology products in Japan and the Company’s largest volume distributor in Japan. The Company paid 26.9 billion Japanese Yen in cash to acquire 100% of the outstanding common stock of Getz Japan. Net consideration paid was $219.2 million, which includes closing costs less $12.0 million of cash acquired.

        On April 1, 2003, the Company also acquired the net assets of Getz Bros. & Co. (Aust) Pty. Limited and Medtel Pty. Limited related to the distribution of the Company’s products in Australia for $6.2 million in cash, including closing costs.

        In May 2003, the Company made a $15 million minority investment in Epicor Medical, Inc. (Epicor), a development stage company focused on developing products which use high intensity focused ultrasound (HIFU) to ablate cardiac tissue. In conjunction with this investment, the Company also agreed to acquire the remaining ownership of Epicor in 2004 for an additional $185 million in cash if Epicor receives approval from the U.S. Food and Drug Administration (FDA) by June 30, 2004 to begin marketing its device to ablate cardiac tissue and if Epicor achieves certain success criteria, as defined in the purchase agreement, in connection with its European clinical study. In addition, the Company has an option to purchase the remaining ownership of Epicor for $185 million even if FDA approval is not received and the success criteria are not achieved. This option to purchase Epicor expires on June 30, 2004.

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        The Company has two reportable segments, the Cardiac Rhythm Management/Cardiac Surgery (CRM/CS) segment and the Daig segment, which focus on the development and manufacture of the Company’s products. The primary products produced by each segment are: CRM/CS — pacemaker and ICD systems, mechanical and tissue heart valves and other cardiac surgery products; Daig — electrophysiology catheters, vascular closure devices and other cardiology and vascular access products.

        The Company’s reportable segments include end customer revenues from the sale of products they each develop and manufacture. The costs included in each of the reportable segments’ operating results include the direct costs of the products sold to end customers and operating expenses managed by each of the segments. Certain costs of goods sold and operating expenses managed by the Company’s selling and corporate functions are not included in segment operating profit. Consequently, segment operating profit presented below is not representative of the operating profit of the Company’s products in these segments.

        The following table presents certain financial information about the Company’s reportable segments (in thousands):

CRM/CS Daig Other Total

Fiscal Year Ended December 31, 2003                    
  Net sales   $ 1,499,425   $ 366,433   $ 66,656   $ 1,932,514  
  Operating profit(a)     873,904    202,007    (619,966 )  455,945  
  Total assets    639,724    147,270    1,769,100    2,556,094  

Fiscal Year Ended December 31, 2002   
  Net sales   $ 1,305,750   $ 284,179   $   $ 1,589,929  
  Operating profit(a)     713,341    149,592    (492,978 )  369,955  
  Total assets    723,414    134,610    1,093,355    1,951,379  

Fiscal Year Ended December 31, 2001(b)   
  Net sales   $ 1,135,833   $ 211,523   $   $ 1,347,356  
  Operating profit(a)     583,030    105,947    (453,161 )  235,816  


(a)  

Other operating profit includes certain costs of goods sold and operating expenses managed by the Company's selling and corporate functions. In fiscal year 2001, other also includes special charges and purchased in-process research and development charges.


(b)  

During 2001, the Company completed a reorganization of its global sales activities, which resulted in changes to its internal management and financial reporting structure. Due to this restructuring, information relating to 2001 total assets has not been compiled as it is impracticable to do so.


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        Net sales by class of similar products were as follows (in thousands):

Net Sales       2003     2002     2001  

  Cardiac rhythm management   $ 1,365,212   $ 1,147,489   $ 965,968  
  Cardiac surgery    270,933    250,957    248,045  
  Cardiology and vascular access    296,369    191,483    133,343  

    $ 1,932,514   $ 1,589,929   $ 1,347,356  


The following tables present certain geographical information (in thousands):

Net Sales (a)       2003     2002     2001  

  United States   $ 1,129,055   $ 1,042,766   $ 880,086  
  International  
     Europe    465,369    347,936    294,852  
     Japan    207,431    95,813    83,361  
     Other(b)     130,659    103,414    89,057  

       Total International    803,459    547,163    467,270  

    $ 1,932,514   $ 1,589,929   $ 1,347,356  


Long-Lived Assets (c)       2003     2002     2001  

  United States   $ 744,445   $ 674,119   $ 626,140  
  International  
     Europe    96,520    88,194    76,542  
     Japan    152,772    267    46  
     Other    70,020    62,213    61,215  

       Total International    319,312    150,674    137,803  

    $ 1,063,757   $ 824,793   $ 763,943  


(a)   Net sales are attributed to geographies based on location of the customer.
(b)   No one geographic market is greater than 2% of consolidated net sales.
(c)   Long-lived assets exclude deferred income taxes.

    St Jude was incorporated in Minnesota in 1976.

Principal Products

        Cardiac Rhythm Management: The Company’s pacemaker systems treat patients with hearts that beat too slowly, a condition known as bradycardia. Typically implanted pectorally, just below the collarbone, pacemakers monitor the heart’s rate and, when necessary, deliver low-level electrical impulses that stimulate an appropriate heartbeat. The pacemaker is connected to the heart by one or two leads that carry the electrical impulses to the heart and information from the heart back to the pacemaker. An external programmer enables the physician to retrieve diagnostic information from the pacemaker and reprogram the pacemaker in accordance with the patient’s changing needs. Single-chamber pacemakers stimulate only one chamber of the heart (atrium or ventricle), while dual-chamber devices can sense and pace in both the upper and lower chambers.

        St. Jude Medical’s current pacing products include the new Team ADx™ pacemakers, a group comprised of the Identity® ADx, Integrity® ADx, and Verity™ ADx families of devices. The Identity® DR and Identity® XL DR devices were approved by the FDA in March 2003, with the rest of the Team

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ADx™ devices receiving FDA approval in May 2003. The Team ADx devices received European CE Marking in August 2003. The Identity® ADx family models maintain the therapeutic advancements of previous St. Jude Medical pacemakers, including the AF Suppression™ algorithm and the Beat-by-Beat™ AutoCapture™ Pacing System. This family offers new AT/AF arrhythmia diagnostics and dual-channel stored electrograms. The new Integrity® ADx devices also offer dual-channel stored electrograms. These features are designed to help physicians better manage pacemaker patients suffering from atrial fibrillation (AF)—the world’s most common cardiac arrhythmia.

        St. Jude Medical also offers the Identity®and Identity® µ (Micro) pacemakers with stored electrograms; and Integrity®and Integrity® µ (Micro) pacemaker models, which build on the Affinity®platform with its Beat-by-Beat™ AutoCapture™ Pacing System. Other pacing products include the Affinity®pacemakers; the Entity®family of pacemakers, containing the Omnisense® activity-based sensor; and the Tempo®pacemaker family, which uses fifth-generation Minute Ventilation sensor technology. These pacemaker families contain many advanced features and diagnostic capabilities to optimize cardiac therapy. All are small and physiologic in shape to enhance patient comfort. The Microny®II SR+ and Microny® K, the world’s smallest pacemakers, are single-chamber pacemakers available in the United States. Other single-chamber pacemakers, the Microny®SR+ and the Regency®pacemaker families, are also available outside the United States.

        The Identity® ADx, Integrity® ADx, Verity™ ADx, Identity®, Integrity®, Affinity®, Entity® and Regency® families of pacemakers, as well as the Microny® SR+ pacemaker, all offer the unique Beat-by-Beat™ AutoCapture™ Pacing System. The AutoCapture™ Pacing System enables the pacemaker to monitor every paced beat to verify that the heart has been stimulated (known as capture), deliver a back-up pulse in the event of noncapture, continuously measure threshold, and make adjustments in energy output to match changing patient needs. In addition, the Identity® ADx, Integrity® ADx, Identity® and Integrity® pacemakers include St. Jude Medical’s AF Suppression™ Algorithm, a therapy designed to suppress atrial fibrillation.

        Outside the United States, St. Jude Medical also markets low voltage device-based ventricular resynchronization systems designed for the treatment of HF and suppression of atrial fibrillation. These device systems include the Frontier™ 3x2 stimulation device, designed to enhance cardiac function by resynchronizing the contractions of the heart’s two ventricles, the Aescula™ and Quicksite™ LV pacing leads, and the Alliance™, Seal-Away™CS and Apeel™ Catheter Delivery Systems.

        St. Jude Medical’s current pacing leads include the Tendril® SDX (models 1688 and 1488), and Tendril® DX active-fixation lead families, and the IsoFlex™ S and Passive Plus DX passive-fixation lead families, all available worldwide. The Tendril® SDX model 1688T lead received European CE Marking and FDA approval in July 2003. The IsoFlex™ S lead received FDA approval in April 2003. All these lead families feature steroid elution, which helps suppress the body’s inflammatory response to a foreign object. The passive fixation Membrane® EX lead family is also currently available outside the United States.

        ICD systems treat patients with hearts that beat inappropriately fast, a condition known as tachycardia. ICDs monitor the heartbeat and deliver higher energy electrical impulses, or “shocks,” to terminate ventricular tachycardia (VT) and ventricular fibrillation (VF). In VT, the lower chambers of the heart contract at an abnormally rapid rate and typically deliver less blood to the body’s tissues and organs. VT can progress to VF, in which the heart beats so rapidly and erratically that it can no longer pump blood. Like pacemakers, ICDs are typically implanted pectorally, connected to the heart by leads, and programmed non-invasively.

        The Company’s full ICD product offering includes the Epic™+ VR/DR and Epic™ VR/DR ICDs, the Atlas®+ VR/DR and Atlas® VR/DR ICDs, Photon® µ (Micro) DR/VR ICD, Photon® DR ICD, and Contour® MD ICD. St. Jude Medical received FDA approval and European CE Marking of

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the Epic™+ VR/DR ICDs in April 2003, and FDA approval and European CE Marking of the Atlas®+ VR/DR ICDs in October 2003. The Epic™ ICD family devices are very small ICDs that deliver 30 joules of energy. The Atlas® ICD family devices offer high energy and small size without compromising charge times, longevity or feature set flexibility. The Epic™+ DR ICD and the Atlas®+ DR ICD both contain St. Jude Medical’s AF Suppression™ algorithm, which is clinically proven to reduce AF burden.

        The Company’s ICDs are used with the single- and dual-shock electrode Riata® defibrillation leads, dual-shock electrode SPL® leads, and single-shock electrode TVL® and TVL®-ADX (active fixation) transvenous leads. The Riata® single-shock electrode lead received European CE Marking in February 2003 and was FDA approved in March 2003. The Riata® leads are an advanced family of small-diameter, steroid-eluting, active or passive fixation defibrillation leads.

        In December 2003, St. Jude Medical announced that it filed with the FDA the final module in support of its pre-market approval (PMA) application for the following products: the Epic™ HF ICD, the Atlas®+ HF ICD, the Aescula™ 1055K left-heart lead and the QuickSite™ 1056K left-heart lead.  The Company currently anticipates FDA approval of these products during the second quarter of 2004. St. Jude received European CE Marking for the QuickSite™ left-ventricular lead in August 2003 and for its Atlas®+ HF ICD in October 2003. The Atlas®+ HF ICD offers 36 joules of delivered energy, and is designed to treat patients suffering from heart failure (HF) who are also at risk of dangerously fast heart rhythms. HF impairs the heart’s ability to pump blood efficiently, causing shortness of breath, fatigue, swelling and other debilitating symptoms.

        The Company’s pacemakers and ICDs interact with an external device referred to as a programmer. A programmer has two general functions. First, a programmer is used at the time of pacemaker and ICD implants to establish the initial therapeutic settings of these devices as determined by the physician. A programmer is also used for follow-up patient visits, which usually occur every three to 12 months, to download stored diagnostic information from the implanted devices and to verify appropriate therapeutic settings.

        Programmers are small and mobile, and are maintained predominantly by the Company's sales representatives at their homes and transported to the hospitals in their vehicles when either implants or follow-up visits are scheduled. In these cases, the Company's sales representatives are on site at the hospitals to assist the physicians and nurses or technicians in operating the programmers at the time of patient implants or follow-up visits. Programmers are alternatively stored at high-volume cardiac centers as a matter of convenience.

        Since the introduction of programmable pacemakers in about 1977, all pacemaker manufacturers, including the Company, have retained title to their programmers which are used by their field sales force or by physicians and nurses or technicians. Although the Company derives no direct revenue from the use of its programmers, new pacemakers and ICDs generally require the use of the Company’s programmer at the time of implant and follow-up.

        St. Jude’s Model 3510 universal pacemaker and ICD programmer is an easy-to-use programmer that supports the Company’s pacemakers and ICDs. The Model 3510 universal programmer allows the physician to utilize the diagnostic and therapeutic capabilities of the Company’s pacemakers and ICDs.

        Electrophysiology is the study of the electrical activity of the heart, which controls the heart rhythm. EP catheters are placed into the human body percutaneously (through the skin) to aid in the diagnosis and treatment of cardiac arrhythmias (abnormal heart rhythms). Between two and five EP catheters are generally used in each electrophysiology procedure. St. Jude’s EP catheters are available in multiple configurations.

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        St. Jude’s Supreme and Response fixed-curve catheter product lines consist of mapping catheters for the diagnosis of various cardiac arrhythmias, including a line of 4 French Supreme™diagnostic catheters for standard mapping applications. St. Jude also offers Livewire and Reflexion™ steerable catheters with deflectable tips that are used in a wide variety of diagnostic and therapeutic EP procedures, including AF procedures. Finally, St. Jude offers Livewire TC ablation catheters used in therapeutic radio frequency (RF) ablation procedures.

        Cardiac Surgery: Heart valve replacement or repair may be necessary because the natural heart valve has deteriorated due to congenital defects or disease. Heart valves facilitate the one-way flow of blood in the heart and prevent significant backflow of blood into the heart and between the heart’s chambers. St. Jude offers both mechanical and tissue replacement heart valves and valve repair products. The St. Jude Medical® mechanical heart valve has been implanted in over 1.4 million patients worldwide. The SJM Regent™ mechanical heart valve was approved for sale in Europe in December 1999 and received FDA approval for U.S. market release in March 2002. In the United States, the Company markets the Toronto SPV® stentless tissue valve, which received FDA approval in 1997. Outside the United States, the Company markets the SJM Epic™ stented tissue heart valve, the SJM Biocor™ stented tissue valve, the Toronto SPV® stentless tissue valve and the Toronto Root™ tissue valve. The Toronto Root™ tissue valve is a stentless aortic root bioprosthesis used when aortic root disease accompanies valve disease. The Toronto Root™ tissue valve is currently in U.S. and Canadian clinical studies. The SJM Epic™ and SJM Biocor™ stented tissue heart valves are also currently in U.S. clinical studies. St. Jude anticipates FDA approval of the SJM Biocor™ tissue valve by the end of 2004.

        The Company also offers a line of heart valve repair products including the semi-rigid SJM® Séguin annuloplasty ring and the fully flexible SJM Tailor™ annuloplasty ring. Annuloplasty rings are prosthetic devices used to repair diseased or damaged mitral heart valves.

        In addition to prosthetic heart valves, St. Jude markets the Symmetry™ Bypass System Aortic Connector (the Aortic Connector), a suture-free device to facilitate coronary artery bypass graft aortic anastomoses. St. Jude began marketing this product in Western Europe in 2000, in the United States during May 2001, and in Japan during February 2002.

        Cardiology and Vascular Access: The Company produces specialized disposable cardiovascular devices, including vascular closure devices, angiography catheters, bipolar temporary pacing catheters, percutaneous catheter introducers and diagnostic guidewires.

        The Company’s vascular closure devices are used to close femoral artery puncture wounds following angioplasty, stenting and diagnostic procedures. St. Jude Medical’s newest vascular closure product, the Angio-Seal™ STS Plus, was launched globally in the third quarter of 2003. The Angio-Seal™ STS Plus model has incorporated improvements to the STS Platform device design to provide customers a device which provides optimal product performance, reliability and ease of use. The design changes include a newly designed arteriotomy locator that provides a smooth transition from locator to insertion sheath, newly positioned blood inlet holes that eliminate the insertion sheath tip from having to exit and re-enter the arteriotomy site and a new lock-in hub design. The design still incorporates many of the design features of the STS Platform, including the self-tightening suture, which eliminates the need for a post-placement spring, allowing for completion of the entire procedure in the catheterization lab. It also integrates the Secure-Cap™, which facilitates proper deployment through audible, tactile and visual confirmations during the closure process.

        Angiography catheters, such as St. Jude’s Spyglass™ angiography catheters, are used in coronary angiography procedures to obtain images of coronary arteries to identify structural cardiac diseases. St. Jude’s bipolar temporary pacing catheters are inserted percutaneously for temporary use (ranging from less than one hour to a maximum of one week) with external pacemakers to provide patient stabilization prior to implantation of a permanent pacemaker, following a heart attack, or during surgical procedures.

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The Company produces and markets several designs of bipolar temporary pacing catheters, including its Pacel™ biopolar pacing catheters, which are available in both torque control and flow-directed models with a broad range of curve choices and electrode spacing options.

        Percutaneous catheter introducers are used to create passageways for cardiovascular catheters from outside the human body through the skin into a vein, artery or other location inside the body. St. Jude’s percutaneous catheter introducer products consist primarily of peel-away and non peel-away sheaths, sheaths with and without hemostasis valves, dilators, guidewires, repositioning sleeves and needles. These products are offered in a variety of sizes and packaging configurations. The UltimumTM EV introducer, launched in the third quarter of 2003, is the latest introducer offered from St. Jude Medical. These introducers are intended for use during endovascular Abdominal Aortic Aneurysm (AAA) repair procedures in the deployment of stent-graft devices. Diagnostic guidewires, such as St. Jude’s GuideRight™ and HydroSteer™ guidewires, are used in conjunction with percutaneous catheter introducers to aid in the introduction of intravascular catheters. St. Jude’s diagnostic guidewires are available in multiple lengths and incorporate a surface finish for lasting lubricity.

Suppliers

        St. Jude purchases raw materials and other products from numerous suppliers. The Company’s manufacturing requirements comply with the rules and regulations of the FDA, which mandates extensive testing and validation of materials prior to use in the Company’s products. St. Jude maintains a one to three year supply for a small number of sole-sourced inventory items used in certain cardiac surgery products where it would be difficult to quickly establish additional or replacement vendors due to these requirements. St. Jude has been advised periodically by some suppliers that they may terminate sales of products to customers that manufacture implantable medical devices in an effort to reduce their potential product liability exposure. Some of these suppliers have modified their positions and have indicated a willingness to temporarily continue to provide product until an alternative vendor or product can be qualified, or to reconsider the supply relationship. While the Company believes that alternative sources of raw materials are available and that there is sufficient lead time in which to qualify other sources, any supply interruption could have a material adverse effect on the Company’s ability to manufacture its products.

Competition

        The medical technology industry is highly competitive and is characterized by rapid product development and technological change. Within the medical technology industry, competitors range from small start-up companies to companies with significant resources. The Company’s customers consider many factors when choosing supplier partners, including product reliability, clinical outcomes, product availability, inventory consignment, price and product services provided by the manufacturer. St. Jude believes that it competes on the basis of all these factors. Market share can shift as a result of technological innovation, product recalls and product safety alerts and other business factors. As a result, the Company has a need to provide the highest quality products and services. St. Jude expects the competition to continue to increase with the use of tactics such as consigned inventory, bundled product sales and reduced pricing.

        St. Jude is one of the three principal manufacturers and suppliers in the global bradycardia pacemaker market, with strong bradycardia market share in all major developed geographies. The Company’s primary competitors in this market are Medtronic, Inc. and Guidant Corporation. St. Jude is also one of three principal manufacturers and suppliers in the highly competitive global ICD market. The Company’s other two competitors, Medtronic, Inc. and Guidant Corporation, account for more than 80% of the worldwide ICD sales. These two competitors are larger than St. Jude and have invested substantial amounts in ICD research and development.

        St. Jude is the world’s leading manufacturer and supplier in the mechanical heart valve market, which includes two other principal manufacturers and suppliers (Carbomedics (a Sorin Group company)

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and ATS Medical, Inc.) and several smaller manufacturers. The Company also competes against two principal tissue heart valve manufacturers (Edwards Lifesciences Corporation and Medtronic, Inc.) and many other smaller manufacturers.

        The global cardiology and vascular access therapy area is growing and has numerous competitors. Over 70% of the Company’s sales in this area are from vascular closure devices. St. Jude currently holds the number one market position in the highly competitive vascular closure device market. Other vascular closure device competitors include Abbott Laboratories, Datascope Corp. and Vascular Solutions, Inc. We anticipate other large companies will enter this market in the coming years, which will likely increase competition.

Marketing

        The Company’s products are sold in more than 120 countries throughout the world. No distributor organization or single customer accounted for more than 10% of 2003, 2002 or 2001 consolidated net sales.

        In the United States, St. Jude sells directly to hospitals primarily through a direct sales force. In Europe, the Company has direct sales organizations selling in 15 countries. In Japan, the Company sells directly to hospitals through a direct sales force due to its acquisition of Getz Japan on April 1, 2003, and also continues to use longstanding independent distributor relationships. Throughout the rest of the world the Company uses a combination of independent distributors and direct sales forces.

        Group purchasing organizations (GPOs) and independent delivery networks (IDNs) in the United States continue to consolidate purchasing decisions for some of the Company’s hospital customers. The Company has contracts in place with many of these organizations. In some circumstances, the inability of the Company to obtain a contract with a GPO or IDN could adversely affect the Company’s efforts to sell its products to that organization’s hospitals.

        Payment terms worldwide are consistent with local country practices. In some developed markets and in many emerging markets, payment terms are typically longer than those in the United States. Orders are shipped as they are received and, therefore, no material backlog exists.

Seasonality

        The Company’s quarterly net sales are influenced by many factors, including new product introductions, acquisitions, regulatory approvals, patient holiday schedules and other factors. Net sales in the third quarter are typically lower than the other quarters of the year as a result of patient tendencies to defer, if possible, cardiac procedures during the summer months and from the seasonality of the U.S. and European markets, where summer vacation schedules normally result in fewer surgical procedures. Independent distributors may also place large orders that can distort the net sales patterns.

Research and Development

        The Company is focused on the development of new products and on improvements to existing products. Research and development expense reflects the cost of these activities, as well as the costs to obtain regulatory approvals of certain new products and processes and to maintain the highest quality standards with respect to existing products. The Company’s research and development expenses were $241.1 million (12.5% of net sales) in 2003, $200.3 million (12.6% of net sales) in 2002 and $164.1 million (12.2% of net sales) in 2001. Research and development expense for 2001 excludes $10 million of purchased in-process research and development charges relating to the acquisition of Vascular Science, Inc. in September 1999.

Government Regulation

        The medical devices manufactured and marketed by the Company are subject to regulation by the FDA and foreign governmental authorities or their designated representatives. Under the U.S. Federal

8





Food, Drug and Cosmetic Act (FFDCA) and associated regulations, manufacturers of medical devices must comply with certain policies and procedures that regulate the composition, labeling, testing, manufacturing, packaging and distribution of medical devices. Medical devices are subject to different levels of government approval requirements. The most comprehensive level requires the completion of an FDA-approved clinical evaluation program and submission and approval of a PMA application before a device may be commercially marketed. The Company’s mechanical and tissue heart valves, ICDs, certain pacemakers and leads, and certain electrophysiology catheter applications are subject to this level of approval or as a supplement to a PMA. Other pacemakers and leads, annuloplasty ring products and other electrophysiology and cardiology products are currently marketed under the less rigorous 510(k) pre-market notification procedure of the FFDCA.

        In addition, the FDA may require testing and surveillance programs to monitor the effects of approved products that have been commercialized, and it has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs. The FDA also conducts inspections prior to approval of a PMA to determine compliance with the quality system regulations that cover manufacturing and design. At any time after approval of a PMA or granting of a 510(k), the FDA may conduct periodic inspections to determine compliance with both quality system regulations and/or current medical device reporting regulations. If the FDA were to conclude that St. Jude is not in compliance with applicable laws or regulations, it could institute proceedings to detain or seize products, issue a recall, impose operating restrictions, assess civil penalties and recommend criminal prosecution to the U.S. Department of Justice. Furthermore, the FDA could proceed to ban a device, or request recall, repair, replacement or refund of the cost of any device previously manufactured or distributed.

        The FDA also regulates recordkeeping for medical devices and reviews hospital and manufacturers’ required reports of adverse experiences to identify potential problems with FDA- authorized devices. Regulatory actions may be taken by the FDA due to adverse experience reports.

        Diagnostic-related groups (DRG) reimbursement schedules regulate the amount the U.S. government, through the Centers for Medicare and Medicaid Services, will reimburse hospitals and doctors for the inpatient care of persons covered by Medicare. In response to rising Medicare and Medicaid costs, several legislative proposals are under consideration that would restrict future funding increases for these programs. Changes in current DRG reimbursement levels could have an adverse effect on the Company’s domestic pricing flexibility.

        Federal and state laws protect the confidentiality of certain patient health information, including patient records, and restrict the use and disclosure of such information. In particular, in December 2000, the U.S. Department of Health and Human Services published patient privacy rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA privacy rule). This regulation was finalized in October 2002. The HIPAA privacy rule governs the use and disclosure of protected health information by “covered entities,” which are health care providers that submit electronic claims, health plans and health care clearinghouses. Other than to the extent the Company self-insures part of its employee health benefits plans, the HIPAA privacy rule affects the Company only indirectly. The Company’s policy is to maintain patients’ privacy and work with customers and business partners in their HIPAA compliance efforts.

        St. Jude’s international business is subject to medical device laws in individual countries outside the United States. These laws range from extensive device approval requirements in some countries for all or some of the Company’s products, to requests for data or certifications in other countries. Generally, international regulatory requirements are increasing. In the European Union, the regulatory systems have been consolidated, and approval to market in all European Union countries (represented by the CE Mark) can be obtained through one agency. In addition, initiatives to limit the growth of healthcare costs, including price regulation, are also underway in other countries in which we do business. Implementation

9





of healthcare reforms in significant markets such as Japan, Germany and other countries may limit the price of, or the level at which reimbursement is provided for, our products.

        Some medical device regulatory agencies have begun considering whether to continue to permit the sale of medical devices that incorporate any bovine material because of concerns about Bovine Spongiform Encephalopathy (BSE), sometimes referred to as “mad cow disease.” It is believed that in some instances this disease has been transmitted to humans through the consumption of beef. There have been no reported cases of transmission of BSE through medical products. Some of the Company’s products (Angio-Seal™ and vascular grafts) use bovine collagen, which is derived from the bovine component scientifically rated as least likely to transmit the disease. Some of the Company’s tissue heart valves incorporate bovine pericardial material. The Company is cooperating with the regulatory agencies considering these issues.

Patents and Licenses

        The Company’s policy is to protect its intellectual property rights related to its medical devices. Where appropriate, St. Jude applies for U.S. and foreign patents. In those instances where the Company has acquired technology from third parties, it has sought to obtain rights of ownership to the technology through the acquisition of underlying patents or licenses.

        While the Company believes design, development, regulatory and marketing aspects of the medical device business represent the principal barriers to entry, it also recognizes that the Company’s patents and license rights may make it more difficult for competitors to market products similar to those produced by the Company. St. Jude can give no assurance that any of its patent rights, whether issued, subject to license, or in process, will not be circumvented or invalidated. Furthermore, there are numerous existing and pending patents on medical products and biomaterials. There can be no assurance that the Company’s existing or planned products do not or will not infringe such rights or that others will not claim such infringement. No assurance can be given that the Company will be able to prevent competitors from challenging the Company’s patents or entering markets currently served by the Company.

Insurance

        The Company operates in an industry that is susceptible to significant product liability claims. These claims may be brought by individuals seeking relief for themselves or, increasingly, by groups seeking to represent a class. In addition, product liability claims may be asserted against the Company in the future, relative to events that are not known to management at the present time. As a result of the catastrophic events of September 11, 2001, enormous losses were sustained by property and casualty insurers which substantially reduced their capacity and/or willingness to provide future insurance coverage. Consequently, since 2001 the Company’s product liability insurance premiums have increased over 450% and the total coverage has been reduced. The Company’s current product liability policy (for the period April 1, 2003 through March 31, 2004) provides $200 million of insurance coverage, with a $50 million deductible per occurrence. In light of the significant self-insured retention, St. Jude’s product liability insurance coverage is designed to help protect the Company against a catastrophic claim.

        California earthquake insurance is currently difficult to procure, extremely costly, and restrictive in terms of coverage. The Company’s earthquake and related business interruption insurance for its CRM operations located in Sylmar and Sunnyvale, California provides $25 million of insurance coverage, with a deductible equal to 5% of the total value of the facility and contents involved in the claim. Several factors preclude the Company from determining the effect an earthquake may have on its business. These factors include, but are not limited to, the severity and location of the earthquake, the extent of any damage to the Company’s manufacturing facilities, the impact of an earthquake on the Company’s California workforce and the infrastructure of the surrounding communities and the extent, if any, of damage to the Company’s inventory and work in process. While the Company’s exposure to significant losses from a California earthquake would be partially mitigated by its ability to manufacture some of its

10





CRM products at its Swedish manufacturing facility, the losses could have a material adverse effect on the Company for a period of time that cannot be predicted. The Company has expanded the manufacturing capabilities at its Swedish facility and has constructed a pacemaker component manufacturing facility in Arizona. In addition, the Company has moved significant finished goods inventory to locations outside California. These facilities and inventory transfers would further mitigate the adverse impact of a California earthquake.

Employees

        As of December 31, 2003, the Company had 7,391 full-time employees. St. Jude’s employees are not represented by any labor organizations, with the exception of the Company’s employees in Sweden and certain employees in France. St. Jude has never experienced a work stoppage as a result of labor disputes. The Company believes that its relationship with its employees is generally good.

International Operations

        The Company’s international business is subject to such special risks as currency exchange controls and fluctuations, the imposition or increase of import or export duties and surtaxes, and international credit, financial or political problems. Currency exchange rate fluctuations relative to the U.S. dollar can affect reported consolidated revenues and net earnings. The Company may hedge a portion of this exposure from time to time to reduce the effect of foreign currency rate fluctuations on net earnings. See the “Market Risk” section of “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” incorporated herein by reference from the Financial Report included in the Company’s 2003 Annual Report to Shareholders. Operations outside the United States also present complex tax and cash management issues that necessitate sophisticated analysis and diligent monitoring to meet the Company’s financial objectives.

Availability of SEC Reports

        The Company makes available free of charge its annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 as soon as reasonably practical after they are filed or furnished to the Securities and Exchange Commission. Such reports are available on the Company’s website (http://www.sjm.com) under the Investor Relations section or can be obtained by contacting the Company’s Investor Relations group at 1.800.552.7664 or at St. Jude Medical, Inc., One Lillehei Plaza, St. Paul, Minnesota 55117. Information included on the Company’s website is not deemed to be incorporated into this Annual Report on Form 10-K.

Item 2. PROPERTIES

        St. Jude’s principal executive offices are located in St. Paul, Minnesota. These facilities are owned by the Company. Manufacturing facilities are located in California, Minnesota, Arizona, South Carolina, Canada, Brazil, Puerto Rico and Sweden. The Company owns approximately 54%, or 338,000 square feet, of its total manufacturing space. The remaining manufacturing space is leased.

        The Company also maintains sales and administrative offices in the United States at 18 locations in 10 states and outside the United States at 68 locations in 25 countries. With the exception of two locations, all of these locations are leased.

        In management’s opinion, all buildings, machinery and equipment are in good condition, suitable for their purposes and are maintained on a basis consistent with sound operations. The Company believes that it has sufficient space for its current operations and for foreseeable expansion in the next few years.

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Item 3. LEGAL PROCEEDINGS

        Silzone® Litigation: In July 1997, the Company began marketing mechanical heart valves which incorporated a Silzone® coating. The Company later began marketing heart valve repair products incorporating a Silzone® coating. The Silzone® coating was intended to reduce the risk of endocarditis, a bacterial infection affecting heart tissue, which is associated with replacement heart valves.

        In January 2000, the Company voluntarily recalled all field inventories of Silzone® devices after receiving information from a clinical study that patients with a Silzone® valve had a small, but statistically significant, increased incidence of explant due to paravalvular leak compared to patients in that clinical study with non-Silzone® heart valves.

        Subsequent to the Company’s voluntary recall, the Company has been sued in the United States, Canada, and United Kingdom by some patients who received a Silzone® device. Some of these claims allege bodily injuries as a result of an explant or other complications, which they attribute to the Silzone® devices. Others, who have not had their device explanted, seek compensation for past and future costs of special monitoring they allege they need over and above the medical monitoring all replacement heart valve patients receive. Some of the lawsuits seeking the cost of monitoring have been initiated by patients who are asymptomatic and who have no apparent clinical injury to date. Some of these cases have been settled, some have been dismissed and others are on-going. Some of these cases, both in the United States and Canada, are seeking class action status. A summary of the number of Silzone® cases by jurisdiction as of January 26, 2004 follows:

U.S. Cases

  o  

Multi-District Litigation (“MDL”) and federal district court in Minnesota:


    o  

Eight original class action complaints have been consolidated into one case seeking certification of two separate classes. The first complaint seeking class action status was served upon the Company on April 27, 2000 and all eight original complaints seeking class action status were consolidated into one case on October 22, 2001. One proposed class in the consolidated complaint seeks injunctive relief in the form of medical monitoring. A second class in the consolidated complaint seeks an unspecified amount of money damages.


    o  

39 individual cases have been filed. The first individual complaint that was transferred to the MDL court was served upon the Company on November 28, 2000, and the most recent individual complaint that was transferred to the MDL court was served upon the Company on June 27, 2003. The complaints in these cases each request damages ranging from an unspecified amount to $120.5 million.


  o  

25 individual state court suits involving 42 patients have been filed. Cases are venued in the following states: California, Florida, Illinois, Minnesota, Nevada, New York, South Carolina, Tennessee and Texas. The first individual state court complaint was served upon the Company on March 1, 2000 and the most recent individual state court complaint was served upon the Company on November 24, 2003. The complaints in these cases each request damages ranging from an unspecified amount to $70,000.


  o  

Two cases involving 70 patients were dismissed in Texas by the trial court on April 25, 2002 and February 14, 2003, respectively; the plaintiffs in these two cases have appealed. The first of these cases were served on the Company on October 29, 2001, and the second case was served upon the Company on November 8, 2002. The complaints in these cases request damages in an unspecified amount.


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Non-U.S. Cases

Canada:

  o  

 Four class action cases involving five named plaintiffs are pending (cases are venued in the provinces of British Columbia, Ontario and Quebec); in one case, class action status has been granted by the court. The first complaint in Canada was served upon the Company on August 18, 2000, and the most recent Canadian complaint was served upon the Company on December 12, 2002. The complaints in these cases each request damages ranging from 1.5 million to 500 million Canadian dollars.


UK:

  o  

 One case involving one plaintiff has been filed. This complaint was filed on August 28, 2003, but has yet to be served upon the Company. The complaint in this case requests damages of an unspecified amount.


        The Silzone® litigation reserves established by the Company are not based on the amount of the claims because, based on our experience in these types of cases, the amount ultimately paid, if any, often does not bear any relationship to the amount claimed by the plaintiffs and is often significantly less than the amount claimed by plaintiffs.

        In 2001, the U.S. Judicial Panel on Multi-District Litigation ruled that certain lawsuits filed in U.S. federal district court involving products with Silzone® coating should be part of Multi-District Litigation proceedings under the supervision of U.S. District Court Judge John Tunheim in Minnesota. As a result, actions in federal court involving products with Silzone® coating have been and will likely continue to be transferred to Judge Tunheim for coordinated or consolidated pretrial proceedings.

        Certain plaintiffs requested Judge Tunheim to allow some cases to proceed as class actions. Judge Tunheim issued a ruling on plaintiffs’ motions for class certification on March 27, 2003. In his ruling, Judge Tunheim certified one class of plaintiffs under the Minnesota consumer statutes.

        On January 5, 2004, Judge Tunheim ruled on two motions brought by the Company in the Silzone® class action litigation pending in federal district court in Minnesota. In one order, Judge Tunheim ruled on the ability of certain claims to proceed as class actions. He declined to grant class action status to personal injury claims. He also granted class action status to medical monitoring claims of patients from 13 states and the District of Columbia where the law permits a certain type of medical monitoring claim, and yet invited further briefing on exactly which states fall into this category and how a class involving such claims would proceed.

        Judge Tunheim also ruled against the Company in a separate order on the issue of preemption and held that the plaintiff’s causes of action were not preempted by the U.S. Food and Drug Act. The Company is reviewing its options for the appeal of this decision.

        In the meantime, the cases involving Silzone® products not seeking class action status which are consolidated before Judge Tunheim are proceeding in accordance with the scheduling orders he has rendered. There are also other actions involving products with Silzone® coating in various state courts that may or may not be coordinated with the matters presently before Judge Tunheim.

        On January 16, 2004, the court in Ontario, Canada certified a class of Silzone® patients in a class action suit against the Company.

        The Company is not aware of any unasserted claims related to Silzone® devices.

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        Company management believes that the final resolution of the Silzone® cases will take several years. At this time, management cannot reasonably estimate the time frame in which any potential settlements or judgments would be paid out. The Company accrues for contingent losses when it is probable that a loss has been incurred and the amount can be reasonably estimated. The Company has recorded an accrual for probable legal costs that it will incur to defend the various cases involving Silzone® devices, and the Company has recorded a receivable from its product liability insurance carriers for amounts expected to be recovered (see Note 7 to the Consolidated Financial Statements). The Company has not accrued for any amounts associated with probable settlements or judgments because management cannot reasonably estimate such amounts. However, management believes that no significant claims will ultimately be allowed to proceed as class actions in the United States and, therefore, that all settlements and judgments will be covered under the Company’s remaining product liability insurance coverage (approximately $170 million at December 31, 2003), subject to the insurance companies’ performance under the policies (see Note 7 to the Consolidated Financial Statements for further discussion on the Company’s insurance carriers). As such, management believes that any costs (the material components of which are settlements, judgments and legal fees) not covered by its product liability insurance policies or existing reserves will not have a material adverse effect on the Company’s statement of financial position or liquidity, although such costs may be material to the Company’s consolidated results of operations of a future period.

        Guidant 1996 Patent Litigation: In November 1996, Guidant Corporation (“Guidant”) sued St. Jude Medical in federal district court for the Southern District of Indiana alleging that the Company did not have a license to certain patents controlled by Guidant covering ICD products and alleging that the Company was infringing those patents. St. Jude Medical’s contention was that it had obtained a license from Guidant to the patents in issue when it acquired certain assets of Telectronics in November 1996. In July 2000, an arbitrator rejected St. Jude Medical’s position, and in May 2001, a federal district court judge also ruled that the Guidant patent license with Telectronics had not transferred to St. Jude Medical.

        Guidant’s suit originally alleged infringement of four patents by St. Jude Medical. Guidant later dismissed its claim on one patent and a court ruled that a second patent was invalid. This determination of invalidity was appealed by Guidant, and the Court of Appeals upheld the lower court’s invalidity determination. In a jury trial involving the two remaining patents (the ‘288 and ‘472 patents), the jury found that these patents were valid and that St. Jude Medical did not infringe the ‘288 patent. The jury also found that the Company did infringe the ‘472 patent, though such infringement was not willful. The jury awarded damages of $140 million to Guidant. In post-trial rulings, however, the judge overseeing the jury trial ruled that the ‘472 patent was invalid and also was not infringed by St. Jude Medical, thereby eliminating the $140 million verdict against the Company. The trial court also made other rulings as part of the post-trial order, including a ruling that the ‘288 patent was invalid on several grounds.

        In August 2002, Guidant commenced an appeal of certain of the trial judge’s post-trial decisions pertaining to the ‘288 patent. Guidant did not appeal the trial court’s finding of invalidity and non-infringement of the ‘472 patent. As part of its appeal, Guidant requested that the monetary damages awarded by the jury pertaining to the ‘472 patent ($140 million) be transferred to the ‘288 patent infringement claim. The Company maintains that such a request is not supported by the facts or law. After the briefing for this appeal was completed, oral argument before the Court of Appeals occurred on September 4, 2003. The Company expects that the Appellate Court will issue a decision concerning Guidant’s appeal sometime later in 2004. While it is not possible to predict the outcome of the appeal process, the Company believes the decision of the trial court in its post-trial rulings, which is publicly available, was correct.

        The ‘288 patent expired in December 2003. Accordingly, the final outcome of the appeal process cannot involve an injunction precluding the Company from selling ICD products in the future. Sales of the Company’s ICD products which Guidant asserts infringed the ‘288 patent were

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approximately 18%, 16% and 13% of the Company’s consolidated net sales during the fiscal years ended December 31, 2003, 2002 and 2001, respectively.

        The Company has not accrued any amounts for losses related to the Guidant 1996 patent litigation. Although the Company believes that the assertions and claims in these matters are without merit, potential losses arising from this litigation are possible, but not estimable, at this time. The range of such losses could be material to the operations, financial position and liquidity of the Company.

        Guidant 2004 Patent Litigation: In February 2004, Guidant sued the Company in federal district court in Delaware alleging that the Company’s Epic™ HF ICD, Atlas®+ HF ICD and Frontier™ device infringe U.S Patent No. RE 38,119E (the ‘119 patent). Guidant also sued the Company in February 2004 alleging that the Company’s QuickSite™ 1056K pacing lead infringes U.S. Patent No. 5,755,766 (the ‘766 patent). This second suit was initiated in federal district court in Minnesota. Guidant is seeking an injunction against the manufacture and sale of these devices by the Company in the United States and compensation for what it claims are infringing sales of these products up through the effective date of the injunction. Sales of the above St. Jude Medical devices in the United States were not material during fiscal years 2003, 2002 and 2001, although it is anticipated that once FDA approval is received, sales of these devices could become material in the future. The Company has not submitted a substantive response to Guidant's claims at this time. Another competitor of the Company, Medtronic, Inc., which has a license to the ‘119 patent, is contending in a separate lawsuit with Guidant that the ‘119 patent is invalid.

        The Company has not accrued any amounts for losses related to the Guidant 2004 patent litigation. Potential losses arising from this litigation are possible, but not estimable, at this time. The range of such losses could be material to the operations, financial position and liquidity of the Company.

         Symmetry™ Litigation: The Company has been sued in six cases in the United States alleging that its Symmetry Bypass System Aortic Connector (Symmetry™ device) caused bodily injury or might cause bodily injury. The first such suit as filed against the Company on August 5, 2003, in federal district court for the Western District of Tennessee, and the most recently initiated case was served upon the Company on January 28, 2004. The six cases are venued in state court in Minnesota, federal court for the District of Minnesota, federal court in the Western District of Tennessee and federal court for the Northern District of Illinois. Each of the complaints in these cases request damages ranging from an unspecified amount to $100,000. Three of the six cases are seeking class-action status. One of the cases seeking class-action status has been dismissed but the dismissal is being appealed by the plaintiff. The Company believes that those cases seeking class-action status will request damages for injuries and monitoring costs.

        The Company’s Symmetry™ device was cleared through a 510(K) submission to the FDA, and therefore, is not eligible for the defense under the doctrine of federal preemption that such suits are prohibited. Given the Company’s self-insured retention levels under its product liability insurance policies, the Company expects that it will be solely responsible for these lawsuits, including any costs of defense, settlements and judgments. Company management believes that class action status is not appropriate for the claims asserted based on existing facts and case law. Discovery is in the very early stages in these cases.

        The Company has not accrued any amounts for losses related to the Symmetry litigation. Potential losses arising from this litigation are possible, but not estimable, at this time. The range of such losses could be material to the operations, financial position and liquidity of the Company. At this time, Company management cannot reasonably estimate the time frame in which this litigation will be resolved, including when potential settlements or judgments would be paid out, if any.

15





        Other Litigation Matters: The Company is involved in various other product liability lawsuits, claims and proceedings that arise in the ordinary course of business.

Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

        There were no matters submitted to a vote of security holders during the fourth quarter of 2003.

Item 4A. EXECUTIVE OFFICERS OF THE REGISTRANT

Name Age                   Position*

     
Terry L. Shepherd ** 51  Chairman (2002) and Chief Executive Officer (1999)
 
Daniel J. Starks ** 49  President and Chief Operating Officer (2001)
 
David W. Adinolfi 48  President, Daig (2001)
 
Michael J. Coyle 41  President, Cardiac Rhythm Management (2001)
 
Peter L. Gove 56  Vice President, Corporate Relations (1994)
 
John C. Heinmiller 49  Vice President, Finance, Chief Financial Officer
and Treasurer (1998)
 
Jeri L. Lose 46  Vice President, Information Technology (1999)
and Chief Information Officer (2000)
 
Joseph H. McCullough 54  President, International (2001)
 
Thomas R. Northenscold 46  Vice President, Administration (2003)
 
Kevin T. O'Malley 52  Vice President, General Counsel and Secretary (1994)
 
Michael T. Rousseau 48  President, U.S. Sales (2001)
 
Jane J. Song 41  President, Cardiac Surgery (2002)

_________________

*  

 Dates in parentheses indicate year during which each named executive officer began serving in such capacity.


**  

 Mr. Shepherd will retire as Chief Executive Officer of the Company and Chairman of the Board of Directors in May 2004. He will be succeeded by the Company’s President and Chief Operating Officer, Mr. Starks.


        Executive officers serve at the pleasure of the Board of Directors.

        Mr. Shepherd joined the Company in 1994 as President of Cardiac Surgery. In May 1999, he was appointed President and Chief Executive Officer of St. Jude, and since February 2001 he has been the Company’s Chief Executive Officer. Mr. Shepherd has also served on St. Jude’s Board of Directors since May 1999, and in May 2002 was elected Chairman of the Board of Directors.

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        Mr. Starks joined St. Jude in 1996 as a result of the Company’s acquisition of Daig Corporation, where he continued as Chief Executive Officer. In 1997, he was also appointed Chief Executive Officer of Cardiac Rhythm Management, and in April 1998 also became President of Cardiac Rhythm Management. He was appointed President and Chief Operating Officer of St. Jude in February 2001. Mr. Starks has also served on the Company’s Board of Directors since 1996. Mr. Starks serves on the Board of Directors of Urologix, Inc.

        Mr. Adinolfi joined St. Jude in 1994 as a result of the Company’s acquisition of Pacesetter, Inc. He served as Vice President, CRM Global Product Planning and Identification from June 1996 to March 1998. In April 1998, he became Senior Vice President, CRM Global Marketing, and in March 1999 became Senior Vice President of CRM Product Portfolio Management. In February 2001, Mr. Adinolfi was appointed President of Daig. Prior to joining Pacesetter in 1989 as Director of Marketing, Mr. Adinolfi worked for Cordis Corporation and Telectronics, Inc., both medical technology companies, in a variety of marketing, sales and management positions.

        Mr. Coyle joined St. Jude in 1994 as Director, Business Development. He served as President and Chief Operating Officer of Daig from 1997 to 2001 and was appointed President, Cardiac Rhythm Management in February 2001. Prior to joining St. Jude, he spent nine years with Eli Lilly & Company, a pharmaceutical products company, in a variety of technical and business management roles in both its Pharmaceutical and Medical Device Divisions.

        Mr. Gove joined the Company in 1994 as Vice President, Corporate Relations. Prior to joining the Company, Mr. Gove was Vice President, Marketing and Communications of Control Data Systems, Inc., a computer services company, from 1991 to 1994. From 1981 to 1990, Mr. Gove held various executive positions with Control Data Corporation. From 1970 to 1981, Mr. Gove held various management positions with the State of Minnesota and the U.S. Government. Mr. Gove serves on the Board of Directors of QRS Diagnostic, LLC and Information for Public Affairs, Inc.

        Mr. Heinmiller joined the Company in May 1998 as Vice President of Corporate Business Development. In September 1998 he was appointed Vice President, Finance and Chief Financial Officer. Prior to joining the Company, Mr. Heinmiller was president of F3 Corporation, a privately held asset management company, from 1997 to 1998, and was Vice President of Finance and Administration for Daig Corporation from 1995 to 1997. Mr. Heinmiller is also a former audit partner in the Minneapolis office of Grant Thornton LLP, a national public accounting firm. Mr. Heinmiller serves on the Board of Directors of Lifecore Biomedical, Inc.

        Ms. Lose joined St. Jude in 1999 as Vice President, Information Technology, and was also appointed Chief Information Officer in 2000. Prior to joining the Company, Ms. Lose was Vice President of Systems Development at U.S. Bancorp, a multi-state financial services holding company, from 1993 to 1999. From 1990 to 1993, Ms. Lose was a Senior Manager in Information Technology Consulting with Ernst & Young LLP, an international public accounting firm. From 1979 to 1990, she held several positions in Accounting and then Information Technology with General Mills, Inc, a consumer food products company. Ms. Lose serves on the Board of Directors of Apria Healthcare, Inc.

        Mr. McCullough joined St. Jude in 1994 as a CRM Regional Sales Director. He became Director of CRM Marketing in 1996 and was named Vice President of CRM Marketing in January 1997. In December 1997, Mr. McCullough was appointed CRM Business Unit Director. He became Vice President, CRM Europe and Managing Director of the Company’s manufacturing operations in Veddesta, Sweden in January 1999, and Senior Vice President, CRM Europe in August 1999. He was named President, International in July 2001. Prior to joining the Company, Mr. McCullough worked for several medical technology companies for more than 20 years.

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        Mr. Northenscold joined St. Jude in 2001 as Vice President, Finance and Administration of Daig. On March 3, 2003, he was appointed Vice President, Administration. Prior to joining the Company, Mr. Northenscold worked at PPT Vision, Inc., an industrial technology and automation company, where he served as Chief Financial Officer from February 1995 to January 1999, and Division General Manager from January 1999 to September 2001. Prior to 1995, Mr. Northenscold worked for Cardiac Pacemakers, Inc., a medical technology company that is now part of Guidant Corporation, in various finance and operations positions.

        Mr. O’Malley joined the Company in 1994 as Vice President and General Counsel. Since December 1996, he has also served as the Company’s Corporate Secretary. Prior to joining St. Jude, Mr. O’Malley was employed by Eli Lilly & Company, a pharmaceutical products company, for 15 years in various positions, including General Counsel of the Medical Device and Diagnostics Division.

        Mr. Rousseau joined the Company in 1999 as Senior Vice President, CRM Global Marketing. In August 1999, CRM Marketing and Sales were combined under his leadership. In January 2001, he was named President, U.S. CRM Sales, and in July 2001 he was named President, U.S. Sales. Prior to joining St. Jude, Mr. Rousseau worked for Sulzer Intermedics, Inc., a medical device company, for 11 years. At Sulzer, he served as Vice President, Tachycardia, in 1997 and was appointed Vice President, U.S. Sales and Marketing in 1998.

        Ms. Song joined St. Jude in 1998 as Senior Vice President, CRM Operations. In May 2002 she was appointed President, Cardiac Surgery. Prior to joining the Company, Ms. Song was employed by Perkin Elmer (formerly EG&G, Inc.), a global technology company, from 1992 to 1998 where she held executive positions in global operations and business development. Prior to her tenure at Perkin Elmer, she was employed by Coopers & Lybrand LLP, an international public accounting firm, and Texas Instruments Inc., a global semiconductor company.

PART II

Item 5.  MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED
              STOCKHOLDER MATTERS

        The information set forth under the captions “Dividends” and “Stock Exchange Listings” in the Financial Report included in the Company’s 2003 Annual Report to Shareholders is incorporated herein by reference.

Item 6.  SELECTED FINANCIAL DATA

        The information set forth under the caption “Five-Year Summary Financial Data” in the Financial Report included in the Company’s 2003 Annual Report to Shareholders is incorporated herein by reference.

Item 7.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
              AND RESULTS OF OPERATIONS

        The information set forth under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Financial Report included in the Company’s 2003 Annual Report to Shareholders is incorporated herein by reference.

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Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

        The information appearing under the caption “Market Risk” in the Financial Report included in the Company’s 2003 Annual Report to Shareholders is incorporated herein by reference.

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

        The following Consolidated Financial Statements of the Company and Report of Independent Auditors set forth in the Financial Report included in the Company’s 2003 Annual Report to Shareholders are incorporated herein by reference:

  Report of Independent Auditors

  Consolidated Statements of Earnings – Fiscal Years ended December 31, 2003, 2002 and 2001

  Consolidated Balance Sheets – December 31, 2003 and 2002

  Consolidated Statements of Shareholders’ Equity – Fiscal Years ended December 31, 2003, 2002 and 2001

  Consolidated Statements of Cash Flows – Fiscal Years ended December 31, 2003, 2002 and 2001

  Notes to Consolidated Financial Statements

Item 9.   CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
               AND FINANCIAL DISCLOSURE

      None.

Item 9A. CONTROLS AND PROCEDURES

        As of December 31, 2003, the Company carried out an evaluation, under the supervision and with the participation of the Company’s management, including the Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), of the effectiveness of the design and operation of its disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)). Based on that evaluation, the CEO and CFO concluded that the Company’s disclosure controls and procedures were effective as of December 31, 2003 to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms.

        During the fiscal quarter ended December 31, 2003, there were no changes in the Company’s internal controls over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that have materially affected, or are reasonably likely to materially affect, the Company’s internal controls over financial reporting.

19





PART III

Item 10.  DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT

        The information set forth under the captions “Board of Directors,” “Section 16(a) Beneficial Ownership Reporting Compliance” and “Audit Committee Financial Experts” in the Company’s definitive proxy statement dated March 30, 2004, is incorporated herein by reference. Information on executive officers under Item 4A of this Form 10-K is incorporated herein by reference.

        The Company has adopted a Code of Business Conduct for its Principal Executive Officer, Principal Financial Officer, Principal Accounting Officer and all other employees. The Company has made its Code of Business Conduct available on its website (http://www.sjm.com) under the Company Information section “About Us.” The Company intends to satisfy the disclosure requirement under Item 10 of Form 8-K regarding an amendment to, or waiver from, a provision of its Code of Business Conduct by posting such information on its website at the address and location specified above.

        The Company has also made available on its website its Principles of Corporate Governance and the charters for each Committee of its Board of Directors. Such materials are also available in print to any shareholder who submits a request to St. Jude Medical, Inc., One Lillehei Plaza, St. Paul, MN 55117, Attention: Corporate Secretary.

        Information included on the Company’s website is not deemed to be incorporated into this Annual Report on Form 10-K.

Item 11.  EXECUTIVE COMPENSATION

        The information set forth under the caption “Executive Compensation” in the Company’s definitive proxy statement dated March 30, 2004, is incorporated herein by reference.

Item 12.  SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
               AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

        The information set forth under the caption “Share Ownership of Management and Directors and Certain Beneficial Owners” and “Equity Compensation Plan Information” in the Company’s definitive proxy statement dated March 30, 2004, is incorporated herein by reference.

Item 13.  CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS

        The information set forth under the caption “Related Party Transactions” in the Company’s definitive Proxy Statement dated March 30, 2004, is incorporated herein by reference.

Item 14.  PRINCIPAL ACCOUNTANT FEES AND SERVICES

         The information set forth under the caption “Proposal to Ratify the Appointment of Auditors – Independent Accountant’s Fees” in the Company’s definitive proxy statement dated March 30, 2004, is incorporated herein by reference.

20





PART IV

Item 15.  EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS
                ON FORM 8-K

  (a)       List of documents filed as part of this Report

    (1)   Financial Statements

 

The following Consolidated Financial Statements of the Company and Report of Independent Auditors as set forth in the Financial Report included in the Company’s 2003 Annual Report to Shareholders are incorporated herein by reference from Exhibit 13 attached hereto:


  Report of Independent Auditors

  Consolidated Statements of Earnings – Fiscal Years ended December 31, 2003, 2002 and 2001

  Consolidated Balance Sheets — December 31, 2003 and 2002

  Consolidated Statements of Shareholders’ Equity – Fiscal Years ended December 31, 2003, 2002 and 2001

  Consolidated Statements of Cash Flows – Fiscal Years ended December 31, 2003, 2002 and 2001

  Notes to Consolidated Financial Statements

    (2)   Financial Statement Schedule

  Schedule II, Valuation and Qualifying Accounts, is filed as part of this Annual Report on Form 10-K (see Item 15(d)).

 

The Report of Independent Auditors with respect to this financial statement schedule is incorporated herein by reference from Exhibit 23 attached hereto.


        All other financial statements and schedules not listed above have been omitted because the required information is included in the consolidated financial statements or the notes thereto, or is not applicable.

    (3)   Exhibits

 

Pursuant to Item 601(b)(4)(iiii) of Regulation S-K, copies of certain instruments defining the rights of holders of certain long-term debt of the Company are not filed, and in lieu thereof, the Company agrees to furnish copies thereof to the Securities and Exchange Commission upon request.


21





    Exhibit                                   Exhibit Index
- ----------------    -------------------------------------------------------------------
      2.1           Stock Purchase  Agreement  among St. Jude Medical,  Inc., St. Jude
                    Medical   Japan   K.K.,   Getz  Bros.   &  Co.   Zug  Inc.,   Getz
                    International,  Inc. and Muller & Phipps  (Japan) Ltd. dated as of
                    September 17, 2002 (USA). #

      2.2           Amendment,  dated as of  February  20,  2003,  to  Stock  Purchase
                    Agreement  among St. Jude  Medical,  Inc.,  St. Jude Medical Japan
                    K.K.,  Getz Bros.  & Co. Zug Inc.,  Getz  International,  Inc. and
                    Muller &  Phipps  (Japan)  Ltd.  dated as of  September  17,  2002
                    (USA). #

      3.1           Articles of  Incorporation  are  incorporated  by  reference  from
                    Exhibit  3(a) of the  Company's  Form 8 filed on August 20,  1987,
                    amending  the  Company's  Quarterly  Report  on Form  10-Q for the
                    quarter ended June 30, 1987.

      3.2           Articles of  Amendment  dated  September  5, 1996,  to Articles of
                    Incorporation  are  incorporated  by reference from Exhibit 3.2 of
                    the  Company's  Annual  Report  on Form  10-K for the  year  ended
                    December 31, 1996.

      3.3           Bylaws are  incorporated  by reference  from Exhibit  3(ii) of the
                    Company's  Quarterly  Report  on Form 10-Q for the  quarter  ended
                    September 30, 1997.

      4.1           Rights  Agreement  dated as of June 16, 1997,  between the Company
                    and American Stock  Transfer and Trust  Company,  as Rights Agent,
                    including the Certificate of  Designation,  Preferences and Rights
                    of Series B Junior  Preferred  Stock is  incorporated by reference
                    from Exhibit 4 of the Company's  Quarterly Report on Form 10-Q for
                    the quarter ended June 30, 1997.

      4.2           Amendment,  dated as of December  20, 2002,  to Rights  Agreement,
                    dated as of June 16,  1997,  is  incorporated  by  reference  from
                    Exhibit  1 of the  Company's  Current  Report on Form 8-K filed on
                    March 21, 2003.

      4.3           Multi-Year  $350,000,000  Credit Agreement,  dated as of September
                    11, 2003, among St. Jude Medical,  Inc., as the Borrower,  Bank of
                    America,  N.A., as  Administrative  Agent,  L/C Issuer and Lender,
                    the Bank of  Tokyo-Mitsubishi,  Ltd.  and ABN Amro Bank  N.V.,  as
                    Co-Syndication  Agents,  Bank  One,  N.A.  and Wells  Fargo  Bank,
                    National  Association,  as Co-Documentation  Agents, and the Other
                    Lenders  Party Hereto is  incorporated  by reference  from Exhibit
                    4.1 of the  Company's  Quarterly  Report  on  Form  10-Q  for  the
                    quarter ended September 30, 2003.

22





     10.1           Form of  Indemnification  Agreement  that the  Company has entered
                    into with  officers  and  directors is  incorporated  by reference
                    from Exhibit  10(d) of the  Company's  Annual  Report on Form 10-K
                    for the year ended December 31, 1986. *

     10.2           St. Jude Medical,  Inc. Management Incentive  Compensation Plan is
                    incorporated  by  reference  from  Exhibit  10.2 of the  Company's
                    Annual Report on Form 10-K for the year ended  December 31, 2001.*

     10.3           Management  Savings Plan dated  February 1, 1995, is  incorporated
                    by reference  from Exhibit 10.7 of the Company's  Annual Report on
                    Form 10-K for the year ended December 31, 1994. *

     10.4           Retirement Plan for members of the Board of Directors,  as amended
                    on March 15, 1995, is  incorporated by reference from Exhibit 10.6
                    of the  Company's  Annual  Report on Form 10-K for the year  ended
                    December 31, 1994. *

     10.5           St.  Jude  Medical,  Inc.  1991  Stock  Plan  is  incorporated  by
                    reference  from the Company's  Registration  Statement on Form S-8
                    filed June 28, 1991 (Commission File No. 33-41459). *

     10.6           St. Jude Medical,  Inc. 1994 Stock Option Plan is  incorporated by
                    reference   from  Exhibit  4(a)  of  the  Company's   Registration
                    Statement  on Form S-8  filed  July 1, 1994  (Commission  File No.
                    33-54435). *

     10.7           St. Jude Medical,  Inc. 1997 Stock Option Plan is  incorporated by
                    reference   from  Exhibit  4.1  of  the   Company's   Registration
                    Statement  on Form S-8 filed  December 22, 1997  (Commission  File
                    No. 333-42945). *

    10.8            St.  Jude  Medical,  Inc.  2000  Stock  Plan  is  incorporated  by
                    reference  from Exhibit  10.9 of the  Company's  Annual  Report on
                    Form 10-K for the year ended December 31, 2001. *

    10.9            St. Jude Medical,  Inc. 2000 Employee Stock Purchase  Savings Plan
                    is  incorporated  by reference from Exhibit 10.10 of the Company's
                    Annual Report on Form 10-K for the year ended  December 31, 2001.*

23





    10.10           Amended and Restated  Employment  Agreement  dated as of March 25,
                    2001,  between the Company and Daniel J. Starks is incorporated by
                    reference  from Exhibit  10.17 of the  Company's  Annual Report on
                    Form 10-K for the year ended December 31, 2000. *

   10.11            Form of  Severance  Agreement  that the Company  has entered  into
                    with officers  relating to severance  matters in connection with a
                    change in control is  incorporated by reference from Exhibit 10.18
                    of the  Company's  Annual  Report on Form 10-K for the year  ended
                    December 31, 2000. *

   10.12            Amended and Restated  Employment  Agreement  dated as of March 25,
                    2001,  between the Company and Terry L.  Shepherd is  incorporated
                    by reference from Exhibit 10.19 of the Company's  Annual Report on
                    Form 10-K for the year ended December 31, 2000. *

   10.13            St.  Jude  Medical,   Inc.   2002  Stock  Plan,  as  Amended,   is
                    incorporated  by  reference  from Exhibit  10.14 of the  Company's
                    Quarterly  Report  on Form  10-Q for the  quarter  ended  June 30,
                    2002. *

      13            Portions of the Company's 2003 Annual Report to Shareholders.  #

      21            Subsidiaries of the Registrant. #

      23            Consent of Independent Auditors. #

      24            Power of Attorney. #

     31.1           Certification  of Chief Executive  Officer Pursuant to Section 302
                    of the Sarbanes-Oxley Act of 2002. #

     31.2           Certification  of Chief Financial  Officer Pursuant to Section 302
                    of the Sarbanes-Oxley Act of 2002. #

     32.1           Certification  of Chief Executive  Officer Pursuant to Section 906
                    of the Sarbanes-Oxley Act of 2002. #

     32.2           Certification  of Chief Financial  Officer Pursuant to Section 906
                    of the Sarbanes-Oxley Act of 2002. #

_________________

  * Management contract or compensatory plan or arrangement.
# Filed as an exhibit to this Annual Report on Form 10-K.

24





  (b)   Reports on Form 8-K filed during the quarter ended December 31, 2003:

 

        The Company filed a Form 8-K on October 15, 2003 to furnish pursuant to Item 12 its press release issued on October 15, 2003 to report earnings for the third quarter of 2003.


 

        The Company also filed a Form 8-K on December 10, 2003 to announce that the Company’s Chief Executive Officer and Chairman of the Board of Directors, Terry L. Shepherd, will retire in May 2004. Daniel J. Starks, President and Chief Operating Officer, will succeed Mr. Shepherd as Chief Executive Officer and Chairman.


  (c)   Exhibits: Reference is made to Item 15(a)(3).

  (d)   Schedules:

SCHEDULE II — VALUATION AND QUALIFYING ACCOUNTS
(In thousands)

COL. A  COL. B  COL. C  COL. D  COL. E

 
 
 
 
    Additions  Deductions 
   
 
 
Description  Balance
at Beginning
of Year
  Charged to
Expense
  Other (1)  Write-offs (2)  Other (1)  Balance at
End of Year

 
 
 
 
 
 
 
Allowance for doubtful accounts                            
Fiscal Year Ended:  
     December 31, 2003   $ 24,078   $ 5,497   $ 4,564   $ (2,234 ) $   $ 31,905  
     December 31, 2002    17,210    9,188    1,752    (4,072 )      24,078  
     December 31, 2001    13,831    6,468        (2,738 )  (351 )  17,210  

(1)  

 In 2003, $3,622 of this amount represents the balance recorded as part of our 2003 acquisition of Getz Japan, and the remainder represents the effects of changes in foreign currency translation. In 2002 and 2001, all amounts represent the effects of changes in foreign currency translation.


(2)   Uncollectible accounts written off, net of recoveries.

25





SIGNATURES

        Pursuant to the requirements of Sections 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

ST. JUDE MEDICAL, INC.
 
Date: March 12, 2004 By /s/ TERRY L. SHEPHERD
Terry L. Shepherd
Chairman and Chief Executive Officer
(Principal Executive Officer)
 
By /s/ JOHN C. HEINMILLER
John C. Heinmiller
Vice President, Finance and
Chief Financial Officer
(Principal Financial and Accounting Officer)

        Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities indicated, on the 12th day of March, 2004.

/s/ TERRY L. SHEPHERD Director
Terry L. Shepherd

/s/ KEVIN T. O’MALLEY
Directors
Kevin T. O’Malley

as attorney-in-fact for:
Richard R. Devenuti,
Stuart M. Essig,
Thomas H. Garrett III,
Michael A. Rocca,
Daniel J. Starks,
David A. Thompson,
Stefan K. Widensohler,
Wendy L. Yarno, and
Frank C-P Yin

26





EX-2.1 3 stjude041330_ex2-1.txt STOCK PURCHASE AGREEMENT Exhibit 2.1 ================================================================================ STOCK PURCHASE AGREEMENT AMONG ST. JUDE MEDICAL, INC., ST. JUDE MEDICAL JAPAN K.K., GETZ BROS. & CO. ZUG INC., GETZ INTERNATIONAL, INC. AND MULLER & PHIPPS (JAPAN) LTD. DATED AS OF SEPTEMBER 17, 2002 (USA) ================================================================================ I. PURCHASE AND SALE OF SHARES AND CLOSING.............................1 1.1 The Tender Offer...........................................1 1.2 Shareholder Meeting and Stock Transfer.....................2 1.3 Purchase and Sale..........................................3 1.4 Purchase Price.............................................3 1.5 Purchase Price Adjustment..................................3 1.6 The Closing................................................4 1.7 Transfer by Getz Zug Following Tender Offer................5 II. REPRESENTATIONS AND WARRANTIES OF SELLERS...........................5 2.1 Title to Shares............................................5 2.2 Incorporation; Power and Authority.........................5 2.3 Valid and Binding Agreement................................6 2.4 No Breach..................................................6 2.5 Getz Intl Balance Sheet....................................6 III. REPRESENTATIONS AND WARRANTIES REGARDING THE COMPANY................6 3.1 Incorporation; Power and Authority.........................6 3.2 No Breach..................................................6 3.3 Capitalization.............................................7 3.4 Subsidiaries...............................................7 3.5 Financial Statements.......................................7 3.6 Absence of Certain Developments............................7 3.7 Property...................................................8 3.8 Tax Matters................................................9 3.9 Material Contracts.........................................9 3.10 Litigation................................................10 3.11 Insurance.................................................10 3.12 Compliance with Laws; Governmental Authorizations.........10 3.13 Environmental Matters.....................................11 3.14 Warranties................................................12 3.15 Employees.................................................13 3.16 Employee Benefits.........................................13 3.17 Suppliers.................................................13 3.18 Brokerage.................................................13 3.19 Securities Law Compliance.................................14 IV. REPRESENTATIONS AND WARRANTIES OF BUYER AND ST. JUDE...............14 4.1 Incorporation; Power and Authority........................14 4.2 Valid and Binding Agreement...............................14 4.3 No Breach.................................................14 4.4 Brokerage.................................................14 V. AGREEMENTS OF SELLERS..............................................14 5.1 Conduct of the Business...................................14 5.2 Access; Updating of Disclosure Schedule...................16 5.3 Waivers; Payment of Indebtedness..........................16 5.4 Conditions................................................17 2 5.5 Consents and Authorizations...............................17 5.6 Nondisparagement..........................................17 5.7 Non-Hire..................................................17 5.8 Litigation Support........................................17 5.9 Confidentiality...........................................18 5.10 Transfer of Certain Trademark Rights......................18 5.11 No Encumbrance of Shares..................................19 5.12 Getz Intl Net Worth.......................................19 VI. AGREEMENTS OF BUYER AND ST. JUDE...................................19 6.1 Filings and Submissions...................................19 6.2 Buyer Shareholders Meeting................................19 6.3 Inspection................................................19 6.4 Section 338 Election......................................19 VII. CONDITIONS TO CLOSING..............................................20 7.1 Conditions to Buyer's Obligations........................20 7.2 Conditions to Sellers' Obligations.......................20 VIII. TERMINATION........................................................21 8.1 Termination...............................................21 8.2 Contract Extension........................................21 8.3 Effect of Termination.....................................22 IX. INDEMNIFICATION....................................................22 9.1 Indemnification by Sellers................................22 9.2 Third Party Actions.......................................23 9.3 Tax Adjustment............................................24 9.4 Sellers' Representative...................................24 X. ARBITRATION........................................................25 10.1 Disputes..................................................25 10.2 Arbitration...............................................25 10.3 Remedies..................................................26 XI. DEFINITIONS........................................................26 XII. GENERAL............................................................29 12.1 Press Releases and Announcements..........................29 12.2 Expenses..................................................29 12.3 Further Assurances........................................29 12.4 Cooperation...............................................29 12.5 Notices...................................................29 12.6 Assignment................................................31 12.7 No Third Party Beneficiaries..............................31 12.8 Severability..............................................31 12.9 Complete Agreement........................................31 12.10 English Language..........................................31 12.11 Signatures; Counterparts..................................31 12.12 Governing Law.............................................31 3 12.13 Amendment and Waiver......................................32 12.14 Construction..............................................32 XIII. GUARANTY BY ST. JUDE...............................................32 STOCK PURCHASE AGREEMENT This STOCK PURCHASE AGREEMENT (this "AGREEMENT") is made as of September 17, 2002, in the United States of America by and among St. Jude Medical Japan K.K., a company organized under the laws of Japan ("BUYER"), St. Jude Medical, Inc., a Minnesota corporation ("ST. JUDE"), Getz Bros. & Co. Zug Inc., a company organized under the laws of Switzerland ("GETZ ZUG"), Getz International, Inc., a Delaware corporation ("GETZ INTL"), and Muller & Phipps (Japan) Ltd., a company organized under the laws of Japan ("M&P", and together with Getz Zug and Getz Intl., "SELLERS"). Certain capitalized terms used but not defined when first used herein are defined in Article XI. RECITALS WHEREAS, Getz Zug, a wholly owned subsidiary of Getz Intl, owns 72.18% of the outstanding capital stock of Getz Bros. Co., Ltd., a company organized under the laws of Japan (the "COMPANY"). WHEREAS, the remaining 27.82% of the Company's outstanding capital stock is publicly held and registered with the Japan Securities Dealers Association (the "JASDA"). WHEREAS, Sellers desire to sell, and Buyer desires to buy, 100% of the outstanding capital stock of the Company (the "SHARES") on the terms and subject to the conditions set forth in this Agreement (the "ACQUISITION"). WHEREAS, as a first step in the Acquisition, M&P, a wholly owned subsidiary of Getz Intl, will initiate a cash tender offer for the issued and outstanding Shares not owned by Getz Zug (the "TENDER OFFER"). WHEREAS, to complete the Acquisition, Sellers will cause the Company, by exercising their voting rights at a general shareholders meeting of the Company, to create a newly formed holding company of the Company organized under the laws of Japan ("NEWCO") by means of a stock transfer (KABUSHIKI ITEN) (the "STOCK TRANSFER"), whereby, subject to shareholder approval and compliance with applicable legal procedures, all issued and outstanding Shares, including Shares not tendered to and purchased by M&P pursuant to the Tender Offer, will also be exchanged for shares of Newco, following which Sellers will use their reasonable efforts to cause Newco to sell the Shares to Buyer pursuant to the terms and conditions of this Agreement. NOW, THEREFORE, the following agreement is made: I. PURCHASE AND SALE OF SHARES AND CLOSING 1.1 The Tender Offer. (a) M&P, as promptly as practicable, shall commence the Tender Offer whereby M&P will offer to purchase for cash all of the Shares not otherwise held by Sellers. M&P expressly reserves the right to increase the price per share payable in the Tender Offer and to make any other change or changes in the terms or conditions of the Tender Offer, including without limitation extending the expiration date. (b) M&P shall, on the terms of the Tender Offer, accept for payment Shares validly tendered as soon as practicable, and pay for accepted Shares as promptly thereafter as reasonably practicable. (c) On the date of commencement of the Tender Offer, M&P shall file with the Kanto Local Financial Bureau a registration statement for the Tender Offer (KOUKAI KAITSUKE TODOKEDESHO) and all other disclosure documents and related public notices as are required to be filed by M&P with the Kanto Local Financial Bureau in connection with the Tender Offer in accordance with applicable securities Laws (collectively, the "TENDER OFFER Documents"). Sellers will take all steps necessary to ensure that the Tender Offer Documents comply in all material respects with the provisions of applicable Japanese Laws from the date filed with the Kanto Local Financial Bureau until the completion of the Tender Offer. Buyer shall provide M&P with such information on Buyer and its parent company to the extent required by applicable Japanese Laws for inclusion in the Tender Offer Documents and shall take all steps necessary to ensure that all information provided by Buyer for inclusion in the Tender Offer Documents is accurate. (d) Sellers will use all reasonable efforts to cause the Board of Directors of the Company to issue an opinion supporting the Tender Offer and to take all steps necessary to file all documents required to be filed with the Kanto Local Financial Bureau and the JASDA in connection with the Tender Offer in accordance with applicable securities Laws. 1.2 Shareholder Meeting and Stock Transfer. Sellers shall cause the Company to, as promptly as practicable following the acceptance for payment and purchase of Shares by M&P pursuant to the Tender Offer: (a) use all reasonable efforts to duly call, give notice of, convene and hold a general shareholders meeting (the "SHAREHOLDERS MEETING"), to be held as soon as practicable after the completion of the Tender Offer for the purpose of considering and taking action upon the Stock Transfer; (b) use all reasonable efforts to cause the Board of Directors of the Company to recommend to the shareholders of the Company that they vote in favor of the Stock Transfer; and (c) use all reasonable efforts to promptly obtain the necessary approvals by its shareholders of the Stock Transfer. At such meeting, Sellers will vote all Shares owned by them in favor of approval of the Stock Transfer. As promptly as practicable following the Shareholders Meeting, Sellers shall, and shall cause the Company to, take all action necessary to consummate the Stock Transfer, including without limitation the filing of an extraordinary report (RINJI HOUKOKUSHO) with the Kanto Local Financial Bureau, notification with the JASDA and the purchase of any Shares held by a shareholder who notifies the Company of its objection to the Stock Transfer prior to the Shareholders Meeting and requests the purchase of such Shares in accordance with applicable Law. Buyer and St. Jude agree that when the Stock Transfer takes effect the registration of the 2 Shares with the JASDA shall be revoked and the Company will become a private company. As promptly as practicable after the Stock Transfer takes effect, Sellers shall use all reasonable efforts to (i) cause the Company to apply for an exemption from its continuous disclosure obligations to the Prime Minister of Japan pursuant to applicable securities Laws and (ii) cause the Board of Directors of Newco to approve and adopt this Agreement, at which time Newco and the parties hereto will execute an amendment to this Agreement whereby Newco will become a party to this Agreement and be included within the definition of "SELLERS". 1.3 Purchase and Sale. Promptly following (i) the Tender Offer; (ii) the Stock Transfer; (iii) revocation of registration of the Shares with the JASDA; and (iv) the grant to the Company of an exemption from its continuous disclosure obligations, Sellers shall use all reasonable efforts to cause Newco to, and Newco shall, convene a general shareholders meeting to approve the Acquisition on the terms and subject to the conditions set forth in this Agreement. At such meeting, Sellers will vote all shares of Newco owned by them in favor of approval of the Acquisition. Subject to the approval of the shareholders of Newco, Newco shall sell to Buyer, and Buyer agrees to purchase from Newco for the Purchase Price, all of the issued and outstanding Shares. Each Seller waives any co-sale rights, rights of first refusal or similar rights that such Seller may have relating to Buyer's purchase of the Shares, whether conferred by the Company's Organizational Documents, by Contract or otherwise. 1.4 Purchase Price. (a) The aggregate purchase price (the "PURCHASE PRICE") for the Shares is U.S.$220,000,000 payable on the Closing Date in Japanese yen at an exchange rate equal to 122.2480 Japanese yen to one (1) U.S. dollar. (b) If the Inspector (as defined in Section 6.3) submits an opinion to the Buyer shareholders meeting to be held in accordance with Section 6.2 that the Acquisition is unfair to Buyer but would be fair to Buyer at a purchase price that is less than the Purchase Price set forth in Section 1.4(a) (the "REDUCED BUYER PRICE"), or if the Inspector is unable to complete the inspection and to submit an opinion to the Buyer shareholders meeting prior to the Closing Date, then at the Closing (i) Buyer shall pay to Newco the Reduced Buyer Price or, if the Inspector's opinion shall not have been issued to the Buyer shareholders meeting, 499,999 Japanese yen and (ii) St. Jude and Buyer shall cause St. Jude Medical Puerto Rico Holding B.V. to pay to Newco the deficiency amount such that, at the Closing, Newco will receive the full Purchase Price set forth in Section 1.4(a) and the Acquisition will not be voidable under Japanese law as a result of the Inspector's opinion or lack of the Inspector's opinion. All such payments will be made in accordance with Section 1.6(a)(ii)(A). 1.5 Purchase Price Adjustment. Except to the extent caused by or in any way arising out of any act of Buyer or St. Jude, or any affiliate of either of them (whether under the Distribution Agreement (as defined in Section 8.2) or otherwise), if, between the date of this Agreement and the date of Closing (inclusive), there is a change, effect, event or condition, which is not in the Ordinary Course of Business and which results or is reasonably likely to result in either (i) a material loss or decrease in the value of the Company or the business of the Company or (ii) a material gain or increase in the value of the Company or the business of the Company, Buyer and Sellers shall negotiate in good faith an appropriate decrease or increase, as applicable, in the 3 Purchase Price for the Shares. If all of the conditions set forth in Article VII have been fulfilled or waived in accordance with this Agreement but the parties cannot agree on such appropriate decrease or increase before Closing in accordance with Section 1.6, the Closing shall proceed and the Purchase Price shall be paid at the Closing, subject to the appropriate decrease or increase to be subsequently determined by arbitration conducted pursuant to provisions of Article X. 1.6 The Closing. If all of the conditions set forth in Article VII have been fulfilled or waived in accordance with this Agreement, the closing of the purchase and sale of the Shares from Newco to Buyer contemplated by this Agreement (the "Closing") will take place at the offices of Mori Sogo on the later of (i) the first business day following the later of (A) the date on which the shareholders of Newco agree at a general meeting of Newco shareholders to sell all of the Shares to Buyer or (B) the date on which the shareholders of Buyer approve the acquisition of the Shares from Newco, or (ii) March 31, 2003, or at such other place and on such other date as may be mutually agreed by Buyer and Sellers' Representative (as defined in Section 9.4(a)). The date on which the Closing occurs is referred to herein as the "Closing Date." On the Closing Date: (a) Subject to the conditions set forth in this Agreement: (i) Sellers will deliver or cause to be delivered to Buyer: (A) certificates representing all of the issued and outstanding Shares, free and clear of all Encumbrances, duly endorsed, in accordance with applicable Japanese Laws; (B) a certificate of Sellers dated the Closing Date stating that the conditions set forth in Section 7.1(a) have been satisfied; (C) a copy of the text of the resolutions adopted by the Board of Directors (or similar body) of each Seller authorizing the execution, delivery and performance of this Agreement, certified by an appropriate officer of such Seller; (D) the minute books, stock or equity records, corporate seal and other materials related to the corporate administration of the Company or any Subsidiary; (E) resignations in writing (effective as of the Closing Date) from such of the officers and directors of each of the Company and the Subsidiaries as Buyer may have requested prior to the Closing Date; and (F) any instruments and documents necessary to effect the Trademark Assignment (as defined in Section 5.10). (ii) Buyer will deliver or cause to be delivered to Sellers or Newco, as appropriate: 4 (A) the Purchase Price by wire transfer of immediately available funds to accounts that shall be designated by Sellers to Buyer no later than three (3) business days prior to the Closing Date; (B) a certificate of Buyer dated the Closing Date stating that the conditions set forth in Section 7.2(b) have been satisfied; and (C) a copy of the text of the resolutions adopted by the Board of Directors of Buyer and St. Jude authorizing the execution, delivery and performance of this Agreement, certified by an appropriate officer of Buyer or St. Jude, as appropriate. (b) All items delivered by the parties at the Closing will be deemed to have been delivered simultaneously, and no items will be deemed delivered or waived until all have been delivered. (c) Notwithstanding any investigation made by or on behalf of any of the parties to this Agreement or the results of any such investigation, and notwithstanding the fact of, or the participation of any of the parties to this Agreement in, the Closing, the representations, warranties and agreements in this Agreement will survive the Closing. (d) The Confidentiality Agreement will terminate effective as of the Closing Date. (e) All actions to be taken by Buyer or Sellers in connection with consummation of the transactions contemplated by this Agreement and all certificates, opinions, instruments and other documents required to effect the transactions contemplated by this Agreement will be in form and substance reasonably satisfactory to the other. 1.7 Transfer by Getz Zug Following Tender Offer. Buyer acknowledges that after completion of the Tender Offer Getz Zug may transfer its Shares or, after the Stock Transfer, its shares in Newco, to Getz Intl. Such transfer shall not be deemed a breach of any provision of this Agreement. II. REPRESENTATIONS AND WARRANTIES OF SELLERS Each Seller represents and warrants to Buyer as of the date of this Agreement and as of the Closing Date that, as to such Seller, except as described in the corresponding section of the Disclosure Schedule: 2.1 Title to Shares. As of the date hereof and subject to Section 1.7, such Seller owns, of record and beneficially, the number of Shares listed opposite such Seller's name on SCHEDULE 2.1, free and clear of any Encumbrance. At the Closing, Buyer will obtain good and valid title to all Shares owned, of record and beneficially, by such Seller as of the date hereof, free and clear of any Encumbrance. 2.2 Incorporation; Power and Authority. Such Seller is duly organized, validly existing and, if applicable, in good standing under the laws of the jurisdiction of its organization. Such Seller has all necessary power and authority to execute, deliver and perform this Agreement, and, 5 to the extent applicable, to perform the Tender Offer and to perform its obligations under this Agreement in relation to the Stock Transfer. 2.3 Valid and Binding Agreement. The execution, delivery and performance of this Agreement, and, to the extent applicable, the performance of the Tender Offer and the performance of its obligations under this Agreement in relation to the Stock Transfer, by such Seller has been duly and validly authorized by all necessary corporate or equivalent action. This Agreement has been duly executed and delivered by such Seller and constitutes the valid and binding obligation of such Seller, enforceable against it in accordance with its terms, subject to the Remedies Exception. 2.4 No Breach. The execution, delivery and performance of this Agreement and, to the extent applicable, the performance of the Tender Offer and the performance of its obligations under this Agreement in relation to the Stock Transfer, by such Seller will not (a) contravene any provision of the Organizational Documents of such Seller; (b) violate or conflict with any Law, Governmental Order or Governmental Authorization; (c) result in the creation of any Encumbrance upon the Shares held by such Seller; or (d) require any Governmental Authorization other than the filing of the Tender Offer Documents with the Kanto Local Financial Bureau, except, with respect to clauses (a) and (b), where such contravention, violation or conflict would not, individually or in the aggregate, prevent such Seller from performing its obligations under this Agreement. 2.5 Getz Intl Balance Sheet. Getz Intl has furnished Buyer with a true and correct copy of its unaudited consolidated balance sheets as of December 31, 2001 and 2000, which balance sheets are accurate in all material respects. III. REPRESENTATIONS AND WARRANTIES REGARDING THE COMPANY Sellers, jointly and severally, represent and warrant to Buyer as of the date of this Agreement and as of the Closing Date that, except as described in the corresponding section of the Disclosure Schedule: 3.1 Incorporation; Power and Authority. (a) Each of the Company and the Subsidiaries is a legal entity duly organized, validly existing and, if applicable, in good standing under the laws of the jurisdiction of its organization, and has all necessary power and authority necessary to own, lease and operate its assets and to carry on its business as now conducted and presently proposed to be conducted. (b) Each of the Company and the Subsidiaries is in material compliance with all provisions of its Organizational Documents. 3.2 No Breach. The performance of the Stock Transfer will not (a) contravene any provision of the Organizational Documents of the Company or any Subsidiary; (b) violate or conflict with any Law, Governmental Order or Governmental Authorization; (c) result in the creation of any material Encumbrance upon the Company or any Subsidiary or any of the assets of the Company or any Subsidiary; or (d) require any Governmental Authorization, except, with respect to clauses (a) and (b), where such contravention, violation or conflict would not, 6 individually or in the aggregate, prevent Sellers from performing their obligations under this Agreement. 3.3 Capitalization. The authorized capital stock of the Company consists solely of 148,962,000 shares of common stock ("Company Common Stock"), of which, as of June 30, 2002, 38,202,500 shares are issued and outstanding, 560 shares of which are held in treasury. All issued and outstanding shares of Company Common Stock are duly authorized, validly issued, fully paid and non-assessable, free of preemptive rights or any other third-party rights and in certificated form, and have been offered, sold and issued by the Company in compliance with applicable securities and corporate Laws. There is no option, warrant, call, subscription, convertible security, right (including preemptive right) or Contracts of any character to which the Company is a party or by which it is bound obligating the Company to issue, exchange, transfer, sell, repurchase, redeem or otherwise acquire any shares of capital stock of the Company or obligating the Company to grant, extend, accelerate the vesting of or enter into any such option, warrant, call, subscription, convertible security, right or Contract. 3.4 Subsidiaries. Except as listed on SCHEDULE 3.4, neither the Company nor any Subsidiary owns any Subsidiary. For each of the Company's Subsidiaries, SCHEDULE 3.4 shows the equity interests owned by the Company or any Subsidiary, the names of the Persons owning such equity interests and the percentage of the outstanding equity interests so owned. All issued and outstanding equity interests of each Subsidiary of the Company are duly authorized, validly issued, fully paid and non-assessable, free of preemptive rights or any other third-party right except for those statutory preemptive rights arising, granted or existing pursuant to the Japanese Commercial Code, free and clear of all Encumbrances, and in certificated form and have been issued by such Subsidiary in compliance with applicable securities and corporate Laws. There is no option, warrant, call, subscription, convertible security, right (including preemptive right except for statutory preemptive rights) or Contracts of any character to which the Company or any Subsidiary is a party or by which it is bound obligating any Subsidiary of the Company to issue, exchange, transfer, sell, repurchase, redeem or otherwise acquire any equity interest of such Subsidiary or obligating the Company or such Subsidiary to grant, extend, accelerate the vesting of or enter into any such option, warrant, call, subscription, convertible security, right or Contract. 3.5 Financial Statements. The Company has furnished Buyer with true and correct copies of the unaudited balance sheets as of June 30, 2002 of each of the Company, Medtechnica Co., Ltd., Vital Link Co., Ltd. and TechnoMed Co. Ltd. (the "Latest Balance Sheets") and unaudited statements of earnings of each of the Company, Medtechnica Co., Ltd., Vital Link Co., Ltd. and TechnoMed Co. Ltd. for the six-month period then ended and unaudited shareholders' equity and cash flows of the Company for the six-month period then ended (such statements and the Latest Balance Sheets, the "Latest Financial Statements") and the consolidated English-language balance sheets of the Company translated from the audited consolidated Japanese-language balance sheets of the Company, as of December 31, 2001 and December 31, 2000 (collectively, the "Annual Balance Sheets"). The Latest Financial Statements and the Annual Balance Sheets are accurate in all material respects. TechnoMed Co. Ltd. has no material liabilities. 3.6 Absence of Certain Developments. Since December 31, 2001: 7 (a) neither the Company nor any Subsidiary has sold, leased, transferred or assigned any of its assets, tangible or intangible, involving more than (Y)50,000,000 other than for a fair consideration in the Ordinary Course of Business; (b) neither the Company nor any Subsidiary has entered into any Contract (or series of related Contracts) involving more than (Y)50,000,000 other than in the Ordinary Course of Business; (c) no party (including the Company or any Subsidiary) has accelerated, suspended, terminated, modified or canceled any Contract (or series of related Contracts) involving more than (Y)50,000,000, to which the Company or any Subsidiary is a party or by which any of them is bound other than in the Ordinary Course of Business; (d) neither the Company nor any Subsidiary has declared, set aside or paid any dividend or made any distribution with respect to its capital stock or equity interests, whether in cash or in kind (other than routine interim or annual dividends to all shareholders of the Company consistent with past practices and dividends or distributions from a Subsidiary to the Company or another Subsidiary) or, except as listed on SCHEDULE 3.6 or as may be required in connection with the Stock Transfer, redeemed, purchased or otherwise acquired any of its capital stock or split, combined or reclassified any outstanding shares of its capital stock; (e) the Company has not loaned any funds, paid any money or transferred any assets to any affiliate (other than among the Company and the Subsidiaries), except for (i) payments of dividends or distributions permitted under Section 3.6(d), (ii) payments to affiliates for goods or services purchased or obtained in the Ordinary Course of Business in arms' length transactions, and (iii) payments required under the Contracts listed on SCHEDULE 3.6(E); and (f) the Company has not made any material change in accounting principles or practices from those utilized in the preparation of the Annual Financial Statements. 3.7 Property. (a) The real properties owned by the Company or any Subsidiary or demised by the leases listed on SCHEDULE 3.7 constitute all of the real property owned, leased (whether or not occupied and including any leases assigned or leased premises sublet for which the Company remains liable), used or occupied by the Company or any Subsidiary. (b) The leases of real property listed on SCHEDULE 3.7 as being leased by the Company or any Subsidiary (the "Leased Real Property") are in full force and effect, and the Company has used the Leased Real Property undisturbed. (c) The Company and, to Sellers' Knowledge, each Subsidiary owns good and marketable title to each parcel of real property identified on SCHEDULE 3.7 as being owned by the Company or a Subsidiary (the "Owned Real Property" and, together with the Leased Real Property, the "Real Property"). 8 (d) Neither the Company nor any Subsidiary has received any written notice of any violation of any applicable zoning ordinance or other Law relating to the Real Property, which violation has or reasonably could be expected to have a Material Adverse Effect. (e) Sellers have no Knowledge of material improvements made or contemplated to be made by any Governmental Entity, the costs of which are to be assessed as special Taxes or charges against any of the Real Property, and there are no present assessments. (f) Each of the Company and the Subsidiaries has good and marketable title to, or a valid leasehold interest in, the buildings, machinery, equipment and other tangible assets and properties shown in the Latest Balance Sheets or acquired after the date thereof, free and clear of all Encumbrances, except for Encumbrances listed on SCHEDULE 3.7 or disclosed in the Latest Financial Statements and properties and assets disposed of in the Ordinary Course of Business since the date of the Latest Balance Sheets. 3.8 Tax Matters. (a) Each of the Company and any Tax Affiliate has (i) timely filed all Returns required to be filed by it in respect of any Taxes, all which were correct and complete in all material respects; (ii) timely paid all Taxes shown to be due and payable on such Returns; (iii) established on the Latest Balance Sheets reserves that are adequate for the payment of any Taxes accrued but not yet due and payable through the date thereof; and (iv) complied with all Laws relating to the withholding of Taxes and the payment thereof. (b) SCHEDULE 3.8 lists all national, prefectural, provincial, state, local and foreign income Returns filed with respect to the Company or any Tax Affiliate for taxable periods ended on or after December 31, 2000, indicates those Returns that have been audited and indicates those Returns that currently are the subject of audit. (c) No deficiency for any Taxes has been proposed, asserted or assessed against the Company or any Tax Affiliate that has not been resolved and paid in full. 3.9 Material Contracts. (a) SCHEDULE 3.9 lists the following written Contracts to which the Company or any Subsidiary is a party or by which it is bound (the "Material Contracts"): (i) all employment, agency or consulting Contracts; (ii) all stock purchase, stock option and stock incentive plans (other than Plans listed on SCHEDULE 3.16(A)); (iii) all distributor, reseller, dealer, manufacturer's representative, sales agency or advertising agency and finder's Contracts; (iv) all franchise agreements; 9 (v) all leases of real or personal property (excluding any lease with aggregate annual payments of (Y)50,000,000 or less); (vi) any Contract for the sale of any capital assets valued in excess of (Y)50,000,000; (vii) any Contract for the sale of any minority equity investments; (viii) any Contract for capital expenditures in excess of (Y)50,000,000; (ix) all Contracts relating to the borrowing of money or to mortgaging, pledging or otherwise placing an Encumbrance on any of the assets of the Company or any Subsidiary; (x) each warranty, guaranty or other similar undertaking with respect to contractual performance extended by the Company or any Subsidiary other than in the Ordinary Course of Business; (xi) all Contracts relating to any surety bond or letter of credit required to be maintained by the Company or any Subsidiary; (xii) all license agreements, transfer or joint-use agreements or other agreements related to Intellectual Property; (xiii) any Contract for a partnership or joint venture; (xiv) any and all other Contracts of the Company or any Subsidiary that both were not entered into in the Ordinary Course of Business and are material to the business, financial condition, results of operations or prospects of the Company and the Subsidiaries taken as a whole; and (xv) any Contracts not listed above that contain non-competition or non-solicitation provisions or that would otherwise prohibit the Company or any Subsidiary from freely engaging in business anywhere in the world or prohibiting the solicitation of the employees or contractors of any other entity. 3.10 Litigation. SCHEDULE 3.10 lists all Litigation pending or, to the Knowledge of any Seller, threatened against the Company or any Subsidiary and each material Governmental Order to which the Company or any Subsidiary is presently subject. 3.11 Insurance. SCHEDULE 3.11 lists all policies of insurance carried by each of the Company and the Subsidiaries. 3.12 Compliance with Laws; Governmental Authorizations. (a) To Sellers' Knowledge, each of the Company and the Subsidiaries has: 10 (i) complied in all material respects with all material Laws and Governmental Orders, and (ii) neither the Company nor any Subsidiary is relying on any exemption from or deferral of any Law, Governmental Order or Governmental Authorization that would not be available to it after the Closing. (b) To Sellers' Knowledge, each of the Company and the Subsidiaries has in full force and effect all material Governmental Authorizations necessary to conduct its business and own and operate its properties (including, but not limited to, SHONIN issued by the Japan Ministry of Health for each product distributed by the Company or any Subsidiary). To Sellers' Knowledge, each of the Company and the Subsidiaries has complied in all material respects with all Governmental Authorizations applicable to it. (c) To Sellers' Knowledge, since the date one (1) year prior to the date of this Agreement, neither the Company nor any Subsidiary has, in violation of any applicable Law, offered, authorized, promised, made or agreed to make gifts of money, other property or similar benefits (other than incidental gifts of articles of nominal value) to any actual or potential customer, supplier, governmental employee, political party, political party official or candidate, official of a public international organization or any other Person in a position to assist or hinder the Company or any Subsidiary in connection with any actual or proposed transaction. 3.13 Environmental Matters. (a) As used in this Section 3.13, the following terms have the following meanings: (i) "ENVIRONMENTAL COSTS" means any and all reasonable costs and expenditures, including but not limited to any fees and expenses of attorneys and of environmental consultants or engineers incurred in connection with investigating, defending, remediating or otherwise responding to any Release of Hazardous Materials, any violation or alleged violation of Environmental Laws, any fees, fines, penalties or charges associated with any Governmental Authorization, or any actions necessary to comply with any Environmental Laws. (ii) "ENVIRONMENTAL LAWS" means any Law, Governmental Authorization or Governmental Order relating to pollution, contamination, Hazardous Materials or protection of the environment in effect at the time of execution of the Agreement. (iii) "HAZARDOUS MATERIALS" means any dangerous, toxic or hazardous pollutant, contaminant, chemical, waste, material or substance as defined in or governed by any Law relating to such substance or otherwise relating to the environment or human health or safety, including without limitation any waste, material, substance, pollutant or contaminant that subjects the owner or operator of the Property to any Environmental Costs or liability under any Environmental Law in effect at the time of execution of this Agreement. (iv) "PROPERTY" means real property now owned, leased, controlled or occupied by the Company or any Subsidiary. 11 (v) "REGULATORY ACTIONS" means any Litigation with respect to the Company or any Subsidiary brought or instigated by any Governmental Entity in connection with any Environmental Costs, Release of Hazardous Materials or any Environmental Law. (vi) "RELEASE" means the spilling, leaking, disposing, discharging, emitting, depositing, ejecting, leaching, escaping or any other release or threatened release, however defined, whether intentional or unintentional, of any Hazardous Material. (vii) "THIRD-PARTY ENVIRONMENTAL CLAIMS" means any Litigation (other than a Regulatory Action) based on negligence, trespass, strict liability, nuisance, toxic tort or any other cause of action or theory relating to any Environmental Costs, Release of Hazardous Materials or any violation of Environmental Law. (b) No Third-Party Environmental Claims or Regulatory Actions are pending against the Company or any Subsidiary, and, to the Knowledge of Sellers, no Third-Party Environmental Claims or Regulatory Actions are threatened against the Company or any Subsidiary. (c) Since the date two (2) years prior to the date of this Agreement, to Sellers' Knowledge, the transfer, transportation or disposal of Hazardous Materials by the Company or any Subsidiary to properties not owned, leased or operated by the Company or any Subsidiary has been in compliance with applicable Environmental Laws at the time of such transfer, transport or disposal. (d) To Sellers' Knowledge, the Property is used and operated in material compliance with all material Environmental Laws applicable to it. (e) Each of the Company and the Subsidiaries has obtained all material Governmental Authorizations relating to the Environmental Laws, to Sellers' Knowledge, necessary for operation of the Company, each of which is listed on SCHEDULE 3.13(E). (f) The Company has delivered to Buyer all environmental reports and investigations, if any, that any Sellers, the Company or any Subsidiary has obtained or ordered with respect to the Company or any Subsidiary, or the Property. (g) No Encumbrance has been attached or filed against the Company or any Subsidiary in favor of any Person for (i) any liability under or violation of any applicable Environmental Law, (ii) any Release of Hazardous Materials or (iii) any imposition of Environmental Costs. 3.14 Warranties. SCHEDULE 3.14 lists all material claims pending or, to the Knowledge of any Sellers, threatened for breach of any warranty relating to any products sold or services performed by the Company or any Subsidiary prior to the date of this Agreement. Except as listed on SCHEDULE 3.14, none of the products sold, leased or delivered by the Company or any Subsidiary has been the subject of any product recall or return (whether voluntary or involuntary) during the past five (5) years. 12 3.15 Employees. (a) To Sellers' Knowledge, each of the Company and the Subsidiaries has complied at all times in all material respects with all applicable Laws relating to employment and employment practices. (b) Except as set forth in SCHEDULE 3.15(B), none of the employees of the Company or any Subsidiary is covered by any collective bargaining agreement, no collective bargaining agreement is currently being negotiated and, to Sellers' Knowledge, no attempt is currently being made or threatened or during the past five (5) years has been made to organize any employees of the Company or any Subsidiary to form or enter into any labor union, employee association or similar organization. There are no strikes or work stoppages pending or, to the Knowledge of any Seller, threatened against or otherwise affecting the employees or facilities of the Company or any Subsidiary. None of the Company or any Subsidiary has experienced any labor strike or work stoppage involving its employees within the past two (2) years. (c) Each of the Company and the Subsidiaries has paid in full to all employees all wages, salaries, bonuses and commissions due and payable to such employees and have fully reserved on the Latest Financial Statements all amounts for wages, salaries, bonuses and commissions due but not yet payable to such employees as of the date thereof. 3.16 Employee Benefits. (a) Except as set forth in SCHEDULE 3.16(A), with respect to all employees and former employees of the Company or its Subsidiaries and all dependents and beneficiaries of such employees and former employees, neither the Company nor any Subsidiary maintains or contributes to any plan, fund, contract program or arrangement (written or verbal) intended to provide: (i) medical, surgical, health care, hospitalization, dental, vision, workers compensation, life insurance, death, disability, legal services, severance, sickness or accident benefits; (ii) pension, profit sharing, retirement, supplemental retirement or deferred compensation benefits; (iii) bonus, incentive compensation, stock option, stock appreciation rights, phantom stock or stock purchase benefits or change in control benefits; or (iv) salary continuation, unemployment, supplemental unemployment, termination pay, vacation or holiday benefits (each a "PLAN"). (b) For the last two (2) years, neither the Company nor any Subsidiary has incurred any liability for any Tax or civil penalty or any disqualification of any employee benefit plan imposed by the Law of any jurisdiction in which the Company or any Subsidiary does business. 3.17 Suppliers. SCHEDULE 3.17 lists the eight largest suppliers (other than St. Jude Medical, Inc. and its affiliates) of the Company and the Subsidiaries on a consolidated basis for each of the last two (2) fiscal years and for the interim period ended on the date of the Latest Balance Sheets and sets forth opposite the name of each such supplier the amount of purchases by the Company and the Subsidiaries attributable to such supplier for each such period. 3.18 Brokerage. Except for Goldman, Sachs & Co., the Tender Offer agent and KPMG Corporate Finance K.K., no Person will be entitled to receive any brokerage commission, finder's fee, fee for financial advisory services or similar compensation in connection with the 13 transactions contemplated by this Agreement based on any Contract made by or on behalf of the Company for which Buyer or the Company is or could become liable or obligated. 3.19 Securities Law Compliance. Since January 1, 2000 and through the Closing Date, the Company has filed or will file, with the appropriate Japanese regulatory authorities, including the Financial Services Agency, the Kanto Local Financial Bureau, the Japan Securities Dealers Association and any other applicable stock exchange, the forms and documents required to be filed by it under Japanese securities Laws. These filings, including any financial statements or schedules included therein, have complied or will comply in all material respects with the applicable requirements of Japanese securities Laws. IV. REPRESENTATIONS AND WARRANTIES OF BUYER AND ST. JUDE Each of Buyer and St. Jude represents and warrants to Sellers as of the date hereof and as of the Closing Date that: 4.1 Incorporation; Power and Authority. Each of Buyer and St. Jude is a legal entity duly organized, validly existing and, if applicable, in good standing under the laws of its jurisdiction of organization, with all necessary power and authority to execute, deliver and perform this Agreement. 4.2 Valid and Binding Agreement. The execution, delivery and performance of this Agreement by Buyer and St. Jude have been duly and validly authorized by all necessary corporate action. This Agreement has been duly executed and delivered by Buyer and St. Jude and constitutes the valid and binding obligation of Buyer and St. Jude, enforceable against each in accordance with its terms, subject to the Remedies Exception. 4.3 No Breach. The execution, delivery and performance of this Agreement by Buyer and St. Jude will not (a) contravene any provision of the Organizational Documents of Buyer or St. Jude; (b) violate or conflict with any Law, Governmental Order or Governmental Authorization; or (c) require any Governmental Authorization, except, with respect to clauses (a) and (b), where such contravention, violation or conflict would not, individually or in the aggregate, prevent Buyer or St. Jude, respectively, from performing its obligations under this Agreement. 4.4 Brokerage. Except for Goldman, Sachs & Co., no Person will be entitled to receive any brokerage commission, finder's fee, fee for financial advisory services or similar compensation in connection with the transactions contemplated by this Agreement based on any Contract made by or on behalf of Buyer for which any Sellers is or could become liable or obligated. V. AGREEMENTS OF SELLERS Sellers, jointly and severally, agree with Buyer that: 5.1 Conduct of the Business. Unless otherwise consented to by Buyer in writing, Sellers will cause the Company (which, for purposes of this Section 5.1, shall mean the Company and 14 the Subsidiaries taken as a whole) to observe the following provisions from the date of this Agreement to and including the Closing Date: (a) The Company will conduct its business in all material respects in the Ordinary Course of Business and in accordance with applicable Law; (b) The Company will (i) use reasonable efforts to preserve its business organization and goodwill, keep available the services of its officers, employees and consultants and maintain satisfactory relationships with vendors, customers and others having business relationships with it, and (ii) confer on a regular and frequent basis with representatives of Buyer to report operational matters and the general status of ongoing operations as requested by Buyer; (c) The Company will not materially change any of its methods of accounting in effect on the date of the Latest Balance Sheets, other than changes required by GAAP; (d) The Company will provide Buyer with its monthly controller's reports promptly following the distribution of each such report to the Company's management; (e) The Company will not cancel or terminate its current insurance policies or allow any of the coverage thereunder to lapse, unless simultaneously with such termination, cancellation or lapse replacement policies providing coverage equal to or greater than the coverage under the canceled, terminated or lapsed policies for substantially similar premiums are in full force and effect; (f) The Company will file (or cause to be filed) at its own expense, on or prior to the due date, all Returns for all Tax periods ending on or before the Closing Date where the due date for such Returns (taking into account valid extensions of the respective due dates) falls on or before the Closing Date, prepared on a basis consistent with the Returns of the Company prepared for prior Tax periods, and will provide Buyer with copies of each income Tax Return or election of the Company at least ten (10) days before filing such Return or election; provided, however, that the Company will not file any Return, election, claim for refund or information statement or consent to any adjustment or otherwise compromise or settle any matters with respect to Taxes to which Buyer reasonably objects; (g) The Company will not (i) make or rescind any express or deemed election or take any other discretionary position relating to Taxes, (ii) amend any Return, (iii) settle or compromise any Litigation relating to Taxes or (iv) change any of its methods of reporting income or deductions for income Tax purposes from those employed in the preparation of the last filed income Tax Returns unless there is a change in applicable Laws; (h) The Company will not declare, set aside or pay any dividend or make any distribution with respect to its capital stock or equity interests, whether in cash or in kind (other than routine interim or annual dividends to all shareholders of the Company consistent with past practices and dividends or distributions from a Subsidiary to the Company or another Subsidiary); and 15 (i) The Company will not loan any funds, pay any money or transfer any assets to any affiliate (other than among the Company and the Subsidiaries), except for (i) payments of dividends or distributions permitted under Section 5.1(h), (ii) payments to affiliates for goods or services purchased or obtained in the Ordinary Course of Business in arms' length transactions, and (iii) payments required under the Contracts listed on SCHEDULE 5.1(I). 5.2 Access; Updating of Disclosure Schedule. (a) From the date of this Agreement through the Closing Date, Sellers will cause the Company (which, for purposes of this Section 5.2, shall mean the Company and the Subsidiaries taken as a whole) to afford to Buyer and its authorized representatives coordinated access at all reasonable times and upon reasonable notice to the facilities, offices, properties, technology, processes, books, business and financial records, officers, employees, business plans, budget and projections, customers, suppliers and other information of each of the Company and the Subsidiaries, and the work papers of Ernst & Young LLP, the Company's independent accountants, to provide for an orderly transition following the Closing; provided, however, that prior to the Closing Date Buyer and its authorized representatives will not have access to information relating to products distributed or proposed to be distributed by the Company other than products distributed under the Distribution Agreement. In addition, Sellers will cause each of the Company and the Subsidiaries, and their officers and employees, to cooperate as appropriate (including providing introductions where necessary) with Buyer to enable Buyer to contact third parties, including suppliers, customers and prospective customers of the Company. The Confidentiality Agreement, dated May 21, 2002 (the "CONFIDENTIALITY AGREEMENT"), between an affiliate of the Company and St. Jude will apply with respect to information obtained by Buyer under this Section 5.2. To implement this Subsection 5.2(a), Sellers and Buyer will each appoint a due diligence coordinator (the "COORDINATORS"). The initial Coordinators shall be Joe McCullough for Buyer and Ray Simkins for Sellers. Each party may change its Coordinator from time to time at its discretion by providing notice to the other party. Any access will be arranged through the Coordinators as they may mutually determine. (b) After the Closing Date, Sellers will afford to Buyer, its accountants and counsel, during normal business hours, upon reasonable request, full access to the books and records of Sellers pertaining to each of the Company and the Subsidiaries. (c) No later than three (3) business days before the Closing, Sellers may deliver to Buyer an updated Disclosure Schedule reflecting items arising or changes occurring in connection with the operation of the business of the Company and the Subsidiaries between the date of this Agreement and the Closing Date (the "UPDATED DISCLOSURE SCHEDULE"). No additional disclosure made in the Updated Disclosure Schedule shall be deemed to be a breach of any representation or warranty of Sellers contained in this Agreement unless the item disclosed results from conduct in violation of Section 5.1; PROVIDED, HOWEVER, that no disclosure set forth in the Updated Disclosure Schedule will be deemed to cure any inaccuracy or misrepresentation in the Disclosure Schedule that existed as of the date of this Agreement. 5.3 Waivers; Payment of Indebtedness. To assure that Buyer obtains the full benefit of this Agreement, effective as of the Closing Date, each Seller will waive any claim it might have 16 against the Company or any Subsidiary, whether arising out of this Agreement or otherwise, and irrevocably offers to terminate any Contract between such Seller and the Company or any Subsidiary at no cost to the Company or any Subsidiary. Sellers will cause each Seller and any Person controlled by any Seller to repay, in full, prior to the Closing, all indebtedness owed to the Company or any Subsidiary by such Person. 5.4 Conditions. Sellers will use their reasonable efforts to cause the conditions set forth in Section 7.1 to be satisfied and to consummate the transactions contemplated by this Agreement, including without limitation the Tender Offer and Stock Transfer, as soon as reasonably possible and in any event prior to the Closing Date. Such efforts may include taking action as required to change the Company's fiscal year end in order to permit the revocation of the registration of the Shares with the JASDA. Any such action shall not be deemed a breach of any provision of this Agreement. 5.5 Consents and Authorizations. Sellers will cooperate with Buyer to enable Buyer to obtain all Consents and Governmental Authorizations required for the consummation of the transactions contemplated by this Agreement or which could, if not obtained, adversely affect the conduct of the business of the Company or any Subsidiary as it is presently conducted. Without limiting the foregoing, Sellers will make or cause to be made all filings and submissions required by them or the Company under any Law applicable to Sellers or the Company required for the consummation of the transactions contemplated by this Agreement. 5.6 Nondisparagement. No Seller will take any action that is designed or intended to have the effect of discouraging any lessor, licensor, customer, supplier or other business associate of the Company or any Subsidiary from maintaining the same business relationships with each of the Company and the Subsidiaries after the Closing as it maintained with each of the Company and the Subsidiaries prior to the Closing. Each Seller will refer all customer inquiries relating to the businesses of the Company or any Subsidiary to the Buyer from and after the Closing. 5.7 Non-Hire. (a) During the period that commences on the Closing Date and ends on the second anniversary of the Closing Date, no Seller will knowingly employ (or attempt to employ or interfere with any employment relationship with) any employee of the Company or any Subsidiary. (b) Except as otherwise permitted under the Distribution Agreement, from and after the date of this Agreement until the later of (i) two years from the Closing Date or (ii) two years from the date this Agreement is terminated, neither St. Jude nor Buyer or any Subsidiary of either of them will knowingly employ (or attempt to employ or interfere with any employment relationship with) any employee of Sellers or any Subsidiary of Sellers (excluding any employee of the Company or the Subsidiaries after the Closing Date). 5.8 Litigation Support. In the event and for so long as Buyer, the Company or any Subsidiary is actively contesting or defending against any Litigation in connection with any fact, situation, circumstance, status, condition, activity, practice, plan, occurrence, event, incident, 17 action, failure to act or transaction existing or occurring on or prior to the Closing Date involving the Company or any Subsidiary, each Seller will cooperate in the contest or defense, make available its personnel and provide such testimony and access to its books and records as may be necessary in connection with the contest or defense, all at the sole cost and expense of Buyer (unless and to the extent Buyer is entitled to indemnification therefor under Article IX). 5.9 Confidentiality. (a) From and after the Closing, Sellers will keep confidential and protect, and will not disclose to any third party, (i) Intellectual Property Rights, including product specifications, formulae, compositions, processes, designs, sketches, photographs, graphs, drawings, samples, inventions and ideas, past, current and planned research and development, current and planned manufacturing and distribution methods and processes, customer lists, current and anticipated customer requirements, price lists, market studies, business plans, software, database technologies, systems, structures, architectures and data (and related processes, formulae, compositions, improvements, devices, know-how, inventions, discoveries, concepts, ideas, designs, methods and information), (ii) any and all information concerning the business and affairs (including historical financial statements, financial projections and budgets, historical and projected sales, capital spending budgets and plans, the names and backgrounds of key personnel, personnel training and techniques and materials, however documented), and (iii) any and all notes, analyses, compilations, studies, summaries and other material containing or based, in whole or in part, on any information included in the foregoing ("Confidential Information") of the Company or any Subsidiary. Sellers acknowledge that such Confidential Information constitutes a unique and valuable asset of the Company or a Subsidiary and represents a substantial investment of time and expense by the Company or a Subsidiary, and that any disclosure of such Confidential Information other than for the sole benefit of the Company or a Subsidiary would be wrongful and could cause irreparable harm to the Company or a Subsidiary. The foregoing obligations of confidentiality will not apply to any Confidential Information that (i) is now or subsequently becomes generally publicly known, other than as a direct or indirect result of the breach of this Agreement by Sellers; (ii) is or becomes known to Sellers or their affiliates as a result of contracts or business relationships between Sellers or their affiliates (other than the Company and the Subsidiaries) and third parties; or (iii) is independently developed by Sellers or their affiliates (other than the Company and the Subsidiaries) without using Confidential Information of the Company or the Subsidiaries. (b) In the event that any Seller is requested or required (by Law, oral question or request for information or documents in any legal proceeding, interrogatory, subpoena, civil investigative demand or similar process) to disclose any Confidential Information, that Seller will notify Buyer promptly of the request or requirement so that Buyer may seek an appropriate protective order or waive compliance with the provisions of this Section 5.9. If, in the absence of a protective order or the receipt of a waiver hereunder, any Seller is, on the advice of counsel, compelled to disclose any Confidential Information to any tribunal or else stand liable for contempt, that Seller may disclose the Confidential Information to the tribunal. 5.10 Transfer of Certain Trademark Rights. Concurrently with the Closing, Sellers shall cause to be transferred to the Company or Buyer, as Buyer shall designate, all of their rights 18 to use the trademarks, trade names and logos identified on SCHEDULE 5.10 solely in connection with the sale of medical products in Japan (the "TRADEMARK ASSIGNMENT"). 5.11 No Encumbrance of Shares. Sellers shall not take any action to encumber any Shares acquired by M&P in the Tender Offer or acquired by Newco in the Stock Transfer. 5.12 Getz Intl Net Worth. Getz Intl agrees not to take any action to cause its net worth to be less than $50,000,000 for a period of one (1) year after the Closing Date and, thereafter, such amount as is reasonably necessary to satisfy any indemnification claims that have been properly asserted by Buyer under Article IX but remain unresolved at the end of such one year period until the same are finally resolved. VI. AGREEMENTS OF BUYER AND ST. JUDE 6.1 Filings and Submissions. Buyer agrees with Sellers that Buyer will make or cause to be made all filings and submissions required by it under any Law applicable to Buyer required for the consummation of the transactions contemplated by this Agreement; PROVIDED, that neither Buyer nor St. Jude will be required to dispose of, hold separately or make any change in, any portion of its business or assets (or the business or assets of the Company or any Subsidiary). 6.2 Buyer Shareholders Meeting. Buyer shall use all reasonable efforts to convene a general shareholders meeting to approve the Acquisition on the terms and subject to the conditions set forth in this Agreement on or prior to the date of the Newco shareholders meeting set forth in Section 1.3 but in any event no later than April 30, 2003. At such meeting, St. Jude shall cause the parent entity of Buyer to vote all shares of Buyer owned by it in favor of approval of the Acquisition. 6.3 Inspection. Promptly following the incorporation of Newco, Buyer shall apply to the court for appointment of an inspector to undertake an inspection of the Acquisition pursuant to Article 246 of the Commercial Code of Japan (the "INSPECTOR"). Buyer shall use all reasonable efforts to cause the Inspector to submit the final opinion that the Acquisition is not unfair for the purposes of Article 246 of the Commercial Code of Japan to the Buyer shareholders meeting set forth in Section 6.2. 6.4 Section 338 Election. (a) Buyer agrees that no election will be made under Section 338(g) of the Code or any comparable provision of prefectural, provincial, state, local or foreign Law (A "SECTION 338 ELECTION"), with respect to Buyer's acquisition of the Shares unless and until Buyer has first obtained the written consent of Sellers to such election; PROVIDED, HOWEVER, that Sellers agree to consent to a Section 338 Election proposed by Buyer if Sellers determine, in their sole discretion and based upon Buyer's proposed allocation of the Purchase Price and assumed liabilities among the assets of the Company and the Subsidiaries (the "ALLOCATION"), that such Section 338 Election will not have any adverse effect upon Sellers. If Sellers grant their advance written consent with respect to a request by Buyer to make a Section 338 Election, and Buyer thereafter makes the Section 338 Election, Buyer (and its affiliates, including St. Jude) and Sellers (and their affiliates) will file their Tax Returns in a manner consistent with the Allocation. 19 (b) In the event that the Stock Transfer does not occur on or prior to December 31, 2002, and no Section 338 (g) Election is made for United States income tax purposes, then from the Closing Date through and including the last day of the taxable year of the Company within which the Closing occurs (as determined for purposes of the Code), the Company shall not, without the prior written consent of Sellers (which consent will be granted unless Sellers determine in their sole discretion, that such action will have an adverse effect on Sellers), (i) distribute as a dividend any cash or other property, or (ii) undertake any transaction that would cause the Company to be deemed to hold "United States property" as of the close of any quarter of such taxable year (within the meaning of Section 956 of the Code). VII. CONDITIONS TO CLOSING 7.1 Conditions to Buyer's Obligations. The obligation of Buyer to take the actions required to be taken by it at the Closing is subject to the satisfaction or waiver, in whole or in part, in Buyer's sole discretion (but no such waiver will waive any right or remedy otherwise available under this Agreement), of each of the following conditions at or prior to the Closing: (a) Newco shall have acquired all of the issued and outstanding Shares, the register of the Shares with the JASDA shall have been revoked, an exemption from its continuous disclosure obligations shall have been granted to the Company by the Prime Minister of Japan, and the sale of the Shares pursuant to this Agreement shall have been duly approved by the shareholders of Newco in accordance with applicable Law; (b) The acquisition of the Shares pursuant to this Agreement shall have been duly approved by the shareholders of Buyer in accordance with applicable Law, PROVIDED that Buyer shall not be entitled to invoke this condition if, in breach of their obligations contained in this Agreement, Buyer or St. Jude shall have been the cause of the failure of this condition; (c) No Law or Governmental Order shall have been enacted, entered, enforced, promulgated, issued or deemed applicable to the transactions contemplated by this Agreement by any Governmental Entity that prohibits the Closing; and (d) There shall have been no substantial impairment of the business of the Company, except to the extent caused by or in any way arising out of any act of Buyer or St. Jude, or any affiliate of either of them, whether pursuant to the Distribution Agreement or otherwise. 7.2 Conditions to Sellers' Obligations. The obligation of Sellers to take the actions required to be taken by them at the Closing is subject to the satisfaction or waiver, in whole or in part, in Sellers' sole discretion (but no such waiver will waive any rights or remedy otherwise available under this Agreement), of each of the following conditions at or prior to the Closing: (a) Newco shall have acquired all of the issued and outstanding Shares, the register of the Shares with the JASDA shall have been revoked, the exemption from its continuous disclosure obligations shall have been granted to the Company by the Prime Minister of Japan, and the sale of the Shares pursuant to this Agreement shall have been duly approved by the shareholders of Newco in accordance with applicable Law, PROVIDED that Sellers shall not be entitled to invoke this condition if, in breach of their obligations contained in this Agreement, they shall have been the cause of the failure of this condition; 20 (b) The acquisition of the Shares pursuant to this Agreement shall have been duly approved by the shareholders of Buyer in accordance with applicable Law; and (c) No Law or Governmental Order shall have been enacted, entered, enforced, promulgated, issued or deemed applicable to the transactions contemplated by this Agreement by any Governmental Entity that prohibits the Closing. VIII. TERMINATION 8.1 Termination. This Agreement may be terminated prior to the Closing: (a) by the mutual written consent of Buyer and Sellers' Representative; (b) by Sellers' Representative, if (i) any of the conditions set forth in Section 7.2 have become impossible to satisfy through no fault of Sellers; or (ii) the transactions contemplated by this Agreement have not been consummated on or before June 30, 2003; PROVIDED that Sellers' Representative will not be entitled to terminate this Agreement pursuant to this Section 8.1(b)(ii) if Sellers' failure to comply fully with their obligations under this Agreement has prevented the consummation of the transactions contemplated by this Agreement. (c) by Buyer, if (i) the Tender Offer shall have terminated or expired in accordance with its terms without M&P having accepted for payment in accordance with the terms of the Tender Offer any Shares properly tendered; (ii) the Stock Transfer shall not have been approved and adopted at the Shareholders Meeting; (iii) the Acquisition shall not have been approved and adopted at the Newco general shareholder meeting; (iv) the transactions contemplated by this Agreement have not been consummated on or before June 30, 2003; PROVIDED that Buyer will not be entitled to terminate this Agreement pursuant to this Section 8.1(c)(iv) if Buyer's failure to comply fully with its obligations under this Agreement has prevented the consummation of the transactions contemplated by this Agreement; or (v) any of the conditions set forth in Section 7.1 have become impossible to satisfy through no fault of Buyer. 8.2 Contract Extension. On January 7, 2001, the Company and St. Jude entered into an International Sales Agreement--Japan ("Distribution Agreement") for the distribution of heart valves and cardiac pacing products by the Company in Japan. The Distribution Agreement 21 currently expires on December 31, 2009, and St. Jude has the right, at its option, to terminate the Distribution Agreement, in whole or in part, as early as June 30, 2004. Given the importance of the distribution of heart valves and cardiac pacing products to the Company, if not for these negotiations for an Acquisition of the Shares by Buyer, the Company would be taking steps to seek potential replacements for the St. Jude lines of products covered by the Distribution Agreement and to otherwise provide for a transition at the conclusion of the Distribution Agreement. Because of these negotiations for an Acquisition, Sellers and the Company have delayed taking steps to seek potential replacement product lines or provide for a transition at the conclusion of the Distribution Agreement. If this Agreement is terminated for any reason and the Acquisition does not occur, St. Jude acknowledges that Sellers and the Company could suffer a material financial loss because of their forbearance in taking action to find other product lines or provide for a transition. Therefore, if this Agreement is terminated for any reason without the completion of the Acquisition, St. Jude agrees that each of the dates in the definition of "Term" in Section 1, Sections 19.1 and 21.1, and Schedule B of the Distribution Agreement will be extended for a period equal to the number of days between June 13, 2002, and the date this Agreement is terminated. 8.3 Effect of Termination. The right of termination under Section 8.1 is in addition to any other rights Buyer or Sellers may have under this Agreement or otherwise, and the exercise of a right of termination will not be an election of remedies and will not preclude an action for breach of this Agreement. If this Agreement is terminated pursuant to Section 8.1, and provided Buyer is not otherwise in material breach of this Agreement, Buyer, upon written notice to Sellers given within thirty (30) days after Sellers' Representative, on the one hand, or Buyer, on the other hand, notifies the other of its intention to terminate this Agreement, shall have the right to purchase from Sellers, and Sellers shall be obligated to sell to Buyer, all of the Shares owned beneficially or of record by Sellers for a prorated Purchase Price determined by multiplying the Purchase Price by a fraction, the numerator of which is the number of Shares purchased by Buyer and the denominator of which is the total number of Shares. The sale and purchase of such Shares shall take place as soon as practically possible and shall be consummated subject to the applicable Law. If this Agreement is terminated, all continuing obligations of the parties under this Agreement will terminate except that Article X, this Section 8.3 and Sections 12.1 (press releases), 12.2 (expenses), 12.12 (governing law), and the Confidentiality Agreement will survive indefinitely unless sooner terminated or modified by the parties in writing. IX. INDEMNIFICATION 9.1 Indemnification by Sellers. (a) Sellers agree, jointly and severally, to indemnify in full Buyer, St. Jude, and each of the Company and the Subsidiaries (collectively, for purposes of this Article IX only, "BUYER") and hold it harmless against any Loss arising from, relating to or constituting (i) any breach or inaccuracy in any of the representations and warranties of Sellers contained in this Agreement as the same may be brought down to the Closing Date, or (ii) any breach of any of the agreements of any Sellers contained in this Agreement (collectively, "BUYER LOSSES"). In calculating the dollar amount attributable to any Buyer Loss, any materiality qualifications included in the representations and warranties in this Agreement shall be disregarded. 22 (b) Sellers will be liable to Buyer for Buyer Losses only if the aggregate amount of all Buyer Losses exceeds U.S.$2,500,000 (the "BASKET AMOUNT"), in which case Sellers will be liable for the Buyer Losses that exceed the Basket Amount; PROVIDED, HOWEVER, that Buyer Losses attributable to any misrepresentation or inaccuracy in Section 2.1 or any intentional breach of any of the agreements of any Sellers contained in this Agreement shall not be subject to the Basket Amount but shall be indemnified in full, subject to Section 9.1(c). (c) Sellers will not be required to pay Buyer for aggregate Buyer Losses in excess of U.S.$50,000,000 (the "CAP"); PROVIDED, HOWEVER, that Buyer Losses attributable to any misrepresentation or inaccuracy in Section 2.1 or any intentional breach of any of the agreements of any Sellers contained in this Agreement shall not be subject to the Cap but shall be indemnified in full. (d) If Buyer has a claim for indemnification under this Section 9.1, Buyer will deliver to Sellers' Representative one or more written notices of Buyer Losses prior to the first anniversary of the Closing Date, except for Buyer Losses arising from a breach or inaccuracy in the representations and warranties made in Section 3.8 for which Buyer will deliver written notice of Buyer Losses prior to three months after the expiration of the applicable statute of limitations. Sellers will have no liability under this Section 9.1 unless the written notices required by the preceding sentence are given in a timely manner. Any written notice will state in reasonable detail the basis for such Buyer Losses to the extent then known by Buyer and the nature of the Buyer Loss for which indemnification is sought, and it may state the amount of the Buyer Loss claimed. Sellers' Representative will notify Buyer whether it disputes a claim within ninety (90) days after receipt of Buyer's written notice. If Sellers' Representative does not timely dispute the claim, Sellers will pay the amount of the Buyer Loss specified in Buyer's notice within ten (10) days thereafter or, if the amount thereof is not specified in Buyer's notice, within ten (10) days after the amount thereof is determined. If Sellers' Representative has timely disputed the liability of Sellers with respect to such claim, Sellers' Representative and Buyer will proceed in good faith to negotiate a resolution of such dispute. If a written notice does not state the amount of the Buyer Loss claimed, such omission will not preclude Buyer from recovering from Sellers the amount of the Buyer Loss with respect to the claim described in such notice if any such amount is promptly provided after it is determined. In order to assert its right to indemnification under this Article IX, Buyer will not be required to provide any notice except as provided in this Section 9.1(d). (e) Sellers will pay the amount of any Buyer Loss to Buyer within ten (10) days following the determination of Sellers' liability for and the amount of a Buyer Loss (whether such determination is made pursuant to the procedures set forth in this Section 9.1, by agreement between Buyer and Sellers' Representative or by arbitration award). 9.2 Third Party Actions. Buyer shall promptly notify Sellers' Representative of the assertion or institution by a third party, including a Governmental Entity, of any claim, action, arbitration, mediation, hearing, investigation, proceeding or suit that may give rise to Buyer Losses for which Buyer could be entitled to indemnification hereunder (a "THIRD PARTY ACTION"). Sellers' Representative shall be entitled to defend such Third Party Action on behalf of Buyer, at the sole cost and expense of Sellers, by giving notice of the intention to so defend to Buyer within 20 business days after Buyer notifies Sellers' Representative of such Third Party Action. 23 Such defense will be conducted by reputable attorneys retained by Sellers' Representative. Buyer will be entitled at any time, at its own cost and expense, to participate in such defense and to be represented by attorneys of its own choosing, provided that if Buyer elects to so participate, Buyer will cooperate with Sellers in the conduct of such defense. Whether or not Buyer participates in such defense, Buyer will cooperate with Sellers to the extent reasonably requested by Sellers in the defense of such Third Party Action, including providing reasonable access (upon reasonable notice) to the books, records and employees of the Buyer if relevant to the defense of such Third Party Action; provided that such cooperation will not unduly disrupt the operations of the business of Buyer or cause Buyer to waive any statutory or common law privileges, breach any confidentiality obligations owed to third parties or otherwise cause any Confidential Information of Buyer to become public. If at any time Buyer reasonably determines that Sellers' Representative is not adequately representing or, because of a conflict of interest, may not adequately represent any interests of Buyer, Buyer will be entitled to conduct its own defense and to be represented by attorneys of its own choosing. Neither Buyer nor Sellers may concede, settle or compromise any Third Party Action without the consent of the other party, which consent will not be unreasonably withheld. Notwithstanding the foregoing, if (i) the subject matter of a Third Party Action relates to the ongoing business of Buyer, which Third Party Action, if decided against Buyer, would materially adversely affect the ongoing business or reputation of Buyer and (ii) Buyer is unwilling to consent to a settlement of such Third Party Action negotiated by Sellers that provides for a complete release of Buyer, then Buyer shall immediately assume the defense of such Third Party Action and Sellers thereafter will have no responsibility to indemnify Buyer for any Buyer Losses arising from such Third Party Action. 9.3 Tax Adjustment. Any payment to Buyer under this Article IX will be, for Tax purposes, to the extent permitted by Law, an adjustment to the Purchase Price. 9.4 Sellers' Representative. (a) Sellers appoint Henry J. West (or any person appointed as a successor Sellers' Representative pursuant to Section 9.4(b)) as their representative and agent under this Agreement ("SELLERS' REPRESENTATIVE"). (b) Until all obligations under this Agreement have been discharged (including all indemnification obligations under this Article IX), Getz Intl may, from time to time upon written notice to Sellers' Representative and Buyer, remove Sellers' Representative or appoint a new Sellers' Representative upon the death, incapacity, resignation or removal of Sellers' Representative. If, after the death, incapacity, resignation or removal of Sellers' Representative, a successor Sellers' Representative has not been appointed by Sellers within fifteen (15) business days after a request by Buyer, Buyer will have the right to appoint a Sellers' Representative to fill any vacancy so created by written notice of such appointment to Sellers. (c) Sellers authorize Sellers' Representative to take any action and to make and deliver any certificate, notice, consent or instrument required or permitted to be made or delivered under this Agreement or under the documents referred to in this Agreement, to waive any requirements of this Agreement or to enter into one or more amendments or supplements to this Agreement that Sellers' Representative determines in Sellers' Representative's sole and absolute discretion to be necessary, appropriate or advisable, which authority includes the authority to collect and 24 pay funds and dispute, settle, compromise and make all claims. The authority of Sellers' Representative includes the right to hire or retain, at the sole expense of Sellers, such counsel, investment bankers, accountants, representatives and other professional advisors as Sellers' Representative determines in Sellers' Representative's sole and absolute discretion to be necessary, appropriate or advisable in order to perform this Agreement. Any party will have the right to rely upon any action taken by Sellers' Representative, and to act in accordance with such action without independent investigation. (d) Buyer will have no liability to any Seller or otherwise arising out of the acts or omissions of Sellers' Representative or any disputes among Sellers or with Sellers' Representative. Buyer may rely entirely on its dealings with, and notices to and from, Sellers' Representative to satisfy any obligations it might have under this Agreement or any other agreement referred to in this Agreement or otherwise to Sellers. X. ARBITRATION 10.1 Disputes. The parties agree to use their reasonable efforts to resolve any controversy, claim or dispute of whatever nature arising between the parties under this Agreement or in connection with the transactions contemplated hereunder, including those arising out of or relating to the breach, termination, enforceability, scope or validity hereof, whether such claim existed prior to or arises on or after the Closing Date (a "DISPUTE"), through negotiation or, upon failure of such negotiations, through such alternative dispute resolution ("ADR") techniques as they may deem appropriate; PROVIDED, HOWEVER, that any claim or request for interim, temporary or injunctive relief may be immediately submitted to arbitration in accordance with Section 10.2. Any Dispute that is not resolved by negotiation or through ADR within ninety (90) days from the day the Dispute Notice (as hereafter defined) is given shall be finally resolved by binding arbitration in accordance with Section 10.2. The agreement to arbitrate contained in this Article X shall continue in full force and effect despite the expiration, rescission or termination of this Agreement. No party shall commence an arbitration proceeding pursuant to the provisions set forth below unless such party shall first give a written notice (a "DISPUTE NOTICE") to the other parties setting forth the nature of the Dispute and, except as provided above, attempted to resolve the Dispute by negotiation and ADR as provided herein. 10.2 Arbitration. (a) Binding arbitration shall be conducted in accordance with such rules as may be agreed upon by the parties, or failing agreement within thirty (30) days after arbitration is demanded (the "ARBITRATION DEMAND"), in accordance with the CPR Rules for Non-Administered Arbitration of the CPR Institute for Dispute Resolution ("CPR") in effect on the date on which the Arbitration Demand is sent, subject to any modifications contained in this Agreement. The site of arbitration shall be (i) Chicago, Illinois if the Arbitration Demand was given by Buyer, or (ii) Minneapolis, Minnesota, if the Arbitration Demand was given by any Seller. The Dispute shall be resolved by one arbitrator, who will be selected by the parties from the CPR Panels of Distinguished Neutrals and who shall have experience in international transactions. The arbitrator shall base the award on the applicable Law and judicial precedent that would apply in accordance with Section 12.12 if the Dispute were decided by a United States District Judge, and the arbitrator shall have no authority to render an award that is inconsistent therewith; PROVIDED, 25 HOWEVER, that the foregoing shall not expand the statutory grounds to vacate the award. The arbitrator shall have the right to appoint an independent expert (including an independent accounting firm) and the costs and expenses of such expert, together with the costs and expenses of the arbitrator, shall be borne one-half by Sellers and one-half by Buyer. The award shall be in writing and include the findings of fact and conclusions of Law upon which it is based. Unless the parties agree otherwise, discovery will be limited to an exchange of relevant documents. Depositions will not be taken except as needed in lieu of a live appearance or upon mutual agreement of the parties. The arbitrator shall resolve any discovery disputes. The arbitrator and counsel of record will have the power of subpoena process as provided by the Federal Arbitration Act. (b) Except as otherwise required by Law, the parties and the arbitrator agree to keep confidential and not disclose to third parties any information or documents obtained in connection with the arbitration process, including the resolution of the Dispute. If a party fails to proceed with arbitration as provided in this Agreement, or unsuccessfully seeks to stay the arbitration, or fails to comply with the arbitration award, or is unsuccessful in vacating or modifying the award pursuant to a petition or application for judicial review, the other party or parties, as applicable, shall be entitled to be awarded costs, including reasonable attorneys' fees, paid or incurred in successfully compelling such arbitration or defending against the attempt to stay, vacate or modify such arbitration award and/or successfully defending or enforcing the award. (c) Sellers submit to the exclusive jurisdiction of any state or federal court sitting in Minneapolis, Minnesota, and Buyer submits to the exclusive jurisdiction of any state or federal court sitting in Chicago, Illinois, to compel arbitration or enforce or vacate any award entered in the arbitration which such party(ies) respectively initiated, and all such claims shall be heard and determined in such respective courts. Each of the parties waives any defense of inconvenient forum to the maintenance of any such action or proceeding. 10.3 Remedies. Each party hereby waives any and all rights it may have to receive exemplary or punitive damages under this Agreement in the arbitration proceedings with respect to any claim it may have against the other party, it being agreed that no party shall be entitled to receive money damages in excess of its actual compensatory damages, notwithstanding any contrary provision contained in this Agreement or otherwise. The parties knowingly and voluntarily waive their rights to have any Dispute tried and adjudicated by a judge or a jury. Any claim or request for interim, temporary or injunctive relief shall be exclusively submitted to arbitration. XI. DEFINITIONS "CODE" means the United States Internal Revenue Code of 1986, as amended. "CONSENT" means any authorization, consent, approval, filing, waiver, exemption or other action by or notice to any Person. "CONTRACT" means a contract, agreement, commitment or binding understanding that is in effect as of the date of this Agreement or any time after the date of this Agreement. 26 "DISCLOSURE SCHEDULE" means the schedule delivered by Sellers to Buyer on or prior to the date of this Agreement that contains exceptions and disclosures to the representations and warranties set forth in Article III of this Agreement. "ENCUMBRANCE" means any charge, claim, community property interest, condition, equitable interest, lien, option, pledge, security interest, right of first refusal or restriction of any kind, including any restriction on use, voting, transfer, receipt of income or exercise of any other attribute of ownership. "GAAP" means Japanese generally accepted accounting principles, as in effect from time to time. "GOVERNMENTAL AUTHORIZATION" means any approval, consent, license, permit, waiver, registration or other authorization issued, granted, given, made available or otherwise required by any Governmental Entity or pursuant to Law. "GOVERNMENTAL ENTITY" means any national, prefectural, provincial, state, local, foreign, international or multinational entity or authority exercising executive, legislative, judicial, regulatory, administrative or taxing functions of or pertaining to government. "GOVERNMENTAL ORDER" means any judgment, injunction, writ, order, ruling, award or decree by any Governmental Entity or arbitrator. "INTELLECTUAL PROPERTY" means all rights in patents, patent applications, trademarks, service marks, trade names, corporate names, copyrights, software, mask works, trade secrets, know-how and other intellectual property rights. "INTELLECTUAL PROPERTY RIGHTS" means (i) rights in patents, patent applications and patentable subject matter, whether or not the subject of an application, (ii) rights in trademarks, service marks, trade names, trade dress and other designators of origin, registered or unregistered, (iii) rights in copyrightable subject matter or protectable designs, registered or unregistered, (iv) trade secrets, (v) rights in Internet domain names, uniform resource locators and e-mail addresses, (vi) rights in semiconductor topographies (mask works), registered or unregistered, (vii) know-how and (viii) all other intellectual and industrial property rights of every kind and nature and however designated, whether arising by operation of Law, Contract, license or otherwise. "KNOWLEDGE," when used with respect to Sellers, means the actual knowledge of any director or executive officer of Sellers, the Company or the Subsidiaries. "LAW" means any constitution, law, ordinance, principle of common law, regulation, statute or treaty of any Governmental Entity. "LITIGATION" means any claim, action, arbitration, mediation, audit, hearing, investigation, proceeding, litigation or suit (whether civil, criminal, administrative, investigative or informal) commenced, brought, conducted or heard by or before, or otherwise involving, any Governmental Entity or arbitrator or mediator. 27 "LOSS" means any Litigation, damage, deficiency, penalty, fine, cost, amount paid in settlement, liability, obligation, Tax, Encumbrance, loss, expense or fee, including court costs and reasonable attorney's fees and expenses. "MATERIAL ADVERSE EFFECT" means any change, effect, event or condition, individually or in the aggregate, that has had, or, with the passage of time, would have, a material adverse effect on the business, assets, properties, condition (financial or otherwise), results of operations, prospects or customer, supplier or employee relationships of the Company and its Subsidiaries, taken as a whole. "ORDINARY COURSE OF BUSINESS" means the ordinary course of business of the Company and the Subsidiaries consistent with past custom and practice (including with respect to quantity and frequency). "ORGANIZATIONAL DOCUMENTS" means (i) the articles or certificate of incorporation and the bylaws of a corporation, (ii) the partnership agreement and any statement of partnership of a general partnership, (iii) the limited partnership agreement and the certificate of limited partnership of a limited partnership, (iv) the limited liability company agreement and articles or certificate of formation of a limited liability company, (v) any charter, regulations or similar document adopted or filed in connection with the creation, formation or organization of a Person and (vi) any amendment to any of the foregoing. "PERSON" means any individual, corporation (including any non-profit corporation), general or limited partnership, limited liability company, joint venture, estate, trust, association, organization, labor union, Governmental Entity or other entity. "REMEDIES EXCEPTION," when used with respect to any Person, means performance of such Person's obligations except to the extent enforceability may be limited by applicable bankruptcy, insolvency, corporate reorganization, civil rehabilitation, moratorium or other laws affecting the enforcement of creditors' rights generally and by general equitable principles. "RETURNS" means all returns, declarations, reports, estimates, information returns and statements pertaining to any Taxes. "SUBSIDIARY" means any Person in which 50% or more of the ownership interests is owned, directly or indirectly, by another Person. When used without reference to a particular entity, "Subsidiary" means a Subsidiary of the Company. "TAX AFFILIATE" means each of the Company and the Subsidiaries. "TAXES" means all taxes, charges, fees, levies or other assessments, including all net income, gross income, gross receipts, sales, use, consumption, value-added, ad valorem, transfer, franchise, profits, license, withholding, payroll, employment, social security, unemployment, excise, estimated, severance, stamp, occupation, property or other taxes, customs duties, fees, assessments or charges of any kind whatsoever, including all interest and penalties thereon, and additions to tax or additional amounts imposed by any Governmental Entity upon the Company or any Tax Affiliate. 28 XII. GENERAL 12.1 Press Releases and Announcements. Any public announcement, including any announcement to employees, customers or suppliers and others having dealings with the Company, or similar publicity with respect to this Agreement or the transactions contemplated by this Agreement, will be issued at such time and in such manner as the parties may mutually determine and approve, unless such announcement is required to carry out the transactions contemplated under this Agreement; provided that in the event such announcement is necessary, either party will notify the other in advance of such announcement. Notwithstanding the foregoing, nothing contained herein will prevent Buyer, St. Jude, Sellers, Company or its Subsidiaries from making disclosures to their attorneys, accountants, bankers, investment bankers or advisors, or other persons that are necessary or appropriate to carry out the transactions contemplated in this Agreement. 12.2 Expenses. Except as agreed by the parties with respect to the fees identified in a letter agreement, dated September 17, 2002, between St. Jude and Getz Intl (the "FEE LETTER"), Sellers, on the one hand, and Buyer, on the other hand, will each pay all expenses incurred by each of them (and, in the case of Sellers, the expenses incurred by the Company and Sellers' Representative) in connection with the Tender Offer, the Stock Transfer and the other transactions contemplated by this Agreement, including legal, accounting, investment banking and consulting fees and expenses incurred in negotiating, executing and delivering this Agreement and the other agreements, exhibits, documents and instruments contemplated by this Agreement. Sellers agree that neither the Company nor any Subsidiary has or will bear any of Sellers' expenses in connection with the Tender Offer, the Stock Transfer and the other transactions contemplated by this Agreement if the contemplated transactions are concluded. 12.3 Further Assurances. On and after the Closing Date, Sellers and Buyer will take all appropriate action and execute any documents, instruments or conveyances of any kind that may be reasonably requested by the other party to carry out any of the provisions of this Agreement. 12.4 Cooperation. After the Closing Date, Buyer and Sellers will make available to the other, as reasonably requested, all information, records or documents relating to Tax liabilities or potential Tax liabilities of the Company with respect to (i) Tax periods ending on or prior to the Closing Date and (ii) Tax periods beginning before the Closing Date and ending after the Closing Date, but only with respect to the portion of such period up to and including the Closing Date. Buyer and Sellers will preserve all such information, records and documents until the expiration of any applicable statute of limitations thereof. Buyer will prepare and provide to Sellers any information or documents reasonably requested by Sellers for Sellers' use in preparing or reviewing the Returns. Notwithstanding any other provision hereof, each party will bear its own expenses in complying with the foregoing provisions. 12.5 Notices. All notices, demands and other communications to be given or delivered under or by reason of the provisions of this Agreement will be in writing and will be deemed to have been given (i) when delivered if personally delivered by hand (with written confirmation of receipt), (ii) when received if sent by an internationally recognized overnight courier service (receipt requested), (iii) ten business days after being mailed, if sent by first class mail, return 29 receipt requested, or (iv) when receipt is acknowledged by an affirmative act of the party receiving notice, if sent by facsimile, telecopy or other electronic transmission device (provided that such an acknowledgement does not include an acknowledgment generated automatically by a facsimile or telecopy machine or other electronic transmission device). Notices, demands and communications to Buyer and Sellers' Representative will, unless another address is specified in writing, be sent to the address indicated below: If to Buyer or St. Jude: St. Jude Medical, Inc. One Lillehei Plaza St. Paul, MN 55117 USA Attn: Kevin T. O'Malley, Esq. Facsimile No. +1 (651) 481-7690 With a copy to: Dorsey & Whitney LLP Shiroyama MT Building, 9F 4-1-17 Toranomon, Minato-ku Tokyo 105-0001, Japan Attn: Christopher E. O'Brien Facsimile No. +81 (3) 5473 5199 and an additional copy to: Dorsey & Whitney LLP 50 South Sixth Street Minneapolis, MN 55401 USA Attn: Robert A. Kuhns, Esq. Facsimile No. +1 (612) 340-8738 If to Sellers or Sellers' Representative: Getz International, Inc. c/o The Marmon Group, Inc. 225 W. Washington Street, 19th Floor Chicago, Illinois 60606 Attn: Robert W. Webb, Esq. Facsimile No. +1 (312) 845-8769 With a copy to: Neal, Gerber & Eisenberg Two North LaSalle St., Suite 2200 Chicago, Illinois 60602 Attn: Miranda K. Mandel, Esq. Facsimile No. +1 (312) 269-1747 30 and an additional copy to: Mori Sogo NKK Building 1-1-2 Marunouchi, Chiyoda-ku Tokyo 100-0005, Japan Attn: Kanako Muraoka, Esq. Facsimile No. +81 (3) 5223 7665 12.6 Assignment. Neither this Agreement nor any of the rights, interests or obligations hereunder may be assigned by any party to this Agreement without the prior written consent of the other parties to this Agreement, except that Buyer may assign any of its rights under this Agreement to an affiliate of Buyer, so long as Buyer remains responsible for the performance of all of its obligations under this Agreement. Subject to the foregoing, this Agreement and all of the provisions of this Agreement will be binding upon and inure to the benefit of the parties to this Agreement and their respective successors and permitted assigns. 12.7 No Third Party Beneficiaries. Nothing expressed or referred to in this Agreement confers any rights or remedies upon any Person that is not a party or permitted assign of a party to this Agreement. 12.8 Severability. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable Law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable Law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement. 12.9 Complete Agreement. This Agreement (including the Disclosure Schedule and any Updated Disclosure Schedule), the Confidentiality Agreement and the Fee Letter contain the complete agreement between the parties and supersede any prior understandings, agreements or representations by or between the parties, written or oral. 12.10 English Language. This Agreement has been drafted, negotiated, and executed in the English language. If Sellers have this Agreement translated into Japanese, such translation shall be at the Sellers' own expense and with the understanding that the original English version of this Agreement shall govern. All notices, including Dispute Notices, shall be in English and all arbitration proceedings shall be conducted in English. 12.11 Signatures; Counterparts. This Agreement may be executed in one or more counterparts, any one of which need not contain the signatures of more than one party, but all such counterparts taken together will constitute one and the same instrument. A facsimile signature will be considered an original signature. 12.12 Governing Law. THE DOMESTIC LAW, WITHOUT REGARD TO CONFLICTS OF LAWS PRINCIPLES, OF THE STATE OF MINNESOTA WILL GOVERN 31 ALL QUESTIONS CONCERNING THE CONSTRUCTION, VALIDITY AND INTERPRETATION OF THIS AGREEMENT AND THE PERFORMANCE OF THE OBLIGATIONS IMPOSED BY THIS AGREEMENT, EXCEPT TO THE EXTENT THAT PROCEDURAL MATTERS RELATING TO THE TENDER OFFER, THE STOCK TRANSFER, THE ACQUISITION OR THE ORGANIZATION OF, OR ACTIONS TO BE TAKEN BY, A JAPANESE ENTITY ARE GOVERNED BY OR REQUIRED TO BE TAKEN IN ACCORDANCE WITH JAPANESE LAW. 12.13 Amendment and Waiver. This Agreement may not be amended, nor may any provision of this Agreement or any default, misrepresentation, or breach of warranty or agreement under this Agreement be waived, except in writing executed by all of the parties hereto. Notwithstanding the foregoing, any amendment or waiver executed by Sellers' Representative shall be deemed to have been executed by each of the Sellers except as otherwise provided in Section 9.4. 12.14 Construction. The parties and their respective counsel have participated jointly in the negotiation and drafting of this Agreement. In addition, each of the parties acknowledges that it is sophisticated and has been advised by experienced counsel and, to the extent it deemed necessary, other advisors in connection with the negotiation and drafting of this Agreement. In the event an ambiguity or question of intent or interpretation arises, this Agreement will be construed as if drafted jointly by the parties and no presumption or burden of proof will arise favoring or disfavoring any party by virtue of the authorship of any of the provisions of this Agreement. The headings preceding the text of articles and sections included in this Agreement and the headings to the schedules and exhibits are for convenience only and are not be deemed part of this Agreement or given effect in interpreting this Agreement. The word "including" means "including without limitation." The use of the masculine, feminine or neuter gender or the singular or plural form of words will not limit any provisions of this Agreement. A statement in this Agreement that a copy of an item has been delivered means a true and correct copy of the writing has been delivered. XIII. GUARANTY BY ST. JUDE As an inducement to and in consideration of Sellers entering into this Agreement, St. Jude, being the ultimate parent of Buyer, hereby expressly, unconditionally, and irrevocably guarantees Buyer's performance of all of its duties, obligations, and agreements under the Agreement, including (without limitation) payment of all of Buyer's obligations under the Agreement. St. Jude agrees that Sellers shall not be required to take any action whatsoever against Buyer before St. Jude's liability attaches hereunder and that the liability of St. Jude hereunder shall immediately attach and accrue upon default or breach of Buyer with respect to any of its duties, obligations, and agreements under the Agreement. 32 IN WITNESS WHEREOF, Buyer, St. Jude and Sellers have executed this Stock Purchase Agreement as of the date first above written. BUYER: SELLERS: ST. JUDE MEDICAL JAPAN K.K. GETZ BROS. AND CO. ZUG INC. By: /s/ Kevin T. O'Malley By: /s/ R. C. Gluth ----------------------------- -------------------------------- Name: Kevin T. O'Malley Name: R. C. Gluth ----------------------------- -------------------------------- Title: Director Title: Director, Vice President and ----------------------------- Treasurer -------------------------------- ST. JUDE MEDICAL, INC. GETZ INTERNATIONAL, INC. By: /s/ Daniel J. Starks By: /s/ Robert K. Lorch -------------------- ------------------------------- Title: President and COO Name: Robert K. Lorch ----------------------------- ------------------------------- Title: Vice President, Chief Financial Officer ------------------------------- MULLER & PHIPPS (JAPAN) LTD. By: /s/ Raymond Sipkins ------------------------------- Name: Raymond Sipkins ------------------------------- Title: Director ------------------------------- 33 DISCLOSURE SCHEDULE TO THE STOCK PURCHASE AGREEMENT Schedule 2.1 Good Title to Shares Schedule 3.1 Incorporation Schedule 3.4 Subsidiaries Schedule 3.5 Statements Schedule 3.6 Absence of Certain Developments Schedule 3.7 Real Property Schedule 3.8 Taxes Schedule 3.9 Material Contracts Schedule 3.10 Litigation Schedule 3.11 Insurance Schedule 3.14 Warranties Schedule 3.16 Employee Benefits Schedule 3.17 Suppliers Schedule 5.1 Conduct of the Business Schedule 5.10 Trademarks St. Jude Medical, Inc. agrees to furnish supplementally copies of these schedules to the Securities and Exchange Commission upon request. EX-2.2 4 stjude041330_ex2-2.txt AMENDMENT Exhibit 2.2 AMENDMENT This AMENDMENT, dated as of February 20, 2003, by and among Getz Japan Holding KK, a company organized under the laws of Japan ("NEWCO"), St. Jude Medical Japan K.K., a company organized under the laws of Japan ("BUYER"), St. Jude Medical, Inc., a Minnesota corporation ("ST. JUDE"), Getz Bros. & Co. Zug Inc., a company organized under the laws of Switzerland ("GETZ ZUG"), Getz International, Inc., a Delaware corporation ("GETZ Intl"), and Muller & Phipps (Japan) Ltd., a company organized under the laws of Japan ("M&P", and together with Getz Zug and Getz Intl., "SELLERS"), is attached to and made a part of that certain Stock Purchase Agreement (the "AGREEMENT"), dated as of September 17, 2002 (USA), by and among Buyer, St. Jude and Sellers. Capitalized and undefined terms used in this Amendment shall have the same meanings ascribed to them in the Agreement. WHEREAS, Section 1.2 of the Agreement provides that the parties will execute an amendment to the Agreement whereby Newco will become a party to the Agreement and be included within the definition of "SELLERS". THEREFORE, in accordance with Section 1.2 of the Agreement, Newco agrees to (1) be included within the definition of "Sellers" in the Agreement, (2) execute such documents and to take such actions as may reasonably be necessary or appropriate to implement fully the transactions described in the Agreement, and (3) be bound by the covenants, obligations and undertakings applicable to Newco under the Agreement. Notwithstanding the foregoing, the parties acknowledge and agree that because Newco will be liquidated as soon as practicable after the Closing, Newco will be relieved of all of its obligations under the Agreement following the Closing except those arising under Sections 5.6 (Nondisparagement) and 5.9 (Confidentiality), and Buyer and St. Jude will look solely to the other Sellers with respect to any obligations of Sellers arising after the Closing. Buyer and St. Jude further agree not submit any objection as a creditor to the liquidation of Newco. Except as expressly modified by the terms of this Amendment, the terms and conditions of the Agreement and its respective schedules and exhibits shall remain in full force and effect. IN WITNESS WHEREOF, each of the undersigned has executed this Amendment as of the date first above written. GETZ JAPAN HOLDING KK GETZ BROS. & CO. ZUG INC. By: /s/ Ray Sipkins By: /s/ Ray Sipkins ------------------------------ ------------------------------ Name: Ray Sipkins Name: Ray Sipkins ------------------------------ ------------------------------ Title: Representative Liquidator Title: Director ------------------------------ ------------------------------ ST. JUDE MEDICAL JAPAN K.K. GETZ INTERNATIONAL, INC. By: /s/ Kevin T. O'Malley By: /s/ Ray Sipkins ------------------------------ ------------------------------ Name: Kevin T. O'Malley Name: Ray Sipkins ------------------------------ ------------------------------ Title: Director Title: President ------------------------------ ------------------------------ ST. JUDE MEDICAL, INC. MULLER & PHIPPS (JAPAN) LTD. By: /s/ Kevin T. O'Malley By: /s/ Ray Sipkins ------------------------------ ------------------------------ Name: Kevin T. O'Malley Name: Ray Sipkins ------------------------------ ------------------------------ Title: Vice President and General Title: President Counsel ------------------------------ ------------------------------ EX-13 5 stjude041330_ex13.txt MANAGEMENT'S DISCUSSION AND ANALYSIS OF EXHIBIT 13 FINANCIAL CONDITION AND RESULTS OF OPERATIONS OVERVIEW Our business is focused on the development, manufacturing and distribution of cardiovascular medical devices for the global cardiac rhythm management (CRM), cardiac surgery (CS) and cardiology and vascular access (C/VA) therapy areas. Our principal products in each of these therapy areas are as follows: CRM o bradycardia pacemaker systems (pacemakers), o tachycardia implantable cardioverter defibrillator systems (ICDs), and o electrophysiology (EP) catheters CS o mechanical and tissue heart valves, and o valve repair products C/VA o vascular closure devices, o angiography catheters, o guidewires, and o hemostasis introducers Our products are sold in more than 120 countries around the world. Our largest geographic markets are the United States, Europe and Japan. We compete on the basis of providing reliable products with advanced features. Our industry has undergone significant consolidation in the last decade and is very competitive. Our strategy requires significant investments in research and development in order to introduce new products, particularly in the cardiac rhythm management and the cardiology and vascular access therapy areas. We have also sought to improve our operating margins through a variety of techniques, including maintaining our average selling prices while improving the efficiency of our manufacturing operations. Our products are generally not affected by economic cycles. However, we expect cost containment pressure on healthcare systems to continue to place downward pressure on prices for our products, particularly in international markets such as Germany and Japan. The industry in which we operate is characterized by frequent patent litigation and product liability litigation, which are issues that we must manage. Pacemakers and ICDs accounted for 43% and 21% of our total 2003 net sales, respectively. In addition, the pacemaker and ICD markets are the largest markets we participate in, and our strategy is to increase our sales and market share in those markets. In 2002, our primary CRM competitors began selling pacemaker and ICD systems that are capable of pacing the heart from both ventricles, providing cardiac resynchronization therapy (CRT). By pacing the heart from both ventricles, many physicians believe that pacemakers and ICDs with CRT provide a therapeutic advantage over traditional devices for certain patients. In addition, CRT devices have a higher average selling price over traditional devices. Currently, we do not have a pacemaker or ICD system with CRT approved for sale in the 1 United States, which is the largest geographic market for these products. However, we are conducting clinical trials and anticipate introducing pacemakers and ICDs with CRT in the United States in the second quarter of 2004. We estimate that approximately 35% of the worldwide market for pacemakers and ICDs in 2003 was made up of sales of CRT devices. RESULTS OF OPERATIONS FINANCIAL SUMMARY Net sales in 2003 increased approximately 22% over 2002 driven primarily by growth in our ICD and vascular closure devices, incremental revenue as a result of our acquisition of Getz Bros. Co., Ltd. in Japan (Getz Japan), and the positive impact of foreign currency translation as the U.S. dollar weakened against most currencies during 2003 as compared with 2002. Our ICD net sales grew approximately 37% to $414 million during 2003. Our vascular closure net sales increased approximately 40% to $218 million in 2003, strengthening our leadership position in the vascular closure market. During 2003, we completed our acquisition of Getz Japan and Getz's related distribution operations in Australia. The addition of these operations further strengthened our presence in Japan and Australia. Net earnings and diluted net earnings per share for 2003 increased approximately 23% and 21%, respectively, over 2002 due primarily to incremental profits resulting from higher sales. We ended the year with $461 million of cash and equivalents and $352 million of long-term debt. We have strong short-term credit ratings, with an A2 rating from Standard & Poor's and a P2 rating from Moody's. Our cash flows from operations remained strong during 2003, helping to further strengthen our balance sheet and provide cash to repay a portion of the funds borrowed in 2003 to finance the Getz Japan acquisition and the repurchase of 9.25 million shares in August 2003. We expect to use our future cash flows to fund internal development opportunities, reduce our debt and potentially purchase the remaining ownership of Epicor Medical, Inc. (Epicor). See ACQUISTIONS & INVESTMENTS for a discussion of Epicor. We utilize a 52/53-week fiscal year ending on the Saturday nearest December 31, but for simplicity of presentation, describe all periods as if the year end is December 31. Fiscal year 2003 consisted of 53 weeks, adding three additional selling days as compared with 2002. The additional selling days occurred between the Christmas and New Year's Day holidays, which typically are lower volume selling days due to the elective nature of many hospitals' procedures. These additional selling days did not have a material impact on our net sales or results of operations for 2003. Fiscal years 2002 and 2001 each consisted of 52 weeks. CRITICAL ACCOUNTING POLICIES AND ESTIMATES Preparation of our consolidated financial statements in accordance with accounting principles generally accepted in the United States requires us to adopt various accounting policies and to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Our significant accounting policies are disclosed in Note 1 to the consolidated financial statements. On an ongoing basis, we evaluate our estimates and assumptions, including those related to accounts receivable allowance for doubtful accounts; estimated useful lives of property, plant and equipment; income taxes; Silzone(R) special charge accruals; and legal reserves. We base our estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, 2 and the results form the basis for making judgments about the reported values of assets, liabilities, revenues and expenses. Actual results may differ from these estimates. We believe that the following represent our most critical accounting estimates: ACCOUNTS RECEIVABLE ALLOWANCE FOR DOUBTFUL ACCOUNTS: We grant credit to customers in the normal course of business, and generally do not require collateral or any other security to support our accounts receivable. We maintain an allowance for doubtful accounts for potential credit losses, which primarily consists of reserves for specific customer balances that we believe may not be collectible. We determine the adequacy of this allowance by regularly reviewing the accounts receivable agings, customer financial conditions and credit histories, and current economic conditions. In some developed markets and in many emerging markets, payments of certain accounts receivable balances are made by the individual countries' healthcare systems for which payment is dependent, to some extent, upon the political and economic environment within those countries. Although we consider our allowance for doubtful accounts to be adequate, if the financial condition of our customers or the individual countries' healthcare systems were to deteriorate and impair their ability to make payments to us, additional allowances may be required in future periods. The allowance for doubtful accounts was $31.9 million at December 31, 2003 and $24.1 million at December 31, 2002. ESTIMATED USEFUL LIVES OF PROPERTY, PLANT AND EQUIPMENT: Diagnostic equipment is recorded at cost and is depreciated using the straight-line method over its estimated useful life of five to eight years. Diagnostic equipment primarily consists of programmers that are used by physicians and healthcare professionals to program and analyze data from pacemaker and ICD devices. The estimated useful life of this equipment is determined based on our estimates of its usage by the physicians and healthcare professionals, factoring in new technology platforms and rollouts. To the extent that we experience changes in the usage of this equipment or there are introductions of new technologies to the market, the estimated useful lives of this equipment may change in a future period. Diagnostic equipment had a net carrying value of $68.7 million and $81.0 million at December 31, 2003 and 2002, respectively. If we had used an estimated useful life on diagnostic equipment that was one year less than our current estimate, our 2003 depreciation expense would have been approximately $5 million higher. INCOME TAXES: As part of the process of preparing our consolidated financial statements, we are required to estimate our income taxes in each of the jurisdictions in which we operate. This process involves estimating the actual current tax expense as well as assessing temporary differences in the treatment of items for tax and accounting purposes. These timing differences result in deferred tax assets and liabilities, which are included in our consolidated balance sheet. We must then assess the likelihood that our deferred tax assets will be recovered from future taxable income, and to the extent that we believe that recovery is not likely, a valuation allowance must be established. At December 31, 2003, we had approximately $94 million of gross deferred tax assets, including net operating loss and tax credit carryforwards that will expire from 2004 to 2019 if not utilized. We believe that our deferred tax assets, including the net operating loss and tax credit carryforwards, will be fully realized based upon our estimates of future taxable income. As such, we have not recorded any valuation allowance for our deferred tax assets. If our estimates of future taxable income are not met, a valuation allowance for some of these deferred tax assets would be required. We have not recorded U.S. deferred income taxes on certain of our non-U.S. subsidiaries' undistributed earnings, because such amounts are intended to be reinvested outside the United States indefinitely. However, should we change our business and tax strategies in the future and decide to repatriate a 3 portion of these earnings to one of our U.S. subsidiaries, including cash maintained by these non-U.S. subsidiaries (see Liquidity and Capital Resources), additional U.S. tax liabilities would be incurred. We operate within multiple taxing jurisdictions and are subject to audit in these jurisdictions. These audits can involve complex issues, including challenges regarding the timing and amount of deductions and the allocation of income among various tax jurisdictions. Our U.S. federal tax filings prior to 1998 have been examined by the Internal Revenue Service (IRS), and we have settled all differences arising out of those examinations. The U.S. federal tax authorities have designated us as a "coordinated industry case," more commonly known as a "large case," which is an IRS designation used for large companies that means, among other things, that the IRS will audit essentially all of our federal income tax return filings. The IRS is currently in the process of examining our U.S. federal tax returns for the calendar years 1998, 1999 and 2000. We record our income tax provisions based on our knowledge of all relevant facts and circumstances, including the existing tax laws, our experience with previous settlement agreements, the status of current IRS examinations and our understanding of how the tax authorities view certain relevant industry and commercial matters. Although we have recorded all probable income tax accruals in accordance with Statement of Financial Accounting Standards (SFAS) No. 5, "ACCOUNTING FOR CONTINGENCIES" and SFAS No. 109. "ACCOUNTING FOR INCOME TAXES", our accruals represent accounting estimates that are subject to the inherent uncertainties associated with the tax audit process, and therefore include certain contingencies. We believe that any potential tax assessments from the various tax authorities that are not covered by our income tax provision will not have a material adverse impact on our consolidated financial position or liquidity. However, they may be material to our consolidated results of operations of a future period. SILZONE(R) SPECIAL CHARGE ACCRUALS: In January 2000, we initiated a worldwide voluntary recall of all field inventory of heart valve replacement and repair products incorporating Silzone(R) coating on the sewing cuff fabric. We concluded that we would no longer utilize Silzone(R) coating and recorded a special charge totaling $26.1 million during the first quarter of 2000 to cover various asset write-downs and anticipated costs associated with these matters. In the second quarter of 2002, we increased our Silzone(R) reserves by $11 million to cover additional anticipated costs. We have recorded an accrual for probable legal costs that we will incur to defend the various cases involving Silzone(R) devices, and we have recorded a receivable from our product liability insurance carriers for amounts expected to be recovered. We have not accrued for any amounts associated with probable legal settlements or judgments because we cannot reasonably estimate such amounts. However, we believe that no significant claims will ultimately be allowed to proceed as class actions in the United States, and, therefore, that all settlements and judgments will be covered under our remaining product liability insurance coverage (approximately $170 million at December 31, 2003), subject to the insurance companies' performance under the policies. As such, we believe that any costs (the material components of which are settlements, judgments and legal fees) not covered by our product liability insurance policies or existing reserves will not have a material adverse effect on our statement of financial position or liquidity, although such costs may be material to our consolidated results of operations of a future period. Our remaining product liability insurance for Silzone(R) claims consists of a number of layers, each of which is covered by one or more insurance companies. Our next layer of insurance, which is a $30 million layer that would be reached after the present $35 million layer is exhausted, is covered by Lumberman's Mutual Casualty Insurance, a unit of the Kemper Insurance Companies (collectively referred to as Kemper). Kemper's credit rating by A.M. Best has been downgraded to a "D" (poor). Kemper is currently in "run off," which means that it is not issuing new policies and is, therefore, not 4 generating any new revenue that could be used to cover claims made under previously-issued policies. In the event Silzone(R) claims were to reach the Kemper layer and Kemper was unable to pay part or all of such claims, we believe the other insurance carriers in our program will take the position that we will be directly liable for any claims and costs that Kemper is unable to pay, and that insurance carriers at policy layers following Kemper's layer will not provide coverage for Kemper's layer. Kemper also provides part of the coverage for Silzone(R) claims in our final layer of insurance ($20 million of the final $50 million layer). It is possible that Silzone(R) costs and expenses will reach the Kemper layers of insurance coverage, and it is possible that Kemper will be unable to meet its obligations to us. If this were to happen, we could incur a loss of up to $50 million. We have not accrued for any such losses. LEGAL RESERVES: We operate in an industry that is susceptible to significant product liability and intellectual property claims. Product liability claims may be brought by individuals seeking relief for themselves or, increasingly, by groups seeking to represent a class. In addition, claims may be asserted against us in the future relative to events that are not known to us at the present time. Our product liability insurance coverage during most of 2003 was $200 million, with a $50 million deductible per claim. In light of our significant self-insured retention, our product liability insurance coverage is designed to help protect against a catastrophic claim. We record a liability in our consolidated financial statements for any claims where we have assessed that a loss is probable and an amount can be reasonably estimated. A substantial amount of intellectual property litigation occurs in our industry. In November 1996, one of our competitors, Guidant Corporation (Guidant), initiated a lawsuit against us alleging that we did not have a license to certain patents which they controlled and as such, we were infringing on those patents. A jury found against us in July 2000; however, the judge overseeing the trial issued post-trial rulings in February 2001 which essentially set aside the jury's $140 million damage assessment. Guidant is appealing certain aspects of the judge's ruling. While it is not possible to predict the outcome of the appeal process, we believe that the decision of the trial court in its post-trial rulings was correct. In February 2004, Guidant initiated another lawsuit against us alleging that a number of our CRT products infringe two of its patents. We have not submitted a substantive response to Guidant's February 2004 claims at this time. To date, we have not recorded any liability for any losses related to these litigation matters. Potential losses arising from the ultimate resolution of these litigation matters are possible, but not estimable at this time. The range of such a loss could be material to our consolidated financial position, liquidity and results of operations. ACQUISITIONS & INVESTMENTS Acquisitions can have an impact on the comparison of our operating results and financial condition from year to year. On April 1, 2003, we completed the acquisition of Getz Japan, a distributor of medical technology products in Japan and our largest volume distributor in Japan. We paid 26.9 billion Japanese Yen in cash to acquire 100% of the outstanding common stock of Getz Japan. Net consideration paid was $219.2 million, which includes closing costs less $12.0 million of cash acquired. On April 1, 2003, we also acquired the net assets of Getz Bros. & Co. (Aust.) Pty. Limited and Medtel Pty. Limited (collectively referred to as Getz Australia) related to the distribution of our products in Australia for $6.2 million in cash, including closing costs. 5 The results of operations of the Getz Japan and Getz Australia (collectively referred to as Getz) acquisitions have been included in our consolidated results of operations since April 1, 2003. Pro forma results of operations have not been presented for the Getz acquisitions since the effects of these acquisitions were not material to our consolidated financial statements either individually or in aggregate. Net sales for 2003 included approximately $106 million related to the Getz Japan and Getz Australia acquisitions. The additional revenue from Getz was generated from the sale of non-St. Jude Medical manufactured products sold by Getz and the incremental revenue on the sale of St. Jude Medical manufactured products. Prior to April 1, 2003, we recognized revenue from the sale of our products to Getz as our distributor. In May 2003, we made a $15 million minority investment in Epicor, a development stage company focused on developing products which use high intensity focused ultrasound (HIFU) to ablate cardiac tissue. In conjunction with this investment, we also agreed to acquire the remaining ownership of Epicor in 2004 for an additional $185 million in cash if Epicor achieves specific clinical and regulatory milestones by June 30, 2004. SEGMENT REVIEW We have two reportable segments, the Cardiac Rhythm Management/Cardiac Surgery (CRM/CS) segment and the Daig segment, which focus on the development and manufacture of our products. The primary products produced by each segment are: CRM/CS - pacemaker and ICD systems, mechanical and tissue heart valves and other cardiac surgery products; Daig - electrophysiology catheters, vascular closure devices and other cardiology and vascular access products. Our reportable segments include end customer revenues from the sale of products they each develop and manufacture. The costs included in each of the reportable segments' operating results include the direct costs of the products sold to end customers and operating expenses managed by each of the segments. Certain costs of goods sold and operating expenses managed by our selling and corporate functions are not included in segment operating profit. Because of this, segment operating profit is not representative of the operating profit of our products in these segments. The following table presents certain financial information about our reportable segments (in thousands): 6
CRM/CS DAIG OTHER TOTAL ================================================================================================================================== FISCAL YEAR ENDED DECEMBER 31, 2003 Net sales $ 1,499,425 $ 366,433 $ 66,656 $ 1,932,514 Operating profit (a) 873,904 202,007 (619,966) 455,945 Total assets 639,724 147,270 1,769,100 2,556,094 - ---------------------------------------------------------------------------------------------------------------------------------- FISCAL YEAR ENDED DECEMBER 31, 2002 Net sales $ 1,305,750 $ 284,179 $ - $ 1,589,929 Operating profit (a) 713,341 149,592 (492,978) 369,955 Total assets 723,414 134,610 1,093,355 1,951,379 - ---------------------------------------------------------------------------------------------------------------------------------- FISCAL YEAR ENDED DECEMBER 31, 2001 (b) Net sales $ 1,135,833 $ 211,523 $ - $ 1,347,356 Operating profit (a) 583,030 105,947 (453,161) 235,816 ==================================================================================================================================
(a) OTHER OPERATING PROFIT INCLUDES CERTAIN COSTS OF GOODS SOLD AND OPERATING EXPENSES MANAGED BY THE COMPANY'S SELLING AND CORPORATE FUNCTIONS. IN FISCAL YEAR 2001, OTHER ALSO INCLUDES SPECIAL CHARGES AND PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT CHARGES. (b) DURING 2001, THE COMPANY COMPLETED A REORGANIZATION OF ITS GLOBAL SALES ACTIVITIES, WHICH RESULTED IN CHANGES TO ITS INTERNAL MANAGEMENT AND FINANCIAL REPORTING STRUCTURE. DUE TO THIS RESTRUCTURING, INFORMATION RELATING TO 2001 TOTAL ASSETS HAS NOT BEEN COMPILED AS IT IS IMPRACTICABLE TO DO SO. We do not generally manage our business or allocate resources based on the measure of segment operating profit or loss because these measures are not indicative of the operating results of the products sold by these segments. Rather, we utilize the segment results to measure performance against targets for each segment's controllable activities. Additionally, we review global and product line sales information to assess performance of the business. The following discussion of the changes in our net sales is provided by class of similar products, which is the primary focus of our sales activities. That analysis sufficiently describes the changes in our sales results for our two reportable segments. NET SALES Net sales by geographic markets were as follows (in thousands):
2003 2002 2001 ============================================================================================== United States $1,129,055 $1,042,766 $ 880,086 International Europe 465,369 347,936 294,852 Japan 207,431 95,813 83,361 Other 130,659 103,414 89,057 - ---------------------------------------------------------------------------------------------- 803,459 547,163 467,270 - ---------------------------------------------------------------------------------------------- $1,932,514 $1,589,929 $1,347,356 - ----------------------------------------------------------------------------------------------
Foreign currency translation relating to our international operations can have a significant impact on our operating results from year to year. Foreign currency translation had a favorable impact on 2003 net sales as compared with 2002 by approximately $71 million due primarily to the strengthening of the 7 Euro against the U.S. dollar. Foreign currency translation had a net favorable impact on 2002 net sales as compared with 2001 by approximately $9 million due primarily to the strengthening of the Euro against the U.S. dollar, offset in part by the weakening of the Brazilian Real against the U.S. dollar. These amounts are not indicative of the net earnings impact of foreign currency translation for 2003 and 2002 due to partially offsetting unfavorable foreign currency translation impacts on cost of sales and operating expenses. Net sales by class of similar products were as follows (in thousands):
2003 2002 2001 ======================================================================================================================== CARDIAC RHYTHM MANAGEMENT Pacemaker systems $ 826,121 $ 751,575 $ 689,223 ICD systems 414,255 303,218 200,511 Electrophysiology catheters 124,836 92,696 76,234 - ------------------------------------------------------------------------------------------------------------------------ 1,365,212 1,147,489 965,968 CARDIAC SURGERY Heart valves 250,840 232,986 240,829 Other cardiac surgery products 20,093 17,971 7,216 - ------------------------------------------------------------------------------------------------------------------------ 270,933 250,957 248,045 CARDIOLOGY AND VASCULAR ACCESS Vascular closure devices 218,215 156,474 101,591 Other cardiology and vascular access products 78,154 35,009 31,752 - ------------------------------------------------------------------------------------------------------------------------ 296,369 191,483 133,343 - ------------------------------------------------------------------------------------------------------------------------ $1,932,514 $1,589,929 $1,347,356 ========================================================================================================================
2003 NET SALES COMPARED TO 2002 In cardiac rhythm management, net sales of pacemaker systems increased 9.9% in 2003 due to an increase in pacemaker unit sales of approximately 5% from 2002, approximately $33 million of favorable impact from foreign currency translation and $29 million of favorable impact from the Getz acquisitions. Pacemaker net sales in 2003 benefited from the worldwide launches of our Identity(R) ADx, Integrity(R) ADx and Verity(TM) ADx pacemaker product families. These increases were offset in part by average selling price declines of approximately 3%. Net sales of ICD systems increased 36.6% in 2003 due to growth in ICD unit sales of approximately 39%, offset in part by average selling price declines of approximately 6%. ICD net sales in 2003 benefited from the worldwide launch in mid-2003 of our Epic(TM)+ DR ICD containing AF Suppression(TM) technology. Net sales of ICD systems in 2003 also included approximately $12 million of favorable impact from foreign currency translation. Electrophysiology catheter net sales increased 34.7% in 2003 due primarily to a 9% increase in unit sales, $18 million of favorable impact from the Getz acquisitions and approximately $4 million of favorable impact from foreign currency translation. In cardiac surgery, heart valve net sales increased 7.7% in 2003 due primarily to approximately $12 million of favorable impact from foreign currency translation and $10 million of favorable impact from the Getz acquisitions. These increases were partially offset by a global average selling price decline of approximately 4% due to a larger portion of our sales mix coming from lower-priced international markets. Net sales of other cardiac surgery products increased 11.8% in 2003 due primarily to $13 million of favorable impact from the Getz acquisitions, offset in part by a 60% decrease in aortic connector unit sales. 8 In cardiology and vascular access, net sales of vascular closure devices increased 39.5% in 2003 due to an increase of 37% in Angio-Seal(TM) unit sales and approximately $8 million of favorable impact from foreign currency translation. These increases were partially offset by a global average selling price decline of approximately 3% due to a larger portion of our sales mix coming from lower-priced international markets. Net sales in 2003 benefited from the global launch of our fifth-generation Angio-Seal(TM) vascular closure product, the STS Plus, in the third quarter. Net sales of other cardiology and vascular access products increased 123.2% in 2003 due primarily to $36 million of sales of non-St. Jude Medical manufactured products distributed in Japan by Getz, a 19% increase in unit sales and approximately $2 million of favorable impact from foreign currency translation. 2002 NET SALES COMPARED TO 2001 In cardiac rhythm management, net sales of pacemaker systems increased 9.0% in 2002 due primarily to an increase in unit sales of 9%, attributable to the ongoing success of our Identity(R) family of pacemakers and other devices that incorporate BEAT-BY-BEAT AutoCapture(TM) and AF Suppression(TM) technology. Foreign currency translation had a favorable impact on 2002 net sales of pacemakers of approximately $3.5 million. Net sales of ICD systems increased 51.2% in 2002 due primarily to increased ICD unit sales of 48% and approximately $2 million of favorable impact from foreign currency translation. Our ICD net sales benefited from the ongoing success of the Atlas(R) ICD, the new Epic(TM) ICD that was launched worldwide in the fourth quarter of 2002 and the Riata(R) family of ICD leads. EP catheter net sales increased 21.6% in 2002 due primarily to increased unit sales. In cardiac surgery, heart valve net sales decreased 3.3% in 2002 due primarily to an ongoing clinical preference shift from mechanical valves to tissue valves in the U.S. market, where we hold significant mechanical valve market share and a smaller share of the tissue valve market. Heart valve net sales were favorably impacted in 2002 by approximately $1.5 million due to foreign currency translation. Net sales of other cardiac surgery products increased 149% in 2002 due primarily to an increase in aortic connector sales as a result of the ongoing rollout of this product in the U.S. market. In cardiology and vascular access, net sales of vascular sealing devices increased 54.0% in 2002 due primarily to increased Angio-Seal(TM) unit sales of approximately 50%. Net sales in 2002 benefited from the worldwide launch in early 2002 of our newest vascular closure device platform, the Angio-Seal(TM) STS. Net sales of other cardiology and vascular access products increased 10.3% in 2002 due primarily to an increase in unit sales. GROSS PROFIT Gross profits were as follows (in thousands):
2003 2002 2001 - ---------------------------------------------------------------------------------------- Gross profit $1,329,423 $1,083,983 $888,197 Percentage of net sales 68.8% 68.2% 65.9% - ----------------------------------------------------------------------------------------
Our 2003 gross profit percentage increased 0.6 percentage points over 2002 despite a 1.6 percentage point reduction as a result of our Getz Japan acquisition. The increase in our gross profit percentage during 2003 is primarily a result of reduced material costs and increased labor efficiencies due to continued improvements in our CRM manufacturing processes, and to lower overhead costs per unit as a result of higher CRM production volumes. In addition, our ongoing cost management efforts helped to improve our gross profit percentage. 9 On April 1, 2003, we valued the Getz Japan-owned inventory of pacemaker systems and heart valves at fair value in accordance with acquisition accounting rules. This fair value was established as the price at which we had sold the inventory to Getz. As these inventory items were sold subsequent to April 1, 2003, our gross profit percentage was reduced since the gross profit recognized by Getz Japan was less than our historical gross profit related to the sale of these items to Getz Japan as our distributor. Once the original Getz Japan-owned inventory is sold, our gross profit percentage will improve. In 2004, we anticipate that our gross profit percentage will increase to a range of 70.5% to 71.5% due primarily to completing the sale of the remaining original Getz-owned inventory and to additional anticipated cost savings in our CRM operations. Our 2002 gross profit percentage increased 2.3 percentage points over 2001 due primarily to the $21.7 million of inventory write-downs and equipment write-offs in 2001 which did not recur in 2002 (see further details under SPECIAL CHARGES). The remaining 0.7 percentage point improvement in gross profit percentage is due primarily to reduced material costs and increased labor efficiencies as a result of improvements in our CRM manufacturing processes, lower overhead costs per unit as a result of higher CRM production volumes and to ongoing cost management efforts. OPERATING EXPENSES Certain operating expenses were as follows (in thousands):
2003 2002 2001 ============================================================================================= Selling, general and administrative $632,395 $513,691 $467,113 Percentage of net sales 32.7% 32.3% 34.7% Research and development $241,083 $200,337 $164,101 Percentage of net sales 12.5% 12.6% 12.2% =============================================================================================
SELLING, GENERAL AND ADMINISTRATIVE (SG&A) EXPENSE: SG&A expense as a percentage of net sales increased 0.4 percentage points in 2003. This increase is due primarily to the addition of the Getz direct sales organization beginning April 1, 2003, which included approximately 400 sales, sales support and marketing personnel. In addition, we incurred increased selling and marketing expenses in 2003 in anticipation of our entry into the CRT segments of the U.S. pacemaker and ICD markets in 2004. These headcount increases in our worldwide selling organizations were offset, in part, by the effects of spreading certain relatively fixed elements of our selling and administrative costs over a revenue base that grew 22% in 2003. We anticipate that SG&A expense as a percentage of net sales will increase to a range of 33.5% to 34.0% in 2004 as a result of increased spending in our sales and marketing areas in support of our anticipated 2004 launch of our CRT products in the United States and the Getz results in our income statement for the full year in 2004 versus nine months in 2003. SG&A expense as a percentage of net sales decreased by 2.4 percentage points in 2002. Approximately $28 million, or 1.8 percentage points of the decrease in SG&A expense as a percentage of net sales, resulted from the elimination of goodwill amortization expense in 2002 as a result of our adoption of SFAS No. 142, "GOODWILL AND OTHER INTANGIBLE ASSETS," effective January 1, 2002. The remaining SG&A improvement as a percentage of net sales represented the effects of spreading certain relatively fixed elements of our selling and administrative costs over a revenue base that grew 18% in 2002. During the second quarter of 2002, we received a cash payment of $18.5 million relating to the settlement of 10 certain patent litigation, which was recorded as a reduction of SG&A expense. Also during the second quarter of 2002, we recorded in SG&A an $11 million charge to increase the reserve for expenses related to the Silzone(R) recall (see SPECIAL CHARGES) and a $7.5 million discretionary contribution to our charitable foundation, the St. Jude Medical Foundation. During the fourth quarter of 2001, we reversed through SG&A expense a $15 million accrued liability relating to royalties on a license agreement with Guidant that we believed we had acquired as part of our purchase of assets of the Telectronics cardiac stimulation device business. This accrual reversal was necessary as a result of various legal conclusions in the Guidant litigation, including the judge's rulings in February 2002 (see Note 5 to our Consolidated Financial Statements), when it was determined that we would never have to pay any royalties under the license. In addition, during this same quarter we expensed approximately $15 million of legal fees incurred in relation to the Guidant litigation that were subject to recoverability under an indemnification agreement between us and the seller of the Telectronics cardiac stimulation device business. This write-off occurred as a result of the same legal conclusions referred to above, when it was determined that our realization of the indemnity receivable was impaired. RESEARCH AND DEVELOPMENT (R&D) EXPENSE: R&D expense increased in 2003 and 2002 due primarily to our increased spending on the development of new products and related clinical trials, including our CRT devices and other products to treat emerging indications including atrial fibrillation. PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT CHARGES: In September 1999, we recorded purchased in-process research and development charges of $67.5 million in connection with our acquisition of Vascular Science, Inc. (VSI). The purchased in-process research and development charges were computed by an independent third-party appraisal company and were expensed at the close of the acquisition, except as noted below, since technological feasibility had not been established and since there were no alternative future uses for the technology. To date, we have capitalized $.6 million of intangible assets related to the VSI acquisition. The total appraised value of the VSI purchased in-process research and development was $95.5 million, of which $67.5 million was recorded at the close of the acquisition. We paid additional contingent consideration of $10 million in 2001 and $5 million in 2000 as certain regulatory approvals for the proximal and distal connector technologies were obtained. These additional payments were also expensed as purchased in-process research and development at the time of payment. The remaining balance of the purchased in-process research and development valuation ($13 million) will be recorded in our financial statements as purchased in-process research and development expense when payment of the contingent consideration is assured beyond a reasonable doubt. Contingent consideration payments in excess of the $13 million will be capitalized as goodwill. Since 1999, we have continued to develop certain of the in-process technologies acquired in the VSI acquisition. Development of the proximal connector was completed and regulatory approvals and E.U. and U.S. market releases occurred in 2000 and 2001. A second VSI in-process technology, the distal connector, received E.U. regulatory approval in 2001; however, we decided to not release the product to the market until we were able to make additional enhancements. The other in-process technologies acquired in the VSI acquisition continue to be reviewed for ultimate viability in the developing coronary artery bypass graft anastomoses market. 11 At the date of the VSI acquisition, the total estimated costs necessary to complete the proximal and distal connector technologies into commercially viable products and to make certain subsequent product enhancements were approximately $1 million, all of which were scheduled to be incurred in 1999 and 2000. Through December 2003, we have incurred approximately $10 million to complete the proximal connector and the distal connector. The original estimated costs to complete the other in-process technologies into commercially viable products were approximately $6 million, of which only an immaterial amount has been incurred to date. During 2003, our proximal and distal connector products did not continue to develop as they did during 2001 and 2002 nor as we had originally anticipated in September 1999. Product sales declined 54% to $8.2 million during 2003 after increasing 149% to $18.0 million in 2002. We believe that additional investments in research and development and clinical studies to support these products will be required. There can be no assurance that the VSI technologies will achieve the technological or commercial success which we originally anticipated in September 1999. The VSI purchase agreement requires us to make additional payments to the former VSI shareholders upon the achievement of certain regulatory milestones and minimum sales levels. To date, we have paid $15 million related to the achievement of three regulatory milestones. Achievement of the final regulatory milestone, U.S. regulatory approval of the distal connector, requires an additional $5 million payment. This contractual commitment continues indefinitely. The contingent consideration tied to sales requires us to make additional payments totaling 5% of sales once cumulative sales exceed $50 million for the proximal and distal connectors collectively. There is no maximum amount of contingent consideration that could be paid related to sales. This contractual commitment ceases in 2009 if the minimum sales threshold is not attained prior to such date. If the minimum sales threshold is met prior to 2009, the commitment will extend for 10 years from the date the minimum sales threshold is met. Cumulative proximal and distal connector sales totaled $33 million through December 31, 2003. There can be no assurance that we will be able to complete the development of these technologies into commercially viable products. Additionally, we are not able to reasonably predict the level of proximal or distal connector sales over a period of time which could extend beyond the next 10 years. As a result of these factors, we are not able to predict the amount of additional contingent consideration, if any, that may become due. However, we believe that any amounts which may ultimately become due in the next 5 years will not be material to our results of operations, financial position or liquidity. SPECIAL CHARGES: During the first half of 2001, we undertook a review of the organizational structure of our sales operations and our heart valve operations. At that time, the structure our sales organization included four separate sales groups. Additionally, the cardiac surgery markets were experiencing a shift in clinical preference away from mechanical heart valves in favor of tissue heart valves and repair product for certain patients. These changes had the potential to impact the future performance of our heart valve operations. As a result of these reviews, in July 2001 we approved two restructuring plans. The first plan included a restructuring of our sales organizations into two geographically oriented groups (one group focused on the United States and one group focused on locations outside the United States) and changes within each of these new organizations to harmonize their operations within each of their geographies. 12 The second plan included the elimination of excess capacity in our heart valve operations workforce, facilities and equipment and the discontinuance of certain heart valve product lines. As a result of these restructuring plans, we recorded pre-tax charges totaling $20.7 million in the third quarter of 2001 consisting of inventory write-downs ($9.5 million), capital equipment write-offs ($3.4 million), employee termination costs ($5.3 million) and lease termination and other exit costs ($2.5 million). Inventory write-downs represented the estimated net carrying value of various inventory items that would be scrapped in connection with the decision to terminate two heart valve product lines. Capital equipment write-offs were a result of the elimination of certain excess capacity in our heart valve operations. Employee termination costs related to the severance costs for approximately 90 individuals whose positions were eliminated. Lease termination and other exit costs included office closings for international locations, contractual obligations under certain programs that were cancelled and lease termination costs. A summary of the employee termination costs and lease termination and other exit costs activity is as follows (in thousands):
LEASE EMPLOYEE TERMINATION TERMINATION AND OTHER COSTS EXIT COSTS TOTAL =========================================================================================================== Initial expense and accrual in 2001 $ 5,293 $ 2,495 $ 7,788 Cash payments (2,468) (352) (2,820) - ----------------------------------------------------------------------------------------------------------- Balance at December 31, 2001 2,825 2,143 4,968 Cash payments (1,676) (1,970) (3,646) Changes in estimates (639) (53) (692) - ----------------------------------------------------------------------------------------------------------- Balance at December 31, 2002 510 120 630 Cash payments (510) (120) (630) - ----------------------------------------------------------------------------------------------------------- Balance at December 31, 2003 $ - $ - $ - ===========================================================================================================
In addition to the above restructuring activities, we identified a trend early in the third quarter of 2001 related to the usage of certain diagnostic equipment, also referred to as programmers. We noted that customer acceptance of our new programmer, which received FDA regulatory approval in late December 2000 and was subsequently launched during the first and second quarters of 2001, significantly exceeded our expectations, necessitating a special analysis of the recoverability of the older programmers that were not yet fully depreciated. After a review of the situation, we approved a plan to abandon certain older programmer models during the third quarter of 2001. As a result of this plan, we wrote off the remaining net book value of the abandoned programmers ($12.2 million) to cost of sales. The charges relating to employee termination costs, capital equipment write-offs and other costs ($11.2 million) were recorded in operating expenses as special charges. The inventory and diagnostic equipment write-offs ($21.7 million) were included in cost of sales as special charges. On January 21, 2000, we initiated a worldwide voluntary recall of all field inventory of heart valve replacement and repair products incorporating Silzone(R) coating on the sewing cuff fabric. We 13 concluded that we would no longer utilize Silzone(R) coating. As a result of the voluntary recall and product discontinuance, we recorded a special charge totaling $26.1 million during the first quarter of 2000. The $26.1 million special charge consisted of asset write-downs ($9.5 million), legal and patient monitoring costs ($14.4 million) and customer returns and related costs ($2.2 million). The $9.5 million of asset write-downs related to inventory write-offs associated with the physical scrapping of inventory with Silzone(R) coating ($8.6 million), and to the write-off of a prepaid license asset and related costs associated with the Silzone(R) coating technology ($0.9 million). The $14.4 million of legal and patient monitoring costs related to our product liability insurance deductible ($3.5 million) and patient monitoring costs ($10.9 million) related to contractual and future monitoring activities directly related to the product recall and discontinuance. The $2.2 million of customer returns and related costs represented costs associated with the return of customer-owned Silzone(R) inventory. In the second quarter of 2002, we determined that the Silzone(R) reserves should be increased by $11 million as a result of difficulties in obtaining certain reimbursements from our insurance carriers under our product liability insurance policies ($4.6 million), an increase in our estimate of the costs associated with future patient monitoring costs as a result of extending the time period in which we planned to perform patient monitoring activities ($5.8 million) and an increase in other related costs ($0.6 million). This additional accrual was included in selling, general and administrative expense during the second quarter ended June 30, 2002. Our product liability insurance coverage for Silzone(R) claims consists of a number of policies with different carriers. During 2002, we observed a trend where various insurance companies were not reimbursing us or outside legal counsel for a variety of costs incurred, which we believed should be paid under the product liability insurance policies. These insurance companies were either refusing to pay the claims or had delayed providing an explanation for non-payment for an extended period of time. Although we believe we have legal recourse from these insurance carriers for the costs they are refusing to pay, the additional costs we would need to incur to resolve these disputes may exceed the amount we would recover. As a result of these developments, we increased the Silzone(R) reserves by $4.6 million in the second quarter of 2002, which represents the existing disputed costs already incurred at that time plus the anticipated future costs where we expect similar resistance from the insurance companies on reimbursement. During the fourth quarter of 2003, we reclassified $15.7 million of existing accruals to the Silzone(R) special charge accrual from other current assets. This amount related to probable future legal costs associated with the Silzone(R) litigation. Previously, these accruals were offset against a receivable from our insurance carriers. A summary of the legal and monitoring costs and customer returns and related costs activity is as follows (in thousands): 14
LEGAL AND CUSTOMER MONITORING RETURNS AND COSTS RELATED COSTS TOTAL =========================================================================================================== Initial expense and accrual in 2000 $ 14,397 $ 2,239 $ 16,636 Cash payments (5,955) (2,239) (8,194) - ----------------------------------------------------------------------------------------------------------- Balance at December 31, 2000 8,442 - 8,442 Cash payments (3,042) - (3,042) - ----------------------------------------------------------------------------------------------------------- Balance at December 31, 2001 5,400 - 5,400 Additional expense 10,433 567 11,000 Cash payments (2,442) (59) (2,501) - ----------------------------------------------------------------------------------------------------------- Balance at December 31, 2002 13,391 508 13,899 Cash payments (1,206) (22) (1,228) Reclassification of legal accruals 15,721 - 15,721 - ----------------------------------------------------------------------------------------------------------- Balance at December 31, 2003 $ 27,906 $ 486 $ 28,392 - -----------------------------------------------------------------------------------------------------------
In addition to the amounts available under the above Silzone(R) reserves, we have approximately $170 million remaining in product liability insurance currently available for the Silzone(R)-related matters. See discussion of Kemper under CRITICAL ACCOUNTING POLICIES AND ESTIMATES - SILZONE(R) SPECIAL CHARGE ACCRUALS. OTHER INCOME (EXPENSE) Other income (expense) consists of the following (in thousands):
2003 2002 2001 ========================================================================================== Interest income $ 7,031 $ 5,481 $ 3,261 Interest expense (3,746) (1,754) (12,567) Other (593) (324) 1,468 - ------------------------------------------------------------------------------------------ Other income (expense) $ 2,692 $ 3,403 $ (7,838) - ------------------------------------------------------------------------------------------
The decrease in other income (expense) during 2003 as compared with 2002 was due primarily to higher levels of interest expense as a result of borrowings for our Getz Japan acquisition in 2003 and our August 2003 share repurchase, offset in part by higher levels of interest income as a result of higher average invested cash balances. The change in other income (expense) during 2002 as compared with 2001 was due primarily to reduced interest expense as a result of lower debt levels, lower interest rates on our borrowings in 2002 and higher levels of interest income as a result of the increase in cash and equivalents in 2002. INCOME TAXES Our reported effective income tax rates were 26.0% in 2003 and 2002, and 24.3% in 2001. Excluding the purchased in-process research and development and special charges in 2001, our effective income tax rate was 25.0%. The purchased in-process research and development charges were not deductible for income tax purposes, and the special charges were recorded in taxing jurisdictions where income tax rates varied from our blended 25.0% effective tax rate. Our higher effective income tax rate in 2003 and 2002 as compared to 2001 was due to a larger percentage of our taxable income being generated in higher tax rate jurisdictions. 15 NET EARNINGS Net earnings were $339.4 million in 2003, a 22.8% increase over 2002, and diluted net earnings per share was $1.83 in 2003, a 21.2% increase over 2002. Net earnings were $276.3 million in 2002, a 36.0% increase over 2001, and diluted net earnings per share was $1.51 in 2002, a 32.5% increase over 2001. The 2001 net earnings included $42.8 million of pre-tax special charges and purchased in-process research and development charges, or $0.17 per diluted share. In August 2003, we repurchased 9.25 million shares, which we funded through existing cash balances and borrowings under a short-term credit facility and commercial paper program. Our share repurchase decreased our weighted average shares outstanding during 2003 by 3.6 million shares. This impact, offset by the foregone interest income and additional interest expense we incurred, resulted in an immaterial increase to our net earnings per share for 2003. STOCK SPLIT On May 16, 2002, our Board of Directors declared a two-for-one stock split in the form of a 100% stock dividend to shareholders of record on June 10, 2002. Net earnings per share, shares outstanding and weighted average shares outstanding have been restated to reflect this stock split. GOVERNMENT REGULATION, COMPETITION AND OTHER CONSIDERATIONS We expect that market demand, government regulation and reimbursement policies, and societal pressures will continue to change the worldwide healthcare industry resulting in further business consolidations and alliances. We participate with industry groups to promote the use of advanced medical device technology in a cost-conscious environment. The global medical technology industry is highly competitive and is characterized by rapid product development and technological change. Our products must continually improve technologically and provide improved clinical outcomes due to the competitive nature of the industry. In addition, competitors have historically employed litigation to gain a competitive advantage. The pacemaker and ICD markets are highly competitive. There are currently three principal suppliers to these markets, including us, and our two principal competitors each have substantially more assets and sales than us. Rapid technological change in these markets is expected to continue, requiring us to invest heavily in R&D and to effectively market our products. Two trends began to emerge in these markets during 2002. The first involved a shift of some traditional pacemaker patients to ICD devices in the United States, and the second involved the increasing use of resynchronization devices in both the U.S. ICD and pacemaker markets. Our competitors in CRM have U.S. regulatory approval to market ICD and pacemaker devices with resynchronization features. We currently have both a cardiac resynchronization ICD and pacemaker product in U.S. clinical studies. We currently anticipate U.S. approval of these products during the second quarter of 2004. If the approvals of these products are delayed or not received, our pacemaker and ICD sales could be adversely affected if the markets continue to shift towards products with cardiac resynchronization capabilities. We have experienced a modest decline in average selling prices for ICDs in the U.S. market during 2003, which will likely continue until we obtain U.S. approval of our cardiac resynchronization ICD. The cardiac surgery markets, which include mechanical heart valves, tissue heart valves and valve repair products, are also highly competitive. Since 1999, cardiac surgery therapies have shifted to tissue valves and repair products from mechanical heart valves, resulting in an overall market share loss for us. Competition is anticipated to continue to place pressure on pricing and terms, including a trend 16 toward vendor-owned (consignment) inventory at the hospitals. Also, healthcare reform is expected to result in further hospital consolidations over time with related pressure on pricing and terms. The cardiology and vascular access therapy area is also growing and has numerous competitors. Over 70% of our sales in this area are comprised of vascular closure devices. The market for vascular closure devices is highly competitive, and there are several companies, in addition to St. Jude Medical, that manufacture and market these products worldwide. Additionally, we anticipate other large companies will enter this market in the coming years, which will likely increase competition. Group purchasing organizations (GPOs) and independent delivery networks (IDNs) in the United States continue to consolidate purchasing decisions for some of our hospital customers. We have contracts in place with many of these organizations. In some circumstances, our inability to obtain a contract with a GPO or IDN could adversely affect our efforts to sell our products to that organization's hospitals. MARKET RISK We are exposed to foreign currency exchange rate fluctuations due to transactions denominated primarily in Euros, Japanese Yen, Canadian Dollars, Brazilian Reals, British Pounds, and Swedish Kronor. Although we elected not to enter into any hedging contracts during 2003, 2002 or 2001, historically we have, from time to time, hedged a portion of our foreign currency exchange rate risk through the use of forward exchange or option contracts. The gains or losses on these contracts are intended to offset changes in the fair value of the anticipated foreign currency transactions. We do not enter into contracts for trading or speculative purposes. We continue to evaluate our foreign currency exchange rate risk and the different mechanisms for use in managing such risk. We had no forward exchange or option contracts outstanding at December 31, 2003 or 2002. A hypothetical 10% change in the value of the U.S. dollar in relation to our most significant foreign currency exposures would have had an impact of approximately $55 million on our 2003 net sales. This amount is not indicative of the hypothetical net earnings impact due to partially offsetting impacts on cost of sales and operating expenses. With our acquisition of Getz Japan during 2003, we significantly increased our exposure to foreign currency exchange rate fluctuations due to transactions denominated in Japanese Yen. We elected to naturally hedge a portion of our Yen-based net asset exposure by issuing 1.02%Yen-based 7-year notes, the proceeds of which were used to repay the short-term bank debt that we used to fund a portion of the Getz Japan purchase price. Excess cash flows from our Getz Japan operations will be used to fund principal and interest payments on the Yen-based borrowings. We have not entered into any Yen-based hedging contracts to mitigate any remaining foreign currency exchange rate risk. We are exposed to interest rate risk on our short-term, Yen-based bank credit agreement which has a variable interest rate tied to the floating Yen London InterBank Offered Rate (LIBOR). In the United States, we issue short-term, unsecured commercial paper that bears interest at varying market rates. We also have two committed credit facilities that have variable interest rates tied to the LIBOR. Our variable interest rate borrowings had a notional value of $169.5 million at December 31, 2003. A hypothetical 10% change in interest rates assuming the current level of borrowings would have had an impact of approximately $0.2 million on our 2003 interest expense, which is not material to our consolidated results of operations. We are exposed to fair value risk on our 1.02% Yen-based fixed-rate notes. A hypothetical 10% change in interest rates would have an impact of approximately $1.3 million on the fair value of these notes, which is not material to our financial position or consolidated results of operations. 17 We are also exposed to equity market risk on our marketable equity security investments. We periodically invest in marketable equity securities of emerging technology companies. Our investments in these companies had a fair value of $23.7 million and $13.7 million at December 31, 2003 and 2002, which are subject to the underlying price risk of the public equity markets. NEW ACCOUNTING PRONOUNCEMENTS In January 2003, the Financial Accounting Standards Board (FASB) issued FASB Interpretation No. 46, "CONSOLIDATION OF VARIABLE INTEREST ENTITIES" (FIN 46). FIN 46 requires the consolidation of variable interest entities in which an enterprise absorbs a majority of the entity's expected losses, receives a majority of the entity's expected residual returns, or both, as a result of ownership, contractual or other financial interests in the entity. FIN 46 is effective for the first quarter of 2004. We do not expect our adoption of FIN 46 to have an impact on our consolidated results of operations, financial position or cash flows. In May 2003, the FASB issued SFAS No. 150, "ACCOUNTING FOR CERTAIN FINANCIAL INSTRUMENTS WITH CHARACTERISTICS OF BOTH LIABILITIES AND EQUITY" (Statement 150). Statement 150 establishes standards for issuer classification and measurement of certain financial instruments with characteristics of both liabilities and equity. In accordance with this standard, financial instruments that embody obligations for the issuer are required to be classified as liabilities. Statement 150 is effective for all financial instruments entered into or modified after May 31, 2003, and is otherwise effective at the beginning of the first interim period beginning after June 15, 2003. Our adoption of Statement 150 did not have an impact on our consolidated results of operations, financial position or cash flows. Emerging Issues Task Force (EITF) Issue No. 00-21, "ACCOUNTING FOR REVENUE ARRANGEMENTS WITH MULTIPLE DELIVERABLES," addresses certain aspects of the accounting by a vendor for arrangements under which multiple revenue-generating activities are performed. EITF Issue No. 00-21 establishes three principles: revenue arrangements with multiple deliverables should be divided into separate units of accounting; arrangement consideration should be allocated among the separate units of accounting based on their relative fair values; and revenue recognition criteria should be considered separately for separate units of accounting. EITF Issue No. 00-21 was effective for all revenue arrangements entered into in fiscal periods beginning after June 15, 2003. Our adoption of EITF Issue No. 00-21 did not have an impact on our consolidated results of operations, financial position or cash flows. In December 2003, the Securities and Exchange Commission released Staff Accounting Bulletin No. 104, "REVENUE RECOGNITION" (SAB 104). SAB 104 clarifies existing guidance regarding revenue recognition. Our adoption of SAB 104 did not have a material impact on our consolidated results of operation, financial position or cash flows. FINANCIAL CONDITION LIQUIDITY AND CAPITAL RESOURCES Our liquidity and cash flows remained strong during 2003. Cash provided by operating activities was $474.3 million for 2003, up $57.1 million from 2002 due primarily to increased earnings and an increase in the tax benefit realized from the exercise of employee stock options. Offsetting these improvements was an increase in our finished goods inventory levels as a result of fourth quarter 2003 new product launches. Cash provided by operating activities was $417.2 million in 2002, up $107.1 million from 2001 due primarily to increased earnings and to a reduction of our inventory levels during 2002. Our inventory, expressed as the number of days of cost of sales on hand (DIOH), declined from 18 199 days at the end of 2001 to 160 days at the end of 2002 due mostly to more focused inventory management across our business. At December 31, 2003, substantially all of our cash and equivalents were held by our non-U.S. subsidiaries. These funds are available for use by our U.S. operations; however, assuming we accomplished a repatriation under current law by paying a dividend, the amount paid would be subject to additional U.S. taxes upon repatriation which could total as much as 33% of the amount repatriated. On April 1, 2003, we borrowed 24.6 billion Japanese Yen, or approximately $208 million, under a short-term, unsecured bank credit agreement to partially finance the Getz Japan acquisition. These borrowings bore interest at an average rate of 0.58% per annum and were repaid in May 2003. In May 2003, we issued 7-year, 1.02% unsecured notes totaling 20.9 billion Yen, or $194.4 million at December 31, 2003. We also obtained a short-term, unsecured bank credit agreement which provides for borrowings of up to 3.8 billion Yen. Proceeds from the issuance of the 7-year notes and from borrowings under the short-term, bank credit agreement were used to repay the 24.6 billion Yen of short-term bank borrowings. Outstanding borrowings under our short-term bank credit agreement were approximately 1.3 billion Yen, or $12.1 million, at December 31, 2003. Borrowings under the short-term, bank credit agreement bear interest at the floating Yen LIBOR plus 0.50% per annum (effective rate of 0.54% at December 31, 2003) and are due in May 2004. On July 22, 2003, the Board of Directors authorized a share repurchase program of up to $500 million of our outstanding common stock and the establishment of a $500 million credit facility. The share repurchases could be made at the direction of management through transactions in the open market and/or privately negotiated transactions, including the use of options, futures, swaps and accelerated share repurchase contracts. On August 7, 2003, we repurchased approximately 9.25 million shares, or about five percent of our outstanding common stock, for $500 million under a privately-negotiated transaction with an investment bank. The investment bank borrowed the 9.25 million shares to complete the transaction and purchased replacement shares in the open market over a three month period which ended November 7, 2003. We entered into a related accelerated stock buyback contract with the same investment bank which, in return for a separate payment to the investment bank, included a price-protection feature. The price-protection feature provided that if the investment bank's per share purchase price of the replacement shares was lower than the initial share purchase price for the 9.25 million shares ($54.06), then the investment bank would, at our election, make a payment or deliver additional shares to us in the amount of the difference between the initial share purchase price and their replacement price, subject to a maximum amount. In addition, the price-protection feature provided that if the investment bank's replacement price was greater than the initial share purchase price, we would not be required to make any further payments. On November 7, 2003, the investment bank completed its purchase of replacement shares. The market price of our shares during this replacement period exceeded the initial purchase price, resulting in no additional exchange of consideration. In July 2003, we obtained a $400 million short-term revolving credit facility to partially fund our $500 million share repurchase in August 2003. Borrowings under this facility bore interest at an average rate of 1.73% per annum and were repaid in September 2003. In September 2003, we obtained a $150 million unsecured, revolving credit facility that expires in September 2004 and a $350 million unsecured, revolving credit facility that expires in September 2008. These credit facilities bear interest at the LIBOR plus 0.625% and 0.60% per annum, respectively, subject to adjustment in the event of a 19 change in our debt ratings. There were no outstanding borrowings under these credit facilities at December 31, 2003. During September 2003, we began issuing short-term, unsecured commercial paper with maturities up to 270 days. Outstanding commercial paper borrowings totaled $157.4 million at December 31, 2003. These commercial paper borrowings bear interest at varying market rates (effective rate of 1.2% at December 31, 2003). The debt that we incurred to partially fund our $500 million share repurchase reflected our decision to increase the debt component of our current capitalization. Our decision was influenced by a number of factors, including the relatively low interest rates on our borrowings, the relatively low interest rates that we were earning on our excess cash investments, the outlook for our cash flows from operations for the next 1 to 2 years and the adequacy of those cash flows to repay the debt and continue to fund our operations and investments in growth opportunities while maintaining our investment grade status with the debt rating agencies. We classify all of our commercial paper borrowings as long-term on the balance sheet as we have the ability to repay any short-term maturity with available cash from our existing long-term, committed credit facility. We continually review our cash flow projections and may from time to time repay a portion of the borrowings. In May 2003, we made a $15 million minority investment in Epicor, a development stage company focused on developing products which use high intensity focused ultrasound (HIFU) to ablate cardiac tissue. This investment is accounted for under the cost method and is included in other long-term assets on the balance sheet. In conjunction with this investment, we also agreed to acquire the remaining ownership of Epicor in 2004 for an additional $185 million in cash if Epicor receives approval from the FDA by June 30, 2004 to begin marketing its device for general cardiac tissue ablation and if Epicor achieves certain success criteria, as defined in the purchase agreement, in connection with its European clinical study. In addition, we have an option to purchase the remaining ownership of Epicor for $185 million even if FDA approval is not received and the success criteria are not achieved. This option to purchase Epicor expires on June 30, 2004. Our 7-year notes, short-term bank credit agreement and revolving credit facilities contain various operating and financial covenants (see Note 4 to our Consolidated Financial Statements). We were in compliance with all of our debt covenants at December 31, 2003. We believe that these covenants will not have a material impact on our ability to borrow in the future. We believe that our existing cash balances, borrowings under our committed credit facilities and future cash generated from operations will be sufficient to meet our working capital and capital investment needs over the next twelve months and in the foreseeable future thereafter. Should suitable investment opportunities arise, we believe that our earnings, cash flows and balance sheet position will permit us to obtain additional debt financing or equity capital, if necessary. OFF-BALANCE SHEET ARRANGEMENTS We have no off-balance sheet financing arrangements other than operating leases for various facilities and equipment as noted below in the table of contractual obligations and other commitments. CONTRACTUAL OBLIGATIONS AND OTHER COMMITMENTS Presented below is a summary of our contractual obligations and other commitments as of December 31, 2003 (in thousands). See Note 4 to our Consolidated Financial Statements for additional 20 information regarding short-term and long-term debt, and Note 5 for additional information regarding operating leases and contingent acquisitions.
PAYMENTS DUE BY PERIOD -------------------------------------------------------------------------- Less than 1-3 4-5 After 5 Total 1 Year Years Years Years ===================================================================================================================== Short-term bank credit agreement $ 12,115 $ 12,115 $ - $ - $ - Long-term debt (1) 351,813 - - 157,400 194,413 Operating leases (2) 108,040 16,349 29,732 24,950 37,009 Purchase commitments (2)(3) 209,583 132,064 40,919 36,600 - Contingent acquisitions (2)(4) 255,230 209,589 26,851 16,090 2,700 - --------------------------------------------------------------------------------------------------------------------- Total $936,781 $ 370,117 $97,502 $ 235,040 $234,122 =====================================================================================================================
(1) LONG-TERM DEBT INCLUDES $194.4 MILLION OF LONG-TERM NOTES DUE IN MAY 2010 AND $157.4 MILLION OF COMMERCIAL PAPER BORROWINGS THAT ARE BACKED BY OUR COMMITTED CREDIT FACILITY THAT EXPIRES IN SEPTEMBER 2008. WE MAY REPAY THE COMMERICAL PAPER BORROWINGS PRIOR TO THE EXPIRATION OF OUR LONG-TERM COMMITTED CREDIT FACILITY. (2) IN ACCORDANCE WITH ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN THE UNITED STATES, THESE OBLIGATIONS ARE NOT RECORDED IN THE CONSOLIDATED BALANCE SHEET. (3) THESE AMOUNTS INCLUDE COMMITMENTS FOR INVENTORY PURCHASES AND CAPITAL EXPENDITURES THAT DO NOT EXCEED OUR PROJECTED REQUIREMENTS OVER THE RELATED TERMS AND ARE IN THE NORMAL COURSE OF BUSINESS. (4) THESE AMOUNTS INCLUDE A $185 MILLION COMMITMENT TO ACQUIRE THE REMAINING OWNERSHIP OF EPICOR IN 2004 PROVIDED THAT SPECIFIC CLINICAL AND REGULATORY MILESTONES ARE ACHIEVED, AND CONTINGENT COMMITMENTS TO ACQUIRE VARIOUS BUSINESSES INVOLVED IN THE DISTRIBUTION OF OUR PRODUCTS. WHILE IT IS NOT CERTAIN IF AND/OR WHEN THESE PAYMENTS WILL BE MADE, WE HAVE INCLUDED THE PAYMENTS IN THE TABLE BASED ON OUR ESTIMATE OF THE EARLIEST DATE WHEN THE MILESTONES OR CONTINGENCIES MAY BE MET. DIVIDENDS We did not declare or pay any cash dividends during 2003, 2002 or 2001. We currently intend to utilize our earnings for operating and investment purposes. CAUTIONARY STATEMENTS In this discussion and in other written or oral statements made from time to time, we have included and may include statements that may constitute "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not historical facts but instead represent our belief regarding future events, many of which, by their nature, are inherently uncertain and beyond our control. These statements relate to our future plans and objectives, among other things. By identifying these statements for you in this manner, we are alerting you to the possibility that its actual results may differ, possibly materially, from the results indicated by these forward-looking statements. We undertake no obligation to update any forward-looking statements. Various factors contained in the previous discussion and those described below may affect our operations and results. We believe the most significant factors that could affect our future operations 21 and results are set forth in the list below. Since it is not possible to foresee all such factors, you should not consider these factors to be a complete list of all risks or uncertainties. 1. Legislative or administrative reforms to the U.S. Medicare and Medicaid systems or similar reforms of international reimbursement systems in a manner that significantly reduces reimbursement for procedures using our medical devices or denies coverage for such procedures. Adverse decisions relating to our products by administrators of such systems in coverage or reimbursement issues. 2. Acquisition of key patents by others that have the effect of excluding us from market segments or require us to pay royalties. 3. Economic factors, including inflation, changes in interest rates and changes in foreign currency exchange rates. 4. Product introductions by competitors which have advanced technology, better features or lower pricing. 5. Price increases by suppliers of key components, some of which are sole-sourced. 6. A reduction in the number of procedures using our devices caused by cost-containment pressures or preferences for alternate therapies. 7. Safety, performance or efficacy concerns about our marketed products, many of which are expected to be implanted for many years, leading to recalls and/or advisories with the attendant expenses and declining sales. 8. Changes in laws, regulations or administrative practices affecting government regulation of our products, such as FDA laws and regulations, that increase pre-approval testing requirements for products or impose additional burdens on the manufacture and sale of medical devices. 9. Regulatory actions arising from the concern over Bovine Spongiform Encephalopathy (BSE), sometimes referred to as "mad cow disease", that have the effect of limiting the Company's ability to market products using collagen, such as Angio-SealTM, or that impose added costs on the procurement of collagen. 10. Difficulties obtaining, or the inability to obtain, appropriate levels of product liability insurance. 11. The ability of our Silzone(R) product liability insurers, especially Kemper, to meet their obligations to us. 12. A serious earthquake affecting our facilities in Sunnyvale or Sylmar, California, or a hurricane affecting our operations in Puerto Rico. 13. Healthcare industry consolidation leading to demands for price concessions or the exclusion of some suppliers from significant market segments. 14. Adverse developments in litigation including product liability litigation and patent litigation or other intellectual property litigation including that arising from the Telectronics and Ventritex acquisitions. 15. Enactment of a U.S. law repealing the tax benefit of the extraterritorial income exclusion. 22 REPORT OF MANAGEMENT We are responsible for the preparation, integrity and objectivity of the accompanying financial statements. The financial statements were prepared in accordance with accounting principles generally accepted in the United States and include amounts which reflect management's best estimates based on its informed judgment and consideration given to materiality. We are also responsible for the accuracy of the related data in the annual report and its consistency with the financial statements. In our opinion, our accounting systems and procedures, and related internal controls, provide reasonable assurance that transactions are executed in accordance with management's intention and authorization, that financial statements are prepared in accordance with accounting principles generally accepted in the United States and that assets are properly accounted for and safeguarded. The concept of reasonable assurance is based on the recognition that there are inherent limitations in all systems of internal control and that the cost of such systems should not exceed the benefits to be derived therefrom. We review and modify the system of internal controls to improve its effectiveness. The effectiveness of the controls system is supported by the selection, retention and training of qualified personnel, an organizational structure that provides an appropriate division of responsibility and a strong budgeting system of control. We also recognize our responsibility for fostering a strong ethical climate so that our affairs are conducted according to the highest standards of personal and business conduct. This responsibility is reflected in our Code of Business Conduct. The adequacy of our internal accounting controls, the accounting principles employed in our financial reporting and the scope of independent and internal audits are reviewed by the Audit Committee of the Board of Directors, consisting solely of outside directors. The independent auditors meet with, and have confidential access to, the Audit Committee to discuss the results of their audit work. /s/ TERRY L. SHEPHERD Terry L. Shepherd Chairman and Chief Executive Officer /s/ JOHN C. HEINMILLER John C. Heinmiller Vice President, Finance and Chief Financial Officer 23 REPORT OF INDEPENDENT AUDITORS Board of Directors and Shareholders St. Jude Medical, Inc. We have audited the accompanying consolidated balance sheets of St. Jude Medical, Inc. and subsidiaries as of December 31, 2003 and 2002 and the related consolidated statements of earnings, shareholders' equity, and cash flows for each of the three fiscal years in the period ended December 31, 2003. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of St. Jude Medical, Inc. and subsidiaries at December 31, 2003 and 2002 and the consolidated results of their operations and their cash flows for each of the three fiscal years in the period ended December 31, 2003 in conformity with accounting principles generally accepted in the United States. /s/ ERNST & YOUNG LLP Minneapolis, Minnesota January 26, 2004 24 CONSOLIDATED STATEMENTS OF EARNINGS (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
FISCAL YEAR ENDED DECEMBER 31, 2003 2002 2001 =============================================================================================================================== Net sales $ 1,932,514 $ 1,589,929 $ 1,347,356 Cost of sales: Cost of sales before special charges 603,091 505,946 437,492 Special charges - - 21,667 - ------------------------------------------------------------------------------------------------------------------------------- Total cost of sales 603,091 505,946 459,159 - ------------------------------------------------------------------------------------------------------------------------------- Gross profit 1,329,423 1,083,983 888,197 Selling, general and administrative expense 632,395 513,691 467,113 Research and development expense 241,083 200,337 164,101 Purchased in-process research and development charges - - 10,000 Special charges - - 11,167 - ------------------------------------------------------------------------------------------------------------------------------- Operating profit 455,945 369,955 235,816 Other income (expense) 2,692 3,403 (7,838) - ------------------------------------------------------------------------------------------------------------------------------- Earnings before income taxes 458,637 373,358 227,978 Income tax expense 119,246 97,073 55,386 - ------------------------------------------------------------------------------------------------------------------------------- Net earnings $ 339,391 $ 276,285 $ 172,592 =============================================================================================================================== =============================================================================================================================== NET EARNINGS PER SHARE: Basic $ 1.92 $ 1.56 $ 1.00 Diluted $ 1.83 $ 1.51 $ 0.97 WEIGHTED AVERAGE SHARES OUTSTANDING: Basic 176,956 176,570 172,428 Diluted 185,377 183,002 178,767 ===============================================================================================================================
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS. 25 CONSOLIDATED BALANCE SHEETS (IN THOUSANDS, EXCEPT SHARE AMOUNTS)
DECEMBER 31, 2003 2002 ================================================================================================================ ASSETS Current Assets Cash and equivalents $ 461,253 $ 401,860 Accounts receivable, less allowances for doubtful accounts 501,759 381,246 Inventories 311,761 227,024 Deferred income taxes 112,376 56,857 Other 105,188 47,330 - ---------------------------------------------------------------------------------------------------------------- Total current assets 1,492,337 1,114,317 PROPERTY, PLANT AND EQUIPMENT Land, buildings and improvements 145,405 126,471 Machinery and equipment 431,839 393,726 Diagnostic equipment 173,851 181,117 - ---------------------------------------------------------------------------------------------------------------- Property, plant and equipment at cost 751,095 701,314 Less accumulated depreciation (449,442) (400,833) - ---------------------------------------------------------------------------------------------------------------- Net property, plant and equipment 301,653 300,481 OTHER ASSETS Goodwill 407,013 325,575 Other intangible assets, net 154,404 89,491 Deferred income taxes - 12,269 Other 200,687 109,246 - ---------------------------------------------------------------------------------------------------------------- Total other assets 762,104 536,581 - ---------------------------------------------------------------------------------------------------------------- TOTAL ASSETS $ 2,556,094 $ 1,951,379 ================================================================================================================ LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES Short-term debt $ 12,115 $ - Accounts payable 128,206 108,931 Income taxes payable 72,376 51,380 Accrued expenses Employee compensation and related benefits 190,152 135,705 Other 107,466 78,636 - ---------------------------------------------------------------------------------------------------------------- Total current liabilities 510,315 374,652 LONG-TERM DEBT 351,813 - DEFERRED INCOME TAXES 89,719 - COMMITMENTS AND CONTINGENCIES - - SHAREHOLDERS' EQUITY Preferred stock - - Common stock (173,014,167 and 178,028,129 shares issued and outstanding at December 31, 2003 and 2002, respectively) 17,301 17,803 Additional paid-in capital 35,627 216,878 Retained earnings 1,544,499 1,411,194 Accumulated other comprehensive income (loss): Cumulative translation adjustment (4,246) (73,388) Unrealized gain on available-for-sale securities 11,066 4,240 - ---------------------------------------------------------------------------------------------------------------- Total shareholders' equity 1,604,247 1,576,727 - ---------------------------------------------------------------------------------------------------------------- TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 2,556,094 $ 1,951,379 ================================================================================================================
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS. 26 CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (IN THOUSANDS, EXCEPT SHARE AMOUNTS)
COMMON STOCK ACCUMULATED ------------------------ ADDITIONAL OTHER TOTAL NUMBER OF PAID-IN RETAINED COMPREHENSIVE SHAREHOLDERS' SHARES AMOUNT CAPITAL EARNINGS INCOME (LOSS) EQUITY - ----------------------------------------------------------------------------------------------------------------------------------- BALANCE AT JANUARY 1, 2001 170,672,572 $ 17,067 $ 47,190 $ 962,317 $ (85,725) $ 940,849 Comprehensive income: Net earnings 172,592 172,592 Other comprehensive income (loss): Unrealized gain on investments, net of taxes of $928 1,515 1,515 Foreign currency translation adjustment, net of taxes of $(19,393) (10,401) (10,401) ----------------- Other comprehensive loss (8,886) ----------------- Comprehensive income 163,706 ================= Common stock issued under stock plans and other, net 3,746,140 375 57,566 57,941 Tax benefit from stock plans 21,249 21,249 - ----------------------------------------------------------------------------------------------------------------------------------- BALANCE AT DECEMBER 31, 2001 174,418,712 17,442 126,005 1,134,909 (94,611) 1,183,745 Comprehensive income: Net earnings 276,285 276,285 Other comprehensive income (loss): Unrealized loss on investments, net of taxes of $(3,021) (4,930) (4,930) Foreign currency translation adjustment, net of taxes of $4,291 30,393 30,393 ----------------- Other comprehensive income 25,463 ----------------- Comprehensive income 301,748 ================= Common stock issued under stock plans and other, net 3,609,417 361 65,644 66,005 Tax benefit from stock plans 25,229 25,229 - ----------------------------------------------------------------------------------------------------------------------------------- BALANCE AT DECEMBER 31, 2002 178,028,129 17,803 216,878 1,411,194 (69,148) 1,576,727 Comprehensive income: Net earnings 339,391 339,391 Other comprehensive income (loss): Unrealized gain on investments, net of taxes of $4,183 and reclassification adjustment (see below) 6,826 6,826 Foreign currency translation adjustment, net of taxes of $16,719 69,142 69,142 ----------------- Other comprehensive income 75,968 ----------------- Comprehensive income 415,359 ================= Common stock issued under stock plans and other, net 4,234,583 423 89,279 89,702 Tax benefit from stock plans 42,484 42,484 Common stock repurchased, including related costs (9,248,545) (925) (313,014) (206,086) (520,025) - ----------------------------------------------------------------------------------------------------------------------------------- BALANCE AT DECEMBER 31, 2003 173,014,167 $ 17,301 $ 35,627 $ 1,544,499 $ 6,820 $ 1,604,247 ===================================================================================================================================
Other comprehensive income reclassification adjustments for realized losses on the write-down of marketable securities, net of income taxes, were $620 in 2003. SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS. 27 CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS)
FISCAL YEAR ENDED DECEMBER 31 2003 2002 2001 ============================================================================================================================== OPERATING ACTIVITIES Net earnings $339,391 $276,285 $ 172,592 Adjustments to reconcile net earnings to net cash from operating activities: Depreciation 64,695 67,224 58,404 Amortization 11,988 7,696 31,895 Purchased in-process research and development charges - - 10,000 Special charges - - 32,834 Deferred income taxes 33,146 37,695 (11,681) Changes in operating assets and liabilities, net of business acquisitions: Accounts receivable (31,315) (39,146) (23,941) Inventories (17,388) 15,784 (32,373) Other current assets (40,273) (8,719) 13,605 Accounts payable and accrued expenses 52,714 48,376 12,907 Income taxes payable 61,327 12,005 45,893 - ------------------------------------------------------------------------------------------------------------------------------ NET CASH PROVIDED BY OPERATING ACTIVITIES 474,285 417,200 310,135 INVESTING ACTIVITIES Purchase of property, plant and equipment (49,565) (62,176) (63,129) Proceeds from sale or maturity of marketable securities - 7,000 15,000 Business acquisition payments, net of cash acquired (230,839) (29,500) (20,444) Minority investment in Epicor Medical, Inc. (15,505) - - Other (50,691) (31,088) (26,220) - ------------------------------------------------------------------------------------------------------------------------------ NET CASH USED IN INVESTING ACTIVITIES (346,600) (115,764) (94,793) FINANCING ACTIVITIES Proceeds from exercise of stock options and stock issued 89,702 66,005 57,941 Common stock repurchased, including related costs (520,025) - - Net borrowings under short-term debt facilities 9,454 - - Issuance of long-term notes 173,350 - - Borrowings under debt facilities 1,111,450 352,000 2,115,028 Payments under debt facilities (954,050) (475,128) (2,286,400) ============================================================================================================================== NET CASH USED IN FINANCING ACTIVITIES (90,119) (57,123) (113,431) Effect of currency exchange rate changes on cash and equivalents 21,827 9,212 (4,015) - ------------------------------------------------------------------------------------------------------------------------------ NET INCREASE IN CASH AND EQUIVALENTS 59,393 253,525 97,896 CASH AND EQUIVALENTS AT BEGINNING OF YEAR 401,860 148,335 50,439 - ------------------------------------------------------------------------------------------------------------------------------ CASH AND EQUIVALENTS AT END OF YEAR $461,253 $401,860 $ 148,335 ============================================================================================================================== SUPPLEMENTAL CASH FLOW INFORMATION ============================================================================================================================== Cash paid during the year for: Interest $ 3,557 $ 1,473 $ 10,663 Income taxes 57,217 51,243 21,424 - ------------------------------------------------------------------------------------------------------------------------------
SEE NOTES TO CONSOLIDATED FINANCIAL STATEMENTS. 28 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS NOTE 1--SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES COMPANY OVERVIEW: St. Jude Medical, Inc. (St. Jude Medical or the Company) develops, manufactures and distributes cardiovascular medical devices for the global cardiac rhythm management (CRM), cardiac surgery (CS) and cardiology and vascular access (C/VA) therapy areas. The Company's principal products in each of these therapy areas are as follows: CRM o bradycardia pacemaker systems (pacemakers), o tachycardia implantable cardioverter defibrillator systems (ICDs), and o electrophysiology (EP) catheters CS o mechanical and tissue heart valves, and o valve repair products C/VA o vascular closure devices, o angiography catheters, o guidewires, and o hemostasis introducers The Company markets and sells its products primarily through a direct sales force. The principal geographic markets for the Company's products are the United States, Europe and Japan. PRINCIPLES OF CONSOLIDATION: The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Significant intercompany transactions and balances have been eliminated in consolidation. Certain reclassifications of previously reported amounts have been made to conform to the current year presentation. FISCAL YEAR: The Company utilizes a 52/53-week fiscal year ending on the Saturday nearest December 31. For simplicity of presentation, the Company describes all periods as if the year end is December 31. Fiscal year 2003 consisted of 53 weeks and fiscal years 2002 and 2001 consisted of 52 weeks. USE OF ESTIMATES: Preparation of the Company's consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. CASH EQUIVALENTS: The Company considers highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash equivalents are stated at cost, which approximates market. The Company's cash equivalents include bank certificates of deposit, money market funds and instruments, commercial paper investments and repurchase agreements collateralized by U.S. government agency securities. The Company performs periodic evaluations of the relative credit 29 standing of the financial institutions and issuers of its cash equivalents and limits the amount of credit exposure with any one issuer. MARKETABLE SECURITIES: Marketable securities consist of publicly-traded equity securities. Marketable securities are classified as available-for-sale, recorded at fair market value based upon quoted market prices and are classified with other current assets on the balance sheet. The following table summarizes the Company's available-for-sale marketable securities as of December 31 (in thousands): 2003 2002 =============================================================================== Adjusted cost $ 5,826 $ 6,826 Gross unrealized gains 18,461 8,639 Gross unrealized losses (613) (1,800) - ------------------------------------------------------------------------------- Fair value $ 23,674 $ 13,665 =============================================================================== Unrealized gains and losses, net of related incomes taxes, are recorded in other comprehensive income (loss) in shareholders' equity. Realized gains and losses from the sale of marketable securities are recorded in other income (expense) and are computed using the specific identification method. The Company's policy for assessing recoverability of its available-for-sale securities is to record a charge against net earnings when the Company determines that a decline in the fair value of a security drops below the cost basis and judges that decline to be other-than-temporary. During 2003, the Company recorded a $1 million write-down on one of its equity securities, which is included in other income (expense). ACCOUNTS RECEIVABLE: The Company grants credit to customers in the normal course of business, but generally does not require collateral or any other security to support its receivables. The Company maintains an allowance for doubtful accounts for potential credit losses. The allowance for doubtful accounts was $31.9 million at December 31, 2003 and $24.1 million at December 31, 2002. INVENTORIES: Inventories are stated at the lower of cost or market with cost determined using the first-in, first-out method. Inventories consist of the following at December 31 (in thousands): 2003 2002 ================================================================== Finished goods $ 209,236 $ 140,856 Work in process 32,547 27,481 Raw materials 69,978 58,687 - ------------------------------------------------------------------ $ 311,761 $ 227,024 ================================================================== PROPERTY, PLANT AND EQUIPMENT: Property, plant and equipment are recorded at cost and are depreciated using the straight-line method over their estimated useful lives, ranging from 15 to 39 years for buildings and improvements, three to seven years for machinery and equipment and five to eight years for diagnostic equipment. Diagnostic equipment primarily consists of programmers that are used by physicians and healthcare professionals to program and analyze data from pacemaker and ICD devices. The estimated useful lives of this equipment are based on 30 management's estimates of its usage by the physicians and healthcare professionals, factoring in new technology platforms and rollouts by the Company. To the extent that the Company experiences changes in the usage of this equipment or introductions of new technologies to the market, the estimated useful lives of this equipment may change in a future period. Diagnostic equipment had a net carrying value of $68.7 million and $81.0 million at December 31, 2003 and 2002. Accelerated depreciation methods are used for income tax purposes. GOODWILL AND OTHER INTANGIBLE ASSETS: Goodwill represents the excess of cost over the fair value of identifiable net assets of businesses acquired. The Company adopted Statement of Financial Accounting Standards (SFAS) No. 142, "GOODWILL AND OTHER INTANGIBLE ASSETS" (Statement 142), effective January 1, 2002. Under Statement 142, goodwill is no longer amortized, but is subject to annual impairment tests. See Note 3 for pro forma 2001 net earnings and net earnings per share exclusive of goodwill amortization. Other intangible assets consist of purchased technology and patents, distribution agreements, customer relationships, trademarks and licenses and are amortized on a straight-line basis using lives ranging from 10 to 20 years. Statement 142 requires that goodwill for each reporting unit be reviewed for impairment at least annually. The Company has three reporting units at December 31, 2003, consisting of its three operating segments (see Note 11). The Company tests goodwill for impairment using the two-step process prescribed in Statement 142. In the first step, the Company compares the fair value of each reporting unit, as computed primarily by present value cash flow calculations, to its book carrying value, including goodwill. If the fair value exceeds the carrying value, no further work is required and no impairment loss is recognized. If the carrying value exceeds the fair value, the goodwill of the reporting unit is potentially impaired and the Company would then complete step 2 in order to measure the impairment loss. In step 2, the Company would calculate the implied fair value of goodwill by deducting the fair value of all tangible and intangible net assets (including unrecognized intangible assets) of the reporting unit from the fair value of the reporting unit (as determined in step 1). If the implied fair value of goodwill is less than the carrying value of goodwill, the Company would recognize an impairment loss equal to the difference. Management also reviews other intangible assets for impairment at least annually to determine if any adverse conditions exist that would indicate impairment. If the carrying value of other intangible assets exceeds the undiscounted cash flows, the carrying value is written down to fair value in the period identified. Indefinite-lived intangible assets are reviewed at least annually for impairment by calculating the fair value of the assets and comparing with their carrying value. In assessing fair value, management generally utilizes present value cash flow calculations using an appropriate risk-adjusted discount rate. During the fourth quarters of 2003 and 2002, management completed its annual goodwill and other intangible asset impairment reviews with no impairments to the carrying values identified. TECHNOLOGY LICENSE AGREEMENT: The Company has a technology license agreement that provides access to a significant number of patents covering a broad range of technology used in the Company's pacemaker and ICD systems. The agreement provides for payments through September 2004 at which time the Company will have a fully paid-up license, granting access to the underlying patents which expire at various dates through the year 2014. The Company recognizes the total estimated costs under this license agreement as an expense over the term of the underlying patents' lives. The costs deferred under this license are recorded on the balance sheet in other long-term assets. 31 PRODUCT WARRANTIES: The Company offers a warranty on various products, the most significant of which relate to pacemaker and ICD systems. The Company estimates the costs that may be incurred under its warranties and records a liability in the amount of such costs at the time the product is sold. Factors that affect the Company's warranty liability include the number of units sold, historical and anticipated rates of warranty claims and cost per claim. The Company periodically assesses the adequacy of its recorded warranty liabilities and adjusts the amounts as necessary. Changes in the Company's product warranty liability during 2003 and 2002 were as follows (in thousands): 2003 2002 ============================================================================== Balance at beginning of year $ 14,755 $ 11,369 Warranty expense recognized 3,035 5,174 Warranty credits issued (2,569) (1,788) - ------------------------------------------------------------------------------ Balance at end of year $ 15,221 $ 14,755 ============================================================================== REVENUE RECOGNITION: The Company sells its products to hospitals primarily through a direct sales force. In certain international markets, the Company sells its products through independent distributors. The Company recognizes revenue when persuasive evidence of a sales arrangement exists, delivery of goods occurs through the transfer of title and risks and rewards of ownership, the selling price is fixed or determinable and collectibility is reasonably assured. In most markets where the Company has a direct sales force, the Company consigns inventory to hospitals. For consigned products, revenue is recognized at the time the product is used by a physician at the hospital. For products that are not consigned, revenue recognition occurs upon shipment to the hospital or, in the case of distributors, when title transfers under the contract. The Company records estimated sales returns, discounts and rebates as a reduction of net sales in the same period revenue is recognized. RESEARCH AND DEVELOPMENT: Research and development costs are charged to expense as incurred. Purchased in-process research and development charges are recognized in business acquisitions for the portion of the purchase price allocated to the appraised value of in-process technologies. The portion assigned to in-process research and development technologies excludes the value of core and developed technologies, which are recognized as intangible assets. STOCK-BASED COMPENSATION: The Company accounts for its stock-based employee compensation plans (see Note 6) under the recognition and measurement principles of APB Opinion No. 25, "ACCOUNTING FOR STOCK ISSUED TO Employees," and related Interpretations. The following table illustrates the effect on net earnings and net earnings per share if the Company had applied the fair value recognition provisions of SFAS No. 123, "ACCOUNTING FOR STOCK-BASED COMPENSATION," to its stock-based employee compensation (in thousands, except per share amounts): 32
2003 2002 2001 ================================================================================================== Net earnings, as reported $ 339,391 $ 276,285 $ 172,592 Less: Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects (38,030) (33,194) (26,619) - -------------------------------------------------------------------------------------------------- Pro forma net earnings $ 301,361 $ 243,091 $ 145,973 ================================================================================================== ================================================================================================== Net earnings per share: Basic-as reported $ 1.92 $ 1.56 $ 1.00 Basic-pro forma 1.70 1.38 0.85 Diluted-as reported $ 1.83 $ 1.51 $ 0.97 Diluted-pro forma 1.63 1.33 0.82 ==================================================================================================
The weighted-average fair value of options granted and the assumptions used in the Black-Scholes option-pricing model are as follows: 2003 2002 2001 ================================================================================ Fair value of options granted $ 21.75 $ 12.95 $ 12.84 Assumptions used: Expected life (years) 5 5 5 Risk-free rate of return 3.2% 3.3% 4.4% Volatility 35.0% 35.0% 30.9% Dividend yield 0% 0% 0% ================================================================================ NET EARNINGS PER SHARE: Basic net earnings per share is computed by dividing net earnings by the weighted average number of outstanding common shares during the period, exclusive of restricted shares. Diluted net earnings per share is computed by dividing net earnings by the weighted average number of outstanding common shares and dilutive securities. The table below sets forth the computation of basic and diluted net earnings per share (in thousands, except per share amounts). 33
2003 2002 2001 ========================================================================================= Numerator: Net earnings $ 339,391 $ 276,285 $ 172,592 Denominator: Basic-weighted average shares outstanding 176,956 176,570 172,428 Effect of dilutive securities: Employee stock options 8,410 6,410 6,269 Restricted shares 11 22 70 - ----------------------------------------------------------------------------------------- Diluted-weighted average shares outstanding 185,377 183,002 178,767 ========================================================================================= Basic net earnings per share $ 1.92 $ 1.56 $ 1.00 ========================================================================================= Diluted net earnings per share $ 1.83 $ 1.51 $ 0.97 - -----------------------------------------------------------------------------------------
Diluted-weighted average shares outstanding have not been adjusted for certain employee stock options and awards where the effect of those securities would have been anti-dilutive. FOREIGN CURRENCY TRANSLATION: Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates. Gains and losses from translation of net assets of foreign operations, net of related income taxes, are recorded in other comprehensive income (loss). Foreign currency transaction gains and losses are included in other income (expense). NEW ACCOUNTING PRONOUNCEMENTS: In January 2003, the Financial Accounting Standards Board (FASB) issued FASB Interpretation No. 46, "CONSOLIDATION OF VARIABLE INTEREST ENTITIES" (FIN 46). FIN 46 requires the consolidation of variable interest entities in which an enterprise absorbs a majority of the entity's expected losses, receives a majority of the entity's expected residual returns, or both, as a result of ownership, contractual or other financial interests in the entity. FIN 46 is effective for the first quarter of 2004. The Company does not expect its adoption of FIN 46 to have an impact on its consolidated results of operations, financial position or cash flows. In May 2003, the FASB issued SFAS No. 150, "ACCOUNTING FOR CERTAIN FINANCIAL INSTRUMENTS WITH CHARACTERISTICS OF BOTH LIABILITIES AND EQUITY" (Statement 150). Statement 150 establishes standards for issuer classification and measurement of certain financial instruments with characteristics of both liabilities and equity. In accordance with this standard, financial instruments that embody obligations for the issuer are required to be classified as liabilities. Statement 150 is effective for all financial instruments entered into or modified after May 31, 2003, and is otherwise effective at the beginning of the first interim period beginning after June 15, 2003. The Company's adoption of Statement 150 did not have an impact on its consolidated results of operations, financial position or cash flows. Emerging Issues Task Force (EITF) Issue No. 00-21, "ACCOUNTING FOR REVENUE ARRANGEMENTS WITH MULTIPLE DELIVERABLES," addresses certain aspects of the accounting by a vendor for arrangements under which multiple revenue-generating activities are performed. EITF Issue No. 00-21 establishes three principles: revenue arrangements with multiple deliverables should be divided into separate units of accounting; arrangement consideration should be allocated among the separate units of accounting based on their relative fair values; and revenue recognition criteria should be considered separately for separate units of accounting. EITF Issue No. 00-21 was effective for all revenue arrangements entered into in fiscal periods beginning after June 15, 2003. The Company's adoption 34 of EITF Issue No. 00-21 did not have an impact on its consolidated results of operations, financial position or cash flows. In December 2003, the Securities and Exchange Commission released Staff Accounting Bulletin No. 104, "REVENUE RECOGNITION" (SAB 104). SAB 104 clarifies existing guidance regarding revenue recognition. The Company's adoption of SAB 104 did not have a material impact on its consolidated results of operation, financial position or cash flows. NOTE 2--ACQUISITIONS & MINORITY INVESTMENT ACQUISITIONS: On April 1, 2003, the Company completed its acquisition of Getz Bros. Co., Ltd. (Getz Japan), a distributor of medical technology products in Japan and the Company's largest volume distributor in Japan. The Company paid 26.9 billion Japanese Yen in cash to acquire 100% of the outstanding common stock of Getz Japan. Net consideration paid was $219.2 million, which includes closing costs less $12.0 million of cash acquired. On April 1, 2003, the Company also acquired the net assets of Getz Bros. & Co. (Aust.) Pty. Limited and Medtel Pty. Limited (collectively referred to as Getz Australia) related to the distribution of the Company's products in Australia for $6.2 million in cash, including closing costs. The Company acquired Getz Japan and Getz Australia (collectively referred to as Getz) in order to further strengthen its presence in the Japanese and Australian medical technology markets. The purchase price for Getz was based on the future cash flows of the businesses. In addition, Getz Japan had equity securities which traded on a Japanese stock exchange. The goodwill recognized as part of the Getz acquisitions relates primarily to the operating efficiencies that these businesses were able to achieve and the increased levels of efficiencies anticipated in the future as the Company expands its presence in the Japanese and Australian medical technology markets. The goodwill recorded in connection with the Getz acquisitions has been allocated entirely to the Company's Cardiac Rhythm Management/Cardiac Surgery (CRM/CS) reportable segment. The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as a result of these acquisitions (in thousands): ========================================================= Current assets $ 124,961 Goodwill 67,465 Intangible assets 64,106 Other long-term assets 33,945 - --------------------------------------------------------- Total assets acquired $ 290,477 Current liabilities $ 27,724 Deferred income taxes 25,390 - --------------------------------------------------------- Total liabilities assumed $ 53,114 - --------------------------------------------------------- Net assets acquired $ 237,363 ========================================================= The goodwill recorded as a result of these acquisitions is not deductible for income tax purposes. In connection with the acquisitions of Getz, the Company recorded intangible assets valued at $64.1 million that each have a weighted average useful life of 10 years. Total intangible assets subject to amortization include distribution agreements of $44.9 million, customer lists and relationships of $9.5 35 million, and licenses and other of $5.6 million. Intangible assets not subject to amortization include trademarks of $4.1 million. The Getz acquisitions did not provide for the payment of any contingent consideration. The third party appraisal used by the Company for purposes of the purchase price allocation did not include any in-process research and development. There are no material unresolved items relating to the purchase price allocation. During 2003, 2002 and 2001, the Company also acquired various businesses involved in the distribution of the Company's products. Aggregate consideration paid in cash during 2003, 2002 and 2001 was $5.4 million, $24.5 million and $10.4 million, respectively. In December 2002, the Company acquired the assets of a catheter business for $5 million in cash. Substantially all of the purchase price was allocated to technology and patents with estimated useful lives of 15 years. The results of operations of the above-mentioned business acquisitions have been included in the Company's consolidated results of operations since the date of acquisition. Pro forma results of operations have not been presented for these acquisitions since the effects of these business acquisitions were not material to the Company either individually or in aggregate. During 2001, the Company paid $10 million relating to the September 1999 acquisition of Vascular Science, Inc. (VSI - see Note 7). MINORITY INVESTMENT: In May 2003, the Company made a $15 million minority investment in Epicor Medical, Inc. (Epicor), a development stage company focused on developing products which use high intensity focused ultrasound (HIFU) to ablate cardiac tissue. This investment is accounted for under the cost method and is included in other long-term assets on the balance sheet. In conjunction with this investment, the Company also agreed to acquire the remaining ownership of Epicor in 2004 for an additional $185 million in cash if Epicor receives approval from the U.S. Food and Drug Administration (FDA) by June 30, 2004 to begin marketing its device to ablate cardiac tissue and if Epicor achieves certain success criteria, as defined in the purchase agreement, in connection with its European clinical study. In addition, the Company has an option to purchase the remaining ownership of Epicor for $185 million even if FDA approval is not received and the success criteria are not achieved. This option to purchase Epicor expires on June 30, 2004. NOTE 3-- GOODWILL AND OTHER INTANGIBLE ASSETS The Company ceased amortizing goodwill effective January 1, 2002 as discussed in Note 1 - GOODWILL AND OTHER INTANGIBLE ASSETS. The following table provides pro forma fiscal year 2001 net earnings and net earnings per share had Statement 142 been effective January 1, 2001 (in thousands, except per share amounts): 36 2001 =============================================================================== NET EARNINGS: As reported $ 172,592 Goodwill amortization, net of taxes 21,323 - ------------------------------------------------------------------------------- Pro forma net earnings $ 193,915 =============================================================================== BASIC NET EARNINGS PER SHARE: As reported $ 1.00 Goodwill amortization, net of taxes 0.12 - ------------------------------------------------------------------------------- Pro forma basic net earnings per share $ 1.12 =============================================================================== DILUTED NET EARNINGS PER SHARE: As reported $ 0.97 Goodwill amortization, net of taxes 0.12 - ------------------------------------------------------------------------------- Pro forma diluted net earnings per share $ 1.08 =============================================================================== The changes in the carrying amount of goodwill for each of the Company's reportable segments for the fiscal year ended December 31, 2003 are as follows (in thousands):
CRM/CS DAIG TOTAL ========================================================================================================= Balance at December 31, 2002 $ 270,829 $ 54,746 $ 325,575 Goodwill recorded from the Getz acquisitions 67,465 - 67,465 Foreign currency translation 13,372 123 13,495 Other 478 - 478 - --------------------------------------------------------------------------------------------------------- Balance at December 31, 2003 $ 352,144 $ 54,869 $ 407,013 =========================================================================================================
The following table provides the gross carrying amount of other intangible assets and related accumulated amortization at December 31 (in thousands):
2003 2002 ========================================================================================================== GROSS GROSS CARRYING ACCUMULATED CARRYING ACCUMULATED AMOUNT AMORTIZATION AMOUNT AMORTIZATION - ---------------------------------------------------------------------------------------------------------- Amortized intangible assets: Purchased technology and patents $76,189 $ 21,253 $75,749 $ 17,075 Distribution agreements 49,348 3,701 - - Customer lists and relationships 50,511 7,278 33,306 2,822 Licenses and other 6,679 610 435 102 - ---------------------------------------------------------------------------------------------------------- $ 182,727 $ 32,842 $ 109,490 $ 19,999 ========================================================================================================== Unamortized intangible assets: Trademarks $ 4,519 - ----------------------------------------------------------------------------------------------------------
37 Amortization expense of other intangible assets was $12.0 million, $7.7 million and $3.8 million for the fiscal years ended December 31, 2003, 2002 and 2001, respectively. Estimated amortization expense for fiscal years 2004 through 2008 based on the current carrying value of other intangible assets is approximately $14 million per year. NOTE 4-- DEBT On April 1, 2003, the Company borrowed 24.6 billion Japanese Yen, or approximately $208 million, under a short-term, unsecured bank credit agreement to partially finance the Getz Japan acquisition. Borrowings under this agreement bore interest at an average rate of 0.58% per annum and were repaid in May 2003. In May 2003, the Company issued 7-year, 1.02% unsecured notes totaling 20.9 billion Yen. The Company also obtained a short-term, unsecured bank credit agreement that provides for borrowings of up to 3.8 billion Yen. Proceeds from the issuance of the 7-year notes and from borrowings under the short-term, bank credit agreement were used to repay the 24.6 billion Yen of short-term bank borrowings. Outstanding borrowings under the Company's short-term bank credit agreement were approximately 1.3 billion Yen, or $12.1 million, at December 31, 2003. Borrowings under the short-term, bank credit agreement bear interest at the floating Yen London InterBank Offered Rate (LIBOR) plus 0.50% per annum (effective rate of 0.54% at December 31, 2003) and are due in May 2004. In July 2003, the Company obtained a $400 million short-term revolving credit facility to partially fund its $500 million share repurchase in August 2003. Borrowings under this facility bore interest at an average rate of 1.73% per annum and were repaid in September 2003. In September 2003, the Company obtained a $150 million unsecured, revolving credit facility that expires in September 2004 and a $350 million unsecured, revolving credit facility that expires in September 2008. These credit facilities bear interest at the LIBOR plus 0.625% and 0.60% per annum, respectively, subject to adjustment in the event of a change in the Company's debt ratings. There were no outstanding borrowings under these credit facilities at December 31, 2003. During September 2003, the Company began issuing short-term, unsecured commercial paper with maturities up to 270 days. These commercial paper borrowings bear interest at varying market rates (effective rate of 1.2% at December 31, 2003). The Company's long-term debt consisted of the following at December 31, 2003 (in thousands): - ------------------------------------------------------------------------------- 1.02% Yen-denominated notes, due 2010 $ 194,413 Commercial paper borrowings 157,400 - ------------------------------------------------------------------------------- $ 351,813 =============================================================================== The Company classifies all of its commercial paper borrowings as long-term on its balance sheet as the Company has the ability to repay any short-term maturity with available cash from its existing long-term, committed credit facility. Management continually reviews the Company's cash flow projections and may from time to time repay a portion of the Company's borrowings. The Company's 7-year notes, short-term bank credit agreement and revolving credit facilities contain various operating and financial covenants. Specifically, the Company must have a ratio of total debt to total capitalization not exceeding 55%, have a leverage ratio (defined as the ratio of total debt to EBITDA (net earnings before interest, income taxes, depreciation and amortization) and the ratio of 38 total debt to EBIT (net earnings before interest and income taxes)) not exceeding 3.0 to 1.0, and an interest coverage ratio (defined as the ratio of EBITDA to interest expense and the ratio of EBIT to interest expense) not less than 3.0 to 1.0. The Company also has limitations on additional liens or indebtedness and limitations on certain acquisitions, investments and dispositions of assets. However, these agreements do not include provisions for the termination of the agreements or acceleration of repayment due to changes in the Company's credit ratings. The Company was in compliance with all of its debt covenants at December 31, 2003. NOTE 5--COMMITMENTS AND CONTINGENCIES LEASES: The Company leases various facilities and equipment under noncancelable operating lease arrangements. Future minimum lease payments under these leases are as follows: $16.3 million in 2004; $15.5 million in 2005; $14.2 million in 2006; $13.3 million in 2007; $11.7 million in 2008; and $37.0 million in years thereafter. Rent expense under all operating leases was $16.5 million, $10.2 million and $8.9 million in 2003, 2002 and 2001. SILZONE(R) LITIGATION: In July 1997, the Company began marketing mechanical heart valves which incorporated a Silzone(R) coating. The Company later began marketing heart valve repair products incorporating a Silzone(R) coating. The Silzone(R) coating was intended to reduce the risk of endocarditis, a bacterial infection affecting heart tissue, which is associated with replacement heart valves. In January 2000, the Company voluntarily recalled all field inventories of Silzone(R) devices after receiving information from a clinical study that patients with a Silzone valve had a small, but statistically significant, increased incidence of explant due to paravalvular leak compared to patients in that clinical study with non-Silzone(R) heart valves. Subsequent to the Company's voluntary recall, the Company has been sued in the United States, Canada, and United Kingdom by some patients who received a Silzone(R) device. Some of these claims allege bodily injuries as a result of an explant or other complications, which they attribute to the Silzone(R) devices. Others, who have not had their device explanted, seek compensation for past and future costs of special monitoring they allege they need over and above the medical monitoring all replacement heart valve patients receive. Some of the lawsuits seeking the cost of monitoring have been initiated by patients who are asymptomatic and who have no apparent clinical injury to date. The Company has vigorously defended against the claims that have been asserted, and expects to continue to do so with respect to any remaining claims. The Company has settled a number of these Silzone(R)-related cases and others have been dismissed. Cases filed in the United States in federal courts have been consolidated in the federal district court for the district of Minnesota under Judge Tunheim. A number of class action complaints have been consolidated into one case seeking certification of two separate classes. One proposed class in the consolidated complaint seeks injunctive relief in the form of medical monitoring. A second class in the consolidated complaint seeks an unspecified amount of money damages. The Court also certified a class action for patients claiming relief under Minnesota's Consumer Protection Statutes. On January 5, 2004, the judge ruled on the ability of certain claims to proceed as class actions. The judge declined to grant class action status to personal injury claims; however, he granted class action status for patients from a limited group of states to proceed with medical monitoring claims. Further 39 briefing is pending on exactly which states fall into this category and how a class action proceeding involving such claims would proceed. In addition, there have been 39 individual Silzone(R) cases filed in federal court where plaintiffs are each requesting damages ranging from an unspecified amount to $120.5 million. These cases are proceeding in accordance with the orders issued by Judge Tunheim. There have also been 25 individual state court suits filed involving 42 patients. The complaints in these cases each request damages ranging from an unspecified amount to $70,000. These state court cases are proceeding in accordance with the orders issued by the judges in those matters. Four class action cases have been filed against the Company in Canada. In one such case in Ontario, the court certified that a class action may proceed involving Silzone(R) patients. The most recent certification decision was issued on January 16, 2004. In the United Kingdom, one case involving one plaintiff has been filed. The complaint in this case requests damages of an unspecified amount. This matter is in its very early stages. The Company is not aware of any unasserted claims related to Silzone(R) devices. Company management believes that the final resolution of the Silzone(R) cases will take several years. At this time, management cannot reasonably estimate the time frame in which any potential settlements or judgments would be paid out. The Company accrues for contingent losses when it is probable that a loss has been incurred and the amount can be reasonably estimated. The Company has recorded an accrual for probable legal costs that it will incur to defend the various cases involving Silzone(R) devices, and the Company has recorded a receivable from its product liability insurance carriers for amounts expected to be recovered (see Note 7). The Company has not accrued for any amounts associated with probable settlements or judgments because management cannot reasonably estimate such amounts. However, management believes that no significant claims will ultimately be allowed to proceed as class actions in the United States and, therefore, that all settlements and judgments will be covered under the Company's remaining product liability insurance coverage (approximately $170 million at December 31, 2003), subject to the insurance companies' performance under the policies (see Note 7 for further discussion on the Company's insurance carriers). As such, management believes that any costs (the material components of which are settlements, judgments and legal fees) not covered by its product liability insurance policies or existing reserves will not have a material adverse effect on the Company's statement of financial position or liquidity, although such costs may be material to the Company's consolidated results of operations of a future period. GUIDANT 1996 PATENT LITIGATION: In November 1996, Guidant Corporation (Guidant) sued St. Jude Medical alleging that the Company did not have a license to certain patents controlled by Guidant covering ICD products and alleging that the Company was infringing those patents. St. Jude Medical's contention was that it had obtained a license from Guidant to the patents in issue when it acquired certain assets of Telectronics in November 1996. In July 2000, an arbitrator rejected St. Jude Medical's position, and in May 2001, a federal district court judge also ruled that the Guidant patent license with Telectronics had not transferred to St. Jude Medical. Guidant's suit originally alleged infringement of four patents by St. Jude Medical. Guidant later dismissed its claim on one patent and a court ruled that a second patent was invalid. This determination of invalidity was appealed by Guidant and the Court of Appeals upheld the lower court's invalidity determination. In a jury trial involving the two remaining patents (the `288 and `472 patents), the jury found that these patents were valid and that St. Jude Medical did not infringe the `288 patent. The jury also found that the Company did infringe the `472 patent, though such 40 infringement was not willful. The jury awarded damages of $140 million to Guidant. In post-trial rulings, however, the judge overseeing the jury trial ruled that the `472 patent was invalid and also was not infringed by St. Jude Medical, thereby eliminating the $140 million verdict against the Company. The trial court also made other rulings as part of the post-trial order, including a ruling that the `288 patent was invalid on several grounds. In August 2002, Guidant commenced an appeal of certain of the trial judge's post-trial decisions pertaining to the `288 patent. Guidant did not appeal the trial court's finding of invalidity and non-infringement of the `472 patent. As part of its appeal, Guidant requested that the monetary damages awarded by the jury pertaining to the `472 patent ($140 million) be transferred to the `288 patent infringement claim. The Company maintains that such a request is not supported by the facts or law. After the briefing for this appeal was completed, oral argument before the Court of Appeals occurred on September 4, 2003. The Company expects that the Appellate Court will issue a decision concerning Guidant's appeal sometime later in 2004. While it is not possible to predict the outcome of the appeal process, the Company believes that the decision of the trial court in its post-trial rulings, which is publicly available, was correct. The `288 patent expired in December 2003. Accordingly, the final outcome of the appeal process cannot involve an injunction precluding the Company from selling ICD products in the future. Sales of the Company's ICD products which Guidant asserts infringed the `288 patent were approximately 18%, 16% and 13% of the Company's consolidated net sales during the fiscal years ended December 31, 2003, 2002 and 2001, respectively. The Company has not accrued any amounts for losses related to the Guidant 1996 patent litigation. Although the Company believes that the assertions and claims in these matters are without merit, potential losses arising from this litigation are possible, but not estimable, at this time. The range of such losses could be material to the operations, financial position and liquidity of the Company. GUIDANT 2004 PATENT LITIGATION: In February 2004, Guidant sued the Company alleging that the Company's Epic(TM) HF ICD, Atlas(R)+ HF ICD and Frontier(TM) device infringe U.S Patent No. RE 38,119E (the `119 patent). Guidant also sued the Company in February 2004 alleging that the Company's QuickSite(TM) 1056K pacing lead infringes U.S. Patent No. 5,755,766 (the `766 patent). Guidant is seeking an injunction against the manufacture and sale of these devices by the Company in the United States and compensation for what it claims are infringing sales of these products up through the effective date of the injunction. Sales of the above St. Jude Medical devices in the United States were not material during fiscal years 2003, 2002 and 2001, although it is anticipated that once the Company receives FDA approval to market these products during 2004, sales of these devices could become material in the future. The Company has not submitted a substantive response to Guidant's claims at this time. Another competitor of the Company, Medtronic, Inc., which has a license to the `119 patent, is contending in a separate lawsuit with Guidant that the `119 patent is invalid. The Company has not accrued any amounts for losses related to the Guidant 2004 patent litigation. Potential losses arising from this litigation are possible, but not estimable, at this time. The range of such losses could be material to the operations, financial position and liquidity of the Company. SYMMETRY(TM) LITIGATION: The Company has been sued in six cases in the United States alleging that its Symmetry(TM) Bypass System Aortic Connector (Symmetry(TM) device) caused bodily injury or might cause bodily injury. The firST such suit was filed against the Company on August 5, 2003, and the 41 most recently initiated case was served upon the Company on January 28, 2004. Each of the complaints in these cases request damages ranging from an unspecified amount to $100,000. Three of the six cases are seeking class-action status. One of the cases seeking class-action status has been dismissed but the dismissal is being appealed by the plaintiff. The Company believes that those cases seeking class-action status will request damages for injuries and monitoring costs. The Company's Symmetry(TM) device was cleared through a 510(K) submission to the FDA, and therefore, is not eligible for the defense under the doctrine of federal preemption that such suits are prohibited. Given the Company's self-insured retention levels under its product liability insurance policies, the Company expects that it will be solely responsible for these lawsuits, including any costs of defense, settlements and judgments. The Company management believes that class action status is not appropriate for the claims asserted based on existing facts and case law. Discovery is in the very early stages in these cases. The Company has not accrued any amounts for losses related to the Symmetry(TM) litigation. Potential losses arising from this litigation are possible, but not estimable, at this time. The range of such losses could be material to the operations, financial position and liquidity of the Company. At this time, Company management cannot reasonably estimate the time frame in which this litigation will be resolved, including when potential settlements or judgments would be paid out, if any. OTHER LITIGATION MATTERS: The Company is involved in various other product liability lawsuits, claims and proceedings of a nature considered normal to its business. OTHER CONTINGENCIES: The Company has agreed to acquire the remaining ownership of Epicor in 2004 for $185 million in cash, provided that specific clinical and regulatory milestones are achieved (see Note 2 for further discussion on Epicor). The Company also has contingent commitments to acquire various businesses involved in the distribution of its products that could total approximately $70 million in aggregate during 2004 to 2010, provided that certain contingencies are satisfied. The purchase prices of the individual businesses range from approximately $0.1 million to $7.0 million. In addition, the Company is required to make additional payments for the acquisition of VSI upon the achievement of certain regulatory milestones and minimum sales levels (see Note 7 for further discussion on these contingent payments). NOTE 6--SHAREHOLDERS' EQUITY CAPITAL STOCK: The Company has 250,000,000 authorized shares of $0.10 per share par value common stock. The Company also has 25,000,000 authorized shares of $1.00 par value per share preferred stock. The Company has designated 1,100,000 of the authorized preferred shares as a Series B Junior Preferred Stock for its shareholder rights plan (see SHAREHOLDERS' RIGHTS PLAN below for further discussion). There were no shares of preferred stock issued or outstanding during 2003, 2002 or 2001. SHARE REPURCHASE: On July 22, 2003, the Company's Board of Directors authorized a share repurchase program of up to $500 million of the Company's outstanding common stock. The share repurchases could be made at the direction of the Company's management through transactions in the open market and/or privately negotiated transactions, including the use of options, futures, swaps and accelerated share repurchase contracts. 42 On August 7, 2003, the Company repurchased approximately 9.25 million shares, or about five percent of its outstanding common stock, for $500 million under a privately-negotiated transaction with an investment bank. The investment bank borrowed the 9.25 million shares to complete the transaction and purchased replacement shares in the open market over a three month period which ended on November 7, 2003. The Company entered into a related accelerated stock buyback contract with the same investment bank which, in return for a separate payment to the investment bank, included a price-protection feature. The price-protection feature provided that if the investment bank's per share purchase price of the replacement shares was lower than the initial share purchase price for the 9.25 million shares ($54.06), then the investment bank would, at the Company's election, make a payment or deliver additional shares to the Company in the amount of the difference between the initial share purchase price and their replacement price, subject to a maximum amount. In addition, the price-protection feature provided that if the investment bank's replacement price was greater than the initial share purchase price, the Company would not be required to make any further payments. The Company recorded the cost of the shares repurchased and the payment for the price-protection feature, totaling $520 million, as a reduction of shareholders' equity on the date of share repurchase (August 7, 2003). On November 7, 2003, the investment bank completed its purchase of replacement shares. The market price of the Company's shares during this replacement period exceeded the initial purchase price, resulting in no additional exchange of consideration. SHAREHOLDERS' RIGHTS PLAN: The Company has a shareholder rights plan that entitles shareholders to purchase one-tenth of a share of Series B Junior Preferred Stock at a stated price, or to purchase either the Company's shares or shares of an acquiring entity at half their market value, upon the occurrence of certain events which result in a change in control, as defined by the Plan. The rights related to this plan expire in 2007. EMPLOYEE STOCK PURCHASE SAVINGS PLAN: The Company's employee stock purchase savings plan allows participating employees to purchase, through payroll deductions, newly issued shares of the Company's common stock at 85% of the fair market value at specified dates. Employees purchased 0.3 million, 0.2 million and 0.3 million shares in 2003, 2002 and 2001, respectively, under this plan. At December 31, 2003, 1.2 million shares of additional common stock were available for purchase under the plan. STOCK COMPENSATION PLANS: The Company's stock compensation plans provide for the issuance of stock-based awards, such as restricted stock or stock options, to directors, officers, employees and consultants. Stock option awards under these plans generally have an eight to ten year life, an exercise price equal to the fair market value on the date of grant and a four-year vesting term. Under the Company's current stock plans, a majority of the stock option awards have an eight-year life. At December 31, 2003, the Company had 4.5 million shares of common stock available for grant under these plans. Stock option transactions under these plans during each of the three years in the period ended December 31, 2003 are as follows: 43
OPTIONS WEIGHTED AVERAGE OUTSTANDING EXERCISE PRICE ===================================================================================================== Balance at January 1, 2001 26,539,640 $ 18.24 Granted 6,373,310 35.94 Canceled (762,734) 21.08 Exercised (3,467,214) 15.27 - ----------------------------------------------------------------------------------------------------- Balance at December 31, 2001 28,683,002 22.45 Granted 5,041,340 35.60 Canceled (716,452) 26.89 Exercised (3,312,968) 16.66 - ----------------------------------------------------------------------------------------------------- Balance at December 31, 2002 29,694,922 25.22 Granted 4,552,336 60.03 Canceled (721,246) 31.53 Exercised (3,962,865) 20.30 - ----------------------------------------------------------------------------------------------------- Balance at December 31, 2003 29,563,147 $ 31.09 - -----------------------------------------------------------------------------------------------------
Stock options totaling 16.3 million, 15.4 million and 12.6 million were exercisable at December 31, 2003, 2002 and 2001, respectively. The following tables summarize information concerning currently outstanding and exercisable stock options at December 31, 2003:
OPTIONS OUTSTANDING ====================================================================================================== WEIGHTED AVERAGE RANGES OF NUMBER REMAINING CONTRAC- WEIGHTED AVERAGE EXERCISE PRICES OUSTANDING TUAL LIFE (YEARS) EXERCISE PRICE ====================================================================================================== $ 9.29 - $19.02 8,804,726 3.7 $ 14.94 19.03 - 25.37 1,419,478 3.0 20.50 25.38 - 31.71 5,137,790 4.9 26.71 31.72 - 38.05 9,057,277 6.3 35.73 38.06 - 50.74 1,170,520 6.7 44.51 50.75 - 63.36 3,973,356 7.9 61.77 - ------------------------------------------------------------------------------------------------------ 29,563,147 5.4 $ 31.09 ====================================================================================================== OPTIONS EXERCISABLE ====================================================================================================== RANGES OF NUMBER WEIGHTED AVERAGE EXERCISE PRICES OUSTANDING EXERCISE PRICE ====================================================================================================== $ 9.29 - $19.02 8,614,356 $ 14.95 19.03 - 25.37 967,278 20.68 25.38 - 31.71 3,292,158 26.48 31.72 - 38.05 3,266,046 35.93 38.06 - 50.74 181,215 40.63 50.75 - 63.36 28,000 51.70 - ------------------------------------------------------------------------------------------------------ 16,349,053 $ 22.15 ======================================================================================================
44 The Company also granted 18,796 shares of restricted common stock during the three years ended December 31, 2003, under the Company's stock compensation plans. The value of restricted stock awards as of the date of grant is charged to expense over the periods during which the restrictions lapse. NOTE 7--PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT AND SPECIAL CHARGES PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT CHARGES: In September 1999, the Company purchased VSI for $75.1 million in cash, net of cash acquired, plus additional contingent consideration related to product development milestones for regulatory approvals and to future sales. The total consideration paid at close was allocated to the fair value of the net assets acquired ($7.6 million) and in-process research and development ($67.5 million). The Company paid additional amounts totaling $10 million in 2001 and $5 million in 2000, which were recorded as purchased in-process research and development expenses, as certain product development milestones were achieved. The remaining balance of the original $95.5 million in-process research and development valuation ($13 million) will be recorded in the Company's consolidated financial statements as purchased in-process research and development expense when payment of the contingent consideration is assured beyond a reasonable doubt. Contingent consideration payments in excess of the $13 million will be capitalized as goodwill. The VSI purchase agreement requires the Company to make additional payments to the former VSI shareholders upon the achievement of certain regulatory milestones and minimum sales levels. To date, the Company has paid $15 million related to the achievement of three regulatory milestones. Achievement of the final regulatory milestone, U.S. regulatory approval of the distal connector, requires an additional $5 million payment. This contractual commitment continues indefinitely. The contingent consideration tied to sales requires the Company to make additional payments totaling 5% of sales once cumulative sales exceed $50 million for the proximal and distal connectors collectively. There is no maximum amount of contingent consideration that could be paid related to sales. This contractual commitment ceases in 2009 if the minimum sales threshold is not attained prior to such date. If the minimum sales threshold is met prior to 2009, the commitment will extend for 10 years from the date the minimum sales threshold is met. Cumulative proximal and distal connector sales totaled $33 million through December 31, 2003. Company management continues to evaluate the additional research and development expenditures necessary to develop the distal and other connector technologies into commercially viable products. There can be no assurance that the Company will be able to complete the development of these technologies into commercially viable products. Additionally, the Company is not able to reasonably predict the level of proximal or distal connector sales over a period of time which could extend beyond the next 10 years. As a result of these factors, the Company is not able to predict the amount of additional contingent consideration, if any, that may become due. However, the Company believes that any amounts which may ultimately become due in the next 5 years will not be material to the Company's results of operations, financial position or liquidity. 2001 SPECIAL CHARGE: During the first half of 2001, Company management undertook a review of the organizational structure of the Company's sales operations and its heart valve operations. At that time, the structure of the Company's sales organization included four separate sales groups. Additionally, the cardiac surgery markets were experiencing a shift in clinical preference away from mechanical heart 45 valves in favor of tissue heart valves and repair products for certain patients. These changes had the potential to impact the future performance of the Company's heart valve operations. As a result of these reviews, in July 2001 Company management approved two restructuring plans. The first plan included a restructuring of the Company's sales organizations into two geographically oriented groups (one group focused on the United States and one group focused on locations outside the United States) and changes within each of these new organizations to harmonize their operations within each of their geographies. The second plan included the elimination of excess capacity in the Company's heart valve operations workforce, facilities and equipment and the discontinuance of certain heart valve product lines. As a result of these restructuring plans, the Company recorded pre-tax charges totaling $20.7 million in the third quarter of 2001 consisting of inventory write-downs ($9.5 million), capital equipment write-offs ($3.4 million), employee termination costs ($5.3 million) and lease termination and other exit costs ($2.5 million). Inventory write-downs represented the estimated net carrying value of various inventory items that would be scrapped in connection with the decision to terminate two heart valve product lines. Capital equipment write-offs were a result of the elimination of certain excess capacity in the Company's heart valve operations. Employee termination costs related to the severance costs for approximately 90 individuals whose positions were eliminated. Lease termination and other exit costs included office closings for international locations, contractual obligations under certain programs that were cancelled and lease termination costs. A summary of the employee termination costs and lease termination and other exit costs activity is as follows (in thousands):
LEASE EMPLOYEE TERMINATION TERMINATION AND OTHER COSTS EXIT COSTS TOTAL ============================================================================================== Initial expense and accrual in 2001 $ 5,293 $ 2,495 $ 7,788 Cash payments (2,468) (352) (2,820) - ---------------------------------------------------------------------------------------------- Balance at December 31, 2001 2,825 2,143 4,968 Cash payments (1,676) (1,970) (3,646) Changes in estimates (639) (53) (692) - ---------------------------------------------------------------------------------------------- Balance at December 31, 2002 510 120 630 Cash payments (510) (120) (630) - ---------------------------------------------------------------------------------------------- Balance at December 31, 2003 $ - $ - $ - ==============================================================================================
In addition to the above restructuring activities, Company management identified a trend early in the third quarter of 2001 related to the usage of certain diagnostic equipment, also referred to as programmers. Management noted that customer acceptance of its new programmer, which received FDA regulatory approval in late December 2000 and was subsequently launched during the first and second quarters of 2001, significantly exceeded its expectations, necessitating a special analysis of the recoverability of the older programmers that were not yet fully depreciated. After a review of the situation, Company management approved a plan to abandon certain older programmer models during the third quarter of 2001. As a result of this plan, the Company wrote off the remaining net book value of the abandoned programmers ($12.2 million) to cost of sales. 46 The charges relating to employee termination costs, capital equipment write-offs and other costs ($11.2 million) were recorded in operating expenses as special charges. The inventory and diagnostic equipment write-offs ($21.7 million) were included in cost of sales as special charges. SILZONE(R) SPECIAL CHARGES: On January 21, 2000, the Company initiated a worldwide voluntary recall of all field inventory of heart valve replacement and repair products incorporating Silzone(R) coating on the sewing cuff fabric. The Company concluded that it would no longer utilize Silzone(R) coating. As a result of the voluntary recall and product discontinuance, the Company recorded a special charge totaling $26.1 million during the first quarter of 2000. The $26.1 million special charge consisted of asset write-downs ($9.5 million), legal and patient monitoring costs ($14.4 million) and customer returns and related costs ($2.2 million). The $9.5 million of asset write-downs related to inventory write-offs associated with the physical scrapping of inventory with Silzone(R) coating ($8.6 million), and to the write-off of a prepaid license asset and related costs associated with the Silzone(R) coating technology ($0.9 million). The $14.4 million of legal and patient monitoring costs related to the Company's product liability insurance deductible ($3.5 million) and patient monitoring costs ($10.9 million) related to contractual and future monitoring activities directly related to the product recall and discontinuance. The $2.2 million of customer returns and related costs represented costs associated with the return of customer-owned Silzone(R) inventory. In the second quarter of 2002, the Company determined that the Silzone(R) reserves should be increased by $11 million as a result of difficulties in obtaining certain reimbursements from the Company's insurance carriers under its product liability insurance policies ($4.6 million), an increase in management's estimate of the costs associated with future patient monitoring costs as a result of extending the time period in which it planned to perform patient monitoring activities ($5.8 million) and an increase in other related costs ($0.6 million). This additional accrual was included in selling, general and administrative expense during the second quarter ended June 30, 2002. The Company's product liability insurance coverage for Silzone(R) claims consists of a number of policies with different carriers. During 2002, Company management observed a trend where various insurance companies were not reimbursing the Company or outside legal counsel for a variety of costs incurred, which the Company believed should be paid under the product liability insurance policies. These insurance companies were either refusing to pay the claims or had delayed providing an explanation for non-payment for an extended period of time. Although the Company believes it has legal recourse from these insurance carriers for the costs they are refusing to pay, the additional costs the Company would need to incur to resolve these disputes may exceed the amount the Company would recover. As a result of these developments, the Company increased the Silzone(R) reserves by $4.6 million in the second quarter of 2002, which represents the existing disputed costs already incurred at that time plus the anticipated future costs where the Company expects similar resistance from the insurance companies on reimbursement. During the fourth quarter of 2003, the Company reclassified $15.7 million of existing accruals to the Silzone(R) special charge accrual from other current assets. This amount related to probable future legal costs associated with the Silzone(R) litigation. Previously, these accruals were offset against a receivable from the Company's insurance carriers. A summary of the legal and monitoring costs and customer returns and related costs activity is as follows (in thousands): 47
LEGAL AND CUSTOMER MONITORING RETURNS AND COSTS RELATED COSTS TOTAL ========================================================================================================= Initial expense and accrual in 2000 $ 14,397 $ 2,239 $ 16,636 Cash payments (5,955) (2,239) (8,194) - --------------------------------------------------------------------------------------------------------- Balance at December 31, 2000 8,442 - 8,442 Cash payments (3,042) - (3,042) - --------------------------------------------------------------------------------------------------------- Balance at December 31, 2001 5,400 - 5,400 Additional expense 10,433 567 11,000 Cash payments (2,442) (59) (2,501) - --------------------------------------------------------------------------------------------------------- Balance at December 31, 2002 13,391 508 13,899 Cash payments (1,206) (22) (1,228) Reclassification of legal accruals 15,721 - 15,721 - --------------------------------------------------------------------------------------------------------- Balance at December 31, 2003 $ 27,906 $ 486 $ 28,392 - ---------------------------------------------------------------------------------------------------------
In addition to the amounts available under the above Silzone(R) reserves, the Company has approximately $170 million remaining in product liability insurance currently available for the Silzone(R)-related matters. The Company's remaining product liability insurance for Silzone(R) claims consists of a number of layers, each of which is covered by one or more insurance companies. The next layer of insurance, which is a $30 million layer that would be reached after the present $35 million layer is exhausted, is covered by Lumberman's Mutual Casualty Insurance, a unit of the Kemper Insurance Companies (collectively referred to as Kemper). Kemper's credit rating by A.M. Best has been downgraded to a "D" (poor). Kemper is currently in "run off," which means that it is not issuing new policies and is, therefore, not generating any new revenue that could be used to cover claims made under previously-issued policies. In the event Silzone(R) claims were to reach the Kemper layer and Kemper was unable to pay part or all of such claims, the Company believes the other insurance carriers in its program will take the position that the Company will be directly liable for any claims and costs that Kemper is unable to pay, and that insurance carriers at policy layers following Kemper's layer will not provide coverage for Kemper's layer. Kemper also provides part of the coverage for Silzone(R) claims in the Company's final layer of insurance ($20 million of the final $50 million layer). It is possible that Silzone(R) costs and expenses will reach the Kemper layers of insurance coverage, and it is possible that Kemper will be unable to meet its obligations to the Company. If this were to happen, the Company could incur a loss of up to $50 million. The Company has not accrued for any such losses. NOTE 8--OTHER INCOME (EXPENSE) Other income (expense) consists of the following (in thousands): 2003 2002 2001 ================================================================================ Interest income $ 7,031 $ 5,481 $ 3,261 Interest expense (3,746) (1,754) (12,567) Other (593) (324) 1,468 - -------------------------------------------------------------------------------- Other income (expense) $ 2,692 $ 3,403 $ (7,838) ================================================================================ 48 NOTE 9--INCOME TAXES The Company's earnings before income taxes were generated from its U.S. and international operations as follows (in thousands): 2003 2002 2001 ================================================================================ U.S. $285,214 $270,595 $83,128 International 173,423 102,763 144,850 - -------------------------------------------------------------------------------- Earnings before income taxes $458,637 $373,358 $227,978 ================================================================================ Income tax expense consists of the following (in thousands): 2003 2002 2001 ================================================================================ Current: U.S. federal $56,669 $48,459 $48,844 U.S. state and other 4,285 4,732 4,994 International 25,146 6,187 13,229 - -------------------------------------------------------------------------------- Total current 86,100 59,378 67,067 Deferred 33,146 37,695 (11,681) - -------------------------------------------------------------------------------- Income tax expense $119,246 $97,073 $55,386 ================================================================================ The tax effects of the cumulative temporary differences between the tax bases of assets and liabilities and their carrying amounts for financial statement purposes are as follows (in thousands): 2003 2002 ================================================================================ Deferred income tax assets: Net operating loss carryforwards $ 3,088 $ 12,732 Tax credit carryforwards 20,272 30,554 Inventories 53,395 34,403 Intangible assets - 3,552 Accrued liabilities and other 16,801 11,569 - -------------------------------------------------------------------------------- Deferred income tax assets 93,556 92,810 - -------------------------------------------------------------------------------- Deferred income tax liabilities: Unrealized gain on available-for-sale securities (6,782) (2,599) Property, plant and equipment (30,955) (21,085) Intangible assets (33,162) - - -------------------------------------------------------------------------------- Deferred income tax liabilities (70,899) (23,684) - -------------------------------------------------------------------------------- Net deferred income tax asset $ 22,657 $ 69,126 - -------------------------------------------------------------------------------- The increase in the Company's current deferred income taxes during 2003 was due primarily to an increase in the book to tax differences related to profits on intercompany sales of inventory and to various differences related to the acquisition of Getz Japan. The change in the Company's long-term deferred income tax asset/liability during 2003 was due primarily to the utilization of net operating losses and tax credits, the acquisition of Getz Japan, and increases in the book to tax differences related to depreciation of fixed assets and amortization of goodwill and other intangible assets. The 49 Company has not recorded any valuation allowance for its deferred tax assets as of December 31, 2003 or 2002. A reconciliation of the U.S. federal statutory income tax rate to the Company's effective income tax rate is as follows (in thousands):
2003 2002 2001 ======================================================================================================== Income tax expense at the U.S. federal statutory rate of 35% $ 160,523 $ 130,675 $79,792 U.S. state income taxes, net of federal tax benefit 12,533 8,378 3,654 International taxes at lower rates (39,032) (29,972) (20,089) Tax benefits from extraterritorial income exclusion (7,173) (3,675) (3,681) Research and development credits (11,013) (9,467) (5,984) Non-deductible purchased in-process research and development charges - - 3,912 Other 3,408 1,134 (2,218) - -------------------------------------------------------------------------------------------------------- Income tax expense $ 119,246 $97,073 $55,386 ======================================================================================================== Effective income tax rate 26.0% 26.0% 24.3% - --------------------------------------------------------------------------------------------------------
At December 31, 2003, the Company has $8.8 million of U.S. federal net operating loss carryforwards and $6.6 million of U.S. tax credit carryforwards that will expire from 2004 through 2019 if not utilized. The Company also has state tax credit carryforwards of $13.7 million that have an unlimited carryforward period. These amounts are subject to annual usage limitations. The Company's net operating loss carryforwards arose primarily from acquisitions. The Company has not recorded U.S. deferred income taxes on $547 million of its non-U.S. subsidiaries' undistributed earnings, because such amounts are intended to be reinvested outside the United States indefinitely. NOTE 10--RETIREMENT PLANS DEFINED CONTRIBUTION PLANS: The Company has a 401(k) profit sharing plan that provides retirement benefits to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations, with the Company matching a portion of the employees' contributions. The Company also contributes a portion of its earnings to the plan based upon Company performance. The Company's matching and profit sharing contributions are at the discretion of the Company's Board of Directors. In addition, the Company has defined contribution programs for employees in certain countries outside the United States. Company contributions under all defined contribution plans totaled $24.0 million, $18.8 million and $16.2 million in 2003, 2002 and 2001, respectively. DEFINED BENEFIT PLANS: The Company has funded and unfunded defined benefit plans for employees in certain countries outside the United States. The Company had an accrued liability totaling $16.0 million and $10.7 million at December 31, 2003 and 2002, respectively, which approximated the actuarially calculated unfunded liability. The related pension expense was not material. 50 NOTE 11--SEGMENT AND GEOGRAPHIC INFORMATION SEGMENT INFORMATION: The Company develops, manufactures and distributes cardiovascular medical devices for the global cardiac rhythm management (CRM), cardiac surgery (CS) and cardiology and vascular access (C/VA) therapy areas. The Company has three operating segments, Cardiac Rhythm Management (CRM), Cardiac Surgery (CS) and Daig, which focus on the development and manufacture of products for the three therapy areas. The primary products produced by each segment are: CRM - pacemaker and ICD systems; CS - mechanical and tissue heart valves; Daig - electrophysiology catheters, vascular closure devices and other cardiology and vascular access products. The Company has aggregated the CRM and CS segments into one reportable segment based primarily upon their similar operational and economic characteristics. The Company's reportable segments include end customer revenues from the sale of products they each develop and manufacture. The costs included in each of the reportable segments' operating results include the direct costs of the products sold to end customers and operating expenses managed by each of the segments. Certain costs of goods sold and operating expenses managed by the Company's selling and corporate functions are not included in segment operating profit. Consequently, segment operating profit presented below is not representative of the operating profit of the Company's products in these segments. The following table presents certain financial information about the Company's reportable segments (in thousands): 51
CRM/CS DAIG OTHER TOTAL ==================================================================================================================================== FISCAL YEAR ENDED DECEMBER 31, 2003 Net sales $ 1,499,425 $ 366,433 $ 66,656 $ 1,932,514 Operating profit (a) 873,904 202,007 (619,966) 455,945 Depreciation and amortization expense 29,836 8,307 38,540 76,683 Total assets (b)(c) 639,724 147,270 1,769,100 2,556,094 - ------------------------------------------------------------------------------------------------------------------------------------ FISCAL YEAR ENDED DECEMBER 31, 2002 Net sales $ 1,305,750 $ 284,179 $ - $ 1,589,929 Operating profit (a) 713,341 149,592 (492,978) 369,955 Depreciation and amortization expense 33,819 7,158 33,943 74,920 Total assets (b)(c) 723,414 134,610 1,093,355 1,951,379 - ------------------------------------------------------------------------------------------------------------------------------------ FISCAL YEAR ENDED DECEMBER 31, 2001 (D) Net sales $ 1,135,833 $ 211,523 $ - $ 1,347,356 Operating profit (a) 583,030 105,947 (453,161) 235,816 ====================================================================================================================================
(a) OTHER OPERATING PROFIT INCLUDES CERTAIN COSTS OF GOODS SOLD AND OPERATING EXPENSES MANAGED BY THE COMPANY'S SELLING AND CORPORATE FUNCTIONS. IN FISCAL YEAR 2001, OTHER ALSO INCLUDES SPECIAL CHARGES AND PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT CHARGES. (b) OTHER TOTAL ASSETS INCLUDE THE ASSETS MANAGED BY THE COMPANY'S SELLING AND CORPORATE FUNCTIONS, INCLUDING END CUSTOMER RECEIVABLES, INVENTORY, CORPORATE CASH AND EQUIVALENTS AND DEFERRED INCOME TAXES. (c) THE COMPANY DOES NOT COMPILE EXPENDITURES FOR LONG-LIVED ASSETS BY SEGMENT AND, THEREFORE, HAS NOT INCLUDED THIS INFORMATION AS IT IS IMPRACTICABLE TO DO SO. (d) DURING 2001, THE COMPANY COMPLETED A REORGANIZATION OF ITS GLOBAL SALES ACTIVITIES, WHICH RESULTED IN CHANGES TO ITS INTERNAL MANAGEMENT AND FINANCIAL REPORTING STRUCTURE. DUE TO THIS RESTRUCTURING, INFORMATION RELATING TO DEPRECIATION AND AMORTIZATION, TOTAL ASSETS AND EXPENDITURES FOR LONG-LIVED ASSETS FOR FISCAL YEAR 2001 BY CURRENT REPORTING SEGMENTS HAS NOT BEEN COMPILED AS IT IS IMPRACTICABLE TO DO SO. Net sales by class of similar products were as follows (in thousands):
NET SALES 2003 2002 2001 ================================================================================================ Cardiac rhythm management $ 1,365,212 $ 1,147,489 $ 965,968 Cardiac surgery 270,933 250,957 248,045 Cardiology and vascular access 296,369 191,483 133,343 - ------------------------------------------------------------------------------------------------ $ 1,932,514 $ 1,589,929 $ 1,347,356 ================================================================================================
52 GEOGRAPHIC INFORMATION: The following tables present certain geographical financial information (in thousands):
NET SALES (a) 2003 2002 2001 ================================================================================================ United States $ 1,129,055 $ 1,042,766 $ 880,086 International Europe 465,369 347,936 294,852 Japan 207,431 95,813 83,361 Other (b) 130,659 103,414 89,057 - ------------------------------------------------------------------------------------------------ 803,459 547,163 467,270 - ------------------------------------------------------------------------------------------------ $ 1,932,514 $ 1,589,929 $ 1,347,356 ================================================================================================ LONG-LIVED ASSETS (b) 2003 2002 2001 ================================================================================================ United States $ 744,445 $ 674,119 $ 626,140 International Europe 96,520 88,194 76,542 Japan 152,772 267 46 Other 70,020 62,213 61,215 - ------------------------------------------------------------------------------------------------ 319,312 150,674 137,803 - ------------------------------------------------------------------------------------------------ $ 1,063,757 $ 824,793 $ 763,943 ================================================================================================
(a) NET SALES ARE ATTRIBUTED TO GEOGRAPHIES BASED ON LOCATION OF THE CUSTOMER. (b) NO ONE GE0GRAPHIC MARKET IS GREATER THAN 2% OF CONSOLIDATED NET SALES. (c) LONG-LIVED ASSETS EXCLUDE DEFERRED INCOME TAXES. 53 NOTE 12--QUARTERLY FINANCIAL DATA (UNAUDITED) Quarterly financial data for 2003 and 2002 is as follows (in thousands, except per share amounts):
QUARTER FIRST SECOND THIRD FOURTH ============================================================================================ FISCAL YEAR ENDED DECEMBER 31, 2003: Net sales $441,384 $495,093 $477,454 $518,583 Gross profit 301,920 333,793 330,741 362,969 Net earnings 79,987 81,932 84,621 92,851 Basic net earnings per share 0.45 0.45 0.48 0.54 Diluted net earnings per share $ 0.43 $ 0.43 $ 0.46 $ 0.51 FISCAL YEAR ENDED DECEMBER 31, 2002: Net sales $371,193 $404,348 $404,857 $409,531 Gross profit 252,405 275,386 276,476 279,716 Net earnings 62,076 69,555 (a) 71,680 72,974 Basic net earnings per share 0.35 0.39 0.40 0.41 Diluted net earnings per share $ 0.34 $ 0.38 $ 0.39 $ 0.40 ============================================================================================
(a) INCLUDES A CASH RECEIPT OF $18.5 MILLION RELATING TO THE SETTLEMENT OF CERTAIN PATENT LITIGATION, WHICH WAS RECORDED AS A REDUCTION OF SG&A EXPENSE. ALSO, THE COMPANY RECORDED IN SG&A AN $11 MILLION CHARGE TO INCREASE THE RESERVE FOR EXPENSES RELATED TO THE SILZONE(R)RECALL AND A $7.5 MILLION DISCRETIONARY CONTRIBUTION TO THE COMPANY'S CHARITABLE FOUNDATION, THE ST. JUDE MEDICAL FOUNDATION. 54 FIVE-YEAR SUMMARY FINANCIAL DATA (In thousands, except per share amounts)
2003 2002 (a) 2001 (b) 2000 (c) 1999 (d) =============================================================================================================================== SUMMARY OF OPERATIONS FOR THE FISCAL YEAR: Net sales $1,932,514 $1,589,929 $1,347,356 $1,178,806 $1,114,549 Gross profit $1,329,423 $1,083,983 $ 888,197 $ 787,657 $ 733,647 Percent of net sales 68.8% 68.2% 65.9% 66.8% 65.8% Operating profit $ 455,945 $ 369,955 $ 235,816 $ 202,359 $ 89,188 Percent of net sales 23.6% 23.3% 17.5% 17.2% 8.0% Net earnings $ 339,391 $ 276,285 $ 172,592 $ 129,094 $ 24,227 Percent of net sales 17.6% 17.4% 12.8% 11.0% 2.2% Diluted net earnings per share $ 1.83 $ 1.51 $ 0.97 $ 0.75 $ 0.14 - ------------------------------------------------------------------------------------------------------------------------------- FINANCIAL POSITION AT YEAR END: Cash and equivalents $ 461,253 $ 401,860 $ 148,335 $ 50,439 $ 9,655 Working capital (e) 982,022 739,665 475,692 388,322 389,768 Total assets 2,556,094 1,951,379 1,628,727 1,532,716 1,554,038 Long-term debt 351,813 - 123,128 294,500 477,495 Shareholders' equity $1,604,247 $1,576,727 $1,183,745 $ 940,849 $ 794,021 - ------------------------------------------------------------------------------------------------------------------------------- OTHER DATA: Diluted weighted average shares outstanding 185,377 183,002 178,767 171,634 169,470 ===============================================================================================================================
FISCAL YEAR 2003 CONSISTED OF 53 WEEKS. ALL OTHER FISCAL YEARS NOTED ABOVE CONSISTED OF 52 WEEKS. THE COMPANY DID NOT DECLARE OR PAY ANY CASH DIVIDENDS DURING 1999 THROUGH 2003. (a) RESULTS FOR 2002 INCLUDE A CASH RECEIPT OF $18.5 MILLION RELATING TO THE SETTLEMENT OF CERTAIN PATENT LITIGATION, WHICH WAS RECORDED AS A REDUCTION OF SG&A EXPENSE. ALSO, THE COMPANY RECORDED IN SG&A AN $11 MILLION CHARGE TO INCREASE THE RESERVE FOR EXPENSES RELATED TO THE SILZONE(R) RECALL AND A $7.5 MILLION DISCRETIONARY CONTRIBUTION TO THE COMPANY'S CHARITABLE FOUNDATION, THE ST. JUDE MEDICAL FOUNDATION. (b) RESULTS FOR 2001 INCLUDE A $32.8 MILLION SPECIAL CHARGE AND PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT CHARGES OF $10 MILLION. THE IMPACT OF THESE ITEMS ON 2001 NET EARNINGS WAS $30.5 MILLION, OR $0.17 PER DILUTED SHARE. (c) RESULTS FOR 2000 INCLUDE A $26.1 MILLION SPECIAL CHARGE AND A PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT CHARGE OF $5 MILLION. THE IMPACT OF THESE ITEMS ON 2000 NET EARNINGS WAS $27.2 MILLION, OR $0.16 PER DILUTED SHARE. (d) RESULTS FOR 1999 INCLUDE A $9.8 MILLION SPECIAL CHARGE AND PURCHASED IN-PROCESS RESEARCH AND DEVELOPMENT CHARGES TOTALING $115.2 MILLION. THE IMPACT OF THESE ITEMS ON 1999 NET EARNINGS WAS $119.8 MILLION, OR $0.71 PER DILUTED SHARE. (e) TOTAL CURRENT ASSETS LESS TOTAL CURRENT LIABILITIES. 55 INVESTOR INFORMATION TRANSFER AGENT Requests concerning the transfer or exchange of shares, lost stock certificates, duplicate mailings, or change of address should be directed to the Company's Transfer Agent at: EquiServe Trust Company, N.A. P.O. Box 43023 Providence, Rhode Island 02940-3023 1.877.498.8861 www.equiserve.com (Account Access Availability) Hearing impaired #TDD: 1.800.952.9245 ANNUAL MEETING OF SHAREHOLDERS The annual meeting of shareholders will be held at 9:30 a.m. on Wednesday, May 12, 2004, at the Minnesota Historical Center, 345 Kellogg Boulevard West, St. Paul, Minnesota, 55102. Parking is available. INVESTOR CONTACT Laura C. Merriam, Director, Investor Relations To obtain information about the Company call 1.800.552.7664, visit our Web site at www.sjm.com, or write to: Investor Relations St. Jude Medical, Inc. One Lillehei Plaza St. Paul, Minnesota 55117-9983 The Investor Relations (IR) section on St. Jude Medical's Web site includes all SEC filings, a list of analyst coverage, and a calendar of upcoming earnings announcements and IR events. St. Jude Medical's Newsroom features news releases, company background information, fact sheets, executive bios, a product photo portfolio, and other media resources. Patient profiles can be found on our Web site, including the patients featured in this year's annual report. CORPORATE GOVERNANCE (SEE COMPANY INFORMATION ON WEB SITE- WWW.SJM.COM) o Corporate Governance Charter o Code of Business Conduct o SEC Filings COMPANY STOCK SPLITS 2:1 on 4/27/79, 1/25/80, 9/30/86, 3/15/89, 4/30/90 and 6/10/02; 3:2 on 11/16/95 STOCK EXCHANGE LISTINGS New York Stock Exchange Symbol: STJ The range of high and low prices per share for the Company's common stock for fiscal 2003 and 2002 is set forth below. As of February 17, 2004, the Company had 3,234 shareholders of record. Fiscal Year Ended December 31 2003 2002 ======================================================================== Quarter High Low High Low ======================================================================== First $49.48 $38.76 $40.80 $35.75 Second $63.60 $47.50 $43.13 $36.20 Third $59.10 $48.10 $41.00 $30.52 Fourth $64.00 $52.49 $40.35 $31.16 TRADEMARKS Aescula(TM), AF Suppression(TM), Alliance(TM), Angio-Seal(TM), Apeel(TM), Atlas(R), AutoCapture(TM), BEAT-BY-BEAT(TM), BiLinx(TM), Epic(TM), Fast Cath(TM), Fast Cath Duo(TM), FaSt Path(TM), FlexCuff(TM), Frontier(TM), GuideRight(TM), Housecall Plus(TM), HydraSteer(TM), Identity(R), Integrity(R), IsoFlex(R), Linx(TM), LIvewire(TM), Livewire Cannulator(TM), Livewire Spiral HP(TM), Livewire TC(TM), Microny(R), Maximum(TM), NaviFlex(TM), Pacel(TM), Passive PLus(R), Photon(R), QuickSite(TM), Reflexion(TM), Reflexion Cannulator(TM), Response(TM), Riata(R), Seal-Away(TM), SJM(R), SJM Biocor(TM), SJM Epic(TM), SJM Regent(TM), SJM Tailor(TM), Spyglass(TM), St. Jude Medical(R), Supreme(TM), Symmetry(TM), Telesheath(TM), Tendril(R), Toronto Root(TM), Toronto SPV(R), TVL(R), Ultimum(TM), Verity(TM), Victory(TM). (C)2004 ST. JUDE MEDICAL, INC. 56
EX-21 6 stjude041330_ex21.txt EXHIBIT 21 ST. JUDE MEDICAL, INC. SUBSIDIARIES OF THE REGISTRANT St. Jude Medical, Inc. Wholly Owned Subsidiaries: - ------------------------------------------------- o Pacesetter, Inc. - Sylmar, California, Scottsdale, Arizona, and Maven, South Carolina (Delaware corporation) (doing business as St. Jude Medical Cardiac Rhythm Management Division) o St. Jude Medical S.C., Inc. - St. Paul, Minnesota (Minnesota corporation) - Bio-Med Sales, Inc. (Pennsylvania corporation) - HeartBeat Medical, Inc. (Utah corporation) o St. Jude Medical Europe, Inc. - St. Paul, Minnesota (Delaware corporation) - Brussels, Belgium branch o St. Jude Medical Canada, Inc. - Mississauga, Ontario and St. Hyacinthe, Quebec (Ontario, Canada corporation) o St. Jude Medical (Shanghai) Ltd. - Shanghai, China (Chinese corporation) o St. Jude Medical (Hong Kong) Limited - Kowloon, Hong Kong (Hong Kong corporation) - Shanghai and Beijing, China representative offices - Korean and Taiwan branch offices - Mumbai, New Delhi, Calcutta and Chennai, India branch offices - Singapore representative office o St. Jude Medical, Inc., Cardiac Assist Division - St. Paul, Minnesota (Delaware corporation) (Assets of St. Jude Medical, Inc., Cardiac Assist Division sold to Bard 1/19/96) o St. Jude Medical Australia Pty., Ltd. - Sydney Australia (Australian corporation) o St. Jude Medical Brasil, Ltda. - Sao Paulo and Belo Horizonte, Brazil (Brazilian corporation) o St. Jude Medical, Daig Division, Inc.- Minnetonka, Minnesota (Minnesota corporation) o St. Jude Medical Colombia, Ltda. - Bogota, Colombia (Colombian corporation) o St. Jude Medical ATG, Inc. - Maple Grove, Minnesota (Minnesota corporation) o SJM International, Inc. - St. Paul, Minnesota (Delaware corporation) - Tokyo, Japan branch SJM International, Inc. Wholly Owned Legal Entities (Directly and Indirectly): - ------------------------------------------------------------------------------ o St. Jude Medical Puerto Rico, Inc. - Caguas, Puerto Rico (Delaware corporation) - St. Jude Medical Delaware Holding LLC (Delware corporation) (wholly owned subsidiary of St.Jude Medical Puerto Rico, Inc.) o St. Jude Medical Holland Finance C.V. (Netherlands limited partnership) (ownership of St. Jude Medical Holland Finance C.V. is shared by SJM International, Inc., St. Jude Medical Delaware Holding LLC, and the general partner, St. Jude Medical Puerto Rico, Inc.) - St. Jude Medical Investments B.V. (Netherlands corporation headquartered in Luxembourg) (wholly owned subsidiary of St. Jude Medical Holland Finance C.V.) - St. Jude Medical Nederland B.V. (Netherlands corporation) (wholly owned subsidiary of St. Jude Medical Investments B.V.) - Telectronics B.V. (Netherlands corporation) (wholly owned subsidiary of St. Jude Medical Nederland B.V.) - St. Jude Medical Enterprise AB (Swedish corporation headquartered in Luxembourg) (wholly owned subsidiary of St. Jude Medical Investments B.V.) - St. Jude Medical Puerto Rico B.V. (Netherlands corporation) (wholly owned subsidiary of St. Jude Medical Enterprise AB) - Puerto Rico branch of St. Jude Medical Puerto Rico B.V. - St. Jude Medical Coordination Center (Belgium branch of St. Jude Medical Enterprise AB) - St. Jude Medical AB (Swedish corporation) (wholly owned subsidiary of St. Jude Medical Enterprise AB) - St. Jude Medical Holdings B.V. (Netherlands corporation) (wholly owned subsidiary of St. Jude Medical Investments B.V.) - Getz Bros. Co. Ltd. (Japanese corporation) (wholly owned subsidiary of St. Jude Medical Holdings B.V.) o St. Jude Medical Sweden AB (Swedish corporation) o St. Jude Medical Danmark A/S (Danish corporation) o St. Jude Medical (Portugal) - Distribuicao de Produtos Medicos, Lda. (Portuguese corporation) o St. Jude Medical Export Ges.m.b.H. (Austrian corporation) o St. Jude Medical Medizintechnik Ges.m.b.H. (Austrian corporation) o St. Jude Medical Italia S.p.A. (Italian corporation) o N.V. St. Jude Medical Belgium, S.A. (Belgian corporation) o St. Jude Medical Espana, S.A. (Spanish corporation) o St. Jude Medical France S.A. (French corporation) o St. Jude Medical Finland O/y (Finnish corporation) o St. Jude Medical Sp.zo.o. (Polish corporation) o St. Jude Medical GmbH (German corporation) o St. Jude Medical Kft (Hungarian corporation) o St. Jude Medical UK Limited (United Kingdom corporation) o St. Jude Medical AG (Swiss corporation) EX-23 7 stjude041330_ex23.txt EXHIBIT 23 CONSENT OF INDEPENDENT AUDITORS We consent to the incorporation by reference in this Annual Report on Form 10-K of St. Jude Medical, Inc. of our report dated January 26, 2004, included in the 2003 Annual Report to Shareholders of St. Jude Medical, Inc. Our audits also included the financial statement schedule of St. Jude Medical, Inc. listed in Item 15(a) of this Annual Report on Form 10-K. This schedule is the responsibility of the Company's management. Our responsibility is to express an opinion based on our audits. In our opinion, the financial statement schedule referred to above, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the information set forth therein. We also consent to the incorporation by reference in Registration Statement No. 33-9262, Registration Statement No. 33-41459, Registration Statement No. 33-48502, Registration Statement No. 33-54435, Registration Statement No. 333-42945, Registration Statement No. 333-42658, Registration Statement No. 333-42668 and Registration Statement No. 333-96697 on Form S-8 of our report dated January 26, 2004, with respect to the consolidated financial statements incorporated herein by reference, and our report in the preceding paragraph with respect to the financial statement schedule included in this Annual Report on Form 10-K of St. Jude Medical, Inc. /s/ ERNST & YOUNG LLP Minneapolis, Minnesota March 12, 2004 EX-24 8 stjude041330_ex24.txt EXHIBIT 24 POWER OF ATTORNEY KNOW ALL BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Terry L. Shepherd, John C. Heinmiller and Kevin T. O'Malley, each with full power to act without the other, his or her true and lawful attorney-in-fact and agent with full power of substitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign the Annual Report on Form 10-K of St. Jude Medical, Inc. for the fiscal year ended December 31, 2003, and any or all amendments to said Annual Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, and to file the same with such other authorities as necessary, granting unto each such attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that each such attorney-in-fact and agent, or his substitute, may lawfully do or cause to be done by virtue hereof. IN WITNESS WHEREOF, this Power of Attorney has been signed on this 23rd day of February, 2004, by the following persons. /s/ TERRY L. SHEPHERD /s/ DANIEL J. STARKS - ------------------------------------- ------------------------------------- Terry L. Shepherd Daniel J. Starks Chairman and Chief Executive Officer Director (Principal Executive Officer) /s/ JOHN C. HEINMILLER /s/ DAVID A. THOMPSON - ------------------------------------- ------------------------------------- John C. Heinmiller David A. Thompson Vice President, Finance and Director Chief Financial Officer (Principal Financial and Accounting Officer) /s/ RICHARD R. DEVENUTI /s/ STEFAN K. WIDENSOHLER - ------------------------------------- ------------------------------------- Richard R. Devenuti Stefan K. Widensohler Director Director /s/ STUART M. ESSIG /s/ WENDY L. YARNO - ------------------------------------- ------------------------------------- Stuart M. Essig Wendy L. Yarno Director Director /s/ THOMAS H. GARRETT III /s/ FRANK C-P YIN - ------------------------------------- ------------------------------------- Thomas H. Garrett III Frank C-P Yin Director Director IN WITNESS WHEREOF, this Power of Attorney has been signed on this 12th day of March, 2004, by the following persons. /s/ Michael A. Rocca - -------------------- Michael A. Rocca Director EX-31.1 9 stjude041330_ex31-1.txt EXHIBIT 31.1 CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, Terry L. Shepherd, certify that: 1. I have reviewed this annual report on Form 10-K of St. Jude Medical, Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and c) Disclosed in this report any change in the registrant's internal controls over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal controls over financial reporting; and 5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal controls over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls over financial reporting. Date: March 12, 2004 -------------- /s/ TERRY L. SHEPHERD - ------------------------------------ Terry L. Shepherd Chairman and Chief Executive Officer EX-31.2 10 stjude041330_ex31-2.txt EXHIBIT 31.2 CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002 I, John C. Heinmiller, certify that: 1. I have reviewed this annual report on Form 10-K of St. Jude Medical, Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and c) Disclosed in this report any change in the registrant's internal controls over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal controls over financial reporting; and 5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal controls over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls over financial reporting. Date: March 12, 2004 -------------- /s/ JOHN C. HEINMILLER - ------------------------------------ John C. Heinmiller Chief Financial Officer EX-32.1 11 stjude041330_ex32-1.txt EXHIBIT 32.1 CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of St. Jude Medical, Inc. (the "Company") on Form 10-K for the period ended December 31, 2003 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, Terry L. Shepherd, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. ss.1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: 1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and 2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. /s/ TERRY L. SHEPHERD ------------------------------------ Terry L. Shepherd Chairman and Chief Executive Officer March 12, 2004 EX-32.2 12 stjude041330_ex32-2.txt EXHIBIT 32.2 CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of St. Jude Medical, Inc. (the "Company") on Form 10-K for the period ended December 31, 2003 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, John C. Heinmiller, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. ss.1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: 1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and 2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. /s/ JOHN C. HEINMILLER ------------------------------------- John C. Heinmiller Vice President - Finance and Chief Financial Officer March 12, 2004
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